European Union Aviation Safety Agency
Notice of Proposed Amendment 2019-05 (A)
Embodiment of safety management system (SMS) requirements into
Part-145 and Part 21
RMT.0251 PHASE II
EXECUTIVE SUMMARY
With reference to Rulemaking Task (RMT).0251 Phase II in EPAS 2019-2023, this Notice of Proposed Amendment
(NPA) proposes amendments to Annex I (Part 21) to Regulation (EU) No 748/2012 and Annex II (Part-145) to
Regulation (EU) No 1321/2014, in order to:
— introduce safety management principles that implement ICAO Annex 19; and
— foster an organisational culture for effective safety management and effective occurrence reporting in
accordance with Commission Regulation (EU) No 376/2014.
Note 1: Phase I of RMT.0251 was limited to the introduction of safety management requirements into Part-
CAMO (see Opinion No 06/2016).
Note 2: The review of the occurrence reporting system was governed by RMT.0681, but certain additional
changes are proposed through this RMT, in light of the principles of ICAO Annex 19, Chapter 5.
This NPA proposes to consider the applicability of safety management systems (SMSs) to Part-145 approved
maintenance organisations, as well as to production and design organisations that are approved in accordance
with Subparts G and J of Part 21.
By doing so, safety will be enhanced through:
— the establishment of safety policies and objectives that are associated with sufficient resources;
— the systematic identification of hazards, and a risk management system;
— the safety assurance system, including giving consideration to safety performance; and
— safety promotion.
This RMT also aims to streamline the procedures for oversight, and introduce a set of new, common
management system requirements for competent authorities to increase their efficiency.
NPA 2019-05 is divided into three parts. The present NPA 2019-05 (A) includes:
— the procedural information pertaining to the regulatory proposal;
— the explanatory note to the proposed amendments;
— the regulatory impact assessment; and
— a detailed summary of the proposed amendments (see Chapter 7 ‘Appendices’).
The draft implementing rules (IRs) as well as the draft Acceptable Means of Compliance (AMC) and Guidance
Material (GM) for Part 21 are proposed in NPA 2019-05 (B), whereas those for Part-145 are proposed in
NPA 2019-05 (C).
Action area: Systemic enablers to safety — safety management
Affected rules: Part-145 and Part 21
Affected stakeholders: AMOs (Part-145); POA holders; DOA holders; ETSOA holders; competent authorities
Driver: Safety Rulemaking group: No (but Focused Consultation Group)
Impact assessment: Full Rulemaking Procedure: Standard
12.7.2017 17.4.2019 2020/Q1 2020/Q3 2020/Q3
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Table of contents
Table of contents
1. About this NPA...................................................................................................................... 3
1.1. How this NPA was developed .................................................................................................... 3
1.2. How to comment on this NPA ................................................................................................... 4
1.3. The next steps............................................................................................................................ 4
2. In summary — why and what ................................................................................................ 5
2.1. Why we need to change the rules — issue/rationale ............................................................... 5
2.2. What we want to achieve — objectives .................................................................................... 5
2.3. How we want to achieve it — overview of the proposals......................................................... 6
2.3.1. Summary of changes to Part-145 ...................................................................................... 6
2.3.2. Summary of changes to Part 21 ........................................................................................ 7
2.3.3. Specific commonalities and differences between Part-145 and Part 21 .......................... 8
2.4. What are the expected benefits and drawbacks of the proposals ........................................... 9
3. Proposed amendments and rationale .................................................................................. 11
3.1. Draft regulation (Draft EASA opinion) for Part 21 ................................................................... 11
3.2. Draft AMC & GM (Draft EASA decision) for Part 21 ................................................................ 11
3.3. Draft regulation (Draft EASA opinion) for Part-145................................................................. 11
3.4. Draft AMC and GM (Draft EASA decision) for Part-145 .......................................................... 11
4. Impact assessment (IA)........................................................................................................ 12
4.1. What is the issue ..................................................................................................................... 12
4.1.1. Introduction .................................................................................................................... 12
4.1.2. Evidence gathering — EASA questionnaire..................................................................... 13
4.1.3. Safety risk assessment .................................................................................................... 13
4.1.4. Who is affected? ............................................................................................................. 14
4.2. What we want to achieve — objectives .................................................................................. 14
4.3. How it could be achieved — background and options............................................................ 14
4.4. What are the impacts .............................................................................................................. 17
4.4.1. Introduction to the impact analysis ................................................................................ 17
4.4.2. Relevant elements from the EASA questionnaire ........................................................... 18
4.4.3. Safety impact................................................................................................................... 19
4.4.4. Environmental impact ..................................................................................................... 20
4.4.5. Social impact ................................................................................................................... 20
4.4.6. Economic impact ............................................................................................................. 21
4.4.7. Proportionality impact .................................................................................................... 23
4.5. Conclusion ............................................................................................................................... 24
4.6. Monitoring and evaluation ...................................................................................................... 27
5. Proposed actions to support implementation ...................................................................... 29
6. References .......................................................................................................................... 31
6.1. Affected regulations ................................................................................................................ 31
6.2. Affected decisions ................................................................................................................... 31
6.3. Other reference documents .................................................................................................... 31
7. Appendices ......................................................................................................................... 33
7.1. Appendix I — Detailed summary of changes to Part 21.......................................................... 33
7.2. Appendix II — Detailed summary of changes for Part-145 ..................................................... 50
7.3. Appendix III — EASA questionnaire......................................................................................... 61
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1. About this NPA
1. About this NPA
1.1. How this NPA was developed
The European Union Aviation Safety Agency (EASA) developed this NPA in line with Regulation (EU)
2018/11391 (Basic Regulation) and the Rulemaking Procedure2. This rulemaking activity is included in
the European Plan for Aviation Safety (EPAS)3 under RMT.0251. The text of this NPA has been
developed by EASA based on the input from a focused consultation group (FCG). It is hereby submitted
to all interested parties4 for consultation.
RMT.0251 (old task number: MDM.055) was initiated in October 2010 as an ‘Agency task’; it was
originally intended to cover all airworthiness domains. Part-M (Annex I to Regulation (EU)
No 1321/20145) and Part-145 were covered by the issuing of NPA 2013-01(B) and NPA 2013-01(C)
respectively. For efficiency reasons, and due to the parallel RMT for a light Part-M (RMT.0547 in the
context of the GA roadmap), it was then decided to split the work into two phases:
— Phase I focused on the introduction of SMSs into Part-M, and its outcome was Opinion
No 06/2016 (Part-CAMO), in conjunction with the outcome of RMT.0547 — Opinion
No 05/2016 (Part-ML and Part-CAO);
— Phase II focuses on the introduction of SMSs into Part 21 ((Annex I to Regulation (EU)
No 748/20126) and Part-145 (Annex I to Regulation (EU) No 1321/2014), with a new
consultation based on the results of Phase I. Although no CRD was issued for the first NPA 2013-
01(C) on Part-145, the text proposed in this NPA takes into account the comments received on
that first NPA.
A new Terms of Reference (ToR) for Phase II document was published on 12 July 20177, which
established a FCG with competent authority and industry representatives, some of whom had already
taken part in Phase I.
1 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of
civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005,
(EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European
Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European
Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) (https://eur-
lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri= CELEX:32018R1139).
2 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139.
Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’.
See MB Decision No 18-2015 of 15 December 2015 replacing Decision 01/2012 concerning the procedure to be applied
by EASA for the issuing of opinions, certification specifications and guidance material (http://www.easa.europa.eu/the-
agency/management-board/decisions/easa-mb-decision-18-2015-rulemaking-procedure).
3 https://www.easa.europa.eu/document-library/general-publications?publication_type%5B%5D=2467
4 In accordance with Article 115 of Regulation (EU) 2018/1139 and Articles 6(3) and 7 of the Rulemaking Procedure.
5 Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of
aircraft and aeronautical products, parts and appliances, and on the approval of organisations
and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549461562202&uri=CELEX:32014R1321).
6 Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness
and environmental certification of aircraft and related products, parts and appliances, as well as for the
certification of design and production organisations (OJ L 224, 21.8.2012, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549462558558&uri=CELEX:32012R0748).
7 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-rmt0251b-mdm055-
mdm060
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1. About this NPA
Since the publication of Issue 1 of the ToR, ICAO has published the fourth edition of the Safety
Management Manual (ICAO Doc 9859), which is aligned with the second issue of ICAO Annex 19. The
proposed changes to the rules in this NPA benefit, to a certain extent, from the material in that newly
edited ICAO document.
On 20 August 2018, new Basic Regulation (Regulation (EU) 2018/1139), which repealed Regulation
(EC) No 216/2008, was published. In Part-145, all references were updated since this NPA proposes
changes to all points of the Regulation. For Part 21, only the points affected by SMS have been
modified to reference the new Basic Regulation. The remaining points that are not proposed in this
NPA to be amended still refer to Regulation (EC) No 216/2008. The update of the references to
Regulation (EU) 2018/1139 should not be considered as an assessment of the impact of that
Regulation to Part 21. This will be conducted through a dedicated rulemaking task (RMT.0727).
1.2. How to comment on this NPA
Please submit your comments using the automated Comment-Response Tool (CRT) available at
http://hub.easa.europa.eu/crt/8.
The deadline for submission of comments is 17 July 2019.
1.3. The next steps
Following the closing of the public commenting period, EASA will review all the comments with the
support of the FCG.
Based on the comments received, EASA will issue opinions containing the proposed amendments to
Regulations (EU) No 748/2012 and (EU) 1321/2014. Summaries of the comments received will be
provided in the opinions. The opinions will be submitted to the European Commission, which will use
them as a technical basis in order to take a decision on whether or not to amend the Regulations.
If the Commission decides that the Regulations should be amended, EASA will issue decisions that
amend the AMC & GM to comply with the amendments introduced into the Regulation.
The comments received on this NPA and the EASA responses to them will be reflected in
comment-response documents (CRDs). This CRD will be available on the EASA website and will be the
basis for the development of the Opinions and Decisions, which will be respectively proposed for
adoption by the European Commission and approved by EASA.
The opinions will include a proposal for transition measures for organisations and authorities to adapt
to the new requirements. The European Commission, along with the EU Member States, will validate
it. At this stage of the project, a transitional period of two years after the Regulations enter into force
is suggested.
8 In case of technical problems, please contact the CRT webmaster (
[email protected]).
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2. In summary — why and what
2. In summary — why and what
2.1. Why we need to change the rules — issue/rationale
Pursuing the objectives of the Basic Regulation regarding the development of EU rules, EASA shall
issue opinions addressed to the European Commission (proposing amendments to regulations) and
Decisions (issuing AMC & GM). When doing so, it shall consider International Civil Aviation
Organization (ICAO) Standards and Recommended Practices (SARPs) (see EASA Management Board
Decision No 18-2015, Article 6).
At the end of 2013, ICAO published the first Edition of the Safety Management Annex (here referred
to as ‘ICAO Annex 19’). Later in 2016, ICAO published the second edition of that document. According
to that document, the use of an SMS is foreseen in maintenance, design and production.
For design and production organisations, the existing legal EU framework already includes
organisational requirements that cover certain safety management aspects, but the safety
management SARPs9, which stem from ICAO Annex 19, are not consistently implemented. In
particular, Part 21 already imposes, in some cases, the necessity for an organisation to seek an
organisational approval (i.e. design organisation approval (DOA) and production organisation approval
(POA)) after demonstrating that they are able to ensure the safety of their product through the
compliance of the design with the technical specifications or the conformity of the production with
the design data. Some provisions required for such organisational approvals are similar to those
required for an SMS by ICAO Annex 19, as better explained later in this document.
For maintenance, a decision has already been taken on how to introduce SMS into Part-145 (see
Section 4.3 for further details).
No exemptions have been issued in accordance with Article 71 of the Basic Regulation that are
pertinent to the scope of Phase II of this RMT.
2.2. What we want to achieve — objectives
The overall objectives of the EASA system are defined in Article 1 of the Basic Regulation. This proposal
will contribute to the achievement of these objectives by addressing the issues outlined in Section 2.1.
The specific objectives of this proposal are to:
— further improve the level of safety with respect to Part-145 and Part 21 organisations;
— overcome obstacles related to the mutual acceptance of approvals;
— foster the principles of safety management as indicated in the ICAO Annex 19 SARPs, second
edition, taking due account of the critical elements of a State’s safety oversight system as
defined in ICAO Annex 19, Appendix 1;
— streamline the procedures for oversight and enforcement, and increase the efficiency of the
management system requirements for competent authorities; and
9 Design, production and maintenance are the last aviation domains into which safety management requirements have
not yet been introduced.
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2. In summary — why and what
— support the implementation of the 2019-2023 EPAS, notably Section 5.2 (e.g. systemic safety
enablers, safety management), as a strategic priority.
2.3. How we want to achieve it — overview of the proposals
To develop this regulatory proposal, the FCG was consulted during three meetings between December
2017 and June 2018. An additional written consultation of the draft proposal for Part 21 only, for the
sake of maturity, was organised after these three meetings.
2.3.1. Summary of changes to Part-145
For Part-145, the majority of the changes are based on Opinion No 06/2016 (Part-CAMO) and the
associated proposed AMC & GM, which are themselves based on Subparts GEN of the authority and
organisation requirements (AR/OR) in the Regulations for civil aviation air crew10 and air operations11,
and the related AMC & GM respectively.
It thus fosters alignment with the content of Regulation (EU) No 965/2012, notably in the case of
multiple approvals if an aircraft operator also holds Part-CAMO and/or Part-145 approvals. The newly
introduced SMS elements in Part-145 follow the integrated approach used in the other domains,
through the introduction of an integrated management system. As example, the new ‘management
system’ of point 145.A.200 for Part-145 is introduced; it incorporates the existing quality system of
point 145.A.65 with the ICAO SMS SARPs in an integrated management system. The resulting text
resembles ORO.GEN.200 in Regulation (EU) No 965/2012.
This process is called the ‘integrated management system’.
However, some differences may exist with imported Part-CAMO text due to regulatory constraints,
such as differences in the regulatory numbering system; or the specific needs of each of the EU
regulations. For clarity or consistency, the text could not be identical to that in Part-CAMO. In other
cases, no equivalent text existed in Part-145, in particular when the introduced changes went beyond
the straightforward introduction of a management system, dealing with other general aspects such as
applications, alternative means of compliance (AltMoC), changes, access, findings, etc. However,
these differences does not impact the intent of the regulator for that NPA.
Some minor improvements to the imported Part-CAMO text have also been proposed through this
NPA, mainly for reasons of clarity or language improvement. The text may also benefit from some
improvements proposed during the adoption of Part-CAMO being currently under review. Again these
changes should not change the meaning, notably for Section B (i.e. the authority requirements).
Several Part-145 points have also been amended to highlight certain risks related to maintenance
activities (e.g. fatigue and external working teams in 145.A.47).
10 Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and
administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the
European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549467168079&uri=CELEX:32011R1178).
11 Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and
administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the
European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549466927988&uri=CELEX:32012R0965).
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2. In summary — why and what
In accordance with ICAO Annex 19, all Part-145 organisations should implement an SMS without
exception: the new safety management requirements introduced into the EU regulatory framework
apply to all types of Part-145 approved organisations.
A more detailed list of the proposed changes to Part-145 is provided in Appendix II to this NPA.
2.3.2. Summary of changes to Part 21
Rather than ‘organisation-centric’, the Part 21 Section A requirements are more ‘product-centric’.
Moving to an integrated management system in Part 21 would have too much diluted the importance
of the quality (management) system and the design assurance system, which are specific, integral
parts of the production and design system (see points 21.A.139 and 21.A.239). In addition, Part 21
already includes detailed organisational requirements for approved production and design
organisations that match some of the ICAO Annex 19 related SARPs.
Fully aligning Part 21 with the SMS requirements in the other domains would thus:
— entail extensive changes to Part 21, making the alignment complex; and
— potentially affect Part 21 organisations, requiring a review of their processes or procedures,
without leading to a clear safety benefit.
Consequently, the changes to Part 21 Section A (organisation requirements) have been limited to the
introduction of the ICAO SMS framework (ICAO Annex 19, Second Edition, Appendix II), based on a
gap analysis performed between the ICAO SMS framework and the existing Part 21 requirements. It is
therefore proposed in this NPA that the 12 elements of an SMS applicable to an organisation, as
defined in Appendix II to ICAO Annex 19, should be added to the Part 21 organisational requirements,
respectively in points 21.A.139 (i.e. ‘Quality system’ for ‘production’) and 21.A.239 (i.e. ‘Design
assurance system’). By doing so, the existing rule structure for Section A remains unchanged, and the
volume of changes is limited.
The new safety management requirements apply to all Part 21 approved organisations (POA holders
and DOA holders, excluding the alternative procedures to DOAs). See Chapter 4 for further details.
The concepts of hazard identification, risk management and mitigation, as well as occurrence
reporting, are already well embedded in the culture and rules associated with the design and
production of the products, parts and appliances as described in the various Certification
Specifications (CSs) and in points 21.A.3A, 21.A.139 and 21.A.239. This means that the alignment of
the occurrence reporting system required by Regulation (EU) No 376/201412 has been considered in
this NPA to be notably consistent with ICAO Annex 19, Chapter 5 and its Appendix III and the
development of RMT.0681.
For Section B, the authority requirements have been aligned with the other aviation domains, in an
approach that is similar to the one for Part-145. However, some peculiarities of the Part 21 rules had
to be kept. The main following elements have been introduced:
12 Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting,
analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European
Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and
Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1532624380599&uri=CELEX:32014R0376).
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2. In summary — why and what
— risk-based oversight and the recognition of organisations that have good performance through
the use of flexible oversight planning cycles and extensions to 36 and 48 months;
— the concept of AltMoC for production organisations; and
— instead of 36 months currently applied, the text proposed a DOA basic oversight cycle of 24
months with the option to extend it to 36 or 48 months when conditions are met, as already
regulated in the other domains [see ARO.GEN.305]. Once the proposed regulation becomes
applicable, EASA will immediately apply a 36 months cycle to all existing DOAs already meeting
the conditions to be eligible for a 36 month oversight cycle.
Finally, a set of AMC & GM has been developed, consistent with those provided in other domains, to
demonstrate compliance with the SMS requirement. In this way, an organisation that already holds
several approval certificates may reuse the evidence already produced for the other domains or in the
case of an integrated management system.
A more detailed list of the proposed changes to Part 21 is provided in Appendix I to this NPA.
2.3.3. Specific commonalities and differences between Part-145 and Part 21
As mentioned earlier, the volume of changes to Part 21 has been kept as low as possible, by building
on the existing Part 21 structure. On the contrary, it was easier to reshape and align Part-145 with the
Air OPS rules: by doing so, the common regulatory framework is fostered when a CAMO-approved
aircraft operator also holds a Part-145 approval.
Although the two Regulations are considered to be aligned with the SMS principles that stem from
ICAO Annex 19, they might be different in their wording and regulatory structures. As a result, some
SMS principles in Part-145 may have a different regulatory status from that in Part 21. This is inherent
in the fact that the two pieces of legislation have evolved in different manners over time. Notably, for
Section A, Part 21 focuses more on the ‘product’, whereas Part-145 focuses more on the
organisational requirements. The future roadmap for OR/AR should resolve that difference.
Unlike the proposed changes for Part-145, the Part 21 approach does not foster an ‘integrated
management system’. However, the Part 21 organisation may go for an integrated management
system especially when several approvals are held.
All in all, although the approach taken for Part 21 and for Part-145 differ, the proposed changes do
not bring any incompatibility as they basically follow the SMS framework and the spirit of ICAO Annex
19 or ICAO Doc 9859.
Lastly, AMC have been introduced for points 21.A.139 (see AMC1 21.A.139(c)) and 21.A.239 (see
AMC1 21.A.239(c)) for the acceptability of the SMS Industry Standard ‘Implementing a Safety
Management System in Design, Manufacturing and Maintenance Organizations’ SM001 Issue A -
September 17th, 201813 to demonstrate compliance with the EU SMS requirements in Part 21.These
AMC identify some gaps between this SMS industry standard and the SMS elements of the
management system defined in Part 21.
— SMS Industry Standard SM-0001 has been developed by the Aerospace and Defence Industries
Association of Europe (ASD), the Aerospace Industries Association of America (AIA), the
13 https://www.asd-europe.org/sites/default/files/atoms/files/SMS%20Standard_final%20issue%20A_20180917.pdf
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2. In summary — why and what
Aerospace Industries Association of Brazil (AIAB), the Aerospace Industries Association of
Canada (AIAC) and the General Aviation Manufacturers Association (GAMA).
— Intended to improve safety performance and enhance safety culture, this document provides
explanations and some guidance material for compliance with the provisions of ICAO Annex 19,
Appendix II ‘Framework for a Safety Management System’. It essentially contains:
some Part 21 best practices to identify hazards and to conduct safety risk management
(SRM);
sources of data for safety assurance as well as safety performance indicators (SPIs);
interfaces between organisations, notably within consortiums (i.e. corporate SMS) or
with suppliers or organisations that have not implemented an SMS;
considerations regarding other management systems (e.g. quality management system,
security management system); and
an SMS implementation plan and an SMS assessment tool based on the one developed
by SM ICG14.
— However, SMS Industry Standard SM-0001 at Issue A is not found suitable for introduction into
the AMC to Part-145.
2.4. What are the expected benefits and drawbacks of the proposals
The proposed changes:
— implement ICAO Annex 19, notably through the introduction of SMS principles, safety risk
management and continuous improvement;
— foster an organisational safety culture for effective safety management and effective
occurrence reporting, whether it is mandatory or voluntary, to be coherent with Regulation (EU)
No 376/2014; and
— streamline as much as possible the Section B oversight requirements for Part-145 and Part 21
organisations, due to an approach that is common with other domains.
The intended effects would be the:
— enhancement of safety by contributing to effective hazard identification, risk management
capabilities and error reduction, and by improving transparency;
— promotion of a positive safety culture; and
— improvement in terms of flexibility and proportionality, in particular regarding management
system requirements.
Despite the difference in approach between Section A for Part 21 (i.e. gap analysis with ICAO Annex
19) and that of Part-145 (i.e. integrated management system), the alignment of the SMS principles
will facilitate the reuse of activities and documentation that has been already developed for
14 The Safety Management International Collaboration Group (SM ICG) is a group of 18 aviation regulatory bodies,
established in 2009 to promote a common understanding of safety management principles and requirements, facilitating
their application across the international aviation community. A repository of SMICG products can be accessed free of
charge at https://www.skybrary.aero/index.php/Safety_Management_International_Collaboration_Group_(SM_ICG).
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2. In summary — why and what
compliance demonstration in other domains. This is further supported at the AMC & GM level, where
the same material has been used in the two domains, insofar as this was possible. This drawback is
therefore mitigated for Part-145-organisations that hold a DOA or a POA, and vice versa.
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3. Proposed amendments and rationale in detail
3. Proposed amendments and rationale
A detailed summary of the regulatory changes can be found:
— for Part 21 in Appendix 7.1; and
— for Part-145 in Appendix 7.2.
3.1. Draft regulation (Draft EASA opinion) for Part 21
Refer to NPA 2019-05 (B)
3.2. Draft AMC & GM (Draft EASA decision) for Part 21
Refer to NPA 2019-05 (B)
3.3. Draft regulation (Draft EASA opinion) for Part-145
Refer to NPA 2019-05 (C)
3.4. Draft AMC and GM (Draft EASA decision) for Part-145
Refer to NPA 2019-05 (C)
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4. Impact assessment
4. Impact assessment (IA)
4.1. What is the issue
4.1.1. Introduction
The first edition of ICAO Annex 19 became applicable on 14 November 2013 for design, production
and maintenance activities. Without waiting for the EU rules to embed ICAO Annex 19, some
organisations that hold multiple approvals, for which an SMS is already mandatory, or that have
branches or conduct business in non-EU States where an SMS is already mandatory, have already
extended the safety management principles to their design, production and maintenance activities,
for the sake of coherence or business needs. Some major organisations, such as large production or
maintenance organisations, have also felt the benefit of having a risk management system and a
robust occurrence reporting system embedded in their corporate safety culture. Finally, a number of
EASA Member States such as France, Switzerland, and the United Kingdom have already mandated
the implementation of SMSs for maintenance organisations. Some other EASA Member States have
encouraged the implementation of SMSs on a voluntary basis. For all these reasons, an SMS is not a
novelty, and the overall impact is limited, notably for the maintenance organisations.
Pursuing the objectives of the Basic Regulation regarding the development of the EU rules, EASA
proposes to implement the ICAO safety management SARPs for the design, production and
maintenance organisation and authority requirements. Additionally, the Basic Regulation calls for a
management system, for continuous improvement of this system, and an occurrence reporting system
that supports that management system (see its Annex I, Section 3.1).
Design, production and maintenance are the last aviation domains into which safety management
requirements have not yet been introduced.
Failure to implement an SMS as an ICAO international standard will:
(a) pose obstacles for the mutual acceptance of approvals under bilateral agreements;
(b) be detrimental to the objective of continuous improvement of the overall level of safety, as a
significant segment of the air transportation system would not implement the safety
management principles;
(c) minimise the safety role of a reinforced occurrence reporting system as described in Chapter 5
of ICAO Annex 19 and in Regulation (EU) No 376/2014;
(d) not streamline the management system requirements for the competent authorities of the
EASA Member States, which are already required to upgrade their systems and procedures in
accordance with the new authority requirements introduced in Regulations (EU)
Nos 1178/2011, 290/2012 and 965/2012; and
(e) deny the need to consider the critical elements of a state safety oversight system as defined in
ICAO Annex 19, Appendix I.
The way forward is thus the proper consideration of the safety management principles in coherence
with what has been already done for the other aviation domains. Later in this document, the reader
will see that no options have been proposed for Part-145 (for reasons explained further in the text),
whereas for Part 21 some options are proposed to achieve that objective.
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4. Impact assessment
The working method adopted for this IA is a qualitative assessment of the possible impacts, supported
by a questionnaire, as explained in the next section. It is recognised that this is not easy to precisely
quantify the impacts, notably with regard to the real costs. However, the EASA questionnaire helped
to identify the most significant contributors to safety and costs (see Section 4.1.2 and Appendix III).
4.1.2. Evidence gathering — EASA questionnaire
EASA sent out a survey in order to gather evidence for this IA from stakeholders. The input supported
the analysis of the problem definition and the analysis of the options. The survey was sent on 15
February 2018, and it collected specific SMS data related to the design, production and maintenance
domains.
The survey was responded to by 293 organisations (285 organisations with a single or multiple
approval(s); 8 associations or individuals) and 11 competent authorities. The organisations that hold
multiple approvals were invited to provide a consolidated response, representing all the parts of the
organisation that hold approvals.
The details of the survey can be found in Appendix III to this document. Wherever needed, the
outcome of the survey is used throughout this IA by referring to the appropriate figures in Appendix
III. The most relevant ones are repeated in Section 4.4.2.
4.1.3. Safety risk assessment
Several safety recommendations (SRs) that were addressed to EASA by safety investigation authorities
are of interest for this RMT, as they are related to the subject of ICAO Annex 19:
— SR UNKG-2015-001, following the accident to British Airways A319 G-EUOE, which occurred on
24 May 2013, recommends that ‘EASA publishes amended AMCs/GM in Part 145.A.47(b) of
European Commission Regulation (EC) No 2042/2003, containing requirements for the
implementation of an effective fatigue risk management system within approved maintenance
organisations’;
— SR UNKG-2011-018 following the serious incident to Bombardier DHC-8, SX-BIO, which occurred
on 24 April 2010, recommends ‘that the European Aviation Safety Agency expand the advisory
or guidance material in Annex II (Part 145) of European Commission Regulation (EC)
No 2042/2003 on how approved maintenance organisations should manage and monitor the
risk of maintenance engineer fatigue as part of their requirement to take human performance
limitations into account.’;
— According to SR UNKG 2010-072, pertaining to the serious incident to Boeing 737-73V, G-EZJK,
which occurred on 12 January 2009 West of Norwich, Norfolk, ‘It is recommended that the
European Aviation Safety Agency review the regulations and guidance in OPS 1, Part M and
Part-145 to ensure they adequately address complex, multi-tier, sub-contract maintenance and
operational arrangements. The need for assessment of the overall organisational structure,
interfaces, procedures, roles, responsibilities and qualifications/competency of key personnel
across all subcontract levels within such arrangements should be highlighted.’.
These SRs, together with their identified risks, have been properly considered in the proposed changes
to the Part-145 rules.
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4.1.4. Who is affected?
Part-145 maintenance organisations, Part 21 production and design organisations, competent
authorities and EASA are affected by the proposal in this NPA.
4.2. What we want to achieve — objectives
Please refer to Section 2.2.
4.3. How it could be achieved — background and options
Part-145
ICAO Annex 19 states that all approved maintenance organisations that provide services to operators
or aeroplanes or helicopters engaged in international commercial air transport, in accordance with
Annex 6, Parts I or III, should implement an SMS. In the current EASA system, the term ‘approved
maintenance organisations’ refers to either Part-M Subpart F organisations or Part-145 organisations.
With Opinions No 05/2016 ‘Task force for the review of Part-M for General Aviation (PHASE II)’ and
No 06/2016 ‘Embodiment of safety management system (SMS) requirements into Commission
Regulation (EU) No 1321/2014 — SMS in Part-M’, a new structure for Regulation (EU) No 1321/2014
was proposed, in which technical requirements and organisational requirements (e.g. Part-CAMO,
Part-CAO, Part-145) would be addressed in separate Annexes (so Part-M Subparts F and G would
eventually disappear). The technical requirements for General Aviation would be provided in a
separate Annex (Part-ML/Part-M). The organisations with a General Aviation scope (Part-CAO) would
not be required to implement an SMS, whereas other organisations would (i.e. Part-CAMO, and
Part-145), but Part-147 organisations were excluded.
This means that a decision has been already taken to limit the introduction of SMSs into Part-145
organisations. No SMS principles will be requested for future Part-CAO approved maintenance
organisations, which will address General Aviation activities. Only a Part-145 approved organisation
can maintain aircraft operated by licensed air carriers and complex motor-powered aircraft (CMPA),
in line with the spirit of ICAO Annex 19 (SMSs required for organisations that maintain aircraft engaged
in commercial air transport).
Additionally, ICAO Annex 19 does not make any differentiation in the type of maintenance
organisation (e.g. engaged in the maintenance of aeroplanes, helicopters or components, including
engines or propellers). The safety management principles have applied without exception to all Part-
145 maintenance organisations since 14 November 2013.
The implementation of ICAO Annex 19 is thus expected to be straightforward. For Part-145, it has
been decided to proceed without proposing options (i.e. full compliance with Annex 19). This has
also been well received by the FCG. Furthermore, the results of the questionnaire shown below
demonstrate that the majority of the replies are in favour of the implementation of ICAO Annex 19 for
all Part-145 activities (see Figure 16 in Appendix III).
However, the proposed changes introduce flexibility provisions regarding an SMS that should be
commensurate with the size of the organisation and complexity of the operations, so it will limit the
impact on small Part-145 organisations, or organisations with a limited scope of work.
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For further details, the reader can also review the regulatory impact assessment (RIA) in NPA 2013-
01(A), which resulted in Opinion No 06/2016.
Part 21
ICAO Annex 19 defines the applicability of SMSs to all organisations that are responsible for the design
and production of:
— aircraft in accordance with ICAO Annex 8, applicable from 14 November 2013; and
— engines and propellers in accordance with ICAO Annex 8, applicable from 7 November 2019.
Unlike the requirements on maintenance organisations, ICAO Annex 19 does not distinguish between
approved and non-approved organisations. This is because, in some regions of the world, the concept
of ‘approved’ organisations for design and production is not systematically used, even for products.
In addition, ICAO Annex 19 does not make SMSs applicable for the design and production of ‘parts &
appliances’.
Note: Regulation (EU) No 376/2014 already imposes a mandatory and voluntary occurrence reporting
system on all aviation organisations, independently of their approval status and of what they design
or produce. This can be considered a first element that stems from ICAO Annex 19, encouraging
organisations to develop a just culture. Therefore, this element will not be subject to options or to
analysis.
Starting from the scope defined by ICAO Annex 19, explained in Section 4.1.2, three options have been
developed to define the applicability of SMSs to Part 21.
Option 0 — mirroring the scope of ICAO Annex 19
The scope of this option strictly follows that of ICAO Annex 19 (all organisations that design and
produce aircraft, engines and propellers). Therefore Option 0 is considered to implement ICAO Annex
19 without any adaptation, and to mandate SMSs for all organisations, whether they are approved or
not, that design and produce aircraft, engines and propellers.
Option 1 — approved organisations that produce or design only aircraft, engines and propellers
This option would require the implementation of ICAO Annex 19 by all approved organisations that
design and produce only aircraft, engines and propellers (under Subparts J and G). All organisations
that design and produce ‘parts and appliances’ are excluded even when Part 21 requires an approval
[i.e. in the case of a European Technical Standard Order (ETSO) or an auxiliary power unit (APU)].
Under this option, this would exclude SMS for:
— Part 21 Subpart F production organisations15;
— design organisations that are entitled to demonstrate their design capabilities with the
acceptance of procedures that are alternative to DOA;
15 On the basis that the manufacturer of a product, part, or appliance without a POA has convinced the competent authority
that a POA was not needed due to a low volume of production; simple technology; the very small size of the organisation;
or production for a limited period of time; or starting production activities before achieving full compliance with
Subpart G [see point 21.A.124 (b)].
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4. Impact assessment
— design organisations that are required to submit only a certification programme, as per points
21.A.14 (b) or (c)16; and
— natural/legal persons that hold an ETSO authorisation (or ETSO authorisations), even if they are
required to hold a POA.
Since this option would imply that, in some cases, an organisation may be required to be approved
even without having an SMS in place (i.e. in the case of an ETSO), two types of DOA and POA would
be needed: those who are required to implement an SMS and those who are exempted. This leads to
Option 2.
Option 2— all approved organisations
The implementation of ICAO Annex 19 would be limited to all approved organisations that design and
produce aircraft, engines and propellers (under Subparts J and G), and to organisations that design
and produce parts and appliances when a DOA or POA is required (i.e. a POA is required for an ETSO
or a POA/DOA is required for an APU).
Table 1: Part 21 — selected options
Option Title Description
No
0 Full implementation of Full compliance with and implementation of ICAO
ICAO Annex 19 by all Annex 19 (i.e. for approved and non-approved
organisations that are organisations that design and produce products)
responsible for the design
and production of products
1 Implementation of ICAO Implementation of ICAO Annex 19 is limited to approved
Annex 19 is limited to organisations that only design and produce products
approved organisations that (parts and appliances are excluded)
are responsible for the It falls short of the requirements of ICAO Annex 19, as
design and production of it excludes organisations for General Aviation (i.e. ELA1
products & 2, engines, etc.), small organisations for which a POA
is not needed, and organisations that are seeking a DOA
but to which it has not yet been granted.
This approach is coherent with the General Aviation
approach adopted for continuing airworthiness
organisations. (see Opinions No 05/2016 and
No 06/2016)
2 Implementation of ICAO The implementation of ICAO Annex 19 is limited to
Annex 19 is limited to approved organisations that design and produce
approved organisations that products as well as parts and appliances under ETSO
are responsible for the authorisation.
design and production of Built on Option 1, it falls short of the requirements of
products and for ‘parts and ICAO Annex 19, except for organisations that are
appliances’ when an responsible for the design of APUs and the production
organisational approval is of ETSO articles, for which an SMS is an additional
requirement.
16 For ELA 1 or ELA2; or for engine or propeller installed on ELA 1 or 2; or for a piston engine; or a fixed or adjustable
pitch propeller; a robust quality system and assurance design system is supposed to be sufficient.
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4. Impact assessment
required under ETSO
authorisation.
Note: the term ‘product’ means aircraft, engines, or propellers
Compared with Option 0, Option 1 in Europe:
— excludes around 250 organisations that design ELA1/ELA2 (the number of Subpart F
organisations is negligible);
— accounts for around 320 EU DOA holders, 30 DOA holders outside EU, and 500 POA holders.
Compared with Option 1, Option 2 would require some additional organisations in Europe to
implement SMSs, as follows:
— 3 approved design organisations for the design of APUs;
— around 300 POA holders for the production of parts and appliances that are covered by ETSOs.
Discarded option: ‘No action’
Failing to introduce the safety management principles from ICAO Annex 19 into the design, production
and maintenance rules would be neither acceptable nor coherent with what has been achieved in the
other aviation domains. The implications of this option have been clarified in Section 4.1. Therefore,
this option has been discarded.
4.4. What are the impacts
Note: no option has been identified for Part-145. The section below compares the three options for
Part 21 that are identified in Section 4.3.
4.4.1. Introduction to the impact analysis
A detailed analysis of the costs and benefits of implementing an SMS is quite challenging due to the
very nature of ‘safety’. Intangible benefits, such as those from having an improved safety culture,
effective regulatory compliance, a management commitment to safety, shareholder value, and public
confidence, are difficult to quantify. Also, an effective management system that includes safety risk
management results from the interactions of many different organisational elements, actions, and
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4. Impact assessment
processes that are ideally embedded within the organisation’s existing system. Therefore, the effects
of individual elements of the management system framework are not always easy to isolate for the
purpose of the analysis of costs and benefits. It is also acknowledged that an SMS creates immediate
and direct costs, while its benefits are likely to take time to materialise. This view negates the potential
of an SMS, not only to address the risks of major occurrences, but also to identify and tackle
production inefficiencies, improve communication, foster a better company culture, and more
effectively control contractors and suppliers. Building up risk management capabilities that are not
only limited to aviation safety risks will contribute to the adoption of better management strategies.
In addition, through an improved relationship with the competent authorities, the implementation of
a management system that includes safety risk management could result in a reduced oversight
burden. Thus, by considering an SMS as something that is implemented not solely to prevent incidents
and accidents, but also to ensure the success of as many elements of an organisation’s business as
possible, any investment in safety should be seen as an investment in productivity and organisational
success.
4.4.2. Relevant elements from the EASA questionnaire
The results of the EASA questionnaire (see Appendix III) with regard to the main safety benefits
obtained from the implementation of an SMS are shown below. By far the two clearest benefits are:
— a better safety culture; and
— a better hazard identification, which leads to better control of risks.
Figure A - The most significant benefits in SMS implementation (by
those who implemented SMS)
Better safety culture 106
Better hazard identification leading to better risk control 100
Improved communication on safety issues within the company 53
Improved internal reporting (number and types of reports) 50
Better management of changes 31
Faster resolution of safety issues 29
Improved senior management commitment 18
Improved compliance (e.g. lower number of findings in internal or… 14
Improved efficiency of internal processes in general terms 10
Improved communication on safety issues with other parties 9
More efficient allocation of resources 8
Improved relationship with the competent authority 7
Other (please specify)3 6
0 20 40 60 80 100 120
The EASA questionnaire highlighted the following elements regarding the main cost drivers in the
implementation of an SMS:
— additional staff training;
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— organisational changes, such as the creation of new working groups (e.g. a safety review board);
— documentation (e.g. new procedures/manuals); and
— software and other tools (e.g. a reporting system).
Figure B - The main cost drivers in SMS implementation (by all
organisations)
Additional staff Training (e.g. safety training development) 190
Organisational changes, such as creation of additional working groups
(e.g. Safety Review Board, Safety Action Group) 143
Documentation (e.g. new procedures/manuals and updates to existing
ones) 113
Software & other tools (e.g. reporting system, risk analysis tools, risk
registers) 103
Oversight (authority fees, time spent in audits & assessments) 73
Safety investigations 63
Safety promotion & communication 62
Internal audits 42
Consultancy 23
Other 15
0 20 40 60 80 100 120 140 160 180 200
The cost drivers highlighted involved both organisations and authority.
4.4.3. Safety impact
Part 21 | Option 0 — ICAO Annex 19 (all product organisations)
Fully implementing Annex 19 would bring significant positive safety impacts, since all organisations,
irrespective of the type of aircraft they produce, would be required to have an SMS in place, whether
or not the organisation holds an approval. Figure A in Section 4.4.2 clearly highlights the safety
benefits.
However, with this option, organisations that design and produce parts and appliances would not be
required to implement an SMS. Some parts, such as APUs, are considered to have a major impact on
safety.
Part 21 | Option 1 — all approved organisations (products)
Regulation (EU) No 376/2014 is applicable to all organisations (including the non-approved ones) that
are located in Europe, and it mandates some basic elements of an SMS, such as mandatory and
voluntary reporting and the development of a safety culture. It should be noticed that these elements
are the most important safety benefits that were identified by organisations in their responses to the
questionnaire as shown in Figure A in Section 4.4.2. This is why limiting the implementation of SMSs
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to approved organisations that produce products would not significantly decrease the resulting safety
benefits.
Therefore, even if this option provides less safety benefit than Option 0, the difference can be
considered to be negligible. Overall, a positive safety impact is expected.
Part 21 | Option 2 — all approved organisations (products and parts and appliances)
In addition to the organisations defined in Option 1, this option mandates the implementation of an
SMS by those organisations that design and produce parts and appliances under ETSO authorisation,
but only when an approval is already required by Part 21.
Therefore, organisations that design critical elements such as APUs, and which produce parts and
appliances that are covered by ETSO authorisations (i.e. when the organisations are not allowed to
produce under Part 21 Subpart F), will be required to implement an SMS. The risks related to the
design and production of these ETSO articles would be captured and assessed by those organisations.
The aircraft manufacturer would rely on the ETSO authorisation, and would only be responsible for
the proper installation of the article. This would be the additional positive safety effect of adopting
Option 2.
Concerning the design of an APU (which is a major component of an aircraft), having an SMS in place
is considered necessary and appropriate, not only in terms of the ‘complexity’ or ‘criticality’ of APUs,
but also when considering the privileges associated with the design approval for the modifications and
repair designs of those articles. Several accidents, such as uncontained explosions, or the one on 20
January 2015 at Nürnberg airport17 (i.e. that involve the intake and combustion of de-icing fluid),
remind us of how the operation of APUs can pose risks and may endanger human beings if there is a
failure, should it be at product safety level or organisational level.
Safety awareness and safety culture will be also enhanced by more safety training, communication
and safety promotion for the organisations that design and produce parts and appliances.
Finally, most of the organisations that produce parts and appliances under ETSO authorisations or
design/produce APUs, also hold Part-145 approvals for which an SMS will be also required. An
integrated (safety) management system will benefit from a safety perspective.
Compared with Option 1, a higher positive safety impact is thus expected, as more organisations
would be covered.
4.4.4. Environmental impact
No environmental impact is identified, therefore this aspect is not analysed.
4.4.5. Social impact
The following elements are considered in the social impacts for this proposal: better communication,
higher management commitment, fatigue, working conditions, lack of resources, and the level of
subcontracting activities. Two of the essential elements of an SMS as defined by ICAO Annex 19 are
the development of a safety culture and the provision of better safety training for all staff. The social
impact is commensurate with the number of organisations for which an SMS is mandatory.
17 https://aviation-safety.net/database/record.php?id=20150120-2
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Part 21 | Option 0 — ICAO Annex 19 (all product organisations)
Since this option is applicable to all organisations that design and produce aircraft engines and
propellers, the largest number of companies will be affected by this option, so it has a positive social
impact.
Part 21 | Option 1 — approved organisations (products)
This option excludes non-approved organisations that design and produce aircraft engines and
propellers; therefore, its social impact is slightly lower than that of Option 0, but it is still positive.
Overall, the difference in comparison with Option 0 can be considered to be negligible.
Part 21 | Option 2 — all approved organisations (products as well as parts and appliances)
This option includes those organisations that design and produce parts and appliances under ETSO
authorisation, but only when an approval is already required by Part 21. Therefore, the level of social
impact is lower than with Option 0, but higher than with Option 1. Overall, the difference in
comparison with Option 0 can be considered to be negligible.
4.4.6. Economic impact
For the organisations who have not yet implemented safety management principles, there would be
an economic impact.
The organisations and authorities who have already engaged in this proactive strategy to
systematically address safety risks have usefully pinpointed several areas in response to the EASA
survey, as shown in Figure B in Section 4.4.2. These elements need to be kept in mind for this analysis.
The following general features can be highlighted:
Positive impact
Some elements of an SMS, such as a positive safety culture or an internal reporting system, have the
potential to contribute significantly to the overall safety at little or no cost. For certain elements of an
SMS, the implementation will be gradual, which should spread the overall costs over time. The same
applies to the authorities, which should progressively deploy SMS management systems over time.
The effective implementation of SMSs will also improve productivity and efficiency, through the
adoption of better management strategies and the build-up of risk management capabilities that are
not limited to only aviation safety risks. Moreover, the causes of incidents and the contributing factors
to them often also cause or contribute to production losses or inefficiencies. The management system
framework of an SMS provides an organisational structure that supports managers in taking informed
decisions. Without such a framework to manage operational risks, trade-offs between commercial
pressures and safety objectives may not be managed effectively, and decisions may not be justified
objectively. The effective implementation of a management system could, therefore, contribute to a
decrease in insurance costs, to an improved reputation, and to commercial success.
For large, well established production and design organisations, it can be expected that a certain
percentage have already implemented SMSs according to the ICAO framework, on a voluntary basis,
sometimes under contractual obligations imposed on them by their customers.
The level of involvement (LOI) of an authority might be reduced due to an improvement in the
performance of an organisation, as the level of safety might be higher.
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Negative impact
The main elements of an SMS that may initially be missing from an organisation, and for which a
negative economic impact is expected when they are incorporated, stem from:
(a) developing a safety policy and its related objectives;
(b) appointing key safety personnel to execute the safety policy;
(c) establishing, implementing and maintaining a safety risk management process;
(d) establishing, implementing and maintaining a safety assurance process; and
(e) promoting safety in the organisation.
To mitigate this negative impact, the reader is invited to review the proportionality provisions laid
down in the next paragraph, as they contribute to a significant reduction of the costs, notably for small
organisations or when the risks associated with the business are limited.
Part 21 |Option 0 — ICAO Annex 19 (all product organisations)
— Negative impact
Organisations for which Part 21 currently mandates an approval (DOA holders and POA holders) will
have to adapt their structures, and update their policies, plans, procedures and expositions or
handbooks. For them, the economic impact may be considered to be limited because they can build
on their existing structures. Nevertheless, training costs and some organisational changes remain as
major contributors, as identified in the replies to the EASA questionnaire.
Since all organisations that design and produce aircraft, engines and propellers will be mandated to
apply SMSs, each organisation that is currently not required to have an approval will be required to
define an organisational structure and to document their procedures in order to be compliant with
ICAO Annex 19. For all other organisations that are not required to hold a Part 21 approval (i.e. those
that design ELA 1 or ELA and produce according to Subpart F), and which are ‘small’ by definition, the
implementation of SMSs will have a greater economic impact. They might be required to hire new
personnel, to create some new management positions, or to extend the scope of their existing
management positions, and to develop policies, plans, procedures and expositions or handbooks.
— Positive impact
In terms of economic benefits, the implementation of Annex 19 would ensure that there is a level
playing field with consistent airworthiness requirements for aircraft that participate in international
air transport, and for products for which foreign states accept certificates issued by EASA. In addition,
further efficiency/effectiveness would be fostered thanks to:
— more efficient allocation of resources;
— more efficient internal processes;
— greater senior management commitment; and
— faster resolution of safety issues.
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4. Impact assessment
For competent authorities, the impact is significant, since the implementation of SMSs by a large
number of organisations would be required to be assessed, and some of the competent authorities
might not initially have the necessary resources to do this.
Overall, considering that there are both significant positive and negative economic impacts, as
highlighted above, an overall neutral effect is expected.
Part 21 | Option 1 — approved organisations (products)
This option excludes non-approved organisations, so the general costs may therefore be much lower
than with Option 0; however, fewer safety benefits are expected, as fewer organisations would be
affected.
For competent authorities, there will be less impact than with Option 0.
Considering both the negative and positive impacts, which should be of smaller absolute values than
with Option 0, an overall neutral impact is expected over time.
Part 21 |Option 2 — all approved organisations (products as well as parts and appliances)
As mentioned earlier, the changes to these additional approved organisations will be limited because
the organisations will build on their existing procedures and structures. The flexibility provisions would
also apply to make the design/production management system proportionate to the size of the
organisation and complexity of the services. The additional costs incurred are considered rather
limited, keeping in mind the expected safety benefits.
It is also expected that most of the organisations that produce ‘parts and appliances’ under ETSO
authorisation, and those that design and produce APUs, will also already hold a Part-145 approval for
which an SMS will be required; so this will limit the overall economic impact for them.
Overall, neutral impacts are expected, although both the positive and negative impacts may be of
greater magnitude than with Option 1.
4.4.7. Proportionality impact
In all these Part 21 options, the following elements have been introduced in order to reduce the
implementation costs, which are more significant for smaller organisations:
(a) The acceptance that the design/production management system shall correspond to the size
of the organisation, as well as to the nature and complexity of its activities, taking into account
the hazards and associated risks that are inherent to these activities (see the proposed
changes to 21.A.139(b) and 21.A.239(b));
(b) Flexibility provisions contained in the AMC & GM, which allow different scenarios that are
proportionate to the size and complexity of the operations (e.g. a full-time equivalent safety
manager is not required as long as the function of a ‘safety manager’ is properly discharged
by another person, or by a group. The same applies for a formal safety review board. Both
cases must be subject to a risk assessment and must be agreed by the competent authority);
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4. Impact assessment
(c) The planned recognition of SMS Industry Standard SM-0001 as an AMC, which will allow a
level playing field with the Federal Aviation Administration (FAA) SMS approach because the
recognition of that SMS Industry Standard by the FAA is also planned. The implementation
costs could be further reduced by encouraging the implementation of common tools and data-
sharing agreements for safety management at the level of industry associations; and
(d) The changes for Part 21 Section A (requirements on organisations) are limited to the
introduction of the ICAO SMS framework based on an analysis of the gap between the ICAO
SMS framework and the existing Part 21 requirements (see further details in Section 2.3.2).
By reducing the complexity of the changes, an organisation can decide to build its SMS on its
existing exposition manual, or to produce a separate SMS manual, which limits the impact on
their documentation.
Part 21 |Option 0 — ICAO Annex 19 (all product organisations)
Significant negative disproportionate impacts are expected, since small organisations would face
implementation costs that would include, but would not be limited to, additional staff, organisational
changes, and new manuals. These changes might have significant negative repercussions for their
businesses.
Part 21 | Option 1 — approved organisations (products)
Unlike Option 0, SMSs would not be applicable to small organisations that produce or design small
aircraft (notably for General Aviation, as ELA1, and ELA2 aircraft, and their engines would be
excluded). This is very similar to the approach taken in Opinions Nos 05/2016 and 06/2016 in order to
sustain the GA Roadmap.
Therefore, significant positive proportionality impacts are expected.
Part 21 | Option 2 — all approved organisations (products as well as parts and appliances)
This option would maintain the same consistency that is identified in Option 1. Since SMSs would be
applicable to organisations that design APUs and that produce parts and appliances covered by ETSO
authorisations, some additional small organisations would be impacted. For them, the proportionality
provisions mentioned above would significantly reduce the burden. In the same vein, as most of them
would also hold a Part-145 approval, the same proportionality provisions are proposed in Part-145 for
the sake of coherence.
As for Option 1, significant positive proportionality impacts are expected.
4.5. Conclusion
The table below provides a summary of the qualitative assessments made for the various criteria,
which should be read from left to right, comparing Option 0 with Options 1 and 2. The table includes
‘0’ values for Option 0 in order to allow an easy comparison with the other options. However, Option
0 might have both positive and negative impacts, as described in the text. Therefore, the reader should
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4. Impact assessment
check the values of Option 1 and 2 in terms of the differences when they are compared with
Option 0.
Table 2: Conclusions for the options
Criteria Option 0 (basis) Option 1 Option 2
Full implementation Implementation of Implementation of
of ICAO Annex 19 ICAO Annex 19 is ICAO Annex 19 is
affects all limited to approved limited to approved
organisations that organisations that are organisations that are
are responsible for responsible for the responsible for the
the design and design and production design and production
production of of products. of products and also for
products. parts and appliances
when an organisational
approval is required
under ETSO
authorisation.
Safety 0 - -/+
Better safety culture. The impact remains The impact remains
Introduction of a positive, but it is less positive, but is less
systematic hazard than with Option 0 than with Option 0 but
identification because SMSs are not higher than with
process, risk controls applicable for non- Option 1, as SMSs are
and measurement of approved also applicable to parts
safety performance. organisations. and appliances under
ETSO authorisations, as
well as for APUs.
Economic 0 -/+ -/+
The implementation Lower costs but also Lower costs but also
of an SMS will add fewer safety benefits fewer benefits than
costs. The cost- than with Option 0. with Option 0. Non-
safety-analysis shows Non-approved approved organisations
that the burden is on organisations are not are not impacted.
smaller impacted. However, for ETSO
organisations. articles, there are
higher costs than with
Option 1, but these are
mitigated by the fact
that these
organisations hold a
maintenance approval
for which an SMS is
required.
Social 0+ 0+ 0+
Proportionality 0 + +
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4. Impact assessment
Significant Small production (i.e. Some small production
implementation non-approved) organisations are
costs for small organisations are not impacted in a
organisations impacted. proportionate manner.
Total 0 -/+ +
Option 0 would promote the highest level of safety and the most positive social impact. The economic
impact is confirmed for small organisations for which a formal approval is not needed.
Option 1, which falls short of the scope of ICAO Annex 19, has a less negative economic impact.
— It is considered to be an approach that is proportionate for the General Aviation segment (i.e.
consistent with the applicability chosen for continuing airworthiness organisations —
continuing airworthiness management organisations (CAMOs) and approved maintenance
organisations (AMOs)).
— It limits the impact for smaller organisations if an approval is not needed. In addition, this impact
is reduced by the fact that approved organisations can build on their existing structures,
processes, procedures and exposition manuals or handbooks.
— The costs will be further reduced by including proportionality in the requirements, based on the
size of the organisation and on the risks of the activities.
Option 2, which builds on Option 1, would also require approved organisations that design APUs to
implement SMSs, (for which Part 21 currently mandates a DOA), as well as organisations that produce
parts and appliances covered by an ETSO authorisation when a POA is required.
— It goes slightly beyond the scope of Annex 19.
— The implementation of SMSs for these additional organisations would certainly induce costs,
but would also increase the level of safety and the social impact.
— To reduce the costs, the proportionality provisions should be used when the production
activities for these parts and appliances bear fewer risks.
— In addition, for most of these organisations, synergies will be achieved through the use of an
integrated SMS for their Part 21 and Part-145 activities.
In comparison with Option 2, Option 1 has the drawback that it defines two levels of DOAs and POAs:
those that are required to implement the elements of an SMS that were missing (for products) and
those that are not required to do so (for parts and appliances). Option 2 would avoid that
differentiation in Part 21 (i.e. by avoiding the confusion introduced by compliance with two sets of
procedures within the EU regulatory framework or within an organisation). It would also ensure that
there is a level playing field and consistent airworthiness requirements for aircraft that participate in
international air transport, including the assurance that EU certificates will still be accepted by third
countries (therefore there would be a positive economic impact, as shown in the table).
Finally, the EASA questionnaire shows that among the organisations that have an ETSO authorisation,
two out of three respondents considered that SMSs should also be applicable to parts and appliances.
The rationale certainly stems from the fact that most of these organisations also hold Part-145
approvals, for which an SMS will be required, irrespective of the scope of the approval.
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4. Impact assessment
For all these reasons, Option 2 is the preferred option, as the applicability of SMSs would be extended
to all design and production organisations for which Part 21 currently requires an approval (i.e. DOA
holders or POA holders) that design or produce aircraft, engines or propellers, as well as parts and
appliances under ETSO authorisation. This is fully in line with the outcome of the last ICAO Air
Navigation Conference held in October 2018, urging organisations and authorities to develop robust
risk management capabilities. The same conclusion can be drawn from the recent issuance of the Basic
Regulation.
Note: the FAA also recommends SMSs for organisations in charge of TSO articles.
Question to stakeholders
Stakeholders are invited to comment on the IA and to provide any qualitative or quantitative
information that they may find necessary to bring to the attention of EASA.
As a result, EASA might adjust the selection of the best option, as well as the relevant parts of the
impact assessment on a case-by-case basis.
4.6. Monitoring and evaluation
Monitoring is a continuous and systematic process of data collection and analysis about the
implementation/application of a rule/activity. It generates factual information for future possible
evaluations and impact assessments; it also helps to identify actual implementation problems. With
respect to this proposal, EASA would suggest to monitor various elements looking at short and
medium term. Indeed, there are elements that should be monitored as soon as the rules are
implemented and others for which some years would need to pass before the outcome could be
measured. A proposal on indicators to check is presented below:
What to monitor How to monitor Who should monitor How often to
monitor
Number of occurrences ECCAIRS — the split in EASA/competent On a recurrent basis
reported by organisations severity/risk should authority - with the e.g. once a year
affected by this initiative, allow to distinguish the support of the Network
split by severity/risk improvement of of Analyst (NoA)
reporting versus the
improvement of safety
performance
Number of occurrences ECCAIRS — the split in EASA/competent On a recurrent basis
reported by organisations severity/risk should authority - with the e.g. once a year
affected by this initiative allow distinguish the support of the Network
on topics directly related to improvement of of Analyst (NoA)
SMS or safety reporting vs the
performance split by improvement of safety
severity/risk performance
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4. Impact assessment
Number of DOA/POA Surveys, interviews, competent On a recurrent basis
holders applying SMS as audits authorities/EASA e.g. once a year
defined in Part 21
Number and level of
findings related to SMS
requirements per audit on
Part 21 organisations at
state level; effectiveness of
SMS implementation (SMS
maturity indicator)
Number of AMOs applying Surveys, interviews, competent On a recurrent basis
SMS as defined in Part-145 audits authorities/EASA e.g. once a year
Number and level of
findings related to SMS
requirements per audit on
Part-145 organisations at
state level; effectiveness of
SMS implementation (SMS
maturity indicator)
This monitoring will have to be fine-tuned in accordance with the outcome of MST.026 from EPAS
2019-2023, for which the Safety Management Member States Technical bodies (SM.TeB) currently try
to establish markers to assess the effective implementation of SMS throughout the European Union.
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5. Proposed actions to support implementation
5. Proposed actions to support implementation
A number of actions took place during the preparation of this NPA, which helped to foster the
understanding and implementation of the proposed new rules. It is also understood that more actions
will come, notably for Design, Production and Maintenance insofar as the SMS-associated Opinions
will reach the final stage (i.e. adoption and entry into force):
— Workshops
A series of thematic SMS workshops were organised, as follows:
— ACAM implementation for the competent authorities on 27 September 2018, as part of Part-M,
point M.B.303, where a risk-based approach was discussed with the Member States;
— A ‘Product certification & DOA workshop’ on 29-31 October 2018, where this NPA was
presented; a video is available here;
— An SM ICG Industry day on 13 November 2018 where the topic was ‘SMSs made simple’; and
— An SMS workshop on 12-13 February 2019, to which competent authority Air Ops inspectors
were invited - SMS implementation was extensively discussed and there are lessons learned to
use in the Design, Production and Maintenance domains. The presentations and takeaways are
available here.
EASA is also regularly in contact with the Certification Committee (C.COM); the Design and
Manufacturing Technical Committee (DM.TeC); Production and Continuing Airworthiness Committee
(P & CA) TeB; or Engineering and Maintenance Committee (EM.TeC).
Speakers who would like to propose SMS presentations in the fields of Production, Design and
Maintenance can contact EASA at
[email protected]. This may serve the
preparation of an EASA SMS workshop in the fields of Production, Design and Maintenance, once the
final text is known, after this consultation.
— SMS industry standards
SMS Industry Standard SM-000118 ‘Implementing a SMS for Design, Manufacturing and Maintenance
Providers’ as earlier described in Section 2.3.3 is intended to improve safety and to enhance safety
culture.
— Safety promotion and SMS
There is a significant volume of material that promotes SMSs on the EASA website here. An EASA
‘safety promotion’ policy is currently being developed to better support that activity in the future.
EASA also intends to develop, as appropriate, safety promotion material to better explain SMSs in the
fields of design, production and maintenance; several targeted actions are already envisaged.
As part of the introduction of the ‘safety risk management’ in this NPA, ‘fatigue’ is a risk to be carefully
mitigated, notably for Part-145 maintenance organisations (see Section 4.1.3). Guidelines on how to
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5. Proposed actions to support implementation
introduce an effective fatigue risk management system (FRMS) within approved maintenance
organisations will be developed.
Two safety promotion bulletins are being developed about:
— the risks associated with deviation from the use of maintenance data; and
— the risks associated with recurrent defects in aircraft or components.
— When it is ready, this material will be posted and promoted on the EASA website.
— Baines Simmons published a paper on ‘Hazard Identification and Risk Management challenges
throughout the Supply Chain’.
— Anyone can also propose SMS examples, tools and supporting educational material on the ICAO
safety management implementation website (ICAO SMI), which is a repository of SMS
documents to support the implementation of SMS and to complement the 4th edition of the
ICAO Safety Management Manual (ICAO Doc 9859).
— Finally, SMS experts, who would like to propose safety promotion material or presentations, or
SMS implementation cases in the fields of production, design and maintenance, can contact
EASA at
[email protected].
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6. References
6. References
6.1. Affected regulations
— Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing
airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval
of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1)
— Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules
for the airworthiness and environmental certification of aircraft and related products, parts
and appliances, as well as for the certification of design and production organisations (OJ L
224, 21.8.2012, p. 1)
6.2. Affected decisions
— ED Decision 2012/020/R of the Executive Director of the Agency of 30th October 2012 on
Acceptable Means of Compliance and Guidance Material for the airworthiness and
environmental certification of aircraft and related products, parts and appliances, as well as for
the certification of design and production organisations (‘AMC and GM to Part 21’) repealing
Decision No 2003/01/RM of the Executive Director of the Agency of 17 October 2003
— ED Decision 2015/029/R of 17 December 2015 issuing acceptable means of compliance and
guidance material to Part-M, Part-145, Part-66, and Part-147 of Regulation (EU) No 1321/2014
and repealing Decision 2003/19/RM of the Executive Director of the Agency of 28 November
2003 ‘AMC and GM to the Annexes to Regulation (EU) No 1321/2014 — Issue 2’
— ED Decision 2016/011/R of 11 July 2016 amending the Acceptable Means of Compliance and
Guidance Material to Annex I (Part-M), Annex II (Part-145) and Annex III (Part-66) to
Commission Regulation (EU) No 1321/2014 in order to support the implementation of
Commission Regulation (EU) 2015/1536, and issuing the Acceptable Means of Compliance and
Guidance Material to Annex Va (Part-T) ‘Amendments to the AMC & GM to Annex I to
Commission Regulation (EU) No 1321/2014 “Issue 2 — Amendment 1”, amendments to the
AMC & GM to Annex II to Commission Regulation (EU) No 1321/2014 “Issue 2 — Amendment
1”, amendments to the AMC & GM to Annex III to Commission Regulation (EU) No 1321/2014
“Issue 2 — Amendment 1”, and issue of the AMC & GM to Annex Va to Commission Regulation
(EU) No 1321/2014 “Issue 1”’
6.3. Other reference documents
— Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on
the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU)
No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC
of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007
and (EC) No 1330/2007
— ICAO Annex 19 ‘Safety Management’, Edition 2, July 2016.
— ICAO Documentation 9859 ‘Safety Management Manual’ (SMM), Edition 4; June 2018.
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6. References
— Opinions Nos 05/2016 ‘Task force for the review of Part-M for General Aviation (PHASE II)’ and
06/2016 ‘Embodiment of safety management system (SMS) requirements into Commission
Regulation (EU) No 1321/2014 - SMS in Part-M’
— Common, general authority and organisation requirements already published in the areas of air
operations (see Regulation (EU) No 965/2012), aircrew (see Regulation (EU) No 1178/2011),
aerodromes (see Regulation (EU) No 139/2014), air traffic controller training (see Regulation
(EU) 2015/340), and ATM/ANS (see. Regulation (EU) 2017/373).
— Opinion No 07/2016 ‘Embodiment of level of involvement (LOI) requirements into Part 21’
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7. Appendices
7. Appendices
7.1. Appendix I — Detailed summary of changes to Part 21
NPA 2019-05 (B) includes the draft implementing rules (IRs) as well the draft Acceptable Means of
Compliance (AMC) and Guidance Material (GM) for Part 21. The following text is just a summary of
the SMS-related changes to Part-21.
As mentioned in Section 2.1, Part 21 already includes organisational requirements for design and
production organisations ensuring the safety of their products. Some of these requirements may be
easily traced to the ICAO Annex 19 SARPs, such as:
— the identification of an accountable manager or, in the case of a DOA holder, of a head of the
design organisation, ultimate responsible for the activities of the organisation;
— a system to ensure safety (i.e. the design assurance system for the DOA and the quality system
for the POA are elements to ensure the safety of the product, part or appliance);
— independent monitoring of compliance with, and the adequacy of, the documented procedures;
— a system to record the activities;
— an exposition or handbook to document the procedures; and
— the management of changes.
A gap analysis was therefore performed first. Where gaps were identified, EASA developed draft text
that inserted the missing elements and focused on the final goal of improving safety, without imposing
requirements on how organisations should structure themselves in order to reach the final goal.
Moreover, it was decided to keep the structure of Section A unchanged, and to reduce the changes as
much as possible, keeping the current text if it achieves the goals of ICAO Annex 19.
The majority of changes were made to points 21.A.139 and 21.A.239, which were renamed
respectively ‘production management organisation’ and ‘design management organisation’. The
management system will include two elements:
(a) a safety management system; and
(b) a quality system for production organisations, or a design assurance system for design
organisations.
The requirements related to the second element were not changed. In this way, organisations may
keep their current structure and procedures. To build a safety management system, organisations will
be required to do the following (ICAO Annex 19 SARPs missing in the current Part 21):
— develop a safety policy and the related objectives;
— appoint key safety personnel to execute the safety policy;
— establish, implement and maintain a safety risk management process;
— establish, implement and maintain a safety assurance process; and
— promote safety in the organisation.
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If an organisation holds more than one organisational certificate that was issued on the basis of EU
legislation, it is possible to integrate the different management systems into one single system.
A set of AMC & GM is proposed in this NPA that is consistent with the AMC & GM provided in other
domains to demonstrate compliance with the SMS requirements. In this way, an organisation that
already holds an organisational certificate (e.g. CAMO, Part-145, etc.) may reuse most of the evidence
that it has already produced to demonstrate compliance with that regulation.
In this NPA, EASA proposes alternative AMC with which an organisation may also demonstrate
compliance with ‘SMS Industry Standard SM-0001’19 which was developed by AIA-USA, AIA-B, AIA-C,
ASD and GAMA (see the tables included in AMC1 21.A.139(c) and AMC1 21.A.239(c)). An organisation
that intends to demonstrate compliance through the use of the SMS Industry Standard should thus
additionally demonstrate compliance through the elements listed in those AMC in order to
demonstrate compliance with the EU SMS requirements in Part 21.
The AMC contain proportionality elements that allow an organisation to adapt its management system
according to its size and to the nature and complexity of its activities.
Whenever a point in Part 21 was amended to address an SMS requirement, the opportunity was taken
to:
— enhance, when possible, the consistency between the requirements in the various subparts
(e.g. point 21.A.245 has been amended to harmonise its content with the requirements defined
for POA holders in point 21.A.145);
— keep in Section A only organisational requirements, thus separating them from the authority
requirements that have been transferred into Section B:
the classification of findings in points 21.A.125B, 21.A.158 and 21.A.has been
moved to Section B; and
some EASA forms pertaining to applicants, such as EASA Form 50, have been
moved to Section A;
— move to Subpart A all the general requirements that are valid for all applicants:
in point 21.A.3A, requirements related to occurrence reports for production
organisations were moved from points 21.A.129 and 21.A.165;
two new points 21.A.5 for ‘record-keeping’ and 21.A.9 for ‘investigations’
have been added, which replace all the similar requirements that were in
different subparts;
— expand point 21.1 to generally define the competent authority; and
— incorporate some improvements, as proposed by the ASD task force 3 (TF3), to add clarity to
the text of some points.
Moreover, a new process was included in Subparts F and G (production) for an applicant or for a
competent authority to use an AltMoC. This new process is similar to what is already included in other
aviation domains. The new point added defines the procedure to be applied by organisations to
propose such AltMoC, and by competent authorities to inform EASA and other Member States about
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7. Appendices
it. It was considered that for design organisations, such a process is not required, since there is only
one competent authority (EASA), and the process for an organisation to propose AltMoC is already
available as part of EASA procedures. It has been used for a long time with positive results.
Changes in Section B were, in contrast, more extensive. In this case, it was considered beneficial to
align the authority requirements with those defined in other aviation domains, and to also include the
requirements that are applicable when EASA is the competent authority (which today are contained
in EASA procedures). Therefore, several new points have been added to Subpart A of Section B
(‘General’, applicable to all competent authorities) to include requirements for the authority’s
management system, the management of changes, record-keeping, and the use of qualified entities.
Subparts F and G have been amended to harmonise the requirements for the oversight of
organisations, while in Subpart J, requirements similar to Subpart G, applicable to EASA when issuing
a DOA, and to oversight of organisations, have been included.
Point 21.B.40(b), resolution of disputes, has been deleted since EASA does not have any mandate for
mediation of internal disputes in national organisations.
Finally, all the existing AMC and GM that were affected by changes introduced through this RMT were
reviewed and aligned as much as possible with those that are anticipated to cover Part-CAMO and
Part-145. In several cases, it was noticed that GM did not provide explanations or examples, but rather
means of compliance. It was then decided to redefine them as AMC, or to split them into two parts,
keeping explanations as GM and means of compliance as AMC.
List of changes to Part 21 IR
Only new, deleted or modified points are listed. Unmodified points are not reported.
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7. Appendices
Part 21 reference Action
Change of the title in harmonisation with the
content of the rule; all requirements currently
21.1 General Competent authority
spread in Part 21 and defining the competent
authority, have been moved to this point
SECTION A — TECHNICAL REQUIREMENTS
SUBPART A — GENERAL PROVISIONS
21.A.1 Scope Improvement of the text
21.A.3A Failures, malfunctions and defects Requirements for production organisations have
Occurrence reporting been moved from points 21.A.129 and 21.A.165
21.A.5 Record-keeping Replacement of all the record-keeping
requirements spread in Section A
21.A.9 Investigations Replacement of all the investigation requirements
spread in Section A
SUBPART B — TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES
21.A.44 Obligations of the holder References have been updated
21.A.55 Record-keeping The requirement has been moved to 21.A.5
SUBPART D — CHANGES TO TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES
21.A.105 Record-keeping The requirement has been moved to 21.A.5
21.A.109 Obligations and EPA marking References have been updated
SUBPART E — SUPPLEMENTAL TYPE CERTIFICATES
21.A.118A Obligations and EPA marking References have been updated
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.A.124A Alternative means of compliance New point to introduce AltMoC
21.A.125B Findings Update to move classification and requirements
for competent authority to Section B
21.A.125C Duration and continued validity Text improvement and harmonisation with similar
requirements in other Subparts
21.A.126 Production inspection system The record-keeping requirements have been
moved to 21.A.5
21.A.129 Obligations of the manufacturer The reporting requirements have been moved to
21.A.3A
SUBPART G — PRODUCTION ORGANISATION APPROVAL
21.A.134A Alternative means of compliance New point to introduce AltMoC
21.A.139 Quality Production management Introduction of the 12 elements of the safety
system management system as defined by ICAO Annex 19
21.A.143 Exposition Improvement of text
21.A.145 Approval requirements Resources Improvement of text
21.A.147 Changes to the approved production Improvement of text
management system organisation
21.A.157 Investigations The requirement has been moved to 21.A.9
21.A.158 Findings Update to move classification and requirements
for competent authority to Section B
21.A.159 Duration and continued validity References have been updated
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21.A.165 Obligations of the holder Reporting requirements have been moved to
21.A.3A
SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.A.180 Inspections The requirement has been moved to 21.A.9
21.A.181 Duration and continued validity References have been updated
SUBPART I — NOISE CERTIFICATES
21.A.210 Inspections The requirement has been moved to 21.A.9
21.A.211 Duration and continued validity References have been updated
SUBPART J — DESIGN ORGANISATION APPROVAL
21.A.239 Design assurance management system Introduction of the 12 elements of the safety
management system as defined by ICAO Annex 19
21.A.243 Data Handbook Improvement of text
21.A.245 Approval requirements Resources The requirement has been made consistent with
requirement 21.A.145
21.A.247 Changes in to the design management Improvement of text
assurance system
21.A.257 Investigations The requirement has been moved to 21.A.9
21.A.258 Findings Update to move classification and requirements
for competent authority to Section B
21.A.259 Duration and continued validity References have been updated
21.A.263 Privileges Minor changes proposed by this NPA, based on
the text proposed with Opinion No 07/2016 (LOI),
replacing ‘design assurance system’ with ‘design
management system’
21.A.265 Obligations of the holder Minor changes proposed by this NPA, based on
the text proposed with Opinion No 07/2016 (LOI)
SUBPART M — REPAIRS
21.A.447 Record-keeping The requirement has been moved to 21.A.5
21.A.451 Obligations and EPA marking References have been updated
SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
21.A.604 ETSO Authorisation for an Auxiliary References have been updated
Power Unit (APU)
21.A.609 Obligations of holders of ETSO References have been updated
authorisations
21.A.613 Record-keeping The requirement has been moved to 21.A.5
21.A.615 Inspection by the Agency The requirement has been moved to 21.A.9
21.A.619 Duration and continued validity Improvement of text
SUBPART P — PERMIT TO FLY
21.A.705 Competent authority The requirement has been moved to 21.1
21.A.721 Inspections The requirement has been moved to 21.A.9
21.A.723 Duration and continued validity Improvement of text
21.A.729 Record-keeping The requirement has been moved to 21.A.5
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SECTION B — PROCEDURES FOR COMPETENT AUTHORITIES
SUBPART A — GENERAL PROVISIONS
21.B.5 Scope The text has been improved to better specify scope of
Section B and aligned with Part-CAMO Section B
21.B.10 Oversight documentation New point aligned with Part-CAMO Section B
21.B.15 Information to EASA New point aligned with Part-CAMO Section B
21.B.20 Obligations of the competent authority Deleted to align with Part-CAMO Section B
21.B.20 Immediate reaction to a safety problem New point aligned with Part-CAMO Section B
21.B.25 Requirements for the organisation of the Deleted to align with Part-CAMO Section B
competent authority
21.B.25 Management system New point aligned with Part-CAMO Section B
21.B.30 Allocation of tasks to qualified entities New point aligned with Part-CAMO Section B
21.B.30 Documented procedures Deleted to align with Part-CAMO Section B
21.B.35 Changes in organisation and procedures Deleted to align with Part-CAMO Section B
21.B.35 Changes in the management system New point aligned with Part-CAMO Section B
21.B.40 Resolution of disputes Paragraph b was deleted
21.B.45 Reporting/coordination Deleted to align with Part-CAMO Section B
21.B.55 Record-keeping The text has been aligned with Part-CAMO Section B
21.B.65 Suspension, limitation and revocation New point aligned with Part-CAMO Section B
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.B.115 Alternative means of compliance New point aligned with Part-CAMO Section B
21.B.120 Investigation Deleted to align with Part-CAMO Section B
21.B.120 Initial certification procedure New point aligned with Part-CAMO Section B
21.B.125 Findings and corrective actions Updated to include classification and requirements
for competent authority, previously in Section A
21.B.130 Issue of letter of agreement The content has been moved to 21.B.120, to be
consistent with Part-CAMO Section B
21.B.145 Limitation, suspension and revocation of The requirement has been moved to 21.B.65
a letter of agreement
21.B.150 Record-keeping The requirement has been moved to 21.B.55
SUBPART G — PRODUCTION ORGANISATION APPROVAL
21.B.215 Alternative means of compliance New point aligned with Part-CAMO Section B
21.B.220 Investigation Deleted to align with Part-CAMO Section B
21.B.220 Initial certification procedure New point aligned with Part-CAMO Section B
21.B.221 Oversight principles New point aligned with Part-CAMO Section B
21.B.222 Oversight programme New point aligned with Part-CAMO Section B
21.B.225 Findings and corrective actions Updated to include classification and requirements
for competent authority, previously in Section A
21.B.230 Issue of letter of agreement The content has been moved to 21.B.220, to be
consistent with Part-CAMO Section B
21.B.235 Continued surveillance The content has been moved to 21.B.221 and
21.B.222 to align with Part-CAMO Section B
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21.B.240 Amendment of a production organisation Deleted to align with Part-CAMO Section B
approval
21.B.240 Changes to a production organisation New point aligned with Part-CAMO Section B
approval
21.B.245 Suspension and revocation of a The requirement has been moved to 21.B.65
production organisation approval
21.B.260 Record-keeping The requirement has been moved to 21.B.55
SUBPART H — AIRWORTHINESS CERTIFICATES AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.B.330 Suspension and revocation of a noise The requirement has been moved to 21.B.65
certificate
21.B.345 Record-keeping The requirement has been moved to 21.B.55
SUBPART I — NOISE CERTIFICATES
21.B.430 Suspension and revocation of a noise The requirement has been moved to 21.B.65
certificate
21.B.445 Record-keeping The requirement has been moved to 21.B.55
SUBPART J — DESIGN ORGANISATION APPROVAL
21.B.430 Initial certification procedure New point aligned with Part-CAMO Section B
21.B.431 Oversight principles New point aligned with Part-CAMO Section B
21.B.432 Oversight programme New point aligned with Part-CAMO Section B
21.B.433 Findings and corrective actions New point aligned with Part-CAMO Section B
21.B.435 Changes to a design organisation New point aligned with Part-CAMO Section B
approval
SUBPART P — PERMIT TO FLY
21.B.530 Revocation of permits to fly The requirement has been moved to 21.B.65
21.B.545 Record-keeping The requirement has been moved to 21.B.55
APPENDICES
Appendix VIII EASA Form 52 — Aircraft statement of conformity References updated
Appendix X EASA Form 55 — Production organisation approval certificate References updated
Appendix XI EASA Form 65 — Letter of agreement for production without References updated
production organisation approval
List of changes to Part 21 AMC & GM
GENERAL
GM1 Annex 1 Definitions New
GM1 21.1 Competent authority — Responsibility for implementation former GM 21.B.20
GM1 21.1(c) Competent authority — Permit to fly former GM 21.A.705
SECTION A — TECHNICAL REQUIREMENTS
Subpart A — General provisions
AMC1 21.A.3A(a)(1) Occurrence reporting — Collection, investigation and Amended to make it also
analysis of data related to flammability reduction means (FRM) reliability applicable to applicants for a
certificate
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AMC2 21.A.3A(a)(1) Occurrence reporting — Collection, investigation and Amended to make it also
analysis of data related to ETOPS significant occurrences applicable to applicants for a
certificate
GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting — Collecting system The title has been amended
The system for collection, investigation and analysis of data
GM2 21.A.3A(b)(a) and (b) Occurrence reporting The reference in the title has
been amended
GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting — Mandatory and New to provide an overview of
voluntary occurrence reporting Regulation (EU) No 376/2014
GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting — Internal safety New, based on
reporting scheme GM1 ORO.GEN.200(a)(3)
AMC1 21.A.3A(b)(2)(d) Occurrence reporting — Reporting to EASA The reference has been
amended and the text improved
AMC1 21.A.5 Record-keeping New, based on
AMC1 ORO.GEN.220(b)
GM1 21.A.5 Record-keeping New proposed by ASD TF3
AMC1 21.A.5(a) and 21.A.433(a) Record-keeping — Repair design former AMC 21.A.433(a) and
21.A.447
GM1 21.A.5(a) and (b) Record-keeping — Recording and archiving system Former GM 21.A.165(d) and (h),
adapted to cover also design
organisations
AMC1 21.A.5(e) Record-keeping — Record of personnel involved in design Former AMC 21.A.145(d)(2),
or production adapted to cover also design
organisations
GM1 21.A.9 Investigations — Arrangements Former GM 21.A.157,
improvement of text
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
AMC1 21.A.122 Eligibility — Link between design and production References have been amended
AMC1 21.A.124 Application Text moved form from
AMC 21.B.120(c)(1)
GM 21.A.124(a) Application – Application form Deleted, its content has been
moved to AMC3 21.B.120(a)
AMC1 21.A.124A Alternative means of compliance New based on
AMC1 ORO.GEN.120(a)
GM No 1 to 21.A.125(b) Uncontrolled non-compliance with applicable design Deleted, its content has been
data moved to GM1 21.B.125(b)(1),
21.B.225(b)(1) and
21.B430(b)(1)
GM No 2 to 21.A.125(b) Examples of level one findings Deleted, its content has been
moved to GM1 21.B.125(b)
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings — Causal analysis New, as proposed in NPA 2013-
01(C)
GM 21.A.126(b)(6) Production inspection system – Recording and record Deleted, its content has been
keeping moved to GM1 21.A.5 (a) and (b)
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SUBPART G — PRODUCTION ORGANISATION APPROVAL FOR PRODUCTS, PARTS AND APPLIANCES
GM 21.A.134 Application – Application form and manner Deleted, its content has been
moved to AMC1 21.A.134
AMC1 21.A.134 Application Former AMC21.B.220(c) and GM
21.A.134
AMC1 21.A.134A Alternative means of compliance New, based on
AMC1 ORO.GEN.120(a)
GM1 21.A.139(c) Production management system — Safety management New, based on
element GM2 ORO.GEN.200(a)(1)
AMC1 21.A.139(c) Production management system — Safety management New to define the acceptability
element of the SMS industry standard
AMC1 21.A.139(c)(1) Production management system — Safety policy & New, based on
objectives AMC1 ORO.GEN.200(a)(2)
GM1 21.A.139(c)(1) Production management system — Safety policy New, based on
GM1 ORO.GEN.200(a)(2)
AMC1 21.A.139(c)(2) Production management system — Safety New, based on
management element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
GM1 21.A.139(c)(2) Production management system — Safety management New, based on
element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
AMC1 21.A.139(c)(3) Production management system — Safety risk New, based on
management — Interfaces between organisations GM1 ORO.GEN.200(a)(3)
AMC1 21.A.139(c)(3) and (4) Production management system — Safety New, based on
management key processes AMC1 ORO.GEN.200(a)(3)
GM1 21.A.139(c)(4)(ii) Production management system — Management of New, as proposed in NPA 2013-
change 01(C)
AMC1 21.A.139(c)(4)(ii) Production management system — Management of New, as proposed in NPA 2013-
change 01(C)
AMC1 21.A.139(c)(5) Production management system — Safety New, based on
communication AMC1 ORO.GEN.200(a)(4)
GM1 21.A.139(c)(5) Production management system — Safety promotion New GM on safety promotion
AMC1 21.A.139(c)(5)(i) Production management system — Safety training New, dedicated to safety
training
GM1 21.A.139(c)(5)(i) Production management system — Safety training New, dedicated to safety
training
AMC1 GM no1 to 21.A.139(a)(d) Production management system — Quality Amended to be extended to the
system element production management system
AMC1 GM 21.A.139(d)(2)(b)(1) Production management system Quality References have been amended
System — Elements of the quality system
GM1 No2 21.A.139(d)(1)(a) Production management system — Conformity References have been amended
of supplied parts or appliances
AMC1 21.A.139(d)(2)(ii) (b)(1)(ii) Production management system — Vendor References have been amended
and subcontractor assessment, audit and control — Production Organisation
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Approval (POA) holder using documented arrangements with other parties
for assessment and surveillance of a supplier
AMC2 21.A.139(d)(2)(ii) (b)(1)(ii) Production management system — Vendor References have been amended;
and sub-contractor assessment, audit and control — Production the text in the note and the point
Organisation Approval (POA) holder using other party supplier certification on competent authority
approval have been moved to
GM1 21.A.139(d)(2)(ii)
GM1 21.A.139(d)(2)(ii) Production management system — Vendor and sub- The text has been derived from
contractor assessment, audit and control the note and the point on
competent authority approval in
AMC No2 to 21.A.139(b)(1)(ii)
AMC1 21.A.139(e) Production management system — Documentation New, based on
GM1 ORO.GEN.200(a)(5)
AMC1 21.A.139(f) Production management system — Independent New, based on
monitoring of compliance and adequacy AMC1 ORO.GEN.200(a)(6))
GM No 1 to 21.A.139(b)(2) Quality System – Independent quality assurance Deleted
function
GM1 No2 21.A.139(f)(b)(2) Production management system — Adequacy of References have been amended
procedures and monitoring function
GM1 21.A.143 Exposition - Production Organisation Exposition (POE) Amended to improve the text
AMC1 21.A.143(a)(1) Exposition New, to include the commitment
statement
AMC1 21.A.145(a) Resources Text derived from
GM 21.A.145(a)
GM1 21.A.145(a) Resources Approval Requirements Amended to move text
containing means of compliance
in AMC1 21.A.145(a)
GM1 21.A.145(b)(2) Approval requirements Resources — Airworthiness, Amended to improve the text
noise, fuel venting and exhaust emissions /production data procedures
AMC1 21.A.145(c)(1) Resources — Accountable manager New, based on CAMO.A.305 and
on GM 21.A.145(c)(1)
GM1 21.A.145(c)(1) Approval requirements Resources — Accountable Amended, some of the text has
manager been moved to
AMC1 21.A.145(c)(1)
AMC1 GM21.A.145(c)(2) Approval requirements Resources — Responsible Amended to improve the text
managers and include text based on
AMC1 ORO.GEN.200(a)(6)
AMC2 21.A.145(c)(2) Resources — Competency of personnel New, to define competency of
personnel
AMC1 21.A.145(d)(1) Approval requirements Resources — Certifying staff Amended to improve the text
AMC 21.A.145(d)(2) Approval requirements – Record of certifying staff Deleted, its content has been
moved to AMC1 21.A.5(e)
AMC1 21.A.145(d)(2)(3) Approval requirements Resources – Evidence of Amended to improve the text
authorisation
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AMC1 21.A.147 Changes to the production management system — New to include the text deleted
Application for variation of scope and terms of the POA from point 21.A.147 and the text
from AMC No1 to 21.B.240
GM1 21.A.147(a) Changes to the approved production management system Amended to improve the text
organisation — Significant changes
GM1 21.A.149 Transferability References have been amended
AMC1 21.A.153 Changes to the terms of approval — Application for a change References have been amended
to the terms of approval
GM 21.A.157 Investigations – Arrangements deleted
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design Deleted, its content has been
data moved to GM1 21.B.125(b)(1),
21.B.225(b)(1) and
21.B430(b)(1)
GM No 2 to 21.A.158(a) Examples of level one findings Deleted, its content has been
moved to GM1 21.B.125(b)
GM 21.A.165(d) and (h) Obligations of the holder – Recording and archiving Deleted, its content has been
system moved to GM1 21.A.5(a) and (b))
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings — Causal analysis New, as proposed in NPA 2013-
01(C)
SUBPART J — DESIGN ORGANISATION APPROVAL
GM1 21.A.239(c) Design management system — Safety management New, based on
element GM2 ORO.GEN.200(a)(1)
AMC1 21.A.239(c) Design management system — Safety management New to define acceptability of
element SMS industry standard
AMC1 21.A.239(c)(1) Design management system — Safety policy & New, based on
objectives AMC1 ORO.GEN.200(a)(2)
GM1 21.A.239(c)(1) Design management system — Safety policy New, based on
GM1 ORO.GEN.200(a)(2)
AMC1 21.A.239(c)(2) Design management system — Safety management New, based on
element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
GM1 21.A.239(c)(2) Design management system — Safety management New, based on
element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
AMC1 21.A.239(c)(3) and (4) Design management system — Safety New, based on
management key processes AMC1 ORO.GEN.200(a)(3)
AMC1 21.A.239(c)(3) Design management system — Safety risk management New, based on
— Interfaces between organisations GM1 ORO.GEN.200(a)(3)
AMC1 21.A.239(c)(4)(ii) Design management system — Management of New, as proposed in NPA 2013-
change 01(C)
GM1 21.A.239(c)(4)(ii) Design management system — Management of New, as proposed in NPA 2013-
change 01(C)
AMC1 21.A.239(c)(5) Design management system — Safety communication New, based on
AMC1 ORO.GEN.200(a)(4)
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GM1 21.A.239(c)(5) Design management system — Safety Promotion New GM on safety promotion
AMC1 21.A.239(c)(5)(i) Design management system — Safety training New, dedicated to safety
training
GM1 21.A.239(c)(5)(i) Design management system — Safety training New, dedicated to safety
training
GM1 21.A.239(d)(a) Design management system — Design assurance system Part of the text has been moved
element to AMC1 21.A.239(d)
AMC1 21.A.239(d) Design management system — Design assurance element Former GM1 21.A.239(d)
AMC2 GM21.A.239(d)(a) Design management system — Design assurance Change of title to reflect the
element system for minor changes to type design or minor repairs to content
products
AMC1 21.A.239(a)(3) Design assurance system – Independent system Deleted
monitoring
AMC1 21.A.239(d)(2)(b) Design management assurance system — References have been amended
Independent verification checking function of the demonstration of
compliance
GM1 21.A.239(d)(3)(c) Design management system — Design assurance References have been amended
element system
AMC1 21.A.239(e) Design management system — Documentation New, based on
GM1 ORO.GEN.200(a)(5)
AMC1 21.A.239(f) Design management system — Independent monitoring of New, based on
compliance and adequacy AMC1 ORO.GEN.200(a)(6))
AMC1 21.A.243(a) Data Handbook Amended to improve the text,
change references and include
the commitment statement
AMC2 21.A.243(a) Data Handbook — Model content of handbook for References have been amended
organisations designing minor changes to type design or minor repairs to
products
AMC1 21.A.243(d) Handbook — Statement of qualifications and experience Text from GM No 1 to
21.A.243(d)
GM1 21.A.243(d) Handbook — Statement of qualifications and experience Amended to update references,
to include safety functions, and
to delete means of compliance
and move them to
AMC1 21.A.243(d)
AMC2 21.A.243(d) Handbook Data requirements — Statement of the Amended to improve the text
qualification and experience – Organisations designing minor changes to type
design or minor repairs to products
AMC GM No1 21.A.245 Resources Requirements for approval Amended to improve the text
and update references
AMC GM No 2 21.A.245 Resources Requirements for approval — Amended to improve the text
Organisations designing minor changes to type design or minor repairs to
products
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AMC1 21.A.245(a) Resources — Head of the design organisation New, based on CAMO.A.305 and
on GM 21.A.145(c)(1)
AMC1 21.A.245(b) Resources — Responsible managers New text based on
AMC1 ORO.GEN.200(a)(6) and
AMC1 21.A.145(c)(2)
AMC2 21.A.245(b) Resources — Competency of personnel New, to define competency of
personnel
AMC1 21.A.247 Changes to the design management system — Application New, text derived from the
for a significant change or a variation of scope and terms of the DOA deleted point 21.A.247
GM1 21.A.247 Changes to in the design management assurance system Amended to improve the text
GM 21.A.257(a) Investigations Deleted, its content has been
moved to GM1 21.A.9
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings — Causal analysis New, as proposed in NPA 2013-
01(C)
SUBPART M — REPAIRS
AMC1 AMC 21.A.433(a) and 21.A.447 Repair design and record keeping Deleted, its content has been
moved to AMC1 21.A.5(a) and
21.A.433(a)
SUBPART P — PERMIT TO FLY
GM 21.A.705 Competent authority Deleted, its content has been
moved to GM1 21.1(c)
SECTION B PROCEDURES FOR COMPETENT AUTHORITIES
SUBPART A — GENERAL
GM 21.B.20 Responsibility for implementation Deleted, its content has been
moved to 21.1(a)(2) and (3)
AMC1 21.B.25 Management system — General New, based on
AMC1 ARO.GEN.120(e)
AMC2 GM21.B.25 Organisation Management System — General Amended to improve the text
GM 21.B.25(b)– Resources deleted
GM 21.B.25(c) Qualification and training deleted
AMC1 21.B.25(a)(1) Management system — Documented procedures former AMC 21.B.30(a)
GM1 21.B.25(a)(2) Management system — Personnel New, based on
GM1 ARO.GEN.200(a)(2)
AMC1 21.B.25(a)(3) Management system — Qualification and training — New, based on
General AMC1 ARO.GEN.200(a)(2)
AMC2 21.B.25(a)(3) Management system — Qualification and training — New, based on the current
Technical personnel including inspectors AMC 145.B.10(3)
AMC3 21.B.25(a)(3) Management system — Initial and recurrent training — New, based on
Inspectors AMC2 ARO.GEN.200(a)(2)
AMC1 21.B.25(a)(5) Management system — Safety risk management process New AMC on safety risk
management as part of the
management system framework
for competent authorities
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7. Appendices
GM1 21.B.25(a)(5) Management system — Safety risk management process New GM on the same subject
AMC1 21.B.25(d) Management system — Procedures available to EASA New AMC based on
AMC1 ARO.GEN.200(d)
AMC 21.B.30(a) Documented procedures Deleted, its content has been
moved to AMC1 21.B.25(a)(1)
GM1 21.B.30 Allocation of tasks to qualified entities — Certification tasks New, based on
GM1 ARO.GEN.205
AMC 21.B.35(a) Changes deleted
GM No 1 to 21.B.45 Co-ordination with other related activities deleted
GM No 2 to 21.B.45 Co-ordination deleted
GM No 3 to 21.B.45 Reporting – Information relevant to registers established deleted
by the Agency
AMC1 21.B.55(a) Record-keeping — General New, based on
AMC1 ARO.GEN.220(a)
AMC1 21.B.55(a)(1) Record-keeping — Competent authority management New, based on
system AMC1 ARO.GEN.220(a)(1);(2);(3)
GM1 21.B.55 Record-keeping — Design approvals transferred to the Agency References have been amended
GM1 21.B.55(e) Record-keeping — Traceability of release certificates former GM 21.B.150(d)
AMC1 21.B.65 Suspension, limitation and revocation — Corrective action former AMC 21.B.245
plan
AMC1 21.B.65(c) Suspension, limitation and revocation — Information on New AMC, as proposed in NPA
security situation 2013-01(C)
GM1 21.B.65 Suspension, limitation and revocation former GM 21.B.245
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
GM1 21.B.115 and 21.B.215 Alternative means of compliance New, based on
GM1 ARO.GEN.120
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance — New, based on
Demonstration of compliance AMC1 ARO.GEN.120(e)
AMC1 21.B.120(a) Initial certification procedure — Investigation team New, based on the curent
21.B.120
AMC2 21.B.120(a) Initial certification procedure — Investigation team Amended to improve the text
Qualification criteria for the investigation team members
AMC3 21.B.120(a)(c)(1) Initial certification procedure — Evaluation of Amended to improve the text
applications and remove Form 60 that has
been moved to AMC1 21.A.124
AMC4 GM 21.B.120(a)(c)(3) Initial certification procedure — Investigation Amended to improve the text
preparation and planning and update references
GM1 21.B.120(c) Initial certification procedure — Auditing and investigation The title has been updated
findings
AMC1 21.B.120(d) Initial certification procedure — Issue of the letter of Former AMC 21.B.130 and
agreement GM 21.B.130(b)
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and former GM 21.B.125(a)
corrective actions — Objective evidence
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7. Appendices
GM1 21.B.125(b) Findings and corrective actions — Examples of level 1 Former GM No 2 to 21.A.125B(a)
findings
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions — Former GM No1 to 21.A.125B(a)
Uncontrolled non-compliance with applicable design data
AMC1 21.B.125(d) Findings and corrective actions — Notification of findings New, based on AMC 21.B.225(a)
AMC 21.B.130 Issue of the letter of agreement Deleted, its content has been
oved to AMC1 21.B.120(d)
GM 21.B.130(b) Issue of the letter of agreement Deleted, its content has been
oved to AMC1 21.B.120(d)
AMC1 21.B.140 Amendment of a letter of agreement The text has been improved and
references have been amended
GM 21.B.150(d) Record keeping – Traceability of release certificates Deleted, its content has been
oved to GM1 21.B.55(e)
SUBPART G — PRODUCTION ORGANISATION APPROVAL
GM1 21.B.115 and 21.B.215 Alternative means of compliance New, based on
GM1 ARO.GEN.120
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance — New, based on
Demonstration of compliance AMC1 ARO.GEN.120(e)
AMC1 21.B.220 and 21.B.430 Initial certification procedure — Verification of New, based on
compliance AMC1 ARO.GEN.310(a)
AMC1 GM No 1 to 21.B.220(c) Procedures for investigation Initial Amended to improve the text
certification procedure — Investigation preparation and planning
AMC1 21.B.220 and 21.B.221 Initial certification procedure — Investigation New text, based on 21.B.220
team
AMC1GM 21.B.220(a) Initial certification procedure — Investigation team Amended to improve the text
AMC 21.B.220(c) Procedures for investigation – Evaluation of applications Deleted, its content has been
oved to AMC1 21.A.134
GM1 No 2 to 21.B.220(c) Initial certification procedure — Organisation Amended to improve the text
approval Procedures for investigation — General and update references
GM2 No 3 to 21.B.220(c) Initial certification procedure — Procedures for Amended to update references
investigation – POA applications Application received from organisations
with facilities/partners/suppliers/subcontractors located in a third country
GM3 No 4 to 21.B.220(c) Initial certification procedure Procedures for Amended to update references
investigation — Competent authority surveillance of suppliers of a POA
holder located in other Member States
AMC1 21.B.220(d)(1) Initial certification procedure — Issuance of the former AMC No1 to 21.B.230
certificate
AMC1 21.B.221(a), (b) and (c) Oversight principles — Management system New, based on
assessment GM1 ARO.GEN.300(a);(b);(c)
AMC1 21.B.222 and 21.B.432 Oversight programme — Annual review New, as proposed in NPA 2013-
01(C)
GM1 21.B.222(a) Oversight programme — Maintenance of the POA — Work former GM 21.B.235(b)
allocation within the competent authority
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7. Appendices
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme — Specific nature New, based on
and complexity of the organisation — results of past oversight AMC1 ARO.GEN.305(b);(d);(d1)
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme — Subcontracted New AMC added for determine
activities the need for oversight for
subcontracted organisations
GM1 21.B.222(b) Oversight programme former GM 21.B.235(b) and (c)
AMC1 21.B.222(b)(1) Oversight programme — Audit New, based on
AMC1 ARO.GEN.305(b)(1)
GM1 21.B.222(b)(1)(ii) Oversight programme — Guide to the conduct of Former GM 21.B.235(a)(4)
monitoring production standards
AMC1 21.B.222(c) Oversight programme — Oversight planning cycle audit New, based on
and inspection AMC1 ARO.GEN.305(c)
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme — Oversight New, based on
planning cycle — Audit AMC1 ARO.GEN.305(c)
AMC1 21.B.222(d) Oversight programme — Extension of the oversight New, as proposed in NPA 2013-
planning cycle beyond 24 months 01(C)
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and former GM 21.B.125(a)
corrective actions — Objective evidence
AMC1 21.B.225(d)(a) Findings and corrective actions — Notification of Amended to improve the text
findings
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions — Former GM No1 to 21.A.125B(a)
Uncontrolled non-compliance with applicable design data
AMC No 1 to 21.B.230 Issue of the certificate Deleted, its content has been
moved to AMC1 21.B.220(d)(1)
GM 21.B.235(a)(4) Guide to the conduct of monitoring production standards. Deleted, its content has been
moved to GM1 21.B.222(b)(1)(ii)
GM 21.B.235(b) Maintenance of the POA - Work allocation within the Deleted, its content has been
competent authority moved to GM1 21.B.222(a)
GM 21.B.235(b) and (c) Continued surveillance Deleted, its content has been
moved to GM1 21.B.222(b)
AMC 21.B.235(c) Continuation of POA Deleted, its content has been
moved to AMC1 21.B.222(b)(1)
and 21.B.432(b)(1)
AMC1 No 1 to 21.B.240 Changes to a production organisation approval — Amended, based on
Application for significant changes or a variation of scope and terms of the AMC1 ARO.GEN.33 and removal
POA of Form 51 that has been moved
to AMC1 21.A.147
GM 21.B.245 Continued validity Deleted, its content has been
moved to GM1 21.B.65
AMC 21.B.245 Corrective action plan Deleted, its content has been
moved to AMC1 21.B.65
SUBPART J — DESIGN ORGANISATION APPROVAL
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7. Appendices
AMC1 21.B.220 and 21.B.430 Initial certification procedure — Verification of New, based on
compliance AMC1 ARO.GEN.310(a)
AMC1 21.B.430 and 21.B.431 Initial certification procedure — Investigation New, based on AMC1 21.B.220
team and 21.B.221
AMC1 21.B.430(a) Initial certification procedure — Organisation approval New, based on
team AMC1 21.B.220(a)
AMC1 21.B.430(d)(1) Initial certification procedure — Issuance of the New based on
certificate AMC1 21.B.220(d)(1)
AMC1 21.B.431(a), (b) and (c) Oversight principles — Management system New, based on
assessment GM1 ARO.GEN.300(a);(b);(c)
AMC1 21.B.222 and 21.B.432 Oversight programme — Annual review New, as proposed in NPA 2013-
01(C)
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme — Specific nature New, based on
and complexity of the organisation — results of past oversight AMC1 ARO.GEN.305(b);(d);(d1)
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme — Subcontracted New AMC, added for determine
activities the need for oversight for
subcontracted organisations
AMC1 21.B.432(b)(1) Oversight programme — Audit New, based on
AMC1 ARO.GEN.305(b)(1)
AMC1 21.B.432(c) Oversight programme — Oversight planning cycle audit New, based on
and inspection AMC1 ARO.GEN.305(c)
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme — Oversight New, based on
planning cycle — Audit AMC1 ARO.GEN.305(c)
AMC1 21.B.432(d) Oversight programme — Extension of the oversight New, as proposed in NPA 2013-
planning cycle beyond 24 months 01(C)
GM1 21.B.125(b), 21.B.225(b) and 21.B4.30(b) Findings and corrective former GM 21.B.125(a)
actions — Objective evidence
AMC1 21.B.433(d) Findings and corrective actions — Notification of findings New, based on AMC1
21.B.225(d) Findings and
corrective actions - Notification
of findings
AMC1 21.B.435 Changes to a design organisation approval — Application for New, based on on
significant changes or A variation of scope and terms of the DOA AMC1 ARO.GEN.33
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7. Appendices
7.2. Appendix II — Detailed summary of changes for Part-145
NPA 2019-05 (C) includes the draft implementing rules (IRs) as well the draft Acceptable Means of
Compliance (AMC) and Guidance Material (GM) for Part-145. The following text is just a summary of
the SMS-related changes to Part-145.
General changes to Part-145 text (IR/AMC/GM Section A and Section B):
— All references to a ‘quality system’ are replaced by a ‘management system’ or ‘compliance
monitoring’ (depending on the context).
— All references to ‘continuation training’ are replaced by ‘recurrent training’.
— All references to a ‘surveyor’ are replaced by ‘inspector’.
— All references to personnel ‘competence’ are replaced by ‘competency’.
— All references to personnel ‘human factors training’ are replaced by ‘safety training’.
— General linguistic improvement.
— All references to ‘approval schedule’ are replaced by ‘terms of approval’. Several changes were
made to clarify the use of the terms ‘approval’ (in the sense of approval process) and ‘certificate’
(in the sense of the output of an approval process).
— References to Regulation (EC) No 216/2008 have been changed to Regulation (EU) 2018/1139.
— References to ‘indirect approval’ are adapted, where applicable, to the concept of ‘change not
requiring prior approval’ (see 145.A.85).
— References to Flight Engineer (FE) licences are deleted, as these are no longer foreseen in
Part-FCL (Commission Regulation (EU) No 1178/2011). The existing authorisation is to be
‘grandfathered’ through the amendment of Article 4.
— References to EASA Form 4 are deleted, as also discussed for Part-CAMO, and this is for all cases
(nominated post holders, safety manager, compliance monitoring manager). The relevant
points are amended to define the acceptance process through oversight and formal acceptance
through approving the exposition.
— When the content of existing AMC or GM is amended or for new AMC or GM, the title of the
AMC or GM takes a sequential number (e.g. AMC1, GM2, etc.).
— Remark: at the AMC & GM level, similarly to the approach taken for Part-CAMO and explained
in Opinion No 06/2016, no distinction will be made between complex and non-complex
organisations, and a single set of AMC & GM will be applicable to all Part-145 organisations.
List of changes to the Cover Regulation
COVER REGULATION
Article 4 New paragraph 9 to ensure that any existing
certification authorisation issued on the basis of a
flight engineer licence continues to remain valid.
New paragraph 10 for the adaptation of the
organisation with the management system
List of changes to Part-145 IR*
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* For Section B, because it is replaced by a new content aligned with Part-CAMO, the deleted rule
points are not listed. For Section A, to give a complete picture, also the unchanged points are
indicated.
Numbering convention:
Section A: any existing/amended point keeps the current numbering; any ‘new’ point takes the CAMO
numbering.
Section B: full alignment with the Part-CAMO numbering
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7. Appendices
Part-145 reference Action
Change of the title in harmonisation with CAMO.A.105;
consideration of new Basic Regulation Article 65 on
reallocation of competent authority responsibility to EASA
145.1 General Competent authority upon request of organisations operating in more than one
Member State; consideration of new Basic Regulation Article
64 on reallocation of responsibility upon request of Member
States
SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS
145.A.10 Scope Alignment with CAMO.A.005 (Scope)
145.A.15 Application for an organisation Alignment with CAMO.A.115 (Application for an organisation
certificate certificate)
Alignment with part of CAMO.A.125 (Terms of approval and
145.A.20 Terms of approval
privileges of the organisation)
145.A.25 Facility requirements No change
Alignment of with CAMO.A.305 (Personnel requirements) for
the accountable manager and nominated persons
145.A.30 Personnel requirements
The reference to flight engineer has been deleted in (j); the
reference to 145.A.37 has been introduced in (k)
See ‘General changes’; point (j) is moved to 145.A.55 (Record-
145.A.35 Certifying staff and support staff
keeping)
145.A.36 Records of airworthiness review Deleted, its content has been moved to 145.A.55 (Record-
staff keeping)
New, based on CAO.A.045 (Airworthiness review staff)
145.A.37 Airworthiness review staff
(Opinion No 05/2016)
145.A.40 Equipment and tools No change
145.A.42 Components No change
see ‘General changes’; the reference to 145.A.202 has been
145.A.45 Maintenance data introduced in (c); the reference to HF has been introduced in
(e)
Points (b) and (d) have been amended to introduce the risks
145.A.47 Production planning related to (respectively) personnel fatigue and external
working teams
Alignment with M.A.201(c) and 145.A.80; adaptation to
145.A.48 Performance of maintenance
management system
145.A.50 Certification of maintenance Alignment with M.A.801 as amended by Opinion No 05/2016
Alignment with CAMO.A.220 (Record-keeping), former
145.A.55 Maintenance and airworthiness
145.A.35(j) and 145.A.36; alignment with ML.A.904(d)
review records Record-keeping
(Opinion No 05/2016) for airworthiness review records;
Alignment with CAMO.A.160; elements of internal reporting
145.A.60 Occurrence reporting
to be covered by 145.A.202
Delete ‘safety/quality’ elements (see 145.A.200); keep
145.A.65 Safety and quality policy,
145.A.65(b) with minor alignment to CAMO.A.315(e)
Maintenance procedures and quality system
(Continuing airworthiness management)
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Clarification on the MOE objective; certain alignment with
145.A.70 Maintenance organisation
CAMO.A.300 (CAME); deletion of ‘where applicable’ when not
exposition (MOE)
referring to a given implementing rule requirement
Simplification of (b) to prevent the interpretation that
subcontracting maintenance to approved organisation is
145.A.75 Privileges of the organisation prohibited; the limitation of airworthiness review privilege
inside the Member States has been added (see
CAMO.A.125(e))
145.A.80 Limitations on the organisation Deleted, its content has been moved to 145.A.48
145.A.85 Changes to the organisation Alignment with CAMO.A.130 (Changes to the organisation)
145.A.90 Continued validity Alignment with CAMO.A.135 (Continued validity)
145.A.95 Findings Alignment with CAMO.A.150 (Findings)
145.A.120 Means of compliance Alignment with CAMO.A.120 (Means of compliance)
145.A.140 Access Alignment with CAMO.A.140 (Access)
145.A.155 Immediate reaction to a safety Alignment with CAMO.A.155 (Immediate reaction to a safety
problem problem)
145.A.200 Management system Alignment with CAMO.A.200 (Management system)
Alignment with CAMO.A.202 (Internal safety reporting
145.A.202 Internal safety reporting scheme
scheme)
Based on CAMO.A.205 (Contracting and subcontracting) and
145.A.205 Contracting and subcontracting ORO.GEN.205 (contracted activities) for purchased
equipment or services
SECTION B — AUTHORITY REQUIREMENTS PROCEDURES FOR COMPETENT AUTHORITIES
145.B.005 Scope New/aligned with Part-CAMO Section B
145.B.115 Oversight documentation New/aligned with Part-CAMO Section B
New/aligned with Part-CAMO Section B with a minor
145.B.120 Means of compliance
clarification in point (a)
145.B.125 Information to EASA New/aligned with Part-CAMO Section B
145.B.135 Immediate reaction to a safety New/aligned with Part-CAMO Section B
problem
New/aligned with Part-CAMO Section B with a minor
145.B.200 Management system
difference in point (d)
New/aligned with Part-CAMO Section B with a minor change
145.B.205 Allocation of tasks to qualified
in point (a) to remove the reference to the Member State,
entities
because the regulated entity is the Competent Authority.
145.B.210 Changes in the management New/aligned with Part-CAMO Section B
system
145.B.220 Record-keeping New/aligned with Part-CAMO Section B
New/aligned with Part-CAMO Section B with a minor
145.B.300 Oversight principles
improvement in points (d) and (e)
145.B.305 Oversight programme New/aligned with Part-CAMO Section B
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New/aligned with Part-CAMO Section B with a minor
145.B.310 Initial certification procedure
clarification in point (b)
New/aligned with Part-CAMO Section B with a clarification in
145.B.330 Changes — organisations
point (e)
145.B.350 Findings and corrective actions New/aligned with Part-CAMO Section B
145.B.355 Suspension, limitation, and New/aligned with Part-CAMO Section B
revocation
APPENDICES TO PART-145
Appendix I — Authorised Release Certificate — EASA
No change
Form 1
Appendix II — Class and Rratings Ssystem used for the Incorporate the content from Appendix IV to Part-M;
Aapproval of Mmaintenance Oorganisations referred adapt indirect approval of capability list with the
to in Annex I (Part-M) Subpart F and Annex II (Part-145) approach of change not requiring prior approval
Appendix III — Maintenance Oorganisation certificate Alignment with Appendix I to Part-CAMO
Approval referred to in Annex II (Part-145) — EASA (Certificate); Change related to the airworthiness
Form 3-145 review privilege (modified by Opinion No 06/2016)
Appendix IV — Conditions for the use of staff not
qualified in accordance with Annex III (Part-66) No change
referred to in points 145.A.30(j)1 and 2
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7. Appendices
List of changes to Part-145 AMC & GM*
*For Section A, only AMC & GM affected by this RMT are listed. For Section B, because it is
replaced by a new content aligned with Part-CAMO, the deleted AMC & GM are not listed.
GENERAL
GM1 to Annex II (Part-145) Definitions New
SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS
AMC1 145.A.10 Scope Minor adaptation to management system
GM1 145.A.10 Scope Adaptation to management system; clarification that the
external organisation performing the independent audit is
subcontracted.
AMC1 145.A.15 Application for an organisation Alignment with AMC M.A.702 (to become AMC1 CAMO.A.115)
certificate
AMC2 145.A.15 Application for an organisation New; information on ‘pre-audit’
certificate
GM1 145.A.15(b) Application for an organisation New; the purpose is to explain that the ‘shall’ in 145.A.15(b)
certificate does not mean that ‘changes not requiring prior approval’
(145.A.85(c)) is a privilege and can be used from the start of
operation
AMC1 145.A.25(a) Facility requirements New point (5), introduced to clarify that, considering a risk
assessment, flexibility is allowed for certain base maintenance
tasks to be carried in facility other than a hangar enclosing the
whole aircraft (EM.TEC input).
AMC1 145.A.30(a) Personnel requirements Alignment with AMC M.A.706(a) (to become
AMC1 CAMO.A.305(a))
AMC1 145.A.30(b) Personnel requirements Partial alignment with AMC M.A.706 (to become
AMC1 CAMO.A.305(a)(3)) and adaptation to management
system; quality and safety manager are not subject of this AMC
GM1 145.A.30(b) Personnel requirements New; explanation of the purpose of ‘ensuring compliance’ (as
opposed to ‘monitoring compliance’)
AMC1 145.A.30(c) Personnel requirements Adaptation to management system
AMC1 145.A.30(c);(ca) Personnel requirements New AMC for the safety management and compliance
monitoring function (based on AMC1 ORO.GEN.200(a)(1) and
AMC1 ORO.GEN.200(a)(6))
GM1 145.A.30(ca) Personnel requirements New GM for the safety manager, based on
GM1 ORO.GEN.200(a)(1)
AMC1 145.A.30(cc) Personnel requirements New AMC for nominated persons, based on AMC M.A.706 (to
become AMC1 CAMO.A.305(c))
AMC1 145.A.30(d) Personnel requirements Adaptation to management system
AMC1 145.A.30(e) Personnel requirements Adaptation to management system
AMC2 145.A.30(e) Personnel requirements Adaptation to management system and change from HF
training to safety training
AMC3 145.A.30(e) Personnel requirements Simplification and update of reference
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AMC4 145.A.30(e) Personnel requirements Simplification and ‘general change’
AMC5 145.A.30(e) Personnel requirements New AMC, based on the current GM2 145.A.30(e),
AMC M.A.706(k) (to become AMC3 CAMO.A.305(g)) and
AMC M.A.607
GM1 145.A.30(e) Personnel requirements Adaptation to management system as safety training
GM2 145.A.30(e) Personnel requirements Elements moved to new AMC5 145.A.30(e); Adaptation to
management system and safety training
GM3 145.A.30(e) Personnel requirements Adaptation to management system
GM4 145.A.30(e) Personnel requirements New GM, based on EHFAG (former HF CAG) inputs
GM5 145.A.30(e) Personnel requirements New GM, based on HF CAG inputs
GM6 145.A.30(e) Personnel requirements New GM, added to clarify the scope of safety training
depending on the complexity of the organisation.
AMC1 145.A.30(f) Personnel requirements See ‘general changes’
AMC1 145.A.30(h) Personnel requirements See ‘general changes’
AMC1 145.A.30(j)(4) Personnel requirements Deletion of the point relevant to flight engineer which no
longer exists under Part-FCL.
GM 145.A.30(j)(4) Personnel requirements (Flight Deleted because it is relevant to flight engineer which no
crew) longer exist under Part-FCL.
AMC1 145.A.30(j)(5) Personnel requirements Adaptation to management system
AMC1 145.A.30(j)(5)(i) Personnel requirements Adaptation to management system
AMC1 145.A.30(j)(5)(ii) Personnel requirements Adaptation to management system
AMC1 145.A.35(a) Certifying staff and support See ‘general changes’ and update of reference
staff
AMC1 145.A.35(d) Certifying staff and support See ‘general changes’ and adaptation to management system
staff
AMC1 145.A.35(e) Certifying staff and support See ‘general changes’ and update of reference
staff
AMC1 145.A.35(f) Certifying staff and support See ‘general changes’ and update of reference
staff
AMC1 145.A.45(c) Maintenance data Use of internal safety reporting scheme (145.A.202)
AMC1 145.A.45(d) Maintenance data Adaptation to management system
AMC1 145.A.45(e) Maintenance data New point linked to the risk when using a work card system
provided by the operator/CAMO
AMC1 145.A.47(b) Production planning New AMC related to fatigue risk management
AMC GM1 145.A.47(b) Production planning AMC changed to GM and expanded with fatigue information
GM1 145.A.47(d) Production planning New GM to explain the meaning of ‘external working teams’
AMC1 145.A.48(a) AMC 145.A.80 Limitations on Provision extended to component maintenance organisation;
the organisation Performance of maintenance see also ‘general changes’
AMC1 145.A.48(c)(2) AMC1 145.A.48(b) Reference of the AMC amended to reflect the revised
Performance of maintenance implementing rule
AMC2 145.A.48(c)(2) AMC2 145.A.48(b) Reference of the AMC amended; clarification provided on the
Performance of maintenance source used for critical task identification
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7. Appendices
AMC3 145.A.48(c)(2) AMC3 145.A.48(b) Reference of the AMC amended
Performance of maintenance
AMC4 145.A.48(c)(2) AMC4 145.A.48(b) Reference of the AMC amended
Performance of maintenance
AMC1 145.A.48(c)(3) Performance of Amended references
maintenance
GM1 145.A.48(c)(3) Performance of maintenance Amended references; correct the term ‘duplicate’ by
‘independent’
GM1 145.A.48(c)(4) GM 145.A.48(d) Performance Amended references
of maintenance — critical design configuration
control limitations (CDCCL)
GM1 AMC 145.A.50(a) Certification of AMC changed into GM; clarification of the responsibilities
maintenance linked to the issue of a CRS
AMC1 145.A.50(b) Certification of maintenance Alignment with ICAO Annex 6, Part I, Paragraph 8.8.
AMC1 145.A.50(e) Certification of maintenance Change relevant to the convention for referencing the rule
AMC1 145.A.55 Record-keeping New AMC; alignment with AMC1 ORO.GEN.220(b)
GM1 145.A.55 Record-keeping New GM; alignment with GM1 ORO.GEN.220(b)
GM1 145.A.55(a)(1) Record-keeping Maintenance Amended to limit to ‘maintenance records’; general points 4.,
and airworthiness review records 5. and 6. covered by AMC1 145.A.55
AMC1 145.A.55(a)(3) AMC 145.A.55(c) Record- Amended reference and title
keeping Maintenance and airworthiness review
records
AMC1 145.A.55(d) AMC 145.A.35(j) Certifying Amended to limit to certifying staff and support staff records;
staff and support staff Record-keeping See ‘general changes’
AMC2 145.A.55(d) AMC 145.A.36 Record-keeping AMC 145.A.36 relocated under 145.A.55(d)
Records of airworthiness review staff
AMC 145.A.60(b) Occurrence reporting Deleted; intent covered by the new AMC1 145.A.202
AMC 145.A.65(a) Safety and quality policy, Deleted; covered by AMC1 145.A.200(a)(2)
maintenance procedures and quality system
AMC1 145.A.65(b) Safety and quality policy, Amended reference and use of internal safety reporting
mMaintenance procedures and quality system scheme (145.A.202)
GM1 145.A.65 Maintenance procedures New GM added to provide guidance on the design and
presentation of technical procedures in line with human
factors principles.
GM2 145.A.65(b)(1) Safety and quality policy, Amended references
mMaintenance procedures and quality system
AMC1 145.A.65(b)(2) Safety and quality policy, Amended references
mMaintenance procedures and quality system
AMC1 145.A.70(a) Maintenance organisation Amended to reflect the change to the implementing rule and
exposition (MOE) adaptation to management system
GM1 145.A.70(a) Maintenance organisation Same as above ; point 9 transferred to new
exposition (MOE) AMC1 145.A.70(a)(1)
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AMC1 145.A.70(a)(1) Maintenance organisation New AMC, based on point 9 of GM 145.A.70(a); the text of the
exposition (MOE) accountable manager statement is simplified.
AMC1 145.A.75(b) Privileges of the organisation See ‘general changes’ and adaptation to management system
and change to 145.A.75; note in paragraph 1 on the FAR
Part 145 deleted, because relevant to foreign regulation.
GM1 145.A.75(b) Privileges of the organisation New GM to clarify that it is not prohibited to subcontract
certain activities to an approved organisation. The rule does
neither foresee an AMO to work solely as subcontractor (they
should exercise their privilege).
AMC1 145.A.85 Changes to the organisation New AMC; alignment with AMC1 ORO.GEN.130
AMC2 145.A.85 Changes to the organisation New AMC, based on AMC1 ORO.GEN.130(b)
GM1 145.A.85 Changes to the organisation New GM to clarify that 145.A.85 is also applicable to MOE
changes
GM1 145.A.85(a)(1) Changes to the organisation New GM to provide example for changes that may affect the
scope of the certificate or the terms of approval
GM2 145.A.85(a)(1) Changes to the organisation New GM; alignment with GM2 ORO.GEN.130(a)
GM1 145.A.85(b) Changes to the organisation New GM in the spirit of GM1 ORO.GEN.130(b)
GM1 145.A.85(c) Changes to the organisation New GM clarifying the intent of ‘changes not requiring prior
approval’
AMC1 145.A.95 Findings New AMC, based on AMC1 ORO.GEN.150(b)
GM1 145.A.95 Findings New GM, as proposed in NPA 2013-01(C), also to be used for
compliance monitoring (145.A.200(a)(6))
AMC1 145.A.120 Means of compliance New GM, based on AMC1 ORO.GEN.120(a)
GM1 145.A.200 Management system New GM explaining the management system concept
AMC1 145.A.200(a)(1) Management system New AMC, based on AMC1 ORO.GEN.200(a)(1)
GM1 145.A.200(a)(1) Management system New GM, based on GM2 ORO.GEN.200(a)(1)
GM2 145.A.200(a)(1) Management system New GM, aligned with GM3 ORO.GEN.200(a)(1)
AMC1 145.A.200(a)(2) Management system New AMC, based on AMC1 ORO.GEN.200(a)(2)
GM1 145.A.200(a)(2) Management system New GM, based on GM1 ORO.GEN.200(a)(2) and extended to
safety culture and just culture
AMC1 145.A.200(a)(3) Management system New AMC, based on AMC1 ORO.GEN.200(a)(3)
GM1 145.A.200(a)(3) Management system New GM, based on GM4 ORO.GEN.200(a)(3)
GM2 145.A.200(a)(3) Management system New GM, as proposed in NPA 2013-01(C)
AMC1 145.A.200(a)(4) Management system New AMC, based on AMC1 ORO.GEN.200(a)(4)
GM1 145.A.200(a)(4) Management system New GM on safety promotion
GM1 145.A.200(a)(5) Management system New GM, based on GM1 ORO.GEN.200(a)(5)
AMC1 145.A.200(a)(6) Management system New AMC, based on AMC 145.A.65(c)(1) point 1
AMC2 145.A.200(a)(6) AMC 145.A.65(c)(1) Safety AMC based on AMC 145.A.65(c)(1) points 2. to 11.
and quality policy, maintenance procedures and
quality system Management system
AMC3 145.A.200(a)(6) Management system New AMC, based on GM1 ORO.GEN.200(a)(6)
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AMC4 145.A.200(a)(6) AMC 145.A.65(c)(2) Safety AMC based on AMC 145.A.65(c)(2)
and quality policy, maintenance procedures and
quality system Management system
GM1 145.A.200(a)(6) Management system New GM to clarify that the compliance monitoring function
itself needs to be monitored for compliance.
GM2 145.A.200(a)(6) GM 145.A.65(c)(1) Safety GM based on GM 145.A.65(c)(1), but extensively revised to
and quality policy, maintenance procedures and provide better guidance and an example on compliance
quality system Management system monitoring audit plan.
AMC1 145.A.202 Internal safety reporting scheme New AMC, based on NPA 2013-01(C)
GM1 145.A.202 Internal safety reporting scheme New GM, based on GM1 ORO.GEN.200(a)(3)
GM1 145.A.205 Contracting and subcontracting New GM, based on GM2 ORO.GEN.205 and extended to
address particular maintenance aspects
GM2 145.A.205 Contracting and subcontracting New GM to explain the difference between contracting and
subcontracting maintenance
SECTION B — AUTHORITY REQUIREMENTS PROCEDURE FOR COMPETENT AUTHORITIES
GM1 145.B.120 Means of compliance New GM, based on GM1 ARO.GEN.120
AMC1 145.B.120(e) Means of compliance New AMC, based on AMC1 ARO.GEN.120(e)
AMC1 145.B.200 Management system New AMC, based on current AMC 145.B.10(1)
AMC2 145.B.200 Management system New AMC, based on GM1 ARO.GEN.200(a)
AMC1 145.B.200(a)(1) Management system New AMC, aligned with AMC1 ARO.GEN.200(a)(1)
GM1 145.B.200(a)(2) Management system New GM, based on GM1 ARO.GEN.200(a)(2)
AMC1 145.B.200(a)(3) Management system New AMC, based on AMC1 ARO.GEN.200(a)(2)
AMC2 145.B.200(a)(3) Management system New AMC, based on the current AMC 145.B.10(3)
AMC3 145.B.200(a)(3) Management system New AMC, based on AMC2 ARO.GEN.200(a)(2)
AMC1 145.B.200(a)(5) Management system New AMC on safety risk management as part of the
management system framework for competent authorities
GM1 145.B.200(a)(5) Management system New GM on the same subject
AMC1 145.B.200(d) Management system New AMC, based on AMC1 ARO.GEN.200(d)
GM1 145.B.205 Allocation of tasks to qualified New GM, based on GM1 ARO.GEN.205
entities
AMC1 145.B.220(a) Record-keeping AMC based on AMC1 ARO.GEN.220(a) and the current AMC
145.B.55
AMC1 145.B.220(a)(1) Record-keeping New AMC, based on AMC1 ARO.GEN.220(a)(1);(2);(3)
AMC1 145.B.300(a);(b);(c) Oversight principles New AMC, based on GM1 ARO.GEN.300(a);(b);(c) and AMC2
ARO.GEN.300(a);(b);(c)
AMC1 145.B.300(f) Oversight principles New AMC on information deemed useful for oversight
AMC1 145.B.305(a);(b) Oversight programme New AMC, as proposed in NPA 2013-01(C)
AMC1 145.B.305(b) Oversight programme New AMC, based on AMC1 ARO.GEN.305(b);(d);(d1)
AMC2 145.B.305(b) Oversight programme New AMC added for determine the need of oversight for
subcontracted organisations
AMC1 145.B.305(b)(1) Oversight programme New AMC, based on AMC1 ARO.GEN.305(b)(1)
AMC1 145.B.305(c) Oversight programme New AMC, based on AMC1 ARO.GEN.305(c)
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7. Appendices
AMC2 145.B.305(c) Oversight programme New AMC, based on AMC2 ARO.GEN.305(c)
AMC1 145.B.305(d) Oversight programme New AMC, as proposed in NPA 2013-01(C)
AMC1 145.B.310 Initial certification procedure New AMC, based on AMC1 ARO.GEN.310(a)
AMC1 145.B.310(a) Initial certification procedure AMC based on the current AMC 145.B.20(3)
AMC1 145.B.310(c) Initial certification procedure AMC based on the current AMC 145.B.20(6)
AMC2 145.B.310(c) Initial certification procedure AMC based on the current AMC 145.B.20(5)
AMC1 145.B.310(d) Initial certification procedure AMC based on the current AMC 145.B.20(6)
AMC1 145.B.310(e)(2) Initial certification AMC based on the current AMC 145.B.20(1) and AMC
procedure 145.B.25(1)
AMC1 145.B.330 Changes — organisations AMC based on AMC1 ARO.GEN.330 and the current AMC
145.B.35
GM1 145.B.330 Changes — organisations New GM, based on GM1 ARO.GEN.330
GM1 145.B.350(b);(c) Findings and corrective GM, based on the current AMC 145.B.50(a)
actions
AMC1 145.B.355(c) Suspension, limitation and New AMC, as proposed in NPA 2013-01(C)
revocation
APPENDICES TO AMC TO ANNEX II (PART-145)
Appendix I to AMC 145.B.20(1) EASA Form 4 Deleted because EASA Form 4 is not used any more
Appendix II to AMC2 145.B.310(c) AMC Update of reference
145.B.20(5) EASA Form 6
Update of reference (Part-M Subpart G is deleted with Opinion
Appendix III to AMC 145.A.15 EASA Form 2 No 06/216)
Appendix IV to AMC3 145.A.30(e) and See ‘general changes’
AMC2 145.B.200(a)(3) 145.B.10(3) Fuel Ttank
Ssafety Ttraining
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7. Appendices
7.3. Appendix III — EASA questionnaire
In the context of the preparation of the RIA for RMT.0251 Phase II, EASA launched a survey to the
competent authorities and industry.
The aim of the survey was to gather evidence to support the applicability of SMSs, and to identify
where proportionality is needed, as well as to collect data on potential impacts, difficulties and
opportunities in the implementation of SMSs.
The input supported the analysis of the problem definition and the analysis of the options. The survey
was run from 21 December 2017 until 15 February 2018, and it collected specific SMS data related to
the design, production and maintenance domains. Some key results of the survey, including a
description of the respondents, are as follows:
The survey was responded to by 293 organisations [285 organisations with a single or multiple
approval(s) and 8 associations/individual representatives] and 11 competent authorities. The
organisations that hold multiple approvals were invited to provide a consolidated response,
representing all parts of the organisation that hold approvals.
The organisations were classified into 12 groups according to their business areas or the approvals
they hold.
The following provides a more detailed overview of the organisations that replied to the
questionnaire, grouped according to Part 21 and Part-145 and the number of employees:
Part 21 organisations by product design/manufacture
120
101
100
80
60
45
40
20 14
9 5 3
0
Part and Other aircraft Engine Aircraft ELA 1 Aircraft ELA 2 Propeller
appliance (other than ELA
1)
Figure 1: Part 21 organisations by product design/manufacture
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7. Appendices
Part-145 organisations by class rating
120 112
95
100
80 64
56 50
60 44
35
40
19 15
20 7
0
Figure 2: Part-145 organisations by class rating
Organisations by company size (number of
employees for all activities)
no data
501-1000 5%
5%
101-500
18%
51-100
11%
26-50 1-10
13% 18%
11-25
14% >1000
16%
Figure 3: Organisations by company size (number of employees for all activities)
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7. Appendices
The following are some of the responses to the survey questions on the implementation of SMSs.
Have you already implemented SMS in your company?
no reply
6%
No
40% No
Yes
no reply
Yes
54%
Figure 4: Reply to the question ‘Have you already implemented an SMS in your company?’
Have you already implemented SMS in your company? (answers by
group of organisations )
group 13 Other 26
10
group 12 AOC 26
0
group 11 Approved Training Organisation (ATO) 32
1
group 10 Part-147 Maintenance Training… 23
1
group 9 CAMO 56
11
group 8 Part-145 Maintenance organisation 132
76
group 7 Approved Design Organisation (DOA) 82
39
group 6 Approved Production Organisation (POA) 50
45
group 5 Production organisation without Approval 0
1
group 4 Approved Design Organisation (DOA)… 1
1
group 3 Design Organisation with certification… 7
3
group 2 Alternative Procedures to Approved Design… 7
12
group 1 ETSO approval holder (other than APU) 9
6
0 20 40 60 80 100 120 140
Yes No
Figure 5: Replies to the question ‘Have you already implemented SMS in your company?’ (Answers
by group of organisations)
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The decision to implement SMS was made
due to multiple approvals held by
7% the organisation (e.g. organisation
21% also holding an AOC)
other (please specify)
10%
on a voluntary basis
41%
21% due to national aviation
regulations mandating SMS
Figure 6: Reasons for implementing an SMS
Breakdown of the organisations that have implemented SMS on a
voluntary basis (by type of organisation)
group 13 Other 11
group 12 AOC 5
group 11 ATO 14
group 10 Part-147 13
group 9 CAMO 17
group 8 Part-145 39
group 7 DOA 48
group 6 POA 20
group 5 Production organisation without Approval 0
group 4 DOA (Subpart J) ETSO approval holder (for APU) 1
group 3 Design Organisation with certification programme 5
group 2 ADOA 5
group 1 ETSO approval holder (other than APU) 4
0 10 20 30 40 50 60
Figure 7: Implementation of an SMS on a voluntary basis
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7. Appendices
SMS applicability for Part 21
Regarding Part 21, the first question addressed the applicability of SMSs. The following charts show
the answers aggregated by organisations, by groups and by the types of product. In all cases, the
majority of respondents believed that some SMS requirements should be imposed on all
organisations. The questions also allowed respondents to provide comments in support of their
answers. In many cases, respondents that were not in favour of the application of SMSs to all
organisations, also included comments that proposed the exclusion of small organisations, especially
those that only deal with minor changes or that produce products, parts and appliances under
Subpart F. In general, several respondents proposed the application of proportional requirements,
and even the definition of a minimum set of common requirements, to encourage organisations to
develop safety cultures. The following are some of the comments that were received:
— ‘In small companies, informal communication can lead to an equivalent level of safety.
However, I would still encourage voluntary adoption. E.g. provide suitable templates that they
can use and explanations of benefits.’
— ‘Some applicable SMS elements (e.g. visible management commitment to safety, safety risk
assessment or safety promotion to increase safety awareness among staff) should apply to all
aviation parties, as we all work together in one aviation network.’
— ‘Safety culture must be in all part of the process.’
In your opinion, are there any
organisations/activities/products addressed in Part 21 that
should not be subject to any SMS requirements? (answers
by Part 21 organisations)
no reply
2%
Yes
29%
No
69%
Figure 8: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (Answers by Part 21
organisations)
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In your opinion, are there any
organisations/activities/products addressed in Part 21 that
should not be subject to any SMS requirements? (answers
by groups of Part 21 organisations)
group 7 Approved Design Organisation (DOA) 86 35
group 6 Approved Production Organisation (POA) 66 30
group 5 Production organisation without Approval 1
group 4 Approved Design Organisation (DOA)… 2
group 3 Design Organisation with certification… 8 3
group 2 Alternative Procedures to Approved Design… 13 6
group 1 ETSO approval holder (other than APU) 10 5
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
No Yes
Figure 09: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (answers by groups of
Part 21 organisations)
In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS
requirements? (answers by Part 21 organisations type of product)
0
Propeller 0
3
0
Engine 3
11
2
Other aircraft 18
25
1
Aircraft ELA 2 (other than ELA 1) 3
1
1
Aircraft ELA 1 4
4
2
Part and appliance 28
71
0 10 20 30 40 50 60 70 80
no reply Yes No
Figure 10: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (Answers divided by the
type of product produced by Part 21 organisations)
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7. Appendices
SMS applicability for Part-145
Given the decision to apply SMSs to Part-145 (see Section 4.1), the questionnaire was developed to
collect feedback on the extent of SMSs within Part-145.
Figure 11: Replies to question ‘In your opinion, are there any categories of Part-145 organisations
that should not be subject to any SMS requirements?’ and the corresponding rationale for the ‘no’
answers.
Figure 12: Categories of Part-145 organisations proposed to be excluded from SMS requirements
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In your opinion, are there any categories of Part-145 organisations
that should not be subject to any SMS requirements? (responses by
Part-145 maintenance organisations by class rating)
Engines B2 03 16
Engines B3 0 4 11
Engines B1 0 11
33
D1 NDT 2 10
44
C components to be installed on complex motor-powered aircraft (CMPA) 3 23
86
C components to be installed on other than CMPA 4 18
42
Aircraft A4 02 5
Aircraft A3 1 12
22
Aircraft A2 1 18
31
Aircraft A1 3 22
70
0 10 20 30 40 50 60 70 80 90 100
Yes no reply No
Figure 13: Replies to the question ‘In your opinion are there any categories of EASA Part-145
organisations that should not be subject to any SMS requirements?’ (Replies by Part-145
Maintenance organisation by class rating.)
Opinions of competent authorities
The same question regarding the applicability of SMSs was addressed to competent authorities. For
Part 21, the distribution of answers and justifications is similar to what was provided by organisations
and explained above.
In your opinion are there any
organisations/activities/products
addressed in EASA Part 21 that should
not be subject to any SMS
requirements? (answers from the
competent authorities)
No
36%
Yes
64%
Figure 14: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (Answers from the
competent authorities.)
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In your opinion, are there any categories
of Part-145 organisations that should
not be subject to any SMS
requirements? (answers from the
competent authorities)
Yes
27%
No
73%
Figure 15: Replies to the question ‘In your opinion, are there any categories of Part-145
organisations that should not be subject to any SMS requirements?’ (Answers by the competent
authorities)
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Notice of Proposed Amendment 2019-05 (B)
Embodiment of safety management system (SMS) requirements into
Part-145 and Part 21
RMT.0251 PHASE II
EXECUTIVE SUMMARY
With reference to Rulemaking Task (RMT).0251 Phase II in EPAS 2019-2023, this Notice of Proposed
Amendment (NPA) proposes amendments to Annex I (Part 21) to Regulation (EU) No 748/2012 and Annex II
(Part-145) to Regulation (EU) No 1321/2014, in order to:
— introduce safety management principles that implement ICAO Annex 19; and
— foster an organisational culture for effective safety management and effective occurrence reporting in
accordance with Commission Regulation (EU) No 376/2014.
Note 1: Phase I of RMT.0251 was limited to the introduction of safety management requirements into Part-
CAMO (see Opinion No 06/2016).
Note 2: The review of the occurrence reporting system was governed by RMT.0681, but certain additional
changes are proposed through this RMT, in light of the principles of ICAO Annex 19, Chapter 5.
This NPA proposes to consider the applicability of safety management systems (SMSs) to Part-145 approved
maintenance organisations, as well as to production and design organisations that are approved in accordance
with Subparts G and J of Part 21.
By doing so, safety will be enhanced through:
— the establishment of safety policies and objectives that are associated with sufficient resources;
— the systematic identification of hazards, and a risk management system;
— the safety assurance system, including giving consideration to safety performance; and
— safety promotion.
This RMT also aims to streamline the procedures for oversight, and introduce a set of new, common
management system requirements for competent authorities to increase their efficiency.
NPA 2019-05 is divided into three parts. The present NPA 2019-05 (B) includes the draft implementing rules
(IRs) as well the draft Acceptable Means of Compliance (AMC) and Guidance Material (GM) for Part 21.
NPA 2019-05 (A) includes:
— the procedural information pertaining to the regulatory proposal;
— the explanatory note to the proposed amendments;
— the regulatory impact assessment; and
— a detailed summary of the proposed amendments (see Chapter 7 ‘Appendices’).
The draft IRs as well as the draft AMC and GM for Part-145 are proposed in NPA 2019-05 (C).
Action area: Systemic enablers to safety — safety management
Affected rules: Part-145 and Part 21
Affected stakeholders: AMOs (Part-145); POA holders; DOA holders; ETSOA holders; competent authorities
Driver: Safety Rulemaking group: No (but Focused Consultation Group)
Impact assessment: Full Rulemaking Procedure: Standard
12.7.2017 17.4.2019 2020/Q1 2020/Q3 2020/Q3
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Draft cover regulation (EU) xxx/xxx amending Regulation (EU)
No 748/2012 (Draft EASA opinion) ................................ 11
Article 1 ........................................................................................................................... 12
Article 2 ........................................................................................................................... 12
Draft Annex (Draft EASA opinion) ................................................. 13
21.1 General Competent authority ........................................................................ 13
SECTION A TECHNICAL REQUIREMENTS ............................................................................. 14
SUBPART A — GENERAL PROVISIONS ............................................................................. 14
21.A.1 Scope........................................................................................................... 14
21.A.3A Failures, malfunctions and defects Occurrence reporting ....................... 14
21.A.5 Record-keeping ........................................................................................... 16
21.A.9 Investigations .............................................................................................. 17
SUBPART B — TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES ...................... 18
21.A.44 Obligations of the holder .......................................................................... 18
21.A.55 Record-keeping ......................................................................................... 18
SUBPART D — CHANGES TO TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES 19
21.A.105 Record-keeping ....................................................................................... 19
21.A.109 Obligations and EPA marking.................................................................. 19
SUBPART E — SUPPLEMENTAL TYPE CERTIFICATES ........................................................ 20
21.A.118A Obligations and EPA marking ............................................................... 20
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ...... 21
21.A.124A Alternative means of compliance ......................................................... 21
21.A.125B Findings ................................................................................................. 21
21.A.125C Duration and continued validity ........................................................... 22
21.A.126 Production inspection system ................................................................ 22
21.A.129 Obligations of the manufacturer ............................................................ 24
SUBPART G — PRODUCTION ORGANISATION APPROVAL.............................................. 25
21.A.134A Alternative means of compliance ......................................................... 25
21.A.139 Quality Production management Ssystem ............................................. 25
21.A.143 Exposition................................................................................................ 28
21.A.145 Approval requirements Resources ......................................................... 29
21.A.147 Changes to the approved production management system organisation
................................................................................................................................ 31
21.A.157 Investigations .......................................................................................... 31
21.A.158 Findings ................................................................................................... 31
21.A.159 Duration and continued validity ............................................................. 32
21.A.165 Obligations of the holder ........................................................................ 32
SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF
AIRWORTHINESS .............................................................................................................. 35
21.A.180 Inspections .............................................................................................. 35
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21.A.181 Duration and continued validity ............................................................. 35
SUBPART I — NOISE CERTIFICATES .................................................................................. 36
21.A.210 Inspections .............................................................................................. 36
21.A.211 Duration and continued validity ............................................................. 36
SUBPART J — DESIGN ORGANISATION APPROVAL ......................................................... 37
21.A.239 Design assurance management system.................................................. 37
21.A.243 Data Handbook ....................................................................................... 39
21.A.245 Resources Approval requirements ......................................................... 40
21.A.247 Changes in to the design management assurance system ..................... 41
21.A.257 Investigations .......................................................................................... 41
21.A.258 Findings ................................................................................................... 41
21.A.259 Duration and continued validity ............................................................. 42
21.A.263 Privileges ................................................................................................. 43
21.A.265 Obligations of the holder ........................................................................ 44
SUBPART M — REPAIRS .................................................................................................... 46
21.A.447 Record-keeping ....................................................................................... 46
21.A.451 Obligations and EPA marking.................................................................. 46
SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS .............. 47
21.A.604 ETSO Aauthorisation for an Aauxiliary Ppower Uunit (APU) .................. 47
21.A.609 Obligations of holders of ETSO authorisations ....................................... 47
21.A.613 Record-keeping ....................................................................................... 47
21.A.615 Inspection by the Agency ........................................................................ 48
21.A.619 Duration and continued validity ............................................................. 48
SUBPART P — PERMIT TO FLY .......................................................................................... 49
21.A.705 Competent authority .............................................................................. 49
21.A.721 Inspections .............................................................................................. 49
21.A.723 Duration and continued validity ............................................................. 49
21.A.729 Record-keeping ....................................................................................... 49
SECTION B PROCEDURES FOR COMPETENT AUTHORITIES .................................................. 51
SUBPART A — GENERAL PROVISIONS .............................................................................. 51
21.B.5 Scope ........................................................................................................... 51
21.B.10 Oversight documentation ......................................................................... 51
21.B.15 Information to EASA ................................................................................. 51
21.B.20 Obligations of the competent authority ................................................... 51
21.B.20 Immediate reaction to a safety problem .................................................. 51
21.B.25 Requirements for the organisation of the competent authority.............. 52
21.B.25 Management system ................................................................................ 52
21.B.30 Documented procedures .......................................................................... 54
21.B.30 Allocation of tasks to qualified entities .................................................... 54
21.B.35 Changes in the management system organisation and procedures ........ 54
21.B.40 Resolution of disputes .............................................................................. 55
21.B.45 Reporting/coordination ............................................................................ 55
21.B.55 Record-keeping ......................................................................................... 55
21.B.65 Suspension, limitation and revocation ..................................................... 57
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ........ 58
21.B.115 Alternative means of compliance ........................................................... 58
21.B.120 Investigation............................................................................................ 58
21.B.120 Initial certification procedure ................................................................. 59
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21.B.125 Findings and corrective actions .............................................................. 60
21.B.130 Issue of letter of agreement ................................................................... 61
21.B.145 Limitation, suspension and revocation of a letter of agreement ........... 62
21.B.150 Record-keeping ....................................................................................... 62
SUBPART G — PRODUCTION ORGANISATION APPROVAL ............................................... 63
21.B.215 Alternative means of compliance ........................................................... 63
21.B.220 Investigation............................................................................................ 63
21.B.220 Initial certification procedure ................................................................. 64
21.B.221 Oversight principles ................................................................................ 65
21.B.222 Oversight programme ............................................................................. 66
21.B.225 Findings and corrective actions .............................................................. 67
21.B.230 Issue of certificate ................................................................................... 69
21.B.235 Continued surveillance ........................................................................... 69
21.B.240 Amendment of a production organisation approval .............................. 69
21.B.240 Changes to a production organisation approval..................................... 70
21.B.245 Suspension and revocation of a production organisation approval ....... 70
21.B.260 Record-keeping ....................................................................................... 71
SUBPART H — AIRWORTHINESS CERTIFICATES AND RESTRICTED CERTIFICATES OF
AIRWORTHINESS .............................................................................................................. 72
21.B.330 Suspension and revocation of certificates of airworthiness and restricted
certificates of airworthiness .................................................................................. 72
21.B.345 Record-keeping ....................................................................................... 72
SUBPART I — NOISE CERTIFICATES .................................................................................. 73
21.B.430 Suspension and revocation of a noise certificate ................................... 73
21.B.445 Record-keeping ....................................................................................... 73
SUBPART J — DESIGN ORGANISATION APPROVAL .......................................................... 74
21.B.430 Initial certification procedure ................................................................. 74
21.B.431 Oversight principles ................................................................................ 74
21.B.432 Oversight programme ............................................................................. 75
21.B.433 Findings and corrective actions .............................................................. 76
21.B.435 Changes to a design organisation approval ............................................ 78
SUBPART P — PERMIT TO FLY .......................................................................................... 79
21.B.530 Revocation of permits to fly.................................................................... 79
21.B.545 Record-keeping ....................................................................................... 79
APPENDICES TO ANNEX I .................................................................................................. 80
EASA FORMS ..................................................................................................................... 80
Appendix VIII — Aircraft statement of conformity — EASA Form 52 .................... 81
Appendix X — Production organisation approval certificate — EASA Form 55 .... 85
Appendix XI — Letter of agreement for production without production
organisation approval — EASA Form 65 ................................................................ 87
Draft AMC & GM to Annex I (Part 21) to Regulation (EU)
No 748/2012 (Draft EASA Decision) ............................... 88
GM1 Annex I Definitions ........................................................................................ 88
GM2 Annex I Acronyms.......................................................................................... 90
GM1 21.1 Competent authority ............................................................................. 91
GM1 21.1(c) Competent authority......................................................................... 92
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SECTION A TECHNICAL REQUIREMENTS ............................................................................. 93
SUBPART A — GENERAL PROVISIONS .............................................................................. 93
AMC1 No 1 to 21.A.3A(a)(1) Occurrence reporting Collection, investigation and
analysis of data related to Flammability Reduction Means (FRM) Reliability ....... 93
AMC2 No 2 to 21.A.3A(a)(1) Occurrence reporting Collection, investigation and
analysis of data related to ETOPS significant occurrences .................................... 93
GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting The system for collection,
investigation and analysis of data .......................................................................... 94
GM2 21.A.3A(b)(a) and (b) Occurrence reporting ................................................. 94
GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting ............................................. 94
GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting ..................................... 98
AMC1 21.A.3A(b)(2)(d) Occurrence reporting Reporting to the Agency ............... 98
AMC1 21.A.5 Record-keeping ................................................................................ 99
GM1 21.A.5 Record-keeping .................................................................................. 99
AMC1 21.A.5(a) and 21.A.433(a) Record-keeping ............................................... 100
GM1 21.A.5(a) and (b) Record-keeping ............................................................... 101
AMC1 21.A.5(e) Record-keeping .......................................................................... 102
GM1 21.A.9 Investigations ................................................................................... 103
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ...... 105
AMC1 No1 to 21.A.122 Eligibility — Link between design and production ......... 105
AMC1 21.A.124 Application ................................................................................. 106
GM 21.A.124(a) Application – Application form .................................................. 107
AMC1 21.A.124A Alternative means of compliance ............................................ 108
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design data
.............................................................................................................................. 108
GM No 2 to 21.A.158(a) Examples of level one findings...................................... 108
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings .................................. 108
GM 21.A.126(b)(6) Production inspection system – Recording and record keeping
.............................................................................................................................. 109
SUBPART G — PRODUCTION ORGANISATION APPROVAL FOR PRODUCTS, PARTS AND
APPLIANCES .................................................................................................................... 110
GM 21.A.134 Application – Application form and manner.................................. 110
AMC1 21.A.134 Application ................................................................................. 110
AMC1 21.A.134A Alternative means of compliance ............................................ 111
GM1 21.A.139(c) Production management system ............................................. 112
AMC1 21.A.139(c) Production management system ........................................... 113
AMC1 21.A.139(c)(1) Production management system ...................................... 115
GM1 21.A.139(c)(1) Production management system ........................................ 116
AMC1 21.A.139(c)(2) Production management system ...................................... 116
GM1 21.A.139(c)(2) Production management system ........................................ 116
AMC1 21.A.139(c)(3) Production management system ...................................... 117
AMC1 21.A.139(c)(3) and (4) Production management system .......................... 117
GM1 21.A.139(c)(4)(ii) Production management system .................................... 120
AMC1 21.A.139(c)(4)(ii) Production management system .................................. 121
AMC1 21.A.139(c)(5) Production management system ..................................... 121
GM1 21.A.139(c)(5) Production management system ........................................ 121
AMC1 21.A.139(c)(5)(i) Production management system ................................... 122
GM1 21.A.139(c)(5)(i) Production management system ..................................... 122
AMC1GM No1 to 21.A.139(d)(a) Production management system Quality system
.............................................................................................................................. 123
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AMC1 GM 21.A.139(d)(2)(b)(1) Production management system Quality System –
Elements of the quality system ............................................................................ 124
GM1 No 2 to 21.A.139(d)(1)(a) Production management system Quality System –
Conformity of supplied parts or appliances ......................................................... 124
AMC No 1 to 21.A.139(d)(2)(ii)(b)(1)(ii) Production management system Vendor
and sub-contractor assessment, audit and control – Production Organisation
Approval (POA) holder using documented arrangements with other parties for
assessment and surveillance of a supplier. .......................................................... 126
AMC No 2 to 21.A.139(d)(2)(ii) (b)(1)(ii) Production management system Vendor
and sub-contractor assessment, audit and control - Production Organisation
Approval (POA) holder using other party supplier certification .......................... 128
GM1 21.A.139(d)(2)(ii) Production management system.................................... 130
AMC1 21.A.139(e) Production management system .......................................... 130
AMC1 21.A.139(f) Production management system ........................................... 131
GM No 1 to 21.A.139(b)(2) Quality System – Independent quality assurance
function ................................................................................................................ 132
GM1 No 2 to 21.A.139(f)(b)(2) Production management system Quality System –
Adequacy of procedures and monitoring function .............................................. 132
GM1 21.A.143 Exposition – Production Organisation Exposition (POE) .............. 132
AMC1 21.A.143(a)(1) Exposition .......................................................................... 133
AMC1 21.A.145(a) Resources ............................................................................... 134
GM1 21.A.145(a) Resources Approval Requirements ......................................... 134
GM1 21.A.145(b)(2) Resources Approval Requirements – Airworthiness, noise,
fuel venting and exhaust emissions /production data procedures ..................... 134
AMC1 21.A.145(c)(1) Resources .......................................................................... 135
GM1 21.A.145(c)(1) Resources Approval Requirements – Accountable manager
.............................................................................................................................. 135
AMC1 GM 21.A.145(c)(2) Resources Approval Requirements – Responsible
managers .............................................................................................................. 136
AMC2 21.A.145(c)(2) Resources .......................................................................... 138
AMC1 21.A.145(d)(1) Resources Approval Requirements – Certifying staff ....... 139
AMC 21.A.145(d)(2) Approval requirements – Record of certifying staff ........... 140
AMC1 21.A.145(d)(2)(3) Resources Approval requirements – Evidence of
authorisation ........................................................................................................ 141
AMC1 21.A.147 Changes to the production management system ...................... 141
GM1 21.A.147(a) Changes to the approved production management system
organisation — Significant changes ..................................................................... 143
GM1 21.A.149 Transferability .............................................................................. 144
AMC1 21.A.153 Changes to the terms of approval — Application for a change to
the terms of approval........................................................................................... 144
GM 21.A.157 Investigations – Arrangements ...................................................... 144
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design data
.............................................................................................................................. 145
GM No 2 to 21.A.158(a) Examples of level one findings...................................... 145
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings .................................. 146
GM 21.A.165(d) and (h) Obligations of the holder – Recording and archiving
system .................................................................................................................. 146
SUBPART J — DESIGN ORGANISATION APPROVAL ........................................................ 148
GM1 21.A.239(c) Design management system .................................................... 148
AMC1 21.A.239(c) Design management system .................................................. 149
AMC1 21.A.239(c)(1) Design management system ............................................. 151
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GM1 21.A.239(c)(1) Design management system ............................................... 152
AMC1 21.A.239(c)(2) Design management system ............................................. 152
GM1 21.A.239(c)(2) Design management system ............................................... 153
AMC1 21.A.239(c)(3) and (4) Design management system ................................. 154
AMC1 21.A.239(c)(3) Design management system - ........................................... 155
AMC1 21.A.239(c)(4)(ii) Design management system ......................................... 156
GM1 21.A.239(c)(4)(ii) Design management system ........................................... 157
AMC1 21.A.239(c)(5) Design management system ............................................. 157
GM1 21.A.239(c)(5) Design management system ............................................... 158
AMC1 21.A.239(c)(5)(i) Design management system .......................................... 158
GM1 21.A.239(c)(5)(i) Design management system ............................................ 159
GM No 1 to 21.A.239(d)(a) Design assurance management system ................... 159
AMC1 21.A.239(d) Design management system ................................................. 165
AMC2 GM No 2 to 21.A.239(d)(a) Design management system Design assurance
system for minor changes to type design or minor repairs to products ............. 171
AMC 21.A.239(a)(3) Design assurance system – Independent system monitoring
.............................................................................................................................. 171
AMC1 21.A.239(d)(2)(b) Design management assurance system - Independent
checking function of the demonstration of compliance ...................................... 171
GM1 21.A.239(d)(3)(c) Design management system Design assurance system.. 172
AMC1 21.A.239(e) Design management system ................................................. 172
AMC1 21.A.239(f) Design management system .................................................. 173
AMC1 No 1 to 21.A.243(a) Data requirements Handbook .................................. 173
AMC2 No 2 to 21.A.243(a) Data requirements – Model content of handbook for
organisations designing minor changes to type design or minor repairs to
products Handbook.............................................................................................. 176
AMC1 21.A.243(d) Handbook .............................................................................. 177
GM1 No 1 to 21.A.243(d) Handbook Statement of qualifications and experience
.............................................................................................................................. 178
GM No AMC2 to 21.A.243(d) Handbook Data requirements – – Statement of the
qualification and experience – Organisations designing minor changes to type
design or minor repairs to products .................................................................... 181
AMC GM No 1 to 21.A.245 Requirements for approval Resources ..................... 182
AMC GM No 2 to 21.A.245 Resources Requirements for approval – Organisations
designing minor changes to type design or minor repairs to products ............... 183
AMC1 21.A.245(a) Resources ............................................................................... 184
AMC1 21.A.245(b) Resources............................................................................... 185
AMC2 21.A.245(b) Resources............................................................................... 186
AMC1 21.A.247 Changes to the design management system ............................. 187
GM1 21.A.247 Changes to in the design management assurance system .......... 187
GM 21.A.257(a) Investigations ............................................................................. 189
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings .................................. 189
SUBPART M — REPAIRS .................................................................................................. 190
AMC 21.A.433(a) and 21.A.447 Repair design and record keeping ..................... 190
SUBPART P — PERMIT TO FLY ........................................................................................ 191
GM 21.A.705 Competent authority ..................................................................... 191
SECTION B PROCEDURES FOR COMPETENT AUTHORITIES ................................................ 192
SUBPART A — GENERAL PROVISIONS ............................................................................ 192
GM 21.B.20 Responsibility for implementation................................................... 192
AMC1 21.B.25 Management system.................................................................... 192
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AMC2GM 21.B.25(a) Organisation Management system .................................... 193
GM 21.B.25(b) Resources..................................................................................... 194
GM 21.B.25(c) Qualification and training ............................................................ 195
AMC1 21.B.25(a)(1) Management system ........................................................... 195
GM1 21.B.25(a)(2) Management system ............................................................. 196
AMC1 21.B.25(a)(3) Management system ........................................................... 198
AMC2 21.B.25(a)(3) Management system ........................................................... 198
AMC3 21.B.25(a)(3) Management system ........................................................... 199
AMC1 21.B.25(a)(5) Management system ........................................................... 200
GM1 21.B.25(a)(5) Management system ............................................................. 201
AMC1 21.B.25(d) Management system ............................................................... 202
AMC 21.B.30(a) Documented procedures ........................................................... 203
GM1 21.B.30 Allocation of tasks to qualified entities .......................................... 203
AMC 21.B.35(a) Changes ...................................................................................... 204
GM No 1 to 21.B.45 Co-ordination with other related activities ......................... 204
GM No 2 to 21.B.45 Co-ordination ...................................................................... 204
GM No 3 to 21.B.45 Reporting – Information relevant to registers established by
the Agency............................................................................................................ 205
AMC1 21.B.55(a) Record-keeping ........................................................................ 205
AMC1 21.B.55(a)(1) Record-keeping.................................................................... 205
GM1 21.B.55 Record-keeping .............................................................................. 206
GM1 21.B.55(e) Record-keeping .......................................................................... 207
AMC1 21.B.65 Suspension, limitation and revocation......................................... 207
AMC1 21.B.65(c) Suspension, limitation and revocation..................................... 208
GM1 21.B.65 Suspension, limitation and revocation........................................... 208
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL ...... 209
GM1 21.B.115 and 21.B.215 Alternative means of compliance .......................... 210
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance ............... 210
AMC1 21.B.120(a) Initial certification procedure ................................................ 210
AMC2 21.B.120(a) Initial certification procedure Investigation team –
Qualification criteria for the investigation team members ................................. 211
AMC3 21.B.120(a)(c)(1) Initial certification procedure........................................ 211
AMC4 GM 21.B.120(a)(c)(3) Initial certification procedure Investigation
preparation and planning..................................................................................... 214
GM1 21.B.120(c)(5) and (6) Initial certification procedure Auditing and
investigation findings ........................................................................................... 215
AMC1 21.B.120(d) Initial certification procedure ................................................ 215
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective
actions Objective evidence .................................................................................. 215
GM1 21.B.125(b) Findings and corrective actions ............................................... 216
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions ........... 216
AMC1 21.B.125(d) Findings and corrective actions ..................................... 216
AMC 21.B.130 Issue of the letter of agreement .................................................. 216
GM 21.B.130(b) Issue of the letter of agreement ................................................ 217
AMC1 21.B.140 Amendment of a letter of agreement ........................................ 217
GM 21.B.150(d) Record keeping – Traceability of release certificates ................ 217
SUBPART G — PRODUCTION ORGANISATION APPROVAL ............................................. 218
GM1 21.B.115 and 21.B.215 Alternative means of compliance .......................... 218
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance ............... 218
AMC1 21.B.220 and 21.B.221 Initial certification procedure .............................. 218
AMC1 21.B.220 and 21.B.430 Initial certification procedure ............................. 219
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AMC1 GM No 1 to 21.B.220(c) Procedures for investigation– Investigation
preparation and planning Initial certification procedure ................................... 219
AMC2GM 21.B.220(a) Initial certification procedure Investigation team ........... 220
AMC 21.B.220(c) Procedures for investigation – Evaluation of applications ...... 221
GM1 No 2 to 21.B.220(c) Initial certification procedure Procedures for
investigation — GeneralROCEDURES FOR INVESTIGATION ................................. 222
GM2 No 3 to 21.B.220(c) Initial certification procedure - Procedures for
investigation – POA applications received from organisations with
facilities/partners/ suppliers/sub-contractors located in a third country ........... 244
GM3 No 4 to 21.B.220(c) Initial certification procedure Procedures for
investigation — Competent authority surveillance of suppliers of a POA holder
located in other Member States .......................................................................... 246
AMC1 21.B.220(d)(1) Initial certification procedure............................................ 252
AMC1 21.B.221(a), (b) and (c) Oversight principles ............................................. 253
AMC1 21.B.222 and 21.B.432 Oversight programme .......................................... 253
GM1 21.B.222(a) Oversight programme.............................................................. 254
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 254
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 254
GM1 21.B.222(b) Oversight programme ............................................................. 255
AMC1 21.B.222(b)(1) Oversight programme ....................................................... 255
GM1 21.B.222(b)(1)(ii) Oversight programme ..................................................... 255
AMC1 21.B.222(c) Oversight programme ............................................................ 256
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme .................................. 257
AMC1 21.B.222(d) Oversight programme............................................................ 258
GM1 21.B.225(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective
actions Objective evidence .................................................................................. 258
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions ........... 258
AMC1 21.B.225(d)(a) Findings and corrective actions Notification of findings ... 258
AMC No 1 to 21.B.230 Issue of the certificate ..................................................... 259
GM 21.B.235(a)(4) Guide to the conduct of monitoring production standards. . 259
GM 21.B.235(b) Maintenance of the POA - Work allocation within the competent
authority............................................................................................................... 260
GM 21.B.235(b) and (c) Continued surveillance .................................................. 261
AMC 21.B.235(c) Continuation of POA ................................................................ 261
AMC1 No 1 to 21.B.240 Changes to a production organisation approval
Application for significant changes or variation of scope and terms of the POA 261
GM 21.B.245 Continued validity .......................................................................... 264
AMC 21.B.245 Corrective action plan .................................................................. 265
SUBPART J — DESIGN ORGANISATION APPROVAL ........................................................ 266
AMC1 21.B.220 and 21.B.430 Initial certification procedure ............................. 266
AMC1 21.B.430 and 21.B.431 Initial certification procedure .............................. 266
AMC1 21.B.430(a) Initial certification procedure ................................................ 267
AMC1 21.B.430(d)(1) Initial certification procedure............................................ 267
AMC1 21.B.431(a), (b) and (c) Oversight principles ............................................. 268
AMC1 21.B.222 and 21.B.432 Oversight programme .......................................... 268
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 268
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme ................................. 269
AMC1 21.B.432(b)(1) Oversight programme ....................................................... 269
AMC1 21.B.432(c) Oversight programme ............................................................ 269
AMC2 21.B.222(c) and 21.B.432(c) Oversight programme.................................. 270
AMC1 21.B.432(d) Oversight programme ........................................................... 270
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Table of contents
GM1 21.B.125(b), 21.B.225(b) and 21.B.430(b) Findings and corrective actions 271
AMC1 21.B.433(d) Findings and corrective actions ............................................. 271
AMC1 21.B.435 Changes to a design organisation approval ............................... 271
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Proposed amendments to Part 21
Proposed amendments to Part 21
The text of the amendment is arranged to show deleted text, new or amended text as shown below:
— deleted text is struck through;
— new or amended text is highlighted in grey;
— text proposed to be added or amended by Opinion No 07/2016, whose adoption by the
European Commission is pending, is highlighted in blue;
— an ellipsis ‘[…]’ indicates that the rest of the text is unchanged.
Important note: ‘easy-to-read document’
Under each modified requirement (i.e. implementing rules), the blue underlined AMC or GM, when
also modified, can be accessed through the associated hyperlinks [press Ctrl and click]. In order to
return to the previous view (i.e. initial text), please use [press Alt + left arrow].
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Proposed amendments to Part 21
Draft cover regulation (EU) xxx/xxx amending Regulation (EU) No 748/2012
(Draft EASA opinion)
Article 1
Annex I (Part 21) to Commission Regulation (EU) No 748/2012 is amended in accordance with the
Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
It shall apply from [2 years after the entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
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Proposed amendments to Part 21
Draft Annex (Draft EASA opinion)
[Note: related AMC/GM:
— GM1 Annex I Definitions
— GM2 Annex I Acronyms]
21.1 General Competent authority
For the purpose of this Annex I (Part 21), the ‘competent authority’ shall be:
(a) for Section A, Subparts B, D, E, J, K, M, O, and Q, EASA;
(b) for Section A, Subparts F, G, H, and I:
(a1) for organisations having that have their principal place of business in a Member State,
the authority designated by that Member State; or the Agency EASA if so requested by
that Member State; or
(b2) for organisations having that have their principal place of business in a non-member
State third country, the Agency EASA.
(c) for Section A, Subpart P:
(1) for registered aircraft, the authority designated by the Member State of registry;
(2) for unregistered aircraft, the authority designated by the Member State which
prescribed the identification marks.
[Note: related AMC/GM:
— GM1 21.1 Competent authority
— GM1 21.1(c) Competent authority]
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SECTION A TECHNICAL REQUIREMENTS
SUBPART A — GENERAL PROVISIONS
21.A.1 Scope
This Section Subpart establishes general provisions governing the rights and obligations of the
applicant for, and holder of, any certificate issued or to be issued in accordance with this Section
Annex.
21.A.3A Failures, malfunctions and defects Occurrence reporting
(a) System for Collection, Investigation and Analysis of Data
The holder of Without prejudice to Regulation (EU) No 376/2014, all natural or legal persons
who hold or who have applied for a type-certificate type certificate, restricted type certificate
type-certificate, supplemental type certificate type-certificate, European Technical Standard
Order (ETSO) authorisation, major repair design approval or any other relevant approval
deemed to have been issued under this Regulation Annex shall:
(1) have establish and maintain a system for collecting, investigating and analysing
mandatory and voluntary occurrence reports in order to identify any adverse trends or
to address any deficiencies, and to extract reportable occurrences. The system shall
include:
(i) reports of and information related to failures, malfunctions, defects or other
occurrences which cause or might cause adverse effects on the continuing
airworthiness of the product, part or appliance covered by the type certificate
type-certificate, restricted type certificate type-certificate, supplemental type
certificate type-certificate, ETSO authorisation, major repair design approval or
any other relevant approval deemed to have been issued under this Annex
Regulation.; and
(ii) internal errors, near misses, and hazards that do not fall under point (i).
(2) Information about this system shall be made available to all make available to known
operators of the product, part or appliance and, on request, to any person authorised
under other associated implementing Regulations, the information about the system
established in accordance with point (a)(1), and on how to provide such reports of and
information related to failures, malfunctions, defects or other occurrences.
(b3) Reporting to the Agency
The holder of a type-certificate, restricted type-certificate, supplemental
type-certificate, ETSO authorisation, major repair design approval or any other relevant
approval deemed to have been issued under this Regulation shall report to the Agency
EASA any failure, malfunction, defect or other occurrence of which it is aware related to
a product, part, or appliance covered by the type certificate type-certificate, restricted
type certificate type-certificate, supplemental type certificate type-certificate, ETSO
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authorisation, major repair design approval or any other relevant approval deemed to
have been issued under this Annex Regulation, and which has resulted in or may result
in an unsafe condition, in accordance with Commission Implementing Regulation (EU)
2015/1018.
(b) Without prejudice to Regulation (EU) No 376/2014, all natural or legal persons who hold or
have applied for a production approval under Subpart G, or who produce a product, part or
appliance under Subpart F, shall:
(1) establish and maintain a system for collecting and assessing internal mandatory and
voluntary occurrence reports, including reports on internal errors, near misses, and
hazards, in order to identify any adverse trends or to address any deficiencies, and
extract reportable occurrences. This system shall include the evaluation of relevant
information related to occurrences, and the promulgation of the related information;
(2) report to the holder of the type certificate, restricted type certificate or design
approval, all cases in which products, parts or appliances have been released by the
production organisation and subsequently identified to have deviations from the
applicable design data, and investigate with the holder of the type certificate, restricted
type certificate or design approval to identify those deviations which could lead to an
unsafe condition, in accordance with Commission Implementing Regulation (EU)
2015/1018;
(3) report to EASA and the competent authority of the Member State the deviations which
could lead to an unsafe condition that were identified according to point (2);
(4) if the production organisation acts as a supplier to another production organisation,
also report to that other organisation all cases in which it has released products, parts
or appliances to that organisation and subsequently identified them to have possible
deviations from the applicable design data.
(2c) The These reports defined in points (a) and (b) shall appropriately safeguard the
confidentiality of the reporter and of the persons mentioned in the report and be made in a
form and manner established by the competent authority Agency, as soon as practicable and
in any case dispatched not later than 72 hours after the identification of the possible unsafe
condition, unless exceptional circumstances prevent this.
(c) Investigation of Reported Occurrences
(d1.) Without prejudice to Regulation (EU) No 376/2014, if When an occurrence reported under
point (b) point (a)(3), or under point (b)(3) points 21.A.129(f)(2) or 21.A.165(f)(2) results from
a deficiency in the design, or a manufacturing production deficiency, the holder of the type
certificate type-certificate, restricted type certificate type-certificate, supplemental type
certificate type-certificate, major repair design approval, ETSO authorisation, or any other
relevant approval deemed to have been issued under this Annex Regulation, or the production
organisation manufacturer as appropriate, shall investigate the reason for the deficiency and
report to the Agency EASA and to the competent authority of the Member State the results of
its investigation and any action it is taking or proposes to take to correct that deficiency.
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(2.e) If the Agency competent authority finds that an action is required to correct the deficiency,
the holder of the type certificate type-certificate, restricted type certificate type-certificate,
supplemental type certificate type-certificate, major repair design approval, ETSO
authorisation, or any other relevant approval deemed to have been issued under this Annex
Regulation, or the production organisation manufacturer as appropriate, shall submit the
relevant data to the Agency competent authority.
[Note: related AMC/GM:
— AMC1 21.A.3A(a)(1) Occurrence reporting
— AMC2 21.A.3A(a)(1) Occurrence reporting
— GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting
— GM2 21.A.3A(b)(a) and (b) Occurrence reporting
— GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting
— GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting
— AMC1 21.A.3A(b)(2)(d) Occurrence reporting]
21.A.5 Record-keeping
All natural or legal persons who hold or who have applied for a type certificate, restricted type
certificate, supplemental type certificate, ETSO authorisation, major repair design approval, permit
to fly, production organisation approval or letter of agreement under this Annex shall:
(a) when designing a product, part or appliance or changes or repairs to them, maintain
relevant design information/data, and retain them at the disposal of EASA in order to provide
the information necessary to ensure their continued airworthiness, the continued validity of
the operational suitability data, and continued compliance with the applicable environmental
protection requirements;
(b) when producing a product, part or appliance:
(1) maintain the relevant records produced under the production system that was used to
justify the conformity of the products, parts or appliances, and retain them in order to
provide the information necessary to ensure the continued airworthiness of the
product, part or appliance;
(2) for production organisations approved in accordance with Subpart G, record all details
of the work carried out and establish a record-keeping system that incorporates the
requirements imposed on its partners, suppliers and subcontractors, and ensures the
conservation of the data used to justify the conformity of the products, parts or
appliances. This data shall be held at the disposal of the competent authority and be
retained in order to provide the information necessary to ensure the continuing
airworthiness of the products, parts or appliances; and
(c) with regard to permits to fly:
(1) maintain documents produced to establish and justify the flight conditions, and retain
them at the disposal of EASA and the competent authority in order to provide the
information necessary to ensure the continued airworthiness of the aircraft;
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(2) when issuing a permit to fly under the privilege of approved organisations, maintain the
documents associated with it, including inspection records, documents that support the
approval of flight conditions and the permit to fly itself, retain them at the disposal of
EASA or the competent authority, and in order to provide the information necessary to
ensure the continued airworthiness of the aircraft;
(d) retain records of competence and the qualifications of personnel who are involved in design
or production, in independent monitoring of compliance and adequacy, and in safety
management if required by points 21.A.139, 21.A.145, 21.A.239 or 21.A.245; and
(e) when employing personnel who exercise the privileges of the approved organisation
according to points 21.A.163 or 21.A.263, or who carry out the independent monitoring of
compliance and adequacy according to points 21.A.139(f) and 21.A.239(f), retain the records
of their authorisation.
[Note: related AMC/GM:
— AMC1 21.A.5 Record-keeping
— GM1 21.A.5 Record-keeping
— AMC1 21.A.5(a) and 21.A.433(a) Record-keeping
— GM1 21.A.5(a) and (b) Record-keeping
— AMC1 21.A.5(e) Record-keeping]
21.A.9 Investigations
(a) All organisations who hold or who have applied for a type certificate, restricted type
certificate, supplemental type certificate, ETSO authorisation, major repair design approval,
permit to fly, design organisation approval, production organisation approval or letter of
agreement under this Annex, shall make arrangements that allow the competent authority to
make any investigations, including investigations of partners, supplier and subcontractors,
that are necessary to determine the compliance and the continued compliance of the
organisation with the applicable requirements of this Annex.
(b) Design and production organisations and applicants for, or holders of, permits to fly or ETSO
authorisations shall allow the competent authority to review any report and make any
inspection and perform or witness any test that is necessary to check the compliance of the
organisation with this Annex, and to inspect the technical data files.
[Note: related AMC/GM:
— GM1 21.A.9 Investigations]
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SUBPART B — TYPE CERTIFICATES AND RESTRICTED TYPE
CERTIFICATES
21.A.44 Obligations of the holder
Each holder of a type-certificate type certificate or restricted type certificate type-certificate shall:
(a) undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.55, 21.A.5,
21.A.9, 21.A.57, 21.A.61 and 21.A.62; and, for this purpose, shall continue to meet the
qualification requirements for eligibility under point 21.A.14; and
(b) specify the marking in accordance with Subpart Q.
21.A.55 Record-keeping
All relevant design information, drawings and test reports, including inspection records for the
product tested, shall be held by the type-certificate or restricted type-certificate holder at the
disposal of the Agency and shall be retained in order to provide the information necessary to ensure
the continued airworthiness, continued validity of the operational suitability data and compliance
with applicable environmental protection requirements of the product.
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SUBPART D — CHANGES TO TYPE CERTIFICATES AND RESTRICTED
TYPE CERTIFICATES
21.A.105 Record-keeping
For each change, all relevant design information, drawings and test reports, including inspection
records for the changed product tested, shall be held by the applicant at the disposal of the Agency
and shall be retained in order to provide the information necessary to ensure the continued
airworthiness, continued validity of the operational suitability data and compliance with applicable
environmental protection requirements of the changed product.
21.A.109 Obligations and EPA marking
The holder of a minor change approval to a type certificate type-certificate shall:
(a) undertake the obligations laid down in points 21.A.4, 21.A.105, 21.A.5, 21.A.9, 21.A.107 and
21.A.108; and
(b) specify the marking, including EPA (European Part Approval) letters, in accordance with point
21.A.804(a).
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SUBPART E — SUPPLEMENTAL TYPE CERTIFICATES
21.A.118A Obligations and EPA marking
Each holder of a supplemental type certificate type-certificate shall:
(a) undertake the obligations:
(1). laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.105, 21.A.5, 21.A.9, 21.A.119,
21.A.120A and 21.A.120B;
(2). implicit in the collaboration with the type certificate type-certificate holder under
point 21.A.115(d)(2);
and for this purpose continue to meet the criteria of point 21.A.112B;
(b) specify the marking, including EPA letters, in accordance with point 21.A.804(a).
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SUBPART F — PRODUCTION WITHOUT PRODUCTION
ORGANISATION APPROVAL
21.A.124A Alternative means of compliance
(a) Alternative means of compliance to the AMC adopted by EASA may be used by an
organisation to establish compliance with Regulation (EU) 2018/11391 and the delegated and
implementing acts adopted on the basis thereof.
(b) If an organisation wishes to use an alternative means of compliance, it shall, prior to
implementing it, provide the competent authority with a full description of the alternative
means of compliance. The description shall include any revisions to manuals or procedures
that may be relevant, as well as an assessment that demonstrates compliance with Regulation
(EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
The organisation may implement these alternative means of compliance subject to prior
approval by the competent authority, and upon receipt of the notification.
[Note: related AMC/GM:
AMC1 21.A.124A Alternative means of compliance]
21.A.125B Findings
(a) When objective evidence is found showing non-compliance of the holder of a letter of
agreement with the applicable requirements of this Annex I (Part 21), the finding shall be
classified as follows:
1. a level one finding is any non-compliance with this Annex I (Part 21) which could lead to
uncontrolled non-compliances with applicable design data and which could affect the
safety of the aircraft;
2. a level two finding is any non-compliance with this Annex I (Part 21) which is not
classified as level one.
(b) A level three finding is any item where it has been identified, by objective evidence, to contain
potential problems that could lead to a non-compliance under point (a).
(ca) After receipt of notification of findings issued by the competent authority according to point
21.B.125:
(1). in case of a level 1 one or level 2 finding, the holder of the letter of agreement shall
demonstrate corrective action to the satisfaction of the competent authority that it has
taken adequate corrective action within the time period set by the competent authority
in accordance with point 21.B.125 within a period of no more than 21 working days
after written confirmation of the finding;
2. in case of level two findings, the corrective action period granted by the competent
authority shall be appropriate to the nature of the finding but in any case initially shall
1
Or EASA if EASA is the competent authority.
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not be more than three months. In certain circumstances and subject to the nature of
the finding, the competent authority may extend the three months period subject to
the provision of a satisfactory corrective action plan agreed by the competent authority;
(2). a level 3 three finding shall not require immediate action by the holder of the letter of
agreement.
(db) In case of level 1 one or level 2 two findings, the letter of agreement may be subject to a
partial or full limitation, suspension and revocation under point 21.B.65 21.B.145. The In that
case, the holder of the letter of agreement shall provide confirmation of the receipt of the
notice of limitation, suspension or revocation of the letter of agreement in a timely manner.
[Note: related AMC/GM:
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings]
21.A.125C Duration and continued validity
(a) The letter of agreement shall be issued for a limited duration not exceeding one year. It shall
remain valid unless:
(1.) the holder of the letter of agreement fails to demonstrate compliance with the
applicable requirements of this Annex Subpart; or
(2) the competent authority is prevented by the holder or any of its partners or
subcontractors from performing the investigations in accordance with point 21.A.9;
(32.) there is evidence that the production organisation manufacturer cannot maintain
satisfactory control of the manufacture of products, parts, or appliances under the
agreement; or
(43.) the production organisation manufacturer no longer meets the requirements of point
21.A.122; or
(54.) the letter of agreement has been surrendered, revoked under point 21.B.145, 21.B.65,
surrendered or has expired.
(b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the
competent authority.
21.A.126 Production inspection system
(a) The production inspection system required under point 21.A.125A(a) shall provide a means for
determining whether:
(1). incoming materials, and bought or subcontracted parts, used in the finished product are
as specified in the applicable design data;
(2). incoming materials, and bought or subcontracted parts, are properly identified;
(3). processes, manufacturing techniques and methods of assembly affecting the quality
and safety of the finished product are accomplished in accordance with specifications
accepted by the competent authority; and
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(4). design changes, including material substitutions, have been approved under Subpart D
or E and controlled before being incorporated in the finished product.
(b) The production inspection system required by point 21.A.125A(a), shall also be such as to
ensure that:
(1). parts in process are inspected for conformity with the applicable design data at points
in production where accurate determinations can be made;
(2). materials subject to damage and deterioration are suitably stored and adequately
protected;
(3). current design drawings are readily available to manufacturing and inspection
personnel, and used when necessary;
(4). rejected materials and parts are segregated and identified in a manner that precludes
installation in the finished product; and
(5). materials and parts that are withheld because of departures from design data or
specifications, and that are to be considered for installation in the finished product, are
subjected to an approved engineering and manufacturing review procedure. Those
materials and parts determined by this procedure to be serviceable shall be properly
identified and reinspected if rework or repair is necessary. Materials and parts rejected
by this procedure shall be marked and disposed of to ensure that they are not
incorporated in the final product.;
6. records produced under the production inspection system are maintained, identified
with the completed product or part where practicable, and retained by the
manufacturer in order to provide the information necessary to ensure the continued
airworthiness of the product.
[Note: related AMC/GM:
GM 21.A.126 Production inspection system (unchanged)
GM 21.A.126(a)(1) Production inspection system —Conformity of supplied parts, appliances
and material (unchanged)
GM 21.A.126(a)(2) Production inspection system — Identification of incoming materials and
parts (unchanged)
GM No 1 to 21.A.126(a)(3) Production inspection system — List of specifications
(unchanged)
GM No 2 to 21.A.126(a)(3) Production inspection system — Means of checking of the
production processes (unchanged)
GM 21.A.126(a)(4) Production inspection system — Applicable design/production data
procedures (unchanged)
GM 21.A.126(b)(1) Production inspection system — Inspection of parts in process
(unchanged)
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GM 21.A.126(b)(2) Production inspection system — Suitable storage and protection
(unchanged)
GM 21.A.126(b)(3) Production inspection system — Use of derived data instead of original
design data (unchanged)
GM 21.A.126(b)(4) Production inspection system — Segregation of rejected material
(unchanged)
GM 21.A.126(b)(5) Production inspection system — Engineering and manufacturing review
procedure (unchanged)
GM 21.A.126(b)(6) Production inspection system — Recording and record keeping (moved to
GM1 21.A.5(a) and (b))]
21.A.129 Obligations of the manufacturer
Each organisation producing manufacturer of a product, part or appliance being manufactured
under this Subpart shall:
(a) make each product, part or appliance available for inspection by the competent authority;
(b) maintain at the place of manufacture the technical data and drawings necessary to determine
whether the product conforms to the applicable design data;
(c) maintain the production inspection system that ensures that each product conforms to the
applicable design data and is in condition for safe operation;
(d) provide assistance to the holder of the type certificate type-certificate, restricted type
certificate type-certificate or design approval in dealing with any continuing airworthiness
actions that are related to the products, parts or appliances that have been produced; and
(e) comply with Subpart A of this Annex. establish and maintain an internal occurrence reporting
system in the interest of safety, to enable the collection and assessment of occurrence reports
in order to identify adverse trends or to address deficiencies, and to extract reportable
occurrences. This system shall include evaluation of relevant information relating to
occurrences and the promulgation of related information;
(f) 1. report to the holder of the type-certificate, restricted type-certificate or design
approval, all cases where products, parts or appliances have been released by the
manufacturer and subsequently identified to have deviations from the applicable design
data, and investigate with the holder of the type-certificate, restricted type-certificate
or design approval to identify those deviations which could lead to an unsafe condition;
2. report to the Agency and the competent authority of the Member State the deviations
which could lead to an unsafe condition identified according to point (1). Such reports
shall be made in a form and manner established by the Agency under point
21.A.3A(b)(2) or accepted by the competent authority of the Member State;
3. where the manufacturer acts as supplier to another production organisation, report
also to that other organisation all cases where it has released products, parts or
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appliances to that organisation and subsequently identified them to have possible
deviations from the applicable design data.
[Note: related AMC/GM:
GM 21.A.129(a) Availability for inspection by the competent authority (unchanged)
AMC No 1 to 21.A.129(c) Obligations of the manufacturer — Conformity of prototype
models and test specimens (unchanged)
AMC No 2 to 21.A.129(c) Obligations of the manufacturer —Conformity with Applicable
Design Data (unchanged)
AMC No 3 to 21.A.129(c) Obligations of the manufacturer condition for safe operation
(unchanged)]
SUBPART G — PRODUCTION ORGANISATION APPROVAL
21.A.134A Alternative means of compliance
(a) Alternative means of compliance to the AMC adopted by EASA may be used by an
organisation to establish compliance with Regulation (EU) 2018/11391 and the delegated and
implementing acts adopted on the basis thereof.
(b) If an organisation wishes to use an alternative means of compliance, it shall, prior to
implementing it, provide the competent authority with a full description of the alternative
means of compliance. The description shall include any revisions to manuals or procedures
that may be relevant, as well as an assessment that demonstrates compliance with Regulation
(EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
The organisation may implement these alternative means of compliance subject to prior
approval by the competent authority, and upon receipt of the notification.
[Note: related AMC/GM:
AMC1 21.A.134A Alternative means of compliance]
21.A.139 Quality Production management Ssystem
(a) The production organisation shall establish, implement, and maintain a production
management system that includes a safety management system and a quality system with
clear lines of responsibility and accountability throughout the organisation demonstrate that it
has established and is able to maintain a quality system.
(b) The production management system shall:
(1) correspond to the size of the organisation, and to the nature and complexity of its
activities, taking into account the hazards and associated risks inherent in these
activities; and
1
Or EASA if EASA is the competent authority.
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(2) be established under the direct accountability of a single accountable manager
according to point 21.A.145(c)(1).
(c) As part of the safety management element of the production management system, the
production organisation shall:
(1) establish, implement and maintain a safety policy and the corresponding related safety
objectives;
(2) appoint key safety personnel to execute the safety policy in accordance with
point 21.A.145(c)(2);
(3) establish, implement and maintain a safety risk management process that includes:
(i) hazard identification in all domains of the organisation and its production
activities, resulting from analysis of the occurrences collected according to point
21.A.3A; and
(ii) safety risk assessment and mitigation;
(4) establish, implement and maintain a safety assurance process that includes:
(i) the measurement and monitoring of safety performance;
(ii) the management of changes in accordance with points 21.A.143(b) and 21.A.147;
and
(iii) principles for continuous improvement of the safety management system;
(5) promote safety in the organisation through:
(i) training and education; and
(ii) communication.
(d) As part of the quality management element of the production management system, the
production organisation shall:
(1) The quality system shall be documented. This quality system shall be such as to enable
the organisation to ensure that each product, part or appliance produced by the
organisation or by its partners, or supplied from or subcontracted to outside parties,
conforms to the applicable design data and is in condition for safe operation, and thus
exercise the privileges set forth as defined in point 21.A.163.
(2b) The quality system shall contain establish, implement, and maintain, as applicable,
within the scope of approval, control procedures for:
(i) document issue, approval, or change;
(ii) vendor and subcontractor assessment audit and control;
(iii) verification that incoming products, parts, materials, and equipment, including
items supplied new or used by buyers of products, are as specified in the
applicable design data;
(iv) identification and traceability;
(v) manufacturing processes;
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(vi) inspection and testing, including production flight tests;
(vii) calibration of tools, jigs, and test equipment;
(viii) non-conforming item control;
(ix) airworthiness coordination with the applicant for, or holder of, the design
approval;
(x) records the completion and retention of records;
(xi) personnel the competence and qualification qualifications of personnel;
(xii) the issue of airworthiness release documents;
(xiii) handling, storage and packing;
(xiv) internal quality audits and the resulting corrective actions;
(xv) work within the terms of approval performed at any location other than the
approved facilities;
(xvi) work carried out after the completion of production but prior to delivery, to
maintain the aircraft in a condition for safe operation;
(xvii) issue issuance of permit to fly and approval of associated flight conditions.
(3) The control procedures need to include specific provisions for any critical parts in the
control procedures for any critical parts.
(e) The production organisation shall document, in accordance with point 21.A.143, all the key
processes of the production management system, and maintain a process for:
(1) amending that documentation; and
(2) making personnel aware of their responsibilities under the production management
system.
(f) The production organisation shall include in the production management system An
independent quality assurance function to monitor monitoring of compliance with, and the
adequacy of, the production management system and its documented procedures of the
quality system. This monitoring shall include a feedback system to the person or group of
persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point
21.A.145(c)(1) to ensure, as necessary, corrective action.
(g) If the organisation holds other organisation certificates issued on the basis of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof, the
production organisation may integrate the production management system with the
management system that is required for the issuance of the other certificate(s).
[Note: related AMC/GM:
— GM1 21.A.139(c) Production management system
— AMC1 21.A.139(c) Production management system
— AMC1 21.A.139(c)(1) Production management system
— GM1 21.A.139(c)(1) Production management system
— AMC1 21.A.139(c)(2) Production management system
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— GM1 21.A.139(c)(2) Production management system
— AMC1 21.A.139(c)(3) and (4) Production management system
— AMC1 21.A.139(c)(3) Production management system
— GM1 21.A.139(c)(4)(ii) Production management system
— AMC1 21.A.139(c)(4)(ii) Production management system
— AMC1 21.A.139(c)(5) Production management system
— GM1 21.A.139(c)(5) Production management system
— AMC1 21.A.139(c)(5)(i) Production management system
— GM1 21.A.139(c)(5)(i) Production management system
— AMC1 21.A.139(d) Production management system
— AMC1 21.A.139(d)(2) Production management system
— GM1 21.A.139(d)(1) Production management system
— AMC1 21.A.139(d)(2)(ii) Production management system
— AMC2 21.A.139(d)(2)(ii) Production management system
— GM1 21.A.139(d)(2)(ii) Production management system
— AMC1 21.A.139(e) Production management system
— AMC1 21.A.139(f) Production management system]
21.A.143 Exposition
(a) As part of the production management system, the The organisation shall establish submit to
the competent authority a production organisation exposition that provides providing directly
or by cross reference the following information:
(1). a statement signed by the accountable manager confirming that the production
organisation exposition and any associated manuals which define the approved
organisation's compliance with this Annex Subpart will be complied with at all times;
(2). the title(s) and names of managers accepted by the competent authority in accordance
with point 21.A.145(c)(2);
(3). the duties accountabilities and responsibilities of the manager(s) as required by
point 21.A.145(c)(2) including matters on which they may deal directly with the
competent authority on behalf of the organisation;
(4). an organisational chart showing the associated chains of accountability and
responsibility of the managers as required by point 21.A.145(c)(1) and (2);
(5). a list of the certifying staff as referred to in point 21.A.145(d);
(6). a general description of the man-power resources;
(7). a general description of the facilities located at each address specified in the production
organisation's certificate of approval;
(8). a general description of the production organisation's scope of work relevant to the
terms of approval;
(9). the procedure for the notification of organisational changes to the competent
authority;
(10). the amendment procedure for the production organisation exposition;
(11). a description of the quality production management system, the policy, processes and
the procedures as required by point 21.A.139(b)(1);
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(12). a list of those outside parties referred to in point 21.A.139(a). 21.A.139(d)(1); and
(13). if flight tests are to be conducted, a flight test operations manual defining the
organisation’s policies and procedures in relation to flight test. The flight test operations
manual shall include:
(i) a description of the organisation’s processes for flight test, including the flight
test organisation involvement into the permit to fly issuance process;
(ii) crewing policy, including composition, competency, currency and flight time
limitations, in accordance with Appendix XII to this Annex I (Part 21), where
applicable;
(iii) procedures for the carriage of persons other than crew members and for flight
test training, when applicable;
(iv) a policy for risk and safety management and associated methodologies;
(v) procedures to identify the instruments and equipment to be carried; and
(vi) a list of documents that need to be produced for flight test.
(b) The production organisation exposition shall be amended as necessary to remain an up-to-
date description of the organisation, and copies of any amendments shall be supplied to the
competent authority.
[Note: related AMC/GM:
— AMC to 21.A.143, 21.A.243, 21.A.14(b), 21.A.112B(b) and 21.A.432B(b) Flight Test
Operations Manual (FTOM) (unchanged);
— GM1 21.A.143 Exposition
— AMC1 21.A.143(a)(1) Exposition]
21.A.145 Approval requirements Resources
The production organisation shall demonstrate, on the basis of the information submitted in
accordance with point 21.A.143 that:
(a) with regard to general approval requirements, facilities, working conditions, equipment and
tools, processes and associated materials, number and competence of staff, and general
organisation are adequate to discharge the obligations under point 21.A.165;
(b) with regard to all necessary airworthiness and environmental, noise, fuel venting and exhaust
emissions data:
(1). the production organisation is in receipt of such data from the Agency EASA, and from
the holder of, or applicant for, the type certificate type-certificate, restricted type
certificate type-certificate or design approval, including any exemption granted against
the CO2 production cut-off requirements, to determine conformity with the applicable
design data;
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(2). the production organisation has established a procedure to ensure that airworthiness
and environmental noise, fuel venting and exhaust emissions data are correctly
incorporated in its production data;
(3). such data are kept up to date and made available to all personnel who need access to
such data to perform their duties;
(c) with regard to management and staff:
(1). a an accountable manager has been nominated by the production organisation, and is
accountable to the competent with authority to ensure that, His or her responsibility
within the organiszation, shall consist of ensuring that all production is performed to
the required standards and that the production organisation is continuously in
compliance with the requirements of the management system referred to in point
21.A.139, and the data and the procedures identified in the exposition referred to in
point 21.A.143;
(2). the accountable manager shall nominate a person or group of persons have been
nominated by the production organisation to ensure that the organisation is in
compliance with the requirements of this Annex I (Part 21), and are identified, together
with the extent of their authority. Such person(s) shall act under the direct authority of
the accountable manager referred to in point (1). The persons nominated shall be able
to show the appropriate knowledge, background and experience to discharge their
responsibilities;
(3). staff at all levels have been given appropriate authority to be able to discharge their
allocated responsibilities and that there is full and effective coordination within the
production organisation in respect of airworthiness, noise, fuel venting and exhaust
emission data matters;
(d) with regard to certifying staff, authorised by the production organisation to sign the
documents issued under point 21.A.163 under the scope or terms of approval:
(1). the knowledge, background (including other functions in the organisation), and
experience of the certifying staff are appropriate to discharge their allocated
responsibilities;
2. the production organisation maintains a record of all certifying staff which shall include
details of the scope of their authorisation;
(2). certifying staff are provided with evidence of the scope of their authorisation.
[Note: related AMC/GM:
— AMC1 21.A.145(a) Resources
— GM1 21.A.145(a) Resources
— GM1 21.A.145(b)(2) Resources
— AMC1 21.A.145(c)(1) Resources
— GM1 21.A.145(c)(1) Resources
— AMC1 21.A.145(c)(2) Resources
— AMC2 21.A.145(c)(2) Resources
— AMC1 21.A.145(d)(1) Resources
— AMC1 21.A.145(d)(2)Resources]
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21.A.147 Changes to the approved production management system
organisation
(a) After the issue of a production organisation approval, each change to the approved
production management system organisation that is significant to the showing demonstration
of conformity or to the airworthiness and environmental characteristics of noise, fuel venting
and exhaust emissions of the product, part or appliance, particularly changes to the quality
system, shall be approved by the competent authority before being implemented. Before the
implementation of the change, an An application for approval shall be submitted in writing to
the competent authority, and the organisation shall demonstrate, to the competent authority
before implementation of the change, that it will continue to comply with this Subpart Annex
after the implementation.
(b) The competent authority shall establish the conditions under which a production organisation
approved under this Subpart may operate during such changes unless the competent
authority determines that the approval should be suspended.
[Note: related AMC/GM:
— AMC1 21.A.147 Changes to the production management system
— GM1 21.A.147 Changes to the production management system]
21.A.157 Investigations
A production organisation shall make arrangements that allow the competent authority to make any
investigations, including investigations of partners and subcontractors, necessary to determine
compliance and continued compliance with the applicable requirements of this Subpart.
21.A.158 Findings
(a) When objective evidence is found showing non-compliance of the holder of a production
organisation approval with the applicable requirements of this Annex I (Part 21), the finding
shall be classified as follows:
1. a level one finding is any non-compliance with this Annex I (Part 21) which could lead to
uncontrolled non-compliances with applicable design data and which could affect the
safety of the aircraft;
2. a level two finding is any non-compliance with this Annex I (Part 21) which is not
classified as level one.
(b) A level three finding is any item where it has been identified, by objective evidence, to contain
potential problems that could lead to a non-compliance under point (a).
(ca) After receipt of notification of findings issued by the competent authority according to point
21.B.225,
(1). in case of a level 1 or level 2 one findings, the holder of the production organisation
approval shall demonstrate corrective action to the satisfaction of the competent
authority that it has taken adequate corrective action within a the time period set by
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the competent authority in accordance with point 21.B.225 of no more than 21 working
days after written confirmation of the finding;
2. in case of level two findings, the corrective action period granted by the competent
authority shall be appropriate to the nature of the finding but in any case initially shall
not be more than three months. In certain circumstances and subject to the nature of
the finding the competent authority may extend the three months period subject to the
provision of a satisfactory corrective action plan agreed by the competent authority;
(2)3. a level 3 three finding shall not require immediate action by the holder of the
production organisation approval.
(db) In case of level 1 one or level 2 two findings, the production organisation approval may be
subject to a partial or full limitation, suspension or revocation under point 21.B.245 21.B.65. In
that case, the The holder of the production organisation approval shall provide confirmation
of receipt of the notice of limitation, suspension or revocation of the production organisation
approval in a timely manner.
[Note: related AMC/GM:
— GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings]
21.A.159 Duration and continued validity
(a) A production organisation approval shall be issued for an unlimited duration. It shall remain
valid unless:
(1). the production organisation fails to demonstrate compliance with the applicable
requirements of this Subpart Annex; or
(2). the competent authority is prevented by the holder or any of its partners or
subcontractors to perform the investigations in accordance with point 21.A.9 21.A.157;
or
(3). there is evidence that the production organisation cannot maintain satisfactory control
of the manufacture of products, parts or appliances under the approval; or
(4). the production organisation no longer meets the eligibility requirements of
point 21.A.133; or
(5). the certificate has been surrendered or revoked under point 21.B.65 21.B.245 or
surrendered.
(b) Upon surrender or revocation, the certificate shall be returned to the competent authority.
[Note: related AMC/GM:
— GM 21.A.159(a)(3) Evidence of a lack of satisfactory control (unchanged)]
21.A.165 Obligations of the holder
The holder of a production organisation approval shall:
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(a) ensure that the production organisation exposition furnished in accordance with point
21.A.143 and the documents to which it refers, are used as basic working documents within
the organisation;
(b) maintain the production organisation in conformity with the data and procedures approved
for the production organisation approval;
(c) (1). determine that each completed aircraft conforms to the type design and is in condition
for safe operation prior to submitting statements of conformity to the competent
authority; or
(2). determine that other products, parts or appliances are complete and conform to the
approved design data and are in a condition for safe operation before issuing an
EASA Form 1 to certify conformity to approved design data and condition for safe
operation;
(3). additionally, in the case of engines, determine that the completed engine is in
compliance with the applicable emissions requirements on the date of manufacture of
the engine;
(4). determine that other products, parts or appliances conform to the applicable data
before issuing an EASA Form 1 as a conformity certificate.
(d) record all details of work carried out;
(e) establish and maintain an internal occurrence reporting system in the interest of safety, to
enable the collection and assessment of occurrence reports in order to identify adverse trends
or to address deficiencies, and to extract reportable occurrences. This system shall include
evaluation of relevant information relating to occurrences and the promulgation of related
information;
(f) 1. report to the holder of the type-certificate or design approval, all cases where products,
parts or appliances have been released by the production organisation and
subsequently identified to have possible deviations from the applicable design data, and
investigate with the holder of the type-certificate or design approval in order to identify
those deviations which could lead to an unsafe condition;
2. report to the Agency and the competent authority of the Member State the deviations
which could lead to an unsafe condition identified according to point (1). Such reports
shall be made in a form and manner established by the Agency under point
21.A.3A(b)(2) or accepted by the competent authority of the Member State;
3. where the holder of the production organisation approval is acting as a supplier to
another production organisation, report also to that other organisation all cases where
it has released products, parts or appliances to that organisation and subsequently
identified them to have possible deviations from the applicable design data;
(dg) provide assistance to the holder of the type certificate type-certificate or design approval in
dealing with any continuing airworthiness actions that are related to the products parts or
appliances that have been produced;
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(h) establish an archiving system incorporating requirements imposed on its partners, suppliers
and subcontractors, ensuring conservation of the data used to justify conformity of the
products, parts or appliances. Such data shall be held at the disposal of the competent
authority and be retained in order to provide the information necessary to ensure the
continuing airworthiness of the products, parts or appliances;
(ei) where, under its terms of approval, the holder issues a certificate of release to service,
determine that each completed aircraft has been subjected to necessary maintenance and is
in condition for safe operation, prior to issuing the certificate;
(fj) where applicable, under the privilege of point 21.A.163(e), determine the conditions under
which a permit to fly can be issued;
(gk) where applicable, under the privilege of point 21.A.163(e), establish compliance with points
21.A.711(c) and (e) before issuing a permit to fly to an aircraft.;
(h) comply with Subpart A of this Annex.
[Note: related AMC/GM:
— GM 21.A.165(a) Obligations of the holder — Basic working document (unchanged);
— GM No 1 to 21.A.165(c) Obligations of the holder — Conformity of prototype models and
test specimens (unchanged);
— GM No 2 to 21.A.165(c) Obligations of holder — Conformity with type design (unchanged);
— GM No 3 to 21.A.165(c) Obligations of the holder — Condition for safe operation
(unchanged);
— GM No 4 to 21.A.165(c) Airworthiness Release or Conformity Certificate (unchanged);
— AMC 21.A.165(c)(3) Applicable emissions requirements (unchanged);
— GM 21.A.165(c)(3) Definitions of engine type certification date and production date
(unchanged);
— GM 21.A.165(d) and (h) Obligations of the holder — Recording and archiving system (moved
to — GM1 21.A.5(a) and (b))]
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SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED
CERTIFICATES OF AIRWORTHINESS
21.A.180 Inspections
The holder of the airworthiness certificate shall provide access to the aircraft for which that
airworthiness certificate has been issued upon request by the competent authority of the Member
State of registry.
21.A.181 Duration and continued validity
(a) An airworthiness certificate shall be issued for an unlimited duration. It shall remain valid
subject to:
(1). compliance with the applicable type-design and continuing airworthiness requirements;
and
(2). the aircraft remaining on the same register; and
(3). the type certificate type-certificate or restricted type certificate type-certificate under
which it is issued not being previously invalidated under point 21.A.51;
(4). the certificate not being surrendered or revoked under point 21.B.65 21.B.330 or
surrendered.
(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of
the Member State of registry.
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SUBPART I — NOISE CERTIFICATES
21.A.210 Inspections
The holder of the noise certificate shall provide access to the aircraft for which that noise certificate
has been issued upon request by the competent authority of the Member State of registry or by the
Agency for inspection.
21.A.211 Duration and continued validity
(a) A noise certificate shall be issued for an unlimited duration. It shall remain valid subject to:
(1). compliance with the applicable type-design, environmental protection and continuing
airworthiness requirements; and
(2). the aircraft remaining on the same register; and
(3). the type certificate type-certificate or restricted type certificate type-certificate under
which it is issued not being previously invalidated under point 21.A.51;
(4). the certificate not being surrendered or revoked under point 21.B.430 21.B.65 or
surrendered.
(b) Upon surrender or revocation, the certificate shall be returned to the competent authority of
the Member State of registry.
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SUBPART J — DESIGN ORGANISATION APPROVAL
21.A.239 Design assurance management system
(a) The design organisation shall establish, implement, and maintain a design management
system that includes a safety management system and a design assurance system with clear
lines of responsibility and accountability throughout the organisation.
(b) The design management system shall:
(1) correspond to the size of the organisation and the nature and complexity of its
activities, taking into account the hazards and the associated risks that are inherent in
these activities; and
(2) be established under the direct accountability of a single manager according to point
21.A.245(a).
(c) As part of the safety management element of the design management system, the design
organisation shall:
(1) establish, implement and maintain a safety policy and the corresponding related safety
objectives;
(2) appoint key safety personnel to execute the safety policy in accordance with
point 21.A.245(b);
(3) establish, implement and maintain a safety risk management process that includes:
(i) hazard identification in all domains of the organisation and its design activities,
resulting from analysis of the occurrences collected according to point 21.A.3A;
and
(ii) safety risk assessment and mitigation;
(4) establish, implement and maintain a safety assurance process that includes:
(i) measurement and monitoring of safety performance;
(ii) management of changes in accordance with points 21.A.243(c) and 21.A.247; and
(iii) principles for continuous improvement of the safety management system; and
(5) promote safety in the organisation through:
(i) training and education; and
(ii) communication.
(d) As part of the design assurance element of the design management system, the design
organisation shall:
(a1) The design organisation shall demonstrate that it has established and is able to
maintain a design assurance system for establish, implement and maintain a system for
the control and supervision of the design, and of design changes, of products, parts and
appliances covered by the application. This design assurance system shall be such as to
enable the organisation to ensure that:
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(i)1. to ensure that the design of the products, parts and appliances or the design
change thereof, comply with the applicable type-certification basis, the applicable
operational suitability data certification basis and the environmental protection
requirements; and
(ii)2. to ensure that its responsibilities are properly discharge its responsibilities
discharged in accordance with the appropriate provisions of this Annex I (Part
21); and the terms of approval issued under point 21.A.251;
(2) establish, implement and maintain an independent verification function of the
demonstration of compliance on the basis of which the organisation declares
compliance with the applicable airworthiness, operational suitability and environmental
protection requirements; and
(3) specify the manner in which the design assurance system accounts for the acceptability
of the parts or appliances that are designed or the tasks that are performed by partners
or subcontractors according to methods which are the subjects of written procedures.
(e) The design organisation shall document, in accordance with point 21.A.243, all the key
processes of the design management system, and maintain a process for:
(1) amending that documentation;
(2) making personnel aware of their responsibilities under the design management system;
(f) Include in the design management system independent monitoring of to independently
monitor the compliance with, and the adequacy of, the design management system and its
documented procedures of the system. This monitoring shall include a feed-back system to
the a person or a group of persons referred to in point 21.A.245(b), and ultimately to the
manager referred to in point 21.A.245(a) to ensure, as necessary, that corrective action takes
place. having the responsibility to ensure corrective actions.
(g) If the organisation holds other organisation certificates that were issued on the basis of
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof, the design organisation may integrate the design management system with the
management system that is required for the issuance of the other certificate(s).
(b) The design assurance system shall include an independent checking function of the showings
of compliance on the basis of which the organisation submits compliance statements and
associated documentation to the Agency.
(c) The design organisation shall specify the manner in which the design assurance system
accounts for the acceptability of the parts or appliances designed or the tasks performed by
partners or subcontractors according to methods which are the subject of written procedures.
[Note: related AMC/GM:
— GM1 21.A.239(c) Design management system
— AMC1 21.A.239(c) Design management system
— AMC1 21.A.239(c)(1) Design management system
— GM1 21.A.239(c)(1) Design management system
— AMC1 21.A.239(c)(2) Design management system
— GM1 21.A.239(c)(2) Design management system
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— AMC1 21.A.239(c)(3) and (4) Design management system
— AMC1 21.A.239(c)(3) Design management system
— AMC1 21.A.239(c)(4)(ii) Design management system
— GM1 21.A.239(c)(4)(ii) Design management system
— AMC1 21.A.239(c)(5) Design management system
— GM1 21.A.239(c)(5) Design management system
— AMC1 21.A.239(c)(5)(i) Design management system
— GM1 21.A.239(c)(5)(i) Design management system
— GM1 21.A.239(d) Design management system
— AMC1 21.A.239(d) Design management system
— AMC2 21.A.239(d) Design management system
— AMC1 21.A.239(d)(2) Design management system
— GM1 21.A.239(d)(3) Design management system
— AMC1 21.A.239(e) Design management system
— AMC1 21.A.239(f) Design management system]
21.A.243 Data Handbook
(a) The As part of the design management system, the design organisation shall furnish establish
a handbook to the Agency describing, directly or by cross-reference, the organisation, the
relevant procedures and the products or changes to products to be designed and, where
relevant, the interfaces with and the control of partners or subcontractors. If flight tests are to
be conducted, a flight test operations manual defining the organisation’s policies and
procedures in relation to flight test shall be furnished established. The flight test operations
manual shall include:
(1i) a description of the organisation’s processes for flight test, including the flight test
organisation involvement into the permit to fly issuance process;
(2ii) crewing policy, including composition, competency, currency and flight time limitations,
in accordance with Appendix XII to this Annex I (Part 21), where applicable;
(3iii) procedures for the carriage of persons other than crew members and for flight test
training, when applicable;
(4iv) a policy for risk and safety management and associated methodologies;
(5v) procedures to identify the instruments and equipment to be carried;
(6vi) a list of documents that need to be produced for flight test.
(b) Where any parts or appliances or any changes to the products are designed by partner
organisations or subcontractors, the handbook shall include a statement of how the design
organisation is able to give, for all parts and appliances, the assurance of compliance required
by point 21.A.239(b), and shall contain, directly or by cross-reference, descriptions and
information on the design activities and organisation of those partners or subcontractors, as
necessary to establish this statement.
(c) The handbook shall be amended as necessary to remain an up-to-date description of the
organisation, and copies of amendments shall be supplied to the Agency EASA.
(d) The design organisation shall furnish establish and maintain a statement of the qualifications
and experience of the management staff and other persons in the organisation responsible for
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making decisions affecting airworthiness, operational suitability data and environmental
protection in the organisation.
[Note: related AMC/GM:
— AMC to 21.A.143, 21.A.243, 21.A.14(b), 21.A.112B(b) and 21.A.432B(b) Flight Test
Operations Manual (FTOM) (unchanged);
— AMC1 21.A.243(a) Handbook
— AMC2 21.A.243(a) Handbook
— AMC1 21.A.243(d) Handbook
— GM1 21.A.243(d) Handbook
— AMC2 21.A.243(d) Handbook]
21.A.245 Resources Approval requirements
The design organisation shall demonstrate, on the basis of the information submitted in accordance
with point 21.A.243 that, in addition to complying with point 21.A.239:
(a) The organisation shall nominate a head of the design organisation with authority for ensuring
that within the organisation, all design activities are performed to the required standards and
that the design organisation is continuously in compliance with the requirements of the
management system referred to in point 21.A.239 and the procedures identified in the
handbook referred to in point 21.A.243.
(b) Depending on the size of the organisation and on the nature and complexity of its activities,
the head of the design organisation shall nominate and identify, together with the extent of
their authority:
(1) a chief of the office of airworthiness;
(2) a chief of the independent monitoring of compliance and adequacy function; and
(3) any other person or group of persons who are needed to ensure that the organisation is
in compliance with the requirements of this Annex.
(c) The person or group of persons identified in point (b) shall:
(1) act under the direct authority of the head of the design organisation; and
(2) be able to show the appropriate knowledge, background and experience to discharge
their responsibilities.
(d) The design organisation shall ensure that:
(a1) the staff in all technical departments are of sufficient numbers and experience and have
been given appropriate authority to be able to discharge their allocated responsibilities
and these, together with the accommodation, facilities and equipment, are adequate to
enable the staff to achieve the airworthiness, operational suitability and environmental
protection objectives for the product;
(b2) there is full and efficient coordination between departments and within departments in
respect of airworthiness, operational suitability and environmental protection matters.
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[Note: related AMC/GM:
— AMC1 21.A.245 Resources
— AMC2 21.A.245 Resources
— AMC1 21.A.245(a) Resources
— AMC1 21.A.245(b) Resources
— AMC2 21.A.245(b) Resources]
21.A.247 Changes in to the design management assurance system
After the issue of a design organisation approval, each change to the design management assurance
system that is significant to the showing demonstration of compliance or to the airworthiness,
operational suitability and environmental protection of the product, part or appliance shall be
approved by the Agency EASA. Before the implementation of the change, an An application for
approval shall be submitted in writing to the Agency EASA, and the design organisation shall
demonstrate to the Agency, on the basis of the submission of the proposed changes to the
handbook, and before implementation of the change, that it will continue to comply with this
Subpart Annex after the implementation.
[Note: related AMC/GM:
AMC1 21.A.247 Changes to the design management system
GM1 21.A.247 Changes to in the design management assurance system]
21.A.257 Investigations
(a) The design organisation shall make arrangements that allow the Agency to make any
investigations, including investigations of partners and subcontractors, necessary to
determine compliance and continued compliance with the applicable requirements of this
Subpart.
(b) The design organisation shall allow the Agency to review any report and make any inspection
and perform or witness any flight and ground test necessary to check the validity of the
compliance statements submitted by the applicant under point 21.A.239(b).
21.A.258 Findings
(a) When objective evidence is found showing non-compliance of the holder of a design
organisation approval with the applicable requirements of this Annex I (Part 21), the finding
shall be classified as follows:
1. a level one finding is any non-compliance with this Annex I (Part 21) which could lead to
uncontrolled non-compliances with applicable requirements and which could affect the
safety of the aircraft;
2. a level two finding is any non-compliance with this Annex I (Part 21) which is not
classified as level one.
(b) A level three finding is any item where it has been identified, by objective evidence, to contain
potential problems that could lead to a non-compliance under point (a).
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(ac) After receipt of notification of findings issued by EASA according to point 21.B.433 under the
applicable administrative procedures established by the Agency,
(1)1. in case of a level 1 or level 2 one findings, the holder of the design organisation
approval shall demonstrate to the satisfaction of EASA that it has taken adequate
corrective action within the time period set by EASA in accordance with 21.B.433 to the
satisfaction of the Agency within a period of no more than 21 working days after
written confirmation of the finding;
2. in case of level two findings, the corrective action period granted by the Agency shall be
appropriate to the nature of the finding but in any case initially shall not be more than
three months. In certain circumstances and subject to the nature of the finding the
Agency may extend the three months period subject to the provision of a satisfactory
corrective action plan agreed by the Agency;
(2)3. a level 3 three finding shall not require immediate action by the holder of the design
organisation approval.
(bd) In case of level 1 one or level 2 two findings, the design organisation approval may be subject
to a partial or full limitation, suspension or revocation under the applicable administrative
procedures established by the Agency point 21.B.65. In that case, the The holder of the design
organisation approval shall provide confirmation of the receipt of the notice of limitation,
suspension or revocation of the design organisation approval in a timely manner.
[Note: related AMC/GM:
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings]
21.A.259 Duration and continued validity
(a) A design organisation approval shall be issued for an unlimited duration. It shall remain valid
unless:
(1)1. the design organisation fails to demonstrate compliance with the applicable
requirements of this Subpart Annex; or
(2)2. the Agency EASA is prevented by the holder or any of its partners or subcontractors to
from performing perform the investigations in accordance with point 21.A.9 21.A.257;
or
(3)3. there is evidence that the design management assurance system cannot maintain
satisfactory control and supervision of the design of products or changes thereof under
the approval; or
(4) the design organisation no longer meets the eligibility requirements of point 21.A.233;
or
(5)4. the certificate has been surrendered or revoked under point 21.B.65 or surrendered the
applicable administrative procedures established by the Agency.
(b) Upon surrender or revocation, the certificate shall be returned to the Agency EASA.
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21.A.263 Privileges
(a) (Reserved) The holder of a design organisation approval shall be entitled to perform design
activities under this Annex I (Part 21) and within its scope of approval.
(b) (Reserved) Subject to point 21.A.257(b), the Agency shall accept without further verification
the following compliance documents submitted by the applicant for the purpose of obtaining:
1. the approval of flight conditions required for a permit to fly; or
2. a type-certificate or approval of a major change to a type-certificate; or
3. a supplemental type-certificate; or
4. an ETSO authorisation under point 21.A.602B(b)(1); or
5. a major repair design approval.
(c) The A holder of a design organisation approval shall be entitled, within the scope of its terms
of approval as established by EASA and under the relevant procedures of the design
management assurance system:
(1)1. to classify changes to the type certificate type-certificate or to a supplemental type
certificate type-certificate and repair designs as ‘major’ or ‘minor’;
(2)2. to approve minor changes to type certificate type-certificate or to a type certificate
supplemental type-certificate and minor repair designs;
(3)3. (Reserved) to issue information or instructions containing the following statement: ‘The
technical content of this document is approved under the authority of DOA ref. EASA.
21J. [XXXX].’;
(4)4. (Reserved) to approve minor revisions to the aircraft flight manual and supplements,
and issue such revisions containing the following statement: ‘Revision No [YY] to AFM
(or supplement) ref. [ZZ] is approved under the authority of DOA ref. EASA. 21J.
[XXXX].’;
(5)5. to approve the design of certain major repair designs under Subpart M to products or
Auxiliary Power Units (APUs)for which it holds the type-certificate or the supplemental
type-certificate or ETSO authorisation;
(6)6. to approve for certain aircraft, the flight conditions under which a permit to fly can be
issued in accordance with point 21.A.710(a)(2), except for permits to fly to be issued for
the purpose of point 21.A.701(a)(15);
(7)7. to issue a permit to fly in accordance with point 21.A.711(b) for an aircraft it has
designed or modified, or for which it has approved in accordance with under
point 21.A.263(c)(6) the flight conditions under which the permit to fly can be issued,
and when where the design organisation itself:
(i) is controlling controls under its Design Organisation Approval the configuration of
the aircraft and
(ii) is attesting attests conformity with the design conditions approved for the flight.
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(7)7. to approve certain major changes to a type certificate type-certificate under Subpart D;
and
(8)8. to issue certain supplemental type certificate type-certificates under Subpart E and
approve certain major changes to those certificates.
[Note: related AMC/GM:
— GM 21.A.263(b) DOA privilege related to compliance documents (unchanged)
— AMC 21.A.263(b)(1) Compliance documents with conditions related to engine or propeller
without a type-certificate or with unapproved changes and fitted on aircraft for which a
permit to fly is requested (unchanged)
— AMC No 1 to 21.A.263(c)(1) Procedure for the classification of changes to type certificate
(TC) and repairs as minor or major (unchanged)
— AMC No 2 to 21.A.263(c)(1) Privileges —Organisations designing minor changes to a type
certificate (TC) or minor repairs to products: classification procedure (unchanged)
— AMC No 1 to 21.A.263(c)(2) Procedure for the approval of minor changes to a type
certificate (TC) or minor repairs (unchanged)
— AMC No 2 to 21.A.263(c)(2) Privileges —Organisations designing minor changes to a type
certificate (TC) or minor repairs to products: procedure for the approval of minor changes to
a TC or minor repairs (unchanged)
— GM 21.A.263(c)(3) Issue of information or instructions (unchanged)
— GM 21.A.263(c)(4) Procedure for the approval of minor revisions to the aircraft flight
manual (unchanged)
— AMC 21.A.263(c)(6) Procedure for the approval of the conditions for issue of a permit to fly
(unchanged)
— AMC 21.A.263(c)(7) Procedure for the issue of a permit to fly (unchanged)]
21.A.265 Obligations of the holder
The holder of a design organisation approval shall within the scope of its terms of approval, as
established by the Agency EASA:
(a) maintain the handbook required under point 21.A.243 in conformity with the design
management assurance system;
(b) ensure that this handbook or the relevant procedures included by cross-reference are is used
as a basic working document within the organisation;
(c) determine that the design of products, or changes or repairs thereto thereof, as applicable,
comply with applicable specifications and requirements and have no unsafe feature features;
(d) except for minor changes or repairs approved under the privilege of point 21.A.263, provide to
the Agency EASA with statements and associated documentation confirming compliance with
point (c) except for approval processes carried out in accordance with point 21.A.263(c);
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(e) provide to the Agency EASA data and information or instructions related to required actions
under point 21.A.3B;
(f) where applicable, under the privilege of point 21.A.263(c)(6), determine in accordance with
point 21.A.263(c)(6), the flight conditions under which a permit to fly can be issued;
(g) where applicable, under the privilege of point 21.A.263(c)(7), establish in accordance with
point 21.A.263(c)(7), compliance with points (b) and (e) of point 21.A.711(b) and (e) before
issuing a permit to fly to an aircraft.;
(h) designate data and information issued under the authority of the approved design
organisation within the scope of its terms of approval as established by the Agency EASA with
the following statement: ‘The technical content of this document is approved under the
authority of the DOA ref. EASA. 21J.[XXXX]’; and
(i) comply with Subpart A of this Annex.
[Note: related AMC/GM:
— AMC 21.A.265(a) Administration of the Handbook (unchanged)
— GM 21.A.265(b) Use of the Handbook (unchanged)]
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SUBPART M — REPAIRS
21.A.447 Record-keeping
For each repair, all relevant design information, drawings, test reports, instructions and limitations
possibly issued in accordance with point 21.A.443, justification for classification and evidence of the
design approval, shall:
(a) be held by the repair design approval holder at the disposal of the Agency; and
(b) be retained by the repair design approval holder in order to provide the information necessary
to ensure the continued airworthiness of the repaired products, parts or appliances.
[Note: related AMC/GM:
— AMC 21.A.433(a) and 21.A.447 Repair design and record-keeping (moved to AMC1 21.A.5(a)
and 21.A.433(a))]
21.A.451 Obligations and EPA marking
(a) Each holder of a major repair design approval shall:
(1). undertake the obligations:
(i) laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.9, 21.A.439, 21.A.441,
21.A.443, 21.A.447 and 21.A.449;
(ii) implicit in the collaboration with the type certificate type-certificate,
supplemental type certificate type-certificate and with the APU ETSO
authorisation holder under point 21.A.433(b), as appropriate.
(2). specify the marking, including EPA letters, in accordance with point 21.A.804(a).
(b) Except for type certificate type-certificate holders or APU authorisation holders for which
point 21.A.44 applies, the holder of a minor repair design approval shall:
(1). undertake the obligations laid down in points 21.A.4, 21.A.447 and 21.A.449; and
(2). specify the marking, including EPA letters, in accordance with point 21.A.804(a).
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SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER
AUTHORISATIONS
21.A.604 ETSO Aauthorisation for an Aauxiliary Ppower Uunit (APU)
With regard to ETSO authorisation for an APU auxiliary power unit:
(a) by way of derogation from points 21.A.603, 21.A.610 and 21.A.615 21.A.9, the following
points shall apply: points 21.A.15, 21.A.16B, 21.A.17A, 21.A.17B, 21.A.20, 21.A.21, 21.A.31,
21.A.33, 21.A.44 21.B.75 and 21.B.80. shall apply by way of derogation from points 21.A.603,
21.A.606(c), 21.A.610 and 21.A.9 21.A.615, except that However an ETSO Authorisation shall
be issued in accordance with point 21.A.606 instead of the type certificate type-certificate;
(b) by way of derogation from point 21.A.611, the requirements of Subpart D shall apply to the
approval of design changes by the APU ETSO authorisation holder and the requirements of or
Subpart E shall apply to is applicable for the approval of design changes by other applicants
way of derogation from point 21.A.611. When Subpart E is used, a separate ETSO
authorisation shall be issued instead of a supplemental type certificate type-certificate.
(c) the requirements of Subpart M shall apply is applicable to the approval of repair designs.
21.A.609 Obligations of holders of ETSO authorisations
The holder of an ETSO authorisation under this Subpart shall:
(a) manufacture each article in accordance with Subpart G or Subpart F that ensures that each
completed article conforms to its design data and is safe for installation;
(b) prepare and maintain, for each model of each article for which an ETSO authorisation has
been issued, a current file of complete technical data and records in accordance with point
21.A.5 21.A.613;
(c) prepare, maintain and update master copies of all manuals required by the applicable
airworthiness specifications for the article;
(d) make available to users of the article and to the Agency EASA on request those maintenance,
overhaul and repair manuals necessary for the usage and maintenance of the article, and
changes to those manuals;
(e) mark each article in accordance with point 21.A.807;
(f) comply with points 21.A.3A, 21.A.3B, and 21.A.4 and 21.A.9;
(g) continue to meet the qualification requirements of point 21.A.602B.
21.A.613 Record-keeping
Further to the record-keeping requirements appropriate to or associated with the quality system, all
relevant design information, drawings and test reports, including inspection records for the article
tested, shall be held at the disposal of the Agency and shall be retained in order to provide the
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information necessary to ensure the continued airworthiness of the article and of the type-
certificated product in which it is fitted.
21.A.615 Inspection by the Agency
Upon a request of the Agency, each applicant for, or holder of an ETSO authorisation for an article
shall allow the Agency to:
(a) witness any tests;
(b) inspect the technical data files on that article.
21.A.619 Duration and continued validity
(a) An ETSO authorisation shall be issued for an unlimited duration. It shall remain valid unless:
(1). the conditions required when the ETSO authorisation was granted are no longer being
observed; or
(2). the obligations of the holder specified in point 21.A.609 are no longer being discharged;
or
(3) the competent authority is prevented by the holder or any of its partners or
subcontractors from performing the investigations in accordance with point 21.A.9; or
(4)3. the article has proved to give rise to unacceptable hazards in service; or
(5)4. the authorisation has been surrendered or revoked under point 21.B.65, or surrendered
the applicable administrative procedures established by the Agency.
(b) Upon surrender or revocation, the certificate shall be returned to the Agency EASA.
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SUBPART P — PERMIT TO FLY
21.A.705 Competent authority
Notwithstanding point 21.1 of this Annex I (Part 21) for the purpose of this Subpart, the ‘competent
authority’ shall be:
(a) the authority designated by the Member State of registry; or
(b) for unregistered aircraft, the authority designated by the Member State which prescribed the
identification marks.
[Note: related AMC/GM:
GM 21.A.705 Competent authority (moved to GM1 21.1(c))]
21.A.721 Inspections
The holder of, or the applicant for, a permit to fly shall provide access to the aircraft concerned at
the request of the competent authority.
21.A.723 Duration and continued validity
(a) A permit to fly shall be issued for a maximum of 12 months and shall remain valid subject to:
(1). compliance with the conditions and restrictions of point 21.A.711(e) associated with the
permit to fly;
(2) the competent authority is permitted by the holder or any of its partners or
subcontractors to perform the investigations in accordance with point 21.A.9;
(3)2. the permit to fly not being surrendered or revoked under point 21.B.65 or surrendered;
or
(4)3. the aircraft remaining on the same register.
(b) Notwithstanding point (a), a permit to fly issued for the purpose of point 21.A.701(a)(15) may
be issued for unlimited duration.
(c) Upon surrender or revocation, the permit to fly shall be returned to the competent authority.
21.A.729 Record-keeping
(a) All documents produced to establish and justify the flight conditions shall be held by the
holder of the approval of the flight conditions at the disposal of the Agency and competent
authority and shall be retained in order to provide the information necessary to ensure the
continued airworthiness of the aircraft.
(b) All documents associated with the issue of permits to fly under the privilege of approved
organisations, including inspection records, documents supporting the approval of flight
conditions and the permit to fly itself, shall be held by the related approved organisation at
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the disposal of the Agency or the competent authority and shall be retained in order to
provide the information necessary to ensure the continued airworthiness of the aircraft.
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SECTION B PROCEDURES FOR COMPETENT AUTHORITIES
SUBPART A — GENERAL PROVISIONS
21.B.5 Scope
(a) This Section establishes the procedure for the competent authority of the Member State
when exercising its tasks and responsibilities concerned with the issuance, maintenance,
amendment, suspension and revocation of certificates, approvals and authorisations referred
to in this Annex I (Part 21).
(b) The Agency shall develop in accordance with Article 19 of Regulation (EC) No 216/2008
certification specifications and guidance material to assist Member States in the
implementation of this Section.
This section establishes the administrative and management system requirements to be followed by
the competent authority that is in charge of the implementation and enforcement of Section A of
this Annex.
21.B.10 Oversight documentation
The competent authority shall provide all the legislative acts, standards, rules, technical publications,
and related documents to the relevant personnel in order to allow them to perform their tasks and
to discharge their responsibilities.
21.B.15 Information to EASA
(a) The competent authority of the Member State shall notify EASA without undue delay if there
are any significant problems with the implementation of Regulation (EU) 2018/1139 and the
delegated and implementing acts adopted on the basis thereof.
(b) The competent authority of the Member State shall provide EASA with any safety-significant
information stemming from the occurrence reports it has received, pursuant to 21.A.3A.
21.B.20 Obligations of the competent authority
Each competent authority of the Member State is responsible for the implementation of Section A,
Subparts F, G, H, I and P only for applicants, or holders, whose principal place of business is in its
territory.
21.B.20 Immediate reaction to a safety problem
(a) Without prejudice to Regulation (EU) No 376/2014 and its implementing acts, the competent
authority of the Member State shall implement a system to appropriately collect, analyse, and
disseminate safety information.
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(b) EASA shall implement a system to appropriately analyse any relevant safety information
received, and without undue delay, provide to Member States and the Commission any
information, including recommendations or corrective actions to be taken, that is necessary
for them to react in a timely manner to a safety problem involving products, parts, appliances,
persons or organisations that are subject to Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof.
(c) Upon receiving the information referred to in points (a) and (b), the competent authority of
the Member State shall take adequate measures to address the safety problem.
(d) Measures taken under point (c) shall immediately be notified to all persons or organisations
which need to comply with them under Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof. The competent authority of the Member
State shall also notify those measures to EASA and, when combined action is required, to the
other Member States concerned.
[Note: related AMC/GM:
— GM 21.B.20 Responsibility for implementation (moved to 21.1(a)(2) and (3))]
21.B.25 Requirements for the organisation of the competent
authority
(a) General:
The Member State shall designate a competent authority with allocated responsibilities for
the implementation of Section A, Subparts F, G, H, I and P with documented procedures,
organisation structure and staff.
(b) Resources:
1. the number of staff shall be sufficient to perform the allocated tasks;
2. the competent authority of the Member State shall appoint a manager, or managers,
who are responsible for the execution of the related task(s) within the authority,
including the communication with the Agency and the other national authorities as
appropriate.
(c) Qualification and training:
All staff shall be appropriately qualified and have sufficient knowledge, experience and
training to perform their allocated task.
21.B.25 Management system
(a) The competent authority shall establish and maintain a management system, including as a
minimum:
(1) documented policies and procedures to describe its organisation, means and methods
to achieve compliance with Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof. The procedures shall be kept up to
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date, and serve as the basic working documents within that competent authority for all
related tasks;
(2) a sufficient number of personnel to perform its tasks and discharge its responsibilities. A
system shall be in place to plan the availability of personnel, in order to ensure the
proper completion of all tasks;
(3) personnel who are qualified to perform their allocated tasks and who have the
necessary knowledge, experience, initial and recurrent training to ensure continuing
competency;
(4) adequate facilities and office accommodation to perform the allocated tasks;
(5) a function to monitor the compliance of the management system with the relevant
requirements, and the adequacy of the procedures, including the establishment of an
internal audit process, and a safety risk management process. Compliance monitoring
shall include a system to feed back audit findings to the senior management of the
competent authority to ensure the implementation of corrective actions as necessary;
and
(6) a person or group of persons ultimately responsible to the senior management of the
competent authority for the compliance monitoring function.
(b) The competent authority shall, for each field of activity, including the management system,
appoint one or more persons with the overall responsibility for the management of the
relevant task(s).
(c) The competent authority shall establish procedures for participation in a mutual exchange of
all necessary information and assistance with any other competent authorities concerned,
including all findings raised and any follow-up actions taken as a result of the oversight of
persons and organisations that carry out activities in the territory of a Member State, but
certified by the competent authority of another Member State, or by EASA.
(d) A copy of the procedures related to the management system of the competent authority of
the Member State and their amendments shall be made available to EASA for the purpose of
standardisation.
[Note: related AMC/GM:
— AMC1 21.B.25 Management system
— AMC2 21.B.25 Management system
— AMC1 21.B.25(a)(1) Management system
— GM1 21.B.25(a)(2) Management system
— AMC1 21.B.25(a)(3) Management system
— AMC2 21.B.25(a)(3) Management system
— AMC3 21.B.25(a)(3) Management system
— AMC1 21.B.25(a)(5) Management system
— GM1 21.B.25(a)(5) Management system
— AMC1 21.B.25(d) Management system]
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21.B.30 Documented procedures
(a) The competent authority of the Member State shall establish documented procedures to
describe its organisation, means and methods to fulfil the requirements of this Annex I
(Part 21). The procedures shall be kept up to date and serve as the basic working documents
within that authority for all related activities.
(b) A copy of the procedures and their amendments shall be available to the Agency.
21.B.30 Allocation of tasks to qualified entities
(a) Tasks related to the initial certification, or to the continuing oversight of persons, or
organisations subject to Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, may be allocated only to qualified entities. When allocating
tasks, the competent authority shall ensure that it has:
(1) put a system in place to initially and continuously assess whether the qualified entity
complies with Annex VI ‘Essential requirements for qualified entities’ referred to in
Article 69 of Regulation (EU) 2018/1139. This system and the results of the assessments
shall be documented;
(2) established a documented agreement with the qualified entity, approved by both
parties at the appropriate management level, which clearly defines:
(i) the tasks to be performed;
(ii) the declarations, reports, and records to be provided;
(iii) the technical conditions to be met in performing such tasks;
(iv) the related liability coverage; and
(v) the protection given to information acquired in carrying out such tasks.
(b) The competent authority shall ensure that the internal audit process and safety risk
management process required by point 21.B.25(a)(5) cover all the certification and continuing
oversight tasks performed on its behalf.
[Note: related AMC/GM:
GM1 21.B.30 Allocation of tasks to qualified entities]
21.B.35 Changes in the management system organisation and
procedures
(a) The competent authority of the Member State shall notify any significant change in its
organisation and documented procedures to the Agency.
(b) The competent authority of the Member State shall update its documented procedures
relating to any change to regulations in a timely manner to ensure effective implementation.
(a) The competent authority shall have a system in place to identify any changes that affect its
capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU)
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2018/1139 and the delegated and implementing acts adopted on the basis thereof. This
system shall enable it to take action as appropriate to ensure that its management system
remains adequate and effective.
(b) The competent authority shall update its management system to reflect any change to
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof in a timely manner, so as to ensure its effective implementation.
(c) The competent authority of the Member State shall notify EASA of any changes affecting its
capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof.
21.B.40 Resolution of disputes
(a) The competent authority of the Member State shall establish a process for the resolution of
disputes within its organisation documented procedures.
(b) Where a dispute, which cannot be resolved, exists between the competent authorities of the
Member States, the competent authorities shall it is the responsibility of the managers as
defined in point 21.B.25(b)(2) to raise the issue with the Agency for mediation.
[Note: related AMC/GM:
— GM 21.B.40 Principles for the resolution of disputes (unchanged)]
21.B.45 Reporting/coordination
(a) The competent authority of the Member State shall ensure coordination as applicable with
other related certification, investigation, approval or authorisation teams of that authority,
other Member States and the Agency to ensure efficient exchange of information relevant for
safety of the products, parts and appliances.
(b) The competent authority of the Member State shall notify any difficulty in the implementation
of this Annex I (Part 21) to the Agency.
[Note: related AMC/GM:
— GM No 1 to 21.B.45 Co-ordination with other related activities (deleted);
— GM No 2 to 21.B.45 Co-ordination (deleted);
— GM No 3 to 21.B.45 Reporting – Information relevant to registers established by EASA
(deleted)]
21.B.55 Record-keeping
The competent authority of the Member State shall keep, or maintain access to, the appropriate
records related to the certificates, approvals and authorisations it has granted in accordance with
the respective national regulations, and for which responsibility is transferred to the Agency, as long
as these records have not been transferred to the Agency.
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(a) The competent authority shall establish a system of record-keeping that allows adequate
storage, accessibility, and reliable traceability of:
(1) the management system’s documented policies and procedures;
(2) the training, qualifications, and authorisation of its personnel;
(3) the allocation of tasks, covering the elements required by point 21.B.30, as well as the
details of tasks allocated;
(4) certification processes and continuing oversight of certified organisations, including:
(i) the application for a certificate, approval, authorisation and letter of agreement;
(ii) the competent authority’s continuing oversight programme, including all
assessments, audits and inspection records;
(iii) the certificates, approvals, authorisations and letters of agreement issued,
including any changes to them;
(iv) a copy of the oversight programme listing the dates when audits are due and
when audits were carried out;
(v) copies of all formal correspondence;
(vi) details of findings, corrective actions, dates of action closures, any exemptions
and enforcement actions;
(vii) any assessment, audit and inspection report issued by another competent
authority pursuant to points 21.B.120(d), 21.B.221(c) or 21.B.431(c);
(viii) copies of all organisation expositions, handbooks or manuals and amendments to
them; and
(ix) copies of any other document approved by the competent authority; and
(5) the evaluation and notification to EASA of any alternative means of compliance
proposed by organisations, and the assessment of any alternative means of compliance
used by the competent authority itself;
(6) safety information and follow-up measures in accordance with point 21.B.15; and
(7) the use of flexibility provisions in accordance with Article 71 of Regulation (EU)
2018/1139.
(b) The competent authority shall maintain a list of all certificates, approvals, authorisations and
letters of agreement that it has issued.
(c) All records referred to in points (a) and (b) shall be kept for a minimum period of 5 years,
subject to applicable data protection law.
(d) All the records referred to in points (a) and (b) shall be made available upon request to a
competent authorities of another Member State or EASA.
(e) For organisations that produce products, parts or appliances without a production
organisation approval according to Subpart F of Section A of this Annex, the competent
authority shall also maintain records of all Statements of Conformity (EASA Form 52, see
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Appendix VIII) and Authorised Release Certificates (EASA Form 1, see Appendix I) that it has
validated.
[Note: related AMC/GM:
— AMC1 21.B.55(a) Record-keeping
— AMC1 21.B.55(a)(1) Record-keeping
— GM1 21.B.55 Record-keeping
— GM1 21.B.55(e) Record-keeping]
21.B.65 Suspension, limitation and revocation
The competent authority shall:
(a) suspend a certificate, approval, permit to fly, authorisation or letter of agreement on
reasonable grounds in the case of a potential safety threat or if there is evidence that any of
the conditions specified in points 21.A.51(a), 21.A.118B(a) 21.A.181(a) or 21.A.211(a),
21.A.619(a), 21A.723(a) is not met;
(b) suspend, revoke or limit a certificate, approval, authorisation or letter of agreement pursuant
to points 21.B.125, 21.B.225 or 21.B.433; or
(c) suspend a certificate, approval, authorisation or letter of agreement if the competent
authority’s inspectors are unable over a period of 24 months to discharge their oversight
responsibilities through on-site audit(s) due to the security situation in the State where the
facilities are located.
[Note: related AMC/GM:
AMC1 21.B.65 Suspension, limitation and revocation
AMC1 21.B.65(c) Suspension, limitation and revocation
GM1 21.B.65 Suspension, limitation and revocation]
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SUBPART F — PRODUCTION WITHOUT PRODUCTION
ORGANISATION APPROVAL
21.B.115 Alternative means of compliance
(a) Alternative means of compliance may be used to establish compliance with Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof.
(b) The competent authority shall establish a system to consistently evaluate that all alternative
means of compliance used by itself or by organisations under its oversight, allow the
establishment of compliance with Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof.
(c) The competent authority shall evaluate all the alternative means of compliance proposed by
an organisation in accordance with point 21.A.124A by analysing the documentation provided
and, if considered necessary, by conducting an inspection of the organisation.
When the competent authority finds that the alternative means of compliance are in
accordance with Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, it shall without undue delay:
(1) notify the applicant that the alternative means of compliance may be implemented and,
if applicable, amend the letter of agreement of the applicant accordingly;
(2) notify EASA of their content, and include copies of all the relevant documentation.
(d) If the competent authority itself uses alternative means of compliance to achieve compliance
with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the
basis thereof, it shall:
(1) make them available to all the organisations and persons under its oversight;
(2) notify EASA without undue delay; and
(3) provide EASA with a full description of the alternative means of compliance, including
any revisions to procedures that may be relevant, as well as an assessment
demonstrating that the requirements of Regulation (EU) 2018/1139 and the delegated
and implementing acts adopted on the basis thereof have been met.
[Note: related AMC/GM:
— GM1 21.B.115 and 21.B.215 Alternative means of compliance
— AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance]
21.B.120 Investigation
(a) The competent authority shall appoint an investigation team for each applicant for, or holder
of, a letter of agreement to conduct all relevant tasks related to this letter of agreement,
consisting of a team-leader to manage and lead the investigation team and, if required, one or
more team members. The team-leader shall report to the manager responsible for the
activity, as defined in point 21.B.25(b)(2).
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(b) The competent authority shall perform sufficient investigation activities for an applicant for,
or holder of, a letter of agreement to justify recommendations for the issuance, maintenance,
amendment, suspension or revocation of the letter of agreement.
(c) The competent authority shall prepare procedures for the investigation of applicants for, or
holders of, a letter of agreement as part of the documented procedures covering at least the
following elements:
1. evaluation of applications received;
2. determination of investigation team;
3. investigation preparation and planning;
4. evaluation of the documentation (manual, procedures, etc.);
5. auditing and inspection;
6. follow up of corrective actions; and
7. recommendation for issuance, amendment, suspension or revocation of the letter of
agreement.
21.B.120 Initial certification procedure
(a) Upon receiving an application for the initial issue of a letter of agreement, the competent
authority shall verify the organisation’s compliance with the applicable requirements.
(b) The competent authority shall record all findings, actions (i.e. actions required to close a
finding), and recommendations.
(c) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(d) When satisfied that the organisation complies with the applicable requirements and has
corrected all the findings to its satisfaction, the competent authority shall issue a letter of
agreement (EASA Form 65, see Appendix XI) without undue delay.
(e) The letter of agreement shall contain the scope of the agreement, a termination date and,
where applicable, the appropriate limitations related to the authorisation.
(f) The duration of the letter of agreement shall not exceed one year.
[Note: related AMC/GM:
— AMC1 21.B.120(a) Initial certification procedure
— AMC2 21.B.120(a) Initial certification procedure
— AMC3 21.B.120(a)Initial certification procedure
— AMC4 21.B.120(a) Initial certification procedure
— GM1 21.B.120(c) Initial certification procedure
— AMC1 21.B.120(d) Initial certification procedure]
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21.B.125 Findings and corrective actions
(a) When during audits or by other means objective evidence is found by the competent
authority, showing non-compliance of the holder of a letter of agreement with the applicable
requirements of Section A of this Annex, the competent authority shall issue a finding. The
competent authority this finding shall be classified in accordance with point 21.A.125B(a)
classify the findings as follows:
(a) The competent authority shall have a system to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when it detects a non-compliance
that may lead to uncontrolled non-compliances with the applicable design data which lowers
safety or seriously endangers flight safety.
The level 1 findings shall also include:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 21.A.9 during normal operating hours and after two written requests;
(2) obtaining or maintaining the validity of a letter of agreement by falsification the
submitted documentary evidence; and
(3) any evidence of malpractice or of fraudulent use of the letter of agreement.
(c) A level 2 finding shall be issued by the competent authority when any other non-compliance
with the applicable requirements of this Annex which could lower the level of safety or
endanger flight safety, is detected.
(d) A level 3 finding shall be issued by the competent authority when there is objective evidence
that it could lead to a non-compliance under points (b) or (c).
(e) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on the basis thereof, communicate the finding
to the organisation in writing, and request corrective action to address the non-compliance(s)
identified. If a finding directly relates to an aircraft, the competent authority shall inform the
State in which the aircraft is registered.
(fb) The competent authority shall take the following actions:
(1.) in the case of for level 1 findings:
(i) take immediate and appropriate action shall be taken by the competent authority
to prohibit or limit the activities of the organisation involved, and, if appropriate,
it shall take action to limit, suspend or revoke the letter of agreement or to limit
or suspend it in whole or in part, depending upon the extent of the level 1
finding, until successful corrective action has been completed by the
organisation;
(ii) grant the organisation a corrective action implementation period that is
appropriate to the nature of the finding, which shall not in any case be more than
21 working days. It shall commence from the date of the written communication
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of the finding to the organisation, requesting corrective action to address the
non-compliance identified.
(2.) in the case of for level 2 findings:
(i) , the competent authority shall grant a corrective action implementation period
that is appropriate to the nature of the finding, which in any case that shall
initially not be more than 3 months. The period shall commence from the date of
the written communication of the finding to the organisation, requesting
corrective action to address the non-compliance identified. In certain
circumstances, at At the end of this period, and subject to the nature of the
finding and the past safety performance of the organisation, the competent
authority can may extend the 3-month period provided that a satisfactory
corrective action plan provided by the organisation has been agreed by the
competent authority;.
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept them.
(3) in the case of level 3 findings, recommend to the organisation to take action so that the
item identified does not result in a non-compliance with this Annex;
(4) if an organisation fails to submit an acceptable corrective action plan, or fails to perform
the corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid
down in point (d)(1)(i); and
(5) record all the findings that it has raised or that have been communicated to it in
accordance with point (d) and, where applicable, the enforcement measures it has
applied, as well as all the corrective actions and the dates of action closures for findings.
(c) Action shall be taken by the competent authority to suspend the letter of agreement in whole
or in part in case of failure to comply within the timescale granted by the competent
authority.
[Note: related AMC/GM:
— GM1 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective actions
— GM1 21.B.125(b) Findings and corrective actions
— GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions
— AMC1 21.B.125(d) Findings and corrective actions]
21.B.130 Issue of letter of agreement
(a) When satisfied that the manufacturer is in compliance with the applicable requirements of
Section A, Subpart F the competent authority shall issue a letter of agreement to the showing
of conformity of individual products, parts or appliances (EASA Form 65, see Appendix XI)
without undue delay.
(b) The letter of agreement shall contain the scope of the agreement, a termination date and,
where applicable, the appropriate limitations relating to the authorisation.
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(c) The duration of the letter of agreement shall not exceed one year.
[Note: related AMC/GM:
— AMC 21.B.130 Issue of the letter of agreement (moved to AMC1 21.B.120(d))
— GM 21.B.130(b) Issue of the letter of agreement (moved to AMC1 21.B.120(d))]
21.B.145 Limitation, suspension and revocation of a letter of
agreement
(a) The limitation, suspension or revocation of the letter of agreement shall be communicated in
writing to the holder of the letter of agreement. The competent authority shall state the
reasons for the limitation, suspension or revocation and inform the holder of the letter of
agreement on its right to appeal.
(b) When a letter of agreement has been suspended it shall only be reinstated after compliance
with Section A Subpart F has been re-established.
21.B.150 Record-keeping
(a) The competent authority shall establish a system of record-keeping that allows adequate
traceability of the process to issue, maintain, amend, suspend or revoke each individual letter
of agreement.
(b) The records shall at least contain:
1. the documents provided by the applicant for, or holder of, a letter of agreement;
2. documents established during investigation and inspection, in which the activities and
the final results of the elements defined in point 21.B.120 are stated;
3. the letter of agreement, including changes; and
4. minutes of the meetings with the manufacturer.
(c) The records shall be archived for a minimum retention period of six years after termination of
the letter of agreement.
(d) The competent authority shall also maintain records of all Statements of Conformity
(EASA Form 52, see Appendix VIII) and Authorised Release Certificates (EASA Form 1, see
Appendix I) that it has validated.
[Note: related AMC/GM:
— GM 21.B.150(d) Record-keeping – Traceability of release certificates (moved to GM1
21.B.55(e))]
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SUBPART G — PRODUCTION ORGANISATION APPROVAL
21.B.215 Alternative means of compliance
(a) Alternative means of compliance may be used to establish compliance with Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof.
(b) The competent authority shall establish a system to consistently evaluate that all alternative
means of compliance used by itself or by organisations under its oversight, allow the
establishment of compliance with Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof.
(c) The competent authority shall evaluate all the alternative means of compliance proposed by
an organisation in accordance with point 21.A.134A by analysing the documentation provided
and, if considered necessary, conducting an inspection of the organisation.
When the competent authority finds that the alternative means of compliance are in
accordance with Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, it shall without undue delay:
(1) notify the applicant that the alternative means of compliance may be implemented and,
if applicable, amend the approval of the applicant accordingly;
(2) notify EASA of their content, including copies of all relevant documentation.
(d) If the competent authority itself uses alternative means of compliance to achieve compliance
with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the
basis thereof, it shall:
(1) make them available to all the organisations and persons under its oversight;
(2) notify EASA without undue delay.
(3) provide EASA with a full description of the alternative means of compliance, including
any revisions to procedures that may be relevant, as well as an assessment
demonstrating that the implementing rules have been met.
[Note: related AMC/GM:
— GM1 21.B.115 and 21.B.215 Alternative means of compliance
— AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance]
21.B.220 Investigation
(a) The competent authority shall appoint a production organisation approval team for each
applicant, or holder of, a production organisation approval to conduct all relevant tasks
related to this production organisation approval, consisting of a team leader to manage and
lead the approval team and, if required, one or more team members. The team leader shall
report to the manager responsible for the activity as defined in point 21.B.25(b)(2).
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(b) The competent authority shall perform sufficient investigation activities for an applicant for,
or holder of, a production organisation approval to justify recommendations for the issuance,
maintenance, amendment, suspension or revocation of the approval.
(c) The competent authority shall prepare procedures for the investigation of a production
organisation approval as part of the documented procedures covering at least the following
elements:
1. evaluation of applications received;
2. determination of production organisation approval team;
3. investigation preparation and planning;
4. evaluation of the documentation (production organisation exposition, procedures, etc.);
5. auditing;
6. follow up of corrective actions;
7. recommendation for issuance, amendment, suspension or revocation of production
organisation approval;
8. continued surveillance.
21.B.220 Initial certification procedure
(a) Upon receiving an application for the initial issue of a production organisation approval
certificate, the competent authority shall verify the organisation’s compliance with the
applicable requirements.
(b) A meeting with the accountable manager of the organisation shall be convened at least once
during the investigation for initial certification to ensure that he or she fully understands the
significance of the certification process, and the reason for signing the statement specified in
point 21.A.143(a)(1).
(c) The competent authority shall record all findings, closure actions (i.e. actions required to close
a finding), and recommendations.
(d) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(e) When satisfied that the organisation complies with the applicable requirements and has
corrected all the findings to its satisfaction, the competent authority shall issue a production
organisation approval (EASA Form 55, see Appendix X) without undue delay.
(f) The certificate reference number shall be included on the EASA Form 55 in a manner specified
by EASA.
(g) The certificate shall be issued for an unlimited duration. The privileges and the scope of the
activities that the organisation is approved to conduct, including any limitations as applicable,
shall be specified in the terms of approval attached to the certificate.
[Note: related AMC/GM:
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— AMC1 21.B.220 and 21.B.221 Initial certification procedure
— AMC1 21.B.220 and 21.B.430 Initial certification procedure
— AMC1 21.B.220 Initial certification procedure
— AMC1 21.B.220 Initial certification procedure
— GM1 21.B.220 Initial certification procedure
— GM2 21.B.220 Initial certification procedure
— GM3 21.B.220 Initial certification procedure
— AMC1 21.B.220(d)(1) Initial certification procedure]
21.B.221 Oversight principles
(a) The competent authority shall verify:
(1) compliance with the requirements that are applicable to organisations prior to issuing
of an organisation certificate;
(2) continued compliance with the applicable requirements of the organisations that it has
certified; and
(3) the implementation of appropriate safety measures mandated by the competent
authority as defined in points 21.B.20(c) and (d).
(b) This verification shall:
(1) be supported by documentation specifically intended to provide personnel responsible
for safety oversight with guidance to perform their functions;
(2) provide the organisations concerned with the results of safety oversight activities;
(3) be based on assessments, audits, inspections, and, if needed, unannounced inspections;
and
(4) provide the competent authority with the evidence needed in case further action is
required, including the measures provided for in point 21.B.225.
(c) The scope of the oversight defined in points (a) and (b) shall take into account the results of
past oversight activities and the safety priorities.
(d) If the facilities of an organisation are located in more than one State, the competent authority
as defined in point 21.1 may agree to have oversight tasks performed by the competent
authority(ies) of the Member State(s) where the facilities are located, or by EASA for facilities
that are located in a third country. Any organisation that is subject to such an agreement shall
be informed of its existence and of its scope.
(e) For any oversight activities that are performed at facilities located in a Member State other
than where the organisation has its principal place of business, the competent authority, as
defined in point 21.1, shall inform the competent authority of that Member State before
performing any on-site audit or inspection of the facilities.
(f) The competent authority shall collect and process any information deemed useful for
conducting oversight activities, including unannounced inspections.
[Note: related AMC/GM:
AMC1 21.B.221(a), (b) and (c) Oversight principles]
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21.B.222 Oversight programme
(a) The competent authority shall establish and maintain an oversight programme covering the
oversight activities required by point 21.B.221(a).
(b) The oversight programme shall be developed taking into account the specific nature of the
organisation, the complexity of its activities, the results of past certification and/or oversight
activities, and it shall be based on the assessment of the associated risks. It shall include,
within each oversight planning cycle:
(1) assessments, audits and inspections, including unannounced inspections and, as
applicable:
(i) management system assessments and process audits;
(ii) product audits of a relevant sample of the products, parts and appliances that are
under the scope of the organisation;
(iii) sampling of the work performed; and
(2) meetings convened between the accountable manager and the competent authority to
ensure that they both remain informed of any significant issues.
(c) For organisations certified by the competent authority, an oversight planning cycle that does
not exceed 24 months shall be applied.
(d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the
competent authority has established that during the previous 24 months:
(1) the organisation has demonstrated that it can effectively identify aviation safety
hazards and manage the associated risks;
(2) the organisation has continuously demonstrated under point 21.A.147 that it has full
control over all changes;
(3) no level 1 findings have been issued; and
(4) all corrective actions have been implemented within the time period that was accepted
or extended by the competent authority as defined in point 21.B.225.
Notwithstanding point (c), the oversight planning cycle may be further extended to a
maximum of 48 months if, in addition to the conditions provided in points (1) to (4) above, the
organisation has established, and the competent authority has approved, an effective
continuous system for reporting to the competent authority on the safety performance and
regulatory compliance of the organisation itself.
(e) The oversight planning cycle may be reduced if there is evidence that the safety performance
of the organisation has decreased.
(f) The oversight programme shall include records of the dates when assessments, audits,
inspections and meetings are due, and when assessments, audits, inspections and meetings
have been effectively carried out.
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(g) At the completion of each oversight planning cycle, the competent authority shall issue a
recommendation report on the continuation of the approval, reflecting the results of
oversight.
[Note: related AMC/GM:
— AMC1 21.B.222 and 21.B.432 Oversight programme
— GM1 21.B.222(a) Oversight programme
— AMC1 21.B.222(b) and 21.B.432(b) Oversight programme
— AMC2 21.B.222(b) and 21.B.432(b) Oversight programme
— GM1 21.B.222(b) Oversight programme
— AMC1 21.B.222(b)(1) Oversight programme
— GM1 21.B.222(b)(1)(ii) Oversight programme
— AMC1 21.B.222(c) Oversight programme
— AMC1 21.B.222(c) and 21.B.432(c) Oversight programme
— AMC1 21.B.222(d) Oversight programme]
21.B.225 Findings and corrective actions
(a) The competent authority shall have a system to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when it detects a non-compliance
that may lead to uncontrolled non-compliances with the applicable design data which lowers
safety or seriously endangers flight safety.
The level 1 findings shall also include:
(a) When, during audits or by other means, objective evidence is found by the competent
authority, showing non-compliance of the holder of a production organisation approval with
the applicable requirements of Section A of this Annex, the competent authority shall issue a
finding. The competent authority this finding shall be classified in accordance with
point 21.A.158(a) classify each finding as follows:
(1) level 1 finding:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 21.A.9 during normal operating hours and after two written requests;
(2) obtaining or maintaining the validity of the POA certificate by falsification of the
submitted documentary evidence;
(3) any evidence of malpractice or of fraudulent use of the POA certificate; and
(4) the lack of an accountable manager.
(c) A level 2 finding shall be issued by the competent authority when any other non-compliance
with the applicable requirements of this Annex which could lower the level of safety or
endanger flight safety, is detected.
(d) A level 3 finding shall be issued by the competent authority when there is objective evidence
that it could lead to a non-compliance under points (b) or (c).
(e) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on the basis thereof, communicate the finding
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to the organisation in writing, and request corrective action to address the non-compliance(s)
identified. If a finding directly relates to an aircraft, the competent authority shall inform the
State in which the aircraft is registered.
(fb) The competent authority shall take the following actions:
(1.) in the case of for level 1 findings take immediate and appropriate action shall be taken
by the competent authority to prohibit or limit the activities of the organisation
involved, and, if appropriate, it shall take action to limit, suspend or revoke the
production organisation approval or to limit or suspend it in whole or in part, depending
upon the extent of the level 1 finding, until successful corrective action has been
completed by the organisation;
(2.) in the case of for level 2 findings:
(i) the competent authority shall grant a corrective action implementation period
that is appropriate to the nature of the finding, which in any case that shall
initially not be more than 3 months. The period shall commence from the date of
the written communication of the finding to the organisation, requesting
corrective action to address the non-compliance identified. In certain
circumstances, at At the end of this period, and subject to the nature of the
finding and the past safety performance of the organisation, the competent
authority can may extend the 3-month period provided that a satisfactory
corrective action plan provided by the organisation has been agreed by the
competent authority; and
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept them;
(3) in case of level 3 findings, recommend to the organisation to take action so that the
item identified does not result in a non-compliance with this Annex;
(4) if an organisation fails to submit an acceptable corrective action plan, or fails to perform
the corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid
down in point (d)(1)(i); and
(5) record all the findings that it has raised or that have been communicated to it in
accordance with point (d) and, where applicable, the enforcement measures it has
applied, as well as all the corrective actions and the dates of action closures for findings.
(c) Action shall be taken by the competent authority to suspend the approval in whole or in part
in case of failure to comply within the timescale granted by the competent authority.
[Note: related AMC/GM:
— GM1 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and corrective actions
— GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions
— AMC1 21.B.225(d) Findings and corrective actions]
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21.B.230 Issue of certificate
(a) When satisfied that the production organisation is in compliance with the applicable
requirements of Section A, Subpart G, the competent authority shall issue a Production
Organisation Approval (EASA Form 55, see Appendix X) without undue delay.
(b) The reference number shall be included on the EASA Form 55 in a manner specified by the
Agency.
[Note: related AMC/GM:
— AMC No 1 to 21.B.230 Issue of the certificate (deleted)]
21.B.235 Continued surveillance
(a) In order to justify the maintenance of the production organisation approval the competent
authority shall perform continued surveillance:
1. to verify that the production organisation approval holder's quality system complies
with Section A Subpart G;
2. to verify that the organisation of the production organisation approval holder operates
in accordance with the production organisation exposition;
3. to verify the effectiveness of the production organisation exposition procedures; and
4. to monitor by sample the standards of the product, part or appliance.
(b) Continued surveillance shall be performed in accordance with point 21.B.220.
(c) The competent authority shall provide through planned continued surveillance that a
production organisation approval is completely reviewed for compliance with this Annex I
(Part 21) during a period of 24 months. The continued surveillance may be made up of several
investigation activities during this period. The number of audits may vary depending upon the
complexity of the organisation, the number of sites and the criticality of the production. As a
minimum the holder of a production organisation approval shall be subject to continued
surveillance activity by the competent authority at least once every year.
[Note: related AMC/GM:
— GM 21.B.235(a)(4) Guide to the conduct of monitoring production standards. (moved to
GM1 21.B.222(b)(1)(ii)
— GM 21.B.235(b) Maintenance of the POA —Work allocation within the competent authority
(moved to GM1 21.B.222(a)
— GM 21.B.235(b) and (c) Continued surveillance (moved to GM1 21.B.222(b)
— AMC 21.B.235(c) Continuation of POA (moved to AMC1 21.B.222(b)(1) and 21.B.432(b)(1)]
21.B.240 Amendment of a production organisation approval
(a) The competent authority shall monitor any minor change through the continued surveillance
activities.
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(b) The competent authority shall investigate as appropriate in accordance with point 21.B.220
any significant change of a production organisation approval or application by the holder of a
production organisation approval for an amendment of the scope and terms of approval.
(c) When the competent authority is satisfied that the requirements of Section A, Subpart G
continue to be complied with it shall amend the production organisation approval accordingly.
21.B.240 Changes to a production organisation approval
(a) Upon receiving an application for a change that requires prior approval, the competent
authority shall verify the organisation’s compliance with the applicable requirements before
issuing the approval.
(b) The competent authority shall establish the conditions under which the organisation may
operate during the change, unless the competent authority determines that the production
organisation approval needs to be suspended.
(c) When satisfied that the organisation is in compliance with the applicable requirements, the
competent authority shall approve the change.
(d) Without prejudice to any additional enforcement measures, if the organisation implements
changes that require prior approval without having received the approval of the competent
authority pursuant to point (c), the competent authority shall suspend, limit or revoke the
organisation’s certificate.
(e) For changes do not require prior approval, the competent authority shall include the review of
such changes in its continuing oversight in accordance with the principles set forth in point
21.B.221. If any non-compliance is found, the competent authority shall:
(1) notify the organisation about the non-compliance and request further changes;
(2) in the case of level 1 or level 2 findings, act in accordance with point 21.B.225.
[Note: related AMC/GM:
AMC1 No 1 to 21.B.240 Changes to a production organisation approval]
21.B.245 Suspension and revocation of a production organisation
approval
(a) In case of a level one or level two finding, the competent authority shall partly or fully limit,
suspend or revoke a production organisation approval as follows:
1. in case of a level one finding the production organisation approval shall be immediately
limited or suspended. If the holder of the production organisation approval fails to
comply with point 21.A.158(c)(1), the production organisation approval shall be
revoked;
2. in case of a level two finding, the competent authority shall decide on any restriction to
the scope of approval by temporary suspension of the production organisation approval
or parts thereof. If the holder of a production organisation approval fails to comply with
point 21.A.158(c)(2), the production organisation approval shall be revoked.
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(b) The limitation, suspension or revocation of the production organisation approval shall be
communicated in writing to the holder of the production organisation approval. The
competent authority shall state the reasons for the suspension or revocation and inform the
holder of the production organisation approval of its right to appeal.
(c) When a production organisation approval has been suspended it shall only be reinstated after
compliance with Section A, Subpart G has been re-established.
[Note: related AMC/GM:
— GM 21.B.245 Continued validity (moved to GM1 21.B.65)
— AMC 21.B.245 Corrective action plan (moved to AMC1 21.B.65)]
21.B.260 Record-keeping
(a) The competent authority shall establish a system of record-keeping that allows adequate
traceability of the process to issue, maintain, amend, suspend or revoke each individual
production organisation approval.
(b) The records shall at least contain:
1. the documents provided by the applicant for, or holder of, a production organisation
approval certificate;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.220 are stated, including findings
established in accordance with point 21.B.225;
3. the continued surveillance programme, including records of investigations performed;
4. the production organisation approval certificate, including changes;
5. minutes of the meetings with the holder of the production organisation approval.
(c) The records shall be archived for a minimum retention period of six years.
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SUBPART H — AIRWORTHINESS CERTIFICATES AND RESTRICTED
CERTIFICATES OF AIRWORTHINESS
21.B.330 Suspension and revocation of certificates of airworthiness
and restricted certificates of airworthiness
(a) Upon evidence that any of the conditions specified in point 21.A.181(a) is not met, the
competent authority of the Member State of registry shall suspend or revoke an airworthiness
certificate.
(b) Upon issuance of the notice of suspension and revocation of a certificate of airworthiness or
restricted certificate of airworthiness the competent authority of the Member State of registry
shall state the reasons for the suspension or revocation and inform the holder of the
certificate of its right to appeal.
21.B.345 Record-keeping
(a) The competent authority of the Member State of registry shall establish a system of record-
keeping that allows adequate traceability of the process to issue, maintain, amend, suspend or
revoke each individual airworthiness certificate.
(b) The records shall at least contain:
1. the documents provided by the applicant;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.320(b) are stated; and
3. a copy of the certificate or permit, including amendments.
(c) The records shall be archived for a minimum retention period of six years after leaving that
national register.
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SUBPART I — NOISE CERTIFICATES
21.B.430 Suspension and revocation of a noise certificate
(a) Upon evidence that some of the conditions specified in point 21.A.211(a) are not met, the
competent authority of the Member State of registry shall suspend or revoke a noise
certificate.
(b) Upon issuance of the notice of suspension and revocation of a noise certificate the competent
authority of the Member State of registry shall state the reasons for the suspension and
revocation and shall inform the holder of the certificate on its right to appeal.
21.B.445 Record-keeping
(a) The competent authority of the Member State of registry shall establish a system of record-
keeping with minimum retention criteria that allows adequate traceability of the process to
issue, maintain, amend, suspend or revoke each individual noise certificate.
(b) The records shall at least contain:
1. the documents provided by the applicant;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.420(b) are stated;
3. a copy of the certificate including amendments.
(c) The records shall be archived for a minimum retention period of six years after leaving that
national register.
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SUBPART J — DESIGN ORGANISATION APPROVAL
21.B.430 Initial certification procedure
(a) Upon receiving an application for the initial issue of a design organisation approval certificate,
the competent authority shall verify the organisation’s compliance with the applicable
requirements.
(b) A meeting with the head of the design organisation shall be convened at least once during the
investigation for initial certification to ensure that he or she fully understands the significance
of the certification process, and the reason for signing the statement specified in point
21.A.243(b).
(c) The competent authority shall record all the findings, closure actions (i.e. actions required to
close a finding), and recommendations.
(d) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(e) When satisfied that the organisation complies with the applicable requirements and has
corrected all the findings to its satisfaction, the competent authority shall issue a design
organisation approval without undue delay.
(f) The certificate reference number shall be included in the design organisation approval
certificate in a manner specified by EASA.
(g) The certificate shall be issued for an unlimited duration. The privileges and the scope of the
activities that the organisation is approved to conduct, including any limitations as applicable,
shall be specified in the terms of approval attached to the certificate.
[Note: related AMC/GM:
— AMC1 21.B.220 and 21.B.430 Initial certification procedure
— AMC1 21.B.430 and 21.B.431 Initial certification procedure
— AMC1 21.B.430(a) Initial certification procedure
— AMC1 21.B.430(d)(1) Initial certification procedure]
21.B.431 Oversight principles
(a) The competent authority shall verify:
(1) compliance with the requirements that are applicable to organisations prior to issuing
an organisation certificate;
(2) continued compliance with the applicable requirements of the organisations that it has
certified;
(3) the implementation of appropriate safety measures mandated by the competent
authority as defined in points 21.B.20(c) and (d).
(b) This verification shall:
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(1) be supported by documentation specifically intended to provide personnel responsible
for safety oversight with guidance to perform their functions;
(2) provide the organisations concerned with the results of safety oversight activities;
(3) be based on assessments, audits, inspections, and, if needed, unannounced inspections;
(4) provide the competent authority with the evidence needed in case further action is
required, including the measures provided for in point 21.B.433.
(c) The scope of the oversight defined in (a) and (b) shall take into account the results of past
oversight activities and safety priorities.
(d) The competent authority shall collect and process any information deemed useful for
conducting oversight activities, including unannounced inspections.
[Note: related AMC/GM:
— AMC1 21.B.431(a), (b) and (c) Oversight principles]
21.B.432 Oversight programme
(a) The competent authority shall establish and maintain an oversight programme that covers the
oversight activities required by point 21.B.431(a).
(b) The oversight programme shall be developed taking into account the specific nature of the
organisation, the complexity of its activities, the results of past certification and/or oversight
activities, and it shall be based on the assessment of the associated risks. It shall include
within each oversight planning cycle:
(1) assessments, audits and inspections, including unannounced inspections, and, as
applicable:
(i) management system assessments and process audits;
(ii) product audits of a relevant sample of the products, parts and appliances that are
under the scope of the organisation; and
(iii) sampling of the work performed; and
(2) meetings convened between the head of the design organisation and the competent
authority to ensure that both remain informed of significant issues.
(c) For organisations certified by the competent authority, an oversight planning cycle that does
not exceed 24 months shall be applied.
(d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the
competent authority has established that during the previous 24 months:
(1) the organisation has demonstrated that they it effectively identify aviation safety
hazards and manage the associated risks;
(2) the organisation has continuously demonstrated under point 21.A.247 that it has full
control over all changes;
(3) no level 1 findings have been issued; and
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(4) all corrective actions have been implemented within the time period that was accepted
or extended by the competent authority as defined in point 21.B.433.
Notwithstanding point (c), the oversight planning cycle may be further extended to a
maximum of 48 months if, in addition to the conditions provided in points (1) to (4) above, the
organisation has established, and the competent authority has approved, an effective
continuous system for reporting to the competent authority on the safety performance and
regulatory compliance of the organisation itself.
(e) The oversight planning cycle may be reduced if there is evidence that the safety performance
of the organisation has decreased.
(f) The oversight programme shall include records of the dates when assessments, audits,
inspections and meetings are due, and when assessments, audits, inspections and meetings
have been effectively carried out.
(g) At the completion of each oversight planning cycle, the competent authority shall issue a
recommendation report on the continuation of the approval, reflecting the results of
oversight.
Note: related AMC/GM:
— AMC1 21.B.222 and 21.B.432 Oversight programme
— AMC1 21.B.222(b) and 21.B.432(b) Oversight programme
— AMC2 21.B.222(b) and 21.B.432(b) Oversight programme
— AMC1 21.B.432(b)(1) Oversight programme
— AMC1 21.B.432(c) Oversight programme
— AMC2 21.B.222(c) and 21.B.432(c) Oversight programme
— AMC1 21.B.432(d) Oversight programme]
21.B.433 Findings and corrective actions
(a) The competent authority shall have a system to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when it detects a non-compliance
that may lead to uncontrolled non-compliances with the applicable requirements which
lowers safety or seriously endangers flight safety.
The level 1 findings shall also include:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 21.A.9 during normal operating hours and after two written requests;
(2) obtaining or maintaining the validity of the DOA certificate by falsification of the
submitted documentary evidence;
(3) any evidence of malpractice or of fraudulent use of the DOA certificate;
(4) the lack of a head of the design organisation.
(c) A level 2 finding shall be issued by the competent authority when any other non-compliance
with the applicable requirements of this Annex which could lower the level of safety or
endanger flight safety, is detected.
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(d) A level 3 finding shall be issued by the competent authority when there is objective evidence
that it could lead to a non-compliance under points (b) or (c).
(e) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
the delegated and implementing acts adopted on the basis thereof, communicate the finding
to the organisation in writing, and request corrective action to address the non-compliance(s)
identified. If a finding directly relates to an aircraft, the competent authority shall inform the
State in which the aircraft is registered.
(d) The competent authority shall:
(1) in the case of level 1 findings take immediate and appropriate action to prohibit or limit
the activities of the organisation involved, and, if appropriate, it shall take action to
revoke the design organisation approval or to limit or suspend it in whole or in part,
depending upon the extent of the level 1 finding, until successful corrective action has
been completed by the organisation;
(2) in the case of level 2 findings:
(i) grant a corrective action implementation period that is appropriate to the nature
of the finding, which in any case shall initially not be more than 3 months. The
period shall commence from the date of the written communication of the
finding to the organisation, requesting corrective action to address the
non-compliance identified. At the end of this period, and subject to the nature of
the finding and the past safety performance of the organisation, the competent
authority may extend the 3-month period provided that a satisfactory corrective
action plan has been agreed by the competent authority; and
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept them;
(3) in the case of level 3 findings, recommend to the organisation to take action so that the
item identified does not result in a non-compliance with this Annex;
(4) if an organisation fails to submit an acceptable corrective action plan, or fails to perform
the corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid
down in point (d)(1)(i); and
(5) record all the findings that it has raised or that have been communicated to it in
accordance with point (d) and, where applicable, the enforcement measures it has
applied, as well as all the corrective actions and the dates of action closures for findings.
[Note: related AMC/GM:
— GM1 21.B.125(b), 21.B.225(b) and 21.B.430(b) Findings and corrective actions
— AMC1 21.B.433(d) Findings and corrective actions]
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21.B.435 Changes to a design organisation approval
(a) Upon receiving an application for a change that requires prior approval, the competent
authority shall verify the organisation’s compliance with the applicable requirements before
issuing the approval.
(b) The competent authority shall establish the conditions under which the organisation may
operate during the change, unless the competent authority determines that the design
organisation approval needs to be suspended.
(c) When satisfied that the organisation is in compliance with the applicable requirements, the
competent authority shall approve the change.
(d) Without prejudice to any additional enforcement measures, if the organisation implements
changes that require prior approval without having received the approval of the competent
authority pursuant to point (c), the competent authority shall suspend, limit or revoke the
organisation’s certificate.
(e) For changes that do not require prior approval, the competent authority shall include the
review of those changes in their continuing oversight activities in accordance with the
principles stated in point 21.B.431. In case of any non-compliance, the competent authority
shall:
(1) notify the organisation about the non-compliance and request further changes;
(2) in case of level 1 or level 2 findings, act in accordance with point 21.B.433.
[Note: related AMC/GM:
AMC1 21.B.435 Changes to a design organisation approval]
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SUBPART P — PERMIT TO FLY
21.B.530 Revocation of permits to fly
(a) Upon evidence that any of the conditions specified in point 21.A.723(a) are not met for a
permit to fly it has issued, the competent authority shall revoke that permit to fly.
(b) Upon issuance of the notice of revocation of a permit to fly the competent authority shall
state the reasons for the revocation and inform the holder of the permit to fly on the right to
appeal.
21.B.545 Record-keeping
(a) The competent authority shall operate a system of record-keeping that provides adequate
traceability of the process for the issue and revocation of each individual permit to fly.
(b) The records shall at least contain:
1. the documents provided by the applicant;
2. documents established during the investigation, in which the activities and the final
results of the elements defined in point 21.B.520(b) are stated; and
3. a copy of the permit to fly.
(c) The records shall be kept for a minimum of six years after the permit ceases to be valid.
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APPENDICES TO ANNEX I
EASA FORMS
Regulation (EU) No 748/2012
When the Forms of this Annex are issued in a language other than English, they shall include an English
translation.
The EASA ('European Union Aviation Safety Agency') Forms referred to in the appendices to this Part
shall have the following obligatory features. Member States shall ensure that the EASA Forms they
issue are recognisable and shall be responsible for having those Forms printed.
Appendix I — EASA Form 1 Authorised release Ccertificate
Appendix II — EASA Form 15a Airworthiness Rreview Ccertificate
Appendix III — EASA Form 20a Permit to Ffly
Appendix IV — EASA Form 20b Permit to Ffly (issued by approved organisations)
Appendix V — EASA Form 24 Restricted Ccertificate of Aairworthiness
Appendix VI — EASA Form 25 Certificate of Aairworthiness
Appendix VII — EASA Form 45 Noise Ccertificate
Appendix VIII — EASA Form 52 Aircraft Sstatement of Cconformity
Appendix IX — EASA Form 53 Certificate of Rrelease to Sservice
Appendix X — EASA Form 55 Production Oorganisation Aapproval Ccertificate
Appendix XI — EASA Form 65 Letter of Aagreement for production without production
organisation approval
Appendix XII — Categories of flight tests and associated flight test crew qualifications 85
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Appendix VIII — Aircraft statement of conformity — EASA Form 52
AIRCRAFT STATEMENT OF CONFORMITY
1. State of manufacture 2. [MEMBER STATE]1 A Member of the European 3. Statement Ref No:
Union2
4. Organisation
5. Aircraft Type 6. Type-certificate Refs:
7. Aircraft Registration Or Mark 8. Manufacturers Identification No
3
9. Engine/Propeller Details
10. Modifications and/or Service Bulletins3
11. Airworthiness Directives
12. Concessions
13. Exemptions, Waivers or Derogations3
14. Remarks
15. Certificate of Airworthiness
16. Additional Requirements
17. Statement of Conformity
It is hereby certified that this aircraft confirms conforms fully to the type-certificated design and to the
items above in boxes 9, 10, 11, 12 and 13.
The aircraft is in a condition for safe operation.
The aircraft has been satisfactorily tested in flight.
18. Signed 19. Name 20. Date (d/m/y)
21. Production Organisation Approval Reference
EASA Form 52 Issue 2.
Instructions for the use of the Aaircraft Sstatement of Cconformity EASA Form 52
1. PURPOSE AND SCOPE
1.1. Use of the aircraft Sstatement of Cconformity issued by a production organisation
manufacturer producing under Part 21 Section A Subpart F is described under point
21.A.130 and the corresponding acceptable means of compliance.
1.2. The purpose of the aircraft Sstatement of Csonformity (EASA Form 52) issued under
Part 21 Section A Subpart G is to enable the holder of an appropriate production
organisation approval to exercise the privilege to obtain an individual aircraft certificate
of airworthiness from the competent authority of the Member State of registry.
2. GENERAL
2.1. The Sstatement of Cconformity must comply with the format attached, including the
block numbers and the location of each block. The size of each block may, however, be
varied to suit the individual application, but not to the extent that would make the
1 Or EASA if EASA is the competent authority.
2 Delete for non-EU Member States or EASA.
3 Delete as applicable.
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Sstatement of Cconformity unrecognisable. If in doubt, consult the competent
authority.
2.2. The Sstatement of Cconformity must either be pre-printed or computer generated, but
in either case, the printing of lines and characters must be clear and legible. Pre-printed
wording is permitted in accordance with the attached model, but no other certification
statements are permitted.
2.3. Completion may be either machine/computer printed or hand-written using block
letters to permit easy reading. English, and where relevant, one or more of the official
language(s) of the issuing Member State are acceptable.
2.4. A copy of the Sstatement and all the referenced attachments are to be retained by the
approved production organisation.
3. COMPLETION OF THE STATEMENT OF CONFORMITY BY THE ORIGINATOR
3.1. There should be an entry in all the blocks to make the document a valid statement.
3.2. A Sstatement of Cconformity may not be issued to the competent authority of the
Member State of registry unless the design of the aircraft and its installed products are
approved.
3.3. The information required in blocks 9, 10, 11, 12, 13 and 14 may be by reference to
separate identified documents held on file by the production organisation, unless the
competent authority agrees otherwise.
3.4. This Sstatement of Cconformity is not intended to include those items of equipment
that may be required to be fitted in order to satisfy the applicable operational rules.
However, some of these individual items may be included in block 10 or in the approved
type design. Operators are therefore reminded of their responsibility to ensure
compliance with the applicable operational rules for their own particular operation.
Block 1 Enter the name of the State of manufacture.
Block 2 The competent authority under which authority the Sstatement of Cconformity is
issued.
Block 3 A unique serial number should be pre-printed in this block for statement control and
traceability purposes. An exception is Except that iIn the case of a computer-generated
document, the number need not be pre-printed where the computer is programmed to
produce and print a unique number.
Block 4 The full name and the address of the location of the organisation issuing the statement.
This block may be pre-printed. Logos, etc. are permitted if the logo can be contained
within the block.
Block 5 The aircraft type in full as defined in the type certificate type-certificate and its
associated data sheet.
Block 6 The type certificate type-certificate reference numbers and issue for the subject
aircraft.
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Block 7 If the aircraft is registered, then this mark will be the registration mark. If the aircraft is
not registered, then this will be such a mark that is accepted by the competent
authority of the Member State and, if applicable, by the competent authority of a third
country.
Block 8 The identification number assigned by the production organisation manufacturer for
control and traceability and product support. This is sometimes referred to as a
production organisation manufacturer Sserial No or Cconstructors No.
Block 9 The engine type and the propeller type(s) in full as defined in the relevant type
certificate type-certificate and its associated data sheet. Their production organisation
manufacturer identification No and the associated location should also be shown.
Block 10 Approved design changes to the aircraft definition.
Block 11 A listing of all the applicable airworthiness directives (or equivalent) and a declaration
of compliance, together with a description of the method of compliance of on the
subject individual aircraft, including products and installed parts, appliances and
equipment. Any future compliance requirement time should be shown.
Block 12 Approved unintentional deviation deviations to from the approved type design,
sometimes referred to as concessions, divergences, or non-conformances.
Block 13 Only agreed exemptions, waivers or derogations may be included here.
Block 14 Remarks. Any statement, information, particular data or limitation which may affect the
airworthiness of the aircraft. If there is no such information or data, state; ‘NONE’.
Block 15 Enter ‘Ccertificate of Aairworthiness’, or ‘Rrestricted Ccertificate of Aairworthiness’, or
for the Ccertificate of Aairworthiness requested.
Block 16 Additional requirements such as those notified by an importing country should be
noted in this block.
Block 17 The validity Validity of the Sstatement of Cconformity is dependent on full completion
of all the blocks on the form. A copy of the flight test report, together with any recorded
defects and rectification details, should be kept on file by the POA holder. The report
should be signed as satisfactory by the appropriate certifying staff and a flight crew
member, e.g. the test pilot or the flight test engineer. The flight tests performed are
those defined under the control of the quality management element of the production
system system, as established by point 21.A.139, in particular 21.A.139(d)(1)(vi)
21.A.139(b)(1)(vi), to ensure that the aircraft conforms with to the applicable design
data, and is in condition for safe operation.
The listing of items provided (or made available) to satisfy the safe operation aspects of
this statement should be kept on file by the POA holder.
Block 18 The Sstatement of Cconformity may be signed by the person authorised to do so by the
production approval holder in accordance with point 21.A.145(d). A rubber stamp
signature should not be used.
Block 19 The name of the person signing the certificate should be typed or printed in a legible
form.
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Block 20 The date on which the Sstatement of Cconformity is signed should be given.
Block 21 The competent authority approval reference should be quoted.
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Appendix X — Production organisation approval certificate — EASA
Form 55
Regulation (EU) No 748/2012
Production Oorganisation Aapproval Ccertificates referred to in Subpart G of Annex I (Part 21)
[MEMBER STATE]1
A Member of the European Union2
PRODUCTION ORGANISATION APPROVAL CERTIFICATE
Reference: [MEMBER STATE CODE1].21G.XXXX
Pursuant to Regulation (EU) 2018/1139 Regulation (EC) No 216/2008 of the European Parliament and of the
Council and to Commission Regulation (EU) No 748/2012 [(EC) No 1702/2003] for the time being in force
and subject to the condition specified below, the [COMPETENT AUTHORITY OF THE MEMBER STATE] hereby
certifies:
[COMPANY NAME AND ADDRESS]
as a production organisation in compliance with Annex I (Part 21), Section A, Subpart G of Regulation [(EU)
No 748/2012 (EC) No 1702/2003], approved to produce products, parts and appliances listed in the attached
approval schedule and issue related certificates using the above references.
CONDITIONS:
1. This approval is limited to that specified in the enclosed terms of approval, and
2. This approval requires compliance with the procedures specified in the approved production
organisation exposition, and
3. This approval is valid whilst the approved production organisation remains in compliance with Annex
I (Part 21) of to Regulation EU) No 748/2012 [(EC) No 1702/2003].
4. Subject to compliance with the foregoing conditions, this approval shall remain valid for an unlimited
duration unless the approval has previously been surrendered, superseded, suspended or revoked.
Date of original issue: ………………………………………………………………………………………………………………………………
Date of this revision: ………………………………………………………………………………………………………………………………..
Revision No: …………………………………………………………………………………………………………………………………………….
Signed: …………………………………………………………………………………………………………………………………………………….
For the competent authority: [COMPETENTAUTHORITY IDENTIFICATION 1]
EASA Form 55a issue 2.
1 Or EASA if EASA is the competent authority.
2 Delete for non-EU Member States.
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[MEMBER STATE]1 TA: [MEMBER STATE
Terms of Aapproval
A Member of the European Union2 CODE1].21G.XXXX
This document is part of Pproduction Oorganisation Aopproval Nnumber [MEMBER STATE CODE1].21G.XXXX
issued to:
Company name:
Section 1. SCOPE OF WORK:
PRODUCTION OF PRODUCTS/CATEGORIES
For details and limitations, refer to the Production Organisation Exposition, Section xxx
Section 2. LOCATIONS:
Section 3. PRIVILEGES:
The Production Organisation is entitled to exercise, within its Tterms of Aapproval and in accordance with
the procedures of its Production Organisation Exposition, the privileges set forth defined in 21.A.163,
Subject subject to the following:
[keep only applicable text]
Prior to approval of the design of the product, an EASA Form 1 may be issued only for conformity purposes.
A Sstatement of Cconformity may not be issued for a non-approved aircraft
Maintenance may be performed, until compliance with the maintenance regulations is required, in
accordance with the Production Organisation Exposition Section xxx
Permits to fly may be issued in accordance with the Production Organisation Exposition Section yyy
Date of original issue: Signed:
Date of this revision:
Revision No.: For [COMPETENT AUTHORITY IDENTIFICATION1]
EASA Form 55b Issue 2.
1 Or EASA if EASA is the competent authority.
2 Delete for non-EU Member States.
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Appendix XI — Letter of agreement for production without
production organisation approval — EASA Form 65
Regulation (EU) No 748/2012
Letter of agreement referred to in Subpart F of Annex I (Part 21)
[MEMBER STATE]1
A Member of the European Union2
LETTER OF AGREEMENT FOR PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
[NAME OF THE APPLICANT]
[TRADE NAME (if different)]
[FULL ADDRESS OF THE APPLICANT]
Date (Day, Month, Year)
Reference: [MEMBER STATE CODE2].21F.XXXX
Dear Sirs,Mr/Ms [Name of the Applicant],
Your production inspection system has been evaluated and found to be in compliance with Section A, Subpart
A and Subpart F of Annex I (Part 21) of to Regulation [(EC) No 1702/2003] (EU) No 748/2012.
Therefore, subject to the conditions specified below, we agree that the showing of conformity of the
products, parts and appliances mentioned below may be done under Section A, Subpart F of Annex I (Part 21)
of to Regulation [(EC) No 1702/2003](EU) No 748/2012].
No of Units P/N S/N
AIRCRAFT
PARTS
The following conditions are applicable to this agreement:
(1) It is valid whilst [Company Name] remains in compliance with Section A, Subpart A and Subpart F of
Annex I (Part 21) of to Regulation [(EC) No 1702/2003](EU) No 748/2012.
(2) It requires compliance with the procedures specified in [Company Name] Manual Rref./Issue
date………………………
(3) It terminates on ……………………………..
(4) The Sstatement of Cconformity issued by [Company Name] under the provisions of point 21.A.130 of
the above-mentioned rRegulation shall be validated by the issuing authority of this letter of agreement
in accordance with the procedure ……………………………. of the referenced manual.
(5) [Company Name] shall notify the issuing authority of this letter of agreement immediately of any
changes to the production inspection system that may affect the inspection, conformity, or
airworthiness of the products and parts listed in this letter.
For the competent authority: [COMPETENT AUTHORITY IDENTIFICATION (1)2]
Date and Signature
EASA Form 65, Issue 2.
1 Or EASA if EASA is the competent authority.
2
Delete for non-EU Member States.
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Draft AMC & GM to Annex I (Part 21) to Regulation (EU) No 748/2012 (Draft
EASA Decision)
GM1 Annex I Definitions
For the purpose of the AMC & GM to Part 21, the following definitions are used:
Audit refers to a systematic, independent, and documented process for obtaining
evidence, and evaluating it objectively to determine the extent to which
requirements are complied with.
Note: an audit may include an inspection
Assessment in the context of management system performance monitoring, continuous
improvement and oversight, refers to a planned and documented activity
performed by competent personnel to:
review provided evidence in combination with demonstrated
behaviour against the concepts and principles of a model or standard,
analyse the achieved levels of performance in relation to the
organisation’s strategy and objectives, and
evaluate the ability of the organisation to reach these objectives.
Note: assessment focuses on desirable outcomes and the overall
performance, looking at the organisation as a whole. The main objective of
the assessment is to identify strengths and weaknesses to drive continual
improvement.
Certificate is any certificate, approval, licence, authorisation, attestation or other
document issued as the result of a certification attesting compliance with
the applicable requirements.
Competency is a combination of individual skills, practical and theoretical knowledge,
attitude, training, and experience.
Correction is the action to eliminate a detected non-compliance.
Corrective action is the action to eliminate or mitigate the root cause(s) and prevent the
recurrence of an existing detected non-compliance, or any other undesirable
condition or situation. The proper determination of the root cause(s) is
crucial for defining effective corrective actions to prevent reoccurrences.
Error is an action or inaction by a person that may lead to deviations from the
accepted procedures or regulations.
Note: errors are often associated with occasions when a planned sequence of
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mental or physical activities either fails to achieve its intended outcome, or is
not appropriate with regard to the intended outcome, and when results
cannot be attributed purely to chance.
Hazard is a condition or an object that has the potential to cause or contribute to an
aircraft incident or accident.
Human factors is anything that affects human performance and refers to principles that
apply to aeronautical design, certification, training, operations and
maintenance, and which seek safe interfaces between the human and other
system components by proper consideration of human performance.
Human refers to human capabilities and limitations which have an impact on the
performance safety and the efficiency of aeronautical operations.
Near miss is an event in which an occurrence that has to be mandatorily reported
according to Regulation (EU) No 376/2014 was narrowly averted or avoided.
Example: a staff member, on rechecking his or her work at the end of a task,
realises that one work card step was not properly carried out.
Inspection in the context of compliance monitoring and oversight, refers to an
independent and documented conformity evaluation by observation and
judgement that is accompanied, as appropriate, by measurements, testing or
gauging, in order to verify compliance with applicable requirements.
Note: an inspection may be part of an audit (e.g. a product audit), but may
also be conducted outside the normal audit plan, for example to verify the
closure of a particular finding.
Just Culture Ref. Regulation (EU) No 376/2014, Article 2.
Organisational is a latent condition that affects the effectiveness of safety risk controls,
factor related to culture, policies, processes, resources, and the workplace of an
organisation.
Oversight planning refers to the time frame within which all areas of the approval and all
cycle processes should be reviewed by the competent authority by means of
audits and inspections.
Oversight refers to the detailed oversight schedule that defines the number of audits
programme and inspections, the scope and duration of each audit and inspection,
including details on product audits and locations, as appropriate, to be
performed by the competent authority, and the tentative time frame for
performing each audit and inspection.
Preventive action is the action to eliminate the cause(s) of a potential non-compliance, or any
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other undesirable potential situation.
Risk assessment is an evaluation based on engineering and operational judgement and/or
analysis methods in order to establish whether the achieved or perceived risk
is acceptable or tolerable.
Safety culture is an enduring set of values, norms, attitudes, and practices within an
organisation concerned with minimising the exposure of the workforce and
the general public to dangerous or hazardous conditions. In a positive safety
culture, a shared concern for, commitment to, and accountability for safety
is promoted.
Safety risk refers to the predicted probability and severity of the consequences or
outcomes of a hazard.
21.1 Competent authority
GM2 Annex I Acronyms
For the purpose of the AMC & GM to Part 21, the following acronyms are used:
AFM Aircraft flight manual
AMC Acceptable means of compliance
CoA Certificate of airworthiness
CRI Certification review item
CS Certification specification
CS-CCD Certification specification – cabin crew data
CS-FCD Certification specification – flight crew data
CS-GEN-MMEL Certification specification – generic master minimum equipment list
CS-MMEL Certification specification – master minimum equipment list
CS-MCSD Certification specification – maintenance certifying staff data
CS-SIMD Certification specification – simulator data
DO Design organisation
DOA Design organisation approval
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ELOS Equivalent level of safety
ESF Equivalent safety finding
ETSO European technical standard order
OP Other party
OSD Operational suitability data
PO Production organisation
POA Production organisation approval
POATL Production organisation approval team leader
POE Production organisation exposition
GM Guidance material
MOC Means of compliance
RCoA Restricted certificate of airworthiness
RTC Restricted type certificate
SC Special condition
SMS Safety management system
STC Supplemental type certificate
TC Type certificate
TCDS Type certificate data sheet
21.1 Competent authority
GM1 21.1 Competent authority
RESPONSIBILITY FOR IMPLEMENTATION
Each certificate or approval in accordance with Part 21 Section A Subparts F, G, H, I and P will
normally be issued and controlled by the competent authority of the Member State in whose
country the applicant or holder is located. Therefore, to ensure consistency between the competent
authorities of the Member States in issuing certificates and approvals, the implementation of Part 21
should be based on the following three principles:
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(a) The establishment and maintenance of an effective organisation and the corresponding
processes by all competent authorities.
(b) The operation of all the competent authorities in accordance with Part 21 and its acceptable
means of compliance (AMC) and guidance material (GM).
(c) A standardisation process established and operated by EASA to assess the standard achieved,
and to provide timely advice and guidance to the competent authorities of the Member
States.
As a result, the responsibility for implementation consists of the two main objectives:
(a) To ensure that certificates and approvals are only granted to applicants that comply with the
requirements of Part 21; and
(b) To ensure that there is sufficient visibility of the processes to give EASA and the other Member
States the necessary confidence in the certificates or approvals granted.
21.1 Competent authority
GM1 21.1(c) Competent authority
PERMIT TO FLY
An aircraft registered in a Member State is under the responsibility of this Member State regarding
continuing airworthiness aspects. Consequently, any permit to fly under Part 21 is issued by that
Member State, including any cases in which the aircraft will fly in another State. The permit to fly
contains all the conditions and restrictions to ensure safe flight, but other airspace and operational
rules remain within the competence of the authority of the State where the flight will take place.
The applicant is also therefore required to ensure compliance with the relevant regulations of that
State.
21.1 Competent authority
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SECTION A TECHNICAL REQUIREMENTS
SUBPART A — GENERAL PROVISIONS
AMC1 No 1 to 21.A.3A(a)(1) Occurrence reporting Collection,
investigation and analysis of data related to Flammability
Reduction Means (FRM) Reliability
COLLECTION, INVESTIGATION AND ANALYSIS OF DATA RELATED TO FLAMMABILITY REDUCTION
MEANS (FRM) RELIABILITY
Applicants for or holders Holders of a TC type-certificate, RTCtype-certificate, STCtype-certificate or
any other relevant approval deemed to have been issued under Part 21 and which have included a
an FRM in their design should assess on an on-going ongoing basis the effects of aeroplane
component failures on FRM reliability. This should be part of the system for the collection,
investigation and analysis of data required by point 21.A.3A(a)(1). The applicant/holder should do
the following:
(a) Demonstrate effective means to ensure collection of FRM reliability data. The means should
provide data affecting FRM reliability, such as component failures.
(b) Unless alternative reporting procedures are approved by the Agency EASA, provide a report to
the Agency EASA every six 6 months for the first five years after service introduction. After
that period, continued reporting every six 6 months may be replaced with other reliability
tracking methods found acceptable to the Agency EASA or eliminated if it is established that
the reliability of the FRM meets, and will continue to meet, the exposure specifications of
paragraph M25.1 of Appendix M to CS-25.
(c) Develop service instructions or revise the applicable aeroplane manual, according to a
schedule approved by the Agency EASA, to correct any failures of the FRM that occur in
service that could increase any fuel tank’s Fleet Average Flammability Exposure to more than
that specified by paragraph M25.1 of Appendix M to CS-25.
21.A.3A Occurrence reporting
AMC2 No 2 to 21.A.3A(a)(1) Occurrence reporting Collection,
investigation and analysis of data related to ETOPS significant
occurrences
COLLECTION, INVESTIGATION AND ANALYSIS OF DATA RELATED TO ETOPS SIGNIFICANT
OCCURRENCES
(1) Applicants for or holders Holders of a TC type-certificate, RTC type-certificate, STCtype-
certificate or any other relevant approval deemed to have been issued under Part 21 and
which includes extended range operation with two-engined aeroplane (ETOPS) capability
should implement a specific tracking, reporting and resolution system for ETOPS significant
occurrences, suitable to ensure the initial and continued fleet compliance with the applicable
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ETOPS reliability objectives. This system should be part of the system for collection,
investigation and analysis of data required by point 21.A.3A(a).
Appropriate coordination should exist between the engine TC holder, the propeller TC holder,
and the APU ETSO authorisation holder with and the aircraft TC holder to ensure compliance
with the ETOPS reliability objectives.
(2) For the tracking, reporting and resolution of ETOPS significant occurrences, refer to the latest
edition of AMC 20-6 (see the AMC-20 document).
21.A.3A Occurrence reporting
GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting The system
for collection, investigation and analysis of data
COLLECTING SYSTEM
In the context of this requirement, the word ‘Ccollection’ refers to means the setting up of systems
and procedures which will enable relevant malfunctions, failures and defects to be properly reported
when they occur.
21.A.3A Occurrence reporting
GM2 21.A.3A(b)(a) and (b) Occurrence reporting
For occurrence reporting, refer to the latest edition of AMC 20-8 (see the AMC-20 document).
21.A.3A Occurrence reporting
GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting
MANDATORY AND VOLUNTARY OCCURRENCE REPORTING
The list below provides an overview of the main elements of an occurrence reporting system that is
compliant with Regulation (EU) No 376/2014, and provides references to the relevant Articles of
Regulation (EU) No 376/2014.
(a) An occurrence reporting system that caters both for mandatory and voluntary reporting (see
Articles 4 and 5).
Note 1: the mandatory reporting system established under Regulation (EU) No 376/2014 is
also intended for the reporting of those additional items that qualify for mandatory reporting
that are defined in Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof.
Note 2: the voluntary reporting system is intended to facilitate the collection of details of
occurrences that may not be captured by the mandatory system, and of other safety-related
information which is perceived by the reporting organisation as indicating that there is an
actual or potential hazard to aviation safety.
(b) The designation of one or more persons to independently handle the collection, evaluation,
processing, analysis and storage of details of occurrences with regard to data collection and
hazard identification (see Article 6(1)).
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Note 1: in agreement with their competent authority, small organisations may make use of
simplified mechanisms to ensure the collection, evaluation, processing, analysis and storage of
details of occurrences, possibly by sharing those tasks with other similar organisations.
Note 2: an existing internal safety-reporting scheme, which collects safety-relevant data,
proposals and information, including data on potential safety issues that have not resulted in
any occurrence, may serve as a basis for the mandatory and voluntary occurrence reporting
system. From this pool of safety-relevant information and data collected internally, the
organisation will determine whether a mandatory report is required or whether a voluntary
report may be adequate.
(c) The reporting of details of occurrences collected under the mandatory scheme as soon as
possible, and in any event, no later than 72 hours after becoming aware of the occurrence
(see Article 4(8) & (9);
Note 1: the reference to ‘becoming aware of’ an occurrence implies that a person in the
organisation identifies the occurrence as one that falls into the category of a mandatory
occurrence report — usually through being involved in the occurrence or witnessing it, but
also on review or investigation of information reported to the organisation’s safety reporting
scheme. In the case of design or production organisations, the 72-hour period starts at the
point when the unsafe condition is identified.
In the case of automated data collection systems, the 72-hour period starts when the person
responsible for the analysis of the data detected the reportable occurrence.
Note 2: the 72-hour time frame does not apply to the reporting of details of occurrences
which may involve an actual or potential aviation safety risk, or to safety-related information
collected under the voluntary scheme. These are to be reported in a timely manner (see
Article 5 (5) & (6)).
(d) The establishment of data quality checking processes, to ensure that the information initially
collected and the data stored in the database(s) are consistent (see Article 7(3).
Note: it is understood that data quality checking processes should address four main areas:
— errors in data entry;
— the completeness of data, specially referring to mandatory data;
— the proper use of the ADREP taxonomy;
— improving the consistency of data, notably between the information collected initially
and the report stored in the database (see Article 7(3)).
(e) The storage of occurrence reports that qualify for mandatory and voluntary reporting in one
or more databases (see Article 6(5)) using formats that are standardised to facilitate
information exchange and are compatible with the ECCAIRS software and the ADREP
taxonomy (see Article 7(4)).
Note: organisations that are able to report through an ECCAIRs software compatible reporting
system provided by their competent authority are deemed automatically compliant with the
reporting system requirements in Article 7(4) and do not need to have their own ECCAIRS
software compatible reporting system.
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(f) The application of the safety risk management process to occurrences:
(1) identification of the safety hazards associated with identified occurrences or groups of
occurrences reported to the competent authority (see Article 13(1));
(2) analysis of the related risks in terms of the probability and severity of the outcomes, as
well as the assessment of risks in terms of their tolerability;
(3) based on the result of the risk assessment: the determination of the need for mitigation
action, as required to improve aviation safety (see Article 13(2)); and
(4) monitoring the timely implementation and effectiveness of any mitigation action that is
required (see Article 13(2)).
(g) If the organisations identify that no potential aviation unsafe condition exists as a result of
their analysis of occurrences:
(1) they can delay the reporting to EASA up to the issuance of the final report and report
the occurrence as closed on issue (data exchange). In such cases, no follow-up report
should be submitted. However, the report to EASA should include confirmation and
justification that no unsafe condition exists. It is requested that the organisation
provides information on the cause(s) of the occurrence and on the corrective or
preventive actions (if any) put in place by the organisation; or
(2) after an initial report was sent, the closure report should include confirmation and
justification that no unsafe condition exists. It is requested that the organisation
provides information on the cause(s) of the occurrence and on the corrective or
preventive actions (if any) put in place by the organisation.
This way of reporting should not be understood as an accepted deviation from the
requirements of Part 21 or the requirements of Regulation (EU) No 376/2014. If, at any stage
during the course of the investigation, the organisation identifies that a potential unsafe
condition exists, it should be reported to EASA within 72 hours.
(h) If the organisation identifies an actual or potential aviation safety risk as a result of its analysis
of occurrences or group of occurrences, it should transmit the following information to the
competent authority within 30 days from the date of notification of the occurrence to the
authority (see Article 13(4)):
(1) the latest position of the organisation as to whether the (potential) unsafe condition is
confirmed;
(2) the occurrence analysis and first investigation results — including the cause(s) of
occurrence if known;
(3) the containment actions that have already been defined and put in place (if any);
(4) a risk assessment supporting that the product can be operated safely (see
GM 21.A.3B(d)(4) Defect correction — Sufficiency of proposed corrective action or the
relevant DOA procedure) until the corrective actions have been defined and
implemented, or until a more refined risk assessment can be provided.
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Organisations are encouraged to provide a complete analysis and follow-up as soon as
available and, in principle, no later than 3 months after the occurrence notification. It is
recognised that analysing an occurrence may take longer than 3 months, especially in the
event of a complex investigation or where the services of a specialist investigator are required.
The follow-up requirements are not intended to jeopardise the quality and thoroughness of an
occurrence analysis. It may be detrimental to safety if rushed in order to be completed within
the encouraged 3-month period without properly establishing the root cause(s) and
determining the relevant remedial action.
The final (close-out) report shall include:
(1) the final TC holder position as to whether a (potential) unsafe condition exists;
(2) the occurrence analysis and final investigation results — including the cause(s) of
occurrence;
(3) the corrective and preventive actions; and
(4) a risk assessment supporting that these corrective and preventive actions allow the
product to be operated safely (refer to GM 21.A.3B(d)(4) Defect correction —
Sufficiency of proposed corrective action or the relevant DOA procedure).
Note: the legal obligation to provide the initial results of the analysis of the occurrence,
follow-up reports and final results lies with the other organisation that is the source of the
initial report. If an organisation receives a copy of a report from another organisation that
initially reported the occurrence to the competent authority, depending on its contribution to
the actual or potential aviation safety risk that underlies the occurrence, it may, however, be
required to perform its own analysis of the issue reported, and to provide a follow-up report
to the competent authority.
(i) Safety policy and just culture: consultation of staff representatives to ensure that there is
mutual agreement on and adoption of rules that describe how the ‘just culture’ principles are
guaranteed and implemented within the organisation.
Note 1: the purpose of those rules is to ensure that none of the employees and contracted
personnel that report or are mentioned in occurrence reports, either mandatory or voluntary,
are subjected to any prejudice by their employer or any other organisation for which the
services are provided on the basis of the information supplied by the reporter (see
Article 16(9)), unless an exception applies (see Article 16(10)).
Note 2: staff representatives may be nominated either by the union(s) or by the staff
themselves.
(j) Ensuring that employees and contracted personnel are regularly provided with information
concerning the analysis of, and follow-up on, occurrences for which mitigation action is taken
(see Article 13(3)), while ensuring that only anonymised information is distributed.
(k) Ensuring that personal details are only made available to staff members of their organisation
other than the persons designated in accordance with point (c) if this is necessary to
investigate occurrences with a view to enhancing aviation safety.
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(l) Ensuring that reports addressed to the competent authority contain at least the information
listed in Annex I to Regulation (EU) No 376/2014.
21.A.3A Occurrence reporting
GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting
INTERNAL SAFETY REPORTING SCHEME
The overall purpose of the internal safety reporting scheme is to use reported information to
improve the level of the safety performance of the organisation, and not to attribute blame.
The objectives of the scheme are to:
(a) enable an assessment of the safety implications of each relevant incident (errors), safety issue
and hazard reported, including previous similar issues, so that any necessary action can be
initiated; and
(b) ensure that knowledge of relevant incidents, safety issues and hazards is distributed so that
other persons and organisations may learn from them.
The scheme is an essential part of the overall monitoring function, and it should be complementary
to the normal day-to-day procedures and ‘control’ systems; it is not intended to duplicate or
supersede any of them. The scheme is a tool to identify those instances when routine procedures
have failed or may fail.
All safety reports that are judged to be reportable by the person submitting the report should be
retained, as the significance of such reports may only become obvious at a later date.
Typical occurrences to be reported are those where aviation safety was, or could have been
endangered, or which could have led to an unsafe condition. If, in the view of the reporter, an
occurrence did not endanger aviation safety but, if it was repeated in different but likely
circumstances, would create an unsafe situation that could lead to an accident or a serious incident,
then a report should be made. What is judged to be reportable on one class of product, part, or
appliance may not be the same for another, and the absence or presence of a single factor,
organisational, human, or technical, can transform an occurrence into an accident or serious
incident.
The collection and analysis of timely, appropriate and accurate data will allow the organisation to
react to the information received, and apply the necessary action.
21.A.3A Occurrence reporting
AMC1 21.A.3A(b)(2)(d) Occurrence reporting Reporting to the
Agency
REPORTING TO EASA
Within the overall limit of 72 hours, the degree of urgency for the submission of a report should be
determined by the level of hazard that is judged to have resulted from the occurrence.
Where If an occurrence is judged by the person identifying the possible unsafe condition to have
resulted in an immediate and particularly significant hazard, the Agency EASA (or the competent
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authority of the Member State as required) expects to should be advised immediately and by the
fastest possible means (telephone, fax, email, telex, etc.) of whatever details are available at that
time. This initial report must be followed up by a full written report within 72 hours. An A typical
example would be an uncontained engine failure resulting in damage to aircraft primary structure.
In all other cases in which the possible unsafe condition does not result Where the occurrence is
judged to have resulted in a less an immediate and less more significant hazard, the report
submission may be delayed up to the maximum of three 3 days in order to provide more details.
21.A.3A Occurrence reporting
AMC1 21.A.5 Record-keeping
(a) The record-keeping system should ensure that all the records required by point 21.A.5 are
accessible within a reasonable time. These records should be organised in a manner that
ensures that there is traceability and retrievability throughout the required retention period.
(b) The records should remain legible throughout the required retention period and be protected
against damage, alteration and tampering.
(c) The format of the records should be specified in the organisation’s procedures.
(d) Organisations approved according to Subparts G and J of Part 21 should ensure that the
following records related to the management system defined in accordance with 21.A.139 and
21.A.239 are retained as long as the organisation carries out activities related to Part 21:
(1) the relevant records of management system key processes as defined in points
21.A.126A, 21.A.139, 21.A.239; and
(2) contracts, including with partners, subcontractors and suppliers,
(e) The organisation should ensure that copies of all the documents and supporting
information developed:
(1) under the privileges according to points 21.A.163 and 21.A.263; or
(2) for major repairs, major changes, STCs, and RTCs not issued under privileges
according to point 21.A.263,
are retained until 3 years after the date when the organisation ceases to hold the TC, RTC,
STC, ETSO authorisation, major repair design approval, or production organisation approval.
(f) The retention period starts when the record is created or when it was last amended.
(g) If the organisation transfers a certificate or a letter of agreement to another natural or legal
person, the records related to the certificate should be transferred to the new holder.
21.A.5 Record-keeping
GM1 21.A.5 Record-keeping
For organisations that hold or have applied for a TC, RTC, STC, ETSO authorisation, major repair
design approval, permit to fly, production organisation approval or letter of agreement under Part
21, the relevant design information/data includes at least, as applicable:
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— design data such as type design data as defined in point 21.A.31 and changes to that data,
ETSO design data, and repair design data;
— drawings and test reports, including inspection records for the product tested;
— the certification programme; and
— compliance demonstration data.
For production organisations, the relevant records include at least:
— conformity justification data with a specific focus on the production and inspection phases;
and
— conformity attestation data (e.g. EASA Form 1, EASA Form 52).
— 21.A.5 Record-keeping
AMC1 21.A.5(a) and 21.A.433(a) Record-keeping
REPAIR DESIGN
(a) The relevant substantiation data associated with a new major repair design and
record-keeping should include:
(1) identification of the damage and the source of the report;
(2) the major repair design approval sheet, identifying the applicable specifications and the
references of the justifications;
(3) the repair drawing and/or instructions, and the scheme identifier;
(4) any correspondence with the TC, STC, or APU ETSO authorisation holder, if its advice on
the design has been sought;
(5) the structural justification (static strength, fatigue, damage tolerance, flutter, etc.) or
references to this data;
(6) the effect on the aircraft, engines and/or systems, (performance, flight handling, etc. as
appropriate);
(7) the effect on the maintenance programme;
(8) the effect on the airworthiness limitations, the flight manual and the operating manual;
(9) any change in the weight and moment; and
(10) any special test requirements.
(b) The relevant minor repair documentation includes points (a)(1) and (a)(3). Other elements of
point (a) may be included where necessary. If the repair is outside the approved data, a
justification for the classification is required.
(c) Special consideration should be given to repairs that impose subsequent limitations on the
part, product or appliance (e.g. engine turbine segments that may only be repaired a finite
number of times, the number of repaired turbine blades per set, oversizing of fastener holes,
etc.).
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(d) Special consideration should also be given to life-limited parts and critical parts, notably with
the involvement of the TC or STC holder, when deemed necessary under point 21.A.433(b).
(e) Repairs to engines or to APU critical parts would normally only be accepted with the
involvement of the TC holder.
21.A.5 Record-keeping
GM1 21.A.5(a) and (b) Record-keeping
RECORDING AND ARCHIVING SYSTEM
Records within a design or production environment satisfy two purposes. Firstly, they are required,
during the:
— design process to ensure that the configuration of products, parts, or appliances is in
compliance with the certification basis; or
— production process to ensure that products, parts, or appliances are in conformity with the
controlling data throughout the manufacturing cycle.
Secondly, certain records of milestone events are needed to subsequently provide objective
evidence that all the prescribed stages of the design or production process have been satisfactorily
completed.
Therefore, the approved design or production organisation or natural or legal person who produces
products, parts and appliances under Part 21 Subpart G are required to implement a system for the
compilation and retention of records during all stages of design or production, covering short-term
and long-term records appropriate to the nature of the product and its processes.
The management of such information is subject to the appropriately documented procedures in the
management system required by points 21.A.139, 21.A.239 or in the manual required by point
21.A.125A(b), as appropriate.
All forms of recording media are acceptable (paper, film, magnetic, etc.) provided they can meet the
required duration for archiving under the conditions provided.
The related procedures are required to:
— identify the records to be kept;
— describe the organisation of, and responsibility for, the archiving system (its location,
compilation, format) and the conditions for access to the information (e.g. by product,
subject);
— control access to the data and provide effective protection from deterioration or accidental
damage;
— ensure the continued readability of the records;
— demonstrate to the competent authority the proper functioning of the records system;
— define an archiving period for each type of data subject to the following:
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production data which supports the conformity of a product, part, or appliance is kept
for not less than 3 years from the issue date of the related statement of conformity or
authorised release certificate.
design data which supports the compliance of a product, part, or appliance is kept for
not less than 3 years after the surrender or revocation of the TC, RTC, STC, major repair
or ETSO authorisation This may include minor changes and minor repairs to those TCs,
RTCs, STCs, major repairs, or ETSO authorisations; and
data that is considered essential for continuing airworthiness is kept throughout the
operational life of the product, part or appliance;
for organisations approved according to Subparts G and J of Part 21, ensure that the recording
and record-keeping system used by the partners, suppliers and subcontractors meet the
record-keeping objectives with the same level of confidence as for their own system. In each
case, it should be defined who is to retain the data record (organisation or partner, supplier or
subcontractor) as well as the method for surveillance of the recording/record-keeping system
of the partners, suppliers or subcontractors; and
for natural or legal persons who produce items under Part 21 Subpart F, the data related to
supplied parts may be retained by the supplier if the supplier has a system agreed under
Part 21, Section A, Subpart F, by the competent authority. The production organisation
manufacturer, in each case, is required to define the archiving period and satisfy itself and the
competent authority that the recording media are acceptable.
21.A.5 Record-keeping
AMC1 21.A.5(e) Record-keeping
RECORD OF PERSONNEL INVOLVED IN DESIGN OR PRODUCTION
(a) The following should be the minimum information to be recorded for each person who
exercises the privileges of an organisation approved according to Subparts G and J of Part 21
according to points 21.A.163 or 21.A.263, or who carries out the independent monitoring of
compliance and adequacy according to point 21.A.139(f) and 21.A.239(f):
(1) name
(2) date of birth
(3) basic training and standard attained
(4) specific training and standard attained
(5) continuation training (if appropriate)
(6) experience
(7) scope of the authorisation
(8) date of first issue of the authorisation
(9) expiry date of the authorisation (if appropriate)
(10) identification number of the authorisation
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(b) The record may be kept in any format and should be controlled by an internal procedure of
the organisation. This procedure forms part of the management system.
(c) The person should be given reasonable access on request to his or her own records in respect
of provisions defined by Regulation (EU) 2016/679.
(d) A production organisation should keep the record for at least 3 years after the:
(1) person has ceased employment with the organisation or has changed his or her position
in the organisation, or the withdrawal of the authorisation in the case of certifying staff,
whichever is the sooner.
(2) the organisation surrendered the TC, RTC, STC, ETSO authorisation, major repair
design approval, or production organisation approval.
(e) A design organisation should retain the records as long as it carries out activities related to
Part 21.
21.A.5 Record-keeping
GM1 21.A.9 Investigations
ARRANGEMENTS
The arrangements made by the applicant for, or holder of a TC, RTC, STC, ETSO authorisation, major
repair design approval, permit to fly, production organisation approval or letter of agreement under
Part 21 are required to allow the competent authority to make investigations that include the
complete organisation including its partners, subcontractors and suppliers, whether they are in the
State of the applicant or not.
The investigations may include audits, enquiries, questions, discussions and explanations,
monitoring, witnessing, inspections, checks, flight and ground tests and inspections of completed
products, parts or appliances designed or produced.
In order to maintain its confidence in the standards achieved by the organisation, the competent
authority may make an investigation of a sample product part or appliance and its associated
records, reports and certifications.
The arrangements are required to enable the organisation to give positive assistance to the
competent authority and cooperate in performing the investigation during both the initial
assessment and for the subsequent surveillance.
Cooperation in performing investigations refers to the competent authority having been given full
and free access to the facilities and to any information relevant to demonstrate compliance with the
Part 21 requirements, and assistance (personnel support, records, reports, computer data, etc. as
necessary).
Assistance to the competent authority includes all the appropriate means associated with the
facilities of the organisation to allow the competent authority to perform these investigations, such
as the availability of a meeting room, office and personnel support, documentation and data, and
communication facilities, all properly and promptly made available as necessary.
The competent authority seeks to have an open relationship with the organisation, and suitable
liaison personnel are required to be nominated to facilitate this, including suitable representative(s)
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to accompany competent authority staff during visits, not only at the organisation’s own facilities,
but also at subcontractors, partners or suppliers.
21.A.9 Investigations
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SUBPART F — PRODUCTION WITHOUT PRODUCTION
ORGANISATION APPROVAL
AMC1 No1 to 21.A.122 Eligibility — Link between design and
production
LINK BETWEEN DESIGN AND PRODUCTION
An ‘arrangement’ is considered suitable if it is documented and satisfies the competent authority
that co-ordination coordination is satisfactory.
To achieve satisfactory coordination co-ordination, the documented arrangements must at least
define the following aspects, irrespective of whether the design organisation and the person
producing or intending to produce under Part 21 Subpart F are separate legal entities or not:
(a)1 The responsibilities of a design organisation which assure correct and timely transfer of up-to-
date applicable design data (e.g., drawings, material specifications, dimensional data,
processes, surface treatments, shipping conditions, quality requirements, etc.);
(b)2 The responsibilities and procedures of the production organisation manufacturer for
receiving, managing and using the applicable design data provided by the design organisation;.
(c)3 The responsibilities and procedures of the production organisation manufacturer for
developing, where applicable, its own manufacturing data in compliance with the applicable
design data package;.
(d)4 The responsibilities of the production organisation manufacturer to assist the design
organisation in dealing with continuing airworthiness matters and for required actions (e.g.,
traceability of parts in case of direct delivery to users, retrofitting of modifications, traceability
of processes’ outputs and approved deviations for individual parts as applicable, technical
information and assistance, etc.);
(e)5 The scope of the arrangements covering Subpart F requirements, in particular: points
21.A.126(a)(4), and 21.A.129(d) and (f) 21.A.3A and any associated GM or AMC;.
(f)6 The responsibilities of the production organisation manufacturer, in the case of products prior
to type certification, to assist a design organisation in demonstrating compliance with the CS
(access and suitability of production and test facilities for manufacturing and testing of
prototype models and test specimen);
(g)7 The procedures to deal adequately with production deviations and non-conforming parts;
(h)8 The means to achieve adequate configuration control of manufactured parts, to enable the
production organisation manufacturer to make the final determination and identification for
conformity or airworthiness release and eligibility status;
(i)9 The identification of responsible persons/offices who controls control the above; and.
(j)10 The acknowledgment by the holder of the TC/STC/repair or change approval/ETSO
authorisation that the approved design data provided, controlled and modified in accordance
with the arrangement are is recognised as approved.
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In many cases, the person producing or intending to produce under Part 21 Subpart F may receive
the approved design data through an intermediate production organisation. This is acceptable,
provided that an effective link between the design approval holder and the production organisation
can be maintained to satisfy the intent of point 21.A.122.
When the design organisation and the production organisation manufacturer are two separate legal
entities, a Ddirect Ddelivery Aauthorisation should be available for direct delivery to end users in
order to guarantee continued airworthiness control of the released parts and appliances.
Where there is no general agreement for Ddirect Ddelivery Aauthorisation, specific permissions may
be granted (see AMC 21.A.4).
AMC1 21.A.124 Application
An applicant should submit to the competent authority an EASA Form 60 (see below) completed in
all blocks.
EASA Form 60
Application for agreement of production under Part 21 Subpart F
Competent authority
of an EU Member State or
EASA
1. Registered name and address of the applicant:
2. Trade name (if different):
3. Location(s) of manufacturing activities:
4. Description of the manufacturing activities under application
a) Identification (TC, P/N , … as appropriate):
b) Termination (No. of units, Termination date, …):
5. Evidence supporting the application, as per point
21.A.124(b):
6. Links/arrangements with design approval
holder(s)/ design organisation(s) where different
from Block 1. :
7. Human resources:
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8. Name of the person signing the application:
______________________________ ______________________________________
Date Signature
EASA Form 60 Issue 3
Block 1: the name of the applicant should be entered. For legal entities, the name should be as stated in the
register of the National Companies Registration Office. In this case, a copy of the entry in the register of
the National Companies Registration Office should be provided to the competent authority.
Block 2: state the trade name by which the applicant is known to the public if it is different from the
information given in Block 1. The use of a logo may be indicated in this block.
Block 3: state all the locations of the manufacturing activities that are covered by the application. Only those
locations should be stated that are directly under the control of the applicant stated in Block 1.
Block 4: this block should include further details of the manufacturing activities under the approval for the
addresses indicated in Block 3. The ‘Identification’ block should indicate the products, parts or
appliances intended to be produced, while the ‘Termination’ block should address any information on
the limitation of the activity, e.g. by stating the intended number of units to be manufactured or the
expected date of completion of the manufacturing activities.
Block 5: this block should state the evidence that supports the determination of applicability as stated in point
21.A.121. In addition, an outline of the manual required by point 21.A.125A(b) should be provided with
the application.
Block 6: the information entered here is essential for the evaluation of the eligibility of the application.
Therefore, special attention should be given concerning the completion of this block, either directly, or
by reference to supporting documentation in relation to the requirements of point 21.A.122 and
AMC1 21.A.122.
Block 7: the information to be entered here should reflect the number of staff, or in the case of an initial
approval, the intended number of staff, for the manufacturing activities under this application, and
therefore it should also include any associated administrative staff.
Block 8: State the name of the person authorised to sign the application.
GM 21.A.124(a) Application – Application form
EASA Form 60 (see AMC 21.B.120(c)(1)) should be obtained from the competent authority and
completed by the applicant.
An application may be accepted from:
An individual applying on his or her own behalf, or
In the case of an organisation, an individual with the authority to make agreements on
behalf of the organisation.
The completed form should be forwarded to the competent authority.
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AMC1 21.A.124A Alternative means of compliance
In order to demonstrate that the requirements are met, a risk assessment should be completed and
documented. The result of this risk assessment should demonstrate that the alternative means of
compliance reaches a level of safety that is acceptable to the competent authority.
21.A.124A Alternative means of compliance
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with
applicable design data
An uncontrolled non-compliance with applicable design data is a non-compliance:
that cannot be discovered through systematic analysis; or
that prevents identification of affected products, parts, appliances, or material.
GM No 2 to 21.A.158(a) Examples of level one findings
Examples of level one findings are non-compliances with any of the following points, that could
affect the safety of the aircraft:
21.A.126, 21.A.127, 21.A.128, 21.A.129..
It should be anticipated that a non-compliance with these points is only considered a level one
finding when objective evidence has been found that this finding is an uncontrolled non-compliance
that could affect the safety of the aircraft.
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings
CAUSAL ANALYIS
It is important that the causal analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root-cause(s) of a non-compliance
often requires an overarching view of the events and circumstances that led to it, to identify all the
possible systemic and contributing factors (regulatory, human factors, organisational factors,
technical, etc.) in addition to the direct factors.
A narrow focus on single events or failures, or the use of a simple, linear model, such as fault tree, to
identify the chain of events that led to the non-compliance may not properly reflect the complexity
of the issue, and, it therefore bears the risk that important factors that need to be addressed in
order to prevent reoccurrences will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address
the symptoms of the non-conformity. A peer review of the results of the causal analysis may
increase its reliability and objectivity.
A system description of the organisation that considers the organisational structures, processes and
their interfaces, procedures, staff, equipment, facilities and the environment in which the
organisation operates, will support both effective causal (reactive) and hazard (proactive) analysis.
21.A.125B Findings
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GM 21.A.126(b)(6) Production inspection system – Recording and
record keeping
1. Records within a production environment satisfy two purposes. Firstly, they should, during the
production process to ensure that products, parts, or appliances are in conformity with the
controlling data throughout the manufacturing cycle. Secondly, certain records of milestone
events are needed to subsequently provide objective evidence that all prescribed stages of
the production process have been satisfactorily completed and that compliance with the
applicable design data has been achieved.
Therefore, the person producing under Part 21 Subpart F should implement a system for the
compilation and retention of records during all stages of manufacture, covering short-term
and long-term records appropriate to the nature of the product and its production processes.
The management of such information should be subject to appropriate documented
procedures in the Manual required by 21.A.125A(b).
All forms of recording media are acceptable (paper, film, magnetic ...) provided they can meet
the required duration for archiving under the conditions provided.
2. The related procedures should:
2.1 Identify records to be kept.
2.2 Describe the organisation of and responsibility for the archiving system (location,
compilation, format) and conditions for access to the information (e.g., by product,
subject).
2.3 Control access and provide effective protection from deterioration or accidental
damage.
2.4 Ensure continued readability of the records.
2.5 Demonstrate to the competent authority proper functioning of the records system.
2.6 Clearly identify the persons involved in conformity determination.
2.7 Define an archiving period for each type of data taking into account importance in
relation to conformity determination subject to the following:
a) Data which supports conformity of a product, part, or appliance should be kept
for not less than three years from the issue date of the related Statement of
Conformity or Authorised Release Certificate.
b) Data considered essential for continuing airworthiness should be kept throughout
the operational life of the product, part or appliance.
2.8 Data related to supplied parts may be retained by the supplier if the supplier has a
system agreed under Part 21 Section A Subpart F by the competent authority. The
manufacturer should, in each case, define the archiving period and satisfy himself or
herself and the competent authority that the recording media are acceptable.
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SUBPART G — PRODUCTION ORGANISATION APPROVAL FOR
PRODUCTS, PARTS AND APPLIANCES
GM 21.A.134 Application – Application form and manner
EASA Form 50 (see AMC 21.B.220(c)) should be obtained from the competent authority, and
completed by the accountable manager of the organisation.
The completed form, an outline of the production organisation exposition, and details of the
proposed terms of approval are to be forwarded to the competent authority.
AMC1 21.A.134 Application
An applicant for a POA should submit to the competent authority an EASA Form 50 (see below)
completed by the applicant.
The completed form, an outline of the production organisation exposition, and details of the
proposed terms of approval should be forwarded to the competent authority
EASA Form 50
Application for a Part 21 production organisation approval
Competent authority
of an EU Member State or
EASA
1. Registered name and address of the organisation:
2. Trade name (if different):
3. Location(s) for which the approval is applied for:
4. Brief summary of proposed activities at the item 3 addresses
a) General:
b) Scope of approval:
c) Nature of privileges:
5. Description of organisation:
6. Links/arrangements with design approval
holder(s)/design organisation(s) where different
from 1.:
7. Approximate number of staff engaged or intended
to be engaged in the activities:
8. Position and name of the accountable manager:
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_____________________________________ ___________________________________
Date Signature of the accountable manager
EASA Form 50
Block 1: the name of the organisation should be entered as stated in the register of the National Companies
Registration Office. For the initial application, a copy of the entry in the register of the National
Companies Registration Office should be provided to the competent authority.
Block 2: state the trade name by which the organisation is known to the public if it is different from the
information given in Block 1. The use of a logo may be indicated in this Block.
Block 3: state all the locations for which the approval is applied for. Only those locations should be stated
that are directly under the control of the legal entity stated in Block 1.
Block 4: this block should include further details of the activities under the approval for the addresses
indicated in Block 4. The ‘General’ block must include overall information, while the ‘Scope of
approval’ Block should address the scope of work and the products/categories following the
principles laid down in GM 21.A.151. The ‘nature of privileges’ block should indicate the requested
privileges as defined in points 21.A.163(b)-(e). For an application for renewal, state ‘not applicable’.
Block 5: this block should provide a summary of the organisation with reference to the outline of the
production organisation exposition, including the organisational structure, functions and
responsibilities. The nomination of the responsible managers in accordance with point
21.A.145(c)(2) should be included as far as possible, accompanied by the corresponding EASA Form
4. For an application for renewal, state ‘not applicable’.
Block 6: the information entered here is essential for the evaluation of the eligibility of the application.
Therefore, special attention should be given concerning the completion of this block, either directly
or by reference to supporting documentation, in relation to the requirements of points 21.A.133(b)
and (c) and the AMC to 21.A.133(b) and (c).
Block 7: the information to be entered here should reflect the number of staff, or in the case of an initial
approval, the intended number of staff for the complete set of activities that are to be covered by
the approval, and it should also therefore include any associated administrative staff.
Block 8: State the position and name of the accountable manager.
AMC1 21.A.134A Alternative means of compliance
(a) In order to demonstrate that the requirements are met, a risk assessment should be
completed and documented. The result of this risk assessment should demonstrate that the
alternative means of compliance reaches a level of safety that is acceptable to the competent
authority.
(b) The result of the risk assessment forms an integral part of the management system records to
be managed in accordance with point 21.A.139.
21.A.134A Alternative means of compliance
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GM1 21.A.139(c) Production management system
SAFETY MANAGEMENT ELEMENT
Safety management seeks to proactively identify hazards and mitigate the related safety risks before
they result in aviation accidents and incidents. Safety management enables an organisation to
manage its activities in a more systematic and focused manner. When an organisation has a clear
understanding of its role and contribution to aviation safety, it enables the organisation to prioritise
safety risks and more effectively manage its resources for optimal results.
Safety should not be considered the responsibility of a single person or a limited group of people in
the organisation. A safety culture should be developed throughout the organisation that involves all
the personnel as active contributors to the safety of the final product, part or appliance in
accordance with AMC1.21.A.139(c)(1).
The requirements established in points 21.A.3A, 21.A.5, 21.A.139, 21.A.145 and 21.A.147 and the
related AMC constitute the EU production management system framework for aviation safety
management. This framework transposes Appendix 2 to ICAO Annex 19. The EU approach aims at
facilitating the introduction of safety management systems into production organisations by
inserting the components of safety management into Part 21, thus building upon the existing
management systems.
Therefore, the approach aims at encouraging organisations to embed safety management and
risk-based decision-making into all their activities, instead of superimposing another system onto
their existing management system and governance structure. In addition, where the organisation
holds multiple organisation certificates issued under Regulation (EU) 2018/1139 and the delegated
and implementing acts adopted on the basis thereof (according to point 21.A.139(h)), the
organisation may choose to implement a single management system to cover all of its activities. An
integrated management system may not only be used to capture multiple certification
requirements, but also to cover other business management systems such as quality, security,
occupational health and environmental management systems. Integration will remove duplication
and exploit synergies by managing safety risks across multiple activities. Organisations may
determine the best means to structure their management systems to suit their business and
organisational needs.
It is important to recognise that safety management will be a continuous activity, as hazards, risks
and the effectiveness of safety risk mitigations will change over time.
The safety management capability of an organisation should be commensurate with the safety risks
to be managed, which can be at the products, parts and appliances level or at the organisational
level:
— If an organisation produces parts that have a limited effect on safety, it may limit the scope of
its safety management system to cover only the areas that contribute to safety (e.g. the
criticality will be different for the production of parts such as safety belts, or major elements
such as an autopilot system).
— The risks that are inherent in a complex structure require a robust safety risk management
process (e.g. a complex supply chain may induce hazards that are complex to mitigate, or the
rate of production, when stretched to the limit, will require more efficient safety barriers).
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As a consequence, scalability should be a function of the inherent safety risk capability of the
organisation. For instance:
— the risk assessment model used may be very simple in small organisations where the
identified hazards are easy to mitigate;
— expert judgement might be sufficient to measure the efficiency of safety barriers;
— the collection of data, safety information and occurrences might be very limited;
— there might be no need for software and tools to manage the SMS;
— the communication policy might be limited.
However, small organisations that are involved in activities that entail significant aviation safety risks
might require greater SMS resources.
21.A.139 Production management system
AMC1 21.A.139(c) Production management system
SAFETY MANAGEMENT ELEMENT
An organisation that has a safety management element, compliant with the SMS Industry Standard
‘Implementing a Safety Management System in Design, Manufacturing and Maintenance
Organizations’ SM001 Issue A - September 17th, 20181, should be considered compliant with the EU
framework for aviation safety management as described in GM1 21.A.139(c), provided that
compliance with the following additional topics, as appropriate, is demonstrated.
Paragraph of SMS Industry Standard
Point Additional topics
SM001 Issue A - September 17th, 2018
§6.1.1.1 Safety Policy
Reporting to EASA as per 21.A.3A (b)(3)
§6.2.1 Hazard identification
(refer to AMC 20-8 and AMC1 21.A.3A(d)
§6.2.2 Safety Risk Assessment and as acceptable means of compliance)
21.A.3A Mitigation
Compliance with Regulation (EU)
§6.3 Safety Assurance No 376/2014 (refer to GM1 21.A.3A(a)(1)
and (b)(1) as a summary of the
§6.4.2 Safety Communication
requirements)
§7 Interfaces between organizations
Record-keeping (refer to the AMC and
21.A.5 Not available GM related to 21.A.5 as acceptable
means of compliance and guidance)
§6.1.2 Safety Accountability and
Responsibilities
§6.1.3 Appointment of Key Safety
21.A.139 (b) none
Personnel
§6.2 Safety Risk Management (system
description)
1
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§6.3.2 Management of Change
§6.3.3 Continuous Improvement of
the SMS
§6.4.1 Training and Education
§1 Introduction
§6.1.1.1 Safety Policy
Human factors in the safety policy (refer
§6.1.1.2 Safety Objectives to AMC1 21.A.139(c)(1) as acceptable
§6.1.2 Safety Accountability and means of compliance)
Responsibilities Functions of safety review board & safety
§6.1.3 Appointment of Key Safety action group (refer to
Personnel AMC1 21.A.139(c)(2) and
GM1 21.A.139(c)(2) for acceptable means
§6.2 Safety Risk Management
of compliance and guidance)
§6.2.1 Hazard identification
Interface risk management in case of
§6.2.2 Safety Risk Assessment and subcontracts (refer to
(c) Mitigation AMC1 21.A.139(c)(3) for acceptable
means of compliance)
§6.3 Safety Assurance
Systematic management of all changes,
§6.3.1 Safety Performance Monitoring
not limited to those having substantive
and Measurement
impact on safety management (refer to
§6.3.2 Management of Change AMC1 21.A.139(c)(4)(ii) for acceptable
§6.3.3 Continuous Improvement of means of compliance)
the SMS More structured safety training (refer to
§6.4 Safety Promotion AMC1 21.A.139(c)(5)(i) for acceptable
means of compliance)
§6.4.1 Training and Education
§6.4.2 Safety Communication
§7 Interfaces between organizations
§6.1.5 SMS Documentation
(e) None
§6.4.2 Safety Communication
Independency of the monitoring of
§6.3.1 Safety Performance Monitoring
compliance and adequacy as per
(f) and Measurement (paragraph title:
21.A.139(f). Refer to AMC1 21.A.139(f)
Need for additional measurement)
for acceptable means of compliance)
(g) §7.3 Corporate SMS approach None
21.A.143 §6.1.5 SMS Documentation None
§6.1.1.1 Safety Policy Identification of managers responsible for
the essential functions (refer to
§6.1.2 Safety Accountability and
AMC1 21.A.145(c)(2) for acceptable
21.A.145(c) Responsibilities
means of compliance)
§6.1.3 Appointment of Key Safety
Definition of competency of personnel
Personnel
(refer to AMC2 21.A.145(c)(2) for
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§6.4.1 Training and Education acceptable means of compliance)
Systematic management of all changes,
not limited to those having substantive
21.A.147 §6.3.2 Management of Change impact on safety management (refer to
AMC1 21.A.139(c)(4)(ii) for acceptable
means of compliance)
21.A.139 Production management system
AMC1 21.A.139(c)(1) Production management system
SAFETY POLICY & OBJECTIVES
(a) The safety policy should:
(1) reflect organisational commitments regarding safety, and its proactive and systematic
management, including the promotion of a positive safety culture;
(2) include internal reporting principles, and encourage personnel to report
production-related errors, incidents and hazards;
(3) be endorsed by the accountable manager;
(4) be communicated, with visible endorsement, throughout the organisation; and
(5) be periodically reviewed to ensure that it remains relevant and appropriate to the
organisation.
(b) The safety policy should include commitments to:
(1) comply with all the applicable legislation, meet all the applicable requirements, and
adopt practices that work towards improving safety standards;
(2) provide the necessary resources for its implementation;
(3) apply human factors principles;
(4) enforce safety as a primary responsibility of all managers; and
(5) apply ‘just culture’ principles, and, in particular, to not make available or use any
personal information on occurrences:
(i) to attribute blame or liability for actions, omissions or decisions taken by
personnel that are commensurate with their experience and training; or
(ii) for any purpose other than the improvement of aviation safety.
(c) Senior management should continuously promote the safety policy to all personnel, and
demonstrate their commitment to it and provide the necessary human and financial resources
for its implementation.
(d) Taking due account of its safety policy, the organisation should define safety objectives. The
safety objectives should:
(1) form the basis for safety performance monitoring and measurement;
(2) reflect the organisation’s commitment to maintain or continuously improve the overall
effectiveness of the management system;
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(3) be communicated throughout the organisation; and
(4) be periodically reviewed to ensure that they remain relevant and appropriate to the
organisation.
21.A.139 Production management system
GM1 21.A.139(c)(1) Production management system
SAFETY POLICY
The safety policy is the means for the organisation to state its intention to maintain and, where
practicable, improve safety levels in all its activities, and to minimise its contribution to the risk of an
aircraft accident or serious incident as far as is reasonably practicable. It reflects the management’s
commitment to safety and the organisation’s philosophy of safety management. It is the foundation
on which the organisation’s management system is built and serves as a reminder of ‘how we do
business here’. The creation of a positive safety culture begins with the issuance of a clear,
unequivocal policy statement.
The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules
that describe how ‘just culture’ principles are guaranteed and implemented.
For organisations that have their principal place of business in a Member State, Regulation (EU)
No 376/2014 defines the ‘just culture’ principles to be applied (refer, in particular, to Article 16(11)
of that Regulation).
21.A.139 Production Management System
AMC1 21.A.139(c)(2) Production management system
SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
(a) The management system should encompass safety by defining a structure that is able to
administrate and maintain the processes and functions of the safety management system as
described in point 21.A.139(c). The accountable manager should establish and maintain
functions which act as:
(1) the safety manager; and
(2) a high-level committee that considers matters of strategic safety, sometimes referred to
as the ‘safety review board’, depending on the size of the organisation and the nature
and complexity of its activities, and subject to a risk assessment that is agreed by the
competent authority.
(b) The safety review board function should monitor:
(1) the safety performance against the safety policy and objectives;
(2) whether any safety action is taken in a timely manner; and
(3) the effectiveness of the organisation’s management system processes.
(c) The accountable manager may also establish and maintain a function, referred to as the
‘safety action group’, in support of the two functions above.
21.A.139 Production management system
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GM1 21.A.139(c)(2) Production management system
SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
The organisation may define its structure in the manner that best fits its needs. The following is an
example of a possible organisation that complies with the safety management element of the
production management system.
The role of the person who assumes, or persons who assume, the function of safety manager should
include, but not be limited, to:
— support of the accountable manager in ensuring that the activities described in point
21.A.139(c) are performed;
— advice to the accountable manager on safety matters; and
— provision of periodic reports on safety performance to the accountable manager and to the
safety review board.
Regardless of the organisational set-up, it is important for the safety manager or a designated
person to remain the unique focal point for the development, administration, and maintenance of
the organisation’s safety management system.
When established by the accountable manager, the function of the safety review board is to:
— ensure that appropriate resources are allocated to achieve the established safety objectives;
— review the results of compliance monitoring; and
— monitor the implementation of the related corrective and preventive actions.
It is composed of heads of functional areas, and it is chaired by the accountable manager.
The role of the safety action group is to:
— analyse specific events;
— assess mitigation measures;
— monitor the safety performance of the organisation;
— define actions to control risks to an acceptable level;
— assess the impact of organisational changes on safety;
— ensure that safety actions are implemented within the agreed timescales; and
— review the effectiveness of previous safety actions and safety promotion.
— 21.A.139 Production management system
AMC1 21.A.139(c)(3) Production management system
SAFETY RISK MANAGEMENT — INTERFACES BETWEEN ORGANISATIONS
(a) Safety risk management processes should specifically address the planned implementation of,
or participation of the organisation in, any complex arrangements (such as when the PO
subcontracts work to multiple organisations).
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(b) Hazard identification and risk assessment should start with the identification of all the parties
involved in the arrangement, including independent experts and non-approved organisations.
This extends to the overall control structure, assessing in particular the following elements
across all subcontract levels and all parties within these arrangements:
(1) coordination and interfaces between the different parties;
(2) applicable procedures;
(3) communication between all the parties involved, including the reporting and feedback
channels;
(4) task allocation, responsibilities and authorities; and
(5) the qualifications and competency of key personnel with reference to point 21.A.145.
(c) Safety risk management should focus on the following aspects:
(1) clear assignment of accountability and allocation of responsibilities;
(2) only one party should be responsible for a specific aspect of the arrangement, with no
overlapping or conflicting responsibilities, in order to eliminate coordination errors;
(3) the existence of clear reporting lines, both for occurrence reporting and progress
reporting; and
(4) the possibility for staff to directly notify the organisation of any hazard that suggests
that there is an obviously unacceptable safety risk as a result of the potential
consequences of this hazard.
(d) Regular communication should be ensured between all the parties to discuss work progress,
risk mitigation actions, changes to the arrangements, as well as any other significant issues.
(e) For subcontracted activities, interfaces and communication channels are also needed for the
purposes of the internal safety reporting scheme (point 21.A.3A).
21.A.139 Production management system
AMC1 21.A.139(c)(3) and (4) Production management system
SAFETY MANAGEMENT KEY PROCESSES
(a) Hazard identification processes
(1) Hazard identification should be based on a combination of reactive and proactive
methods.
(2) The organisation should in particular focus on the hazards that may generate a
non-conformity of the product, part or appliance that is produced.
(b) Safety risk management processes
(1) A safety risk management process should be developed and maintained that ensures
that the safety risks are:
(i) analysed (in terms of their probability and the severity of the consequences of
hazards and occurrences);
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(ii) assessed (in terms of their tolerability); and
(iii) controlled (in terms of the mitigation of risks to an acceptable level).
(2) Within the safety risk management process, the organisation should specify who has
the authority to make decisions regarding the tolerability of safety risks, in accordance
with (b)(1)(ii).
(c) Regardless of the approval status of the subcontracted organisations, the production
organisation is responsible for ensuring that all subcontracted activities are subject to hazard
identification and safety risk management, as required by point 21.A.139(c)(3), and for
monitoring of their compliance and adequacy, as required by point 21.A.139(f).
(d) Internal investigation
(1) In line with its just culture policy, the organisation should define how to investigate
incidents such as errors or near misses, in order to understand not only what happened,
but also how it happened, to prevent or reduce the probability and/or consequences of
any future recurrences (refer to AMC3 21.A.3A(a)(1) and (b)(1)).
(2) The scope of internal investigations should extend beyond the scope of the occurrences
that are required to be reported to the competent authority in accordance with point
21.A.3A.
(e) Safety performance monitoring and measurement
(1) The organisation should establish, implement and maintain a process by which the
safety performance of the organisation is continuously verified against the safety policy
and safety objectives.
(2) This process may include, as appropriate to the size, nature and complexity of the
organisation:
(i) safety reporting that also addresses the status of compliance with the applicable
requirements;
(ii) safety reviews, including trend reviews, which would be conducted during
introduction and deployment of new products and their components, new
equipment/technologies, the implementation of new or changed procedures, or
in situations of organisational changes that may have an impact on safety;
(iii) safety audits that focus on the integrity of the organisation’s management
system, and periodically assess the status of safety risk controls; and
(iv) safety surveys that examine particular elements or procedures of a specific area,
such as the problem areas identified, or any bottlenecks in daily production
management activities, the perceptions and opinions of the production
management personnel, and any areas of dissent or confusion.
(f) Management of change
The organisation should manage any safety risks that are related to a change. The
management of change should be a documented process to identify any external or internal
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change that may have an adverse effect on safety. It should make use of the organisation’s
existing hazard identification, risk assessment and risk mitigation processes.
(g) Continuous improvement
The organisation should continuously seek to improve its safety performance and the
effectiveness of its management system. Continuous improvement may be achieved through:
(1) compliance monitoring and audits carried out by external organisations;
(2) assessments, including assessments of the effectiveness of the safety culture and
management system, in particular to assess the effectiveness of the safety risk
management processes;
(3) staff surveys, including cultural surveys, that can provide useful feedback on how
engaged personnel are with the management system;
(4) monitoring incidents and their recurrences;
(5) evaluating safety performance indicators and reviewing all the available safety
performance information; and
(6) identifying the lessons learned.
21.A.139 Production management system
GM1 21.A.139(c)(4)(ii) Production management system
MANAGEMENT OF CHANGE
Unless properly managed, changes in the organisational structure, facilities, scope of work,
personnel, documentation, policies and procedures, etc. can result in the inadvertent introduction of
new hazards, which can expose the organisation to new or greater risks. Effective organisations seek
to improve their processes, with conscious recognition that changes can expose the organisation to
potentially latent hazards and risks if they are not properly and effectively managed.
The process for the management of change typically provides principles and a structured framework
for managing all aspects of changes. Disciplined application of change management can maximise
the effectiveness of the change, engage staff, and minimise the risks inherent in change.
A change may have the potential to introduce new human factor issues, or to exacerbate pre-
existing ones. For example, changes in computer systems, equipment, technology, personnel
changes, including changes in management personnel, procedures, the work organisation, or work
processes are likely to affect performance.
Effective management of change is supported by the following:
— Implementation of a process for formal hazard identification/risk analysis and assessment for
major operational changes, major organisational changes, changes in key personnel, and
changes that may affect the way in which production management is carried out.
— Identification of changes that are likely to occur in business, which would have a noticeable
impact on:
resources — material and human;
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management direction — policies, processes, procedures, training; and
management control.
— Safety cases/risk assessments that are aviation-safety focused.
— The involvement of key stakeholders in the change management process as appropriate.
— 21.A.139 Production management system
AMC1 21.A.139(c)(4)(ii) Production management system
MANAGEMENT OF CHANGE
(a) Regardless of the magnitude of a change, large or small, there should always be proactive
consideration of the safety implications. This is primarily the responsibility of the team that
proposes or implements the change. However, a change can only be successful if all the
personnel affected by the change are engaged and involved, and they participate in the
process. The magnitude of a change, its safety criticality, and its potential impact on human
performance should be assessed in any change management process.
(b) Special consideration, including human factor issues, should be given to the transition period
during which the change will become effective. In addition, the activities utilised to manage
these issues should be integrated into the change management plan. The purpose of
integrating human factors into the management of change is to minimise the potential risks by
specifically considering the impact of the change on the people within a system.
(c) During the process for the management of a change, previous risk assessments and existing
hazards should be reviewed for their possible effects.
21.A.139 Production management system
AMC1 21.A.139(c)(5) Production management system
SAFETY COMMUNICATION
(a) The organisation should establish communication with its personnel, as appropriate for their
safety responsibilities, about safety matters that:
(1) ensures that all the personnel are aware of the safety management activities;
(2) conveys safety-critical information, especially related to assessed risks and analysed
hazards;
(3) explains why particular actions are taken; and
(4) explains why safety procedures are introduced or changed.
(b) Regular meetings with personnel, as appropriate for their safety responsibilities, during which
information, actions, and procedures are discussed, may be used to communicate safety
matters.
21.A.139 Production management system
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GM1 21.A.139(c)(5) Production management system
SAFETY PROMOTION
Safety training, combined with safety communication and information sharing, is a part of safety
promotion.
Safety promotion activities are intended to:
— support the organisation’s policies;
— encourage a positive safety culture;
— create an environment that is favourable to the achievement of the organisation’s safety
objectives;
— support organisational learning;
— support the implementation of an effective safety reporting scheme; and
— support the development of a just culture.
Depending on the particular safety issue, safety promotion may also constitute or complement risk
mitigation actions.
21.A.139 Production management system
AMC1 21.A.139(c)(5)(i) Production management system
SAFETY TRAINING
(a) The production staff, as described in points 21.A.145(c)(2) and (3), should receive initial and
recurring safety training, as appropriate for their responsibilities, to ensure their continued
competency, including safety management principles, the associated safety objectives and
human factors. The organisation should assess the category of staff for which this training
should be provided.
(b) Adequate records of all the safety training provided should be kept in accordance with point
21.A.5.
(c) Initial training that is compliant with the organisation’s training standards should be provided
to each member of the personnel within 6 months of joining the organisation, unless their
competency assessment justifies that there is no need for such a training. Personnel who are
recruited from another organisation and temporary staff should be assessed for whether they
need to receive any additional safety management training.
(d) Recurrent safety training should be delivered either as a dedicated course, or else integrated
within other training. It should be of an appropriate duration in each 2-year period, in relation
to the relevant compliance monitoring audit findings and any other internal/external sources
of information that are available to the organisation on safety, and in production.
21.A.139 Production management system
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GM1 21.A.139(c)(5)(i) Production management system
SAFETY TRAINING
The main purpose of the safety training programme is to:
— support safety management policies and processes, including human factors training; and
— ensure that personnel at all levels of the organisation develop and maintain their competency
to fulfil their safety roles.
Each organisation should adapt the syllabus to its own needs. Typically, at least the following items
should be included:
— The organisational roles and responsibilities related to safety, including the hazard
identification and risk management processes, and to fostering a positive safety culture;
— Safety objectives and the associated safety performance indicators;
— Human factors principles, including human performance and limitations;
— Legislation, where applicable;
— Safety reporting systems and investigations; and
— Safety issues.
The purpose of the recurrent safety training is:
— primarily to ensure that staff remain current, notably on changes to SMS principles, processes
and procedures; and
— also to share feedback on safety issues that are relevant to the organisation or lessons
learned.
The training staff should have sufficient knowledge and experience to teach the topics at the
required level, with the skills to influence attitudes and behaviours.
21.A.139 Production management system
AMC1GM No1 to 21.A.139(d)(a) Production management system
Quality system
QUALITY SYSTEM ELEMENT
The quality system is an organisational structure, included in the production management system,
with responsibilities, procedures, processes, and resources which implement a management
function to determine and enforce quality principles.
The quality system should be documented in such a way that the documentation can be made easily
available to personnel who need to use the material for performing their normal duties, in
particular:
— procedures, instructions, data to cover the issues of point 21.A.139(d)(2)(b)(1) are available in
a written form,;
— distribution of relevant procedures to offices/persons is made in a controlled manner,;
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— procedures which identify persons responsible for the prescribed actions are established,; and
— the updating process is clearly described.
The manager responsible for ensuring that the quality system is implemented and maintained
should be identified.
The competent authority will verify on the basis of the exposition and by appropriate investigations
that the production organisation has established and can maintain their documented quality system.
21.A.139 Production management system
AMC1 GM 21.A.139(d)(2)(b)(1) Production management system
Quality System – Elements of the quality system
QUALITY SYSTEM — ELEMENTS OF THE QUALITY SYSTEM
(1). The control procedures covering the elements of point 21.A.139(d)(2)(b)(1) should document
the standards to which the production organisation intends to work.
(2). An organisation having a Qquality system designed to meet a recognised Standard such as
ISO 9001 (relevant to the scope of approval being requested) should expand it to include at
least the following additional topics, as appropriate, in order to demonstrate compliance with
the requirements of Part 21 Subpart G:
— Mandatory and voluntary Ooccurrence Rreporting as required by point 21.A.3A and
continued airworthiness as required by point 21.A.165(e)
— Control of work occasionally performed (outside the POA facility by POA personnel)
— Co-ordination Coordination with the applicant for, or holder of, an approved design as
required by points 21.A.133(b) and (c) and 21.A.165(g)
— Issue of certifications within the scope of approval for the privileges of point 21.A.163
— Incorporation of airworthiness data in production and inspection data as required in
points 21.A.133(b) and (c) and 21.A.145(b)
— When applicable, ground test and/or production flight test of products in accordance
with procedures defined by the applicant for, or holder of, the design approval
— Procedures for traceability including a definition of clear criteria of which items need
such traceability. Traceability is defined as a means of establishing the origin of an
article by reference to historical records for the purpose of providing evidence of
conformity
— Personnel training and qualification procedures especially for certifying staff as required
in point 21.A.145(d).
(3). An organisation having a quality system designed to meet a recognised aerospace quality
standard will still need to ensure compliance with all the requirements of Subpart G of Part
21. In all cases, the competent authority will still need to be satisfied that compliance with
Part 21 Subpart G is established.
21.A.139 Production management system
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GM1 No 2 to 21.A.139(d)(1)(a) Production management system
Quality System – Conformity of supplied parts or appliances
CONFORMITY OF SUPPLIED PARTS OR APPLIANCES
The POA holder is responsible for determining and applying acceptance standards for physical
condition, configuration status and conformity of supplied products, parts or appliances, whether to
be used in production or delivered to customers as spare parts. This responsibility also includes BFE
(Buyer Furnished Equipment) items.
To discharge this responsibility the quality system needs an organisational structure and procedures
to adequately control suppliers. Elements of the quality system for the control of suppliers may be
performed by other parties provided that the conditions of AMC No 1 or No 2 to point
21.A.139(d)(2)(ii)(b)(1)(ii) are met.
Control can be based upon use of the following techniques (as appropriate to the system or product
orientation necessary to ensure conformity):
— qualification and auditing of the supplier’s quality system;,
— evaluation of supplier capability in performing all the manufacturing activities, inspections and
tests necessary to establish the conformity of parts or appliances to the type design;,
— first article inspection inspections, including destruction if necessary, to verify that the article
conforms to the applicable data for a new production line or a new supplier;,
— incoming inspections and tests of supplied parts or appliances that can be satisfactorily
inspected on receipt;,
— identification of incoming documentation and data relevant to the showing of conformity to
be included in the certification documents;,
— a vendor rating system which gives confidence in the performance and reliability of this
supplier; and,
— any additional work, tests or inspection which may be needed for parts or appliances which
are to be delivered as spare parts and which are not subjected to the checks normally
provided by subsequent production or inspection stages.
The POA holder may rely on the results of inspection inspections /tests performed by the supplier if
it can establish that:
— the personnel responsible in charge of for these tasks satisfy the competency standards of the
POA quality system;,
— quality measurements are clearly identified; and,
— the records or reports showing evidence of conformity are available for review and audit.
The control of suppliers holding a POA for the parts or appliances to be supplied can be reduced, to a
level at which a satisfactory interface between the two quality systems can be demonstrated. Thus,
for the purpose of showing conformity, a POA holder can rely upon documentation for parts or
appliances released under a suppliers in accordance with the supplier’s privileges defined in point
21.A.163 privileges.
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A supplier who does not hold a POA is considered as to be a sub-contract subcontract or under the
direct control of the POA quality system.
The POA holder retains direct responsibility for inspections/tests carried out either at its own
facilities or at the supplier’s facilities.
21.A.139 Production management system
AMC No 1 to 21.A.139(d)(2)(ii)(b)(1)(ii) Production management
system Vendor and sub-contractor assessment, audit and control –
Production Organisation Approval (POA) holder using documented
arrangements with other parties for assessment and surveillance of
a supplier.
VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL — PRODUCTION
ORGANISATION APPROVAL (POA) HOLDER USING DOCUMENTED ARRANGEMENTS WITH OTHER
PARTIES FOR ASSESSMENT AND SURVEILLANCE OF A SUPPLIER
1. General
Note:
For the purpose of this AMC, vendors and sub-contractors are hereafter referred to as
‘suppliers’, regardless of whether or not they hold a POA and audit and control is hereafter
referred to as ‘surveillance’.
The production organisation is required by Part 21 point 21.A.139(d) to demonstrate that it
has established and maintains a quality system that enables the organisation to ensure that
each item produced conforms to the applicable design data and is in a condition for safe
operation. To discharge this responsibility, the quality system should have, among other
requirements, procedures to adequately carry out the assessment and surveillance of
suppliers.
The use of Oother Pparties (OP OPs), such as a consulting firm or quality assurance company,
for supplier assessment and surveillance does not exempt the POA holder from its obligations
under point 21.A.165. The supplier assessment and surveillance, corrective action and follow-
up activity conducted at any of its supplier’s facilities may be performed by OP OPs.
The purpose of using an OP cannot be to replace the assessment, audit and control of the POA
Hholder. It is to allow an element (i.e. the assessment of the quality system) to be delegated
to another organisation under controlled conditions.
The use of OP OPs to perform supplier assessments and surveillance should be part of the
production organisation quality system and fulfil the conditions of this AMC.
This AMC is applicable to a method whereby a POA holder has a documented arrangement
with an OP for the purpose of assessing and/or surveying a POA's supplier.
2. Approval by the competent authority Reserved
Implementing or changing procedures for using OP for supplier assessment and surveillance is
a significant change to the quality system and requires approval in accordance with 21.A.147.
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3. Conditions and criteria for the use of OP OPs to perform supplier assessment and surveillance
(a) The POA holder should include the use of OP OPs for supplier assessment and
surveillance in the POA holders’ quality system to demonstrate compliance with the
applicable requirements of Part 21.
(b) The Pprocedures required for using OP OPs for supplier assessment and surveillance
should be consistent with other procedures of the POA holders’ quality system.
(c) The Pprocedures of the POA holder that uses OP OPs to perform supplier assessment
and surveillance should include the following:
(1) Identification of the OP that will conduct the supplier assessment and
surveillance.
(2) A listing of suppliers under surveillance by the OP. This listing should be
maintained by the POA holder and made available to the competent authority
upon request.
(3) The method used by the POA holder to evaluate and monitor the OP. The method
should include the following as a minimum:
(i) Verification that standards and checklists used by the OP are acceptable for
the applicable scope.
(ii) Verification that the OP is appropriately qualified and have has sufficient
knowledge, experience and training to perform their its allocated tasks.
(iii) Verification that the frequency with which the OP carry out surveillance
frequency of the suppliers is commensurate with the complexity of the
product and with the surveillance frequency established by the POA
holder’s suppliers control programme.
(iv) Verification that the assessment and surveillance of the suppliers’ suppliers
assessment and surveillance is conducted on-site by the OP.
(v) Verification that the OP has access to the applicable proprietary data to the
level of detail necessary to survey suppliers functions.
Where the POA holder uses an OP accredited by a signatory to the European
cooperation for Accreditation (EA) Multilateral Agreement and working works in
accordance with an aviation standard (e.g. EN 9104 series of requirements) that
describes requirements for the other party assessment and surveillance by the
other party, the items (ii) and (iv) shall be deemed to be complied with.
(4) A definition that states to what scope extent the OP will conduct surveillance of
the suppliers surveillance on behalf of the POA holder. If the OP replaces
surveillance in part, the POA holder should identify the functions that will
continue to be surveyed by the POA holder.
(5) The procedures used by the OP to notify the POA holder of any non-conformities
discovered at the supplier’s facility, and of the corrective action and follow-up.
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(d) The POA should make arrangements that allow the competent authority to make
investigation investigations in accordance with point 21.A.9 21.A.157to include OP
activities.
21.A.139 Production management system
AMC No 2 to 21.A.139(d)(2)(ii) (b)(1)(ii) Production management
system Vendor and sub-contractor assessment, audit and control -
Production Organisation Approval (POA) holder using other party
supplier certification
VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL — PRODUCTION
ORGANISATION APPROVAL (POA) HOLDER USING OTHER PARTY SUPPLIER CERTIFICATION
1. General
Note:
For the purpose of this AMC, vendors and sub-contractors are hereafter referred to as
‘suppliers’, regardless of whether or not they hold a POA and audit and control is hereafter
referred to as ‘surveillance’.
Other party supplier certification is a method whereby a supplier contracts with an
appropriately recognised or accredited Other Party (OP) for the purpose of obtaining a
certification from that OP. Certification indicates that the supplier has satisfactorily
demonstrated to meet that it meets the applicable standard on a continuing basis. OP
certification results in placing the supplier on the OP list of certified organisations, or in the
supplier receiving a certificate identifying the requirements that have been met. Periodic
follow-up evaluations are conducted by the OP to verify continued compliance with the
requirements of the applicable standard.
The production organisation is required by Part 21 point 21.A.139(d) to demonstrate that it
has established and maintains a quality system that enables the organisation to ensure that
each item produced conforms to the applicable design data and is in a condition for safe
operation. To discharge this responsibility, the quality system should have, among other
requirements, procedures to adequately carry out the assessment and surveillance of
suppliers.
The assessment and surveillance of suppliers by an OP should be deemed to satisfy the
requirements of point 21.A.139(b)(1)(ii) when the conditions of this AMC are satisfied. The
assessment and surveillance of suppliers by OP as part of supplier certification does not
exempt the POA holder from its obligations under point 21.A.165. The supplier assessment
and surveillance, corrective action and follow-up activity conducted at any of its supplier’s
facilities may be performed by OP.
The purpose of using an OP cannot be to replace the assessment, audit and control of the POA
Hholder. It is to allow an element (i.e. the assessment of the quality system) to be delegated
to another organisation under controlled conditions.
The use of suppliers that are certified by OP in accordance with this AMC should be part of a
production organisation quality system.
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2. Approval by the competent authority Reserved
Implementing or changing procedures for using suppliers that are certified by an OP is a
significant change to the quality system and requires approval in accordance with 21.A.147.
3. Conditions and criteria for using supplier certification for the supplier assessment and
surveillance
(a) The POA holder should include the use of supplier certification for the supplier
assessment and surveillance in the POA holder’s quality system to demonstrate
compliance with the applicable requirements of Part 21.
(b) The procedures Procedures required for use of supplier certification for the supplier
assessment and surveillance should be consistent with the other procedures of the POA
holders’ quality system.
(c) The procedures Procedures of the POA holder that uses supplier certification for the
supplier assessment and surveillance should include the following:
(1) A listing Listing of the OPs OP that have certified or will certify suppliers and will
conduct supplier assessment and surveillance or the scheme under which the
accreditation of the OP is controlled. This listing should be maintained by the POA
holder and made available to the competent authority upon request.
(2) A listing of the certified suppliers that are under surveillance by the OP and that
are used by the POA holder. This listing should be maintained by the POA holder
and made available to the competent authority upon request.
(3) The method used by the POA holder to evaluate and monitor the certification
process of any OP certification body or OP certification scheme used. This applies
not only to new suppliers, but also to any decision by the POA holder to rely on
OP certification of current suppliers. The method should include the following as
a minimum:
(i) Verification that certification standards and checklists are acceptable and
applied to the applicable scope.
(ii) Verification that the OP is appropriately qualified and has sufficient
knowledge, experience and training to perform its allocated tasks.
(iii) Verification that the frequency with which the OP carries out surveillance
frequency of the suppliers is commensurate with the complexity of the
product and with the surveillance frequency established by the POA
holder’s suppliers control programme.
(iv) Verification that the surveillance of the suppliers’ surveillance is conducted
on-site by the OP.
(v) Verification that the surveillance report will be made available to the
competent authority upon request.
(vi) Verification that the OP continues to be recognised or accredited.
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(vii) Verification that the OP has access to the applicable proprietary data to the
level of detail necessary to survey suppliers’ suppliers functions.
Where the POA holder uses an OP accredited by a signatory to the European cooperation for
Accreditation (EA) Multilateral Agreement and working works in accordance with an aviation
standard (e.g. EN 9104 series of requirements) that describes the requirements for the OP
certification, the items (ii), (iv) and (v) shall be deemed to be complied with:
(4) A definition that states to what scope extent the OP will conduct suppliers
supplier surveillance on behalf of the POA holder. If the OP partly replaces
surveillance by the POA holder in part, the POA holder should identify the
functions that will continue to be surveyed by the POA holder.
(5) Procedures that ensure that the POA is aware of the loss of an existing
certification.
(6) Procedures that ensure that the POA holder is aware of any non-conformities and
has access to detailed information of on these non-conformities.
(7) Procedures to evaluate the consequences of non-conformities and take
appropriate actions.
(d) The POA should make arrangements that allow the competent authority to make
investigation investigations in accordance with point 21.A.9 21.A.157to include OP
activities.
21.A.139 Production management system
GM1 21.A.139(d)(2)(ii) Production management system
VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL
For the purposes of AMC1 21.A.139(d)(2)(ii) and AMC2 21.A.139(d)(2)(ii), vendors and
subcontractors are referred to as ‘suppliers’, regardless of whether or not they hold POAs, and audit
and control is hereafter referred to as ‘surveillance’. Implementing or changing procedures to use an
OP for supplier assessment and surveillance is a significant change to the quality system, and it
requires approval in accordance with point 21.A.147.
21.A.139 Production management system
AMC1 21.A.139(e) Production management system
DOCUMENTATION
(a) The manual or the exposition that is used to document the management system, should be
the key instrument used by an organisation to internally communicate its approach to
management systems.
(b) The organisation may document its safety policy, safety objectives and all the safety
management system key processes (as required in point 21.A.139(a)(1)) in a separate manual
(e.g. a safety management manual or a management system manual) or in its exposition.
Organisations that hold multiple organisation approvals, issued on the basis of Regulation (EU)
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2018/1139 and the delegated and implementing acts adopted on the basis thereof, may
prefer to have separate manuals in order to avoid duplication.
(a) The organisation may also choose to place in separate documents (e.g. policy documents,
procedures) some of the information that is required to be documented.
(b) If any required information is placed in a separate document, the manual or the exposition
should contain adequate references to that document. Any such referenced documents
should be considered integral parts of the production management system documentation.
21.A.139 Production management system
AMC1 21.A.139(f) Production management system
INDEPENDENT MONITORING OF COMPLIANCE AND ADEQUACY
(a) The function that carries out independent monitoring of the compliance and adequacy of the
documented procedures of the production management system should ensure that:
(1) the activities of the organisation are monitored for their adequacy and compliance with
the applicable requirements and with any additional requirements as established by the
organisation, and that these activities are carried out properly under the supervision of
the nominated persons referred to in point 21.A.145(c)(2);
(2) an objective review of the complete set of production-management-related activities is
provided through independent audits;
(3) the independence of an audit is established by always ensuring that audits and
inspections are carried out by personnel who are not responsible for the function,
procedure or products that they audit or inspect;
(4) an audit plan is established to show when and how often the activities required by
Part 21 will be audited;
(5) the audit cycle is determined through a risk assessment agreed by the competent
authority and that does not exceed the applicable audit planning cycle according to
point 21.B.222. That determination should consider at least:
(i) the criticality of the items checked during the audit; and
(ii) the safety performance of the organisation, including any previous findings and
root causes;
(6) when a non-compliance is found, the root cause(s) and contributing factor(s) are
identified and corrective actions are defined. The feedback part of the compliance
monitoring function should define who is required to address any non-compliance in
each particular case, and the procedure to be followed if the corrective action is not
completed within the defined time frame;
(7) the compliance monitoring function that ensures the aspects above performs the
planned continuing and systematic evaluations or audits of the factors that affect the
conformity (and, where required, the safe operation) of the products, parts or
appliances to the applicable design. This evaluation should include all the elements of
the production management system in order to demonstrate compliance with Part 21.
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21.A.139 Production management system
GM No 1 to 21.A.139(b)(2) Quality System – Independent quality
assurance function
The quality assurance function which is part of the organisation is required to be independent from
the functions being monitored. This required independence relates to the lines of reporting,
authority and access within the organisation and assumes an ability to work without technical
reliance on the monitored functions.
GM1 No 2 to 21.A.139(f)(b)(2) Production management system
Quality System – Adequacy of procedures and monitoring function
ADEQUACY OF PROCEDURES AND MONITORING FUNCTION
Adequacy of procedures means that the production management system, through the use of the
procedures as set forth defined, is capable of meeting the conformity objectives identified in point
21.A.139(d)(1)(a).
The quality assurance function to ensure the above should perform planned continuing and
systematic evaluations or audits of factors that affect the conformity (and, where required, safe
operation) of the products, parts or appliances to the applicable design. This evaluation should
include all elements of the quality system in order to demonstrate compliance with Part 21 Subpart
G.
21.A.139 Production management system
GM1 21.A.143 Exposition – Production Organisation Exposition
(POE)
(a) The purpose of the production organisation exposition (POE) is to set forth state in a concise
document documented format the organisational relationships, responsibilities, terms of
reference, and the associated authority, procedures, means and methods of the organisation.
The information to be provided is specified in point 21.A.143(a). Where this information is
documented and integrated in manuals, procedures and instruction instructions, the POE
should provide a summary of the information and an appropriate cross-reference.
(b) The document does not require approval in itself, but it will be considered as such approved
by virtue of the approval of the organisation.
(c) When changes to the organisation occur, according to point 21.A.143(b), the POE is required
to be kept up to date. This should be done as per a procedure, laid down in the POE. If the
changes are significant, Significant changes to the organisation shall not amend the exposition
before the competent authority has approved the change in accordance with point 21.A.147.
(as defined in GM 21.A.147(a)) should be approved by the competent authority prior to
update of the POE.
When an organisation is approved against any other implementing rule containing a requirement for
an exposition, a supplement covering the differences may suffice to meet the requirements of Part
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21 Subpart G except that the supplement should have an index identifying where those parts missing
from the supplement are covered. Those items then formally become part of the POE. In any
combined documents the POE should be easily identifiable.
21.A.143 Exposition
AMC1 21.A.143(a)(1) Exposition
(a) All personnel should be familiar with those parts of the POE that are relevant to their tasks.
(b) A paragraph in the POE should provide the description of the organisation, the safety policy
and the objectives as required by point 21.A.139(c)(1).
(c) The POE should include a statement, signed by the accountable manager (and countersigned
by the chief executive officer, if different), confirming that the POE and any associated
manuals will be complied with at all times.
This statement should read as follows, or embrace the intent of the following paragraph.
‘This exposition defines the organisation and procedures upon which the competent
authority’s* production organisation approval is based.
These procedures are approved by the undersigned, and must be complied with, as applicable,
in order to ensure that all production activities are carried out on time and to an approved
standard.
It is understood that the approval of the production organisation is based on the continuous
compliance of the organisation with the applicable requirements of Part 21, and with the
organisation’s procedures described in this exposition. The competent authority* is entitled to
limit, suspend, or revoke the approval if the organisation fails to fulfil the obligations imposed
by Part 21, or any conditions according to which the approval was issued.
Signed .....................................
Dated ......................................
Accountable manager and ... (quote position)
Chief executive officer …
For and on behalf of ... (quote organisation’s name)’
*Where ‘competent authority’ is stated, please insert the actual name of the approving
competent authority organisation or administration granting the POA approval.
The statement should be re-issued at the earliest opportunity, whenever the accountable
manager is changed.
(d) The POE should include the description of the internal safety reporting scheme that is
required by point 21.A.3A(a)(1)(ii);
(e) If the organisation holds one or more additional organisation certificates within the scope of
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof, so that the organisation is required to establish another exposition, the organisation
may combine the documents by establishing a separate manual or supplement that covers the
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differences between the production organisation exposition and that other exposition. In such
a case, the supplement should identify where in the other exposition the remaining
information on the production organisation is covered. That remaining information then
formally becomes part of the exposition.
21.A.143 Exposition
AMC1 21.A.145(a) Resources
(a) The organisation’s equipment and tools should enable all the specified tasks to be
accomplished in a repeatable manner without any detrimental effects. The calibration control
of the equipment and tools which affect the critical dimensions and values of products should
demonstrate compliance with, and be traceable to, national or international standards.
(b) Sufficient personnel means that according to the nature of the work and the production rate
of each function, the organisation has a sufficient quantity of qualified personnel to
accomplish all the specified manufacturing tasks and to attest their conformity. The number of
personnel should be such that the relevant airworthiness considerations may be applied in all
areas without any undue pressure.
(c) An evaluation of the competence of the personnel is performed as part of the quality system.
This should include, where appropriate, verification that specific qualification standards have
been implemented, for example for NDT, welding, etc. Training should be organised to
establish and maintain the competence of the personnel at the levels determined to be
necessary by the organisation.
21.A.145 Resources
GM1 21.A.145(a) Resources Approval Requirements
A facility is a working area where the working conditions and the environment are controlled as
appropriate in respect of: cleanliness, temperature, humidity, ventilation, lighting, space/access,
noise, and air pollution.
Equipment and tools should be such as to enable all specified tasks to be accomplished in a
repeatable manner without detrimental effect. Calibration control of equipment and tools which
affect critical dimensions and values should demonstrate compliance with, and be traceable to,
national or international standards.
Sufficient personnel means that the organisation has for each function according to the nature of
the work and the production rate, a sufficient quantity of qualified personnel to accomplish all
specified manufacturing tasks and to attest the conformity. Their number should be such that
airworthiness consideration may be applied in all areas without undue pressure.
An evaluation of the competence of personnel is performed as part of the quality system. This
should include, where appropriate, verification that specific qualification standards have been
implemented, for example NDT, welding, etc. Training should be organised to establish and maintain
the personal competence levels determined by the organisation to be necessary.
21.A.145 Resources
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GM1 21.A.145(b)(2) Resources Approval Requirements –
Airworthiness, noise, fuel venting and exhaust emissions
/production data procedures
AIRWORTHINESS, NOISE, FUEL VENTING AND EXHAUST EMISSIONS/PRODUCTION DATA
PROCEDURES
1 When a POA holder/ or an applicant for a POA is developing its own manufacturing data, such
as computer based data, from the design data package delivered by a design organisation,
procedures are required to demonstrate the right correct transcription of the original design
data.
2 Procedures are required to define the manner in which airworthiness, noise, fuel venting and
exhaust emissions data is used to issue and update the production/quality data, which
determines the conformity of products, parts and appliances. The procedure must also define
the traceability of such data to each individual product, part or appliance for the purpose of
certifying their condition for safe operation and issuing a Sstatement of Cconformity or EASA
Form 1.
21.A.145 Resources
AMC1 21.A.145(c)(1) Resources
ACCOUNTABLE MANAGER
The accountable manager should:
(a) have sufficient knowledge and authority to be able to respond to the competent authority
regarding major issues of the production approval, and to implement any necessary
improvements;
(b) promote the quality and safety policies of the organisation; and
(c) demonstrate a basic understanding of this Regulation.
21.A.145 Resources
GM1 21.A.145(c)(1) Resources Approval Requirements –
Accountable manager
ACCOUNTABLE MANAGER
Accountable manager refers to means the manager who is responsible, and has corporate authority
for ensuring that all production work is carried out to the required standard. This function may be
carried out by the Chief Executive chief executive officer or by another person in the organisation,
nominated by him or her the chief executive officer to fulfil the function, provided that the his or her
position and authority of the person in the organisation permits permit him or her to discharge the
attached responsibilities.
The manager is responsible for ensuring that all necessary resources are available and properly used
in order to produce under the production approval in accordance with Part 21 Section A Subpart G.
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The manager needs to have sufficient knowledge and authority to enable him or her to respond to
the competent authority regarding major issues of the production approval and implement
necessary improvements.
The manager needs to be able to demonstrate that he or she is fully aware of and supports the
quality policy and maintains adequate links with the quality manager.
21.A.145 Resources
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AMC1 GM 21.A.145(c)(2) Resources Approval Requirements –
Responsible managers
RESPONSIBLE MANAGERS
(a) The person or group of persons nominated in accordance with 21.A.145(c)(2) should
represent the management structure of the organisation and be responsible for all the
functions as specified in Part 21. Section A Subpart G. It therefore follows that, depending
Depending on the size of the Part 21 Section A Subpart G approved production organisation,
the functions may be subdivided under individual managers (and in fact may be further
subdivided) or combined in a variety of ways.
(b) The organisation should nominate a person or a group of persons who are responsible for:
(1) monitoring the adequacy of the organisation and its compliance with Part 21;
(2) ensuring the effectiveness of the safety management system,
and they should be able to request other managers or the accountable manager to carry out
any necessary and appropriate remedial action. They should have direct access to the
accountable manager.
(c) The competent authority requires the Each nominated managers manager to should be
identified and their credentials submitted on an EASA Form 4 (see EASA Form 4 for Production
Organisations on the EASA website under: http://easa.europa.eu/certification/application-
forms.php) to the competent authority in order so that they may be seen to be appropriate in
terms of their relevant knowledge and satisfactory experience related to the nature of the
production activities as performed by the Part 21 Section A Subpart G approved production
organisation.
(d) The responsibilities and the tasks of each individual manager are required to should be clearly
defined, in order to prevent any uncertainties about the relations, within the organisation. In
the case of organisation organisational structures where staff-members staff members are
responsible to more than one person, as, for instance, in matrix and project organisations, the
responsibilities of the managers should be defined in such a way that all the responsibilities
are covered.
(e) Where a Part 21 Section A Subpart G an approved production organisation chooses to appoint
managers for all or for any combination of the functions identified in Part 21 functions
because of the size of the undertaking, it is necessary that these managers should ultimately
report ultimately to the accountable manager. In cases where a manager does not directly
report to the accountable manager, he or she should have a formally established direct access
to the accountable manager formally established.
(f) The organisation should have a system in place to plan the availability of staff to ensure that
the organisation has sufficient appropriately qualified staff to plan, perform, supervise, inspect
and monitor the organisation’s activities in accordance with the terms of approval.
(g) The organisation should establish and control the competency of the personnel involved in
production, compliance monitoring, safety management, and, if applicable, in issuing permits
to fly, in accordance with a procedure and to a standard agreed by the competent authority.
In addition to the necessary expertise related to the job function, the competency of each
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person should include an understanding of the safety management and human factors
principles that are appropriate to the person’s function and responsibilities in the
organisation.
(h) The person or group of persons responsible for the monitoring of compliance and adequacy
should:
(1) not be one of the persons referred to in point 21.A.145(c)(2);
(2) be able to demonstrate their relevant knowledge, background and appropriate
experience related to the activities of the organisation, including knowledge and
experience in compliance monitoring; and
(3) have access to all parts of the organisation, and as necessary, to any supplier.
(i) If any of the functions related to compliance monitoring or safety management are combined
with other duties, the organisation should ensure this does not result in any conflicts of
interest.
(j) Subject to a risk assessment and agreement by the competent authority, with due regard to
the size of the organisation and the nature and complexity of its activities, the functions of the
compliance monitoring manager and the safety manager may be exercised by the accountable
manager provided that he or she has demonstrated the related level of competence.
One such manager, normally known as the quality manager is responsible for monitoring the
organisation’s compliance with Part 21 Section A Subpart G and requesting remedial action as
necessary by the other managers or the accountable manager as appropriate. He or she should have
a direct access to the accountable manager.
21.A.145 Resources
AMC2 21.A.145(c)(2) Resources
COMPETENCY OF PERSONNEL
(a) To assist in the assessment of competency and to perform the training needs analysis, the
organisation should establish job descriptions for all the job functions in the organisation.
These job descriptions should contain sufficient criteria to enable the competency of each
person to be assessed.
(b) The organisation should provide initial and recurrent training, to the persons or group of
persons nominated in accordance with point 21.A.145(c)(2), which is adequate to their job
function, and which ensures that their continued competency is maintained throughout the
duration of their employment/contract.
(c) The organisation should record the training provided in accordance with point (a).
(d) All prospective members of the production management staff should be assessed for their
competency, qualifications, and capabilities related to their intended duties.
(e) All the staff nominated according to point 21.A.145(c)(2) should be able to demonstrate their
knowledge of, and compliance with, the production management organisation procedures
that are applicable to their job function.
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(f) All the staff nominated according to point 21.A.145(c)(2) should be able to demonstrate an
understanding of the safety management principles, human factors and human performance
issues related to their tasks.
(g) The competency of the person who assumes, or persons who assume, the function of safety
manager should include, but not be limited to, the following:
(1) knowledge of the ICAO standards and European requirements for safety management;
(2) an understanding of management systems, including compliance monitoring systems;
(3) an understanding of risk management;
(4) an understanding of safety investigation techniques;
(5) an understanding of human factors;
(6) an understanding of a positive safety culture and its promotion; and
(7) operational experience related to the activities of the organisation.
(h) The organisation should develop a procedure that describes the process for assessing the
competency of the person. The procedure should specify:
(1) the persons responsible for this process;
(2) the means and methods for the initial assessment;
(3) the means and methods for the continuous control of their competency, including
feedback on their performance;
(4) the actions to be taken if the assessment is not satisfactory; and
(5) how to record assessment results.
21.A.145 Resources
AMC1 21.A.145(d)(1) Resources Approval Requirements – Certifying
staff
CERTIFYING STAFF
(a) Certifying Sstaff should be are nominated by the production organisation to ensure that each
of their products, parts and/or appliances qualify qualifies for a Sstatements of Cconformity or
a Rrelease Ccertificates. The position and number of Ccertifying Sstaff positions and numbers
are to should be appropriate to the complexity of the product and the production rate.
(b) The qualification qualifications of certifying staff is should be based on their knowledge,
background and experience and on a specific training (or testing) established by the
organisation to ensure that it is appropriate to the product, part, or appliance to be released.
(c) Training should must be given to develop a satisfactory level of knowledge of organisation the
organisation’s procedures, safety management systems (including compliance monitoring),
aviation legislation, and the associated regulations implementing rules, CSs CS and GM that
are relevant to the their particular role.
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(d) For that purpose, in addition to the general training policy, the organisation should must
define its own standards for training, including pre-qualification standards, for personnel to be
identified as certifying staff.
(e) The training policy is part of the Quality System management system, and its appropriateness
forms a part of the investigation investigations by the competent authority within the
organisation approval process, and of the subsequent surveillance of the persons proposed by
the managers.
(f) The training must should be updated in response to experience gained and changes in
technology.
(g) A feedback system to ascertain that the required standards are being maintained must should
be put in place to ensure the continuing compliance of personnel to with authorisation
requirements.
(h) For the release of products, parts or appliances, the responsibilities to issue statements of
conformity or/release certificates (EASA Form 1) or permit permits to fly, including the
approval of flight conditions, are allocated to the certifying staff identified in point
21.A.145(d)(2).
(i) The competent authority holds the right to reject those personnel, appointed by the
organisation, if they are found to have inappropriate experience or not to otherwise comply
with its requirements.
21.A.145 Resources
AMC 21.A.145(d)(2) Approval requirements – Record of certifying
staff
1. The following is the minimum information to be recorded in respect of each certifying person:
(a) Name
(b) Date of Birth
(c) Basic Training and standard attained
(d) Specific Training and standard attained
(e) If appropriate – Continuation Training
(f) Experience
(g) Scope of the authorisation
(h) Date of first issue of the authorisation
(i) If appropriate – expiry date of the authorisation
(j) Identification Number of the authorisation
2. The record may be kept in any format and must be controlled by an internal procedure of the
organisation. This procedure forms part of the quality system.
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3. Persons authorised to access the system must be maintained at a minimum to ensure that
records cannot be altered in an unauthorised manner and that confidential records cannot
become accessible to unauthorised persons.
4. The certifying person must be given reasonable access on request to his or her own records.
5. Under the provision of 21.A.157 the competent authority has a right of access to the data held
in such a system.
6. The organisation must keep the record for at least two years after the certifying person has
ceased employment with the organisation or withdrawal of the authorisation, whichever is
the sooner.
AMC1 21.A.145(d)(2)(3) Resources Approval requirements –
Evidence of authorisation
EVIDENCE OF AUTHORISATION
(1) The authorisation document must should be in a style that makes its scope clear to the
certifying staff and any authorised person who may require to examine the authorisation.
Where codes are used to define the scope, an interpretation document should be readily
available.
(2) Certifying staff are not required to carry the authorisation document at all times, but they
should be able to make it available within a reasonable time after of a request from an
authorised person. Authorised persons include the competent authority.
21.A.145 Resources
AMC1 21.A.147 Changes to the production management system
APPLICATION FOR VARIATION OF SCOPE AND TERMS OF THE POA
(a) An application for approval should be submitted in writing to the competent authority, and
the production organisation should demonstrate to the competent authority, on the basis of
the submission of any proposed changes to the exposition, and before the implementation of
the change, that it will continue to comply with Part 21 after the implementation.
(b) The approved production organisation should provide to the competent authority an
application for any significant changes, or for a variation in the scope or terms of their POA, on
an EASA Form 51 (see below) completed by the applicant.
21.A.147 Changes to the production management system
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EASA Form 51
Application for significant changes or a variation of the scope or terms of a Part 21 POA
Competent authority
of an EU Member State or
EASA
1. Name and address of the POA holder:
2. Approval reference number:
3. Location(s) for which changes in the terms of
approval are requested:
4. Brief summary of the proposed changes to the activities at the item 3 addresses:
a) General:
b) Scope of approval:
c) Nature of privileges:
5. Description of organisational changes:
6. Position and name of the accountable
manager or nominee:
_______________________________ __________________________________
Date Signature of the accountable manager (or nominee)
EASA Form 51
Block 1: the name should be entered as written on the current approval certificate. If a change in the name is
to be announced, state the old name and address here, while using Block 5 for the information about
the new name and address. The change of name and/or address should be supported by evidence, e.g.
by a copy of the entry in the register of commerce.
Block 2: state the current approval reference number.
Block 3: state the location(s) for which changes in the terms of approval are requested, or state ‘not
applicable’ here if no change is anticipated.
Block 4: this block should include further details for the variation of the scope of approval for the addresses
indicated in Block 3. The ‘General’ block should include overall information for the change (including
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changes e.g. in workforce, facilities, etc.), while the ‘Scope of approval’ block should address the change
in the scope of work and products/categories following the principles laid down in GM 21.A.151. The
‘nature of privileges’ block should indicate a change in the privileges as defined in points 21.A.163(b)-
(d). State ‘not applicable’ here if no change is anticipated.
Block 5: this block should state the changes to the organisation as it is defined in the current production
organisation exposition, including changes to the organisational structure, functions and
responsibilities. This block should therefore also be used to indicate a change in the accountable
manager in accordance with point 21.A.145(c)(1) or a change in the nomination of the responsible
managers in accordance with point 21.A.145(c)(2). A change in the nomination of the responsible
managers should be accompanied by the corresponding EASA Forms 4. State ‘not applicable’ here if no
change is anticipated.
Block 6: state the position and name of the accountable manager here. Where there is a change in the
nomination of the accountable manager, the information should refer to the nominee for this position.
State ‘not applicable’ here if no change is anticipated.
In case of an application for a change of the accountable manager, EASA Form 51 should be signed by
the new nominee for this position. In all other cases, EASA Form 51 should be signed by the
accountable manager.
21.A.147 Changes to the production management system
GM1 21.A.147(a) Changes to the approved production
management system organisation — Significant changes
SIGNIFICANT CHANGES
1 Changes to be approved by the competent authority include:
Ssignificant changes to the production capacity or methods;.
Cchanges in the organisation’s structure, especially those parts of the organisation in charge
of quality and safety;.
A a change of the accountable manager or of any other person nominated under point
21.A.145(c)(2);.
Cchanges in the production or quality in the production management systems that may have
an important impact on the conformity/ or airworthiness of each product, part or appliance
including reporting lines between the personnel nominated in accordance with point
21.A.145(c)(2)), and the accountable manager; and.
Cchanges in the placement or control of significant sub-contracted subcontracted work or
supplied parts.
2 To ensure that changes do not result in non-compliance with Part 21, Section A Subpart G it is in
the interest of both the competent authority and the approval holder to establish a relationship and
exchange information that will permit the necessary evaluation work to be conducted before the
implementation of a change. This relationship should also permit agreement on the need for
variation of the terms of approval (refer to point 21.A.143(a)(9)).
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3 Where a change of name or ownership results in the issue of a new approval, the investigation will
normally take account of the competent authority’s knowledge and information from the preceding
approval.
4 Changes of location are addressed in point 21.A.148, and changes of ownership in point 21.A.149,
and the change of scope of approval in point 21.A.153.
21.A.147 Changes to the production management system
GM1 21.A.149 Transferability
Transfer of approval would normally only be agreed in cases where the ownership changes but the
organisation itself remains effectively unchanged. For example:
An acceptable transfer situation could be a change of company name (supported by the appropriate
certificate from the National Companies Registration Office or equivalent) but with no changes to
the site address, facilities, type of work, staff, accountable manager or person nominated under
point 21.A.145.
Alternatively, in the event of receivership (bankruptcy, insolvency or other equivalent legal process),
there may be good technical justification for continuation of the approval, provided that the
company continues to function in a satisfactory manner in accordance with their POE. It is likely that
at a later stage, the approval might be voluntarily surrendered or the organisation transferred to
new owners, in which case the former paragraphs apply. If it does not continue to operate
satisfactorily, then the competent authority could suspend or revoke the approval under point
21.B.65 21.B.245.
In order for the competent authority to agree to a transfer of approval, it will normally prescribe, it
as a condition in accordance with point 21.B.240(b) 21.A.147(b), that the obligations and
responsibilities of the former organisation should be transferred to the new organisation, otherwise
a transfer is not possible and an application for a new approval will be required.
AMC1 21.A.153 Changes to the terms of approval — Application for
a change to the terms of approval
APPLICATION FOR A CHANGE TO THE TERMS OF APPROVAL
EASA Form 51 (see AMC1 21.A.147 AMC No 1 to 21.B.240) must should be obtained from the
competent authority and completed in accordance with the procedures of the POE.
The information entered on the form is the minimum required by the competent authority to assess
the need for a change of to the production organisation approval.
The completed form and an outline of the changed POE, and details of the proposed change to the
POA terms of approval, must be forwarded to the competent authority.
GM 21.A.157 Investigations – Arrangements
The arrangements made by the applicant for, or holder of an approval under Part 21 Section A
Subpart G should allow the competent authority to make investigations that include the complete
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production organisation including partners, sub-contractors and suppliers, whether they are in the
State of the applicant or not.
The investigation may include; audits, enquiries, questions, discussions and explanations,
monitoring, witnessing, inspections, checks, flight and ground tests and inspection of completed
products, parts or appliances produced under the POA.
In order to maintain its confidence in the standards achieved by a POA holder or applicant the
competent authority may make an investigation of a sample product part or appliance and its
associated records, reports and certifications.
The arrangements should enable the organisation to give positive assistance to the competent
authority and co-operate in performing the investigation during both initial assessment and for the
subsequent surveillance to maintain the POA.
Co-operation in performing investigation means that the competent authority has been given full
and free access to the facilities and to any information relevant to demonstrate compliance to
Part 21 Section A Subpart G requirements, and assistance (personnel support, records, reports,
computer data, etc., as necessary).
Assistance to the competent authority includes all appropriate means associated with the facilities
of the production organisation to allow the competent authority to perform these investigations,
such as the availability of a meeting room, office and personnel support, documentation and data,
and communication facilities, all properly and promptly available as necessary.
The competent authority seeks to have an open relationship with the organisation and suitable
liaison personnel should be nominated to facilitate this, including suitable representative(s) to
accompany competent authority staff during visits not only at the organisations own facilities but
also at sub-contractors, partners or suppliers.
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with
applicable design data
An uncontrolled non-compliance with applicable design data is a non-compliance:
that cannot be discovered through systematic analysis; or
that prevents identification of affected products, parts, appliances, or material.
GM No 2 to 21.A.158(a) Examples of level one findings
Examples of level one findings are non-compliances with any of the following points, that could
affect the safety of the aircraft:
21.A.139, 21.A.145, 21.A.147, 21.A.148, 21.A.151, 21.A.163, 21.A.165(b), (c), (d), (e), (f) and (g).
It should be anticipated that a non-compliance with these points is only considered a level one
finding when objective evidence has been found that this finding is an uncontrolled non-compliance
that could affect the safety of the aircraft.
In addition, the failure to arrange for investigations under 21.A.157, in particular to obtain access to
facilities, after denial of one written request should be classified as a level one finding.
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GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings
CAUSAL ANALYIS
It is important that the causal analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root-cause(s) of a non-compliance
often requires an overarching view of the events and circumstances that led to it, to identify all the
possible systemic and contributing factors (regulatory, human factors, organisational factors,
technical, etc.) in addition to the direct factors.
A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree,
to identify the chain of events that led to the non-compliance, may not properly reflect the
complexity of the issue, and, it therefore bears the risk that important factors that need to be
addressed in order to prevent reoccurrence will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address
the symptoms of the non-conformity. A peer review of the results of the causal analysis may
increase its reliability and objectivity.
A system description of the organisation that considers organisational structures, processes and
their interfaces, procedures, staff, equipment, facilities and the environment in which the
organisation operates, will support both effective causal (reactive) and hazard (proactive) analysis.
21.A.158 Findings
GM 21.A.165(d) and (h) Obligations of the holder – Recording and
archiving system
Records within a production environment satisfy two purposes. Firstly, they are required, during the
production process to ensure that products, parts, or appliances are in conformity with the
controlling data throughout the manufacturing cycle. Secondly, certain records of milestone events
are needed to subsequently provide objective evidence that all prescribed stages of the production
process have been satisfactorily completed and that compliance with the applicable design data has
been achieved.
Therefore, the approved production organisation should implement a system for the compilation
and retention of records during all stages of manufacture, covering short-term and long-term
records appropriate to the nature of the product and its production processes.
The management of such information should be subject to appropriate procedures in the Quality
System required by 21.A.139.
All forms of recording media are acceptable (paper, film, magnetic, ...) provided they can meet the
required duration for archiving under the conditions provided.
The related organisation procedures should:
Identify records to be kept.
Describe the organisation of and responsibility for the archiving system (location, compilation,
format) and conditions for access to the information (e.g., by product, subject).
Control access and provide effective protection from deterioration or accidental damage.
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Ensure continued readability of the records.
Demonstrate to the competent authority proper functioning of the records system.
Clearly identify the persons involved in conformity determination.
Define an archiving period for each type of data taking into account importance in relation to
conformity determination subject to the following:
a) Data which supports conformity of a product, part, or appliance should be kept for not
less than three years from the issue date of the related Statement of Conformity or
Authorised Release Certificate.
b) Data considered essential for continuing airworthiness should be kept throughout the
operational life of the product, part or appliance.
Ensure that the recording and record-keeping system used by the partners, supplier and sub-
contractors meet the objective of conformity of the product, part or appliance with the same
level of confidence as for their own manufacture. They should define in each case who is to
retain the record data (organisation or partner, supplier or sub-contractor). They should also
define method for surveillance of the recording/record keeping system of the partners,
suppliers or sub-contractors.
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SUBPART J — DESIGN ORGANISATION APPROVAL
GM1 21.A.239(c) Design management system
SAFETY MANAGEMENT ELEMENT
Safety management seeks to proactively identify hazards and mitigate the related safety risks before
they result in aviation accidents and incidents. Safety management enables an organisation to
manage its activities in a more systematic and focused manner. When an organisation has a clear
understanding of its role and contribution to aviation safety, it enables the organisation to prioritise
safety risks and more effectively manage its resources for optimal results.
Safety should not be considered the responsibility of a single person or a limited group of people in
the organisation. A safety culture should be developed throughout the organisation that involves all
the personnel as active contributors to the safety of the final product, part or appliance in
accordance with AMC1.21.A.239(c)(1).
The requirements established in points 21.A.3A, 21.A.5, 21.A.239, 21.A.245 and 21.A.247 and the
related AMC constitute the EU design management system framework for aviation safety
management. This framework transposes Appendix 2 to ICAO Annex 19. The EU approach aims at
facilitating the introduction of the safety management system into design organisations by inserting
the components of safety management into Part 21, thus building upon the existing management
systems.
Therefore, the approach aims at encouraging organisations to embed safety management and
risk-based decision-making into all their activities, instead of superimposing another system onto
their existing management system and governance structure. In addition, if the organisation holds
multiple organisation certificates issued under Regulation (EU) 2018/1139 and the delegated and
implementing acts adopted on the basis thereof (according to point 21.A.239(h)), the organisation
may choose to implement a single management system to cover all of its activities. An integrated
management system may not only be used to capture multiple certification requirements, but also
to cover other business management systems such as quality, security, occupational health and
environmental management systems. Integration will remove duplication and exploit synergies by
managing safety risks across multiple activities. Organisations may determine the best means to
structure their management systems to suit their business and organisational needs.
It is important to recognise that safety management will be a continuous activity as hazards, risks
and the effectiveness of safety risk mitigations will change over time.
The safety management capability of an organisation should be commensurate with the safety risks
to be managed, which can be at the product level or at the organisational level:
— For instance, the criticality of variants may have no impact on safety, in which case, the safety
management system may not need to address this aspect; however, if a large number of
variants need to be managed, this may generate additional hazards that need to be mitigated.
— The risks that are inherent in a complex structure require a robust safety risk management
process (e.g. complex interfaces with different partners who participate in the design of a
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product may induce hazards that are complex to mitigate, due to the management of
organisational or technical changes).
As a consequence, scalability should be a function of the inherent safety risk capability of the
organisation. For instance:
— the risk assessment model used may be very simple in small organisations where the
identified hazards are easy to mitigate;
— expert judgement might be sufficient to measure the efficiency of safety barriers;
— the collection of data, safety information and occurrences might be very limited;
— there might be no need for software or tools to manage the SMS;
— the communication policy might be limited.
However, small organisations that are involved in activities that entail significant aviation safety risks
might require greater SMS resources.
21.A.239 Design management system
AMC1 21.A.239(c) Design management system
SAFETY MANAGEMENT ELEMENT
An organisation that has a safety management element that is compliant with the SMS Industry
Standard ‘Implementing a Safety Management System in Design, Manufacturing and Maintenance
Organizations’ SM001 Issue A - September 17th, 2018 1, should be considered compliant with the EU
framework for aviation safety management as described in GM1 21.A.239(c), provided that
compliance with the following additional topics, as appropriate, is demonstrated.
Paragraph of SMS Industry Standard
Point Additional topics
SM001 Issue A - September 17th, 2018
Reporting to EASA as per 21.A.3A (a)(3)
(refer to AMC 20-8 and AMC1 21.A.3A(d)
as acceptable means of compliance)
§6.1.1.1 Safety Policy
Compliance with Regulation (EU)
§6.2.1 Hazard identification
No 376/2014 (refer to GM1 21.A.3A(a)(1)
§6.2.2 Safety Risk Assessment and and (b)(1) as a summary of the
21.A.3A Mitigation requirements)
§6.3 Safety Assurance Collection, investigation and analysis of
data related to flammability reduction
§6.4.2 Safety Communication
means (FRM) reliability
§7 Interfaces between organizations
Collection, investigation and analysis of
data related to ETOPS significant
occurrences
Record-keeping (refer to the AMC and
21.A.5 Not available GM related to 21.A.5 as acceptable
means of compliance and guidance)
1 https://www.asd-europe.org/sites/default/files/atoms/files/SMS%20Standard_final%20issue%20A_20180917.pdf
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§6.1.2 Safety Accountability and
Responsibilities
§6.1.3 Appointment of Key Safety
Personnel
§6.2 Safety Risk Management (system
(b) description) none
§6.3.2 Management of Change
§6.3.3 Continuous Improvement of
the SMS
§6.4.1 Training and Education
§1 Introduction
§6.1.1.1 Safety Policy
Human factors in the safety policy (refer
§6.1.1.2 Safety Objectives to AMC1 21.A.239(c)(1) as acceptable
§6.1.2 Safety Accountability and means of compliance)
Responsibilities Functions of safety review board & safety
§6.1.3 Appointment of Key Safety action group (refer to
Personnel AMC1 21.A.239(c)(2) and
GM1 21.A.239(c)(2) for acceptable means
§6.2 Safety Risk Management
of compliance and guidance)
§6.2.1 Hazard identification
Interface risk management in case of
21.A.239 §6.2.2 Safety Risk Assessment and subcontracts (refer to
(c) Mitigation AMC1 21.A.239(c)(3) for acceptable
means of compliance)
§6.3 Safety Assurance
Systematic management of all changes,
§6.3.1 Safety Performance Monitoring
not limited to those having substantive
and Measurement
impact on safety management (refer to
§6.3.2 Management of Change AMC1 21.A.239(c)(4)(ii) for acceptable
§6.3.3 Continuous Improvement of means of compliance)
the SMS More structured safety training (refer to
§6.4 Safety Promotion AMC1 21.A.239(c)(5)(i) for acceptable
means of compliance)
§6.4.1 Training and Education
§6.4.2 Safety Communication
§7 Interfaces between organizations
§6.1.5 SMS Documentation
(e) None
§6.4.2 Safety Communication
Independency of the monitoring of
§6.3.1 Safety Performance Monitoring
compliance and adequacy as per
(f) and Measurement (paragraph title:
21.A.239(f). Refer to AMC1 21.A.239(f)
Need for additional measurement)
for acceptable means of compliance)
(g) §7.3 Corporate SMS approach None
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21.A.243 §6.1.5 SMS Documentation None
§6.1.1.1 Safety Policy Identification of managers responsible for
the essential functions (refer to
§6.1.2 Safety Accountability and
AMC1 21.A.245(c)(2) for acceptable
Responsibilities
21.A.245(c) means of compliance)
§6.1.3 Appointment of Key Safety
Definition of competency of personnel
Personnel
(refer to AMC2 21.A.245(c)(2) for
§6.4.1 Training and Education acceptable means of compliance)
Systematic management of all changes,
not limited to those having substantive
21.A.247 §6.3.2 Management of Change impact on safety management (refer to
AMC1 21.A.239(c)(4)(ii) for acceptable
means of compliance)
21.A.239 Design management system
AMC1 21.A.239(c)(1) Design management system
SAFETY POLICY & OBJECTIVES
(a) The safety policy should:
(1) reflect organisational commitments regarding safety, and its proactive and systematic
management, including the promotion of a positive safety culture;
(2) include internal reporting principles, and encourage personnel to report design-related
errors, incidents and hazards;
(3) be endorsed by the head of the design organisation;
(4) be communicated, with visible endorsement, throughout the organisation; and
(5) be periodically reviewed to ensure that it remains relevant and appropriate to the
organisation.
(c) The safety policy should include commitments to:
(1) comply with all the applicable legislation, meet all the applicable requirements, and
adopt practices that work towards improving safety standards;
(2) provide the necessary resources for its implementation;
(3) apply human factors principles;
(4) enforce safety as a primary responsibility of all managers; and
(5) apply ‘just culture’ principles and, in particular, to not make available or use any
personal information on occurrences:
(i) attribute blame or liability for actions, omissions or decisions taken by personnel
that are commensurate with their experience and training; or
(ii) for any purpose other than the improvement of aviation safety.
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(d) Senior management should continuously promote the safety policy to all personnel, and
demonstrate their commitment to it and provide the necessary human and financial resources
for its implementation.
(e) Taking due account of its safety policy, the organisation should define safety objectives. The
safety objectives should:
(1) form the basis for safety performance monitoring and measurement;
(2) reflect the organisation’s commitment to maintain or continuously improve the overall
effectiveness of the management system;
(3) be communicated throughout the organisation; and
(4) be periodically reviewed to ensure that they remain relevant and appropriate to the
organisation.
21.A.239 Design management system
GM1 21.A.239(c)(1) Design management system
SAFETY POLICY
The safety policy is the means for the organisation to state its intention to maintain and, where
practicable, improve safety levels in all its activities, and to minimise its contribution to the risk of an
aircraft accident or serious incident as far as is reasonably practicable. It reflects the management’s
commitment to safety and the organisation’s philosophy of safety management. It is the foundation
on which the organisation’s management system is built and serves as a reminder of ‘how we do
business here’. The creation of a positive safety culture begins with the issuance of a clear,
unequivocal policy statement.
The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules
that describe how ‘just culture’ principles are guaranteed and implemented.
For organisations that have their principal place of business in a Member State, Regulation (EU)
No 376/2014 defines the ‘just culture’ principles to be applied (refer, in particular, to Article 16(11)
of that Regulation).
21.A.239 Design management system
AMC1 21.A.239(c)(2) Design management system
SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
(a) The management system should encompass safety by defining a structure that is able to
administrate and maintain the processes and functions of the safety management system as
described in point 21.A.239(c). The head of the design organisation should establish and
maintain functions which act as:
(1) the safety manager; and
(2) a high-level committee that considers matters of strategic safety, sometimes referred to
as the ‘safety review board’, depending on the size of the organisation and the nature
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and complexity of its activities, and subject to a risk assessment that is agreed by the
competent authority.
(b) The safety review board function should monitor:
(1) the safety performance against the safety policy and objectives;
(2) whether any safety action is taken in a timely manner; and
(3) the effectiveness of the organisation’s management system processes.
(c) The head of the design organisation may also establish and maintain a function, referred to as
the ‘safety action group’, in support of the two functions above.
21.A.239 Design management system
GM1 21.A.239(c)(2) Design management system
SAFETY MANAGEMENT ELEMENT — ORGANISATION AND ACCOUNTABILITIES
The organisation may define its structure in the manner that best fits its needs. The following is an
example of a possible organisation that complies with the safety management elements of the
design management system.
The role of the person who assumes, or persons who assume, the function of safety manager should
include, but not be limited, to:
— support of the head of the design organisation in ensuring the activities described in
AMC1 21.A.239(c) are performed
— advice to the head of the design organisation on safety matters; and
— provision of periodic reports on safety performance to the head of the design organisation
and to the safety review board.
Regardless of the organisational set-up, it is important for the safety manager or a designated
person to remain the unique focal point for the development, administration, and maintenance of
the organisation’s management system.
When established by the head of the design organisation, the function of the high-level committee
(safety review board) is to:
— ensure that appropriate resources are allocated to achieve the established safety objectives;
— review the results of compliance monitoring; and
— monitor the implementation of related corrective and preventive actions.
It is composed of heads of functional areas and it is chaired by the head of the design organisation.
The role of the safety action group is to:
— analyse specific events;
— assess mitigation measures;
— monitor the safety performance of the organisation;
— define actions to control risks to an acceptable level;
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— assess the impact of organisational changes on safety;
— ensure that safety actions are implemented within the agreed timescales; and
— review the effectiveness of previous safety actions and safety promotion.
— 21.A.239 Design management system
AMC1 21.A.239(c)(3) and (4) Design management system
SAFETY MANAGEMENT KEY PROCESSES
(a) Hazard identification processes
(1) Hazard identification should be based on a combination of reactive and proactive
methods.
(2) The organisation should in particular focus on hazards that may result from
non-compliances or errors in the design of the product, part or appliance.
(b) Risk management processes
(1) A safety risk management process should be developed and maintained that ensures
that the safety risks are:
(i) analysed (in terms of their probability and the severity of the consequences of
hazards and occurrences);
(ii) assessed (in terms of their tolerability); and
(iii) controlled (in terms of the mitigation of risks to an acceptable level).
(2) Within the risk management process, the organisation should specify, who has the
authority to make decisions regarding the tolerability of safety risks, in accordance with
(b)(1)(ii).
(c) Regardless of the approval status of the subcontracted organisations, the design organisation
is responsible for ensuring that hazard identification and risk management activities are
conducted on all subcontracted activities, as required by point 21.A.239(c)(3), as well as for
monitoring of their compliance and adequacy, as required by point 21.A.239(f).
(d) Internal investigation
(1) In line with its just culture policy, the organisation should define how to investigate
incidents such as errors or near misses, in order to understand not only what happened,
but also how it happened, and to prevent or reduce the probability and/or
consequences of any future recurrences (refer to AMC3 21.A.3A(a)(1) and (b)(1)).
(2) The scope of internal investigations should extend beyond the scope of the occurrences
that are required to be reported to the competent authority in accordance with point
21.A.3A.
(e) Safety performance monitoring and measurement
(1) The organisation should establish, implement and maintain a process by which the
safety performance of the organisation is continuously verified against the safety policy
and safety objectives.
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(2) This process may include, as appropriate to the size, nature and complexity of the
organisation:
(i) safety reporting that also addresses the status of compliance with the applicable
requirements;
(ii) safety reviews, including trend reviews, which should be conducted during the
introduction and deployment of new products and their components, new
equipment/technologies, the implementation of new or changed procedures, or
in situations of organisational changes that may have an impact on safety;
(iii) safety audits that focus on the integrity of the organisation’s management
system, and periodically assess the status of safety risk controls; and
(iv) safety surveys that examine particular elements or procedures of a specific area,
such as the problem areas identified, or any bottlenecks in the daily design
management activities, the perceptions and opinions of the design management
personnel, and any areas of dissent or confusion.
(f) Management of change
The organisation should manage any safety risks that are related to a change. The
management of change should be a documented process to identify any external or internal
change that may have an adverse effect on safety. It should make use of the organisation’s
existing hazard identification, risk assessment and mitigation processes.
(g) Continuous improvement
The organisation should continuously seek to improve its safety performance and the
effectiveness of its management system. Continuous improvement may be achieved through:
(1) compliance monitoring and audits carried out by external organisations;
(2) assessments, including assessments of the effectiveness of the safety culture and the
management system, in particular to assess the effectiveness of safety risk
management processes;
(3) staff surveys, including cultural surveys, that can provide useful feedback on how
engaged personnel are with the management system;
(4) monitoring incidents and their recurrences;
(5) evaluating the safety performance indicators and reviewing all the available safety
performance information; and
(6) identifying the lessons learned.
21.A.239 Design management system
AMC1 21.A.239(c)(3) Design management system -
SAFETY MANAGEMENT ELEMENT — INTERFACES BETWEEN ORGANISATIONS
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(a) The safety risk management processes should specifically address the planned
implementation of, or participation of the organisation in, any complex arrangements (such as
when the DO subcontracts work to multiple organisations).
(b) Hazard identification and risk assessment start with the identification of all the parties
involved in the arrangement, including any independent experts and non-approved
organisations. It extends to the overall control structure, assessing in particular the following
elements across all subcontract levels and all parties within these arrangements:
(1) coordination and interfaces between the different parties;
(2) applicable procedures;
(3) communication between all the parties involved, including the reporting and feedback
channels;
(4) task allocation, responsibilities and authorities; and
(5) the qualifications and competency of key personnel with reference to point 21.A.245.
(c) Safety risk management should focus on the following aspects:
(1) clear assignment of accountability and allocation of responsibilities;
(2) only one party should be responsible for a specific aspect of the arrangement, with no
overlapping or conflicting responsibilities, in order to eliminate coordination errors;
(3) the existence of clear reporting lines, both for occurrence reporting and progress
reporting; and
(4) the possibility for staff to directly notify the organisation of any hazard that suggests an
obviously unacceptable safety risk as a result of the potential consequences of this
hazard.
(d) Regular communication should be ensured between all the parties to discuss work progress,
risk mitigation actions, changes to the arrangements, as well as any other significant issues.
(e) For any subcontracted activities, interfaces and communication channels are also needed for
the purposes of the internal safety reporting scheme (point 21.A.3A).
21.A.239 Design management system
AMC1 21.A.239(c)(4)(ii) Design management system
MANAGEMENT OF CHANGE
(a) Regardless of the magnitude of change, large or small, there should always be proactive
consideration of the safety implications. This is primarily the responsibility of the team that
proposes or implements the change. However, a change can only be successful if all the
personnel affected by the change are engaged and involved, and they participate in the
process. The magnitude of a change, its safety criticality, and its potential impact on human
performance should be assessed in any change management process.
(b) Special consideration, including human factor issues, should be given to the transition period
during which the change will become effective. In addition, the activities utilised to manage
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these issues should be integrated into the change management plan. The purpose of
integrating human factors into the management of change is to minimise the potential risks by
specifically considering the impact of the change on the people within a system.
(c) During the process for the management of a change, previous risk assessments and existing
hazards should be reviewed for their possible effects.
21.A.239 Design management system
GM1 21.A.239(c)(4)(ii) Design management system
MANAGEMENT OF CHANGE
Unless properly managed, changes in the organisational structure, facilities, scope of work,
personnel, documentation, policies and procedures, etc. can result in the inadvertent introduction of
new hazards, which can expose the organisation to new, or greater risks. Effective organisations
seek to improve their processes, with conscious recognition that changes can expose the
organisation to potentially latent hazards and risks if they are not properly and effectively managed.
The process for the management of change typically provides principles and a structured framework
for managing all aspects of changes. Disciplined application of change management can maximise
the effectiveness of the change, engage staff, and minimise the risks inherent in change.
A change may have the potential to introduce new human factor issues, or to exacerbate pre-
existing ones. For example, changes in computer systems, equipment, technology, personnel
changes, including changes in management personnel, procedures, the work organisation, or work
processes are likely to affect performance.
Effective management of change is supported by the following:
— Implementation of a process for formal hazard identification/risk analysis and assessment for
major operational changes, major organisational changes, changes in key personnel, and
changes that may affect the way in which design management is carried out.
— Identification of changes that are likely to occur in business, which would have a noticeable
impact on:
resources — material and human;
management direction — policies, processes, procedures, training; and
management control.
— Safety cases/risk assessments that are aviation-safety focused.
— The involvement of key stakeholders in the change management process, as appropriate.
— 21.A.239 Design management system
AMC1 21.A.239(c)(5) Design management system
SAFETY COMMUNICATION
(a) The organisation should establish communication with its personnel, as appropriate for their
safety responsibilities, about safety matters that:
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(1) ensures that all the personnel are aware of the safety management activities;
(2) conveys safety-critical information, especially related to assessed risks and analysed
hazards;
(3) explains why particular actions are taken; and
(4) explains why safety procedures are introduced or changed.
(b) Regular meetings with personnel, as appropriate for their safety responsibilities, during which
information, actions, and procedures are discussed, may be used to communicate safety
matters.
21.A.239 Design management system
GM1 21.A.239(c)(5) Design management system
SAFETY PROMOTION
Safety training, combined with safety communication and information sharing, is a part of safety
promotion.
Safety promotion activities are intended to:
— support the organisation’s policies;
— encourage a positive safety culture;
— create an environment that is favourable to the achievement of the organisation’s safety
objectives;
— support organisational learning;
— support the implementation of an effective safety reporting scheme; and
— support the development of a just culture.
Depending on the particular safety issue, safety promotion may also constitute or complement risk
mitigation actions.
21.A.239 Design management system
AMC1 21.A.239(c)(5)(i) Design management system
SAFETY TRAINING
(a) The design management staff, as described in points 21.A.245(a) and (b), should receive initial
and recurring safety training, as appropriate for their responsibilities, to ensure their
continued competency, including safety management principles and the associated safety
objectives. The organisation should assess the category of staff for which this training should
be provided.
(b) Adequate records of all the safety training provided should be kept in accordance with point
21.A.5.
(c) Initial training that is compliant with the organisation’s training standards should be provided
to each member of the personnel within 6 months of joining the organisation, unless their
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competency assessment justifies that there is no need for such a training. Personnel who are
recruited from another organisation and temporary staff should be assessed for whether they
need to receive any additional safety management training.
(d) Recurrent safety training should be delivered either as a dedicated course, or else integrated
within other training. It should be of an appropriate duration in each 2-year period, in relation
to the relevant compliance monitoring audit findings and any other internal/external sources
of information available to the organisation on safety, and in design.
21.A.239 Design management system.
GM1 21.A.239(c)(5)(i) Design management system
SAFETY TRAINING
The main purpose of the safety training programme is to:
— support safety management policies and processes, including human factors training; and
— ensure that personnel at all levels of the organisation develop and maintain their competency
to fulfil their safety roles.
Each organisation should adapt the syllabus to its own needs. Typically, at least the following items
should be included:
— The organisational roles and responsibilities related to safety, including the hazard
identification and risk management processes, and to fostering a positive safety culture;
— Safety objectives and the associated safety performance indicators;
— Human factors principles, including human performance and limitations;
— Legislation, where applicable;
— Safety reporting systems and investigations; and
— Safety issues.
The purpose of the recurrent safety training is:
— primarily to ensure that staff remain current, notably on changes to SMS principles, processes
and procedures; and
— also to share feedback on safety issues that are relevant to the organisation or lessons
learned.
The training staff should have sufficient knowledge and experience to teach the topics at the
required level, with the skills to influence attitudes and behaviours.
21.A.239 Design management system
GM No 1 to 21.A.239(d)(a) Design assurance management system
DESIGN ASSURANCE ELEMENT
(a)1. Purpose
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This GM outlines some basic principles and objectives of 21.A.239(a).the design assurance
element.
(b)2. Definitions
2.(1) The design assurance system is includes the organisational structure, responsibilities,
procedures and resources to ensure the proper functioning of the design organisation.
2.(2) The design Design assurance refers to means all those planned and systematic actions
necessary to provide adequate confidence that the organisation has the capability to:
— to design products or parts in accordance with the applicable type
certification basis, the OSD certification basis CS and the environmental
protection requirements;,
— to demonstrate and verify the compliance with these type certification
basis, the OSD certification basis CS and the environmental protection
requirements;, and
— to demonstrate to the Agency EASA this compliance.
2.(3) The ‘Type Iinvestigation’ means refers to the tasks of the organisation in support of the
TCtype-certificate, STCtype-certificate or other design approval processes necessary to
demonstrate and verify and to maintain compliance with the applicable type
certification basis, OSD certification basis CS and environmental protection
requirements.
3. Design Assurance
The complete process, starting with the CS and environmental protection requirements and
product specifications and culminating with the issuing of a type-certificate, is shown in the
diagram on Figure 1. This identifies the relationship between the design, the Type
Investigation and design assurance processes.
Effective design assurance demands a continuing evaluation of factors that affect the
adequacy of the design for intended applications, in particular that the product, or part,
complies with applicable CS and environmental protection requirements and will continue to
comply after any change.
Two main aspects should therefore be considered:
How the planned and systematic actions are defined and implemented, from the very
beginning of design activities up to continued airworthiness activities;
How these actions are regularly evaluated and corrective actions implemented as
necessary.
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Figure 1 - RELATIONSHIPS BETWEEN DESIGN, DESIGN ASSURANCE AND TYPE INVESTIGATION
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3.1 Planned and Systematic Actions
For design organisations carrying out Type Investigation of products, the planned and
systematic actions should cover the following tasks and procedures should be defined
accordingly:
3.1.1 General
a. To issue or, where applicable, supplement or amend the handbook in
accordance with 21.A.243, in particular to indicate the initiation of design
activities on a product.
b. To assure that all instructions of the Handbook are adhered to.
c. To conduct Type Investigation.
d. To nominate staff as ‘compliance verification engineers’ responsible to
approve compliance documents as defined in paragraph 3.1.3.
e. To nominate personnel belonging to the Office of Airworthiness
responsible as defined in paragraph 3.1.4.
f. In the case of an applicant for a supplemental type-certificate, to obtain
the agreement of the type-certificate holder for the proposed
supplemental type-certificate to the extent defined in 21.A.115.
g. To ensure full and complete liaison between the type design organisation
and related organisations having responsibility for products manufactured
to the type-certificate.
h. To provide the assurance to the Agency that prototype models and test
specimens adequately conform to the type design (see 21.A.33(b)(1)).
3.1.2 Chief Executive and Head of design organisation (or his or her Deputy)
a. The Chief Executive should provide the necessary resources for the proper
functioning of the design organisation.
b. The Head of the design organisation, or an authorised representative,
should sign a declaration of compliance (see 21.A.20(d) and 21.A.97(a)(3))
with the applicable CS and environmental protection requirements after
verification of satisfactory completion of the Type Investigation. In
accordance with 21.A.20(e) and 21.A.97(a)(4), his or her signature on the
declaration of compliance confirms that the procedures as specified in the
handbook have been followed (see also GM 21.A.265(b)).
c. The functions of Chief Executive and Head of the design organisation may
be performed by the same person.
3.1.3 Compliance Verification
a. Approval by signing of all compliance documents, including test
programmes and data, necessary for the verification of compliance with
the applicable CS and environmental protection requirements as defined in
the certification programme.
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b. Approval of the technical content (completeness, technical accuracy...),
including any subsequent revisions, of the manuals approved by the
Agency (Aircraft Flight Manual, the Airworthiness Limitations section of the
Instructions for Continued Airworthiness and the Certification Maintenance
Requirements (CMR) document, where applicable).
3.1.4 Office of Airworthiness
a. Liaison between the design organisation and the Agency with respect to all
aspects of the certification programme.
b. Ensuring that a handbook is prepared and updated as required in 21.A.243.
c. Co-operation with the Agency in developing procedures to be used for the
type certification process.
d. Issuing of guidelines for documenting compliance.
e. Co-operation in issuing guidelines for the preparation of the manuals
required by the applicable implementing rules, Service Bulletins, drawings,
specifications, and standards.
f. Ensuring procurement and distribution of applicable CS and environmental
protection requirements and other specifications.
g. Co-operating with the Agency in proposing the type-certification basis
h. Interpretation of CS and environmental protection requirements and
requesting decisions of the Agency in case of doubt.
i. Advising of all departments of the design organisation in all questions
regarding airworthiness, operational suitability, environmental protection
approvals and certification.
j. Preparation of the certification programme and co-ordination of all tasks
related to Type Investigation in concurrence with the Agency.
k. Regular reporting to the Agency about Type Investigation progress and
announcement of scheduled tests in due time.
l. Ensuring co-operation in preparing inspection and test programmes
needed for demonstration of compliance.
m. Establishing the compliance checklist and updating for changes.
n. Checking that all compliance documents are prepared as necessary to
demonstrate compliance with all CS and environmental protection
requirements, as well as for completeness, and signing for release of the
documents.
o. Checking the required type design definition documents described in
21.A.31 and ensuring that they are provided to the Agency for approval
when required.
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p. Preparation, if necessary, of a draft for a type-certificate data sheet and/or
type-certificate data sheet modification.
q. Providing verification to the head of the design organisation that all
activities required for Type Investigation have been properly completed.
r. Approving the classification of changes in accordance with 21.A.91 and
granting the approval for minor changes in accordance with 21.A.95(b).
s. Monitoring of significant events on other aeronautical products as far as
relevant to determine their effect on airworthiness or operational
suitability of products being designed by the design organisation.
t. Ensuring co-operation in preparing Service Bulletins and the Structural
Repair Manual, and subsequent revisions, with special attention being
given to the manner in which the contents affect airworthiness and
environmental protection and granting the approval on behalf of the
Agency.
u. Ensuring the initiation of activities as a response to a failure
(accident/incident/in-service occurrence) evaluation and complaints from
the operation and providing of information to the Agency in case of
airworthiness or operational suitability impairment (continuing
airworthiness and continued operational suitability).
v. Advising the Agency with regard to the issue of airworthiness directives in
general based on Service Bulletins.
w. Ensuring that the manuals approved by the Agency, including any
subsequent revisions (the Aircraft Flight Manual, MMEL, the Airworthiness
Limitations section of the Instructions for Continued Airworthiness and the
Certification Maintenance Requirements (CMR) document, where
applicable) are checked to determine that they meet the respective
requirements, and that they are provided to the Agency for approval.
3.1.5 Maintenance and Operating Instructions
a. Ensuring the preparation and updating of all maintenance and operating
instructions (including Services Bulletins) needed to maintain airworthiness
(continuing airworthiness) in accordance with relevant CS. For that
purpose, the applicant should:
establish the list of all documents it is producing to comply with the
Appendix referred to in CS 23.1529, CS 25.1529, CS 27.1529,
CS 29.1529, CS-E 25 or CS-P 40 (NPA P-3);
define procedures and organisation to produce and issue these
documents, using where applicable and so elected 21.A.263(c)(3)
privilege.
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b. In accordance with 21.A.57, 21.A.61, 21.A.107, 21.A.119, 21.A.120A and
21.A.449, ensuring that these documents are provided to all affected
operators and all involved authorities.
3.1.6 Operational Suitability Data
a. Ensuring the preparation and updating of all operational suitability data in
accordance with relevant CS. For that purpose, the applicant should:
establish the list of all documents it is producing to comply with CS-
MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD and CS-MCSD as
applicable;
define procedures and organisation to produce and issue these
documents, using where applicable and so elected 21.A.263(c)(3)
privilege.
b. In accordance with 21.A.57, 21.A.62, 21.A.108, 21.A.119 and 21.A.120B,
ensuring that these documents are provided to all affected operators and
training organisations and all involved authorities.
3.2 Continued effectiveness of the design assurance system. The organisation should
establish the means by which the continuing evaluation (system monitoring) of the
design assurance system will be performed in order to ensure that it remains effective.
21.A.239 Design management system
AMC1 21.A.239(d) Design management system
DESIGN ASSURANCE ELEMENT
(a) Reserved
(b) Reserved
(c) Design assurance system
The complete design process, starting with the type certification basis, OSD certification basis
and environmental protection requirements and product specifications and culminating with
the issuing of a TC, is shown in the diagram on Figure 1. This identifies the relationship
between the design, the type investigation and the design assurance processes.
Effective design assurance demands a continuing evaluation of any factors that affect the
adequacy of the design for the intended applications. In particular, it must be ensured that the
product or part complies with the applicable type certification basis, the OSD certification
basis and the environmental protection requirements, and will continue to comply after any
change.
Two main aspects should therefore be considered:
— How the planned and systematic actions are defined and implemented from the very
beginning of the design activities up to the continued airworthiness activities;
— How these actions are regularly evaluated and corrective actions are implemented as
necessary.
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Figure 1 — RELATIONSHIPS BETWEEN DESIGN, DESIGN ASSURANCE AND TYPE INVESTIGATION
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(1) Planned and systematic actions
For design organisations that carry out type investigations of products, their planned
and systematic actions should cover the following tasks, and the related procedures
should be defined accordingly:
(i) General
(A) To issue or, where applicable, supplement or amend the handbook in
accordance with point 21.A.243, in particular to indicate the initiation of
design activities on a product.
(B) To assure that all the instructions of the handbook are adhered to.
(C) To conduct type investigations.
(D) To nominate staff as ‘compliance verification engineers’ who are
responsible for approving compliance documents as defined in point
(c)(1)(iii).
(E) To nominate personnel who belong to the Office of Airworthiness and are
responsible as defined in point (c)(1)(iv).
(F) In the case of an applicant for a STC, to obtain the agreement of the
TCholder for the proposed STCto the extent defined in point 21.A.115.
(G) To ensure that there is full and complete liaison between the type design
organisation and the related organisations who have responsibility for the
products manufactured to the TC.
(H) To provide assurance to EASA that any prototype models and test
specimens adequately conform to the type design (see point
21.A.33(b)(1)).
(ii) Chief executive officer and head of the design organisation (or his or her deputy)
(A) The chief executive officer should provide the necessary resources for the
proper functioning of the design organisation.
(B) The head of the design organisation, or an authorised representative,
should sign a declaration of compliance (see points 21.A.20(d) and
21.A.97(a)(3)) with the applicable type certification basis, the OSD
certification basis and the environmental protection requirements after
verifying the satisfactory completion of the type investigation. In
accordance with points 21.A.20(e) and 21.A.97(a)(4), his or her signature
on the declaration of compliance confirms that the procedures as specified
in the handbook have been followed (see also GM 21.A.265(b)).
(C) The functions of the chief executive officer and the head of the design
organisation may be performed by the same person.
(iii) Compliance verification
(A) Approval by the signing of all the compliance documents, including test
programmes and data that are necessary for the verification of compliance
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with the applicable type certification basis, the OSD certification basis and
the environmental protection requirements as defined in the certification
programme.
(B) Approval of the technical content (completeness, technical accuracy, etc.),
including any subsequent revisions, of the manuals approved by EASA (the
aircraft flight manual, the airworthiness limitations section of the
instructions for continued airworthiness and the certification maintenance
requirements (CMR) document, where applicable).
(iv) Office of Airworthiness
(A) Liaison between the design organisation and EASA with respect to all
aspects of the certification programme.
(B) Ensuring that a handbook is prepared and updated as required in point
21.A.243.
(C) Cooperation with EASA in developing procedures to be used for the type
certification process.
(D) Issuing of guidelines for documenting compliance.
(E) Cooperation in issuing guidelines for the preparation of the manuals
required by the applicable requirements, service bulletins, drawings,
specifications, and standards.
(F) Ensuring procurement and distribution of the applicable type certification
basis, OSD certification basis and environmental protection requirements
and other specifications.
(G) Cooperating with EASA in proposing the type certification basis
(H) The interpretation of the type certification basis, the OSD certification basis
and the environmental protection requirements and requesting decisions
from EASA in cases of doubt.
(I) Advising all the departments of the design organisation on all questions
regarding airworthiness, operational suitability, environmental protection
approvals and certification.
(J) Preparation of the certification programme and coordination of all the
tasks related to type investigations in concurrence with EASA.
(K) Regular reporting to EASA about the progress of type investigations, and
announcing scheduled tests in due time.
(L) Ensuring cooperation in preparing the inspection and test programmes
needed for demonstrations of compliance.
(M) Establishing the compliance checklist and updating it with any changes.
(N) Checking that all the compliance documents are prepared that are
necessary to demonstrate compliance with the type certification basis, the
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OSD certification basis and the environmental protection requirements, as
well as for completeness, and signing the documents for release.
(O) Checking the required type design definition documents described in point
21.A.31 and ensuring that they are provided to EASA for approval when
required.
(P) Preparation, if necessary, of a draft of a TCDS and/or a modification to a
TCDS.
(Q) Providing verification to the head of the design organisation that all the
activities required for a type investigation have been properly completed.
(R) Approving the classification of changes in accordance with point 21.A.91
and granting approvals for minor changes in accordance with point
21.A.95(b).
(S) Monitoring significant events on other aeronautical products, as far as they
are relevant, to determine their effect on the airworthiness or the
operational suitability of the products designed by the design organisation.
(T) Ensuring that there is cooperation in preparing service bulletins and the
structural repair manual, and any subsequent revisions, with special
attention being given to the manner in which the contents affect
airworthiness and environmental protection, and granting the approval on
behalf of EASA.
(U) Ensuring the initiation of activities as a response to a failure
(accident/incident/in-service occurrence) evaluation and complaints from
the operation, and providing information to EASA if the airworthiness or
the operational suitability are impaired (continuing airworthiness and
continued operational suitability).
(V) Advising EASA on the issuing of airworthiness directives in general based
on Service Bulletins.
(W) Ensuring that the manuals approved by EASA, including any subsequent
revisions (to the aircraft flight manual, the MMEL, the airworthiness
limitations section of the instructions for continued airworthiness and the
certification maintenance requirements (CMR) document, where
applicable) are checked to determine whether they meet their respective
requirements, and that they are provided to EASA for approval.
(v) Maintenance and operating instructions
(A) Ensuring the preparation and updating of all the maintenance and
operating instructions (including instructions for continued airworthiness
and service bulletins) that are needed to maintain airworthiness (i.e.
continuing airworthiness) in accordance with the relevant CSs. For that
purpose, the applicant should:
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— establish the list of all the documents it is producing to comply with
the Appendix referred to in CS 23.1529, CS 25.1529, CS 27.1529,
CS 29.1529, CS-E 20/25 or CS-P 40 (NPA P-3);
— establish a system to collect in-service experience to be used for the
improvement of the instructions;
— define the procedures and the organisation that will produce and
issue these documents, under the obligation of point 21.A.265(h);
the procedures should cover the:
preparation, including the format and language (available
industrial standards can be referred to and used);
proofreading (checking for clarity, readability, typos, etc.);
checking of technical consistency with the corresponding
approved change(s), repair(s) or approved data, including the
effectivity, description, effects on airworthiness and
environmental protection, especially when limitations are
changed;
checking of feasibility in practical applications; and
responsibilities and authorised signatories.
(B) In accordance with points 21.A.57, 21.A.61, 21.A.107, 21.A.119, 21.A.120A
and 21.A.449, ensuring that these documents are provided to all known
operators and all the involved authorities.
(vi) Operational suitability data (OSD)
(A) Ensuring the preparation and updating of all OSD in accordance with the
relevant CSs. For that purpose, the applicant should:
— establish the list of all the documents it is producing to comply with
CS-MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD and CS-MCSD,
as applicable;
— define the procedures and the organisation that will produce and
issue these documents, under the obligation of point 21.A.265(h);
the procedure should cover the aspects described in (c)(1)(v)(A)
above.
(B) In accordance with points 21.A.57, 21.A.62, 21.A.108, 21.A.119 and
21.A.120B, ensuring that these documents are provided to all the affected
operators and training organisations, and all the involved authorities.
(d) Continued effectiveness of the design assurance system
The organisation should establish the means by which the independent monitoring of the
compliance and adequacy of the design assurance system will be performed in order to
ensure that it remains effective.
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21.A.239 Design management system
AMC2 GM No 2 to 21.A.239(d)(a) Design management system
Design assurance system for minor changes to type design or minor
repairs to products
DESIGN ASSURANCE ELEMENT FOR MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO
PRODUCTS
(a)1. Purpose
This GM AMC outlines some basic principles and objectives in order to comply with
21.A.239(a) the design assurance element for organisations designing only minor changes to
type design or minor repairs to products.
(b)2. Design assurance system
The design assurance system should include the following:
— an organisational structure to:
control the design;
demonstrate compliance with the applicable type certification basis, the
OSD certification basis CS and the environmental protection requirements;
independently check demonstrations of compliance;
liaise with the Agency EASA;
continuously evaluate the design organisation; and
control sub-contractors subcontractors; and
— procedures and responsibilities associated with the functions listed above, taking
due account of Part 21 requirements applicable to design and approval of minor
changes to type design or minor repairs to products.
— 21.A.239 Design management system
AMC 21.A.239(a)(3) Design assurance system – Independent system
monitoring
The system monitoring function required by 21.A.239(a)(3) may be undertaken by the existing
quality assurance organisation when the design organisation is part of a larger organisation.
AMC1 21.A.239(d)(2)(b) Design management assurance system -
Independent checking function of the demonstration of compliance
INDEPENDENT VERIFICATION FUNCTION OF THE DEMONSTRATION OF COMPLIANCE
(a)1. The independent verification checking function of the demonstration of compliance should
consist of the verification by a person who did not creating create the compliance data. Such a
person may work in conjunction with the individuals who prepare compliance data.
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(b)2. The verification should be shown by signing compliance documents, including test
programmes and data.
(c)3. For a product, there is normally only one compliance verification engineer nominated for each
relevant subject. A procedure should cover the non-availability of nominated persons and
their replacement when necessary.
(d)4. For STC cases, when compliance statement and associated documentation are produced by
the TC holder, and when this these data is are approved under the system of the authority of
TC holder, then the STC applicant does not need to provide, within its own DOA, the
independent verification checking function required in point 21.A.239(d)(2)(b) for these this
data.
21.A.239 Design management system.
GM1 21.A.239(d)(3)(c) Design management system Design
assurance system
DESIGN ASSURANCE ELEMENT
In meeting the requirements of point 21.A.239(d)(3)(c), the applicant for a design organisation
approval under Subpart J may adopt the following policy:
(a)1. The satisfactory integration of the Partner/Sub-contractor partner/subcontractor and
applicant’s design assurance systems should be is demonstrated for the activities covered
under the applicant’s terms of approval.
(b)2. In the event that a Partner/Sub-contractor partner/subcontractor holds a design organisation
approval (DOA), then in accordance with point 21.A.239(d)(3)(c), the applicant may take this
into account in demonstrating the effectiveness of this integrated system.
(c)3. When any Partner/Sub-contractor partner/subcontractor does not hold a DOA, then the
applicant will need to establish to its own satisfaction and the satisfaction of the Agency EASA,
the adequacy of that partner’s/sub-contractor’ subcontractor’s design assurance system in
accordance with point 21.A.243(b).
21.A.239 Design management system
AMC1 21.A.239(e) Design management system
DOCUMENTATION
(a) The manual or the handbook that is used to document the management system should be the
key instrument used by an organisation to internally communicate its approach to
management systems.
(b) The organisation may document its safety policy, safety objectives and all the safety
management system key processes (as required in point 21.A.239(a)(1)) in a separate manual
(e.g. a safety management manual or management system manual) or in its handbook.
Organisations that hold multiple organisation approvals, issued on the basis of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof, may
prefer to have a separate manual in order to avoid duplication.
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(c) The organisation may also choose to place in separate documents (e.g. policy documents,
procedures) some of the information that is required to be documented.
(d) If any required information is placed in a separate document, the manual or the handbook
should contain adequate references to that document. Any such referenced documents
should be considered integral parts of the organisation’s management system documentation.
21.A.239 Design management system
AMC1 21.A.239(f) Design management system
INDEPENDENT MONITORING OF COMPLIANCE AND ADEQUACY
(a) The function that carries out independent monitoring of the compliance and adequacy of the
documented procedures of the design management system should ensure that:
(1) the activities of the organisation are monitored for their adequacy and compliance with
the applicable requirements and with any additional requirements as established by the
organisation, and that these activities are carried out properly under the supervision of
the nominated persons referred to in point 21.A.245(b);
(2) all subcontracted design activities are monitored;
(3) an objective review of the complete set of design management related activities is
provided through independent audits;
(4) the independence of the audit is established by always ensuring that audits and
inspections are carried out by personnel who are not responsible for the function,
procedure or products that they audit or inspect;
(5) an audit plan is established to show when and how often the activities required by
Part 21 will be audited; and
(6) the audit cycle should be determined through a risk assessment agreed by the
competent authority and that it does not exceed the applicable audit planning cycle
according to 21.B.432. That determination should consider at least the following
aspects:
(i) the criticality of the items checked during the audit; and
(ii) the safety performance of the organisation, including any previous findings and
root causes;
(7) when a non-compliance is found, the root cause(s) and contributing factor(s) are
identified and corrective actions are defined. The feedback part of the compliance
monitoring function should define who is required to address any non-compliance in
each particular case, and the procedure to be followed if the corrective action is not
completed within the defined time frame.
(c) The independent monitoring of compliance and adequacy required by point 21.A.239(f) may
be undertaken by the existing quality assurance organisation if the design organisation is part
of a larger organisation.
21.A.239 Design management system
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AMC1 No 1 to 21.A.243(a) Data requirements Handbook
(a) Personnel should be familiar with those parts of the handbook that are relevant to their tasks.
(b) The handbook should provide the following information for each product covered by the
design organisation approval.
(1). A description of the tasks which can be performed under the approval, according to the
following classification:
(i)a. General areas, like subsonic turbojet aeroplanes, turbopropeller turboprop
aeroplanes, small aeroplanes, rotorcraft.
(ii)b. Technologies handled by the organisation (composite, wood or metallic
construction, electronic systems, etc.)
(iii)c. A list of types and models for which the design approval has been granted and for
which privileges may be exercised, supported by a brief description for each
product.
(iv)d. For repair design, classification and (if appropriate) approval activities it is
necessary to specify the scope of activity in terms of structures, systems, engines,
etc.
(2). A general description of the organisation, its main departments, their functions and the
names of those in charge; a description of the line management and of the functional
relationships between the various departments.
(3). A description of the assigned responsibilities and delegated authority of all parts of the
organisation which, taken together, constitute the organisation’s design assurance
management system, together with a chart indicating the functional and hierarchical
relationship of the design assurance management system to the Mmanagement and to
other parts of the organisation; also the chains of responsibilities within the design
assurance management system, and the control of the work of all partners and sub-
contractors subcontractors.
(4). A general description of the way in which the organisation performs all the design
functions in relation to airworthiness, operational suitability and environmental
protection approvals including:
(i)a. The procedures followed and forms used in the type investigation Type
Investigation process to ensure that the design of, or the change to the design of,
the product, as applicable, is identified and documented, and complies with the
applicable type certification basis, the OSD certification basis CS and the
environmental protection requirements, including specific requirements for
import by importing authorities
(ii)b. The procedures for classifying design changes as ‘major’ or ‘minor’ and for the
approval of minor changes.
(iii)c. The procedures for classifying and approving unintentional deviations from the
approved design data occurring in production (concessions or non-conformities
non-conformance’s).
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(iv)d. The procedure for classifying and obtaining approval for repairs.
(5) A general description of the way in which the organisation performs its functions in
relation to the continuing airworthiness and continued operational suitability of the
product it designs, including co-operation cooperation with the production organisation
when dealing with any continuing airworthiness actions that are related to the
production of the product, part or appliance, as applicable.
(6) A description of the human resources, facilities and equipment, which constitutes the
means for design, and where appropriate, for ground and flight testing.
(7) An outline of a system for controlling and informing the staff Staff of the organisation of
current changes in engineering drawings, specifications and design assurance
management procedures.
(8) A description of the recording system for:
(i)a. The the type design, including relevant design information, drawings and test
reports, including inspection records of test specimens.;
(ii)b. The the means of compliance.; and
(iii)c. The the compliance documentation (compliance checklist check list, reports,
etc....).
(9) A description of the record-keeping system to comply with point 21.A.5 21.A.55 and
21.A.105.
(10) A description of the means by which the organisation monitors and responds to
problems affecting the airworthiness or operational suitability of its product during
design, production and in service in particular to comply with point 21.A.3A (see also
AMC1 21.A.239(d), GM No 1 to 21.A.239(a), paragraphs points (c)(1)(iv)(S) and (U).
(11) The names of the design organisation authorised signatories. Nominated persons with
specific responsibilities such as mentioned in points 21.A.33 and 21.A.35 should be
listed.
(12) (Reserved) The description of the organisation’s safety policy and the objectives of the
organisation as required by point 21.A.239(c)(1).
(13) A clear definition of the tasks, competence and areas of responsibility of the Office of
Airworthiness.
(14) A description of the procedures for the establishment and the control of the
maintenance and operating instructions (see points 21.A.57, 21.A.61, 21.A.107,
21.A.119, 21.A.120A and 21.A.449).
(15) A description of the means by which the continuing evaluation (system monitoring) of
the design assurance management system will be performed in order to ensure that it
remains effective.
(16) A description of the procedures for the establishment and the control of the operational
suitability data (see points 21.A.57, 21.A.62, 21.A.108, 21.A.119 and 21.A.120B).
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(17) A description of the internal safety reporting scheme as required by point
21.A.3A(a)(1)(ii);
(18) A statement, signed by the head of the design organisation (and countersigned by the
chief executive officer, if different), confirming that the design management handbook
and any associated manuals will be complied with at all times.
This statement should read as follows, or embrace the intent of the following
paragraph:
‘This handbook defines the organisation and procedures upon which EASA’s design
organisation approval is based.
These procedures are approved by the undersigned, and must be complied with, as
applicable, in order to ensure that all design activities are carried out on time and to an
approved standard.
It is understood that the approval of the design organisation is based on the continuous
compliance or the organisation with the applicable requirements of Part 21, and with
the organisation’s procedures described in this handbook. EASA is entitled to limit,
suspend, or revoke the approval, if the organisation fails to fulfil the obligations imposed
by Part 21, or any conditions according to which the approval was issued.
Signed .....................................
Dated ......................................
Head of the design organisation and ... (quote position)
Chief executive officer…
For and on behalf of ... (quote organisation’s name)
The statement should be re-issued, at the earliest opportunity, whenever the head of
the design organisation is changed.
21.A.243 Handbook
AMC2 No 2 to 21.A.243(a) Data requirements – Model content of
handbook for organisations designing minor changes to type design
or minor repairs to products Handbook
MODEL CONTENT OF HANDBOOK FOR ORGANISATIONS DESIGNING MINOR CHANGES TO TYPE
DESIGN OR MINOR REPAIRS TO PRODUCTS
Part 1. Organisation
1.1 Objective of the handbook and binding statement
1.2 Responsible person for administration of the handbook
1.3 Amendment procedure
1.4 List of effective pages
1.5 Distribution list
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1.6 Presentation of the design organisation (including locations)
1.7 Scope of work (with identification of type and models of products)
1.8 Organisation charts
1.9 Human resources
1.10 Management staff
1.11 Certifying personnel (see GM No 2 to 21.A.243(d), paragraph 2)
1.12 Independent system monitoring
Part 2. Procedures
2.1 Management of changes to type design and design of repairs
configuration control
classification
approval of minor changes to type design and minor repairs
2.2 Control of design sub-contractors subcontractors
2.3 Collecting/Investigating of failures, malfunctions and defects
2.4 Co-ordination Coordination with production
2.5 Documentation control
in relations relation with the changes and repairs
in relation with failures/malfunctions and defects (i.e. Services Bulletins)
2.6 Record-keeping
21.A.243 Handbook
AMC1 21.A.243(d) Handbook
STATEMENT OF QUALIFICATIONS AND EXPERIENCE
(a) The following statements should be provided:
(1) Other management staff
The person nominated represents, or persons nominated represent, the management
structure of the organisation and is, or are, responsible through the head of the design
organisation to the chief executive officer for the execution of all the functions specified
in Subpart J of Part 21. Depending on the size of the organisation, the functions may be
subdivided under individual managers.
The nominated managers should be identified, and their relevant knowledge and
satisfactory experience related to the nature of the design activities that they perform
should be demonstrated. For each nominated manager, the organisation should provide
this data to EASA on EASA Form 4-DOA (see EASA website:
http://easa.europa.eu/certification/application-forms.php) to show that they are
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suitable in terms of their relevant knowledge and satisfactory experience related to the
nature of the design activities performed by the organisation.
The responsibilities and the tasks of each individual manager should be clearly defined,
in order to prevent any uncertainties about the relations within the organisation. The
responsibilities of the managers should be defined in a way that all responsibilities are
covered.
(2) The personnel who make decisions that affect airworthiness, operational suitability and
environmental protection
For these personnel, no individual statements are required. The organisation should
demonstrate that there is a system to select, train, maintain and identify them for all
the tasks for which they are needed.
(b) The personnel defined in (a) should be identified in the handbook or in a document linked to
the handbook. This, and the corresponding procedures, should enable them to carry out the
assigned tasks and to properly discharge the associated responsibilities.
(c) The number of these personnel who are needed to sustain the design activities should be
identified by the organisation.
(d) The personnel defined in (a) should be chosen on the basis of their knowledge, background
and experience.
(e) When necessary, complementary training should be established, to ensure that personnel
have sufficient background and knowledge in the scope of their authorisation. The minimum
standards for new personnel to qualify in the functions should be established. The training
should lead to a satisfactory level of knowledge of the procedures that are relevant for each
particular role.
(f) Training policy forms a part of the design management system, and its appropriateness forms
a part of investigation by EASA within the organisation approval process and the subsequent
surveillance of the persons proposed by the organisation.
(g) This training should be adapted in response to experience gained within the organisation
(h) The organisation should maintain a record of the personnel defined in (a) as defined in
AMC 21.A.5(d).
21.A.243 Handbook
GM1 No 1 to 21.A.243(d) Handbook Statement of qualifications and
experience
STATEMENT OF QUALIFICATIONS AND EXPERIENCE
1. Purpose
This GM provides guidelines on the following points:
Who are the persons covered by 21.A.243(d)?
What is requested from the applicant for these persons?
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2. Who are the persons?
Three different types of functions are named or implicitly identified in the requirements of
Part 21 Subpart J or in the associated AMC and GM, using qualified and experienced
personnel:
the Chief Executive chief executive officer [see GM No 1 to 21.A.239(a)
AMC1 21.A.239(d), point (c)(1)(ii) para. 3.1.2, GM 21.A.249, GM 21.A.265(b)]
the other management staff:
the Head head of the design organisation [see GM No 1 to 21.A.239(a)
AMC1 21.A.239(d), point (c)(1)(ii) para.3.1.2, GM No 1 21.A.245 AMC1 21.A.245,
point (d)(1)4.1, GM 21.A.265(b)]
the Chief of the Office of Airworthiness, or [see GM No 1 21.A.245 AMC1
21.A.245, point (d)(2) 4.2]
the Chief of the independent monitoring function of the design assurance
system [see point 21.A.239(a)(3) and AMC1 No 1 to 21.A.243(a), point (b)(2)
para.2]
the safety manager function [see AMC1 21.A.239(c)(2)]
the safety review board function, depending on the size of the organisation, the
nature and complexity of its activities [see AMC1 21.A.239(c)(2)]
the personnel making decisions affecting airworthiness, operational suitability
and environmental protection:
compliance verification engineers [see AMC1 to 21.A.239(d), para.3.1.3;
AMC 21.A.239(b) AMC1 21.A.239(d)(2)]
personnel of the Office of Airworthiness making decisions affecting
airworthiness, operational suitability and environmental protection, especially
those linked with the point 21.A.263 privileges (signing documents for release,
approving classification of changes and repairs, and granting the approval of
minor changes and minor repairs, granting the approval of SBs, and minor
revisions to the aircraft flight manual) [see AMC1 to 21.A.239(d), para. 3.1.4].
A statement of the qualifications and experience of the chief executive officer is not
required.
3. Kind of statement
3.1 Chief Executive
The Chief Executive should provide the necessary resources for the proper functioning
of the design organisation.
A statement of the qualification and experience of the Chief Executive is normally not
required.
3.2 Other management staff
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The person or persons nominated should represent the management structure of the
organisation and be responsible through the Head of design organisation to the Chief
Executive for the execution of all functions as specified in Part 21, Subpart J. Depending
on the size of the organisation, the functions may be subdivided under individual
managers.
The nominated managers should be identified and their credentials furnished to the
Agency on EASA Form 4-DOA (see EASA website:
http://easa.europa.eu/certification/application-forms.php) in order that they may be
seen to be appropriate in terms of relevant knowledge and satisfactory experience
related to the nature of the design activities as performed by the organisation.
The responsibilities and the tasks of each individual manager should be clearly defined,
in order to prevent uncertainties about the relations, within the organisation.
Responsibilities of the managers should be defined in a way that all responsibilities are
covered.
3.3 Personnel making decisions affecting airworthiness, operational suitability and
environmental protection
For these personnel, no individual statement is required. The applicant should show to
the Agency that there is a system to select, train, maintain and identify them for all
tasks where they are necessary.
The following guidelines for such a system are proposed:
These personnel should be identified in the handbook, or in a document
linked to the handbook. This, and the corresponding procedures, should enable
them to carry out the assigned tasks and to properly discharge associated
responsibilities.
The needs, in terms of quantity of these personnel to sustain the design
activities, should be identified by the organisation.
These personnel should be chosen on the basis of their knowledge,
background and experience.
When necessary, complementary training should be established, to ensure
sufficient background and knowledge in the scope of their authorization. The
minimum standards for new personnel to qualify in the functions should be
established. The training should lead to a satisfactory level of knowledge of the
procedures relevant for the particular role.
Training policy forms part of the design assurance system and its
appropriateness forms part of investigation by the Agency within the organisation
approval process and subsequent surveillance of persons proposed by the
organisation.
This training should be adapted in response to experience gained within
the organisation
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The organisation should maintain a record of these personnel which
includes details of the scope of their authorisation. The personnel concerned
should be provided with evidence of the scope of their authorisation.
The following minimum information should be kept on record:
a) Name
b) Date of birth
c) Experience and training
d) Position in organisation
e) Scope of the authorisation
f) Date of first issue of the authorisation
g) If appropriate, date of expiry of the authorisation
h) Identification number of the authorisation.
The record may be kept in any format and should be controlled.
Persons authorised to access the system should be maintained at a
minimum to ensure that records cannot be altered in an unauthorised manner or
that such confidential records do not become accessible to unauthorised persons.
Personnel should be given access to their own record.
Under the provision of 21.A.257 the Agency has a right of access to the
data held in such a system.
The organisation should keep the record for at least two years after a
person has ceased employment with the organisation or withdrawal of the
authorisation, whichever is the sooner.
21.A.243 Handbook
GM No AMC2 to 21.A.243(d) Handbook Data requirements – –
Statement of the qualification and experience – Organisations
designing minor changes to type design or minor repairs to
products
STATEMENT OF THE QUALIFICATION AND EXPERIENCE — ORGANISATIONS DESIGNING MINOR
CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
For organisations designing minor changes to type design designs or minor repairs to products, the
statement of the qualifications and experience required by point 21.A.243(d) should be addressed as
follows:
(a)1. The nominated managers should be identified and their relevant knowledge and satisfactory
experience related to the nature of the design activities that they perform should be
demonstrated. For each nominated manager, the organisation should provide evidence of
competency credentials submitted to the Agency EASA on EASA Form 4 - DOA (see EASA
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website: http://easa.europa.eu/certification/application-forms.php) in order that they may be
seen to be appropriate in terms of relevant knowledge and satisfactory experience related to
the nature of the design activities as performed by the organisation.
(b)2. The persons responsible to for:
classify classifying changes to type design designs or repairs;
verify verifying compliance [point 21.A.239(b)];
approve approving minor changes to type design designs and minor repairs [point
21.A.263(c)(2)]; and
issue issuing information or instructions [point 21.A.263(c)(3)],
should be selected by the organisation in accordance with a procedure and criteria agreed
with the Agency EASA.
21.A.243 Handbook
AMC GM No 1 to 21.A.245 Requirements for approval Resources
See 21.A.245
(a)1. General. The data handbook submitted in accordance with point 21.A.243 should show that
sufficient skilled personnel are available, and suitable technical and organisational provisions
have been made for carrying out the type investigation Type Investigation defined by GM No 1
to 21.A.239(a)(d), point (b)(3) paragraph 2.3.
(b)2. Personnel. The applicant organisation should show that the personnel available to comply
with point 21.A.245(a)(c)(1) are, due to their special qualifications and number numbers, able
to provide assurance of the design or modification of a product, as well as the compilation and
verification of all data needed to meet the applicable type certification basis, OSD certification
basis CS and environmental protection requirements while taking into account the present
state of the art and new experience.
(c)3. Technical. The applicant should have access to:
(1)a. Wworkshops and production facilities which are suitable for manufacturing prototype
models and test specimens; and.
(2)b. Aaccommodation and test facilities which are suitable for carrying out the tests and
measurements needed to demonstrate compliance with the type certification basis,
OSD certification basis CS and environmental protection requirements. The test facilities
may be subjected to additional technical conditions related to the nature of tests
performed.
(d)4. Organisation. The data handbook submitted in accordance with point 21.A.243 should show
that:
4.(1) the The Head head of the design organisation for which an application for approval has
been made, has the direct or functional responsibility for all departments of the
organisation which are responsible for the design of the product. If the departments
responsible for design are functionally linked, the Head head of the design organisation
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still carries the ultimate responsibility for the compliance of the organisation with Part
21 Subpart J.
4.(2) an An Office of Airworthiness, or equivalent function, has been established and staffed
on a permanent basis to act as the focal point for co-ordinating coordinating
airworthiness, operational suitability and environmental protection matters (see GM No
1 to 21.A.239(a) AMC1 21.A.239(d) point (c)(1)(iv) paragraph 3.1.4); it reports directly to
the head Head of the design organisation or is integrated into an independent quality
assurance organisation reporting to the Head head of the design organisation.
4.(3) [Reserved]
4.(4) The responsibilities Responsibilities for all the tasks related to Tyype Iinvestigations are
assigned in such a way that gaps in authority are excluded.
4.(5) The responsibility for a number of tasks as in point (c)(4) paragraph 4.4 may be assigned
to one person, especially in the case cases of simple projects.
4.(6) Co-ordination Coordination between technical departments and the persons in charge
of the system monitoring required by point 21.A.239(f)(a)(3) has been established to:
(i)a. to ensure the quick and efficient reporting and resolution of difficulties
encountered using the handbook and associated procedures;
(ii)b. to maintain the design assurance management system; and
(iii)c. to optimise auditing activities.
21.A.245 Resources
AMC GM No 2 to 21.A.245 Resources Requirements for approval –
Organisations designing minor changes to type design or minor
repairs to products
ORGANISATIONS DESIGNING MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
The data handbook submitted in accordance with point 21.A.243 should show that:
(a)1. The the manager responsible for design has the direct or functional responsibility for all the
departments of the organisation which are involved in the design of minor changes to type
design designs or minor repairs to products;.
(b)2. a person has, or persons have, Person(s) have been nominated to liaise with the Agency EASA
and to coordinate co-ordinate airworthiness, operational suitability and environmental
protection matters. Their position in the organisation should allow them to direcly direct
report to the manager responsible for design;.
(c)3. the responsibilities Responsibilities for all tasks related to the design and approval of minor
changes to type design designs or minor repairs to products are assigned to ensure that all
areas are covered; and.
(d)4. the The responsibility for a number of tasks as in point (c) paragraph 3 may be assigned to one
person, especially in the case cases of simple projects.
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AMC1 21.A.245(a) Resources
HEAD OF THE DESIGN ORGANISATION
The head of the design organisation should:
(a) have sufficient knowledge and authority to enable him or her to respond to the competent
authority regarding major issues of the design approval, and to implement necessary
improvements;
(b) promote the safety policy specified in AMC1 21.A.239(c)(1); and
(c) demonstrate a basic understanding of this Regulation.
21.A.245 Resources
AMC1 21.A.245(b) Resources
RESPONSIBLE MANAGERS
(a) The person or group of persons nominated in accordance with point 21.A.245(b) should
represent the management structure of the organisation and be responsible for all the
functions as specified in Part 21. Depending on the size of the design organisation, the
functions may be subdivided under individual managers (and further subdivided), or
combined.
(b) The nominated managers should be identified in accordance to GM1 21.A.243(d).
(c) The responsibilities and the tasks of each individual manager should be clearly defined, in
order to prevent uncertainties about the relations within the organisation. For organisations
with structures in which staff-members are responsible to more than one person, as, for
instance, in matrix and project organisations, the responsibilities of the managers should be
defined in such a way that all the responsibilities are covered.
(d) If an approved design organisation chooses to appoint managers for all or any combination of
the functions identified in Part 21 because of the size of the undertaking, these managers
should ultimately report to the head of the design organisation. If a manager does not directly
report to the head of design organisation, he or she should have direct access to the head of
the design organisation formally established.
(e) The organisation should have a system in place to plan the availability of staff to ensure that
the organisation has sufficient appropriately qualified staff to plan, perform, supervise, inspect
and monitor the organisation’s activities in accordance with the terms of approval.
(f) The organisation should establish and control the competency of personnel involved in design,
compliance monitoring and safety management and, if applicable, issuing permits to fly, in
accordance with a procedure and to a standard agreed by the competent authority. In
addition to the necessary expertise related to the job function, the competency of the
personnel should include an understanding of safety management and human factors
principles that is appropriate to the person’s function and responsibilities in the organisation.
(g) The chief of the function for the independent monitoring of compliance and adequacy should:
(1) not be one of the persons referred to in point 21.A.245(b);
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(2) be able to demonstrate relevant knowledge, background and appropriate experience
related to the activities of the organisation, including knowledge and experience in
compliance monitoring; and
(3) have access to all parts of the organisation, and as necessary, any subcontracted
organisations.
(h) If functions related to compliance monitoring or safety management are combined with other
duties, the organisation should ensure that this does not result in any conflicts of interest.
(i) Subject to a risk assessment and agreement by the competent authority, with due regard to
the size of the organisation and the nature and complexity of its activities, the compliance
monitoring manager function and the safety manager function may be exercised by the head
of the design organisation provided that he or she has demonstrated the related competence.
21.A.245 Resources
AMC2 21.A.245(b) Resources
COMPETENCY OF PERSONNEL
(a) To assist in the assessment of competency and to perform the training needs analysis, the
organisation should establish job descriptions for all the job functions in the organisation.
These job descriptions should contain sufficient criteria to enable the competency of each
person to be assessed.
(b) The organisation should provide initial and recurrent training, to the persons or group of
persons nominated in accordance with point 21.A.245(b), which is adequate to their job
function, and which ensures that their continued competency is maintained throughout the
duration of their employment/contract.
(c) The organisation should record the training provided in accordance with point (a).
(d) All prospective members of the design management staff should be assessed for their
competency, qualifications, and capabilities related to their intended duties.
(e) All the staff nominated according to point 21.A.245(b) should be able to demonstrate their
knowledge of, and compliance with, the design management organisation procedures that are
applicable to their tasks.
(f) All the staff nominated according to point 21.A.245(b) should be able to demonstrate an
understanding of the safety management principles, human factors and human performance
issues related to their tasks.
(g) The competency of the person who assumes, or persons who assume, the function of safety
manager should include, but not be limited to, the following:
— knowledge of the ICAO standards and European requirements for safety management;
— an understanding of management systems, including compliance monitoring systems;
— an understanding of risk management;
— an understanding of safety investigation techniques;
— an understanding of human factors;
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— an understanding of a positive safety culture and its promotion; and
— operational experience related to the activities of the organisation.
(h) The organisation should develop a procedure that describes the process for assessing the
competency of the person. The procedure should specify:
(1) the persons responsible for this process;
(2) the means and methods for the initial assessment;
(3) the means and methods for the continuous control of their competency, including
feedback on their performance;
(4) the actions to be taken if the assessment is not satisfactory; and
(5) how to record assessment results.
21.A.245 Resources
AMC1 21.A.247 Changes to the design management system
APPLICATION FOR A SIGNIFICANT CHANGE OR A VARIATION OF SCOPE AND TERMS OF THE DOA
An application for a significant change or a variation of scope should be submitted in writing to the
competent authority, and the design organisation should demonstrate to the competent authority,
on the basis of the submission of the proposed changes to the handbook, and before the
implementation of the change, that it will continue to comply with Part 21 after the implementation.
21.A.247 Changes to the design management system
GM1 21.A.247 Changes to in the design management assurance
system
In addition to a change in ownership (see point 21.A.249), the following changes to the design
assurance management system should be considered as ‘significant’ to for the demonstration of
compliance, or to for the airworthiness, operational suitability or environmental protection of the
products:
(a)1. Organisation
Relocation to new premises (see also GM 21.A.249);
A change Change in the industrial organisation (partnership, subcontractors suppliers,
design work sharing), unless it can be shown that the independent verification checking
function of the demonstration of compliance is not affected;
A change Change in the parts of the organisation that contribute directly to the
airworthiness, operational suitability or environmental protection (independent
verification checking function, Office of Airworthiness office of airworthiness [or
equivalent])
A change Change to the independent monitoring principles of compliance and adequacy
(see point 21.A.239(f)(a)(3))
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(b)2. Responsibilities
Change of the management staff
the head Head of the design organisation [GM No 1 to 21.A.239(a)
AMC1 21.A.239(d), point (c)(1)(ii) para.3.1.2, GM No 1 to 21.A.245 AMC1
21.A.245, point (d)(1) para.4.1, GM 21.A.265(b)]
the Chief of the Office of Airworthiness [GM No AMC1 to 21.A.245, point
(d)(2)para. 4.2]
the Chief of the independent monitoring function of compliance and
adequacy of the design management assurance system [point 21.A.239(f)(a)(3)
and AMC No 1 to 21.A.243(a), para.2 point (b)(2)]
Reporting lines between the personnel nominated in accordance with point
21.A.245(b), and the head of the design organisation;
New distribution Allocation of responsibilities affecting safety, airworthiness,
operational suitability or environmental protection; and
For organisations designing minor changes to type design designs or minor
repairs to products, change of the persons identified in GM No 2 to 21.A.243(d).
(c)3. Procedures
Change to the principles of procedures related to:
the type certification;,
the classification of changes and repairs as ‘major’ or ‘minor’ [point
21.A.263(c)(1)];,
the treatment handling of major changes and major repairs, ;
the approval of the design of minor changes and minor repairs [point 21.A.263(c)(2)], ;
the issue issuing of information and instructions under the privilege of point
21.A.263(c)(3), ;
the approval of minor revisions to the Aaircraft Fflight Mmanual [point 21.A.263(c)(4)], ;
the approval approvals of the design designs of major repairs [point 21.A.437 or
21.A.263(c)(5)], ;
continued airworthiness or continued operational suitability (see point 21.A.3B), ;
the configuration control, when airworthiness, operational suitability or
environmental protection is affected, ; and
the acceptability of design tasks undertaken by partners or sub-contractors
subcontractors [point 21.A.239(d)(3)(c)].
(d)4. Resources
A substantial Substantial reduction in the number and/or experience of staff (see point
21.A.245(d)(1)(a)).
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21.A.247 Changes to the design management system
GM 21.A.257(a) Investigations
Arrangements that allow the Agency to make investigations include the complete design
organisation including partners, sub-contractors and suppliers, whether they are in the State of the
applicant or not, assisting and co-operating with the Agency in performing inspections and audits
conducted during initial assessment and subsequent surveillance.
Assistance to the Agency includes all appropriate means associated with the facilities of the design
organisation to allow the Agency to perform these inspections and audits, such as a meeting room
and office support.
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings
CAUSAL ANALYSIS
It is important that the causal analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root-cause(s) of a non-compliance
often requires an overarching view of the events and circumstances that led to it, to identify all the
possible systemic and contributing factors (regulatory, human factors, organisational factors,
technical, etc.) in addition to the direct factors.
A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree,
to identify the chain of events that led to the non-compliance, may not properly reflect the
complexity of the issue, and, it therefore bears the risk that important factors that need to be
addressed in order to prevent reoccurrences will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address
the symptoms of the nonconformity. A peer review of the results of the causal analysis may increase
its reliability and objectivity.
A system description of the organisation that considers organisational structures, processes and
their interfaces, procedures, staff, equipment, facilities and the environment in which the
organisation operates, will support both effective causal (reactive) and hazard (proactive) analysis.
21.A.258 Findings
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SUBPART M — REPAIRS
AMC 21.A.433(a) and 21.A.447 Repair design and record keeping
1. Relevant substantiation data associated with a new major repair design and record keeping
should include:
a. damage identification and reporting source,
b. major repair design approval sheet identifying applicable specifications and references
of justifications,
c. repair drawing and/or instructions and scheme identifier,
d. correspondence with the TC, STC, or APU ETSO authorisation holder, if its advice on the
design has been sought,
e. structural justification (static strength, fatigue, damage tolerance, flutter etc.) or
references to this data,
f. effect on the aircraft, engines and/or systems, (performance, flight handling, etc., as
appropriate)
g. effect on maintenance programme,
h. effect on Airworthiness limitations, the Flight Manual and the Operating Manual,
i. weight and moment change,
j. special test requirements.
2. Relevant minor repair documentation includes paragraphs 1(a) and (c). Other points of
paragraph 1 may be included where necessary. If the repair is outside the approved data,
justification for classification is required.
3. Special consideration should be given to repairs that impose subsequent limitations on the
part, product or appliance, (e.g., engine turbine segments that may only be repaired a finite
number of times, number of repaired turbine blades per set, oversizing of fastener holes,
etc.).
4. Special consideration should also be given to Life Limited parts and Critical Parts, notably with
the involvement of the type-certificate or STC holder, when deemed necessary under
21.A.433(b).
5. Repairs to engine or APU critical parts would normally only be accepted with the involvement
of the TC holder.
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SUBPART P — PERMIT TO FLY
GM 21.A.705 Competent authority
An aircraft registered in a Member State is under the responsibility of this Member State for
continuing airworthiness aspects. Consequently, any permit to fly under Part 21 should be issued by
that Member State including cases where the aircraft will fly in another State. The permit to fly
contains all the conditions and restrictions to ensure safe flight but other airspace and operational
rules remain the competence of the authority of the State where the flight will take place. The
applicant should therefore also ensure compliance with the relevant regulations of that State.
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SECTION B PROCEDURES FOR COMPETENT AUTHORITIES
SUBPART A — GENERAL PROVISIONS
GM 21.B.20 Responsibility for implementation
Each certificate or approval in accordance with Part 21 Section A Subparts F, G, H, I and P will
normally be issued and controlled by the competent authority of the Member State in whose
country the applicant or holder is located. Therefore, to ensure consistency between the competent
authorities of the Member States in issuing certificates and approvals, implementation of Part 21
should be based on the following three principles:
a) The establishment and maintenance of an effective organisation and corresponding processes
by all competent authorities.
b) The operation of all competent authorities in accordance with Part 21 and its Acceptable
Means of Compliance (AMC) and guidance material (GM).
c) A standardisation process established and operated by the Agency to access the standard
achieved, and to provide timely advice and guidance to the competent authorities of the
Member States.
As a result the responsibility for implementation comprises of the two main objectives:
a) To ensure that certificates and approvals are only granted to applicants that comply with the
requirements of Part 21; and
b) To ensure sufficient visibility of the processes to give the Agency and the other Member States
the necessary confidence in the certificates or approvals granted.
AMC1 21.B.25 Management system
GENERAL
(a) In deciding upon the required airworthiness organisational structure, the competent authority
should review:
(1) the number of certificates, approvals, authorisations and letters of agreement to be
issued,
(2) the number, complexity and sizes of the organisations under its oversight obligations;
(3) the possible use of qualified entities and of the resources of the competent authorities
of other Member States to fulfil the continuing oversight obligations;
(4) the complexity of the aviation industry, taking into consideration the diversity of the
products, parts and appliances; and
(5) the potential growth of activities in the field of civil aviation.
(b) The competent authority should retain effective control of the important inspection functions
and not delegate them in such a way that organisations, in effect, regulate themselves in
airworthiness matters.
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(c) The set-up of the organisational structure should ensure that the various tasks and obligations
of the competent authority do not solely rely on individuals. The continuous and undisturbed
fulfilment of these tasks and obligations of the competent authority should also be
guaranteed in cases of illness, accidents or leave of individual employees.
21.B.25 Management system
AMC2GM 21.B.25(a) Organisation Management system
GENERAL
(a) The competent authority designated by each Member State should have an organisation in
such a way that:
a)(1) there is specific and effective management authority in the conduct of all the relevant
activities,;
b)(2) the functions and processes described in Part 21 and its AMC and GM may be properly
implemented, ;
c)(3) the competent authority of the Member State’s policy policies, organisation and
operating procedures for the implementation of Part 21 are properly documented and
applied,;
d)(4) all the personnel of the competent authority of the Member State personnel involved in
the related activities are provided with training where necessary,;
e)(5) specific and effective provision is made for the communication and interface as
necessary with the Agency EASA and the competent authorities of the Member States,;
and
f)(6) all the functions related to the implementation of Part 21 are adequately described and
shown (Standardisation).
(b) A general policy in respect of Part 21 the activities related to the applicable requirements of
Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis
thereof should be developed, sponsored promoted and implemented by the manager at the
highest appropriate level, for example, the top of the functional area of the competent
authority of the Member State that is responsible for the related matters.
(c) Appropriate steps should be taken to ensure that the policy is known and understood by all
the personnel staff involved, and all the necessary steps should be taken to implement and
maintain the policy.
(d) The general policy, Whilst whilst also satisfying also the additional national regulatory
responsibilities, the general policy should, in particular, take into account:
(1) the provisions of the Regulation (EU) 2018/1139 (EC) No 216/2008;
(2) the provisions of the applicable requirements and their Part 21 and its AMC and GM;
(3) the needs of industry; and
(4) the needs of the Agency and of the other competent authorities of the Member States.
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(d) The policy should define specific objectives for the key elements of the organisation and
processes for the implementation of the related Part 21 activities, including the corresponding
control procedures and the measurement of the achieved standard.
21.B.25 Management system
GM 21.B.25(b) Resources
(a) The organisation for related Part 21 activities should be clearly defined within the general
organisation of the competent authority of the Member State, with the hierarchical and
functional links, and the names of the senior staff. Although final responsibility should be
placed at the top of the functional area that is responsible for the related Part 21 activities as
a whole, all subordinate levels of management should be suitably resourced and empowered
to fulfil their delegated tasks.
(b) The definition of an organisation for the implementation of related Part 21 activities should
include the specification of
(1) a manager responsible for the specific Part 21 activity acting as internal and external
focal point. The responsibility is best placed with the manager who is in control of the
day-to-day functions concerning the specific Part 21 activity, although he may delegate
specific tasks to other individuals;
(2) individual or group responsibilities, duties and associated reporting lines;
(3) the resources, human and material;
(4) the documented procedures to be operated in respect of the relevant Part 21 activities.
(c) The various tasks and responsibilities of the personnel involved in the related Part 21 activities
should be clearly identified. The authority attached to the responsibilities should be enough to
ensure that the activities will be performed correctly.
(d) These responsibilities include among others:
(1) the management of the organisation
(2) the management of investigation teams
(3) the team leadership/membership
(4) the investigation and surveillance activities
(5) the administrative management of certificates and approvals, , including record
keeping;
(6) the external and internal interface activities including feedback to the Agency;
(7) the control and distribution of documentation
The definition of the organisation should include means to ensure continued effectivity of the
organisation. The means should provide for a regular assessment of the organisation and its related
activities as well as a feedback system for the follow up of necessary corrective actions (e.g., through
the implementation of a quality system, internal audit system, etc.).
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GM 21.B.25(c) Qualification and training
The competent authority of the Member State should ensure appropriate and adequate training of
its personnel to meet the standard that is considered by the Agency necessary to perform the work.
Arrangements should be made for initial and continuation training as required.
It is understood that the basic competence of the competent authority of the Member State staff is
a matter of recruitment and normal management functions in selection of staff for particular duties.
Moreover, it is understood that the competent authority of the Member State provides training in
the basic skills as required for those duties.
However, to avoid differences in understanding and interpretation, it is considered important that
all personnel involved in Part 21 activities should be provided with further training specifically
related to the relevant Part 21 activity up to the common Agency standard.
The competent authority of the Member State should provide training through its own training
organisation with qualified trainers or through another qualified training source (e.g., training
provided by other competent authorities, the Agency or qualified entities).
AMC1 21.B.25(a)(1) Management system
DOCUMENTED POLICIES AND PROCEDURES
(a) The various elements of the organisation for the activities related Regulation (EU) 2018/1139
and the delegated and implementing acts adopted on the basis thereof should be
documented in order to establish a reference source for the establishment and maintenance
of this organisation.
(b) The documented procedures should be established in a way that it will facilitate their use.
They should be clearly identified, kept up-to-date and made readily available to all the
personnel involved in the relevant activities.
(c) The documented procedures should cover, as a minimum, the following aspects:
(1) policies and objectives;
(2) the structure of the organisation;
(3) responsibilities and the associated authority;
(4) procedures and processes;
(5) internal and external interfaces;
(6) internal control procedures;
(7) the training of personnel;
(8) cross-references to associated documents; and
(9) assistance from other competent authorities or EASA (where required).
(d) The information may be held in more than one document or in a series of documents, in
which case suitable cross-reference information should be provided. For example, the
organisational structure and the job descriptions are not usually in the same documentation
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as the detailed working procedures. In such cases, it is recommended that the documented
procedures should include an index of cross-references to all such other related information,
and the related documentation should be readily available when required.
21.B.25 Management system
GM1 21.B.25(a)(2) Management system
PERSONNEL
(a) This GM on the determination of the required personnel is limited to the performance of
certification and oversight tasks, excluding any personnel who are required to perform tasks
subject to any national regulatory requirements.
(b) The elements to be considered when determining the required personnel and planning their
availability may be divided into quantitative and qualitative elements and there should be, at
least:
(1) quantitative elements in accordance with AMC1 21.B.25; and
(2) the following qualitative elements:
(i) the size, nature, and complexity of the activities of certified organisations, taking
into account:
(A) the privileges of the organisation;
(B) the type of the approval, the scope of the approval;
(C) the possible use of industry certification standards;
(D) the number of personnel; and
(E) the structure of the organisational;
(ii) the safety priorities identified;
(iii) the results of past oversight activities, including audits, inspections and reviews,
in terms of risks and regulatory compliance, taking into account the:
(A) number and the levels of findings;
(B) time frame for the implementation of corrective actions; and
(C) maturity of the management systems implemented by the organisation,
and its ability to effectively manage safety risks; and
(iv) the size and complexity of the aviation industry under its oversight, and the
potential growth of activities in the field of civil aviation, which may be an
indication of the number of new applications, and of changes to existing
certificates, approvals, authorisations and letters of agreement to be expected.
(c) Based on existing data from previous oversight planning cycles, and taking into account the
situation within the Member State’s aviation industry, the competent authority may estimate:
(1) the standard working time required for processing applications for new certificates,
approvals, authorisations or letters of agreement;
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(2) the number of new certificates, approvals, authorisations or letters of agreement to be
issued for each planning period; and
(3) the number of changes to existing certificates, approvals, authorisations or letters of
agreement to be processed for each planning period.
(d) In line with the competent authority’s oversight policy, the following planning data should be
determined:
(1) the standard number of audits to be performed per oversight planning cycle;
(2) the standard duration of each audit;
(3) the standard working time for audit preparation, on-site auditing, reporting, and
follow-up, per inspector;
(4) the standard number of unannounced inspections to be performed;
(5) the standard duration of inspections, including the preparation, reporting, and follow-
up, per inspector; and
(6) the minimum number and required qualifications of inspectors for each
audit/inspection.
(e) Standard working time could be expressed either in working hours per inspector, or in working
days per inspector. All planning calculations should, then, be based on the same units (hours
or working days).
(f) It is a good practice to use a spreadsheet application to process the data defined under (c) and
(d), to assist in determining the total number of working hours/days per oversight planning
cycle required for certification, oversight and enforcement activities. This application could
also serve as a basis for implementing a system for planning the availability of personnel.
(g) The number of working hours/days per planning period for each qualified inspector that may
be allocated for certification, oversight and enforcement activities should be determined,
taking into account:
(1) purely administrative tasks not directly related to certification and oversight;
(2) training;
(3) participation in other projects;
(4) planned absences; and
(5) the need to include a reserve for unplanned tasks or unforeseeable events.
(h) The determination of working time available for certification, oversight and enforcement
activities should also consider, if applicable:
(1) the use of qualified entities;
(2) cooperation with other competent authorities for approvals that involve more than one
Member State; and
(3) oversight activities under a bilateral aviation safety agreement.
(i) Based on the elements listed above, the competent authority should be able to:
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(1) monitor the dates when audits and inspections are due, and when they were carried
out;
(2) implement a system to plan the availability of personnel; and
(3) identify possible gaps between the number and the qualifications of personnel and the
required volume of certification and oversight.
Care should be taken to keep planning data up to date in line with changes in the underlying
planning assumptions, with a particular focus on risk-based oversight principles.
21.B.25 Management system
AMC1 21.B.25(a)(3) Management system
QUALIFICATIONS AND TRAINING — GENERAL
(a) It is essential that the competent authority has the full capability to adequately assess the
compliance and performance of an organisation by ensuring that the whole range of activities
is assessed by appropriately qualified personnel.
(b) For each inspector, the competent authority should:
(1) define the competencies required to perform the allocated certification and oversight
tasks;
(2) define the associated minimum required qualifications;
(3) establish initial and recurrent training programmes in order to maintain and to enhance
competency at the level necessary to perform the allocated tasks; and
(4) ensure that the training provided meets the established standards and is regularly
reviewed and updated whenever necessary.
(c) The competent authority may provide training through its own training organisation with
qualified trainers, or through another qualified training source.
(d) When training is not provided through an internal training organisation, adequately
experienced and qualified persons may act as trainers, provided that their training skills have
been assessed. If required, an individual training plan should be established that covers
specific training skills. Records should be kept of such a training, and of the assessment, as
appropriate.
21.B.25 Management system
AMC2 21.B.25(a)(3) Management system
QUALIFICATIONS AND TRAINING — TECHNICAL PERSONNEL INCLUDING INSPECTORS
(a) Competent authority technical personnel should have:
(1) practical experience and expertise in the application of aviation safety standards and
safe operating practices;
(2) comprehensive knowledge of:
(i) relevant parts of the implementing rules, AMC, CSs and GM;
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(ii) the competent authority’s procedures;
(iii) their rights and obligations;
(iv) systems based on the EU management system requirements (including
compliance monitoring) and on ICAO Annex 19; and
(v) design- or production-, as applicable, related human factors and human
performance principles;
(3) a relevant engineering degree or an aircraft maintenance technician qualification with
additional education. ‘Relevant engineering degree’ means an engineering degree from
aeronautical, mechanical, electrical, electronic, avionic or other studies relevant to the
design and production of aircraft/aircraft components; and
(4) knowledge of design or production standards, as applicable.
(b) In addition, competent authority inspectors should have:
(1) training on auditing techniques and on assessing and evaluating management systems
and safety risk management processes; and
(2) 5 years of relevant work experience to be allowed to work independently as an
inspector. This may include experience gained during training to obtain the
qualifications described in point (a)(2).
(c) In addition to their technical competency, the technical personnel should have a high degree
of integrity, be impartial in carrying out their tasks, be tactful, and have a good understanding
of human nature.
(d) A programme for recurrent training should be developed to ensure that technical personnel
remain competent to perform their allocated tasks. As a general policy, it is not desirable for
the technical personnel to obtain technical qualifications from those entities that are under
their direct regulatory oversight.
21.B.25 Management system
AMC3 21.B.25(a)(3) Management system
INITIAL AND RECURRENT TRAINING — INSPECTORS
(a) Initial training programme:
The initial training programme for inspectors should include, as relevant to their role, current
knowledge, experience and skills in at least all of the following:
(1) aviation legislation, organisation, and structure;
(2) the Chicago Convention, the relevant ICAO annexes and documents;
(3) Regulation (EU) No 376/2014 on the reporting, analysis and follow-up of
occurrences in civil aviation;
(4) an overview of Regulation (EU) 2018/1139 and the delegated and implementing acts
adopted on the basis thereof, and the related AMC, CSs, and GM;
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(5) specific knowledge of Regulation (EU) No 748/2012, its related AMC, GM and CSs, as
well as any other applicable requirements;
(6) management systems, including the assessment of the effectiveness of a management
system, in particular hazard identification and risk assessment, and non-punitive
reporting techniques in the context of the implementation of a ‘just culture’;
(7) auditing techniques;
(8) competent authority procedures relevant to the inspectors’ tasks;
(9) human factors principles;
(10) the rights and obligations of inspecting personnel of the competent authority;
(11) ‘on-the-job’ training relevant to the inspector’s tasks; and
(12) technical training appropriate to the role and tasks of the inspector, in particular for
those areas that require approvals.
NOTE: the duration of the on-the-job training should take into account the scope and
complexity of the inspector’s tasks. The competent authority should assess whether the
required competence has been achieved before an inspector is authorised to perform a
task without supervision.
(b) Recurrent training programme
Once qualified, the inspector should undergo training periodically, as well as whenever it is
deemed necessary by the competent authority, in order to remain competent to perform the
allocated tasks. The recurrent training programme for inspectors should include, as
appropriate to their role, at least the following topics:
(1) changes in aviation legislation, the operational environment and technologies;
(2) competent authority procedures that are relevant to the inspector’s tasks;
(3) technical training appropriate to the role and tasks of the inspector; and
(4) results from past oversight.
(c) Assessments of an inspector’s competency should take place at regular intervals that do not
exceed 3 years. The results of these assessments, as well as any actions taken following these
assessments, should be recorded.
21.B.25 Management system
AMC1 21.B.25(a)(5) Management system
SAFETY RISK MANAGEMENT PROCESS
(a) The safety risk management process required by point 21.B.25 should be documented. The
following should be defined in the related documentation:
(1) the means used for hazard identification and the related data sources, taking into
account data that comes from other competent authorities with which the competent
authority interfaces in the State or from the competent authorities of other Member
States;
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(2) risk management steps including:
(i) analysis (in terms of the probability and severity of the consequences of hazards
and occurrences);
(ii) assessment (in terms of their tolerability); and
(iii) control (in terms of the mitigation of risks to an acceptable level);
(3) who holds the responsibilities for hazard identification and risk management;
(4) who holds the responsibilities for the follow-up of risk mitigation actions;
(5) the levels of management who have the authority to make decisions regarding the
tolerability of risks;
(6) the means to assess the effectiveness of risk mitigation actions; and
(7) the link with the compliance monitoring function.
(b) To demonstrate that the safety risk management process is operational, competent
authorities should be able to provide evidence that:
(1) the persons involved in internal safety risk management activities are properly trained;
(2) hazards that could impact the authority’s capabilities to perform its tasks and discharge
its responsibilities have been identified, and the related risk assessment is documented;
(3) regular meetings take place at appropriate levels of management of the competent
authority to discuss the risks identified and to decide on the risk tolerability and
possible risk mitigations;
(4) in addition to the initial hazard identification exercise, the risk management process is
triggered as a minimum whenever changes occur that may affect the competent
authority’s capability to perform any of the tasks required by Part 21;
(5) a record of the actions taken to mitigate risks is maintained, showing the status of each
action and the owner of the action;
(6) there is follow-up on the implementation of all risk mitigation actions;
(7) risk mitigation actions are assessed for their effectiveness; and
(8) the results of risk assessments are periodically reviewed to check whether they remain
relevant (e.g. are the assumptions still valid? Is there any new information?).
21.B.25 Management system
GM1 21.B.25(a)(5) Management system
SAFETY RISK MANAGEMENT PROCESS
The purpose of safety risk management as part of the management system framework for
competent authorities is to ensure the effectiveness of the management system. As for any
organisation, hazard identification and risk management are expected to contribute to effective
decision-making, to guide resource allocation and contribute to organisational success.
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The safety risk management process required by point 21.B.25 is intended to address safety risks
that are directly related to the competent authority’s organisation and processes, and which may
affect its capability to perform its tasks and discharge its responsibilities. This process is not intended
as a substitute for the State safety risk management SARPs defined in ICAO Annex 19, Chapter 3,
component 3.3. This does not mean, however, that the competent authority may not use
information and data obtained through its SSP, including oversight data and information, for the
purpose of safety risk management as part of its management system.
The safety risk management process is also to be applied to the management of changes (point
21.B.35), which is intended to ensure that the management system remains effective whenever
changes occur.
21.B.25 Management system
AMC1 21.B.25(d) Management system
PROCEDURES AVAILABLE TO EASA
(a) Copies of the procedures related to the management system of the competent authority of
the Member States, and their amendments, that should be made available to EASA for the
purpose of standardisation, should provide at least the following information:
(1) the competent authority’s organisational structure for the continuing oversight
functions that it undertakes, with a description of the main processes. This information
should demonstrate the allocation of responsibilities within the competent authority,
and that the competent authority is capable of carrying out the full range of tasks
regarding the size and complexity of the Member State’s aviation industry. It should
also consider the overall proficiency and the scope of authorisation of the competent
authority personnel;
(2) for personnel who are involved in oversight activities, the minimum professional
qualification requirements and experience, and the principles that guide their
appointment (e.g. assessment);
(3) how the following are carried out: the assessment of applications and evaluations of
compliance, the issuance of certificates, approvals, authorisations and letters of
agreement, the performance of continuing oversight, the follow-up of findings,
enforcement measures and the resolution of safety concerns;
(4) the principles used to manage exemptions and derogations;
(5) the processes that are in place to distribute applicable safety information for timely
reaction to a safety problem;
(6) the criteria for planning continuing oversight activities (i.e. an oversight programme),
including the adequate management of interfaces when conducting continuing
oversight activities; and
(7) an outline of the initial training of newly recruited oversight personnel (taking future
activities into account), and the basic framework for the recurrent training of oversight
personnel.
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(b) As part of the continuous monitoring of a competent authority, EASA may request details of
the working methods used, in addition to a copy of the procedures of the competent
authority’s management system (and amendments). These additional details are the
procedures and related guidance material that describe the working methods for the
competent authority personnel who conduct oversight activities.
(c) Information related to the competent authority’s management system may be submitted in
an electronic format.
21.B.25 Management system
AMC 21.B.30(a) Documented procedures
The various elements of the organisation for the related Part 21 activities must be documented in
order to establish a reference source for the establishment and maintenance of this organisation.
The documented procedures must be established in a way that it will facilitate its use. They must be
clearly identified, kept up-to-date and made readily available to all the personnel involved in the
relevant activities.
The documented procedures must cover, as a minimum, the following aspects:
a) policy and objectives,
b) organisation structure,
c) responsibilities and attached authority,
d) procedures and processes,
e) internal and external interfaces,
f) internal control procedures,
g) training of personnel,
h) cross-references to associated documents,
i) assistance from other competent authorities or the Agency (where required).
Except for smaller competent authorities, it is likely that the information is held in more than one
document or series of documents, and suitable cross-reference information must be provided. For
example, organisational structure and job descriptions are not usually in the same documentation as
the detailed working procedures. In such cases it is recommended that the documented procedures
include an index of cross-references to all such other related information, and the related
documentation must be readily available when required.
GM1 21.B.30 Allocation of tasks to qualified entities
CERTIFICATION TASKS
The tasks that may be performed by a qualified entity on behalf of the competent authority include
those that are related to the initial certification and the continuing oversight of persons and
organisations as defined in the Regulation (EU) No 748/2012.
21.B.30 Allocation of tasks to qualified entities
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AMC 21.B.35(a) Changes
Standardisation is based on the assessment of the organisation and procedures of the competent
authorities of the Member States and their implementation and suitability by the Agency.
Consequently, a significant change in the competent authority of the Member State organisation
and documented procedures validated by the Agency needs a reassessment to maintain the
confidence in the standardisation process.
Examples of significant changes include changes in the organisation hierarchy, decision making
levels, number and qualification of personnel, etc.
The competent authority of the Member State must notify any of these changes to the Agency and
must be prepared to provide any further explanation/information requested by the Agency. The
Agency may decide to review the documented organisation and procedures of the competent
authority of the Member State and request any clarification or changes. This might also apply when
a change in the regulations takes place and the Agency decides that a specific
assessment/monitoring of the competent authorities related to that change is necessary.
GM No 1 to 21.B.45 Co-ordination with other related activities
The purpose of co-ordination with other related activities is to
a) harmonise the effects of various approval and certification teams especially when dealing with
one organisation / applicant to prevent conflicts of conclusions,
b) ensure efficient flow of information between the various approval and certification teams to
facilitate the execution of their duties
c) optimise the use of the Agency and the competent authorities resources to minimise
disruption and cost.
Therefore, for a given organisation / applicant the responsible person(s) of the Agency or competent
authorities of the Member State should arrange for exchange of information with, and provide
necessary assistance, as appropriate, to the relevant competent authority of the Member State or
Agency teams or staff - e.g.:
a) the appropriate certification teams;
b) the design organisation approval team;
c) the production organisation approval team;
d) the maintenance organisation approval team; or
e) other approval or certification teams as appropriate.
GM No 2 to 21.B.45 Co-ordination
An exchange of information should especially take place in accordance with Article 15 of the
Regulation (EC) No 216/2008:
(a) an immediate reaction of a competent authority of the Member State to a safety problem
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(b) granting of exemptions by the competent authority of the Member State from the substantive
requirements of the Regulation (EC) No 216/2008 and its implementing rules (for a period of
more than two months or when the exemptions become repetitive)
(c) granting of approvals on an equivalent level of protection by the competent authority of the
Member State by derogation from the Part 21 requirements
GM No 3 to 21.B.45 Reporting – Information relevant to registers
established by the Agency
When so requested by the Agency, the competent authority of the Member State should notify any
certificate or approval issued, changed or revoked including details of the scope of that certificate or
approval to the Agency for inclusion in a central register managed by the Agency.
AMC1 21.B.55(a) Record-keeping
GENERAL
(a) The record-keeping system should ensure that all records are accessible whenever needed
within a reasonable time. These records should be organised in a manner that ensures that
there is traceability and retrievability throughout the required retention period.
(b) All records that contain sensitive data regarding applicants or organisations should be stored
in a secure manner with controlled access to ensure their confidentiality.
(c) Records should be kept in paper form, or in an electronic format, or a combination of the two.
Records that are stored on microfilm or optical discs are also acceptable. The records should
remain legible and accessible throughout the required retention period. The retention period
starts when the record is created or was last amended.
(d) Paper systems should use robust material which can withstand normal handling and filing.
Computer systems should have at least one backup system, which should be updated within
24 hours of any new entry. Computer systems should include safeguards against any
unauthorised personnel from altering the data.
(e) All the computer hardware used to ensure data backup should be stored in a different
location from the one that contains the working data, and in an environment that ensures the
data remains in a good condition. When hardware or software changes take place, special
care should be taken that all the necessary data continues to be accessible at least throughout
the full period specified in point 21.B.25(d).
21.B.55 Record-keeping
AMC1 21.B.55(a)(1) Record-keeping
COMPETENT AUTHORITY MANAGEMENT SYSTEM
Records related to the competent authority’s management system should include, as a minimum
and as applicable:
(a) the documented policies and procedures;
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(b) the personnel files of the competent authority personnel, with the supporting documents
related to their training and qualifications;
(c) the results of the competent authority’s internal audits and safety risk management
processes, including audit findings, and corrective, preventive and risk mitigation actions; and
(d) the contract(s) established with qualified entities that perform certification or oversight tasks
on behalf of the competent authority.
21.B.55 Record-keeping
GM1 21.B.55 Record-keeping
FOR DESIGN APPROVALS TRANSFERRED TO EASA
Record-keeping related to design approvals, for which the responsibility is transferred to the Agency
EASA, will remain initially with the competent authority of the Member State that has granted the
approvals, at the disposal the Agency EASA. This GM specifies the administrative documents to be
kept for the various kinds of design approvals. It does not repeat the requirements put on holders of
design approvals to keep records (ref. 21.A.5, 21.A.55, 21.A.105, 21.A.118A(a)(1), 21.A.447,
21.A.605).
(a)1. Type-certificate Type certificate
(a)(1) Copy of the type-certificate TC
b) (2) Copy of the type-certificate TCDS
c) (3) Environmental protection approval data
d) (4) Documents defining the type-certification basis including information to justify special
conditions, equivalent safety findings and exemptions (Certification Review Items or
equivalent)
e) (5) List of approved modifications,
f) (6) List of the competent authority’s approved publications (Flight Manual, Repair Manual,
Airworthiness Limitations, Certification Maintenance Requirements)
g) (7) Airworthiness directives
h) (8) Master Minimum Equipment List
i) (9) Maintenance Review Board Report
(b)2. Supplemental type certificate
- (1) Copy of STC
- (2) Environmental protection approval data
- (3) Documents defining the certification basis including information to justify special
conditions, equivalent safety findings and exemptions (Certification Review Items or
equivalent)
- (4) List of the competent authority’s approved documents
- (5) Airworthiness directives
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(c)3. JTSOETSO Aauthorisation
- (1) Copy of JTSO the ETSO authorisation letter
- (2) Copy of Declaration of Design and Performance
- (3) Statement of compliance with applicable standards
- (4) Airworthiness directives
(d)4. Other part or appliance approvals
a(1) Copy of the approval letter,
b(2) Copy of Declaration of Design and Performance or equivalent
c(3) Statement of compliance with applicable standards
d(4) Airworthiness Ddirectives
(e)5. Changes from non TC or STC holders
a(1) Modification approval sheet, or equivalent document
b(2) Documents required by point 21.A.5 21.A.105, or equivalent national requirement
Note: Not applicable to minor design changes approved under a DOA privilege, for which
record-keeping is under the DOA holder responsibility.
(f)6. Repair design approvals
a(1) Repair approval sheet
b(2) Documents listed in point 21.A.5 21.A.447, or equivalent national requirement
Note: Not applicable to repair design approved under a DOA privilege, for which record-
keeping is under the DOA holder responsibility.
21.B.55 Record-keeping
GM1 21.B.55(e) Record-keeping
TRACEABILITY OF RELEASE CERTIFICATES
The record-keeping for those EASA Forms 52 and 1 that have been validated by the competent
authority should allow the verification of that validation by the parties concerned, including the
recipients of the release certificates.
21.B.55 Record-keeping
AMC1 21.B.65 Suspension, limitation and revocation
CORRECTIVE ACTION PLAN
It is expected that any established organisation approved according to Subparts G or J will move
quickly to re-establish compliance with Part 21 and will not risk the possibility of their approval being
suspended. Therefore, the corrective action period granted by the competent authority should be
appropriate to the nature of the finding, and in any case, it should not initially be more than 3
months. In certain circumstances and subject to the nature of the finding, the competent authority
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may vary the 3-month period provided that a satisfactory corrective action plan has been agreed by
the competent authority.
If the organisation fails to comply within the time period agreed by the competent authority, a
provisional suspension of the approval, in whole or in part, should proceed.
21.B.65 Suspension, limitation and revocation
AMC1 21.B.65(c) Suspension, limitation and revocation
INFORMATION ON SECURITY SITUATION
(a) The European Commission Security Directorate generally advises against any non-essential
travel to a country where hostile conditions, or a combination of the following conditions,
reduce the level of security, and pose a high level of threat to personnel, as follows:
(1) international or internal armed conflict with frequent armed confrontation taking place,
numerous casualties, and/or serious damage to infrastructures;
(2) a situation that could lead to war, or characterised by high internal or external tension
that could escalate into instability in the short term; very poorly functioning institutions;
(3) relatively frequent terrorist attacks due to the presence of active terrorist groups, either
domestic or transnational, and state authorities that are unable to ensure a satisfactory
level of security; and
(4) frequent criminal violence that also targets non-nationals. State authorities have a
limited ability to counter criminal activities and ensure security.
(b) Countries where the above conditions apply should not be considered compatible with the
performance of on-site audits by the competent authority.
21.B.65 Suspension, limitation and revocation
GM1 21.B.65 Suspension, limitation and revocation
(a) GENERAL
Decisions on the suspension or revocation of a certificate, approval, authorisation or letter of
agreement will always be actioned in such a way as to comply with any applicable national
laws or regulations related to appeal rights and the conduct of appeals.
(b) LIMITATION
A limitation is an amendment to the certificate, approval, authorisation or letter of agreement
that partially limits the privileges of the organisation .
(c) SUSPENSION
A suspension is a temporary withdrawal of all the privileges of an organisation’s approval. The
approval remains valid, but no activities that invoke the approval can be made while the
suspension is in force. Approval privileges may be re-instated when the circumstances that
caused the suspension are corrected and the organisation can once again demonstrate full
compliance with the requirements.
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(d) REVOCATION
A revocation is a permanent cancellation of the whole of an approval. All the rights and
privileges of the organisation under the approval are withdrawn, and, after revocation, the
organisation cannot perform activities that invoke the approval, and must remove all
references to the approval from its company documentation.
21.B.65 Suspension, limitation and revocation
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SUBPART F — PRODUCTION WITHOUT PRODUCTION
ORGANISATION APPROVAL
GM1 21.B.115 and 21.B.215 Alternative means of compliance
Alternative means of compliance that are used by a competent authority, or by a person or
organisation under its oversight, may be used by other competent authorities, persons, or
organisations only if they are processed again in accordance with points 21.B.115(d) and (e) or
21.B.215(d).
21.B.115 Alternative means of compliance
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of
compliance
DEMONSTRATION OF COMPLIANCE
In order to demonstrate that the implementing rules are met, a risk assessment should be
completed and documented.
21.B.115 Alternative means of compliance
AMC1 21.B.120(a) Initial certification procedure
INVESTIGATION TEAM
(a) The competent authority should appoint a team for each applicant for, or holder of, a letter of
agreement. This team is responsible for conducting all the relevant tasks related to the
issuance of the letter of agreement. The team should consist of a team leader to manage and
lead the approval team, and, if needed, one or more team members. The team leader should
report to the manager who is responsible for the activities of the competent authority as
defined in point 21.B.25(a).
(b) The competent authority should perform sufficient investigation activities for an applicant for,
or holder of, a letter of agreement, to justify the recommendations for the issuance,
maintenance, amendment, suspension or revocation of the letter of agreement.
(c) The competent authority should prepare procedures for the investigation of applicant for, or a
holder of, a letter of agreement, as part of the documented procedures that cover at least the
following elements:
(1) evaluation of the applications received;
(2) appointment of the investigation team;
(3) preparation and planning of the investigation;
(4) evaluation of the documentation (manual, procedures, etc.);
(5) auditing;
(6) follow-up of corrective actions; and
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(7) recommendations for the issuance, amendment, suspension or revocation of a letter of
agreement.
21.B.120 Initial certification procedure
AMC2 21.B.120(a) Initial certification procedure Investigation team
– Qualification criteria for the investigation team members
QUALIFICATION CRITERIA FOR THE INVESTIGATION TEAM MEMBERS
The competent authority must should ensure that the team leader and team members have
received appropriate training in the relevant Subpart Subparts of Part 21 and in the related
competent authority documentation before performing investigations in accordance with AMC2
21.B.25(a)(3). They must should also have knowledge and experience at the appropriate level in
aviation production and inspection activities relative related to the particular application for a letter
of agreement.
21.B.120 Initial certification procedure
AMC3 21.B.120(a)(c)(1) Initial certification procedure
EVALUATION OF APPLICATIONS
(a)1. General
When applying Part 21 Section A, Subpart F and Section B, Subpart F, the competent authority
should must consider that these Subparts are only an alternative way alternatives for
production to Part 21 Section A, Subpart G and Section B, Subpart G. To meet the ICAO
airworthiness obligations and to issue a Ccertificate of Aairworthiness for an individual aircraft
in a practical and efficient way, the competent authority must should use a system of approval
of production organisations (POA) under Part 21 Section A, Subpart G and Section B,
Subpart G, providing to the competent authority the necessary confidence in the technical
standards. The consistent standards of these approvals will also support the standardisation
efforts by the Agency EASA. Nevertheless, it is recognised that it is not always practical,
economical and/or advisable to use the POA.
Considering the ICAO airworthiness obligations as well, Part 21 Section A, Subpart F and
Section B, Subpart F is are provided for such a case on the basis of the following principles:
(1)a) Subpart F should must be considered as an alternative option for particular cases.
(2)b) Its adoption should must be done on an individual basis, as a consequence of an
assessment by the competent authority (see point 21.A.121, 21.A.133(a) and its their
associated CS AMC and GM).
(b)2. Application
The competent authority should must receive an application for a letter of agreement on an
EASA Form 60 (see below) completed by the applicant. The eligibility of the application should
be verified in relation to the competent authority procedures, based on point 21.A.121 and its
associated AMC CS and GM. The applicant should be advised accordingly about the
acceptance or rejection of the application.
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An application may be accepted from:
— an individual applying on his or her own behalf; or
— in the case of an organisation, an individual with the authority to make agreements on
behalf of the organisation.
(c)3. Location of the applicant
The location of the applicant seeking acceptance for production under Part 21 Section A
Subpart F determines which competent authority is responsible for issuing the letter of
agreement.
21.B.120 Initial certification procedure
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EASA Form 60
Application for agreement of production under Part 21 Subpart F
Competent authority
of an EU Member State or
EASA
1. Registered name and address of the applicant:
2. Trade name (if different):
3. Location(s) of manufacturing activities:
4. Description of the manufacturing activities under application
a) Identification (TC, P/N , … as appropriate):
b) Termination (No. of units, Termination date, …):
5. Evidence supporting the application, as per
21.A.124(b):
6. Links/arrangements with design approval
holder(s)/ design organisation(s) where different
from Block 1. :
7. Human resources:
8. Name of the person signing the application:
______________________________ ______________________________________
Date Signature
EASA Form 60 Issue 3
Block 1: The name of the applicant must be entered. For legal entities the name must be as stated in the
register of the National Companies Registration Office. In this case a copy of the entry in the register of
the National Companies Registration Office must be provided to the competent authority.
Block 2: State the trade name by which the applicant is known to the public if different from the information
given in Block 1. The use of a logo may be indicated in this Block.
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Block 3: State all locations of manufacturing activities that are covered by the application. Only those locations
must be stated that are directly under the control of the applicant stated in Block 1.
Block 4: This Block must include further details of the manufacturing activities under the approval for the
addresses indicated in Block 3. The Block ‘Identification’ must indicate the products, parts or appliances
intended to be produced, while the Block ‘Termination’ must address any information on the limitation
of the activity, e.g., by stating the intended number of units to be manufactured or the expected date of
completion of the manufacturing activities.
Block 5: This Block must state evidence supporting the determination of applicability as stated in 21.A.121. In
addition an outline of the manual required by 21.A.125A(b) must be provided with the application.
Block 6: The information entered here is essential for the evaluation of eligibility of the application. Therefore
special attention must be given concerning the completion of this Block either directly or by reference
to supporting documentation in relation to the requirements of 21.A.122 and AMC No 1 to 21.A.122.
Block 7: The information to be entered here must reflect the number of staff, or in case of an initial approval
the intended number of staff, for the manufacturing activities under this application and therefore must
include also any associated administrative staff.
Block 8: State the name of the person authorised to sign the application.
AMC4 GM 21.B.120(a)(c)(3) Initial certification procedure
Investigation preparation and planning
INVESTIGATION PREPARATION AND PLANNING
Following acceptance of an application for a letter of agreement and before commencing an
investigation, the competent authority should:
--(a) identify the site locations that they needing need to investigate investigation;
--(b) liaise with the competent authority of another a Member State where the investigation of the
organisation should include a there is seen to be a need to visit a production facility in that
Member State for one of the following reasons:
(1)a) where a manufacturer production organisation has contracted part of the production to
another organisation holding a production organisation approval and a need arises to
ensure that the contract has the same meaning for all the parties to the contract, and
the local competent authority of the Member State agrees;
(2)b) to inspect a product (or part or appliance) under production where the sub-contractor
subcontractor is does not hold holding a POA.
--(c) co-ordinate coordinate with the competent authority of a third country and/or the Agency
EASA where the investigation of the organisation should include there is seen to be a need to
visit a production a facility in that country for one of the following reasons:
(1)a) where a manufacturer production organisation has contracted part of the production to
another organisation holding a production organisation approval issued by the Agency
EASA or accepted through an recognition agreement in accordance with Article 68 of
the Basic Regulation (EU) 2018/1139, and a need arises to ensure that the contract has
the same meaning for all the parties to the contract, and the Agency EASA and/or the
competent authority agrees;
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to inspect a product (or part or appliance) under production where the sub-contractor
subcontractor is does not holding hold a POA.
21.B.120 Initial certification procedure
GM1 21.B.120(c)(5) and (6) Initial certification procedure Auditing
and investigation findings
AUDITING AND INVESTIGATION FINDINGS
During its investigation process, the competent authority may make findings which should then be
recorded. These may be non-conformities to the requirements, the manual as supplied by the
production organisation manufacturer describing its inspection procedures or non-conformities
related to the items under inspection. The manner in which the findings will be handled by the
competent authority before and during the validity of the letter of agreement, should be detailed in
its procedures.
21.B.120 Initial certification procedure
AMC1 21.B.120(d) Initial certification procedure
ISSUE OF THE LETTER OF AGREEMENT
(a) Unless otherwise agreed by the competent authority, no production before the issue of the
letter of agreement may be accepted under Part 21 Section A, Subpart F.
(b) The agreement should include or reference a pre-defined plan of inspection points established
as part of the production inspection system and agreed with the competent authority to be
used as a basis for the inspections described in points 21.A.129 and 21.B.120(a) and their
associated AMC and GM. The plan should clearly identify the inspection points, places,
inspection subjects (materials, processes, tooling documentation, human resources, etc.), as
well as the focal points and the method of communication between the production
organisation and the competent authority.
(c) The competent authority should detail the method by which it will assure itself that the
production organisation is working in accordance with the manual and the agreed inspection
procedures during the validity period of the agreement. For a renewal of this validity period,
the procedure as defined in point 21.B.140 should be used.
(d) Any conditions under which the agreement will expire (such as the termination date and/or
number of units to produce) should be clearly stated in the letter of agreement.
21.B.120 Initial certification procedure
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings
and corrective actions Objective evidence
OBJECTIVE EVIDENCE
Objective evidence is a fact which is, or can be, documented, based on observations, measurements
or tests that can be verified. Objective evidence generally comes from the following:
(a) documents or manuals;
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(b) examination of equipment/products; and
(c) information from interview questions and observations of production or design activities, as
applicable.
21.B.120 Initial certification procedure
GM1 21.B.125(b) Findings and corrective actions
EXAMPLES OF LEVEL 1 FINDINGS
Examples of level 1 findings are non-compliances with any of the following points that could affect
the safety of the aircraft are found under points:
— 21.A.126;
— 21.A.127;
— 21.A.128; and
— 21.A.129.
It should be anticipated that a non-compliance with these points is only considered a level 1 finding
if there is objective evidence that this finding is an uncontrolled non-compliance that could affect
the safety of the aircraft.
21.B.125 Findings and corrective actions
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective
actions
UNCONTROLLED NON-COMPLIANCE WITH APPLICABLE DESIGN DATA
An uncontrolled non-compliance with applicable design data is a non-compliance that:
(a) cannot be discovered through systematic analysis; or
(b) prevents the identification of the affected products, parts, appliances, or material.
21.B.125 Findings and corrective actions
AMC1 21.B.125(d) Findings and corrective actions
NOTIFICATION OF FINDINGS
In the case of a level 1 finding, confirmation should be obtained in a timely manner that the
accountable manager has taken note of the finding and its details.
Level 1 and level 2 findings require timely and effective oversight by the competent authority to
ensure the completion of the corrective action. This oversight may include intermediate
communication, such as letters as necessary, to remind the approval holder to verify that the
corrective action plan is followed.
21.B.125 Findings and corrective actions
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AMC 21.B.130 Issue of the letter of agreement
Unless otherwise agreed by the competent authority no production before the issue of the letter of
agreement may be accepted under Part 21 Section A Subpart F.
GM 21.B.130(b) Issue of the letter of agreement
The agreement should include or reference a pre-defined plan of inspection points established as
part of the production inspection system and agreed with the competent authority to be used as a
basis for the inspections described in 21.A.129 and 21.B.120(c)(5) and its associated CS and GM. The
plan should clearly identify inspection point, places, inspection subjects (materials, process, tooling
documentation, human resources, etc.), as well as the focal points and the method of
communication between the manufacturer and the competent authority.
The competent authority should detail a method how it will assure itself that the manufacturer is
working in accordance with the manual and the agreed inspection procedures during the validity
period of the agreement. For renewal of this validity period the procedure as defined in 21.B.140
should be used.
Any conditions under which the agreement will expire (such as termination date and/or number of
units to produce), should be clearly stated in the letter of agreement.
AMC1 21.B.140 Amendment of a letter of agreement
The competent authority must should be satisfied that any change affecting a letter of agreement
comply complies with the shows of Section A Subpart F before implementation can start. A plan for
the change should be agreed with the applicant in accordance with AMC1 21.B.120(d)21.B.130. If
the change affects the content of the letter of agreement, a new application should be filed, and an
amended/revised letter of agreement should be obtained subsequently.
GM 21.B.150(d) Record keeping – Traceability of release certificates
The recordkeeping for those EASA Forms 52 and 1 that have been validated by the competent
authority should allow verification of such validation by concerned parties including the recipients of
the release certificates.
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SUBPART G — PRODUCTION ORGANISATION APPROVAL
GM1 21.B.115 and 21.B.215 Alternative means of compliance
Alternative means of compliance that are used by a competent authority, or by a person or
organisations under its oversight, may be used by other competent authorities, persons, or
organisations only if they are processed again in accordance with points 21.B.115(d) and (e) or
21.B.215(d).
21.B.215 Alternative means of compliance
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of
compliance
DEMONSTRATION OF COMPLIANCE
In order to demonstrate that the implementing rules are met, a risk assessment should be
completed and documented.
21.B.215 Alternative means of compliance
AMC1 21.B.220 and 21.B.221 Initial certification procedure
INVESTIGATION TEAM
(a) The competent authority should appoint a production organisation investigation team for
each applicant for, or holder of, a production organisation approval. This team is responsible
for conducting all the relevant tasks related to the approval. The team should consist of a
team leader to manage and lead the approval team and, if needed, one or more team
members. The team leader should report to the manager who is responsible for the activities
of the competent authority as defined in point 21.B.25(c).
(b) The competent authority should perform sufficient investigation activities for an applicant for
a production organisation approval, or a holder of one, to justify the recommendations for the
issuance, maintenance, amendment, suspension or revocation of the approval.
(c) The competent authority should prepare procedures for the investigation of a production
organisation approval as part of the documented procedures that cover at least the following
elements:
(1) evaluation of the applications received;
(2) appointment of the organisation approval team;
(3) preparation and planning of the investigation;
(4) evaluation of the documentation (production organisation exposition, procedures, etc.);
(5) auditing;
(6) follow-up of corrective actions;
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(7) recommendation for the issuance, amendment, suspension or revocation of a
production organisation approval; and
(8) continued surveillance.
21.B.220 Initial certification procedure
AMC1 21.B.220 and 21.B.430 Initial certification procedure
VERIFICATION OF COMPLIANCE
(a) In order to verify the organisation’s compliance with the applicable requirements, the
competent authority should conduct an audit of the organisation, including interviews of the
personnel, and inspections carried out at the organisation’s facilities.
(b) The competent authority should only conduct such an audit if it is satisfied that the
application and supporting documentation are in compliance with the applicable
requirements.
(c) The audit should focus on the following areas:
(1) the detailed management structure, notably its adequacy;
(2) the personnel: the adequacy of the number of staff, and of their qualifications and
experience with regard to the intended terms of approval and the associated privileges;
(3) the processes used for safety risk management and compliance monitoring;
(4) the facilities and their adequacy regarding the organisation’s scope of work; and
(5) the documentation based on which the approval should be granted.
(d) If an application for an approval is refused, the applicant should be informed of the right of
appeal that exists under national law.
21.B.220 Initial certification procedure
AMC1 GM No 1 to 21.B.220(c) Procedures for investigation–
Investigation preparation and planning Initial certification
procedure
INVESTIGATION PREPARATION AND PLANNING
Following the acceptance of the application for a production organisational approval and before
commencing an investigation, the competent authority should, for the preparation and planning of
the investigation:
-(a) identify the site locations needing investigation taking into account the scope of any other
POA issued by a Member State according to Part 21, which are valid in the circumstances;
-(b) when EASA is not the competent authority, liaise with the Agency EASA for the appointment
of any necessary observer(s) for standardisation purposes and seek any necessary advice and
guidance from EASA;
-(c) establish any necessary liaison arrangement with other competent authorities;
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-(d) agree the size and composition of the POAT investigation team and any specialist tasks likely
to be covered and to select suitable team members from all involved competent authorities;
and
- seek any necessary advice and guidance from the Agency
-(e) liaise with the competent authority of the other a Member State where the investigation of
the organisation should include a there is seen to be a need to visit a production approval
holder facility in that Member State for one of the following reasons:
(1) where a production organisation manufacturer has subcontracted production to
another organisation and therefore a need arises to ensure that contract has the same
meaning for all the parties to the contract, and the competent authority of the Member
State agrees
(2) to inspect a product, part, appliance, or material under production for its own, Member
States or non-EU register.
21.B.220 Initial certification procedure
AMC2GM 21.B.220(a) Initial certification procedure Investigation
team
INVESTIGATION TEAM
(a)1. Type of Team team
Where the applicant is located in a Member State, the competent authority should appoint a
production organisation approval team (POAT) leader and members appropriate to the nature
and scope of the applicant’s organisation.
If EASA is not the competent authority and Where the facilities of the applicant are located in
more than one Member State, the competent authority of the country of manufacture should
liaise with the other involved competent authorities to agree and appoint a production
organisation approval team POAT leader and members appropriate to the nature and scope of
the applicant’s organisation.
(b)2. Team leader selection
The team leader should satisfy all of the criteria for a team member and will be selected by
considering the following additional criteria:
(1)a) the capability to lead and manage a team;
(2)b) the capability to prepare reports and be diplomatic;
(3)c) experience in approval team investigations (not necessarily only Part 21 Section A,
Subpart G) ; and
(4)d) a knowledge of production and quality systems for aircraft and related products and
parts.
(c)3. Team member selection
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The team leader should agree with the The competent authority should determine on the size
of the POA team and the specialisations to be covered taking into account the scope of work
and the characteristics of the applicant. Team members should be selected by considering the
following criteria:
(a) training, which is mandatory, for Part 21 Section A, Subpart Subparts A and G and
Section B, Subpart Subparts A and G;
(b) education and experience, to cover appropriate aviation knowledge, audit
practices and approval procedures; and
(c) the ability to verify that an applicant’s organisation conforms to its own POA
procedures, and that its key personnel are competent.
21.B.220 Initial certification procedure
AMC 21.B.220(c) Procedures for investigation – Evaluation of
applications
The competent authority must receive an application for POA on an EASA Form 50 (see below)
completed by the applicant. The eligibility and appropriateness of the application must be evaluated
in accordance with 21.A.133 at that time and the applicant must be advised about acceptance or
rejection of its application in writing accordingly.
EASA Form 50
Application for Part 21 production organisation approval
Competent authority
of an EU Member State or
EASA
1. Registered name and address of the organisation:
2. Trade name (if different):
3. Locations for which the approval is applied for:
4. Brief summary of proposed activities at the item 3 addresses
a) General:
b) Scope of approval:
c) Nature of privileges:
5. Description of organisation:
6. Links/arrangements with design approval
holder(s)/design organisation(s) where different
from 1.:
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7. Approximate number of staff engaged or intended
to be engaged in the activities:
8. Position and name of the accountable manager:
_____________________________________ ___________________________________
Date Signature of the accountable manager
EASA Form 50
Block 1: The name of the organisation must be entered as stated in the register of the National Companies
Registration Office. For the initial application a copy of the entry in the register of the National
Companies Registration Office must be provided to the competent authority.
Block 2: State the trade name by which the organisation is known to the public if different from the
information given in Block 1. The use of a logo may be indicated in this Block.
Block 3: State all locations for which the approval is applied for. Only those locations must be stated that are
directly under the control of the legal entity stated in Block 1.
Block 4: This Block must include further details of the activities under the approval for the addresses
indicated in Block 4. The Block ‘General’ must include overall information, while the Block ‘Scope of
approval’ must address the scope of work and products/categories following the principles laid
down in the GM 21.A.151. The Block ‘nature of privileges’ must indicate the requested privileges as
defined in 21.A.163(b)-(e). For an application for renewal state ‘not applicable’.
Block 5: This Block must state a summary of the organisation with reference to the outline of the production
organisation exposition, including the organisational structure, functions and responsibilities. The
nomination of the responsible managers in accordance with 21.A.145(c)(2) must be included as far
as possible, accompanied by the corresponding EASA Forms 4.
For an application for renewal state ‘not applicable’.
Block 6: The information entered here is essential for the evaluation of eligibility of the application.
Therefore special attention must be given concerning the completion of this Block either directly or
by reference to supporting documentation in relation to the requirements of 21.A.133(b) and (c)
and the AMC to 21.A.133(b) and (c).
Block 7: The information to be entered here must reflect the number of staff, or in case of an initial approval
the intended number of staff, for the complete activities to be covered by the approval and
therefore must include also any associated administrative staff.
Block 8: State the position and name of the accountable manager.
GM1 No 2 to 21.B.220(c) Initial certification procedure Procedures
for investigation — GeneralROCEDURES FOR INVESTIGATION
ORGANISATION APPROVAL — GENERAL
(a)1. Purpose of the Pprocedures
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The purpose of the procedures is to investigate the applicant’s production organisation for
compliance with Part 21 Subpart G in relation to the requested terms of approval. When
appropriate, this procedure these procedures should also be used to investigate significant
changes or applications for variation variations of in the scope of approval.
The following procedure assumes that the application has been accepted and that an
investigation team has been selected.
(b)2. Initiation
The POA Tteam Lleader initiates the procedure by:
2.(1) arranging a meeting with the POAT team members to review the information provided
in accordance with the application (according to point 21.A.134) and to take account of
any other information available within the competent authority about the applicant.
knowledge that the POAT members have regarding the production standards of the
applicant;
2.(2). obtaining collecting information from other teams of a competent authorities authority
of the Member State or the Agency EASA on the functioning of the applicant’s
organisation (see GM No 1 GM1 21.B.25(c) to 21.B.45);
2.(3) arranging a meeting with the applicant in order to:
(i) enable the applicant to make a general presentation of its organisation and
products, parts or appliances;
(ii) ensure that the accountable manager understands the reason for signing the
statement specified in point 21.A.143(a)(1);
(iii) enable the investigation team POAT to describe the proposed investigation
process; and
(iv) enable the investigation team POAT to confirm to the applicant the identity of
those managers nominated in accordance with Part 21 Subpart G who need to
complete an EASA Form 4 (See EASA Form 4 for Production Organisations on
EASA website: http://easa.europa.eu/certification/application-forms.php). The
applicant should provide a completed copy of EASA Form 4 for each of the key
management staff identified by Part 21 Subpart G. The EASA Form 4 is a
confidential document and will be treated as such.
(c)3. Preparation
The investigation team POAT:
3.(1) studies the information gathered in the initiation phase;
3.(2) establishes an investigation plan which:
(i) takes account of the location of the POA applicant’s facility as identified
per GM3 No 3 to 21.B.65220(c);
(ii) defines areas of coverage and work-sharing between team POAT members
taking account of their individual expertise;
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(iii) defines areas where more detailed investigation is considered necessary;
(iv) establishes the need for external advice to team POAT members where
expertise may be lacking within the team;
(v) includes completion of a comprehensive plan for the investigation in order
to present it to the applicant; and
(vi) recognises the need to:
(A) review the documentation and procedures;
(B) verify compliance and implementation; and
(C) audit a sample of products, parts, and appliances;
3.(3) co-ordinates coordinates with the appropriate Part 21 Section A, Subpart J design
organisation approval Tteams sufficiently for both parties to have confidence in the
applicants co-ordination coordination links with the holder of the approval of the design
(as required by point 21.A.133) ; and
3.(4) establishes liaison with the applicant to plan mutually suitable dates and times for visits
at each location that need investigation needs to be investigated, and also to agree the
investigation plan and approximate time scales with the applicant.
(d)4. Investigation
The investigation team POAT:
4.(1) makes a check of the exposition POE for compliance with Part 21; Subpart G
4.(2) audits the organisation, its organisational structure, and its procedures for compliance
with Part 21 Subpart G, using EASA Form 56 as a guide during the investigation, and as a
checklist at the end of it;
4.(3). generates compliance checklists for investigations of working processes and procedures
on site as required;
4.(4) accepts or rejects each EASA Form 4 completed by the key nominated personnel in
accordance with point 21.A.145(c)(2) ;
4.(5) checks that the exposition production organisation exposition (POE) standard reflects
the organisation, its procedures, practices and the requirements defined in point
21.A.143. Having checked and agreed a an exposition POE issue or subsequent
amendment, the competent authority should have a clear procedure to indicate its
acceptance or rejection;
4.(6) makes sample audits at working level to verify that:
(i) work is performed in accordance with the system described in the exposition
POE;
(ii) products, parts, appliances or material produced by the organisation are in
conformity with the applicable design data (see GM 21.B.235(b)(4));
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(iii) facilities, working conditions, equipment and tools are in accordance with the
exposition POE and appropriate for the work being performed;
(iv) competence competency and numbers of personnel is are appropriate for the
work being performed; and
(v) co-ordination coordination between production and design is satisfactory; and
4.(7) at an advanced stage of the investigation, conducts an interim team review of audit
results and matters arising, in order to determine any additional areas requiring
investigation.
Each investigation team should be accompanied during the process by company
representatives who are knowledgeable of the applicant’s organisation and procedures. This
will ensure that the organisation is aware of the audit progress and problems as they arise.
Access to information will also be facilitated.
The team leader POATL should co-ordinate coordinate the work of the team POAT members
for an efficient investigation process, which will provide a consistent and effective
investigation and reporting standards.
(e)5. Conclusions
5.(1) The team leader POATL holds a team meeting to review the findings and observations
so as to produce a final agreed report of findings.
5.(2) The team leader POATL, on completion of the investigation, holds a meeting to verbally
presents present the report to the applicant.
The team leader POATL should be the chairman of this meeting, but individual team
members may present their own findings and observations.
5.(3) The meeting should agree the findings, corrective action time scales, and preliminary
arrangements for any follow-up that may be necessary.
5.(4) Some items may as a result of this meeting be withdrawn by the team leader POATL but
if the investigation has been correctly performed, at this stage there should be no
disagreement over the facts presented.
5.(5) Inevitably there will be occasions when the team POAT member carrying out the audit
may find situations in the applicant or POA approval holder where he or she it is unsure
about compliance. In this case, the organisation is informed about possible non-
compliance at the time and advised that the situation will be reviewed within the
competent authority before a decision is made. The organisation should be informed of
the decision without undue delay. Only if the decision results in a confirmation of non-
compliance, this is recorded in Part 4 of EASA Form 56.
5.(6) The team leader POATL will transmit the final signed report on EASA Form 56 together
with notes of the final meeting with the applicant to the competent authority of the
country in which where the applicant is located, or to EASA according to the
competence defined in point 21.1. The report will include recommendations and
significant findings, together with appropriate conclusions and corrective actions. In
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particular, it should indicate if whether the exposition POE is acceptable, or changes are
required.
5.(7) Completion of EASA Form 56 includes the need to record in Part 4 comments, criticisms,
etc., and this must should reflect any problems found during the visit and must should
be the same as the comments, criticisms made to the organisation during the debrief.
Under no circumstances should additional comments, criticisms, etc., be included in
Part 4 of the report unless the applicant or POA approval holder has previously been
made aware of such comments.
Many applicants Applicants may need to take corrective action and amend the
proposed exposition before the competent authority is able to conclude its
investigation. Such corrective actions should be summarised in Part 4 of the EASA Form
56 and a copy always given to the applicant, so that there is a common understanding
of the actions necessary before approval can be granted.
The intention of the EASA Form 56 Part 4 is to provide a summary report of
findings and outstanding items during initial investigation and major changes. The
competent authority will need to operate a supporting audit system to manage
corrective action monitoring, closure, etc. While the EASA Form 56 Part 4 format may
be used for monitoring purposes, it is not adequate on its own to manage such a
system.
5.(8) If the findings Findings made during the investigation mean that approval
recommendation will not or cannot be issued, then it is essential that such findings are
confirmed in writing to the organisations within two weeks of the visit. The reason for
confirmation in writing is that many organisations take a considerable time to establish
compliance. As a result, it is too easy to establish a position of confusion where the
organisation claims it was not aware of the findings that prevented the issue of an
approval.
(f)6. Management Involvement
The investigation team shall see the accountable manager will be seen at least once during the
investigation process and preferably twice, because he or she is ultimately responsible for
ensuring compliance with the requirements for the initial grant granting and subsequent
maintenance of the production organisation approval. Two Twice is the preferred number of
visits to the accountable manager, with one being conducted at the beginning of the audit to
explain the investigation process, and the second, at the end, to debrief on the results of the
investigation.
21.B.220 Initial certification procedure
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Competent authority
of an EU Member State or
EASA
RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL
ISSUE / CONTINUATION / VARIATION / SIGNIFICANT CHANGE
PART ONE OF FIVE PARTS: BASIC DETAILS OF THE ASSESSMENT
Name of the organisation:
Approval reference: ___________
Address(es) of the facilities surveyed:
Main Part 21 Subpart G activities at facilities surveyed:
Date(s) of survey:
Names and positions of the organisation's senior management attended during survey:
Names of the competent authority staff:
Office: EASA Form 56 completion date:
Note: If it is determined that a recommendation for issue/continuation/variation/significant change of
approval cannot be made because of a non-compliance with Part 21 Subpart G, the reasons for the
non-compliance need to be identified in PART 4 of the report. A copy of PART 1 and PART 4, or at
least the information included in these parts, must be given to the organisation to ensure that the
organisation, in failing to obtain Part 21 Subpart G approval, even if only temporarily, has the same
information as is on the files of the competent authority.
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Competent authority
of an EU Member State or
EASA
RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G ISSUE /
CONTINUATION / VARIATION/SIGNIFICANT CHANGE
PART TWO OF FIVE PARTS: Part 21 SUBPART G COMPLIANCE
Name of organisation:
Approval of organisation:
Approval reference: ___________ Survey reference:
Note A: This form has been compiled according to those points of Part 21 Subpart G which are relevant to an organisation
trying to demonstrate compliance.
Note B: The right-hand part of each box must be completed with one of the following three indicators:
1. a tick () which means compliance;
2. NR which means that the requirement is Not Relevant to the activity at the address surveyed; (the reason for NR
should be stated in Part 4 of the report, unless the reason is obvious)
3. a number relating to a comment which must be recorded in Part 4 of the report.
The left-hand part of each box is optional for use by the competent authority.
21.A.3A Failures, malfunctions and defects
(a) N/A
(b) Without prejudice to Regulation (EU) No 376/2014, all natural or legal persons who hold or have
applied for a production approval under Subpart G, or who produce a product, part or appliance
under Subpart F, shall:
(1) establish and maintain a system for collecting and assessing internal mandatory and
voluntary occurrence reports, including reports on internal errors, near misses, and hazards,
in order to identify any adverse trends or to address any deficiencies, and extract reportable
occurrences. This system shall include the evaluation of relevant information related to
occurrences, and the promulgation of the related information;
(2) report to the holder of the type certificate, restricted type certificate or design approval, all
cases in which products, parts or appliances have been released by the production
organisation and subsequently identified to have deviations from the applicable design data,
and investigate with the holder of the type certificate, restricted type certificate or design
approval to identify those deviations which could lead to an unsafe condition;
(3) report to EASA and the competent authority of the Member State the deviations that were
identified according to point (2) which could lead to an unsafe condition; and
(4) if the production organisation acts as a supplier to another production organisation, also
report to that other organisation all cases in which it has released products, parts or
appliances to that organisation and subsequently identified them to have possible deviations
from the applicable design data.
(c) The reports defined in points (a) and (b) shall appropriately safeguard the confidentiality of the
reporter and of the persons mentioned in the report and be made in a form and manner
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established by the competent authority, as soon as practicable and in any case dispatched not later
than 72 hours after the identification of the possible unsafe condition, unless exceptional
circumstances prevent this.
(d) Without prejudice to Regulation (EU) No 376/2014, if an occurrence reported under points (a)(3) or
(b)(3) results from a deficiency in the design, or a production deficiency, the holder of the type
certificate, restricted type certificate, supplemental type certificate, major repair design approval,
ETSO authorisation, or any other relevant approval deemed to have been issued under this Annex,
or the production organisation as appropriate, shall investigate the reason for the deficiency and
report to EASA the results of its investigation and any action it is taking or proposes to take to
correct that deficiency.
(e) If the competent authority finds that an action is required to correct the deficiency, the holder of
the type certificate, restricted type certificate, supplemental type certificate, major repair design
approval, ETSO authorisation, or any other relevant approval deemed to have been issued under
this Annex, or the production organisation as appropriate, shall submit the relevant data to the
competent authority.
21.A.5 Record-keeping
All natural or legal persons who hold or who have applied for a type certificate, restricted type certificate,
supplemental type certificate, ETSO authorisation, major repair design approval, permit to fly, production
organisation approval or letter of agreement under this Annex shall:
(a) N/A
(b) when producing a product, part or appliance:
(1) maintain the relevant records produced under the production system that was used to
justify the conformity of the products, parts or appliances, and retain them in order to
provide the information necessary to ensure the continued airworthiness of the product,
part or appliance; and
(2) for production organisations approved in accordance with Subpart G, record all details of
work carried out and establish a record-keeping system that incorporates the requirements
imposed on its partners, suppliers and subcontractors, and ensures the conservation of the
data used to justify the conformity of the products, parts or appliances. This data shall be
held at the disposal of the competent authority and be retained in order to provide the
information necessary to ensure the continuing airworthiness of the products, parts or
appliances;
(c) regarding permits to fly:
(1) maintain documents produced to establish and justify the flight conditions, and retain them
at the disposal of EASA and the competent authority in order to provide the information
necessary to ensure the continued airworthiness of the aircraft; and
(2) when issuing a permit to fly under the privilege of approved organisations, maintain the
documents associated with it, including inspection records, documents that support the
approval of flight conditions and the permit to fly itself, retain them at the disposal of EASA
or the competent authority, in order to provide the information necessary to ensure the
continued airworthiness of the aircraft;
(d) retain records of competence and the qualifications of personnel who are involved in design or
production, in independent monitoring of compliance and adequacy, and in safety management if
required by points 21.A.139, 21.A.145, 21.A.239 or 21.A.245; and
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(e) when employing personnel who exercise the privileges of the approved organisation according to
points 21.A.163 or 21.A.263, or who carry out the independent monitoring of compliance and
adequacy according to points 21.A.139(f) and 21.A.239(f), retain the records of their authorisation.
21.A.9 Investigation
(a) All organisations who hold or who have applied for a type certificate, restricted type certificate,
supplemental type certificate, ETSO authorisation, major repair design approval, permit to fly,
design organisation approval, production organisation approval or letter of agreement under this
Annex, shall make arrangements that allow the competent authority to make any investigations,
including investigations of partners, suppliers and subcontractors, that are necessary to determine
the compliance and the continued compliance of the organisation with the applicable requirements
of this Annex.
(b) Design and production organisations and applicants for, or holders of, permits to fly or of ETSO
authorisations shall allow the competent authority to review any report and make any inspection
and perform or witness any test that is necessary to check the compliance of the organisation with
this Annex, and to inspect the technical data files.
21.A.133 Eligibility
Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this
Subpart. The applicant shall:
(a) justify that, for a defined scope of work, an approval under this Subpart is appropriate for the
purpose of showing conformity with a specific design; and
(b) hold or have applied for an approval of that specific design; or
(c) have ensured, through an appropriate arrangement with the applicant for, or holder of, an approval
of that specific design, satisfactory co-ordination coordination between production and design.
21.A.134 Application
Each application for a production organisation approval shall be made to the competent authority in a
form and manner established by that authority, and shall include an outline of the information required by
point 21.A.143 and the terms of approval requested to be issued under point 21.A.151.
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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:
21.A.139 Quality System Production management system
(a) The production organisation shall establish, implement, and maintain a production management
system that includes a safety management system and a quality system with clear lines of
responsibility and accountability throughout the organisation demonstrate that it has established
and is able to maintain a quality system.
(b) The production management system shall:
(1) correspond to the size of the organisation, and to the nature and complexity of its activities,
taking into account the hazards and associated risks inherent in these activities; and
(2) be established under the direct accountability of a single accountable manager according to
point 21.A.145(c)(1).
(c) As part of the safety management element of the production management system, the production
organisation shall:
(1) establish, implement and maintain a safety policy and the corresponding related safety
objectives;
(2) appoint key safety personnel to execute the safety policy in accordance with point
21.A.145(c)(2);
(3) establish, implement and maintain a safety risk management process that includes:
(i) hazard identification in all domains of the organisation and its production activities,
resulting from analysis of occurrences collected according to point 21.A.3A; and
(ii) safety risk assessment and mitigation;
(4) establish, implement and maintain a safety assurance process including:
(i) the measurement and monitoring of safety performance;
(ii) the management of changes in accordance with points 21.A.143(b) and 21.A.147; and
(iii) principles for continuous improvement of the safety management system; and
(5) promote safety in the organisation through:
(i) training and education; and
(ii) communication.
(d) As part of the quality management element of the production management system, the production
organisation shall:
(1) The quality system shall be documented. This quality system shall be such as to enable the
organisation to ensure that each product, part or appliance produced by the organisation or
by its partners, or supplied from or subcontracted to outside parties, conforms to the
applicable design data and is in condition for safe operation, and thus exercise the privileges
set forth as defined in point 21.A.163.;
(2) The quality system shall contain establish, implement, and maintain, as applicable, within
the scope of approval, control procedures for:
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(i) document issue, approval, or change;
(ii) vendor and subcontractor assessment, audit and control;
(iii) verification that incoming products, parts, materials, and equipment, including items
supplied new or used by buyers of products, are as specified in the applicable design
data;
(iv) identification and traceability;
(v) manufacturing processes;
(vi) inspection and testing, including production flight tests;
(vii) calibration of tools, jigs, and test equipment;
(viii) non-conforming item control;
(ix) airworthiness co-ordination coordination with the applicant for, or holder of, a design
approval;
(x) records the completion and retention of records;
(xi) personnel the competence and qualification qualifications of personnel;
(xii) the issue of airworthiness release documents;
(xiii) handling, storage and packing;
(xiv) internal quality audits and the resulting corrective actions;
(xv) work within the terms of approval performed at any location other than the approved
facilities;
(xvi) work carried out after the completion of production but prior to delivery, to maintain .
the aircraft in a condition for safe operation; and
(xvii) issue issuance of permits to fly and approval of associated flight conditions.;
(3) The control procedures need to include specific provisions for any critical parts in the control
procedures for any critical parts.
(e) The production organisation shall document in accordance with point 21.A.143 all production
management system key processes, and maintain a process for:
(1) amending that documentation; and
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(2) making personnel aware of their responsibilities under the production management system.
(f) The production organisation shall include in the production management system An independent
quality assurance function to monitor monitoring of compliance with, and the adequacy of, the
production management system and its documented procedures of the quality system. This
monitoring shall include a feedback system to the person or group of persons referred to in point
21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as
necessary, corrective action.
(g) If the organisation holds other organisation certificates issued on the basis of Regulation (EU)
2018/1139 and the delegated and implementing acts adopted on the basis thereof, the production
organisation may integrate the production management system with the management system that
is required for the issuance of the other certificate(s).
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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:
21.A.143 Exposition
(a) As part of the production management system, the The organisation shall establish submit to the
competent authority a production organisation exposition that provides providing directly or by
cross reference the following information: (see Part 3 of this Form)
(b) The production organisation exposition shall be amended as necessary to remain an up-to-date
description of the organisation, and copies of any amendments shall be supplied to the competent
authority.
21.A.145 Approval requirements Resources
The production organisation shall demonstrate, on the basis of the information submitted in accordance
with point 21.A.143 that:
(a) with regard to general approval requirements, facilities, working conditions, equipment and tools,
processes and associated materials, number and competence of staff, and general organisation are
adequate to discharge the obligations under point 21.A.165;
(b) with regard to all necessary airworthiness, noise, fuel venting and exhaust emissions data:
(1) the production organisation is in receipt of such data from the Agency EASA, and from
the holder of, or applicant for, the type certificate type-certificate, restricted type certificate
type-certificate or design approval to determine conformity with the applicable design data;
(2) the production organisation has established a procedure to ensure that airworthiness,
noise, fuel venting and exhaust emissions data are correctly incorporated in its production
data; and
(3) such data is are kept up to date and made available to all personnel who need access
to such data to perform their duties;
(c) with regard to management and staff:
(1) a an accountable manager has been nominated by the production organisation, and is
accountable to the competent with authority to ensure that, His or her responsibility within
the organiszation, shall consist of ensuring that all production is performed to the required
standards and that the production organisation is continuously in compliance with the
requirements of the management system referred to in point 21.A.139, and the data and the
procedures identified in the exposition referred to in point 21.A.143.
(2) the accountable manager shall nominate a person or a group of persons have been
nominated by the production organisation to ensure that the organisation is in compliance
with the requirements of this Annex I (Part 21), and are identified, together with the extent
of their authority. Such a person (or persons) shall act under the direct authority of the
accountable manager referred to in point (1). The knowledge, background and experience of
the persons nominated shall be appropriate to discharge their responsibilities; and
(3) staff at all levels have been given appropriate authority to be able to discharge their
allocated responsibilities and that there is full and effective co-ordination coordination
within the production organisation in respect of airworthiness, noise, fuel venting and
exhaust emission data matters;
(d) with regard to certifying staff, authorised by the production organisation to sign the documents
issued under point 21.A.163 under the scope or terms of approval:
(1) the knowledge, background (including other functions in the organisation), and
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experience of the certifying staff are appropriate to discharge their allocated responsibilities;
and
(2) the production organisation maintains a record of all certifying staff which shall
include details of the scope of their authorisation;
(2) certifying staff are provided with evidence of the scope of their authorisation.
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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:
21.A.147 Changes to the approved production management system organisation
After the issue of a production organisation approval, each change to the approved production
management system organisation that is significant to the showing demonstration of conformity or to
the airworthiness and characteristics of noise, fuel venting and exhaust emissions of the product, part
or appliance, particularly changes to the quality system, shall be approved by the competent authority
before being implemented. Before the implementation of the change, an An application for approval
shall be submitted in writing to the competent authority, and the organisation shall demonstrate, to
the competent authority before implementation of the change, that it will continue to comply with this
Subpart Annex after the implementation.
The competent authority shall establish the conditions under which a production organisation approved
under this Subpart may operate during such changes unless the competent authority determines that the
approval should be suspended.
21.A.148 Changes of location
A change of the location of the manufacturing facilities of the approved production organisation shall
be deemed of significance and therefore shall comply with point 21.A.147.
21.A.149 Transferability
Except as a result of a change in ownership, which is deemed significant for the purposes of point
21.A.147, a production organisation approval is not transferable.
21.A.151 Terms of approval
The terms of approval shall identify the scope of work, the products or the categories of parts and
appliances, or both, for which the holder is entitled to exercise the privileges under point 21.A.163.
Those terms shall be issued as part of a production organisation approval.
21.A.153 Changes to the terms of approval
Each change to the terms of approval shall be approved by the competent authority. An application for
a change to the terms of approval shall be made in a form and manner established by the competent
authority. The applicant shall comply with the applicable requirements of this Subpart.
21.A.157 Investigations
A production organisation shall make arrangements that allow the competent authority to make any
investigations, including investigations of partners and sub-contractors, necessary to determine
compliance and continued compliance with the applicable requirements of this Subpart.
21.A.163 Privileges
Pursuant to the terms of approval issued under point 21.A.135, the holder of a production organisation
approval may:
(a) perform production activities under this Annex; I (Part 21).
(b) in the case of complete aircraft and upon presentation of a statement of conformity (EASA Form 52)
under point 21.A.174, obtain an aircraft certificate of airworthiness and a noise certificate without
further showing;
(c) in the case of other products, parts or appliances, issue authorised release certificates (EASA Form
1) under point 21.A.307 without further showing;
(d) maintain a new aircraft that it has produced and issue a certificate of release to service (EASA Form
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53) in respect of that maintenance;
(e) under procedures agreed with its competent authority for production, for an aircraft it has
produced, and when the production organisation itself is controlling under its POA the
configuration of the aircraft and is attesting conformity with the design conditions approved for the
flight, to issue a permit to fly in accordance with point 21.A.711(c) including approval of the flight
conditions in accordance with point 21.A.710(b).
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PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE:
21.A.165 Obligations of the holder
The holder of a production organisation approval shall:
(a) ensure that the production organisation exposition furnished in accordance with point 21.A.143 and
the documents to which it refers, are used as basic working documents within the organisation;
(b) maintain the production organisation in conformity with the data and procedures approved for the
production organisation approval;
(c) (1) determine that each completed aircraft conforms to the type design and is in condition for
safe operation prior to submitting statements of conformity to the competent authority; or
(2) determine that other products, parts or appliances are complete and conform to the
approved design data and are in a condition for safe operation before issuing an EASA Form
1 to certify conformity to approved design data and in a condition for safe operation, and
additionally in the case of engines, determine according to data provided by the engine type-
certificate holder that each completed engine is in compliance with the applicable emissions
requirements as defined in point 21.A.18(b), current at the date of manufacture of the
engine, to certify emissions compliance; or
(3) additionally, in the case of engines, determine that the completed engine is in compliance
with the applicable emissions requirements on the date of manufacture of the engine;
(4) determine that other products, parts or appliances conform to the applicable data before
issuing EASA Form 1 as a conformity certificate;
(d) comply with Subpart A of this Annex record all details of work carried out;
(e) establish and maintain an internal occurrence reporting system in the interest of safety, to enable
the collection and assessment of occurrence reports in order to identify adverse trends or to
address deficiencies, and to extract reportable occurrences. This system shall include evaluation of
relevant information relating to occurrences and the promulgation of related information;
(f) (1) report to the holder of the type-certificate or design approval, all cases where products,
parts or appliances have been released by the production organisation and subsequently
identified to have possible deviations from the applicable design data, and investigate with
the holder of the type-certificate or design approval in order to identify those deviations
which could lead to an unsafe condition;
(2) report to the Agency and the competent authority of the Member State, or both, the
deviations which could lead to an unsafe condition identified according to point (1). Such
reports shall be made in a form and manner established by the Agency under point
21.A.3A(b)(2) or accepted by the competent authority of the Member State;
(3) where the holder of the production organisation approval is acting as a supplier to
another production organisation, report also to that other organisation all cases where it has
released products, parts or appliances to that organisation and subsequently identified them
to have possible deviations from the applicable design data;
(e) provide assistance to the holder of the type certificate type-certificate or design approval in dealing
with any continuing airworthiness actions that are related to the products parts or appliances that
have been produced;
(h) establish an archiving system incorporating requirements imposed on its partners, suppliers and
sub-contractors, ensuring conservation of the data used to justify conformity of the products, parts
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or appliances. Such data shall be held at the disposal of the competent authority and be retained in
order to provide the information necessary to ensure the continuing airworthiness of the products,
parts or appliances;
(f) where, under its terms of approval, the holder issues a certificate of release to service, determine
that each completed aircraft has been subjected to necessary maintenance and is in condition for
safe operation, prior to issuing the certificate;
(g) where applicable, under the privilege of point 21.A.163(e), determine the conditions under which a
permit to fly can be issued;
(h) where applicable, under the privilege of point 21.A.163(e), establish compliance with points
21.A.711(c) and (e) before issuing a permit to fly to an aircraft;.
(i) comply with Subpart A of this Annex.
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Competent authority
of an EU Member State or
EASA
RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G ISSUE / CONTINUATION /
VARIATION/SIGNIFICANT CHANGE
PART THREE OF FIVE PARTS: Part 21 SUBPART G EXPOSITION COMPLIANCE
Name of organisation:
Approval of organisation:
Approval reference: ___________ Survey reference:
Note A: Each box must be completed with one of the three following indicators:
1. a tick () which means compliance;
2. NR which means the requirement is NOT RELEVANT to the activity at the address
surveyed; (The reason for NR should be stated in Part 4 of the report unless the reason is
obvious.);
3. a number relating to a comment which must be recorded in Part 4 of the report.
Note B: The exposition may be compiled in any subject order as long as all applicable subjects are covered.
Note C: If the organisation holds another Part approval requiring an exposition or handbook, it is
acceptable to use this index as a supplement to the existing exposition or handbook and to cross-
refer each subject to the position in the existing exposition or handbook.
Production organisation exposition
Revision Status:
(Content as required by point 21.A.143(a))
(1) A statement signed by the accountable manager confirming that the production organisation
exposition and any associated manuals which define the approved organisation’s compliance with
this Annex Subpart will be complied with at all times;
(2) the title(s) and names of the managers accepted by the competent authority in accordance with
point 21.A.145(c)(2);
(3) the accountabilities duties and responsibilities of the manager(s) as required by point 21.A.145(c)(2)
including matters on which they may deal directly with the competent authority on behalf of the
organisation.
(4) an organisational chart showing the associated chains of accountability and responsibility of the
managers as required by points 21.A.145(c)(1) and (c)(2);
(5) a list of certifying staff as referred to in point 21.A.145(d)
[Note : a separate document may be referenced]
(6) a general description of man-power resources;
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PART THREE OF FIVE (CONTINUED): SURVEY REFERENCE:
(7) a general description of the facilities located at each address specified in the production
organisation’s certificate of approval.
(8) a general description of the production organisation’s scope of work that is relevant to the terms of
approval;
(9) the procedure for the notification of organisational changes to the competent authority;
(10) the amendment procedure for the production organisation exposition;
(11) a description of the quality production management system and the policy, processes and the
procedures as required by point 21.A.139(b)(1);
(12) a list of those outside parties referred to in point 21.A.139 (a) (d)(1); and
[Note : a separate document may be referenced]
(13) if flight tests are to be conducted, a flight test operations manual defining the organisation’s
policies and procedures in relation to flight test.
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Competent authority
of an EU Member State or
EASA
RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL ISSUE / CONTINUATION /
VARIATION/SIGNIFICANT CHANGE
PART FOUR OF FIVE PARTS: FINDINGS ON Part 21 SUBPART G COMPLIANCE STATUS
Name of organisation:
Approval reference: _______________ Survey reference: _______________
Note A: Each finding must be identified by number and the number must cross-refer to the same number
in a box in Parts 2 or 3 of the Part 21 Subpart G survey report.
Note B: As stated in Part 1, any comments recorded in this Part 4 should be copied to the organisation
surveyed, together with Part 1.
Note C: In the case of a partial clearance of a finding with some outstanding actions remaining, these
actions have to be identified.
CLEARANCE
NO: FINDING LEVEL OUTSTANDING ACTION
DATE REP.REF.
NAME & SIGNATURE OF INSPECTOR: Date:
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PART FOUR OF FIVE (CONTINUED): Sheet ___ of ___
SURVEY REFERENCE:
CLEARANCE
NO: FINDING LEVEL OUTSTANDING ACTION
DATE REP.REF.
NAME & SIGNATURE OF INSPECTOR: Date:
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Competent authority
of an EU Member State or
EASA
RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL ISSUE / CONTINUATION /
VARIATION/SIGNIFICANT CHANGE
PART FIVE OF FIVE PARTS: Part 21 SUBPART G APPROVAL RECOMMENDATION
Name of organisation:
Approval reference: _______________ Survey reference: _______________
Recommendation for issue / variation of approval/significant change:
The following Part 21 Subpart G Tterms of approval are recommended for the above organisation at the
address(es) specified in Part 1 of this report:
or
Recommendation for continuation of existing approval:
It is recommended that the Part 21 Subpart G Tterms of approval identified in EASA Form 55 referenced
_______________ be continued.
Reporting performed according to the procedure for authority surveillance of suppliers of a POA holder
located in other Member States, if applicable. (Strict confidentiality to be observed)
Name of the competent authority inspector making the recommendation:
Signature of the competent authority inspector:
Competent authority office: Date:
EASA Form 56 Issue 3 - POAT Recommendation Report POA Audit Report - Part 5 of 5, Page 1 of 1 MONTH YEAR
21.B.220 Initial certification procedure
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GM2 No 3 to 21.B.220(c) Initial certification procedure - Procedures
for investigation – POA applications received from organisations
with facilities/partners/ suppliers/sub-contractors located in a third
country
APPLICATION RECEIVED FROM ORGANISATIONS WITH FACILITIES/PARTNERS/
SUPPLIERS/SUBCONTRACTORS LOCATED IN A THIRD COUNTRY
The obligations of the applicant are totally independent from the surveillance exercised by the
competent authority. It is not acceptable that the applicant relies on the surveillance activities of the
competent authority to simplify its tasks.
Facilities located in a third country
When any part of the production facilities of an applicant for POA is located outside the Member
States, then the location will be treated in all aspects as part of the applicant’s POA organisation.
Therefore, the investigating competent authority will include the facilities outside the Member
States:
(a) include the facilities outside the Member States fully in their investigation and surveillance
activities for the applicant for, or holder of, the POA;
(b) include the facilities outside the Member States in the terms of approval of the EASA Form 55
(see Annex I Part 21 Appendix X) when issuing the POA.
Partners/suppliers/subcontractors sub-contractors located in a third country
The competent authority should define on the basis of Part 21 and, its associated CS and GM, a clear
procedure on supplier control. This procedure should include the control of
partners/suppliers/subcontractors sub-contractors of the applicant for, or holder of, a POA that are
located outside the Member States.
In respect of the applicant for, or holder, of the POA, the competent authority should:
(1) investigate, for the initial approval and consequent continued surveillance, the production
organisation, and its partners/suppliers/subcontractors sub-contractors at the necessary level,
to ensure that the organisation can comply with the requirements of Part 21;,
(2) in accordance with the competent authority procedure, assess and accept the documented
procedure for supplier control as part of the POA holder’s quality system, and changes to that
procedure prior to implementation; and,
(3) in accordance with competent authority procedure, assess the necessary level of surveillance
to be exercised by the production organisation on partners / suppliers / subcontractors sub-
contractors and check the audit plan of the production organisation against this level.
The level of co-operation cooperation between the competent authority and the competent
authority of the third country where a partner/supplier/subcontractor sub-contractors or of the
production organisation is located may influence the authorities’ activities concerning this
partner/supplier/ subcontractor subcontractors. Co-operation Cooperation with the competent
authority of the third country should be based on the capability and goodwill of that authority, and a
complete interchange of necessary information.
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The involvement of this competent authority of the third country in the surveillance of the
partner/supplier/ sub contractors sub-contractors will be based on the following principles:
(a) When a recognition agreement under Article 68 of Regulation (EU) 2018/1139 covering
production subjects has been concluded:
a(1) The competent authority in accordance with GM1 No 2 to 21.A.139(a) (d)(1) may decide
that direct surveillance of the POA holder activities at the foreign location may not be
necessary.
b(2) In any other case, the provisions of the recognition agreement on the subject apply
(technical assistance, etc....).
(b) If a recognition agreement has not been concluded, or it does not cover production subjects, it
may be necessary that the competent authority of the Member State, the Agency EASA, and
the competent authority of a third country enter into a specific working arrangement
addressing the following matters:
a(1) acceptance by the competent authority of the third country of conducting
manufacturing surveillance of the relevant production activities on behalf of the
competent authority, under the respective quality standards defined by the competent
authority;.
b(2) tasks to be performed; and
c(3) practical methods.
These arrangements are between authorities and do not relieve the applicant of its
obligations.
— In all cases, even though surveillance tasks are delegated to the competent authority of
the third country, the competent authority remains the responsible authority and may
consequently exercise direct surveillance if necessary.
— If in case that it is not possible to delegate surveillance tasks to the competent authority
of the third country, the competent authority will have to establish a direct surveillance
programme in accordance with its procedure concerning supplier control as part of the
overall surveillance of the POA holder.
— 21.B.220 Initial certification procedure
GM3 No 4 to 21.B.220(c) Initial certification procedure Procedures
for investigation — Competent authority surveillance of suppliers
of a POA holder located in other Member States
COMPETENT AUTHORITY SURVEILLANCE OF SUPPLIERS OF A POA HOLDER LOCATED IN OTHER
MEMBER STATES
(a)1. The aviation legislation identifies specific State obligations in relation to complete products.:
The State of manufacture, as used in ICAO Annex 8, normally identifies the country where the
final assembly and the final determination of airworthiness is made. However, sub-assemblies
and parts may be produced by POA holders in other countries and the EASA Form 1 -
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Authorised Release Certificate will identify those countries as the locations location for
production.
Among Member States, the obligations of the State of manufacture may be discharged
through the use of the Part 21 POA system.
According to Part 21 Subpart G, each POA holder must have established and documented in
its POE a system for its own control of suppliers/supplies. Surveillance of this system is part of
the responsibility of the competent authority of the POA holder wherever the suppliers are
located.
This surveillance may be exercised through the POA holder and/or at supplier level especially
in the cases where the supplier would be eligible for its own POA.
The purpose of this procedure is to ensure the completeness of the chain of responsibilities
chain so that no separate technical agreement between these national authorities is
necessary, and when necessary, to establish a means of communication between the involved
competent authorities of the Member States.
(b)2. Principle to organise competent authority supplier surveillance between Member States.:
In order to avoid duplication and to take the best advantage of Regulation (EC) No 216/2008
that establishes under Article 11 mutual recognition of certificates issued by production
organisations approved in accordance with Part 21 Section A Subpart G by a an Member State,
the principle for the competent authority surveillance of the suppliers of a POA holder located
in other Member States is for the responsible competent authority to delegate surveillance
activity activities to the other competent authority of the supplier.
This applies between Member States and for to suppliers holding a Part 21 POA.
Delegation of surveillance tasks does not imply a delegation of the overall responsibility,
therefore the competent authority of the POA contractor always retains the right of direct
supervision at the supplier location, especially when serious quality problems are
encountered. In such a case, co-ordination there will be coordination will be organised
between both competent authorities.
This delegation of surveillance is to be considered automatic as soon as the supplier holds a
Part 21 POA, provided that the intended supply is included in the approved scope of work.
Evidence of that approval will normally be found through the release of the supplied parts
with an EASA Form 1. In addition, the competent authority of the supplier should immediately
inform the competent authority of the contractor in any case of a serious quality problem.
In the cases where the competent authority of the contractor considers that it is necessary to
establish closer ties with the competent authority of the supplier (i.e., critical or significant
parts), the exchange of information between the competent authorities should be organised
as follows:
2.(1) Tasks of the competent authority of the POA contractor
The competent authority of the contractor should inform in writing the
competent authority of the sub-contractor subcontractor with of the following:
(i)a. The identification Identification (and location) of the contractor;
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(ii)b. The identification Identification (and location) of the sub-contractor
subcontractor;
(iii)c. The identification Identification of the subcontracting (parts, contract No N°,
etc.);
(iv)d. Reference A reference to the quality requirements attached to the contract;
(v)e. The name Name and address of the competent authority office/person in charge
of the POA;
(vi)f. Whether Ddirect Ddelivery Aauthorisation (DDA) applies;
(vii)g. Any specific action item/requirement from the competent authority; and
(viii)h. Request A request for a bi-annual reporting (both ways).
EASA Form 58A is provided for the convenience of the competent authority for this
purpose.
The competent authority of the contractor should require that the contract/order from
the contractor to the sub-contractor subcontractor should to indicate that it is placed
under the surveillance of its competent authority on behalf of the competent authority
of the contractor, and should address the subject to the payment of the possible
surveillance fees.
2.(2) Tasks of the competent authority of the supplier (sub-contractor subcontractor)
On receipt of the information from the competent authority of the contractor,
the competent authority of the sub-contractor subcontractor should:
–(i) Vverify that the scope of work of the POA of the supplier covers the intended
supply (or envisage to extend extending it in liaison with the supplier);.
–(ii) Vverify that the specific quality requirements for the parts have been introduced
in into the quality system of the supplier;.
–(iii) Cconfirm to the competent authority of the contractor that the procurement is
included in the POA of the supplier and that their surveillance will cover this
activity; and.
–(iv) Iindicate the name and address of the competent authorities office/person in
charge of the POA.
If the supplier has no POA under Part 21, or does not want to extend it, and/or if
its competent authority cannot conduct surveillance on behalf of the other competent
authority, the competent authority of the supplier will inform the competent authority
of the contractor in order for it to decide on the appropriate actions.
2.(3) Exchange of information between the competent authorities
This information should normally take two forms:
— Immediate exchange of information between both competent authorities
in case of serious quality problems;
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— A bi-annual exchange of information at a given date in order to guarantee
proper on going ongoing control of the subcontract by both competent
authorities.
This information should cover in a concise form:
a(i) Ffor the competent authority of the contractor:
— A a résumé resume of the quality problems encountered by the contractor,
on receipt inspection, on installation on aircraft or on in service aircraft;
and
— A a status of the reference documents.
b(ii) For the competent authority of the sub-contractor subcontractor:
A résumé resume of at least the following subjects:
— Changes in organisation and qualification of the sub-contractor
subcontractor (in case of impact on the procurement);,
— Quality problems encountered during manufacture;,
— Corrective actions following problems encountered earlier on in the
procurement;,
— Findings from national authorities’ surveillance that may have an impact on
the procurement; and,
— Quality problems related to the contractor procurement (materials,
documentation, procedures, processes).
Any exchange Exchange of information between competent national authorities according to
this procedure is strictly confidential and should not be disclosed to other parties.
It is recommended to plan at least every 5 years a meeting between industry and the two
competent national authorities to review each major subcontract to verify that there is proper
management by the various parties involved.
3. Miscellaneous
a) Release documentation
The release Release of parts by the POA sub-contractor subcontractor to the contractor
will be accompanied by an « ‘Authorised Release Certificate EASA Form 1»’ issued for
«’Airworthiness »’ or for «’Conformity»’ as appropriate.
b) Sub-subcontracting Subsubcontracting
If the sub-contractor subcontractor wants itself to subcontract, it is up to the
competent authority of the sub-contractor subcontractor to verify that this is done in
accordance with the conditions of the contract, to organise as necessary the related
authority surveillance and to inform the competent authority of the contractor.
c) Language
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Except if it is agreed otherwise, it is recommended to use the English language for the
exchange of information between the competent authorities.
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Competent authority
of an EU Member State or
EASA
REQUEST FOR REPORTING ON SUB-CONTRACTOR SUBCONTRACTOR SURVEILANCE
Document reference number: <REQUEST REF. NO.>
As competent authority which issued a POA to: <CONTRACTOR COMPANY>
With approval reference: <CONTRACTOR POA REF. NO..>
The <COMPETENT AUTHORITY> has determined that there
<SUB-CONTRACTOR COMPANY>
is a need for direct authority supplier surveillance of:
With approval reference: <SUB-CONTRACTOR POA REF.NO.>
Which is situated in: <COUNTRY OF SUB-CONTRACTOR COMPANY>
As part of the surveillance as required for the Part 21 Section A Subpart G approved production
organisation, according to GM3 No. 4 to 21.B.220(c), the competent authority of the sub-contractor
subcontractor is requested to perform authority surveillance on the specific sub-assembly sub-assembly and
parts as details and requirements are defined below.
Identification of subcontracting (parts, contract No., etc.…):
Reference to the quality requirements attached to the
contract between contractor and sub-contractor
subcontractor:
Name and address of the requesting competent authority
office/person in charge of the POA:
Direct Ddelivery Aauthorisation (DDA) applies: Yes No
Specific action item/requirement from the competent
authority of the contractor:
Request and details required for a bi-annual reporting (both
ways) according to GM3 No. 4 to 21.B.220(c)
(Strict confidentiality to be observed):
Name and signature of the competent authority person making the
request:
Competent authority office: Date:
EASA Form 58A – Request for reporting on sub-contractor subcontractor surveillance, Page x of x
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Competent authority
of an EU Member State or
EASA
REPORT ON SUB-CONTRACTOR SUBCONTRACTOR SURVEILLANCE
Document reference number: <REPORT REF. NO.>
Reporting request reference number: < REQUEST REF. NO >
As responsible competent authority, the <COMPETENT
AUTHORITY> issued a POA to and is performing direct <SUB-CONTRACTOR COMPANY>
authority surveillance of:
With approval reference: <SUB-CONTRACTOR POA REF. NO..>
Which is a subcontracted supplier of: <CONTRACTOR COMPANY>
With approval reference: <CONTRACTOR POA REF.NO.>
Which is situated in: <COUNTRY OF CONTRACTOR COMPANY>
According to GM3 No. 4 to 21.B.220(c) and on request of the competent authority of the contractor
company, the <COMPETENT AUTHORITY> reports on the results of its authority surveillance on the specific
parts and appliances defined below:
Identification of subcontracting (parts, contract No., etc. …):
Identification of attachments to this report (if needed):
Date and identification of the previous report:
Resume of surveillance results:
Changes in organisation and qualification of the sub-
contractor subcontractor (in case of impact on the
procurement):
Quality problems encountered during manufacture:
Corrective actions following problems encountered earlier
on in the procurement:
Findings from competent authority surveillance that may
have an impact on the procurement:
Quality problems related with the contractor procurement
(materials, documentation, procedures, processes):
Note: the exchange Exchange of information between national authorities according to this procedure is
strictly confidential and should not be disclosed to other parties.
Name and signature of the competent authority person reporting:
Competent authority office: Date:
EASA Form 58B – Report on sub-contractor subcontractor surveillance, Page x of x
21.B.220 Initial certification procedure
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AMC1 21.B.220(d)(1) Initial certification procedure
ISSUE OF THE CERTIFICATE
(a) The competent authority should base its decision to issue or amend a POA on the
recommendation report (EASA Form 56, see GM1 21.B.220) of the investigation team
submitted by the POA team leader. EASA Form 56 includes a proposal by the investigation
team for the scope and terms of approval that define the products, parts and appliances for
which the approval is to be granted, with appropriate limitations.
(b) When the competent authority issues the approval, a final controlled copy of an acceptable
exposition for the organisation should be supplied to the competent authority.
(c) In some cases, it may be acceptable for some findings to not be fully closed because corrective
actions are still in progress. The competent authority may decide according to the following
principles:
(1) Findings should be equivalent to level 2, which do not need to be rectified as a matter
of urgency within less than 3 months, and should normally not exceed three in number.
(2) A corrective action plan, including timescales, should have been accepted and should
not require an additional and specific follow-up audit by the competent authority.
(d) A record should be kept by the competent authority and should upon request be brought to
the attention of EASA for standardisation purposes.
21.B.220 Initial certification procedure
AMC1 21.B.221(a), (b) and (c) Oversight principles
MANAGEMENT SYSTEM ASSESSMENT
As part of the initial certification of an organisation in accordance with point 21.B.220, the
competent authority should assess the organisation’s management system and its processes to
make sure that all the required enablers of a functioning management system are present and
suitable.
As part of the continuing oversight, the competent authority should remain satisfied as to the
presence of the required enablers, and assess the effectiveness of the organisation’s management
system and its processes.
When significant changes take place in the organisation, the competent authority should determine
whether the existing assessment needs to be reviewed to ensure that it is still appropriate.
21.B.221 Oversight principles
AMC1 21.B.222 and 21.B.432 Oversight programme
ANNUAL REVIEW
(a) The oversight planning cycle and the related oversight programme for each organisation
should be reviewed annually to ensure they remain adequate regarding any changes in the
nature, complexity or safety performance of the organisation.
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(b) When reviewing the oversight programme and the oversight planning cycle, the competent
authority should also consider any relevant information collected in accordance with points
21.A.3A and 21.B.215(d) for production organisations or point 21.B.431(d) for design
organisations.
21.B.222 Oversight programme
GM1 21.B.222(a) Oversight programme
MAINTENANCE OF THE POA — WORK ALLOCATION WITHIN THE COMPETENT AUTHORITY
After the issue of the approval, the competent authority should appoint a suitable member of its
technical staff as the POATL to be in charge of the approval for the purpose of continued
surveillance.
Where the POA holder facilities are located in more than one Member State, the competent
authority of the State of manufacture will liaise with the competent authorities of the various
members to ensure appropriate continued surveillance.
21.B.222 Oversight programme
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme
SPECIFIC NATURE AND COMPLEXITY OF THE ORGANISATION — RESULTS OF PAST OVERSIGHT
When determining the oversight programme, including the relevant sample of product, parts and
appliances under the scope of the organisation as the product audits, the competent authority
should consider in particular the following elements, as applicable:
(a) the effectiveness of the organisation’s management system in identifying and addressing
non-compliances and safety hazards;
(b) the implementation by the organisation of any industry standards that are directly relevant to
the organisation’s activity subject to Part 21;
(c) any specific procedures implemented by the organisation that are related to any alternative
means of compliance used;
(d) the number of approved locations and the activities performed at each location;
(e) the number and type of any subcontractors who perform production or design tasks as
appropriate; and
(f) the volume of activity for each product, parts or appliance.
21.B.222 Oversight programme
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme
SUBCONTRACTED ACTIVITIES
If a Part 21 organisation subcontracts some tasks, the competent authority should determine
whether the subcontracted organisations needs to be audited and included in the oversight
programme, taking into account the specific nature and complexity of the subcontracted activities,
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the results of previous oversight activities of the organisation approved according to Subparts G or J,
and based on the assessment of the associated risks.
For such an audit, the competent authority inspector should ensure that he or she is accompanied
throughout the audit by a senior technical member of the Part 21 organisation.
21.B.222 Oversight programme
GM1 21.B.222(b) Oversight programme
The oversight programme consists of:
(a) planned continued surveillance, in which the total surveillance actions are split into several
audits, which are carried out at planned intervals during the validity period of the production
organisation approval. Within the continued surveillance, one aspect may be audited once or
several times, depending upon its importance; and
(b) unplanned POA reviews, which are specific additional investigations of a POA holder related to
surveillance findings or external needs. The competent authority is responsible for deciding
when a review is necessary, taking into account any changes in the scope of work, changes in
personnel, reports on the organisation’s performance submitted by other EASA or competent
authorities teams, and reports on the in-service product.
21.B.222 Oversight programme
AMC1 21.B.222(b)(1) Oversight programme
AUDIT
(a) The oversight programme should indicate which aspects of the certificate will be covered by
each audit.
(b) A part of each audit should concentrate on the organisation’s audit reports produced by the
compliance monitoring function to determine whether the organisation is identifying and
correcting its problems.
(c) At the conclusion of the audit, an audit report should be completed by the auditing inspector,
identifying the areas and processes that were audited and including all the findings that were
raised.
(d) At the completion of each oversight planning cycle, the POATL responsible for the POA should
complete an EASA Form 56 (see GM1 21.B.220) as a summary report for the continued
surveillance, including the recommendation for a continuation of the POA, as applicable.
EASA Form 56 should be countersigned by the person responsible within the competent
authority for the acceptance. At this stage, there is no limitation on the number of level 2
findings that may be open, provided that they are within the time limits of the respective
corrective action plans.
21.B.222 Oversight programme
GM1 21.B.222(b)(1)(ii) Oversight programme
GUIDE TO THE CONDUCT OF MONITORING PRODUCTION STANDARDS
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(a) Point 21.B.222(b)(1)(ii) identifies the need for a sample investigation of products, parts or
appliances, their associated conformity determinations and the certifications made by a POA
holder. For this to be performed effectively and efficiently, the competent authority should
integrate a sampling plan as part of the planning of the investigation and continued
surveillance activities that are appropriate to the scope and size of the relevant applicant.
(b) The sample investigation could, for example, include:
(1) a modification (or change);
(2) the installation, testing, or operation of a major part or system;
(3) the accuracy and generation of the flight test report data;
(4) the accuracy and generation of the weighing report data;
(5) an engine test bed run;
(6) the traceability of records;
(7) the accuracy and generation of the statement of conformity data and the
associated safe operation determination; and
(8) the accuracy and generation of EASA Form 1 data.
(c) The sampling plan should be flexible so as to:
(1) accommodate changes in the production rate;
(2) make use of the results from other samples;
(3) make use of the results from other POA investigations; and
(4) provide the competent authorities with the maximum degree of confidence.
(d) To be effective, this product sample requires that the individual investigator(s):
(1) have a good practical knowledge of the product, part or appliance;
(2) have a good practical knowledge of the manufacturing processes;
(3) have up-to-date knowledge of the production organisation’s production
programme;
(4) use an appropriate and up-to-date sample plan and compliance checklists;
(5) have a suitable recording system for the results;
(6) have a properly operating system to provide feedback to their competent
authority’s organisation for the POA and the production organisation;
(7) maintain an effective working relationship with the production organisation and
its staff; and
(8) be able to communicate effectively.
21.B.222 Oversight programme
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AMC1 21.B.222(c) Oversight programme
OVERSIGHT PLANNING CYCLE AUDIT AND INSPECTION
(a) When determining the oversight planning cycle and defining the oversight programme, the
competent authority should assess the risks related to the activity of each organisation and
adapt the oversight to the level of risk identified and to the effectiveness of the organisation’s
management system, in particular its ability to effectively manage safety risks.
(b) The competent authority should establish a schedule of audits and inspections that is
appropriate to each organisation. The planning of audits and inspections should take into
account the results of the hazard identification and risk assessment conducted and
maintained by the organisation as part of the organisation’s management system. Inspectors
should work in accordance with the schedule provided to them.
(c) When the competent authority, having regard to the level of risk identified and the
effectiveness of the organisation’s management system, varies the frequency of an audit or
inspection, it should ensure that all the aspects of the organisation’s activities are audited and
inspected within the applicable oversight planning cycle.
21.B.222 Oversight programme
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme
OVERSIGHT PLANNING CYCLE — AUDIT
(a) For each organisation approved by the competent authority, all the processes should be
completely audited at periods that do not exceed the applicable oversight planning cycle. The
beginning of the first oversight planning cycle is normally determined by the date of issue of
the first approval. If the competent authority wishes to align the oversight planning cycle with
the calendar year, it should shorten the first oversight planning cycle accordingly.
(b) Audits should include at least one on-site audit within each oversight planning cycle. For
organisations that exercise their regular activity at more than one site, the determination of
the sites to be audited should consider the results of past oversight, the volume of activity at
each site, as well as the main risk areas identified.
(c) For organisations that hold more than one approval, the competent authority may define an
integrated oversight schedule to include all the applicable audit items. In order to avoid any
duplication of audits, credit may be granted for any specific audit items already completed
during the current oversight planning cycle, subject to the following conditions:
(1) the specific audit item should be the same for all the approvals under consideration;
(2) there should be satisfactory evidence on record that the specific audit items were
carried out and that all corrective actions have been implemented to the satisfaction of
the competent authority;
(3) the competent authority should be satisfied that there is no evidence that standards
have deteriorated in respect of those specific audit items for which credit is granted;
and
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(4) the interval between two audits for the specific item for which credit is granted should
not exceed the applicable oversight planning cycle.
21.B.222 Oversight programme.
AMC1 21.B.222(d) Oversight programme
EXTENSION OF THE OVERSIGHT PLANNING CYCLE BEYOND 24 MONTHS
(a) If the competent authority applies an oversight planning cycle that exceeds 24 months, it
should perform, at a minimum, one inspection of the organisation within each 12-month
segment of the applicable oversight planning cycle to validate the oversight programme.
(b) If the results of this inspection indicate a decrease in the safety performance of the
organisation, the competent authority should revert to a 24-month (or shorter) oversight
planning cycle and review the oversight programme accordingly.
(c) In order to be able to apply an oversight planning cycle of up to 36 months, the competent
authority should determine the format and contents of the regular reports to be made by the
organisation on its safety performance.
(d) To enable the competent authority to apply an oversight planning cycle of up to 48 months,
the competent authority should establish, implement and maintain a methodology to
evaluate the safety performance of the organisation, focusing on the organisation’s ability to
effectively identify aviation safety hazards and manage the associated risks.
21.B.222 Oversight programme
GM1 21.B.225(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings
and corrective actions Objective evidence
OBJECTIVE EVIDENCE
Objective evidence is a fact which is, or can be, documented, based on observations, measurements
or tests that can be verified. Objective evidence generally comes from the following:
(a) documents or manuals;
(b) examination of equipment/products; and
(c) information from interview questions and observations of POA an organisation’s activities.
21.B.225 Findings and corrective actions
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective
actions
UNCONTROLLED NON-COMPLIANCE WITH APPLICABLE DESIGN DATA
An uncontrolled non-compliance with applicable design data is a non-compliance that:
(a) cannot be discovered through systematic analysis; or
(b) prevents the identification of the affected products, parts, appliances, or material.
21.B.225 Findings and corrective actions
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AMC1 21.B.225(d)(a) Findings and corrective actions Notification of
findings
NOTIFICATION OF FINDINGS
In case of a level 1 one finding, confirmation must should be obtained in a timely manner that the
accountable manager has taken note of the finding and its details received the letter containing
details of the level one finding and the approval suspension details.
A level two finding requires timely and effective handling oversight by the competent authority to
ensure the completion of the corrective action. This oversight may includes intermediate
communication, including reminding letters as necessary, with to remind the POA approval holder to
verify that the corrective action plan is followed.
The competent authority should grant the organisation a corrective action implementation period
that is appropriate to the nature of the finding, which should not in any case be more than 21
working days, commencing from the date of the written communication of the finding to the
organisation, requesting corrective action to address the non-compliance identified.
21.B.225 Findings and corrective actions
AMC No 1 to 21.B.230 Issue of the certificate
The competent authority should base its decision to issue or amend a POA on the recommendation
report (EASA Form 56, see GM No 2 to 21.B.220(c)) of the POAT submitted by the POA team leader.
The EASA Form 56 includes a proposal by the POAT for the scope and terms of approval defining the
products, parts and appliances for which the approval is to be granted, with appropriate limitations.
When the competent authority issues the approval a final controlled copy of an acceptable
exposition for the organisation should have been supplied to the competent authority.
In some cases it may be accepted that some findings are not fully closed because corrective actions
are still in progress. The competent authority may decide according to the following principles:
1) Findings should be equivalent to level two, which do not need to be rectified as a matter of
urgency within less than three months, and should normally not exceed three in number.
2) Corrective action plan, including timescales, should have been accepted and should not
require an additional and specific follow-up audit by the competent authority.
A record should be kept by the competent authority and should be brought to the attention of the
Agency on request for standardisation purposes.
GM 21.B.235(a)(4) Guide to the conduct of monitoring production
standards.
1. 21.B.235(a)(4) identifies a need for a sample investigation of products, parts or appliances,
their associated conformity determinations and certifications made by a POA holder. For this
to be performed effectively and efficiently, the competent authority should integrate a
sampling plan as part of the planning of the investigation and continued surveillance activities
appropriate to the scope and size of the relevant applicant.
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2. The sampling plan could, for example, investigate:
(a) a modification (or change)
(b) the installation, testing, or operation of a major part or system
(c) the accuracy and generation of the Flight Test report data
(d) the accuracy and generation of the Weighing report data
(e) an engine test bed run
(f) records traceability
(g) the accuracy and generation of the Statement of Conformity data and the
associated safe operation determination
(h) the accuracy and generation of EASA Form 1 data.
The sampling plan should be flexible so as to:
(i) accommodate changes in production rate
(j) make use of results from other samples
(k) make use of results from other POA Investigations
(l) provide the maximum national authorities confidence
To be effective this product sample requires that the individual investigator(s):
(m) have a good practical knowledge of the product, part or appliance
(n) have a good practical knowledge of the manufacturing processes
(o) have an up to date knowledge of the manufacturers production programme
(p) use an appropriate and up to date sample plan and compliance check lists
(q) have a suitable recording system for the results
(r) have a properly operating feedback system to their national authorities
organisation for POA and the manufacturer
(s) maintain an effective working relationship with the manufacturer and his staff
(t) be able to communicate effectively
GM 21.B.235(b) Maintenance of the POA - Work allocation within
the competent authority
After issue of the approval the competent authority should appoint a suitable member of its
technical staff as the POATL to be in charge of the approval for the purpose of continued
surveillance.
Where the POA holder facilities are located in more than one Member State the competent
authority of the State of manufacture will liaise with the competent authorities of the various
partners/members to ensure appropriate continued surveillance.
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GM 21.B.235(b) and (c) Continued surveillance
Continued surveillance consists of:
1. Planned continued surveillance, in which the total surveillance actions are split into several
audits, which are carried out at planned intervals during the validity period of the production
organisation approval. Within the continued surveillance one aspect may be audited once or
several times depending upon its importance.
2. Unplanned POA reviews, which are specific additional investigation of a POA holder related to
surveillance findings or external needs. The competent authority is responsible for deciding
when a review is necessary taking into account changes in the scope of work, changes in
personnel, reports on the organisation performance submitted by other EASA or national
authorities teams, reports on the in service product.
AMC 21.B.235(c) Continuation of POA
At the end of the 24 months continued surveillance cycle the POATL responsible for the POA should
complete an EASA Form 56 (see GM No 2 to 21.B.220(c)) as a summary report for the continued
surveillance including the recommendation for continuation of the POA as applicable. The
EASA Form 56 should be countersigned by the person responsible within the competent authority
for his acceptance. At this stage there is no limitation to the number of level two findings that may
be open, provided they are within the time limits of the respective corrective action plans.
AMC1 No 1 to 21.B.240 Changes to a production organisation
approval Application for significant changes or variation of scope
and terms of the POA
APPLICATION FOR SIGNIFICANT CHANGES OR A VARIATION OF SCOPE AND TERMS OF THE POA
(a) The competent authority should have adequate control over any changes to the personnel
specified in points 21.A.145(c)(1) and (2). Such changes in personnel will require an
amendment to the exposition.
(b) When an organisation submits the name of a new nominee for any of the personnel specified
in points 21.A.145(c)(1) and (2), the competent authority may require the organisation to
produce a written résumé of the proposed person's qualifications. The competent authority
should reserve the right to interview the nominee or call for additional evidence of his or her
suitability before deciding upon his or her acceptability.
(c) For changes that require prior approval, in order to verify the organisation's compliance with
the applicable requirements, the competent authority should conduct an audit of the
organisation, limited to the extent of the changes, and determine whether the organisation
needs to provide a safety risk assessment.
(d) If a safety risk assessment is deemed necessary, the competent authority should inform the
organisation accordingly.
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(e) If the competent authority considers that it is necessary to review the safety risk assessment
performed by the organisation, it should request the assessment from the organisation and
assess its results.
(f) If required for verification, the audit may conduct interviews and inspections carried out at
the organisation’s facilities.
(g) The competent authority should receive an application for any significant changes or for a
change to the terms of approval of the DOA on an EASA Form 51 completed by the applicant.
The competent authority must receive an application for significant changes or variation of scope
and terms of the POA on an EASA Form 51 (see below) completed by the applicant.
21.B.240 Changes to a production organisation approval
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EASA Form 51
Application for significant changes or variation of scope and terms of Part 21 POA
Competent authority
of an EU Member State or
EASA
1. Name and address of the POA holder:
2. Approval reference number:
3. Locations for which changes in the terms of
approval are requested:
4. Brief summary of proposed changes to the activities at the item 3 addresses:
a) General:
b) Scope of approval:
c) Nature of privileges:
5. Description of organisational changes:
6. Position and name of the accountable
manager or nominee:
_______________________________ __________________________________
Date Signature of the accountable manager (or nominee)
EASA Form 51
Block 1: The name must be entered as written on the current approval certificate. Where a change in the name
is to be announced state the old name and address here, while using Block 5 for the information about
the new name and address. The change of name and/or address must be supported by evidence, e.g.
by a copy of the entry in the register of commerce.
Block 2: State the current approval reference number.
Block 3: State the locations for which changes in the terms of approval are requested or state ‘not applicable’ if
no change is to be anticipated here.
Block 4: This Block should include further details for the variation of the scope of approval for the addresses
indicated in Block 3. The Block ‘General’ must include overall information for the change (including
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changes e.g. in workforce, facilities etc.), while the Block ‘Scope of approval’ must address the change in
the scope of work and products/categories following the principles laid down in the GM 21.A.151. The
Block ‘nature of privileges’ must indicate a change in the privileges as defined in 21.A.163(b)-(d). State
‘not applicable’ if no change is anticipated here.
Block 5: This Block must state the changes to the organisation as defined in the current production
organisation exposition, including changes the organisational structure, functions and responsibilities.
This Block must therefore also be used to indicate a change in the accountable manager in accordance
with 21.A.145(c)(1) or a change in the nomination of the responsible managers in accordance with
21.A.145(c)(2). A change in the nomination of responsible managers must be accompanied by the
corresponding EASA Forms 4. State ‘not applicable’ if no change is anticipated here.
Block 6: State the position and name of the accountable manager here. Where there is a change in the
nomination of the accountable manager, the information must refer to the nominee for this position.
State ‘not applicable’ if no change is anticipated here.
In case of an application for a change of the accountable manager the EASA Form 51 must be signed by
the new nominee for this position. In all other cases the EASA Form 51 must be signed by the
accountable manager.
GM 21.B.245 Continued validity
1. GENERAL
Decisions on restriction, surrender, suspension or revocation of POA will always be actioned in
such a way as to comply with any applicable national laws or regulations relating to appeal
rights and the conduct of appeals, unless the decision has been taken by the Agency. In such
case, the Agency appeal procedures will apply.
2. RESTRICTION is temporary withdrawal of some of the privileges of a POA under 21.A.163.
3. SURRENDER is a permanent cancellation of a production organisation approval by the
competent authority upon formal written request by the accountable manager of the
organisation concerned. The organisation effectively relinquishes its rights and privileges
granted under the approval and, after cancellation, may not make certifications invoking the
approval and must remove all references to the approval from its company documentation.
4. SUSPENSION is temporary withdrawal of all the privileges of a production organisation
approval under 21.A.163. The approval remains valid but no certifications invoking the
approval may be made while the suspension is in force. Approval privileges may be re-instated
when the circumstances causing the suspension are corrected and the organisation once again
can demonstrate full compliance with the Requirements.
5. REVOCATION is a permanent and enforced cancellation of the whole of an approval by the
competent authority. All rights and privileges of the organisation under the approval are
withdrawn and, after revocation, the organisation may not make any certifications or other
statements invoking the approval and must remove all references to the approval from its
company documentation.
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AMC 21.B.245 Corrective action plan
It is expected that any established POA holder will move quickly to re-establish compliance with
Part 21 and not risk the possibility of approval suspension. Therefore, the corrective action period
granted by the competent authority must be appropriate to the nature of the finding but in any case
initially must not be more than six months. In certain circumstances and subject to the nature of the
finding the competent authority can vary the six months period subject to a satisfactory corrective
action plan agreed by the competent authority.
Failure to comply within time scale agreed by the competent authority means that provisional
suspension of the POA in whole or in part must proceed.
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SUBPART J — DESIGN ORGANISATION APPROVAL
AMC1 21.B.220 and 21.B.430 Initial certification procedure
VERIFICATION OF COMPLIANCE
(a) In order to verify the organisation’s compliance with the applicable requirements, the
competent authority should conduct an audit of the organisation, including interviews of the
personnel, and inspections carried out at the organisation’s facilities.
(b) The competent authority should only conduct such an audit if it is satisfied that the
application and supporting documentation are in compliance with the applicable
requirements.
(c) The audit should focus on the following areas:
(1) the detailed management structure, notably its adequacy;
(2) the personnel: the adequacy of the number of staff, and of their qualifications and
experience with regard to the intended terms of approval and the associated privileges;
(3) the processes used for safety risk management and compliance monitoring;
(4) the facilities and their adequacy regarding the organisation’s scope of work; and
(5) the documentation based on which the approval should be granted.
(d) If an application for an approval is refused, the applicant should be informed of the right of
appeal that exists under national law.
21.B.430 Initial certification procedure
AMC1 21.B.430 and 21.B.431 Initial certification procedure
INVESTIGATION TEAM
(a) The competent authority should appoint a design organisation investigation team for each
applicant for, or each holder of, a design organisation approval. This team is responsible for
conducting all the relevant tasks related to the approval. The team should consist of a team
leader to manage and lead the approval team and, if needed, one or more team members.
The team leader should report to the manager who is responsible for the activities of the
competent authority as defined in point 21.B.25(c).
(b) The competent authority should perform sufficient investigation activities for an applicant for,
or a holder of, a DOA to justify the recommendations for the issuance, maintenance,
amendment, suspension or revocation of the approval.
(c) The competent authority should prepare procedures for the investigation of a DOA as part of
the documented procedures that cover at least the following elements:
(1) the evaluation of the applications received;
(2) the appointment of the organisation approval team;
(3) the preparation and planning of the investigation;
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(4) the evaluation of the documentation (design organisation handbook, procedures, etc.);
(5) the auditing;
(6) the follow-up of corrective actions;
(7) any recommendation for the issuance, amendment, suspension or revocation of a
design organisation approval; and
(8) continued surveillance.
21.B.430 Initial certification procedure
AMC1 21.B.430(a) Initial certification procedure
ORGANISATION APPROVAL TEAM
(a) Team leader selection
The team leader should satisfy all of the criteria for a team member and will be selected by
considering the following additional criteria:
(1) the capability to lead and manage a team;
(2) the capability to prepare reports and be diplomatic;
(3) experience in approval team investigations (not necessarily only Part 21 Section A
Subpart J); and
(4) relevant knowledge of the design management system.
(b) Team member selection
The competent authority should determine the size of the team and the specialisations to be
covered, taking into account the scope of work and the characteristics of the applicant. Team
members should be selected by considering the following criteria:
(1) training, which is mandatory, for Part 21 Section A, Subparts A and J, and Section B,
Subparts A and J;
(2) education and experience, to cover the appropriate aviation knowledge, audit
practices and approval procedures; and
(3) the ability to verify that an applicant’s organisation conforms to its own
procedures, and that its key personnel are competent.
21.B.430 Initial certification procedure
AMC1 21.B.430(d)(1) Initial certification procedure
ISSUE OF THE CERTIFICATE
(a) The competent authority should base its decision to issue or amend a DOA on the
recommendation in the DOA investigation report (for an initial investigation) or the significant
change report (for significant changes) submitted by the DOA team leader. The report includes
a proposal by the DOAT for the terms of approval that define the products, technical scope
and privileges for which the approval is to be granted, with appropriate limitations.
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(b) When the competent authority issues the approval, a final controlled copy of an acceptable
handbook for the organisation should be supplied to the competent authority.
(c) In some cases, it may be acceptable for some actions to not be fully closed because work is
still in progress. The competent authority may decide according to the following principles:
(1) The findings should be of level 2 or 3, which do not need to be rectified as a matter of
urgency within less than 3 months, and should normally not exceed three in number.
(2) A corrective action plan, including timescales, should have been accepted, and should
not require an additional specific follow-up audit by the competent authority.
21.B.430 Initial certification procedure
AMC1 21.B.431(a), (b) and (c) Oversight principles
MANAGEMENT SYSTEM ASSESSMENT
As part of the initial certification of an organisation in accordance with point 21.B.430, the
competent authority should assess the organisation’s management system and its processes to
make sure that all the required enablers of a functioning management system are present and
suitable.
As part of their continuing oversight, the competent authority should remain satisfied as to the
presence of the required enablers, and assess the effectiveness of the organisation’s management
system and processes.
When significant changes take place in the organisation, the competent authority should decide
whether it needs to review the existing assessment to ensure it is still appropriate.
21.B.431 Oversight principles
AMC1 21.B.222 and 21.B.432 Oversight programme
ANNUAL REVIEW
(a) The oversight planning cycle and the related oversight programme for each organisation
should be reviewed annually to ensure they remain adequate regarding any changes in the
nature, complexity or safety performance of the organisation.
(b) When reviewing the oversight programme and the oversight planning cycle, the competent
authority should also consider any relevant information collected in accordance with points
21.A.3A and 21.B.215(d) for production organisations, or point 21.B.431(d) for design
organisations.
21.B.432 Oversight programme
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme
SPECIFIC NATURE AND COMPLEXITY OF THE ORGANISATION — RESULTS OF PAST OVERSIGHT
When determining the oversight programme, including the relevant sample of design activities
under the scope of the organisation as product audits, the competent authority should consider in
particular the following elements, as applicable:
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(a) the effectiveness of the organisation’s management system in identifying and addressing
non-compliances and safety hazards;
(b) the implementation by the organisation of any industry standards that are directly relevant to
the organisation’s activity subject to Part 21;
(c) any specific procedures implemented by the organisation that are related to any alternative
means of compliance used;
(d) the number of locations and the activities performed at each location;
(e) the number and type of subcontractors who perform production or design activities as
appropriate; and
(f) the volume of activity for each product, parts or appliance.
21.B.432 Oversight programme
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme
SUBCONTRACTED ACTIVITIES
If a Part 21 organisation subcontracts some activities, the competent authority should determine
whether the Part 21 organisation needs to be audited on how they control particular subcontracted
activities and include this in the oversight programme, taking into account the specific nature and
complexity of the subcontracted activities, the results of previous oversight activities of the
organisation approved according to Subparts G or J, and based on the assessment of the associated
risks.
For such an audit, the competent authority inspector should ensure that he or she is accompanied
throughout the audit by a senior technical member of the Part 21 organisation.
21.B.432 Oversight programme
AMC1 21.B.432(b)(1) Oversight programme
AUDIT
(a) The oversight programme should indicate which aspects of the terms of approval will be
covered by each audit.
(b) Audits may be complemented by a review of the compliance monitoring results particular to
the topics of the audit to determine if the organisation is identifying and correcting its
problems.
(c) At the conclusion of the audit, the auditing inspector should complete an audit report that
identifies the areas and processes that were audited and includes all the findings that were
raised.
21.B.432 Oversight programme
AMC1 21.B.432(c) Oversight programme
OVERSIGHT PLANNING CYCLE AUDIT AND INSPECTION
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(a) When determining the oversight planning cycle and defining the oversight programme, the
competent authority should assess the risks related to the activity of each organisation, and
adapt the oversight to the level of risk identified and to the effectiveness of the organisation’s
management system, in particular its ability to effectively manage safety risks.
(b) The competent authority should establish a schedule of audits and inspections that is
appropriate to each organisation. The planning of audits and inspections should take into
account the results of the hazard identification and the risk assessment conducted and
maintained by the organisation as part of the organisation’s management system.
(c) When the competent authority, having regard to the level of risk identified and the
effectiveness of the organisation’s management system, varies the frequency of an audit or
inspection, it should ensure that all aspects of the organisation’s activity are audited and
inspected within the applicable oversight planning cycle.
21.B.432 Oversight programme
AMC2 21.B.222(c) and 21.B.432(c) Oversight programme
OVERSIGHT PLANNING CYCLE — AUDIT
(a) For each organisation approved by the competent authority, all the processes should be
completely audited at periods that do not exceed the applicable oversight planning cycle. The
beginning of the first oversight planning cycle is normally determined by the date of issue of
the first approval. If the competent authority wishes to align the oversight planning cycle with
the calendar year, it should shorten the first oversight planning cycle accordingly.
(b) Audits should include at least one on-site audit within each oversight planning cycle. For
organisations that exercise their regular activity at more than one site, the determination of
the sites to be audited should consider the results of past oversight, the volume of activity at
each site, as well as the main risk areas identified.
(c) For organisations that hold more than one approval, the competent authority may define an
integrated oversight schedule to include all the applicable audit items. In order to avoid any
duplication of audits, credit may be granted for any specific audit items already completed
during the current oversight planning cycle, subject to the following conditions:
(1) the specific audit item should be the same for all the approvals under consideration;
(2) there should be satisfactory evidence on record that the specific audit items were
carried out and that all corrective actions have been implemented to the satisfaction of
the competent authority;
(3) the competent authority should be satisfied that there is no evidence that standards
have deteriorated in respect of those specific audit items for which credit is granted;
and
(4) the interval between two audits for the specific item for which credit is granted should
not exceed the applicable oversight planning cycle.
21.B.432 Oversight programme
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AMC1 21.B.432(d) Oversight programme
EXTENSION OF THE OVERSIGHT PLANNING CYCLE BEYOND 24 MONTHS
(a) If the during an inspection the competent authority finds a decrease in the safety
performance of the organisation, the competent authority should revert to a 24-month (or
shorter) oversight planning cycle and review the oversight programme accordingly.
(b) In order to be able to apply an oversight planning cycle of up to 36 months, the competent
authority should determine the format and contents of the regular reports to be made by the
organisation on its safety performance.
(c) To enable the competent authority to apply an oversight planning cycle of up to 48 months,
the competent authority should establish, implement and maintain a methodology to
evaluate the safety performance of the organisation, focusing on the organisation’s ability to
effectively identify aviation safety hazards and manage the associated risks.
21.B.432 Oversight programme
GM1 21.B.125(b), 21.B.225(b) and 21.B.430(b) Findings and
corrective actions
OBJECTIVE EVIDENCE
Objective evidence is a fact which is, or can be, documented, based on observations, measurements
or tests that can be verified. Objective evidence generally comes from the following:
(a) documents or manuals;
(b) examination of equipment/products; and
(c) information from interview questions and observations of organisation activities.
21.B.433 Findings and corrective actions
AMC1 21.B.433(d) Findings and corrective actions
NOTIFICATION OF FINDINGS
In the case of a level 1 finding, confirmation should be obtained in a timely manner that the head of
the design organisation has taken note of the finding and its details.
A finding requires timely and effective oversight by the competent authority to ensure the
completion of the corrective action. This oversight may include intermediate communication,
including letters as necessary, to remind the approval holder to verify that the corrective action plan
is followed.
The competent authority should grant the organisation a corrective action implementation period
that is appropriate to the nature of the finding, which should not in any case be more than 21
working days, commencing from the date of the written communication of the finding to the
organisation, requesting corrective action to address the non-compliance identified.
21.B.433 Findings and corrective actions
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AMC1 21.B.435 Changes to a design organisation approval
APPLICATION FOR SIGNIFICANT CHANGES OR VARIATION OF SCOPE AND TERMS OF THE DOA
(a) The competent authority should have adequate control over any changes in the personnel
specified in points 21.A.245(a) and (b). Such changes in personnel will require an amendment
to the handbook.
(b) When an organisation submits the name of a new nominee for any of the personnel positions
specified in points 21.A.245(a) and (b), the competent authority may require the organisation
to produce a written résumé of the proposed person's qualifications. The competent authority
should reserve the right to interview the nominee or call for additional evidence of his or her
suitability before deciding upon his or her acceptability.
(c) For changes that require prior approval, in order to verify the organisation's compliance with
the applicable requirements, the competent authority should conduct an audit of the
organisation, limited to the extent of the changes, and determine whether the organisation
needs to provide a safety risk assessment.
(d) If a safety risk assessment is deemed necessary, the competent authority should inform the
organisation accordingly.
(e) If the competent authority considers that it is necessary to review the safety risk assessment
performed by the organisation, it should request the assessment from the organisation and
assess its results.
(f) If required for verification, the audit may include interviews and inspections carried out at the
organisation’s facilities.
(g) The competent authority should receive an application for any significant changes or for a
change to the terms of approval of the DOA on an EASA Form 82 completed by the applicant.
21.B.435 Changes to a design organisation approval
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Notice of Proposed Amendment 2019-05 (C)
Embodiment of safety management system (SMS) requirements into
Part-145 and Part 21
RMT.0251 PHASE II
EXECUTIVE SUMMARY
With reference to Rulemaking Task (RMT).0251 Phase II in EPAS 2019-2023, this Notice of Proposed
Amendment (NPA) proposes amendments to Annex I (Part 21) to Regulation (EU) No 748/2012 and Annex II
(Part-145) to Regulation (EU) No 1321/2014, in order to:
— introduce safety management principles that implement ICAO Annex 19; and
— foster an organisational culture for effective safety management and effective occurrence reporting in
accordance with Commission Regulation (EU) No 376/2014.
Note 1: Phase I of RMT.0251 was limited to the introduction of safety management requirements into Part-
CAMO (see Opinion No 06/2016).
Note 2: The review of the occurrence reporting system was governed by RMT.0681, but certain additional
changes are proposed through this RMT, in light of the principles of ICAO Annex 19, Chapter 5.
This NPA proposes to consider the applicability of safety management systems (SMSs) to Part-145 approved
maintenance organisations, as well as to production and design organisations that are approved in accordance
with Subparts G and J of Part 21.
By doing so, safety will be enhanced through:
— the establishment of safety policies and objectives that are associated with sufficient resources;
— the systematic identification of hazards, and a risk management system;
— the safety assurance system, including giving consideration to safety performance; and
— safety promotion.
This RMT also aims to streamline the procedures for oversight, and introduce a set of new, common
management system requirements for competent authorities to increase their efficiency.
NPA 2019-05 is divided into three parts. The present NPA 2019-05 (C) includes the draft implementing rules
(IRs) as well the draft Acceptable Means of Compliance (AMC) and Guidance Material (GM) for Part-145.
NPA 2019-05 (A) includes:
— the procedural information pertaining to the regulatory proposal;
— the explanatory note to the proposed amendments;
— the regulatory impact assessment; and
— a detailed summary of the proposed amendments (see Chapter 7 ‘Appendices’).
The draft IRs as well as the draft AMC and GM for Part 21 are proposed in NPA 2019-05 (B).
Action area: Systemic enablers to safety — safety management
Affected rules: Part-145 and Part 21
Affected stakeholders: AMOs (Part-145); POA holders; DOA holders; ETSOA holders; competent authorities
Driver: Safety Rulemaking group: No (but Focused Consultation Group)
Impact assessment: Full Rulemaking Procedure: Standard
12.7.2017 17.4.2019 2020/Q1 2020/Q3 2020/Q3
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Table of contents
Table of contents
Table of contents ........................................................................... 2
Draft Cover Regulation (EU) 1321/2014 (Draft EASA opinion) ......... 6
Article 4 Continuing-airworthiness organisation approvals .................................................. 7
Draft Annex II (Part-145) to Reg. (EU) 1321/2014 (Draft EASA
opinion) .......................................................................... 8
145.1 General Competent authority ........................................................................ 8
SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS ..................................... 9
145.A.10 Scope......................................................................................................... 9
145.A.15 Application for an organisation certificate ............................................... 9
145.A.20 Terms of Approval..................................................................................... 9
145.A.30 Personnel requirements ......................................................................... 10
145.A.35 Certifying staff and support staff ............................................................ 13
145.A.36 Records of airworthiness review staff ................................................... 14
145.A.37 Airworthiness review staff ..................................................................... 15
145.A.45 Maintenance data ................................................................................... 15
145.A.47 Production planning................................................................................ 17
145.A.48 Performance of maintenance ................................................................. 17
145.A.50 Certification of maintenance .................................................................. 18
145.A.55 Record-keeping Maintenance and airworthiness review records .......... 18
145.A.60 Occurrence reporting.............................................................................. 21
145.A.65 Safety and quality policy, Maintenance procedures and quality system22
145.A.70 Maintenance organisation exposition (MOE) ......................................... 23
145.A.75 Privileges of the organisation ................................................................. 25
145.A.80 Limitations on the organisation ............................................................. 25
145.A.85 Changes to the organisation ................................................................... 25
145.A.90 Continued validity ................................................................................... 27
145.A.95 Findings ................................................................................................... 27
145.A.120 Means of compliance ........................................................................... 28
145.A.140 Access................................................................................................... 28
145.A.155 Immediate reaction to a safety problem ............................................. 28
145.A.200 Management system ........................................................................... 28
145.A.202 Internal safety reporting scheme ........................................................ 30
145.A.205 Contracting and subcontracting .......................................................... 30
SECTION B — AUTHORITY REQUIREMENTS PROCEDURE FOR COMPETENT AUTHORITIES
.......................................................................................................................................... 32
145.B.005 Scope ..................................................................................................... 32
145.B.115 Oversight documentation ..................................................................... 32
145.B.120 Means of compliance ............................................................................ 32
145.B.125 Information to the Agency .................................................................... 33
145.B.135 Immediate reaction to a safety problem .............................................. 33
145.B.200 Management system ............................................................................ 33
145.B.205 Allocation of tasks to qualified entities ................................................ 35
145.B.210 Changes in the management system .................................................... 35
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Table of contents
145.B.220 Record-keeping ..................................................................................... 36
145.B.300 Oversight principles .............................................................................. 37
145.B.305 Oversight programme ........................................................................... 38
145.B.310 Initial certification procedure ............................................................... 39
145.B.330 Changes – organisations ....................................................................... 40
145.B.350 Findings and corrective actions ............................................................ 40
145.B.355 Suspension, limitation and revocation ................................................. 42
APPENDICES TO ANNEX II (Part-145)................................................................................ 43
Appendix II — Class and Ratings System used for the Approval of Maintenance
Organisations referred to in Annex I (Part-M) Subpart F and Annex II (Part-145) 43
Appendix III — Maintenance Organisation Approval Certificate - EASA Form 3-145
referred to in Annex II (Part-145)........................................................................... 48
Draft AMC/GM to Annex II (Part-145) (Draft EASA decision) ......... 50
GM1 to Annex II (Part-145) Definitions ................................................................................. 50
SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS ................................... 53
AMC1 145.A.10 Scope ............................................................................................................ 53
GM1 145.A.10 Scope .............................................................................................................. 54
AMC1 145.A.15 Application for an organisation certificate ................................................... 56
AMC2 145.A.15 Application for an organisation certificate .................................................. 56
GM1 145.A.15(b) Application for an organisation certificate ............................................... 56
AMC1 145.A.25(a) Facility requirements ............................................................................... 57
AMC1 145.A.30(a) Personnel requirements .......................................................................... 57
AMC1 145.A.30(b) Personnel requirements .......................................................................... 57
GM1 145.A.30(b) Personnel requirements ........................................................................... 58
AMC1 145.A.30(c) Personnel requirements ........................................................................... 59
AMC1 145.A.30(c);(ca) Personnel requirements ................................................................... 59
GM1 145.A.30(ca) Personnel requirements .......................................................................... 60
AMC1 145.A.30(cc) Personnel requirements ........................................................................ 61
AMC1 145.A.30(d) Personnel requirements .......................................................................... 62
AMC1 145.A.30(e) Personnel requirements .......................................................................... 63
AMC2 145.A.30(e) Personnel requirements .......................................................................... 65
AMC3 145.A.30(e) Personnel requirements .......................................................................... 66
AMC4 145.A.30(e) Personnel requirements .......................................................................... 66
AMC5 145.A.30(e) Personnel requirements ......................................................................... 67
GM1 145.A.30(e) Personnel requirements ............................................................................ 67
GM2 145.A.30(e) Personnel requirements ............................................................................ 70
GM3 145.A.30(e) Personnel requirements ............................................................................ 73
GM4 145.A.30(e) Personnel requirements ........................................................................... 75
GM5 145.A.30(e) Personnel requirements ........................................................................... 75
GM6 145.A.30(e) Personnel requirements ........................................................................... 76
AMC1 145.A.30(f) Personnel requirements ........................................................................... 77
AMC1 145.A.30(h) Personnel requirements .......................................................................... 77
AMC1 145.A.30(j)(4) Personnel requirements ....................................................................... 78
GM 145.A.30(j)(4) Personnel requirements (Flight crew) ..................................................... 79
AMC1 145.A.30(j)(5) Personnel requirements ....................................................................... 80
AMC1 145.A.30(j)(5)(i) Personnel requirements .................................................................... 80
AMC1 145.A.30(j)(5)(ii) Personnel requirements ................................................................... 81
AMC1 145.A.35(a) Certifying staff and support staff ............................................................. 81
AMC1 145.A.35(d) Certifying staff and support staff ............................................................. 82
AMC1 145.A.35(e) Certifying staff and support staff ............................................................. 83
AMC1 145.A.35(f) Certifying staff and support staff .............................................................. 83
AMC1 145.A.45(c) Maintenance data .................................................................................... 84
AMC1 145.A.45(d) Maintenance data .................................................................................... 84
AMC1 145.A.45(e) Maintenance data .................................................................................... 85
AMC1 145.A.47(b) Production planning................................................................................ 85
GM1 AMC 145.A.47(b) Production planning .......................................................................... 86
GM1 145.A.47(d) Production planning ................................................................................. 87
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AMC1 145.A.48(a) AMC 145.A.80 Limitations on the organisation Performance of
maintenance .......................................................................................................................... 87
AMC1 145.A.48(c)(2) AMC1 145.A.48(b) Performance of maintenance ................................ 88
AMC2 145.A.48(c)(2) AMC2 145.A.48(b) Performance of maintenance ................................ 88
AMC3 145.A.48(c)(2) AMC3 145.A.48(b) Performance of maintenance ................................ 88
AMC4 145.A.48(c)(2) AMC4 145.A.48(b) Performance of maintenance ................................ 89
AMC1 145.A.48(c)(3) Performance of maintenance .............................................................. 91
GM1 145.A.48(c)(3) Performance of maintenance ................................................................ 91
GM1 145.A.48(c)(4) GM 145.A.48(d) Performance of maintenance - critical design
configuration control limitations (CDCCL) .............................................................................. 91
GM1 AMC 145.A.50(a) Certification of maintenance............................................................. 92
AMC1 145.A.50(b) Certification of maintenance ................................................................... 92
AMC1 145.A.50(e) Certification of maintenance ................................................................... 93
AMC1 145.A.55 Record-keeping ........................................................................................... 93
GM1 145.A.55 Record-keeping ............................................................................................. 94
GM1 145.A.55(a)(1) Record-keeping Maintenance and airworthiness review records ......... 94
AMC1 145.A.55(a)(3) AMC 145.A.55(c) Record-keeping Maintenance and airworthiness
review records ....................................................................................................................... 95
AMC1 145.A.55(d) AMC 145.A.35(j) Certifying staff and support staff Record-keeping ........ 95
AMC2 145.A.55(d) AMC 145.A.36 Record-keeping Records of airworthiness review staff ... 96
AMC 145.A.60(b) Occurrence reporting ................................................................................ 96
AMC 145.A.65(a) Safety and quality policy, maintenance procedures and quality system .. 97
AMC1 145.A.65(b) Safety and quality policy, Maintenance procedures and quality system . 97
GM1 145.A.65 Maintenance procedures .............................................................................. 97
GM2 145.A.65(b)(1) Safety and quality policy, Maintenance procedures and quality system
............................................................................................................................................... 98
AMC1 145.A.65(b)(2) Safety and quality policy, Maintenance procedures and quality system
............................................................................................................................................... 98
AMC1 145.A.70(a) Maintenance organisation exposition (MOE) .......................................... 98
GM1 145.A.70(a) Maintenance organisation exposition (MOE) .......................................... 103
AMC1 145.A.70(a)(1) Maintenance organisation exposition (MOE) ................................... 104
AMC1 145.A.75(b) Privileges of the organisation ................................................................ 105
GM1 145.A.75(b) Privileges of the organisation ................................................................. 109
AMC1 145.A.85 Changes to the organisation...................................................................... 109
AMC2 145.A.85 Changes to the organisation...................................................................... 109
GM1 145.A.85 Changes to the organisation ....................................................................... 109
GM1 145.A.85(a)(1) Changes to the organisation ............................................................... 110
GM2 145.A.85(a)(1) Changes to the organisation ............................................................... 110
GM1 145.A.85(b) Changes to the organisation ................................................................... 110
GM1 145.A.85(c) Changes to the organisation ................................................................... 111
AMC1 145.A.95 Findings ..................................................................................................... 111
GM1 145.A.95 Findings ....................................................................................................... 112
AMC1 145.A.120 Means of compliance .............................................................................. 112
GM1 145.A.200 Management system ................................................................................. 112
AMC1 145.A.200(a)(1) Management system ...................................................................... 115
GM1 145.A.200(a)(1) Management system ........................................................................ 116
GM2 145.A.200(a)(1) Management system ........................................................................ 116
AMC1 145.A.200(a)(2) Management system ...................................................................... 117
GM1 145.A.200(a)(2) Management system ........................................................................ 118
AMC1 145.A.200(a)(3) Management system ...................................................................... 118
GM1 145.A.200(a)(3) Management system ........................................................................ 120
GM2 145.A.200(a)(3) Management system ........................................................................ 121
AMC1 145.A.200(a)(4) Management system ...................................................................... 123
GM1 145.A.200(a)(4) Management system ........................................................................ 123
GM1 145.A.200(a)(5) Management system ........................................................................ 124
AMC1 145.A.200(a)(6) Management system ....................................................................... 124
AMC2 145.A.200(a)(6) AMC 145.A.65(c)(1) Management System ...................................... 124
AMC3 145.A.200(a)(6) Management System ...................................................................... 126
AMC4 145.A.200(a)(6) AMC 145.A.65(c)(2) Safety and quality policy, maintenance
procedures and quality system Management System ......................................................... 127
GM1 145.A.200(a)(6) Management system ........................................................................ 128
GM2 145.A.200(a)(6) GM 145.A.65(c)(1) Safety and quality policy, maintenance procedures
and quality system Management system ............................................................................ 128
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AMC1 145.A.202 Internal safety reporting scheme ............................................................ 132
GM1 145.A.202 Internal safety reporting scheme .............................................................. 133
GM1 145.A.205 Contracting and subcontracting ................................................................ 133
GM2 145.A.205 Contracting and subcontracting ................................................................ 134
SECTION B — AUTHORITY REQUIREMENTS PROCEDURE FOR COMPETENT AUTHORITIES
........................................................................................................................................ 136
GM1 145.B.120 Means of compliance ................................................................................. 136
AMC1 145.B.120(e) Means of compliance ........................................................................... 136
AMC1 145.B.200 Management system ................................................................................ 136
AMC2 145.B.200 Management system ................................................................................ 137
AMC1 145.B.200(a)(1) Management system ....................................................................... 138
GM1 145.B.200(a)(2) Management system ......................................................................... 138
AMC1 145.B.200(a)(3) Management system ....................................................................... 141
AMC2 145.B.200(a)(3) Management system ....................................................................... 141
AMC3 145.B.200(a)(3) Management system ....................................................................... 142
AMC1 145.B.200(a)(5) Management system ....................................................................... 144
GM1 145.B.200(a)(5) Management system ........................................................................ 145
AMC1 145.B.200(d) Management system ........................................................................... 145
GM1 145.B.205 Allocation of tasks to qualified entities ...................................................... 146
AMC1 145.B.220(a) Record-keeping .................................................................................... 147
AMC1 145.B.220(a)(1) Record-keeping ................................................................................ 147
AMC1 145.B.300(a);(b);(c) Oversight principles ................................................................... 147
AMC1 145.B.300(f) Oversight principles .............................................................................. 148
AMC1 145.B.305(a);(b) Oversight programme .................................................................... 148
AMC1 145.B.305(b) Oversight programme .......................................................................... 149
AMC2 145.B.305(b) Oversight programme .......................................................................... 149
AMC1 145.B.305(b)(1) Oversight programme ..................................................................... 150
AMC1 145.B.305(c) Oversight programme .......................................................................... 150
AMC2 145.B.305(c) Oversight programme .......................................................................... 150
AMC1 145.B.305(d) Oversight programme .......................................................................... 151
AMC1 145.B.310 Initial certification procedure ................................................................... 152
AMC1 145.B.310(a) Initial certification procedure .............................................................. 153
AMC1 145.B.310(c) Initial certification procedure ............................................................... 153
AMC2 145.B.310(c) Initial certification procedure ............................................................... 153
AMC1 145.B.310(d) Initial certification procedure .............................................................. 154
AMC1 145.B.310(e)(2) Initial certification procedure .......................................................... 154
AMC1 145.B.330 Changes .................................................................................................... 154
GM1 145.B.330 Changes ...................................................................................................... 155
GM1 145.B.350(b);(c) Findings and corrective actions ........................................................ 155
AMC1 145.B.355(c) Suspension, limitation and revocation ................................................. 156
APPENDICES TO AMC TO ANNEX II (PART-145).............................................................. 157
Appendix I to AMC 145.B.20(1) EASA Form 4 ..................................................................... 157
Appendix II to AMC2 145.B.310(c) AMC 145.B.20(5) EASA Form 6 ...................................... 158
Appendix III to AMC 145.A.15 EASA Form 2 ......................................................................... 167
Appendix IV to AMC3 145.A.30(e) and AMC2 145.B.200(a)(3) 145.B.10(3) Fuel Ttank Ssafety
Ttraining ............................................................................................................................... 168
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Proposed amendments to Part-145
Proposed amendments to Part-145
The text of the amendment is arranged to show deleted text, new or amended text as shown below:
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Important note: ‘easy-to-read document’
Under each modified requirement (i.e. implementing rules), the blue underlined AMC or GM, when
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Proposed amendments to Part-145
Draft Cover Regulation (EU) No 1321/2014 (Draft EASA opinion)
Article 4 Continuing-airworthiness organisation approvals1
[…]
9. Limited certifying staff authorisations issued in accordance with 145.A.30(j)(3) or (j)(4) to
holders of a flight engineer licence which are valid at the date of entry into force of this
Regulation shall remain valid until they expire or they are revoked by the maintenance
organisation.
10. Organisations that hold a certificate issued in accordance with Annex II (Part-145) before
(insert date of entry into force of the new Regulation) shall adapt their management system,
training programmes, procedures and manuals to be compliant with Annex II to this
Regulation within two years of its entry into force.
[…]
1 This amendment is made to the text of Article 4 as proposed through Opinion No 05/2016
(https://www.easa.europa.eu/document-library/opinions/opinion-052016).
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Proposed amendments to Part-145
Draft Annex II (Part-145) to Regulation (EU) No 1321/2014 (Draft EASA
opinion)
GENERAL
[Note: related AMC/GM:
GM1 to Annex II (Part-145) Definitions]
145.1 General Competent authority
Regulation (EU) No 1321/2014
For the purpose of this Part, the competent authority shall be:
(1). for organisations that haveing their principal place of business in a Member State, the
authority designated by that Member State or by another Member State in accordance with
Article 64 of Regulation (EU) 2018/1139, or the Agency pursuant to Articles 64 or 65 of
Regulation (EU) 2018/1139, or;
(2). for organisations that haveing their principal place of business located in a third country, the
Agency.
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SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS
145.A.10 Scope
This Section establishes the requirements to be met by an organisation to qualify for the issue or
continuation of a certificate an approval for the maintenance of aircraft and components.
[Note: related AMC/GM:
AMC1 145.A.10 Scope
GM1 145.A.10 Scope]
145.A.15 Application for an organisation certificate
An application for the issue or change of an approval shall be made to the competent authority in a
form and manner established by such authority.
(a) An application for a certificate or an amendment to an existing certificate in accordance with
this Annex shall be made in a form and manner established by the competent authority,
taking into account the applicable requirements of Annex I (Part-M), Annex Vb (Part-ML) and
this Annex.
(b) Applicants for an initial certificate pursuant to this Annex shall provide the competent
authority with:
(1) the results of a pre-audit performed by the organisation against the applicable
requirements provided for in Annex I (Part-M), Annex Vb (Part-ML) and this Annex;
(2) documentation demonstrating how they will comply with the requirements established
in this Regulation.
That documentation shall include, as provided for in point 145.A.85, a procedure that
describes how changes not requiring prior approval will be managed and notified to the
competent authority.
[Note: related AMC/GM:
AMC1 145.A.15 Application for an organisation certificate
AMC2 145.A.15 Application for an organisation certificate
GM1 145.A.15(b) Application for an organisation certificate
Appendix III to AMC1 145.A.15 EASA Form 2]
145.A.20 Terms of approval
(a) The approval is indicated on the certificate, which is included in Appendix III, and is issued by
the competent authority.
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(b) The organisation shall specify the scope of work deemed to constitute approval in its
maintenance organisation exposition (MOE) (Appendix IV to Annex I (Part-M) Appendix II
contains a table of all classes and ratings).
145.A.30 Personnel requirements1
(a) The organisation shall appoint an accountable manager who has corporate authority for
ensuring that all maintenance required by the customer can be financed and carried out in
accordance with Regulation (EU) 2018/1139 and its delegated and implementing acts to the
standard required by this Part. The accountable manager shall:
(1). ensure that all necessary resources are available to accomplish maintenance in
accordance with this Annex, Annex I (Part-M) and Annex Vb (Part-ML), as applicable,
with point 145.A.65(b) to support the organisation approval certificate;
(2). establish and promote the safety and quality policy specified in point 145.A.200(a)
145.A.65(a);
(3). demonstrate a basic understanding of this Regulation Annex (Part-145).
(b) The accountable manager organisation shall nominate a person or group of persons, whose
with the responsibility ies include for ensuring that the organisation is always in compliance
complies with this Annex, Annex I (Part-M) and Annex Vb (Part-ML) Part. Such person(s) shall
ultimately be responsible to the accountable manager.
1. The person or persons nominated shall represent the maintenance management
structure of the organisation and be responsible for all functions specified in this Part.
2. The person or persons nominated shall be identified and their credentials submitted in
a form and manner established by the competent authority.
3. The person or persons nominated shall be able to demonstrate relevant knowledge,
background and satisfactory experience related to aircraft or component maintenance
and demonstrate a working knowledge of this Part.
4. Procedures shall make clear who deputises for any particular person in the case of
lengthy absence of the said person.
(c) The accountable manager under point (a) shall appoint nominate a person or group of persons
with the responsibility for managing the compliance monitoring function the quality system,
including the associated feedback system as part of the management system required by
point 145.A.65(c). The appointed person shall have direct access to the accountable manager
to ensure that the accountable manager is kept properly informed on quality and compliance
matters.
(ca) The accountable manager shall nominate a person or group of persons with the responsibility
for managing the development, administration, and maintenance of effective safety
management processes as part of the management system.
1 This amendment is made to the text of 145.A.30 as proposed through Opinion No 06/2016
(https://www.easa.europa.eu/document-library/opinions/opinion-062016).
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(cb) The accountable manager shall ensure that the person or group of persons nominated in
accordance with points 145.A.30(b), (c) and (ca) have direct access to keep him/her properly
informed on compliance and safety matters.
(cc) The person or persons nominated in accordance with points 145.A.30(b), (c) and (ca) shall be
able to demonstrate relevant knowledge, background and satisfactory experience related to
aircraft or component maintenance and demonstrate a working knowledge of this Regulation.
Such person(s) shall be ultimately responsible to the accountable manager.
(d) The organisation shall have a maintenance man-hour plan showing to ensure that the
organisation has sufficient staff to plan, perform, supervise, inspect and quality monitor the
organisation’s activities in accordance with the terms of approval. In addition, the organisation
shall have a procedure to reassess work intended to be carried out when actual staff
availability is less than the planned staffing level for any particular work shift or period.
(e) The organisation shall establish and control the competence competency of personnel
involved in any maintenance, development of maintenance programmes, airworthiness
reviews, safety management and/or quality audits compliance monitoring in accordance with
a procedure and to a standard agreed by the competent authority. In addition to the
necessary expertise related to the job function, the competence competency of the personnel
must include an understanding of the application of safety management principles, as well as
human factors and human performance issues that are appropriate to that person's function
and responsibilities in the organisation. ‘Human factors’ means principles which apply to
aeronautical design, certification, training, operations and maintenance and which seek safe
interface between the human and other system components by proper consideration of
human performance. ‘Human performance’ means human capabilities and limitations which
have an impact on the safety and efficiency of aeronautical operations.
[…]
(j) By derogation to points (g) and (h), in relation to the obligation to comply with Annex III
(Part-66), the organisation may use certifying staff who are qualified in accordance with the
following provisions:
(1). For an organisation whose facilities are located outside the Community territory, the
certifying staff may be qualified in accordance with the national aviation regulations of
the State in which the organisation facility is registered, subject to the conditions
specified in Appendix IV to this Part.
(2). For line maintenance carried out at a line station of an organisation which is located
outside the Community territory, the certifying staff may be qualified in accordance
with the national aviation regulations of the State in which the line station is based,
subject to the conditions specified in Appendix IV to this Part.
(3). For a repetitive pre-flight airworthiness directive which specifically states that the flight
crew may carry out such airworthiness directive, the organisation may issue a limited
certification authorisation to the aircraft commander and/or the flight engineer on the
basis of the flight crew licence held. However, the organisation shall ensure that
sufficient practical training has been carried out to ensure that such the aircraft
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Proposed amendments to Part-145
commander or flight engineer can accomplish the airworthiness directive to the
required standard.
(4). In the case of aircraft operating away from a supported location, the organisation may
issue a limited certification authorisation to the commander and/or the flight engineer
on the basis of the flight crew licence held, subject to being satisfied that sufficient
practical training has been carried out to ensure that the commander or flight engineer
can accomplish the specified task to the required standard. The provisions of this point
shall be detailed in an exposition procedure.
(5). In the following unforeseen cases, where an aircraft is grounded at a location other
than the main base where no appropriate certifying staff are available, the organisation
contracted to provide maintenance support may issue a one-off certification
authorisation:
(i) to one of its employees that holdsing equivalent type authorisations on aircraft of
similar technology, construction and systems; or
(ii) to any person with not less than five 5 years maintenance experience and who
holdsing a valid ICAO aircraft maintenance licence rated for the aircraft type
requiring certification, provided that there is no organisation appropriately
approved under this Part at that location, and the contracted organisation
obtains and holds on file evidence of the experience and the licence of that
person.
All such cases as specified in this point must be reported to the competent authority within
seven 7 days after issuing such a certification authorisation. The organisation that issuesing
the one-off authorisation shall ensure that any such maintenance that could affect flight
safety is re-checked by an appropriately approved organisation.
(k) If the organisation performs airworthiness reviews and issues the corresponding airworthiness
review certificate for ELA1 aircraft not involved in commercial operations in accordance with
point ML.A.903 of Annex Vb (Part-ML), it shall have airworthiness review staff who are
qualified and authorised in accordance with point 145.A.37 point ML.A.904 of Annex Vb (Part-
ML).
[Note: related AMC/GM:
AMC1 145.A.30(a) Personnel requirements
AMC1 145.A.30(b) Personnel requirements
GM1 145.A.30(b) Personnel requirements
AMC1 145.A.30(c) Personnel requirements
AMC1 145.A.30(c);(ca) Personnel requirements
GM1 145.A.30(ca) Personnel requirements
AMC1 145.A.30(cc) Personnel requirements
AMC1 145.A.30(d) Personnel requirements
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AMC1 145.A.30(e) Personnel requirements
AMC2 145.A.30(e) Personnel requirements
AMC3 145.A.30(e) Personnel requirements
AMC4 145.A.30(e) Personnel requirements
AMC5 145.A.30(e) Personnel requirements
GM1 145.A.30(e) Personnel requirements
GM2 145.A.30(e) Personnel requirements
GM3 145.A.30(e) Personnel requirements
GM4 145.A.30(e) Personnel requirements
GM5 145.A.30(e) Personnel requirements
GM6 145.A.30(e) Personnel requirements
AMC1 145.A.30(f) Personnel requirements
AMC1 145.A.30(h) Personnel requirements
AMC1 145.A.30(j)(4) Personnel requirements
GM 145.A.30(j)(4) Personnel requirements (Flight crew)
AMC1 145.A.30(j)(5) Personnel requirements
AMC1 145.A.30(j)(5)(i) Personnel requirements
AMC1 145.A.30(j)(5)(ii) Personnel requirements
Appendix IV to AMC3 145.A.30(e) and AMC2 145.B.200(a)(3) 145.B.10(3) Fuel Ttank Ssafety
Ttraining]
145.A.35 Certifying staff and support staff
[…]
(d) The organisation shall ensure that all certifying staff and support staff receive sufficient
continuation recurrent training in each two-year 2-year period to ensure that such staff have
up-to-date knowledge of relevant technology, organisation procedures and safety
management, as well as human factor issues.
(e) The organisation shall establish a programme for continuation recurrent training for certifying
staff and support staff, including a procedure to ensure compliance with the relevant points of
145.A.35 as the basis for issuing certification authorisations under this Part to certifying staff,
and a procedure to ensure compliance with Annex III (Part-66).
(f) Except where any of the unforeseen cases of point 145.A.30(j)(5) apply, the organisation shall
assess all prospective certifying staff for their competence competency, qualification and
capability to carry out their intended certifying duties in accordance with a procedure as
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Proposed amendments to Part-145
specified in the exposition prior to the issue or re-issue of a certification authorisation under
this Part.
[…]
(i) The person responsible for the quality system compliance monitoring shall also remain
responsible on behalf of the organisation for issuing certification authorisations to certifying
staff. Such That person may nominate other persons to actually issue or revoke the
certification authorisations in accordance with a procedure as specified in the exposition.
(j) (Reserved) The organisation shall maintain a record of all certifying staff and support staff,
which shall contain:
1. the details of any aircraft maintenance licence held under Annex III (Part-66); and
2. all relevant training completed; and
3. the scope of the certification authorisations issued, where relevant; and
4. particulars of staff with limited or one-off certification authorisations.
The organisation shall retain the record for at least three years after the staff referred to in
this point have ceased employment with the organisation or as soon as the authorisation has
been withdrawn. In addition, upon request, the maintenance organisation shall furnish the
staff referred to in this point with a copy of their personal record on leaving the organisation.
The staff referred to in this point shall be given access on request to their personal records as
detailed above.
[…]
[Note: related AMC/GM:
AMC1 145.A.35(a) Certifying staff and support staff
AMC1 145.A.35(d) Certifying staff and support staff
AMC1 145.A.35(e) Certifying staff and support staff
AMC1 145.A.35(f) Certifying staff and support staff]
145.A.36 Records of airworthiness review staff
The organisation shall record all details concerning the airworthiness review staff and maintain a
current list of all the airworthiness review staff together with their scope of approval as part of the
organisation's exposition pursuant to point 145.A.70(a)6.
The organisation shall retain the record for at least three years after the staff referred to in this point
have ceased employment (or engagement as a contractor or volunteer) with the organisation or as
soon as the authorisation has been withdrawn. In addition, upon request, the maintenance
organisation shall provide the staff referred to in this point with a copy of their personal record on
leaving the organisation.
The staff referred to in this point shall be given access on request to their personal records.
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145.A.37 Airworthiness review staff
(a) In order to be approved to carry out airworthiness reviews, a Part-145 organisation shall have
appropriate airworthiness review staff who comply with all of the following requirements:
(1) they have acquired experience in continuing airworthiness of at least 1 year for
sailplanes and balloons and of at least 3 years for all other aircraft;
(2) they hold an appropriate licence issued in accordance with Annex III (Part-66) or a
nationally recognised maintenance personnel qualification appropriate to the aircraft
category (when Article 5(6) refers to national rules) or an aeronautical degree or
equivalent, or they have acquired experience in continuing airworthiness in addition to
that referred to in point (1) of at least 2 years for sailplanes and balloons and at least 4
years for all other aircraft;
(3) they have acquired appropriate aeronautical-maintenance training.
(b) Before the organisation issues an airworthiness review authorisation, the organisation shall
nominate the person who will perform an airworthiness review of an aircraft under
supervision of the competent authority or already authorised airworthiness review staff of the
organisation. If this supervision is satisfactory, the competent authority shall formally accept
that person to become airworthiness review staff.
(c) The Part-145 organisation shall ensure that the airworthiness review staff can demonstrate
appropriate recent continuing airworthiness experience.
145.A.45 Maintenance data
(a) The organisation shall hold and use applicable current maintenance data in the performance
of maintenance, including modifications and repairs. ‘Applicable’ means relevant to any
aircraft, component or process specified in the organisation's terms of approval approval class
rating schedule and in any associated capability list.
In the case of maintenance data provided by an operator or customer, the organisation shall
hold such data when the work is in progress, with the exception of the need to comply with
point 145.A.55(c) 145.A.55(a)(3).
(b) For the purposes of this Part, applicable maintenance data shall be any of the following:
(1). Any applicable requirement, procedure, operational directive or information issued by
the authority responsible for the oversight of the aircraft or component;
(2). Any applicable airworthiness directive issued by the authority responsible for the
oversight of the aircraft or component;
(3). Instructions for continuing airworthiness, issued by type certificate holders,
supplementary type certificate holders, any other organisation required to publish such
data by Annex I (Part- 21) to Regulation (EU) No 748/2012, and in the case of aircraft or
components from third countries, the airworthiness data mandated by the authority
responsible for the oversight of the aircraft or component;
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(4). Any applicable standard, such as but not limited to, maintenance standard practices
recognised by the Agency as a good standards for maintenance;
(5). Any applicable data issued in accordance with point (d).
(c) The organisation shall establish procedures to ensure that if found, any inaccurate, incomplete
or ambiguous procedure, practice, information or maintenance instruction contained in the
maintenance data used by maintenance personnel is found, it is recorded as part of the
internal safety reporting scheme referred to in point 145.A.202, and notified to the author of
the maintenance data.
(d) The organisation may only modify maintenance instructions in accordance with a procedure
that is specified in the maintenance organisation's exposition. With respect to those changes,
the organisation shall demonstrate that they result in equivalent or improved maintenance
standards, and shall inform the type-certificate holder of any such changes. Maintenance
instructions for the purposes of this point means instructions on how to carry out the
particular maintenance task: they exclude the engineering design of repairs and modifications.
(e) The organisation shall provide a common work card or worksheet system to be used
throughout the relevant parts of the organisation. In addition, the organisation shall either
accurately transcribe accurately the maintenance data contained in points (b) and (d) onto
such work cards or worksheets, or make precise reference to the particular maintenance task
or tasks contained in such that maintenance data. Work cards and worksheets may be
computer-generated and held on an electronic database that is subject to both adequate
safeguards against unauthorised alteration, and for which there is a back-up electronic
database, which shall be updated within 24 hours of any entry made to the main electronic
database. Complex maintenance tasks shall be transcribed onto the work cards or worksheets
and subdivided into clear stages to ensure that there is a record of the accomplishment of the
complete maintenance task. The procedures under this point shall take into account human
factors and human performance limitations.
Where the organisation provides a maintenance service to an aircraft operator who requires
their work cards or worksheet system to be used, then such those work cards or that
worksheet system may be used. In this case, the organisation shall establish a procedure to
ensure correct completion of that the aircraft operator’s' work cards or worksheets are
correctly completed.
(f) The organisation shall ensure that all applicable maintenance data is readily available for use
when required by maintenance personnel.
(g) The organisation shall establish a procedure to ensure that maintenance data it controls is
kept up to date. In the case of operator/customer-controlled and provided maintenance data,
the organisation shall be able to show that either it either has written confirmation from the
operator/customer that all such maintenance data is up to date, or that it has work orders
that specifying the amendment status of the maintenance data to be used, or that it can show
that it is on the operator/customer maintenance data amendment list.
[Note: related AMC/GM:
AMC1 145.A.45(c) Maintenance data
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AMC1 145.A.45(d) Maintenance data
AMC1 145.A.45(e) Maintenance data]
145.A.47 Production planning
(a) The organisation shall have a system appropriate to the amount and complexity of work to
plan the availability of all necessary personnel, tools, equipment, material, maintenance data
and facilities in order to ensure the safe completion of the maintenance work.
(b) As part of the management system, The the planning of maintenance tasks, and the organising
of shifts, shall take into account human performance limitations, including the risk of fatigue
for maintenance personnel.
(c) When it is required to hand over the continuation or completion of maintenance tasks for
reasons of a shift or personnel changeover, relevant information shall be adequately
communicated between the outgoing and the incoming personnel.
(d) The organisation shall ensure that any aviation safety hazards associated with external
working teams carrying out maintenance at the organisation’s facility are considered by the
organisation’s management system.
[Note: related AMC/GM:
AMC1 145.A.47(b) Production planning
GM1 AMC 145.A.47(b) Production planning
GM1 145.A.47(d) Production planning]
145.A.48 Performance of maintenance
(a) The organisation shall only carry out maintenance on an aircraft or component for which it is
approved when all the necessary facilities, equipment, tooling, material, maintenance data
and personnel are available.
(b) The organisation shall be responsible for the maintenance that is performed under its
approval.
(c) The organisation shall establish procedures to ensure that:
(1)(a) after the completion of the maintenance, a general verification is carried out to ensure
that the aircraft or component is clear of all tools, equipment and any extraneous parts
or material, and that all access panels that were removed have been refitted;
(2)(b) an error-capturing method is implemented after the performance of any critical
maintenance task;
(3)(c) the risk of multiple errors during maintenance and the risk of errors being repeated in
identical maintenance tasks are minimised; and,
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(4)(d) damage is assessed, and modifications and repairs are carried out using the data
specified in point M.A.304.
Any hazards identified in relation to these tasks shall be addressed in accordance with the
organisation’s safety risk management procedures required by point 145.A.200(a)(3).
[Note: related AMC/GM:
AMC1 145.A.48(a) AMC 145.A.80 Limitations on the organisation Performance of maintenance
AMC1 145.A.48(c)(2) AMC1 145.A.48(b) Performance of maintenance
AMC2 145.A.48(c)(2) AMC2 145.A.48(b) Performance of maintenance
AMC3 145.A.48(c)(2) AMC3 145.A.48(b) Performance of maintenance
AMC4 145.A.48(c)(2) AMC4 145.A.48(b) Performance of maintenance
AMC1 145.A.48(c)(3) Performance of maintenance
GM1 145.A.48(c)(3) Performance of maintenance
GM1 145.A.48(c)(4) GM 145.A.48(d) Performance of maintenance - critical design
configuration control limitations (CDCCL)]
145.A.50 Certification of maintenance
(a) A certificate of release to service shall be issued by appropriately authorised certifying staff on
behalf of the organisation when it has been verified that all the maintenance that was ordered
has been properly carried out by the organisation in accordance with the procedures specified
in point 145.A.70, taking into account the availability and use of the maintenance data
specified in point 145.A.45, and that there are no known non-compliances which are known to
endanger flight safety.
[…]
[Note: related AMC/GM:
GM1 AMC 145.A.50(a) Certification of maintenance
AMC1 145.A.50(b) Certification of maintenance
AMC1 145.A.50(e) Certification of maintenance]
145.A.55 Record-keeping1 Maintenance and airworthiness review
records
(a) Maintenance records
(1)(a) The organisation shall record all the details of any maintenance work that is carried out.
As a minimum, the organisation shall retain all the records that are necessary to prove
1 This amendment is made to the text of 145.A.55 as proposed through Opinion No 13/2016
(https://www.easa.europa.eu/document-library/opinions/opinion-132016).
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that all the requirements have been met for the issue of the certificate of release to
service, including the subcontractor's release documents and for the issue of any
airworthiness review certificate and recommendation.
(2)(b) The organisation shall provide a copy of each certificate of release to service to the
aircraft owner/operator, together with a copiesy of any detailed maintenance records
that are associated with the work carried out and that are necessary to demonstrate
compliance with point M.A.305.
(3)(c) The organisation shall retain a copy of all detailed maintenance records (including
certificates of release to service) and any associated maintenance data for three 3 years
from the date when the aircraft or component to which the work relates was released
from the organisation.
In addition, it shall retain a copy of all the records related to the issue of
airworthiness review certificates and recommendations for three years from the date of
issue and shall provide a copy of them to the owner of the aircraft.
1. The records under this point shall be stored in a manner that ensures protection from
damage, alteration and theft.
2. Computer backup discs, tapes etc. shall be stored in a different location from that
containing the working discs, tapes etc., in an environment that ensures they remain in
good condition.
(4)3. Where If an organisation approved under this Annex (Part-145) terminates its
operation, all the retained maintenance records covering the last three 3 years shall be
transferred distributed to the last owner or customer of the respective aircraft or
component, or shall be stored as in the manner specified by the competent authority.
(b) Airworthiness review records
(1) If an organisation has the privilege referred to in point 145.A.75(f), it shall retain a copy
of each airworthiness review certificate that it has issued, together with all the
supporting documents, and shall make these records available, upon request, to the
owner of the aircraft.
(2) The organisation shall retain a copy of all the records referred to in point (b)(1) for 3
years after the issue of the airworthiness review certificate.
(3) If an organisation terminates its operation, all the retained airworthiness review records
covering the last 3 years shall be transferred to the last owner or customer of the
respective aircraft, or shall be stored in the manner specified by the competent
authority.
(c) Management system, contracting and subcontracting records
(1) The organisation shall ensure that the following records are retained:
(i) records of management system key processes as defined in point 145.A.200;
(ii) contracts, both for contracting and subcontracting, as defined in point 145.A.205;
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(2) Management system records, as well as any contracts pursuant to point 145.A.205,
shall be kept for a minimum period of 5 years.
(d) Personnel records
(1) The organisation shall ensure that the following records are retained:
(i) records of the qualifications and the experience of the personnel involved in
maintenance, compliance monitoring and safety management;
(ii) records of the qualifications and the experience of all the airworthiness review
staff.
(2) The records of all the airworthiness review staff shall include details of any appropriate
qualifications held, together with a summary of their relevant continuing airworthiness
experience and training, and a copy of the authorisation.
(3) The records of all the certifying staff and support staff shall contain the following:
(i) the details of any aircraft maintenance licence held under Annex III (Part-66) or
equivalent;
(ii) all the relevant training that they completed;
(iii) the scope of the certification authorisations that were issued, where relevant;
(iv) the particulars of the staff that held limited or one-off certification
authorisations.
(4) Personnel records shall be kept as long as a person works for the organisation, and shall
be retained until 3 years after the person has left the organisation, or after an
authorisation has been withdrawn.
(5) The staff referred to in (d)(2) and (d)(3) shall upon request be given access to their
personnel records as detailed above. In addition, upon request, the maintenance
organisation shall furnish each of them with a copy of their personnel records on
leaving the organisation.
(e) The organisation shall establish a system of record-keeping that allows adequate storage and
reliable traceability of all the activities developed.
(f) The format of the records shall be specified in the organisation’s procedures.
(g) Records shall be stored in a manner that ensures that they are protected from damage,
alteration and theft.
[Note: related AMC/GM:
AMC1 145.A.55 Record-keeping
GM1 145.A.55 Record-keeping
GM1 145.A.55(a)(1) Record-keeping Maintenance and airworthiness review records
AMC1 145.A.55(a)(3) AMC 145.A.55(c) Record-keeping Maintenance and airworthiness review
records
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Proposed amendments to Part-145
AMC1 145.A.55(d) AMC 145.A.35(j) Certifying staff and support staff Record-keeping
AMC2 145.A.55(d) AMC 145.A.36 Record-keeping Records of airworthiness review staff]
145.A.60 Occurrence reporting
(a) As part of its management system, the organisation shall implement an occurrence reporting
system that meets the requirements as defined in Regulation (EU) No 376/2014(1) and
Implementing Regulation (EU) 2015/1018(2). The organisation shall report to the competent
authority, the state of registry and the organisation responsible for the design of the aircraft
or component any condition of the aircraft or component identified by the organisation that
has resulted or may result in an unsafe condition that hazards seriously the flight safety.
(b) Without prejudice to point (a), the organisation shall ensure that any incident, malfunction,
technical defect, exceeding of technical limitations, occurrence that would highlight
inaccurate, incomplete or ambiguous information contained in data established in accordance
with Annex I (Part 21) to Regulation (EU) No 748/2012 or other irregular circumstance that has
or may have endangered the safe operation of the aircraft and that has not resulted in an
accident or serious incident are reported to the competent authority and to the organisation
responsible for the design of the aircraft. The organisation shall establish an internal
occurrence reporting system as detailed in the exposition to enable the collection and
evaluation of such reports, including the assessment and extraction of those occurrences to
be reported under point (a). This procedure shall identify adverse trends, corrective actions
taken or to be taken by the organisation to address deficiencies and include evaluation of all
known relevant information relating to such occurrences and a method to circulate the
information as necessary.
(c) Without prejudice to Regulation (EU) No 376/2014 and Implementing Regulation (EU)
2015/1018, the reports referred to in points (a) and (b) shall be made The organisation shall
make such reports in a form and manner established by the competent authority and shall
Agency and ensure that they contain all pertinent information about the condition and
evaluation results known to the organisation.
(d) Where If the organisation is contracted by a commercial operator to carry out maintenance,
the organisation shall also report to the operator any such condition that affectsing the
operator's aircraft or component.
(e) The organisation shall produce and submit such reports Reports shall be made as soon as
practicable possible, but in any case within 72 hours of the organisation identifying the
condition to which the report relates, unless exceptional circumstances prevent this.
(1) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis
and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and
of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission
Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1550059605071&uri=CELEX:32014R0376).
(2) Regulation (EU) 2015/1018 of 29 June 2015 laying down a list classifying occurrences in civil aviation to be mandatorily
reported according to Regulation (EU) No 376/2014 of the European Parliament and of the Council (OJ L163,
30,06,2015, p. 1). (https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1550744323518&uri=CELEX:32015R1018)
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(f) Where relevant, the organisation shall produce a follow-up report to provide details of the
actions it intends to take to prevent similar occurrences in the future, as soon as these actions
have been identified. This report shall be produced in a form and manner established by the
competent authority.
[Note: related AMC/GM:
AMC 145.A.60(b) Occurrence reporting]
145.A.65 Safety and quality policy, Maintenance procedures and
quality system
(a) The organisation shall establish a safety and quality policy for the organisation to be included
in the exposition under point 145.A.70.
(b) The organisation shall establish procedures agreed by the competent authority, which ensure
that taking into account human factors, and human performance to ensure and good
maintenance practices are taken into account during maintenance, including all contracted
and subcontracted activities, and which comply with the requirements of this Annex
compliance with the applicable requirements established in 145.A.25 to 145.A.95. The
maintenance procedures established under this point shall:
(1). ensure that a clear work order or contract has been agreed between the organisation
and the organisation requesting maintenance to clearly establish the maintenance to be
carried out so that the aircraft and components may be released to service in
accordance with point 145.A.50; and,
(2). cover all aspects of carrying out the maintenance, including the provision and control of
specialised services, and lay down the standards to which the organisation intends to
work.
(c) The organisation shall establish a quality system that includes the following:
1. Independent audits in order to monitor compliance with required aircraft/aircraft
component standards and adequacy of the procedures to ensure that such procedures
invoke good maintenance practices and airworthy aircraft/aircraft components. In the
smallest organisations the independent audit part of the quality system may be
contracted to another organisation approved under this Part or a person with
appropriate technical knowledge and proven satisfactory audit experience; and
2. A quality feedback reporting system to the person or group of persons specified in point
145.A.30(b) and ultimately to the accountable manager that ensures proper and timely
corrective action is taken in response to reports resulting from the independent audits
established to meet point (1).
[Note: related AMC/GM:
AMC 145.A.65(a) Safety and quality policy, maintenance procedures and quality system
AMC1 145.A.65(b) Safety and quality policy, Maintenance procedures and quality system
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GM1 145.A.65 Maintenance procedures
GM2 145.A.65(b)(1) Safety and quality policy, Maintenance procedures and quality system
AMC1 145.A.65(b)(2) Safety and quality policy, Maintenance procedures and quality system]
145.A.70 Maintenance organisation exposition (MOE)
(a) ‘Maintenance organisation exposition’ means the document or documents that contain the
material specifying the scope of work deemed to constitute approval and showing how the
organisation intends to comply with this Annex (Part-145).
The organisation shall provide the competent authority with establish a maintenance
organisation exposition (MOE) that, containing the following information:
specifies the scope of work and shows how the organisation intends to comply with this
Annex; and
provides all the necessary instructions, information and procedures for the personnel of
the organisation to perform their duties.
It shall contain directly, or by reference, all of the following information:
(1). A statement signed by the accountable manager confirming that the maintenance
organisation will at all times work in accordance exposition and any referenced
associated manuals define the organisation's compliance with this Annex (Part-145),
Annex I (Part-M) and Annex Vb (Part-ML), as applicable, and will be complied with the
approved MOE at all times. When If the accountable manager is not the chief executive
officer of the organisation, then such the chief executive officer shall countersign the
statement;
(2). the organisation's safety and quality policy and the related safety objectives as specified
by point 145.A.200(a)(2) 145.A.65;
(3). the title(s) and name(s) of the persons nominated under point 145.A.30(b), (c) and (ca);
(4). the duties and responsibilities of the persons nominated under point 145.A.30(b), (c)
and (ca), including the matters on which they may deal directly with the competent
authority on behalf of the organisation;
(5). an organisation chart showing the associated chains of accountability and responsibility
between all the persons referred to in nominated under points 145.A.30(b), (c), (ca), (h)
and (k), and related to point 145.A.200(a)(1);
(6). a list of the certifying staff, support staff and, if applicable, the airworthiness review
staff and staff responsible for the development and processing of the maintenance
programme, with their scopes of approval;
(7). a general description of the manpower resources and of the system that is in place to
plan the availability of staff, as required by point 145.A.30(d);
(8). a general description of the facilities located at each address specified in the
organisation's approval certificate;
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(9). a specification of the scope of work of the organisation's that is scope of work relevant
to the extent terms of approval;
(10). the notification procedure of point 145.A.85 for organisation changes; the procedure
that defines the scope of changes not requiring prior approval, and that describes how
such changes will be managed and notified, as required by points 145.A.15(b) and
145.A.85(c);
(11). the procedure for amending the maintenance organisation exposition MOE amendment
procedure;
(12). the procedures and quality management system documentation established by the
organisation under points 145.A.25 to 145.A.205 145.A.90, and any additional
procedure that is followed in accordance with Annex I (Part-M) or Annex Vb (Part-ML);
(13). a list of all the commercial operators, where applicable, to which the organisation
provides an aircraft maintenance service, and the associated procedures;
(14). a list of all the subcontracted organisations, where applicable, as specified in point
145.A.75(b);
(15). a list of all the approved locations, including line stations, where applicable, as specified
in point 145.A.75(d);
(16). a list of all the contracted organisations, where applicable;.
(17) a list of the currently approved alternative means of compliance.
(b) The initial issue of the MOE shall be approved by the competent authority. The exposition It
shall be amended as necessary so that it to remains an up-to-date description of the
organisation. The exposition and any subsequent amendment shall be approved by the
competent authority.
(c) Amendments to the MOE shall be managed as defined in the procedures referred to in points
(10) and (11). Any amendments that are not included in the scope of the procedure referred
to in point (10), as well as any amendments related to the changes listed in point 145.A.85(a),
shall be approved by the competent authority.
Notwithstanding point (b) minor amendments to the exposition may be approved through an
exposition procedure (hereinafter called indirect approval).
[Note: related AMC/GM:
AMC1 145.A.70(a) Maintenance organisation exposition (MOE)
GM1 145.A.70(a) Maintenance organisation exposition (MOE)
AMC1 145.A.70(a)(1) Maintenance organisation exposition (MOE)]
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145.A.75 Privileges of the organisation1
In accordance with the MOE exposition, the organisation shall be entitled to carry out the following
tasks:
(a) Maintain any aircraft and/or component for which it is approved at the locations identified in
the approval certificate and in the MOE exposition;
(b) Arrange for the maintenance of any aircraft or component for which it is approved at another
subcontracted organisation that is working under the quality management system of the
organisation. This refers to work being carried out by an organisation not itself appropriately
approved to carry out such maintenance under this Part and is limited to the work scope
permitted under the procedures laid down in point 145.A.65(b). This work scope and it shall
not include a base maintenance check of an aircraft, or a complete workshop maintenance
check or overhaul of an engine or an engine module;
[…]
(f) If specifically approved to do so for aircraft covered by Annex Vb (Part-ML) ELA1 aircraft not
involved in commercial operations, and if it has its principal place of business in one of the
Member States, it shall perform airworthiness reviews and issue the corresponding
airworthiness review certificate under the conditions specified in point ML.A.903 of Annex Vb
(Part-ML) to this Regulation.
[Note: related AMC/GM:
AMC1 145.A.75(b) Privileges of the organisation
GM1 145.A.75(b) Privileges of the organisation]
145.A.80 Limitations on the organisation
The organisation shall only maintain an aircraft or component for which it is approved when all the
necessary facilities, equipment, tooling, material, maintenance data and certifying staff are available.
145.A.85 Changes to the organisation
(a) The following changes to the organisation shall require prior approval:
(1) changes that affect the scope of the certificate or the terms of approval of the
organisation;
(2) changes to the personnel nominated in accordance with points 145.A.30(b), (c) and (ca);
(3) changes to the reporting lines between the personnel nominated in accordance with
points 145.A.30(b), (c) and (ca), and the accountable manager;
(4) the procedure as regards changes not requiring prior approval referred to in point (c);
1 This amendment is made to the text of 145.A.75 as proposed through Opinion No 06/2016
(https://www.easa.europa.eu/document-library/opinions/opinion-062016).
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(5) additional locations of the organisation other than those that are subject to point
145.A.75(c).
(b) For all changes requiring prior approval in accordance with Regulation (EU) 2018/1139 and its
delegated and implementing acts, the organisation shall apply for and obtain an approval
issued by the competent authority. The application shall be submitted before any such change
takes place, in order to enable the competent authority to determine that there is continued
compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts, and to
amend, if necessary, the organisation certificate and the related terms of approval that are
attached to it.
The organisation shall provide the competent authority with any relevant documentation.
The change shall only be implemented upon the receipt of a formal approval from the
competent authority in accordance with point 145.B.330.
The organisation shall operate under the conditions prescribed by the competent authority
during such changes, as applicable.
(c) All changes not requiring prior approval shall be managed and notified to the competent
authority as defined in the procedure referred to in point 145.A.15(b), which is approved by
the competent authority in accordance with point 145.B.310(h).
The organisation shall notify the competent authority of any proposal to carry out any of the
following changes before such changes take place to enable the competent authority to determine
continued compliance with this Part and to amend, if necessary, the approval certificate, except that
in the case of proposed changes in personnel not known to the management beforehand, these
changes must be notified at the earliest opportunity:
1. the name of the organisation;
2. the main location of the organisation;
3. additional locations of the organisation;
4. the accountable manager;
5. any of the persons nominated under point 145.A.30(b);
6. the facilities, equipment, tools, material, procedures, work scope, certifying staff and
airworthiness review staff that could affect the approval.
[Note: related AMC/GM:
AMC1 145.A.85 Changes to the organisation
AMC2 145.A.85 Changes to the organisation
GM1 145.A.85 Changes to the organisation
GM1 145.A.85(a)(1) Changes to the organisation
GM2 145.A.85(a)(1) Changes to the organisation
GM1 145.A.85(b) Changes to the organisation
GM1 145.A.85(c) Changes to the organisation]
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145.A.90 Continued validity
(a) An approval shall be issued for an unlimited duration. It The organisation’s certificate shall
remain valid, subject to compliance with all of the following conditions:
1. the organisation remaining in compliance with Regulation (EU) 2018/1139 and its
delegated and implementing acts Annex II (Part-145), in accordance with, taking into
account the provisions related to the handling of findings as specified under point
145.B.350 145.B.50; and
2. the competent authority being granted access to the organisation as specified in point
145.A.140 to determine continued compliance with this Part; and
3. the certificate not being surrendered or revoked.
(b) Upon surrender or revocation, the certificate approval shall be returned to the competent
authority without delay.
145.A.95 Findings
(a) After the receipt of a notification of findings according to point 145.B.350, the organisation
shall:
(1) identify the root cause or causes of, and contributing factors to, the non-compliance;
(2) define a corrective action plan;
(3) demonstrate the implementation of corrective action to the satisfaction of the
competent authority.
(b) The actions referred to in points (a)(1), (a)(2) and (a)(3) shall be performed within the period
agreed with that competent authority as defined in point 145.B.350.
(a) A level 1 finding is any significant non-compliance with requirements laid down in this Annex
(Part-145) which lowers the safety standard and hazards seriously the flight safety.
(b) A level 2 finding is any non-compliance with requirements laid down in this Annex (Part-145)
which could lower the safety standard and possibly hazard the flight safety.
(c) After receipt of notification of findings according to point 145.B.50, the holder of the
maintenance organisation approval shall define a corrective action plan and demonstrate
corrective action to the satisfaction of the competent authority within a period agreed with
this authority.
[Note: related AMC/GM:
AMC1 145.A.95 Findings
GM1 145.A.95 Findings]
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145.A.120 Means of compliance
(a) Alternative means of compliance to the AMC adopted by the Agency may be used by an
organisation to establish compliance with Regulation (EU) 2018/1139 and its delegated and
implementing acts.
(b) If an organisation wishes to use an alternative means of compliance, it shall, prior to using it,
provide the competent authority with a full description of the alternative means of
compliance. The description shall include any revisions to manuals or procedures that may be
relevant, as well as an assessment that demonstrates compliance with Regulation (EU)
2018/1139 and its delegated and implementing acts.
The organisation may use these alternative means of compliance subject to receiving a prior
approval from the competent authority, and upon receipt of the notification as provided for in
point 145.B.120.
[Note: related AMC/GM:
AMC1 145.A.120 Means of compliance]
145.A.140 Access
For the purpose of determining compliance with the relevant requirements of Regulation (EU)
2018/1139 and its delegated and implementing acts, the organisation shall grant access at any time
to any facility, aircraft, document, records, data, procedures or any other material relevant to its
activity subject to certification, whether it is contracted/subcontracted or not, to any person
authorised by one of the following authorities:
(a) the competent authority defined in point 145.1;
(b) the authority acting under the provisions of point 145.B.300(d) or 145.B.300(e).
145.A.155 Immediate reaction to a safety problem
The organisation shall implement:
(a) any safety measures mandated by the competent authority in accordance with point
145.B.135;
(b) any relevant mandatory safety information issued by the Agency.
145.A.200 Management system
(a) The organisation shall establish, implement, and maintain a management system that
includes:
(1) clearly defined lines of responsibility and accountability throughout the organisation,
including a direct safety accountability of the accountable manager;
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(2) a description of the overall philosophies and principles of the organisation with regard
to safety, referred to as the safety policy, and the related safety objectives;
(3) the identification of aviation safety hazards entailed by the activities of the
organisation, their evaluation and the management of the associated risks, including
taking actions to mitigate the risks and verify their effectiveness;
(4) maintaining personnel trained and competent to perform their tasks;
(5) documentation of all management system key processes, including a process for making
personnel aware of their responsibilities and the procedure for amending this
documentation;
(6) a function to monitor the compliance of the organisation with the relevant
requirements. Compliance monitoring shall include a system to feed back findings to
the accountable manager to ensure the effective implementation of corrective actions
as necessary;
(7) any additional relevant requirements that are laid down in this Regulation.
(b) The management system shall correspond to the size of the organisation and the nature and
complexity of its activities, taking into account the hazards and the associated risks inherent in
these activities.
(c) If the organisation holds one or more additional organisation certificates within the scope of
Regulation (EU) 2018/1139, the management system may be integrated with that required
under the additional certificate(s) held.
[Note: related AMC/GM:
GM1 145.A.200 Management system
AMC1 145.A.200(a)(1) Management system
GM1 145.A.200(a)(1) Management system
GM2 145.A.200(a)(1) Management system
AMC1 145.A.200(a)(2) Management system
GM1 145.A.200(a)(2) Management system
AMC1 145.A.200(a)(3) Management system
GM1 145.A.200(a)(3) Management system
GM2 145.A.200(a)(3) Management system
AMC1 145.A.200(a)(4) Management system
GM1 145.A.200(a)(4) Management system
GM1 145.A.200(a)(5) Management system
AMC1 145.A.200(a)(6) Management system
AMC2 145.A.200(a)(6) AMC 145.A.65(c)(1) Management System
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Proposed amendments to Part-145
AMC3 145.A.200(a)(6) Management System
AMC4 145.A.200(a)(6) AMC 145.A.65(c)(2) Safety and quality policy, maintenance procedures
and quality system Management System
GM1 145.A.200(a)(6) Management system
GM2 145.A.200(a)(6) GM 145.A.65(c)(1) Safety and quality policy, maintenance procedures
and quality system Management system]
145.A.202 Internal safety reporting scheme
(a) As part of its management system, the organisation shall establish an internal safety reporting
scheme to enable the collection and evaluation of such occurrences that are to be reported
under point 145.A.60.
(b) The scheme shall also enable the collection and evaluation of those errors, near misses, and
hazards reported internally that do not fall under point (a).
(c) Through this scheme, the organisation shall:
(1) identify the causes of, and contributing factors to, any errors, near misses, and hazards
reported, and address them as part of their safety risk management process in
accordance with point 145.A.200(a)(3);
(2) ensure an evaluation of all the known, relevant information relating to errors, the
inability to follow procedures, near misses, and hazards, and a method to circulate the
information as necessary.
(d) The organisation shall make arrangements to ensure the collection of any safety issues related
to subcontracted activities.
(e) The organisation shall cooperate on safety investigations with any other organisation that
makes a significant contribution to the safety of its own maintenance activities.
[Note: related AMC/GM:
AMC1 145.A.202 Internal safety reporting scheme
GM1 145.A.202 Internal safety reporting scheme]
145.A.205 Contracting and subcontracting
(a) The organisation shall ensure that when contracting or subcontracting any part of its
maintenance activities, or when purchasing equipment or services:
(1) these maintenance activities conform to the requirements of this Annex; and
(2) any aviation safety hazards associated with such contracting, subcontracting or
purchase are considered as part of the organisation’s management system.
(b) If the organisation subcontracts any part of its maintenance activities to another organisation,
the subcontracted organisation shall work under the approval of the organisation. The
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organisation shall ensure that the competent authority is given access to the subcontracted
organisation to determine whether there is continued compliance with the applicable
requirements.
[Note: related AMC/GM:
GM1 145.A.205 Contracting and subcontracting
GM2 145.A.205 Contracting and subcontracting]
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[Section B is replaced by:]
SECTION B — AUTHORITY REQUIREMENTS
145.B.005 Scope
This section establishes the administrative and management system requirements to be followed by
the competent authority that is in charge of the implementation and enforcement of Section A of
this Annex.
145.B.115 Oversight documentation
The competent authority shall provide all the legislative acts, standards, rules, technical publications,
and related documents to the relevant personnel in order to allow them to perform their tasks and
to discharge their responsibilities.
145.B.120 Means of compliance
(a) The Agency shall develop Acceptable Means of Compliance (‘AMC’) that may be used to
establish compliance with Regulation (EU) 2018/1139 and its delegated and implementing
acts.
(b) Alternative means of compliance may be used to establish compliance with Regulation
(EU) 2018/1139 and its delegated and implementing acts.
(c) The competent authority shall establish a system to consistently evaluate that all alternative
means of compliance used by itself or by organisations under its oversight allow for the
establishment of compliance with Regulation (EU) 2018/1139 and its delegated and
implementing acts.
(d) The competent authority shall evaluate all the alternative means of compliance proposed by
an organisation in accordance with point 145.A.120 by analysing the documentation provided
and, if considered necessary, by conducting an inspection of the organisation.
When the competent authority finds that the alternative means of compliance are in
accordance with Regulation (EU) 2018/1139 and its delegated and implementing acts, it shall
without undue delay:
(1) notify the applicant that the alternative means of compliance may be implemented and,
if applicable, amend the approval or certificate of the applicant accordingly;
(2) notify the Agency of their content, and include copies of all the relevant
documentation.
(e) If the competent authority itself uses alternative means of compliance to achieve compliance
with Regulation (EU) 2018/1139 and its delegated and implementing acts, it shall:
(1) make them available to all the organisations and persons under its oversight;
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(2) notify the Agency without undue delay .
The competent authority shall provide the Agency with a full description of the alternative
means of compliance, including any revisions to procedures that may be relevant, as well as
an assessment demonstrating that they comply with Regulation (EU) 2018/1139 and its
delegated and implementing acts.
[Note: related AMC/GM:
GM1 145.B.120 Means of compliance
AMC1 145.B.120(e) Means of compliance]
145.B.125 Information to the Agency
(a) The competent authority shall notify the Agency without undue delay if there are any
significant problems with the application of Regulation (EU) 2018/1139 and its delegated and
implementing acts.
(b) The competent authority shall provide the Agency with any safety-significant information
stemming from the occurrence reports it has received pursuant to point 145.A.60.
145.B.135 Immediate reaction to a safety problem
(a) Without prejudice to Regulation (EU) No 376/2014 and Implementing Regulation (EU)
2015/1018, the competent authority shall implement a system to appropriately collect,
analyse, and disseminate safety information.
(b) The Agency shall implement a system to appropriately analyse any relevant safety information
received, and without undue delay, provide to Member States and the Commission any
information, including recommendations or corrective actions to be taken, that is necessary
for them to react in a timely manner to a safety problem involving products, parts, appliances,
persons or organisations that are subject to Regulation (EU) 2018/1139 and its delegated and
implementing acts.
(c) Upon receiving the information referred to in points (a) and (b), the competent authority shall
take adequate measures to address the safety problem.
(d) Measures taken under point (c) shall immediately be notified to all persons or organisations
which need to comply with them under Regulation (EU) 2018/1139 and its delegated and
implementing acts. The competent authority shall also notify those measures to the Agency
and, when combined action is required, to the other Member States concerned.
145.B.200 Management system
(a) The competent authority shall establish and maintain a management system, including as a
minimum:
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(1) documented policies and procedures to describe its organisation, means and methods
to achieve compliance with Regulation (EU) 2018/1139 and its delegated and
implementing acts. The procedures shall be kept up to date, and serve as the basic
working documents within that competent authority for all related tasks;
(2) a sufficient number of personnel to perform its tasks and discharge its responsibilities. A
system shall be in place to plan the availability of personnel, in order to ensure the
proper completion of all tasks;
(3) personnel who are qualified to perform their allocated tasks and who have the
necessary knowledge, experience, initial and recurrent training to ensure continuing
competency;
(4) adequate facilities and office accommodation to perform the allocated tasks;
(5) a function to monitor the compliance of the management system with the relevant
requirements, and the adequacy of the procedures, including the establishment of an
internal audit process and a safety risk management process. Compliance monitoring
shall include a system to feed back audit findings to the senior management of the
competent authority to ensure the implementation of corrective actions as necessary;
(6) a person or group of persons ultimately responsible to the senior management of the
competent authority for the compliance monitoring function.
(b) The competent authority shall, for each field of activity, including the management system,
appoint one or more persons with the overall responsibility for the management of the
relevant task(s).
(c) The competent authority shall establish procedures for participation in a mutual exchange of
all necessary information and assistance with any other competent authorities concerned,
including all findings raised and any follow-up actions taken as a result of the oversight of
persons and organisations who carry out activities in the territory of a Member State, but
certified by the competent authority of another Member State or the Agency.
(d) A copy of the procedures related to the management system and their amendments shall be
made available to the Agency for the purpose of standardisation.
[Note: related AMC/GM:
AMC1 145.B.200 Management system
AMC2 145.B.200 Management system
AMC1 145.B.200(a)(1) Management system
GM1 145.B.200(a)(2) Management system
AMC1 145.B.200(a)(3) Management system
AMC2 145.B.200(a)(3) Management system
AMC3 145.B.200(a)(3) Management system
AMC1 145.B.200(a)(5) Management system
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Proposed amendments to Part-145
GM1 145.B.200(a)(5) Management system
AMC1 145.B.200(d) Management system
Appendix IV to AMC3 145.A.30(e) and AMC2 145.B.200(a)(3) 145.B.10(3) Fuel Ttank Ssafety
Ttraining]
145.B.205 Allocation of tasks to qualified entities
(a) Tasks related to the initial certification, or to the continuing oversight of persons, or
organisations subject to Regulation (EU) 2018/1139 and its delegated and implementing acts,
may be allocated only to qualified entities. When allocating tasks, the competent authority
shall ensure that it has:
(1) put a system in place to initially and continuously assess whether the qualified entity
complies with Annex VI ‘Essential requirements for qualified entities’ to Regulation (EU)
2018/1139. This system and the results of the assessments shall be documented;
(2) established a documented agreement with the qualified entity, approved by both
parties at the appropriate management level, which clearly defines:
(i) the tasks to be performed;
(ii) the declarations, reports, and records to be provided;
(iii) the technical conditions to be met in performing such tasks;
(iv) the related liability coverage;
(v) the protection given to information acquired in carrying out such tasks.
(b) The competent authority shall ensure that the internal audit process and safety risk
management process required by point 145.B.200(a)(5) cover all the certification and
continuing oversight tasks performed on its behalf.
[Note: related AMC/GM:
GM1 145.B.205 Allocation of tasks to qualified entities]
145.B.210 Changes in the management system
(a) The competent authority shall have a system in place to identify any changes that affect its
capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU)
2018/1139 and its delegated and implementing acts. This system shall enable it to take action
as appropriate to ensure that its management system remains adequate and effective.
(b) The competent authority shall update its management system to reflect any change to
Regulation (EU) 2018/1139 and its delegated and implementing acts in a timely manner, so as
to ensure its effective implementation.
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(c) The competent authority shall notify the Agency of any changes affecting its capability to
perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139
and its delegated and implementing acts.
145.B.220 Record-keeping
(a) The competent authority shall establish a system of record-keeping that allows adequate
storage, accessibility, and reliable traceability of:
(1) the management system’s documented policies and procedures;
(2) the training, qualifications, and authorisation of its personnel;
(3) the allocation of tasks, covering the elements required by point 145.B.205, as well as
the details of tasks allocated;
(4) certification processes and continuing oversight of certified organisations, including:
(i) the application for an organisation certificate;
(ii) the competent authority’s continuing oversight programme, including all the
assessments, audits and inspection records;
(iii) the organisation certificate, including any changes to it;
(iv) a copy of the oversight programme, listing the dates when audits are due and
when audits were carried out;
(v) copies of all formal correspondence;
(vi) details of findings, corrective actions, dates of action closures, any exemptions
and enforcement actions;
(vii) any assessment, audit and inspection report issued by another competent
authority pursuant to point 145.B.300(d);
(viii) copies of all organisation MOEs or manuals and any amendments to them;
(ix) copies of any other documents approved by the competent authority;
(5) the evaluation and notification to the Agency of any alternative means of compliance
proposed by organisations, and the assessment of any alternative means of compliance
used by the competent authority itself;
(6) safety information and follow-up measures in accordance with point 145.B.125;
(7) the use of flexibility provisions in accordance with Regulation (EU) 2018/1139.
(b) The competent authority shall maintain a list of all the organisation certificates that it issued.
(c) All the records referred to in points (a) and (b) shall be kept for a minimum period of 5 years,
subject to applicable data protection law.
(d) All the records referred to in points (a) and (b) shall be made available upon request to a
competent authority of another Member State or the Agency.
[Note: related AMC/GM:
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Proposed amendments to Part-145
AMC1 145.B.220(a) Record-keeping
AMC1 145.B.220(a)(1) Record-keeping]
145.B.300 Oversight principles
(a) The competent authority shall verify:
(1) compliance with the requirements that are applicable to organisations prior to issuing
an organisation certificate, as applicable;
(2) continued compliance with the applicable requirements of the organisations that it has
certified;
(3) the implementation of appropriate safety measures mandated by the competent
authority as defined in points 145.B.135(c) and (d).
(b) This verification shall:
(1) be supported by documentation specifically intended to provide personnel responsible
for safety oversight with guidance to perform their functions;
(2) provide the organisations concerned with the results of safety oversight activities;
(3) be based on assessments, audits and inspections, including unannounced inspections;
(4) provide the competent authority with the evidence needed in case further action is
required, including the measures provided for in point 145.B.350 ‘Findings and
corrective actions’.
(c) The scope of the oversight defined in points (a) and (b) shall take into account the results of
past oversight activities and the safety priorities.
(d) If the facilities of an organisation are located in more than one State, the competent authority,
as defined in point 145.1, may agree to have oversight tasks performed by the competent
authority(ies) of the Member State(s) where the facilities are located, or by the Agency for
facilities that are located in a third country. Any organisation that is subject to such an
agreement shall be informed of its existence and of its scope.
(e) For any oversight activities that are performed at facilities located in a Member State other
than where the organisation has its principal place of business, the competent authority, as
defined in point 145.1, shall inform the competent authority of that Member State before
performing any on-site audit or inspection of the facilities.
(f) The competent authority shall collect and process any information deemed useful for
conducting oversight activities, including unannounced inspections.
[Note: related AMC/GM:
AMC1 145.B.300(a);(b);(c) Oversight principles
AMC1 145.B.300(f) Oversight principles]
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145.B.305 Oversight programme
(a) The competent authority shall establish and maintain an oversight programme covering the
oversight activities required by point 145.B.300.
(b) The oversight programme shall be developed taking into account the specific nature of the
organisation, the complexity of its activities, the results of past certification and/or oversight
activities, and it shall be based on the assessment of the associated risks. It shall include
within each oversight planning cycle:
(1) assessments, audits and inspections, including unannounced inspections and, as
applicable:
(i) management system assessments and process audits;
(ii) product audits of a relevant sample of the maintenance carried out by the
organisation;
(iii) sampling of the airworthiness reviews performed;
(2) meetings convened between the accountable manager and the competent authority to
ensure that both remain informed of all significant issues.
(c) For organisations certified by the competent authority, an oversight planning cycle not
exceeding 24 months shall be applied.
(d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the
competent authority has established that during the previous 24 months:
(1) the organisation has demonstrated that it can effectively identify aviation safety
hazards and manage the associated risks;
(2) the organisation has continuously demonstrated under point 145.A.85 that it has full
control over all changes;
(3) no level 1 findings have been issued;
(4) all corrective actions have been implemented within the time period that was accepted
or extended by the competent authority as defined in point 145.B.350.
Notwithstanding point (c), the oversight planning cycle may be further extended to a
maximum of 48 months if, in addition to the conditions provided in points (1) to (4) above, the
organisation has established, and the competent authority has approved, an effective
continuous system for reporting to the competent authority on the safety performance and
regulatory compliance of the organisation itself.
(e) The oversight planning cycle may be reduced if there is evidence that the safety performance
of the organisation has decreased.
(f) The oversight programme shall include records of the dates when assessments, audits,
inspections and meetings are due, and when assessments, audits, inspections and meetings
have been effectively carried out.
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(g) At the completion of each oversight planning cycle, the competent authority shall issue a
recommendation report on the continuation of the approval, reflecting the results of
oversight.
[Note: related AMC/GM:
AMC1 145.B.305(a);(b) Oversight programme
AMC1 145.B.305(b) Oversight programme
AMC2 145.B.305(b) Oversight programme
AMC1 145.B.305(b)(1) Oversight programme
AMC1 145.B.305(c) Oversight programme
AMC2 145.B.305(c) Oversight programme
AMC1 145.B.305(d) Oversight programme]
145.B.310 Initial certification procedure
(a) Upon receiving an application for the initial issue of a certificate for an organisation, the
competent authority shall verify the organisation’s compliance with the applicable
requirements.
(b) A meeting with the accountable manager of the organisation shall be convened at least once
during the investigation for initial certification to ensure that he or she fully understands the
significance of the certification process, and the reason for signing the statement specified in
point 145.A.70(a)(1).
(c) The competent authority shall record all findings, closure actions (i.e. actions required to close
a finding), and recommendations.
(d) The competent authority shall confirm to the organisation in writing all the findings raised
during the verification. For initial certification, all findings must be corrected to the
satisfaction of the competent authority before the certificate can be issued.
(e) When satisfied that the organisation complies with the applicable requirements, the
competent authority shall:
(1) issue the certificate as established in Appendix III ‘EASA Form 3-145’ to this Annex;
(2) formally approve the MOE.
(f) The certificate reference number shall be included on the EASA Form 3-145 certificate in a
manner specified by the Agency.
(g) The certificate shall be issued for an unlimited duration. The privileges and the scope of the
activities that the organisation is approved to conduct, including any limitations as applicable,
shall be specified in the terms of approval attached to the certificate.
(h) To enable the organisation to implement changes without prior competent authority approval
in accordance with point 145.A.85(c), the competent authority shall approve the relevant
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MOE procedure that defines the scope of such changes and describes how such changes will
be managed and notified.
[Note: related AMC/GM:
AMC1 145.B.310 Initial certification procedure
AMC1 145.B.310(a) Initial certification procedure
AMC1 145.B.310(c) Initial certification procedure
AMC2 145.B.310(c) Initial certification procedure
AMC1 145.B.310(d) Initial certification procedure
AMC1 145.B.310(e)(2) Initial certification procedure
Appendix II to AMC2 145.B.310(c) AMC 145.B.20(5) EASA Form 6]
145.B.330 Changes — organisations
(a) Upon receiving an application for a change that requires prior approval, the competent
authority shall verify the organisation’s compliance with the applicable requirements before
issuing the approval.
(b) The competent authority shall establish the conditions under which the organisation may
operate during the change unless the competent authority determines that the organisation’s
certificate needs to be suspended.
(c) When satisfied that the organisation is in compliance with the applicable requirements, the
competent authority shall approve the change.
(d) Without prejudice to any additional enforcement measures, if the organisation implements
changes requiring prior approval without having received the approval of the competent
authority pursuant to point (c), the competent authority shall suspend, limit or revoke the
organisation’s certificate.
(e) For changes not requiring prior approval, the competent authority shall include the review of
such changes in its continuing oversight in accordance with the principles set forth in point
145.B.300. If any non-compliance is found, the competent authority shall:
(1) notify the organisation about the non-compliance and request further changes;
(2) in the case of level 1 or level 2 findings, act in accordance with point 145.B.350.
[Note: related AMC/GM:
AMC1 145.B.330 Changes – organisations
GM1 145.B.330 Changes – organisations]
145.B.350 Findings and corrective actions
(a) The competent authority shall have a system to analyse findings for their safety significance.
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(b) A level 1 finding shall be issued by the competent authority when any significant non-
compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its
delegated and implementing acts, with the organisation’s procedures and manuals, or with
the terms of an approval or certificate which lowers safety or seriously endangers flight safety.
The level 1 findings shall also include:
(1) any failure to give the competent authority access to the organisation's facilities as
defined in point 145.A.140 during normal operating hours and after two written
requests;
(2) obtaining or maintaining the validity of the organisation certificate by falsification of the
submitted documentary evidence;
(3) any evidence of malpractice or fraudulent use of the organisation certificate;
(4) the lack of an accountable manager.
(c) A level 2 finding shall be issued by the competent authority when any non-compliance is
detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated
and implementing acts, with the organisation’s procedures and manuals, or with the terms of
an approval or certificate which may lower safety or endanger flight safety.
(d) When a finding is detected during oversight or by any other means, the competent authority
shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and
its delegated and implementing acts, communicate the finding to the organisation in writing,
and request corrective action to address the non-compliance(s) identified. If a finding directly
relates to an aircraft, the competent authority shall inform the State in which the aircraft is
registered.
(1) If there are any level 1 findings, the competent authority shall take immediate and
appropriate action to prohibit or limit the activities of the organisation involved, and, if
appropriate, it shall take action to revoke the certificate or to limit or suspend it in
whole or in part, depending upon the extent of the level 1 finding, until successful
corrective action has been taken by the organisation.
(2) If there are any level 2 findings, the competent authority shall:
(i) grant the organisation a corrective action implementation period that is
appropriate to the nature of the finding, which in any case shall initially not be
more than 3 months. The period shall commence from the date of the written
communication of the finding to the organisation, requesting corrective action to
address the non-compliance identified. At the end of this period, and subject to
the nature of the finding and the past safety performance of the organisation, the
competent authority may extend the 3-month period provided that a satisfactory
corrective action plan has been agreed by the competent authority;
(ii) assess the corrective action and implementation plan proposed by the
organisation, and if the assessment concludes that they are sufficient to address
the non-compliance(s), accept these.
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(3) If an organisation fails to submit an acceptable corrective action plan, or to perform the
corrective action within the time period accepted or extended by the competent
authority, the finding shall be raised to a level 1 finding and action shall be taken as laid
down in point (d)(1).
(4) The competent authority shall record all the findings that it has raised or that have been
communicated to it in accordance with point (e) below and, where applicable, the
enforcement measures it has applied, as well as all corrective actions and the dates of
the action closures for all the findings.
(e) Without prejudice to any additional enforcement measures, when the authority of a Member
State acting under the provisions of point 145.B.300(d) identifies any non-compliance with the
applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing
acts by an organisation certified by the competent authority of another Member State or the
Agency, it shall inform that competent authority and provide an indication of the level of the
finding.
[Note: related AMC/GM:
GM1 145.B.350(b);(c) Findings and corrective actions]
145.B.355 Suspension, limitation and revocation
The competent authority shall:
(a) suspend a certificate on reasonable grounds in the case of a potential safety threat;
(b) suspend, revoke or limit a certificate pursuant to point 145.B.350; or
(c) suspend a certificate if the competent authority’s inspectors are unable over a period of 24
months to discharge their oversight responsibilities through on-site audit(s) due to the
security situation in the State where the facilities are located.
[Note: related AMC/GM:
AMC1 145.B.355(c) Suspension, limitation and revocation]
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APPENDICES TO ANNEX II (PART-145)
Appendix II — Class and Rratings Ssystem used for the Aapproval of
Part-145 Mmaintenance Oorganisations referred to in Annex I
(Part-M) Subpart F and Annex II (Part-145)
The provisions of Appendix IV to Annex I (Part-M) apply.
(a) Except as stated otherwise for the smallest organisations in point (m), the table referred to in
point (l) provides the standard system for the approval of Part-145 maintenance organisations
and the issuing of the certificate (terms of approval). An organisation must be granted an
approval that ranges from a single class and rating with limitations to an approval for all
classes and ratings with limitations.
(b) In addition to the table referred to in point (l), each maintenance organisation is required to
indicate its scope of work in its MOE. See also point (k).
(c) Within the approval class(es) and rating(s) established by the competent authority, the scope
of work specified in the MOE defines the exact limits of its approval. It is therefore essential
that the approval class(es) and rating(s) and the organisation’s scope of work match.
(d) A category A class rating means that the maintenance organisation may carry out
maintenance on aircraft and components (including engines and/or Auxiliary Power Units
(APUs)), in accordance with the aircraft maintenance data or, if agreed by the competent
authority, in accordance with the component maintenance data, only while such components
are fitted to the aircraft. Nevertheless, such an A-rated maintenance organisation may
temporarily remove a component for maintenance in order to improve access to that
component, except when its removal generates the need for additional maintenance that is
not eligible for the provisions of this point. This is provided that an appropriate control
procedure in the MOE has been approved by the competent authority. The limitation section
will specify the scope of such maintenance, thereby indicating the extent of the approval.
(e) Category A class ratings are subdivided into ‘Base’ or ‘Line’ maintenance categories. Such an
organisation may be approved for either ‘Base’ or ‘Line’ maintenance, or both. It should be
noted that a ‘Line’ facility located at a main base facility requires a ‘Line’ maintenance
approval.
(f) A category B class rating means that the maintenance organisation may carry out
maintenance on uninstalled engines and/or APUs and engine and/or APU components, in
accordance with the engine and/or APU maintenance data or, if agreed by the competent
authority, in accordance with the component maintenance data, only while such components
are fitted to the engine and/or the APU. Nevertheless, such a B-rated approved maintenance
organisation may temporarily remove a component for maintenance in order to improve
access to that component, except when its removal generates the need for additional
maintenance that is not eligible for the provisions of this point. The limitation section will
specify the scope of such maintenance, thereby indicating the extent of the approval. A
maintenance organisation that is approved with a category B class rating may also carry out
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maintenance on an installed engine during ‘base’ and ‘line’ maintenance, provided that an
appropriate control procedure in the MOE has been approved by the competent authority.
The scope of work in the MOE shall reflect these activities if they are permitted by the
competent authority.
(g) A category C class rating means that the maintenance organisation may carry out
maintenance on uninstalled components (excluding complete engines and APUs) that are
intended to be fitted on the aircraft or the engine/APU. The limitation section will specify the
scope of such maintenance, thereby indicating the extent of the approval. A maintenance
organisation that is approved with a category C class rating may also carry out maintenance
on an installed component (other than a complete engine/APU) during base and line
maintenance, or at an engine/APU maintenance facility provided that an appropriate control
procedure in the MOE has been approved by the competent authority. The scope of work in
the MOE shall reflect these activities if they are permitted by the competent authority.
(h) A category D class rating is a self-contained class rating that is not necessarily related to a
specific aircraft, engine or other component. The D1 — Non-Destructive Testing (NDT) rating is
only necessary for a maintenance organisation that carries out NDT as a particular task for
another organisation. A maintenance organisation that is approved with a class rating in the A,
B or C category may carry out NDT on products that it maintains without the need for a D1
class rating provided that the MOE contains NDT procedures.
(i) The limitation section is intended to give the competent authorities the flexibility to customise
an approval for any particular organisation. Ratings shall only be mentioned on the approval if
they are appropriately limited. The table referred to in point (l) specifies the types of
limitation that are possible. It is acceptable to stress the maintenance task rather than the
type or manufacturer of the aircraft or engine, if this is more appropriate to the organisation
(an example could be avionic systems installations and the related maintenance). If that is
mentioned in the limitation section, it indicates that the maintenance organisation is
approved to carry out maintenance up to and including this particular type/task.
(j) When a reference is made to the series, type and group in the limitation section of class A and
B, series means a specific type series such as the Airbus 300, 310 or 319, or the Boeing
737-300 series, the RB211-524 series, the Cessna 150 or Cessna 172, the Beech 55 series, the
continental O-200 series, etc. Type means a specific type or model such as the Airbus 310-240
type, the RB 211-524 B4 type, or the Cessna 172RG type. Any number of series or types may
be quoted. Group means, for example, Cessna single piston engine aircraft or Lycoming non-
supercharged piston engines, etc.
(k) Notwithstanding point 145.A.85(a)(1), when a component capability list is used that could be
subject to frequent amendments, then the organisation may propose to include such
amendments in the procedure referred to in point 145.A.85(c) for changes not requiring prior
approval.
(l) Table
CLASS RATING LIMITATION BASE LINE
AIRCRAFT A1 [Shall state the aeroplane [YES/NO] (*) [YES/NO] (*)
Aeroplanes manufacturer or the group or
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CLASS RATING LIMITATION BASE LINE
above 5 700 kg series or type and/or the
maximum maintenance tasks]
take-off mass
(MTOM) Example: Airbus A320 Series
A2 [Shall state the aeroplane [YES/NO] (*) [YES/NO] (*)
Aeroplanes of manufacturer or the group or
5 700 kg series or type and/or the
MTOM maintenance tasks]
Example: DHC-6 Twin Otter Series
State whether the issuing of
airworthiness review certificates
is authorised (only possible for
aircraft covered by Annex Vb
(Part-ML))
A3 [Shall state the helicopter [YES/NO] (*) [YES/NO] (*)
Helicopters manufacturer or the group or
series or type and/or the
maintenance task(s)]
Example: Robinson R44
A4 [Shall state the aircraft category [YES/NO] (*) [YES/NO] (*)
Aircraft other (sailplane, balloon, airship, etc.),
than A1, A2 the manufacturer or group or
and A3 aircraft series or type and/or the
maintenance task(s)]
State whether the issuing of
airworthiness review certificates
is authorised (only possible for
aircraft covered by Annex Vb
(Part-ML))
ENGINES B1 [Shall state the engine series or type and/or the maintenance
Turbine task(s)]
Example: PT6A Series
B2 [Shall state the engine manufacturer or group or series or type
Piston and/or the maintenance task(s)]
B3 [Shall state the engine manufacturer or series or type and/or
APU the maintenance task(s)]
COMPONENTS C1 Air Cond & [Shall state the aircraft type or aircraft manufacturer or
OTHER THAN Press component manufacturer or the particular component and/or
COMPLETE C2 Auto Flight cross refer to a capability list in the exposition and/or the
ENGINES OR C3 Comms and maintenance task(s)]
APUs Nav
Example: PT6A Fuel Control
C4 Doors —
Hatches
C5 Electrical
Power & Lights
C6 Equipment
C7 Engine —
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CLASS RATING LIMITATION BASE LINE
APU
C8 Flight
Controls
C9 Fuel
C10 Helicopter
— Rotors
C11 Helicopter
— Trans
C12 Hydraulic
Power
C13 Indicating
— recording
system
C14 Landing
Gear
C15 Oxygen
C16 Propellers
C17 Pneumatic
& Vacuum
C18 Protection
ice/rain/fire
C19 Windows
C20 Structural
C21 Water
ballast
C22 Propulsion
Augmentation
SPECIALISED D1 Non- [Shall state particular NDT method(s)]
SERVICES Destructive
Testing
(*) Delete as appropriate
(m) A maintenance organisation which employs only one person to both plan and carry out all its
maintenance activities can only hold a limited scope of approval rating. The maximum
permissible limits are:
CLASS RATING LIMITATION
AIRCRAFT A2 PISTON ENGINE AEROPLANE
OF 5 700 KG MTOM OR LESS
AIRCRAFT A3 SINGLE PISTON ENGINE
HELICOPTER OF 3 175 KG
MTOM OR LESS
AIRCRAFT A4 NO LIMITATIONS
ENGINES B2 LESS THAN 450 HP
COMPONENTS OTHER THAN C1 TO C22 AS PER CAPABILITY LIST
COMPLETE ENGINES OR APUs
SPECIALISED SERVICES D1 NDT NDT METHOD(S) TO BE
SPECIFIED.
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It should be noted that such an organisation may be further limited by the competent
authority in the scope of approval depending on the capabilities of the particular organisation.
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Appendix III — Maintenance Oorganisation Approval certificate -
EASA Form 3-145 referred to in Annex II (Part-145)
Page 1 of 2
[MEMBER STATE (*)]
A Member of the European Union (**)
MAINTENANCE ORGANISATION APPROVAL CERTIFICATE
Reference: [MEMBER STATE CODE(*)].145.XXXX
Pursuant to Regulation (EC) No 216/2008 (EU) 2018/1139 of the European Parliament and of the Council and
to Commission Regulation (EU) No 1321/2014 for the time being in force and subject to the condition
specified below, the [COMPETENT AUTHORITY OF THE MEMBER STATE (*)] hereby certifies:
[COMPANY NAME AND ADDRESS]
as a maintenance organisation in compliance with Section A of Annex II (Part-145) of Regulation (EU)
No 1321/2014, approved to maintain products, parts and appliances listed in the attached approval schedule
terms of approval and issue related certificates of release to service using the above references and, when
stipulated, to issue recommendations and airworthiness review certificates after an airworthiness review as
specified in point M.A.901(l) of Annex I (Part-M) to the same Regulation ML.A.903 of Annex Vb (Part-ML) to
Commission Regulation (EU) No 1321/2014 for those aircraft listed in the attached terms of approval
schedule.
CONDITIONS:
1. This approval is limited to that specified in the scope of work section of the approved maintenance
organisation exposition as referred to in Section A of Annex II (Part-145), and
2. This approval requires compliance with the procedures specified in the approved maintenance
organisation exposition, and
3. This approval is valid whilst the approved maintenance organisation remains in compliance with
Annex II (Part-145) of to Regulation (EU) No 1321/2014.
4. Subject to compliance with the foregoing conditions, this approval shall remain valid for an unlimited
duration unless the approval has previously been surrendered, superseded, suspended or revoked.
Date of original issue: .........................................................................................................................................
Date of this revision: .….......................................................................................................................................
Revision No: ........................................................................................................................................................
Signed: ................................................................................................................................................................
For the competent authority: [COMPETENT AUTHORITY OF THE MEMBER STATE(*)]
EASA Form 3-145 Issue 3 4
(*) Or EASA if EASA is the competent authority
(**) Delete for non-EU Member States or EASA
Page 2 of 2
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MAINTENANCE ORGANISATION
TERMS OF APPROVAL SCHEDULE
Reference: [MEMBER STATE CODE (*)].145.[XXXX]
Organisation: [COMPANY NAME AND ADDRESS]
CLASS RATING LIMITATION BASE LINE
AIRCRAFT (**) (***) (****) [YES/NO] (**) [YES/NO] (**)
(***) (****) [YES/NO] (**) [YES/NO] (**)
(***) (****) [YES/NO] (**) [YES/NO] (**)
(***) (****) [YES/NO] (**) [YES/NO] (**)
ENGINES (**) (***) (***)
(***) (***)
COMPONENTS (***) (***)
OTHER THAN
COMPLETE (***) (***)
ENGINES OR (***) (***)
APUs (**)
(***) (***)
(***) (***)
(***) (***)
SPECIALISED (***) (***)
SERVICES (**)
(***) (***)
This approval schedule is These terms of approval are limited to those products, parts and appliances and to
the activities specified in the scope of work section of the approved maintenance organisation exposition,
Maintenance Organisation Exposition reference: .............................................................................................
Date of original issue: ........................................................................................................................................
Date of last revision approved: ................................................ Revision No: ………………...................................
Signed: ...............................................................................................................................................................
For the competent authority: [COMPETENT AUTHORITY OF THE MEMBER STATE (*)]
EASA Form 3-145 Issue 3 4
(*) Or EASA if EASA is the competent authority
(**) Delete as appropriate if the organisation is not approved.
(***) Complete with the appropriate rating and limitation
(****) Complete with appropriate limitation and, for A2 and A4 ratings, state whether the issue of recommendations and
airworthiness review certificates is authorised or not (only possible for ELA1 aircraft covered by Annex Vb (Part-ML) not
involved in commercial operations when the organisation performs the airworthiness review together with the annual
inspections contained in the maintenance programme).
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Draft AMC & GM to Annex II (Part-145) (Draft EASA decision)
GENERAL
GM1 to Annex II (Part-145) Definitions
For the purpose of the AMC & GM to Part-145, the following definitions are used:
Audit refers to a systematic, independent, and documented process for obtaining
evidence, and evaluating it objectively to determine the extent to which
requirements are complied with.
Note: audits may include inspections
Alternative Ref. Regulation (EU) No 1321/2014, Article 21.
Means of
Compliance
(AltMoC)
Assessment in the context of management system performance monitoring, continuous
improvement and oversight, this refers to a planned and documented activity
performed by competent personnel to evaluate and analyse the achieved level
of performance and maturity in relation to the organisation’s policy and
objectives.
Note: an assessment focuses on desirable outcomes and the overall
performance, looking at the organisation as a whole. The main objective of the
assessment is to identify the strengths and weaknesses to drive continual
improvement.
Remark: for ‘risk assessment’, please refer to the definition below.
Base Ref. AMC1 145.A.10
maintenance
Competency is a combination of individual skills, practical and theoretical knowledge,
attitude, training, and experience.
Correction is the action to eliminate a detected non-compliance.
Corrective is the action to eliminate or mitigate the root cause(s) and prevent the
action recurrence of an existing detected non-compliance, or other undesirable
conditions or situations. Proper determination of the root cause(s) is crucial for
defining effective corrective actions to prevent reoccurrence.
Error is an action or inaction by a person that may lead to deviations from accepted
procedures or regulations.
Note: errors are often associated with occasions when a planned sequence of
mental or physical activities either fails to achieve its intended outcome, or is not
appropriate with regard to the intended outcome, and when results cannot be
attributed purely to chance.
1 As proposed through Opinion No 06/2016 (https://www.easa.europa.eu/document-library/opinions/opinion-062016).
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Fatigue is a physiological state of reduced mental or physical performance capability
resulting from sleep loss or extended wakefulness, the circadian phase, or
workload (mental and/or physical activity) that can impair a person’s alertness
and ability to safely perform safety-related duties.
Hazard is a condition or an object with the potential to cause or contribute to an aircraft
incident or accident.
Human factors is anything that affects human performance, which means principles that apply
to aeronautical design, certification, training, operations and maintenance, and
which seek a safe interface between the human and other system components
by proper consideration of human performance.
Human refers to human capabilities and limitations which have an impact on the safety,
performance and efficiency of aeronautical operations.
Inspection in the context of compliance monitoring and oversight, refers to an independent
documented conformity evaluation by observation and judgement
accompanied, as appropriate, by measurement, testing or gauging, in order to
verify compliance with applicable requirements.
Note: inspection may be part of an audit (e.g. product audit), but may also be
conducted outside of the normal audit plan, for example to verify closure of a
particular finding.
Just Culture Ref. Regulation (EU) No 376/2014, Article 2.
Line Ref. AMC1 145.A.10
maintenance
Near miss is an event in which an occurrence to be mandatorily reported according to
Regulation (EU) No 376/2014 was narrowly averted or avoided.
Example: a mechanic on rechecking his or her work at the end of a task realises
that one work card step was not properly carried-out.
Organisational is a latent condition that affects the effectiveness of safety risk controls, related
factor to the culture, policies, processes, resources, and workplace of an organisation.
Oversight refers to the time frame within which all areas of the approval and all processes
planning cycle should be reviewed by the competent authority by means of audits and
inspections.
Oversight refers to the detailed oversight schedule that defines the number of audits and
programme inspections, the scope and duration of each audit and inspection, including
details of product audits and locations, as appropriate, to be performed by the
competent authority, and the tentative time frame for performing each audit
and inspection.
Preventive is the action to eliminate the cause of a potential non-compliance, or other
action undesirable potential situations.
Risk assessment is an evaluation based on engineering and operational judgement and/or
analysis methods in order to establish whether the achieved or perceived risk is
acceptable or tolerable.
Safety culture is an enduring set of values, norms, attitudes, and practices within an
organisation concerned with minimising the exposure of the workforce and the
general public to dangerous or hazardous conditions. In a positive safety culture,
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a shared concern for, commitment to, and accountability for safety is promoted.
Safety risk refers to the predicted probability and severity of the consequences or
outcomes of a hazard.
Safety training refers to dedicated training to support safety management policies and
processes, including human factors training.
Note: the main purpose of the safety training programme is to ensure that
personnel at all levels of the organisation maintain their competency to fulfil
their safety roles. Safety training should, in particular, consider the safety
knowledge derived from hazard identification and risk management processes,
and support the fostering of a positive safety culture.
Note: safety management training means specific training for the staff involved
in safety management functions in accordance with point 145.A.30(ca) or
145.A.200(a)(3)
Working days refers to days between and including Monday to Friday, not including public
holidays.
[Back to implementing rule:
145.1 Competent authority]
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SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS
AMC1 145.A.10 Scope
1. Line Maintenance should be understood as any maintenance that is carried out before flight
to ensure that the aircraft is fit for the intended flight.
(a) Line Maintenance may include:
Trouble shooting Troubleshooting.
Defect rectification.
Component replacement with the use of external test equipment if required.
Component replacement may include components such as engines and
propellers.
Scheduled maintenance and/or checks, including visual inspections, that will
detect obvious unsatisfactory conditions/discrepancies but do not require
extensive in-depth inspections. It may also include the internal structure, systems
and powerplant items which are visible through quick-opening access
panels/doors.
Minor repairs and modifications which do not require extensive disassembly, and
can be accomplished by simple means.
(b) For temporary or occasional cases (ADs, SBs) the Quality Compliance Monitoring
Manager may accept base maintenance tasks to be performed by a line maintenance
organisation subject to a risk assessment and provided all requirements are fulfilled as
defined by the competent authority.
(c) Maintenance tasks that falling outside these criteria are considered to be Base
Maintenance tasks.
(d) Aircraft that are maintained in accordance with ‘progressive’ type programmes should
be individually assessed in relation to this paragraph. In principle, the decision to allow
some ‘progressive’ checks to be carried out should be determined by the assessment
that all the tasks within the particular check can be carried out safely and to the
required standards at the designated line maintenance station.
2. Where If the organisation uses facilities both inside and outside the Member State, such as
satellite facilities, sub-contractors, line stations, etc., such facilities may be included in the
approval without being identified on the approval organisation certificate, subject to provided
that the maintenance organisation exposition MOE identifiesying the facilities and containsing
procedures to control such facilities, and the competent authority is being satisfied that they
form an integral part of the approved maintenance organisation.
[Back to implementing rule:
145.A.10 Scope]
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GM1 145.A.10 Scope
SMALLEST ORGANISATIONS
This Guidance Material (GM) provides guidance on how the smallest organisations satisfy the intent
of Part-145:
1. By inference, the smallest maintenance organisations would only be involved in the
maintenance of a limited number of light aircraft, or aircraft components, used for
commercial air transport. It is therefore a matter of scale; the maintenance of light aircraft
does not demand require the same level of resources, facilities or complex maintenance
procedures as the maintenance of larger aircraft by large organisations.
2. It is recognised that a Part-145 approval may be required by two quite different types of small
organisations., t The first being is the a light aircraft maintenance hangar, and the second
being is the a component maintenance workshop, e.g. for small piston engines, radio
equipment, etc.
3. Where only one person is employed (in fact having the certifying function and others), these o
Organisations that only employ one person, who carries out the certification function and
other functions, and that are approved under Part-145, may use the alternatives provided in
point 3.1, limited to the following:
Class A2 Base and Line maintenance of aeroplanes of 5 700 kg maximum take-off mass
(MTOM) or less and below (with piston engines only).
Class A3 Base and Line maintenance of single-engined helicopters of 3 175 kg MTOM or less
than 3 175 kg.
Class A4 Aircraft other than A1, A2 and A3 aircraft.
Class B2 Piston engines with maximum output of less than 450 HP.
Class C Components.
Class D1 Non-dDestructive Testing.
3.1. 145.A.30(b): The minimum requirement is for one full-time person who meets the
Part-66 requirements for certifying staff and holds the position of ‘accountable
manager, safety manager, maintenance engineer and is also certifying staff and, if
applicable, airworthiness review staff’. No other person may issue a certificate of
release to service and therefore if that person if absent, no maintenance may be
released during such his or her absence.
3.1.1. The quality independent audit element of the compliance monitoring function of
145.A.65(c) point 145.A.200(a)(6) may be subcontracted to an appropriate
organisation approved under Part-145 or contracted to a person with appropriate
technical knowledge and extensive experience of quality audits, working under
the management system of the organisation, employed on a part-time basis, with
the agreement of the competent authority.
Note: F full-time for the purpose of Part-145 means not less than 35 hrs per
week, except during vacation periods.
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3.1.2. 145.A.35. In the case of an approval based on one person using an subcontracted
quality independent audit monitoring arrangement as referred to in 3.1.1, the
requirement for a record of certifying staff is satisfied by the submission to and
acceptance by the competent authority of the MOE EASA Form 4. With only one
person, the requirement for a separate record of authorisation is unnecessary
because the EASA Form 3 approval schedule certificate defines the authorisation.
An appropriate statement, to reflect this situation, should be included in the
exposition.
3.1.3. 145.A.65(c) 145.A.200(a)(6). It is the responsibility of the contracted quality
monitoring organisation or person referred to in 3.1.1 to make a minimum of 2
on-site audits every year visits per 12 months and it is the responsibility of this
organisation or person to carry out such these activities monitoring on the basis
of 1 pre-announced visit and 1 not unannounced visit to the maintenance
organisation.
It is the responsibility of the Part-145 organisation to ensure that effective
implementation of all corrective actions takes place. comply with the findings of
the contracted quality monitoring organisation or the person.
CAUTION: it should be understood that if the contracted organisation or the
above mentioned person loses or gives up its approval, then the organisation’s
approval will be suspended.
4. Recommended operating procedure for a Part-145 approved maintenance organisation based
upon up to 10 persons involved in maintenance.
4.1. 145.A.30(b) and 145.A.30(c): The normal minimum requirement is for the employment
on a full-time basis of two persons who meet the applicable competent authorities’
requirements for certifying staff, whereby one holds the position of ‘maintenance
engineer’ and the other holds the position of ‘quality audit compliance monitoring
engineer’.
Either person can assume the responsibilities of the accountable manager and safety
manager provideding that they can comply in full with the applicable elements of points
145.A.30(a) and 145.A.30(ca), but the ‘maintenance engineer’ should be the certifying
person to retain the independence of the ‘quality audit compliance monitoring
engineer’ to carry out audits. Nothing prevents either engineer from undertaking
maintenance tasks, provideding that the ‘maintenance engineer’ issues the certificate
of release to service. This ‘maintenance engineer’ may also be nominated as
airworthiness review staff to carry out airworthiness reviews and to issue the
corresponding airworthiness review certificate for ELA1 aircraft not involved in
commercial operations in accordance with ML.A.903 M.A.901(l).
The ‘quality audit compliance monitoring engineer’ should have similar qualifications
and status to the ‘maintenance engineer’ for reasons of credibility, unless he/she he or
she has a proven track record in aircraft compliance monitoring quality assurance, in
which case some reduction in the extent of his or her maintenance qualifications may
be permitted.
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In cases where If the competent authority agrees that it is not practical for the an
organisation to nominate a person as responsible post holder for the quality
independent audit of the compliance monitoring function, this element function may be
contracted in accordance to with paragraph 3.1.1.
[Back to implementing rule:
145.A.10 Scope]
AMC1 145.A.15 Application for an organisation certificate
In a form and in a manner established by the competent authority means that the An application
should be made on an EASA Form 2 (refer to Appendix III to AMC to Part-145) or an equivalent form
that is acceptable to the competent authority.
EASA Form 2 is valid for the application for M.A. Subpart F, Part-CAO, Part-145 and Part-CAMO
organisations. Organisations that apply for several certificates may do so using a single EASA Form 2.
[Back to implementing rule:
145.A.15 Application for an organisation certificate]
AMC2 145.A.15 Application for an organisation certificate
GENERAL
(a) Draft documents should be submitted at the earliest opportunity so that assessment of the
application can begin. The initial certification or approval of changes cannot take place until
the competent authority has received the completed documents.
(b) This information, including the results of the pre-audit specified in point 145.A.15(b)(1), will
enable the competent authority to conduct its assessment in order to determine the volume
of certification and oversight work that is necessary, and the locations where it will be carried
out.
(c) The intent of the internal pre-audit referred to in point 145.A.15(b)(1) is to ensure that the
organisation has internally verified its compliance with the Regulation. This should allow the
organisation to demonstrate to the competent authority the extent to which the applicable
requirements are complied with, and to provide assurance that the organisation management
system is established to a level that is sufficient to perform maintenance activities.
[Back to implementing rule:
145.A.15 Application for an organisation certificate]
GM1 145.A.15(b) Application for an organisation certificate
PROCEDURE FOR CHANGES NOT REQUIRING PRIOR APPROVAL
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The procedure for changes not requiring prior approval should include, as mentioned in point
145.A.70(a)(10), both the scope of those changes and how they will be managed and notified. For
applicants for an initial certificate, the scope may be limited by the competent authority for the first
period of operation. An extension of such a limited scope may be considered later; see
GM1 145.A.85(c).
[Back to implementing rule:
145.A.15 Application for an organisation certificate]
AMC1 145.A.25(a) Facility requirements
[…]
5. Subject to a risk assessment and agreement by the competent authority, the organisation may
use facilities at the approved location, other than a hangar that encloses the whole aircraft,
for certain aircraft base maintenance tasks, provided that those facilities offer levels of
weather and environmental protection that are equivalent to those of a hangar, as well as a
suitable working environment for the particular work package. This does not exempt an
organisation from the requirement to have an aircraft hangar in order to be approved to
conduct base maintenance at a given location.
AMC1 145.A.30(a) Personnel requirements
ACCOUNTABLE MANAGER
With regard to the Accountable manager, it is normally intended to mean the chief executive officer
of the approved maintenance organisation, who by virtue of his or her position, has overall
(including in particular financial) responsibility for running the organisation. The accountable
manager may be the accountable manager for more than one organisation, and is not necessarily
required to be necessarily knowledgeable on technical matters, as the maintenance organisation
exposition MOE defines the maintenance standards. When the accountable manager is not the chief
executive officer, the competent authority will need to should be assured that such an the
accountable manager has direct access to the chief executive officer and has the necessary a
sufficiency of ‘maintenance funding’ allocation.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(b) Personnel requirements
MANAGEMENT STRUCTURE FOR MAINTENANCE
The person or group of persons nominated under point 145.A.30(b) with the responsibility for
ensuring compliance should represent the management structure of the organisation, and be
responsible for all maintenance functions.
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1. Dependent upon the size of the organisation, the Part-145 functions may be subdivided under
individual managers or combined in any number of ways. However, the compliance
monitoring function should be independent from the other functions.
2. The organisation should have, dependent upon the extent of approval, a base maintenance
manager, a line maintenance manager, and a workshop manager, and a quality manager, all of
whom should report to the accountable manager, except in small Part-145 organisations
where any one manager may also be the accountable manager, as determined by the
competent authority, and he/she he or she may also be the line maintenance manager or the
workshop manager.
3. The base maintenance manager is responsible for ensuring that all maintenance required to
be carried out in the hangar, plus any defect rectification carried out during base
maintenance, is carried out to the design and quality standards specified in point 145.A.65(b).
The base maintenance manager is also responsible for any corrective action resulting from the
quality compliance monitoring of point 145.A.200(a)(6) 145.A.65(c).
4. The line maintenance manager is responsible for ensuring that all maintenance required to be
carried out on the line, including line defect rectification, is carried out to the standards
specified in point 145.A.65(b), and is also responsible for any corrective action resulting from
the quality compliance monitoring of point 145.A.200(a)(6) 145.A.65(c).
5. The workshop manager is responsible for ensuring that all work on aircraft components is
carried out to the standards specified in point 145.A.65(b), and is also responsible for any
corrective action resulting from the quality compliance monitoring of point 145.A.200(a)(6)
145.A.65(c).
6. (reserved) The quality manager’s responsibility is specified in 145.A.30(c).
7. Notwithstanding the example sub-paragraphs 2 - 5 6 titles, the organisation may adopt any
titles for the foregoing managerial positions, but it should identify to the competent authority
the titles and the persons chosen to carry out these functions.
8. Where If an organisation chooses to appoint managers for all or any combination of the
identified Part-145 functions because of the size of the undertaking, it is necessary that these
managers should ultimately report to the accountable manager ultimately through either the
base maintenance manager, or the line maintenance manager, or the workshop manager, or
the quality compliance monitoring manager or the safety manager, as appropriate, to the
accountable manager.
NOTE: Ccertifying staff may report to any of the managers specified, depending upon which
type of control the approved maintenance organisation uses (for example, licensed licenced
engineers/independent inspection/dual function supervisors, etc.) so as long as the quality
independence of the compliance monitoring function is ensured staff specified in
145.A.65(c)(1) remain independent.
[Back to implementing rule:
145.A.30 Personnel requirements]
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GM1 145.A.30(b) Personnel requirements
RESPONSIBILITY FOR ENSURING COMPLIANCE
For day-to-day functions, the responsibility for ensuring that all maintenance activities are
performed in accordance with the applicable requirements and procedures lies with the person(s)
nominated in accordance with point 145.A.30(b).
These nominated persons should demonstrate a complete understanding of the applicable
requirements, and ensure that the organisation’s processes and standards accurately reflect the
applicable requirements. It is their role to ensure that compliance is proactively managed, and that
any early warning signs of non-compliance are documented and acted upon.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(c) Personnel requirements
Monitoring the quality system Compliance monitoring may includes the need to involve the
accountable manager and the nominated persons referred to in point 145.A.30(b) in requesting
corrections and corrective remedial actions as necessary by the accountable manager and the
nominated persons referred to in 145.A.30(b).
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(c);(ca) Personnel requirements
SAFETY MANAGEMENT AND COMPLIANCE MONITORING FUNCTION
(a) Safety manager
(1) The safety manager should act as the focal point for effective safety management
processes, and be responsible for their development, administration and maintenance.
(2) The functions of the safety manager should be to:
(i) facilitate hazard identification, risk assessment and management;
(ii) monitor the implementation of actions taken to mitigate risks, as listed in the
safety action plan, unless action follow-up is addressed by the compliance
monitoring function;
(iii) provide periodic reports on safety performance to the safety review board;
(iv) ensure the maintenance of safety management documentation;
(v) ensure that there is safety training available, and that it meets acceptable
standards;
(vi) provide advice on safety matters; and
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(vii) ensure the initiation and follow-up of internal occurrence investigations.
(3) If more than one person is designated for the safety management function, the
accountable manager should identify the person who acts as the unique focal point (i.e.
the ‘safety manager’).
(b) The compliance monitoring function should ensure that:
(1) the activities of the organisation are monitored for compliance with the applicable
requirements and any additional requirements as established by the organisation, and
that these activities are carried out properly under the supervision of the nominated
persons referred to in points 145.A.30(b) to (ca).
(2) any maintenance contracted to another maintenance organisation is monitored for
compliance with the contract;
(3) an audit plan is properly implemented, maintained, and continually reviewed and
improved; and
(4) corrections and corrective actions are requested as necessary.
(c) The compliance monitoring manager should:
(1) not be one of the persons referred to in point 145.A.30(b);
(2) be able to demonstrate relevant knowledge, background and appropriate experience
related to the activities of the organisation, including knowledge and experience in
compliance monitoring; and
(3) have access to all parts of the organisation, and as necessary, any subcontracted
organisation.
(d) If more than one person is designated for the compliance monitoring function, the
accountable manager should identify the person who acts as the unique focal point (i.e. the
‘compliance monitoring manager’).
(e) If the functions related to compliance monitoring or safety management are combined with
other duties, the organisation should ensure that this does not result in any conflicts of
interest.
(f) If the same person is designated to manage both the compliance monitoring function and
safety management-related processes and tasks, the accountable manager, with regard to his
or her direct accountability for safety, should ensure that sufficient resources are allocated to
both functions, taking into account the size of the organisation, and the nature and complexity
of its activities.
(g) Subject to a risk assessment and agreement by the competent authority, with due regard to
the size of the organisation and the nature and complexity of its activities, the compliance
monitoring manager role and/or safety manager role may be exercised by the accountable
manager, provided that he or she has demonstrated the related competency as defined in
point (c)(2).
[Back to implementing rule:
145.A.30 Personnel requirements]
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GM1 145.A.30(ca) Personnel requirements
SAFETY MANAGER
(a) Depending on the size of the organisation and the nature and complexity of its activities, the
safety manager may be assisted by additional safety personnel in performing all the safety
management tasks defined in AMC1 145.A.200(a)(1).
(b) Regardless of the organisational setup, it is important that the safety manager remains the
unique focal point for the development, administration, and maintenance of the
organisation’s management system.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(cc) Personnel requirements
KNOWLEDGE, BACKGROUND AND EXPERIENCE OF NOMINATED PERSON(S)
Persons or group(s) of persons nominated in accordance with points 145.A.30(b), (c) and (ca) should
have:
(a) practical experience and expertise in the application of aviation safety standards and safe
operating practices;
(b) knowledge of:
(1) human factors principles;
(2) safety management systems based on the EU management system requirements
(including compliance monitoring) and ICAO Annex 19.
(c) 5 years of relevant work experience, of which at least 2 years should be from the aeronautical
industry in an appropriate position;
(d) a relevant engineering degree or an aircraft maintenance technician qualification with
additional education that is acceptable to the competent authority. ‘Relevant engineering
degree’ means an engineering degree from aeronautical, mechanical, electrical, electronic,
avionic or other studies that are relevant to the maintenance and continuing airworthiness of
aircraft/aircraft components;
The above recommendation may be replaced by 5 years of experience in addition to those
already recommended by the paragraph (c) above. These 5 years should cover an appropriate
combination of experience in tasks related to aircraft maintenance and/or continuing
airworthiness management and/or the surveillance of such tasks;
(e) thorough knowledge of the organisation's MOE;
(f) knowledge of a relevant sample of the type(s) of aircraft or components gained through a
formalised training course. These courses could be provided by a Part-147 organisation, by the
manufacturer, by the Part-145 organisation or by any other organisation accepted by the
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competent authority. Aircraft/engine type training courses should be at least at a level
equivalent to the Part-66 Appendix III Level 1 General Familiarisation.
‘Relevant sample’ means that these courses should cover typical aircraft or components that
are within the scope of work.
For all balloons and any other aircraft of 2 730 kg MTOM or less, the formalised training
courses may be replaced by a demonstration of the required knowledge by providing
documented evidence, or by an assessment performed by the competent authority. This
assessment should be recorded;
(g) knowledge of the relevant maintenance methods;
(h) knowledge of the applicable regulations.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(d) Personnel requirements
SUFFICIENT NUMBER OF PERSONNEL
[…]
4. For In the case of aircraft base maintenance, the maintenance man-hour plan should relate to
the aircraft hangar visit plan as specified in AMC1 145.A.25(a).
5. For In the case of aircraft component maintenance, the maintenance man-hour plan should
relate to the aircraft component planned maintenance as specified in point 145.A.25(a)(2).
6. The quality monitoring man-hours allocated to the compliance monitoring function man-hours
should be sufficient to meet the requirement of point 145.A.200(a)(6) 145.A.65(c), which
means taking into account AMCs to 145.A.200(a)(6) AMC 145.A.65(c). Where If the quality
compliance monitoring staff also perform other functions, the time allocated to such those
functions needs to be taken into account in determining the number of quality compliance
monitoring staff numbers.
7. The maintenance man-hour plan should be reviewed at least every 3 months and updated
when necessary.
8. Significant deviations from the maintenance man-hour plan should be reported through the
departmental responsible manager to the quality compliance monitoring manager, the safety
manager and the accountable manager for review, as well as through the internal safety
reporting scheme. A Ssignificant deviation means that there is more than a 25 % shortfall in
the available man-hours during a calendar month for any one of the functions specified in
point 145.A.30(d).
9. In addition, as part of its management system in accordance with point 145.A.200, the
organisation should have a procedure to assess and mitigate the risks:
(1) if the actual number of staff available is less than the planned staffing level for any
particular work shift or period;
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(2) if there is a temporary increase in the proportion of subcontracted staff in order to
meet specific operational needs.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(e) Personnel requirements
COMPETENCY ASSESSMENT
Competence Competency should be defined as a measurable skill or standard of performance,
knowledge and understanding, taking into consideration attitude and behaviour.
The referenced procedure requires amongst others that planners, mechanics, specialised services
staff, supervisors, certifying staff and support staff, whether employed or contracted, are assessed
for competence competency before unsupervised work commences and competence competency is
controlled on a continuous basis.
Competence Competency should be assessed by the evaluation of:
on-the-job performance and/or testing of knowledge by appropriately qualified personnel,
and
records for basic, organisational, and/or product type and differences training, and
experience records.
Validation of the above could include a confirmation check with the organisation(s) that issued such
the document(s). For that purpose, experience/training may be recorded in a document such as a
log book, or based on the suggested template in GM3 145.A.30(e).
As a result of this assessment, an individual’s qualifications should determine:
which level of ongoing supervision would be required or and whether unsupervised work
could be permitted.;
whether there is a need for additional training.
A record of should be kept such of each individual’s qualifications and competence competency
assessment should be kept (refer also to point 145.A.55(d)).
This should include copies of all documents that attest to their qualifications, such as the a licence
and/or any authorisation held, as applicable.
For a proper competence competency assessment of its personnel, the organisation should consider
that:
1. In accordance with the job function, adequate initial and recurrent training should be
provided and recorded to ensure continued competence competency so that it is maintained
throughout the duration of the employment/contract.
2. All staff should be able to demonstrate knowledge of, and compliance with, the maintenance
organisation’s procedures, as applicable to their duties.
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3. All staff should be able to demonstrate an understanding of the safety management
principles, human factors and human performance issues in relatedion with to their job
function, and be trained as per AMC2 145.A.30(e).
4. To assist in the assessment of competence competency and to establish the training needs
analysis, job descriptions are recommended for each job function in the organisation. Job
descriptions should contain sufficient criteria to enable the required competence competency
assessment.
5. Criteria should allow the assessment to establish that, among others aspects (titles might be
different in each organisation):
Managers are able to properly manage the work output, processes, resources and
priorities described in their assigned duties, accountabilities and responsibilities in
accordance with the safety policy and objectives and in compliance with the applicable
requirements in a safe compliant manner in accordance with regulations and
organisation procedures.
Planners are able to interpret maintenance requirements into maintenance tasks, and
have an understanding that they have no authority to deviate from the maintenance
data.
Supervisors are able to ensure that all the required maintenance tasks are carried out
and, where if they are not completed or where it is evident that a particular
maintenance task cannot be carried out according to the maintenance data, then such
that these problems will be adequately addressed to eliminate the non-compliance, and
reported through the internal safety reporting scheme to prevent their reoccurrence to
the 145.A.30(c) person for appropriate action. In addition, for those supervisors, who
also carry out maintenance tasks, the assessment should ensure that they understand
that such tasks should not be undertaken when if they are incompatible with their
management responsibilities.
Mechanics are able to carry out maintenance tasks to any standard specified in the
maintenance data, and will notify their supervisors of any defects or mistakes that
requireing rectification to re-establish required maintenance standards.
Specialised services staff are able to carry out specialised maintenance tasks to the
standard specified in the maintenance data. They should be able to communicate with
their supervisors and report accurately when necessary.
Support staff are able to determine that the relevant tasks or inspections have been
carried out to the required standard.
Certifying staff are able to determine when the aircraft or aircraft component
maintenance is ready to be released to service, and when it should not be released to
service.
Quality audit Compliance monitoring staff are able to monitor compliance with Part-145
this Regulation and to identifying non-compliances in an effective and timely manner so
that the organisation may remain in compliance with this Regulation Part-145.
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Staff who have been designated safety management responsibilities are familiar with
the relevant processes in terms of hazard identification, risk management, and the
monitoring of safety performance.
All staff are familiar with the safety policy and the procedures and tools that can be
used for internal safety reporting.
Competence The competency assessment should be based upon the procedure specified in
GM2 145.A.30(e).
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC2 145.A.30(e) Personnel requirements
SAFETY TRAINING (INCLUDING HUMAN FACTORS)
Refer to the definition of safety training in GM1 to Annex II (Part-145).
(a) With In respect to the understanding of the application of safety management, human factors
and human performance issues, all maintenance organisation personnel should have received
an initial and recurrent continuation human factors safety training, appropriate for their
responsibilities. This should concern include to a minimum at least the following staff
members:
Post-holders Nominated persons, line managers, supervisors;
Certifying staff, support staff and mechanics;
Technical support personnel such as planners, engineers, technical record staff;
Quality control/assurance staff Persons involved in any compliance monitoring and/or
safety management-related processes and tasks, including the application of human
factors principles, internal investigations and safety training;
Specialised services staff;
Human factors staff/human factors trainers;
Stores department staff, purchasing department staff;
Ground equipment operators.
The generic term ‘line managers’ refers to departmental heads or persons responsible for
operational departments or functional units that are directly involved in the delivery of the
basic maintenance services of the organisation.
(b)1. Initial human factors safety training should cover all the topics of the training syllabus
specified in GM1 145.A.30(e) either as a dedicated course or else integrated within other
training. The syllabus may be adjusted to reflect the particular nature of the organisation. The
syllabus may also be adjusted to meet suit the particular nature of work for each function
within the organisation. For example:
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small organisations that do not working in shifts may cover in less depth subjects
related to teamwork and communication in less depth;
planners may cover in more depth the scheduling and planning objectives of the
syllabus, and in less depth the objective of developing skills for shift working.
All personnel, including personnel being recruited from any other organisation, should receive
initial human factors safety training that is compliant with the organisation’s training
standards prior to commencing the actual job function, unless their competence competency
assessment justifies that there is no need for such a training. New,ly directly employed
personnel who working under direct supervision may receive training within 6 months after
joining the maintenance organisation.
(c)2. The purpose of human factors continuation recurrent safety training is primarily to ensure
that staff remain current in terms of SMS principles and human factors, and also to collect
feedback on safety and human factors issues. Consideration should be given to the possibility
that such training has the involvingement of the quality department compliance monitoring
staff and the key safety management personnel in this training. There should be a procedure
to ensure that feedback is formally reported by passed from the trainers through the internal
safety reporting scheme to the quality department to initiate action where necessary.
Recurrent safety training should be delivered either as a dedicated course or integrated within
other training. Human factors continuation training It should be of an appropriate duration in
each two year 2-year period in relation to the relevant compliance monitoring quality audit
findings and other internal/external sources of information available to the organisation on
safety and human errors factors maintenance issues in maintenance available to the
organisation.
(d)3. Human factors Safety training should be delivered by a competent trainer, and may be
conducted by the maintenance organisation itself, or independent trainers, or any training
organisations acceptable to the competent authority.
(e)4. The human factors safety training procedures should be specified in the maintenance
organisation exposition MOE.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC3 145.A.30(e) Personnel requirements
Additional training in fuel tank safety, as well as the associated inspection standards and
maintenance procedures, should be required for staff for maintenance organisations’ technical
personnel, especially technical personnel involved in the compliance of CDCCL tasks.
EASA Guidance is provided for the training to of maintenance organisation personnel is provided in
Appendix IV to AMC3 145.A.30(e) and AMC2 145.B.200(a)(3) 145.B.10(3).
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AMC4 145.A.30(e) Personnel requirements
Competence Competency assessments should include the verification for the check whether there is
a need of for additional EWIS training, if this is when relevant.
EASA Guidance is provided for on EWIS training programmes to for maintenance organisation
personnel is provided in AMC 20-22.
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145.A.30 Personnel requirements]
AMC5 145.A.30(e) Personnel requirements
INITIAL AND RECURRENT TRAINING
(a) Adequate initial and recurrent training should be provided and recorded to ensure that staff
remain competent.
(b) All prospective maintenance staff should be assessed for their competency related to their
intended duties (see the definition of competency in GM1 to Annex II (Part-145).
(c) The organisation should develop a procedure that describes the process for conducting
competency assessments of personnel. The procedure should specify:
(1) the persons who are responsible for this process;
(2) when the assessments should take place;
(3) how to give credit from previous assessments;
(4) how to validate qualification records;
(5) the means and methods to be used for the initial assessment;
(6) the means and methods to be used for the continuous control of competency, including
to gather feedback on the performance of personnel;
(7) the aspects of competencies to be observed during the assessment in relation to each
job function;
(8) the actions to be taken if the assessment is not satisfactory; and
(9) how to record the assessment results.
(d) Competency may be assessed by having the person work under the supervision of another
qualified person for a sufficient time to arrive at a conclusion. Sufficient time could be as little
as a few weeks if the person is fully exposed to relevant work. The person need not be
assessed against the complete spectrum of their intended duties. If the person has been
recruited from another approved maintenance organisation, it is reasonable to accept a
written confirmation from the previous organisation.
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GM1 145.A.30(e) Personnel requirements
TRAINING SYLLABUS FOR INITIAL HUMAN FACTORS SAFETY TRAINING
The training syllabus below identifies the topics and subtopics to be addressed during the human
factors safety training.
The maintenance organisation may combine, divide, or change the order of any of the subjects of in
the syllabus to suit its own needs, as long as all the subjects are covered to a level of detail that is
appropriate for to the organisation and its personnel.
Some of the topics may be covered in separate training courses (e.g. health and safety,
management, supervisory skills, etc.) in which case duplication of the training is not necessary.
Where possible, practical illustrations and examples should be used, especially accident and incident
reports.
Topics should be related to existing legislation, where relevant. Topics should be related to existing
guidance/advisory material, where relevant (e.g. ICAO HF Digests and Training Manual).
Topics should be related to maintenance engineering where possible; too much unrelated theory
should be avoided.
1. General/Introduction to safety management and human factors
1.1. Need to address safety management and human factors
1.2. Statistics
1.3. Incidents
1a. Safety risk management
1a.1. Hazard identification
1a.2. Safety risk assessment
1a.3. Risk mitigation and management
1a.4. Effectiveness of safety risk management
2. Safety Culture/Organisational factors
2.1 Just culture
2.2 Reporting culture
2.3 Informed culture
2.4 Flexible culture/learning culture
3. Human Error error
3.1. Error models and theories
3.2. Types of errors in maintenance tasks
3.3. Violations
3.4. Implications of errors
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3.5. Avoiding and managing errors
3.6. Human reliability
4. Human performance & limitations
4.1. Vision
4.2. Hearing
4.3. Information-processing
4.4. Attention and perception
4.5. Situational awareness
4.6. Memory
4.7. Claustrophobia and physical access
4.8. Motivation
4.9. Fitness/Health
4.10. Stress
4.11. Workload management
4.12. Fatigue and fatigue risk management
4.13. Alcohol, medication, drugs
4.14. Physical work
4.15. Repetitive tasks/complacency
5. Environment
5.1. Peer pressure
5.2. Stressors
5.3. Time pressure and deadlines
5.4. Workload
5.5. Shift Work
5.6. Noise and fumes
5.7. Illumination
5.8. Climate and temperature
5.9. Motion and vibration
5.10. Complex systems
5.11. Other hazards in the workplace
5.12. Lack of manpower
5.13. Distractions and interruptions
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6. Procedures, information, tools and practices
6.1. Visual Inspection
6.2. Work logging and recording
6.3. Procedure - practice/mismatch/norms
6.4. Technical documentation - access and quality
6.5. Critical maintenance tasks and error-capturing methods (independent inspection,
reinspection, etc.)
7. Communication
7.1. Shift/Task handover
7.2. Dissemination of information
7.3. Cultural differences
8. Teamwork
8.1. Responsibility
8.2. Management, supervision and leadership
8.3. Decision-making
9. Professionalism and integrity
9.1. Keeping up to date; currency
9.2. Avoiding eError-provoking behaviour
9.3. Assertiveness
10. Organisation’s HF safety programme
10.1. Safety policy and objectives, just culture principles
10.21. Reporting errors and hazards, internal safety reporting scheme
10.2. Disciplinary policy
10.3. Error Occurrence investigation process
10.4. Action to address problems
10.5. Feedback and safety promotion
[Back to implementing rule:
145.A.30 Personnel requirements]
GM2 145.A.30(e) Personnel requirements
COMPETENCY ASSESSMENT
The organisation should develop a procedure describing the process of competence assessment of
personnel. The procedure should specify:
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persons responsible for this process,
when the assessment should take place,
credits from previous assessments,
validation of qualification records,
means and methods for the initial assessment,
means and methods for the continuous control of competence including feedback on
personnel performance,
competences to be observed during the assessment in relation with each job function,
actions to be taken when assessment is not satisfactory,
recording of assessment results.
An example of elements that may be considered during a competency assessment according to the
job functions and the scope, size and complexity of the organisation, is given in the following table
(not exhaustive):
For example, according to the job functions and the scope, size and complexity of the organisation,
the assessment may consider the following (the table is not exhaustive):
and support staff
monitoring staff
Safety manager
Certifying staff
Quality audit
Service staff
Compliance
and key SM
Specialised
Mechanics
Supervisor
personnel
Managers
Planners
Knowledge of applicable officially recognised standards X X X
Knowledge of auditing techniques: planning, conducting
X X
and reporting
Knowledge of safety management, human factors,
X X X X X X X X
human performance and limitations, and just culture
Knowledge of logistics processes X X X
Knowledge of organisation capabilities, privileges and
X X X X X X X
limitations
Knowledge of Part-M, Part-ML,Part-145 and any other
X X X X X X
relevant regulations
Knowledge of relevant parts of the maintenance
X X X X X X X X
organisation exposition and procedures
Knowledge of occurrence reporting system (mandatory
and voluntary), internal reporting scheme and
understanding of the importance of reporting X X X X X X
occurrences, incorrect maintenance data and existing or
potential defects
Knowledge of safety risks linked to the working
X X X X X X X X
environment
Knowledge on of CDCCL when relevant X X X X X X X
Knowledge on of EWIS when relevant X X X X X X X
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and support staff
monitoring staff
Safety manager
Certifying staff
Quality audit
Service staff
Compliance
and key SM
Specialised
Mechanics
Supervisor
personnel
Managers
Planners
Understanding of professional integrity, behaviour and
X X X X X X X X
attitude towards safety
Understanding of conditions for ensuring continuing
X X
airworthiness of aircraft and components
Understanding of his/her own human performance and
X X X X X X X
limitations
Understanding of personnel authorisations and
X X X X X X X
limitations
Understanding critical maintenance tasks X X X X X X
Ability to compile and control completed work cards X X X
Ability to consider human performance and limitations. X X X X X X
Ability to determine required qualifications for task
X X X
performance
Ability to identify and rectify existing and potential
X X X X X X
unsafe conditions
Ability to manage third parties involved in maintenance
X X
activity
Ability to confirm proper accomplishment of
X X X X
maintenance tasks
Ability to identify and properly plan performance of
X X X
critical maintenance tasks
Ability to prioritise tasks and report discrepancies X X X X
Ability to process the work requested by the operator X X X
Ability to promote the safety and quality policy X X X X
Ability to properly process removed, uninstalled and
X X X X
rejected parts
Ability to properly record and sign for work
X X X X
accomplished
Ability to recognise the acceptability of parts to be
X X
installed prior to fitment
Ability to split complex maintenance tasks into clear
X
stages
Ability to understand work orders, work cards and refer
X X X X X X
to and use applicable maintenance data
Ability to use information systems X X X X X X X X
Ability to use, control and be familiar with required
X X X X
tooling and/or equipment
Adequate communication and literacy skills X X X X X X X X
Analytical and proven auditing skills (for example,
X X
objectivity, fairness, open-mindedness, determination,
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and support staff
monitoring staff
Safety manager
Certifying staff
Quality audit
Service staff
Compliance
and key SM
Specialised
Mechanics
Supervisor
personnel
Managers
Planners
…)
Maintenance error investigation skills X X
Resources management and production planning skills X X X
Teamwork, decision-making and leadership skills X X
Ability to encourage a positive safety culture
X X X X
and apply a just culture
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145.A.30 Personnel requirements]
GM3 145.A.30(e) Personnel requirements
TEMPLATE FOR RECORDING EXPERIENCE/TRAINING
The following template may be used to record the professional experience gained in an organisation,
and the training received and to be considered during the competence competency assessment of
the an individual in another organisation.
Aviation Maintenance personnel experience credential
Name Given name
Address
Telephone E-mail
Independent worker
Trade Group: airframe engine electric avionics other (specify) …………………
Employer’s details (when applicable)
Name
Address
Telephone
Maintenance organisation details
Name
Address
Telephone
Approval Number
Period of employment From: To:
Domain of employment
Planning Engineering Technical records
Store department Purchasing
Mechanics/Technician
Line Maintenance Base Maintenance Component Maintenance
Servicing Removal/installation Testing/inspection
Scheduled Maintenance Inspection Repair
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Trouble-shooting Trouble-shooting Troubleshooting Overhaul
Troubleshooting Repair Re-treatment
Reassembly
A/C type A/C type Component type
Certifying Staff and support staff
Cat. A Cat. B1 Cat. B2 Cat. C Component type Other (e.g. NDT)
A/C Type A/C Type A/C Type A/C Type Component Type Specify
Certification privileges: Yes / No
Specialised services Speciality (NDT, composites, welding, etc.):
Skilled personnel Speciality (sheet metal, structures, wireman, upholstery, etc.):
Ground equipment operation
Quality control Quality assurance Training
Supervision Compliance monitoring
Safety investigation Safety management
Total number of check boxes ticked:
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Details of employment
Training received from the contracting organisation
Date Nature of training
Certified by:
Name: Date:
Position: Signature:
Contact details:
Advisory note: A copy of the present credentials will be kept for at least 3 years from its their issuance
by the maintenance organisation.
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145.A.30 Personnel requirements]
GM4 145.A.30(e) Personnel requirements
SAFETY TRAINER
The competency of a trainer to conduct safety training should include:
(a) an understanding of safety management and human factors in a maintenance environment at
a level sufficient to teach the elements of the initial safety training syllabus (see
GM1 145.A.30(e));
(b) a good understanding of training and facilitation techniques, and communication skills that
enable the trainer to influence attitudes and behaviours;
(c) experience within the aviation industry, or a suitable academic background;
(d) knowledge of the organisation’s safety programme (Module 10 of GM1 145.A.30(e)).
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145.A.30 Personnel requirements]
GM5 145.A.30(e) Personnel requirements
COMPETENCY OF THE SAFETY MANAGER
The competency of a safety manager should include, but not be limited to, the following:
(a) knowledge of ICAO standards and European requirements on safety management;
(b) an understanding of management systems, including compliance monitoring systems;
(c) an understanding of risk management;
(d) an understanding of safety investigation techniques;
(e) an understanding of human factors;
(f) understanding and promotion of a positive safety culture;
(g) operational experience related to the activities of the organisation;
(h) safety management experience;
(i) interpersonal and leadership skills, and the ability to influence staff;
(j) oral and written communications skills;
(k) data management, analytical and problem-solving skills;
(l) professional integrity.
[Back to implementing rule:
145.A.30 Personnel requirements]
GM6 145.A.30(e) Personnel requirements
SAFETY TRAINING (INCLUDING HUMAN FACTORS)
(a) The scope of the safety training and the related training programme will vary significantly
depending on the size and complexity of the organisation. Safety training should reflect the
evolving management system, and the changing roles of the personnel who make it work.
(b) In recognition of this, training should be provided to management and staff at least:
(1) during the initial implementation of safety management processes;
(2) for all new staff or personnel recently allocated to any safety management related task;
(3) on a regular basis to refresh their knowledge and to understand changes to the
management system;
(4) when changing roles affect their safety management roles, accountabilities,
responsibilities, and authorities; and
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NOTE: in the context of safety management, the term ‘authority’ is used in relation to the
level of management in the organisation that is necessary to make decisions related to
risk tolerability.
(5) when performing dedicated safety functions in domains such as safety risk
management, compliance monitoring, and internal investigations.
(c) Safety training is subject to the record-keeping requirements in point 145.A.55(d).
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145.A.30 Personnel requirements]
AMC1 145.A.30(f) Personnel requirements
[…]
6. It should be noted that new methods are, and will be, developed, such as, but not limited to
thermography and shearography, which are not specifically addressed by EN 4179. Until the
time this agreed standard is established, such methods should be carried out in accordance
with the particular equipment manufacturer’s recommendations, including any training and
examination process to ensure the competence competency of the personnel in the process.
7. Any maintenance organisation approved under Part-145 that carries out NDT should establish
NDT specialist qualification procedures that are detailed in the exposition and accepted by the
competent authority.
8. Boroscoping and other techniques such as delamination coin tapping are non-destructive
inspections rather than non-destructive testing. Notwithstanding such differentiation, the
maintenance organisation should establish an exposition procedure that is accepted by the
competent authority to ensure that personnel who carry out and interpret such inspections
are properly trained and assessed for their competence competency in the process.
Non-destructive inspections, which are not being considered as to be NDT by Part-145, are not
listed in Appendix II under class rating D1.
[…]
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145.A.30 Personnel requirements]
AMC1 145.A.30(h) Personnel requirements
In accordance with points 145.A.30(h) and 145.A.35, the qualification requirements (basic licence,
aircraft ratings, recent experience and recurrent continuation training) are identical for certifying
staff and for support staff. The only difference is that support staff cannot hold certification
privileges when performing this role, since during base maintenance, the release to service will be
issued by category C certifying staff.
Nevertheless, the organisation may use as support staff (for base maintenance) persons who already
hold certification privileges for line maintenance.
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AMC1 145.A.30(j)(4) Personnel requirements
1. For the issue of a limited certification authorisation:
(a) the commander should hold either an airline transport pilots license licence (ATPL), or a
commercial pilots license licence (CPL) in accordance with Part-FCL.
(b) The flight engineer should hold either an ATPL, CPL or a national flight engineer licence
acceptable to the competent authority on the aircraft type.
2. In addition, the limited certification authorisation is subject to the maintenance organisation
exposition MOE containing procedures to address the personnel requirements of point
145.A.30(e) and the associated AMC and guidance material. The procedures should be
accepted by the competent authority and should include as a minimum:
(a) Completion of adequate maintenance continuing airworthiness regulation training as
related to maintenance.
(b) Completion of adequate task training for the specific task on the aircraft. The task
training should be of sufficient duration to ensure that the individual has a thorough
understanding of the task to be completed, and that it will involve training in the use of
the associated maintenance data.
(c) Completion of the procedural training as specified in Part-145.
2.(i) Typical tasks that may be certified and/or carried out by the a commander who holdsing an
ATPL or CPL are the minor maintenance or simple checks included in the following list:
(a) The Rreplacement of internal lights, filaments and flash tubes.
(b) The Cclosing of cowlings and refitment of quick access inspection panels.
(c) Role changes, e.g. stretcher installation fit, dual controls, FLIR, doors, photographic
equipment etc.
(d) Inspection for, and removal of, de-icing/anti-icing fluid residues, including the
removal/closure of panels, cowls or covers that are easily accessible, but that do not
requireing the use of special tools.
(e) Any check/replacement that involvesing simple techniques that are consistent with this
AMC and that have been as agreed by the competent authority.
2.(ii) Holders of flight engineer licence acceptable to the competent authority on the aircraft type,
may only exercise this limited certification authorisation privilege when performing the duties
of a flight engineer.
In addition to paragraph 2(i)(a) to (e) other typical minor maintenance or simple defect
rectification tasks that may be carried out are included in the following list:
(a) Replacement of wheel assemblies.
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(b) Replacement of simple emergency equipment that is easily accessible.
(c) Replacement of ovens, boilers and beverage makers.
(d) Replacement of external lights.
(e) Replacement of passenger and cabin crew seats, seat belts and harnesses.
(f) Simple replacement of overhead storage compartment doors and cabin furnishing
items.
(g) Replacement of static wicks.
(h) Replacement of aircraft main and APU aircraft batteries.
(i) Replacement of in-flight entertainment system components other than public address.
(j) The de-activation only of sub-systems and aircraft components as permitted by the
operator's minimum equipment list where such de-activation is agreed by the
competent authority as a simple task.
(k) Re-setting of tripped circuit breakers under the guidance of maintenance control.
(l) Any other task agreed by the competent authority as a simple task for a particular
aircraft type.
3. The validity of the authorisation should be limited to have a finite life of twelve 12 months,
and may be renewed subject to if there has been satisfactory re-current recurrent training on
the applicable aircraft type.
[Back to implementing rule:
145.A.30 Personnel requirements]
GM 145.A.30(j)(4) Personnel requirements (Flight crew)
For the holder of a flight engineer licence acceptable to the competent authority appendix 1 to JAR
FCL 4.160 Technical Training Course (TTC) details the following subjects:
Familiarisation with basic maintenance procedures, to give additional technical background
knowledge, especially with respect to the implication of systems malfunctions, and to train the
applicant in maintenance related to the Minimum equipment list (MEL).
The theoretical knowledge instruction consists of 100 hours and includes the following
elements:
1. Airframe and systems
2. Electrics
3. Powerplant and emergency equipment
4. Flight instruments and automatic flight control systems
Practical skills training provided by an organisation approved under Part-145 is given which
includes 35 hours practical experience in the following subjects:
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Fuselage and flight controls,
Engines,
Instruments,
Landing gear and brakes,
Cabin/cockpit/emergency equipment,
De-icing/anti-icing related maintenance activities;
Ground handling and servicing,
Certificate of completion.
Following successful completion of the technical training, the training organisation carrying out the
theoretical knowledge instruction and/or the practical skill training should provide the applicant with
a certificate of satisfactory completion of the course, or part thereof.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(j)(5) Personnel requirements
1. For the purposes of this sub-paragraph, ‘unforeseen’ means that the grounding of the aircraft
grounding could not reasonably have been predicted by the operator because the defect was
unexpected, due to it being part of a hitherto reliable system.
2. Issuing Aa one-off authorisation should only be considered for issue under the responsibility
of the compliance monitoring manager by the quality department of the contracted
organisation after it has made a reasoned judgement was made that such an authorisation
requirement is appropriate under the circumstances, and while at the same time that it
maintainsing the required airworthiness standards. The organisation’s compliance monitoring
personnel quality department will need to should assess each situation individually prior to
the issuingance of a one-off authorisation, and it may request the safety management
personnel to perform a safety risk assessment.
3. A one-off authorisation should not be issued where if the level of certification required could
exceed the knowledge and experience level of the person it is issued to. In all cases, due
consideration should be given to the complexity of the work involved and the availability of
the required tooling and/or test equipment needed to complete the work.
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AMC1 145.A.30(j)(5)(i) Personnel requirements
In those situations where the requirement for If a one-off authorisation to issue a CRS for a task on
an aircraft type for which certifying staff does not hold a type-rated authorisation has been
identified is necessary, the following procedure is recommended:
1. The Fflight crew should communicate full details of the defect to the operator’s supporting
maintenance organisation. If necessary, the supporting maintenance organisation will then
request the use of a one-off authorisation from the compliance monitoring personnel quality
department.
2. When issuing a one-off authorisation, the compliance monitoring personnel, quality
department of the organisation should verify that:
(a) Full technical details relating to the work required to be carried out have been
established and passed on to the certifying staff.
(b) The organisation has an approved procedure in place for coordinating and controlling
the total maintenance activity undertaken at the location under the authority of the
one-off authorisation.
(c) The person to whom a one-off authorisation is issued has been provided with all the
necessary information and guidance relating to maintenance data, and any special
technical instructions associated with the specific task undertaken. A detailed
step-by-step worksheet has been defined by the organisation, and has been
communicated to the holder of the one-off authorisation holder.
(d) The person holds authorisations of equivalent levels and scopes on other aircraft types
that have of similar technology, construction and systems.
3. The holder of the one-off authorisation holder should sign off the detailed step-by-step
worksheet when completing the work steps. The completed tasks should be verified by visual
examination and/or normal system operation upon return to an appropriately approved
Part-145 maintenance facility.
[Back to implementing rule:
145.A.30 Personnel requirements]
AMC1 145.A.30(j)(5)(ii) Personnel requirements
This paragraph addresses the requirements for staff who are not employed by the maintenance
organisation, but who meet the requirements of point 145.A.30(j)(5). In addition to the items listed
in AMC 145.A.30(j)(5)(i), paragraph points 1, 2(a), (b) and (c) and 3, the compliance monitoring
personnel quality department of the organisation may issue such a one-off authorisation providing
provided that full qualification details relating to the qualifications of the proposed certifying
personnel are verified by the compliance monitoring personnel quality department and made
available at the location.
[Back to implementing rule:
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145.A.30 Personnel requirements]
AMC1 145.A.35(a) Certifying staff and support staff
1. Holding a Part-66 licence with the relevant type/group rating, or a national qualification in the
case of components, does not mean by itself that the holder is qualified to be authorised as
certifying staff and/or support staff. The organisation is responsible to for assessing the
competence competency of the holder for the scope of the maintenance to be authorised.
[…]
4. The satisfactory assessment of the competence competency of the holder should be
conducted in accordance with a procedure approved by the competent authority (item 3.4 of
the MOE, as described in AMC1 145.A.70(a)).
5. The organisation should hold copies of all the documents that attest to the competence
competency and recent experience of the holder for the period described in point
145.A.55(d)(4) 145.A.35(j).
Additional information is provided in AMC 66.A.20(b)3.
[Back to implementing rule:
145.A.35 Certifying staff and support staff]
AMC1 145.A.35(d) Certifying staff and support staff
1. Continuation Recurrent training is a two-way process to ensure that certifying staff remain
current in terms of the necessary procedures, safety management, human factors and
technical knowledge, and that the organisation receives feedback on the adequacy of its
procedures and maintenance instructions. Due to the interactive nature of this training,
consideration should be given to the possibility that such training has the involvingement of
the compliance monitoring staff and the key safety management personnel in this training
quality department to ensure that feedback is actioned. Alternatively, there There should be a
procedure to ensure that feedback is formally reported by passed from the trainers through
the internal safety reporting scheme training department to the quality department to initiate
action.
2. Continuation Recurrent training should cover any changes made to in the relevant
requirements such as Part-145, changes in to the organisation’s procedures, safety policy and
objectives, and or to the modification standard of the products being maintained, plus as well
as any human factors and safety issues identified from any internal or external analysis of
incidents. It should also address any instances where in which staff failed to follow the
procedures, and the reasons why particular procedures were are not always followed. In many
cases, the continuation recurrent training will reinforce the need to follow the procedures and
will ensure that any incomplete or incorrect procedures are identified to the company in order
so that they can be corrected. This does not preclude the possible need It may be necessary to
carry out an quality audit of such these procedures.
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3. Continuation Recurrent training should be of sufficient duration in each 2-year period to meet
the intent of point 145.A.35(d) and may be split into a number of separate elements. Point
145.A.35(d) requires such a training to keep certifying staff updated in terms of relevant
technology, procedures, safety management and human factors issues which means it is one
part of ensuring compliance quality. Therefore, sufficient duration should be related to
relevant quality audit findings and other internal / external sources of information available to
the organisation on human errors and safety issues in maintenance. This means that in the
case of an organisation that maintains aircraft with few relevant quality audit findings, hazards
and related safety risks identified, continuation recurrent training could be limited to days
rather than weeks, whereas in the case of a similar organisation with a number of relevant
quality audit findings, hazards and related safety risks identified, such a training may take
several weeks. For an organisation that maintains aircraft components, the duration of
continuation recurrent training would follow the same philosophy but should be scaled down
to reflect the more limited nature of the activity. For example, certifying staff who release
hydraulic pumps may only require a few hours of continuation recurrent training, whereas
those who release turbine engines may only require a few days of such a training. The content
of continuation recurrent training should be related to relevant quality audit findings, hazards
and related safety risks identified. It and it is recommended that such a training is reviewed at
least once in every 24-month period.
4. The method of training is intended to be a flexible process, and this training could, for
example, be provided by include a Part-147 organisation continuation training course, an
aeronautical college courses, by the Part-145 organisation, or by another training or
maintenance organisation internal short duration courses, seminars, etc. The elements,
general content and length of such a training should be specified in the maintenance
organisation exposition MOE unless such training is undertaken by an organisation approved
under Part-147 when such details may be specified under the approval and cross referenced
in the maintenance organisation exposition.
[Back to implementing rule:
145.A.35 Certifying staff and support staff]
AMC1 145.A.35(e) Certifying staff and support staff
The programme for continuation recurrent training should list all certifying staff and support staff
and when the training will take place, the elements of such a training, and an indication that it was
carried out reasonably on time as planned. Such information should subsequently be transferred to
the certifying staff and to the support staff records as required by point 145.A.55(d)(3) 145.A.35(j).
[Back to implementing rule:
145.A.35 Certifying staff and support staff]
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AMC1 145.A.35(f) Certifying staff and support staff
As stated in point 145.A.35(f), except where any of the unforeseen cases of point 145.A.30(j)(5)
applies, all prospective certifying staff and support staff should be assessed for their competence
competency related to their intended duties in accordance with AMCs 1, 2, 3, and 4 and 5 to point
145.A.30(e), as applicable.
[Back to implementing rule:
145.A.35 Certifying staff and support staff]
AMC1 145.A.45(c) Maintenance data
1. The referenced procedure should ensure that when maintenance personnel discover
inaccurate, incomplete or ambiguous information in the maintenance data, they should
record the details as part of the internal safety reporting scheme specified in point 145.A.202.
The procedure should then ensure that the Part-145 approved maintenance organisation
notifies the problem to the author of the maintenance data in a timely manner. A record of
such communications to the author of the maintenance data should be retained by the Part-
145 approved organisation until such time as the type certificate holder has clarified the issue
by e.g. amending the maintenance data.
2. The referenced procedure should be specified in the maintenance organisation exposition
MOE.
[Back to implementing rule:
145.A.45 Maintenance data]
AMC1 145.A.45(d) Maintenance data
The referenced procedure should address the need for a practical demonstration by the mechanic to
the compliance monitoring quality personnel of the proposed modified maintenance instruction.
Depending on the nature of the maintenance instruction modification, the safety management
personnel may be required to perform a safety risk assessment. When satisfied, the quality
compliance monitoring personnel should approve the modified maintenance instruction, and ensure
that the type certificate or supplementary type certificate holder is informed of the modified
maintenance instruction. The procedure should include a paper/electronic traceability of the
complete process from start to finish, and ensure that the relevant maintenance instruction clearly
identifies the modification. Modified maintenance instructions should only be used in the following
circumstances:
(a) Where the type certificate / supplementary type certificate holder’s original intent can be
carried out in a more practical or more efficient manner.
(b) Where the type certificate / supplementary type certificate holder’s original intent cannot be
achieved by following the maintenance instructions. For example, where a component cannot
be replaced following the original maintenance instructions.
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(c) For the use of alternative tools / equipment.
Important Note: Critical Design Configuration Control Limitations (CDCCL) are airworthiness
limitations. Any modification of the maintenance instructions linked to CDCCL constitutes an aircraft
modification that should be approved in accordance with Part 21.
[Back to implementing rule:
145.A.45 Maintenance data]
AMC1 145.A.45(e) Maintenance data
1. The maintenance organisation should:
accurately transcribe accurately the maintenance data onto such work cards or
worksheets, or
make precise reference to the particular maintenance task(s) contained in such the
maintenance data, which already identifies the task as a CDCCL where applicable.
2. Relevant parts of the organisation means, with regard to aircraft base maintenance, aircraft
line maintenance, engine workshops, mechanical workshops and avionic workshops.
Therefore, engine workshops, for example, should have a common system throughout such
the engine workshops that may be different to from that in the aircraft base maintenance.
3. The workcards work cards should differentiate and specify, when relevant, disassembly, the
accomplishment of tasks, reassembly and testing. In the case of a lengthy maintenance task
involving a succession of personnel to complete such a task, it may be necessary to use
supplementary workcards work cards or worksheets to indicate what was actually
accomplished by each individual person.
4. Where required by the operator/CAMO to use their work card or worksheet system, the
maintenance organisation should assess the system for compliance with the maintenance
organisation procedures, for example, the subdivision of complex maintenance tasks into clear
stages.
[Back to implementing rule:
145.A.45 Maintenance data]
AMC1 145.A.47(b) Production planning
FATIGUE RISK MANAGEMENT
(a) Human performance can be affected by excessive hours of duty and shift working, particularly
with multiple shift periods, additional overtime or night work. Induced fatigue is one of the
factors that contributes towards maintenance errors. In accordance with point
145.A.200(a)(3), these risks should be assessed and managed by the organisation, taking into
account the size, nature, and complexity of the organisation and its operational working
hours.
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(b) In order to manage the risk related to the fatigue of personnel, the organisation should:
(1) as part of its management system, develop, define and maintain a policy for the
management of fatigue-related risks, and the related procedures;
(2) define and use work schedules with maximum work and minimum rest hours that
comply with the national and, when applicable, EU legislation on working time and
taking into account the recommendations of Appendix H to Chapter 3 of ICAO Doc
9824;
(3) ensure that existing internal reporting systems enable the identification of
fatigue-related hazards;
(4) assess and manage the risks raised by these reports in accordance with the
organisation’s safety risk management procedures (see AMC1 145.A.200(a)(3)), and
monitor the effectiveness of the related risk mitigation actions that are implemented;
(5) provide training and safety promotion information/briefings on the management of
fatigue.
(c) The work hour limits defined under (b)(2) should not be exceeded merely for management
convenience even when staff is willing to work extended hours. Without prejudice to the
national and, when applicable, EU legislation on working time, in exceptional circumstances
where the maximum work hours are to be exceeded (such as for urgent operational reasons),
the organisation should carry out a risk assessment, and with the agreement of the individual
staff member, it should be recorded how the increased fatigue risk will be mitigated. This may
include:
(1) additional supervision and independent inspection;
(2) limitation of maintenance tasks to non-critical tasks;
(3) use of additional rest breaks;
(4) permission to nap in accordance with guidelines approved by the organisation.
[Back to implementing rule:
145.A.47 Production planning]
GM1 AMC 145.A.47(b) Production planning
HUMAN PERFORMANCE AND FATIGUE (see definitions in GM1 to Annex II (Part-145))
(a) Limitations of human performance, in the context of planning safety related tasks, refers to
the upper and lower limits, and variations, of certain aspects of human performance
(Circadian rhythm / 24 hours body cycle) which personnel should be aware of when planning
work and shifts.
(b) With regard to fatigue, there are three primary factors that are relevant:
(1) the amount of proper sleep;
(2) the amount of time awake;
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(3) the time of day where work is performed.
(c) Fatigue is also impacted by high workloads (mental and/or physical activity) and by the
physical and mental health of the staff concerned.
[Back to implementing rule:
145.A.47 Production planning]
GM1 145.A.47(d) Production planning
‘External working team’ refers to an organisation that does not belong to the Part-145 organisation
in whose facility the maintenance is being carrying out, and which is, for example (this list is not
exhaustive):
contracted by the Part-145 maintenance organisation; or
subcontracted by the Part-145 maintenance organisation; or
contracted by the aircraft owner/CAMO.
The objective of this requirement is to manage the risk involved in the actual execution of
maintenance by the various organisations at the same location.
Example: the need for one organisation to be informed that they should not put the aircraft in a
certain configuration (regarding electrical power, hydraulic power, the flight control configuration,
the aeroplane on jacks, etc.) if this is could adversely affect the work performed by another
organisation.
Note: please refer to the difference between contracting and subcontracting maintenance activities
in GM2 145.A.205.
[Back to implementing rule:
145.A.47 Production planning]
AMC1 145.A.48(a) AMC 145.A.80 Limitations on the organisation
Performance of maintenance
This paragraph is intended to cover the situation where the larger organisation may temporarily not
hold all the necessary tools, equipment, etc., for an aircraft type or variant, or component specified
in the organisation's scope of work approval. This paragraph means that the competent authority
need not amend the approval to delete the aircraft type or variants on the basis that it is a
temporary situation and there is a commitment from the organisation to re-acquire tools,
equipment etc. before maintenance on the type may recommence.
[Back to implementing rule:
145.A.48 Performance of maintenance]
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AMC1 145.A.48(c)(2) AMC1 145.A.48(b) Performance of
maintenance
The procedure should identify the error-capturing methods, the critical maintenance tasks, the
training and the qualifications of staff who applying error-capturing methods, and how the
organisation ensures that its staff is familiar with critical maintenance tasks and error-capturing
methods.
[Back to implementing rule:
145.A.48 Performance of maintenance]
AMC2 145.A.48(c)(2) AMC2 145.A.48(b) Performance of
maintenance
CRITICAL MAINTENANCE TASKS
(a) The procedure should ensure that the following maintenance tasks are reviewed to assess
their impact on flight safety:
(1) tasks that may affect the control of the aircraft’s flight path and attitude, such as the
installation, rigging and adjustments of flight controls;
(2) aircraft stability control systems (autopilots, fuel transfer);
(3) tasks that may affect the propulsive force of the aircraft, including the installation of
aircraft engines, propellers and rotors; and
(4) the overhaul, calibration or rigging of engines, propellers, transmissions and gearboxes.
(b) The procedure should describe which data sources are used to identify critical maintenance
tasks. Several data sources may be used, such as:
(1) information from the design approval holder;
(2) accident reports;
(3) the investigation and follow-up of incidents;
(4) occurrence reporting;
(5) flight data analysis, where this is available from the operator/CAMO;
(6) the results of audits;
(7) monitoring schemes for normal operations monitoring schemes, where these are
available from the operator/CAMO; and
(8) feedback from training.
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145.A.48 Performance of maintenance]
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AMC3 145.A.48(c)(2) AMC3 145.A.48(b) Performance of
maintenance
ERROR-CAPTURING METHODS
(a) Error-capturing methods are those actions defined by the organisation to detect maintenance
errors that are made when while performing maintenance.
(b) The organisation should ensure that the error-capturing methods are adequate for the work
and the disturbance of the system. A combination of several actions (e.g. visual inspections,
operational checks, functional tests, rigging checks) may be necessary in some cases.
[Back to implementing rule:
145.A.48 Performance of maintenance]
AMC4 145.A.48(c)(2) AMC4 145.A.48(b) Performance of
maintenance
INDEPENDENT INSPECTION
Independent inspection is one possible error-capturing method.
(a) What is an independent inspection
An independent inspection is an inspection performed by an ‘independent qualified person’ of
a task carried out by an ‘authorised person’, taking into account that:
(1) the ‘authorised person’ is the person who performs the task or supervises the task, and
they assume the full responsibility for the completion of the task in accordance with the
applicable maintenance data;
(2) the ‘independent qualified person’ is the person who performs the independent
inspection and attests to the satisfactory completion of the task, and that no
deficiencies have been found. The ‘independent qualified person’ does not issue a
certificate of release to service, therefore they are not required to hold certification
privileges;
(3) the ‘authorised person’ issues the certificate of release to service or signs off the
completion of the task after the independent inspection has been carried out
satisfactorily;
(4) the work card system used by the organisation should record the identification of both
persons and the details of the independent inspection as necessary before the
certificate of release to service or the sign-off for the completion of the task is issued.
(b) Qualifications of persons performing independent inspections
The organisation should have procedures to demonstrate that the ‘independent qualified
person’ has been trained and has gained experience in the specific type of inspection to be
performed. The organisation could consider making use of, for example:
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(1) staff who holding a certifying staff, or support staff, or sign-off authorisation or
equivalent that is necessary to release or sign off the critical maintenance task;
(2) staff who holding a certifying staff, or support staff, or sign-off authorisation or
equivalent that is necessary to release or sign off similar tasks in a product of a similar
category, and who haveving received specific practical training in the task to be
inspected; or
(3) a commander who holdsing a limited certification authorisation in accordance with
point 145.A.30(j)(4) and hasving received adequate practical training and hasving
enough experience in the specific task to be inspected, and on how to perform
independent inspections.
(c) How to perform an independent inspection
An independent inspection should ensure the correct assembly, locking and sense of
operation of the parts involved. When inspecting control systems that have undergone
maintenance, the independent qualified person should consider the following points
independently:
(1) all those parts of the system that have actually been disconnected or disturbed should
be inspected for their correct assembly and locking;
(2) the system as a whole should be inspected for full and free movement over the
complete range;
(3) cables should be tensioned correctly with adequate clearance at secondary stops;
(4) the operation of the control system as a whole should be observed to ensure that the
controls are operateing in the correct sense;
(5) if different control systems are interconnected so that they affect each other, all the
interactions should be checked through the full range of the applicable controls; and
(6) software that is part of the critical maintenance task should be checked, for example: its
version, and its compatibility with the aircraft configuration.
(d) What to do in unforeseen cases when only one person is available
REINSPECTION:
(1) Reinspection is an error-capturing method that is subject to the same conditions as an
independent inspection is, except that the ‘authorised person’ who performsing the
maintenance task is also actsing as the ‘independent qualified person’, and performs
the inspection.
(2) Reinspection, as an error-capturing method, should only be performed in unforeseen
circumstances when only one person is available to carry out the task and perform the
independent inspection. The circumstances cannot be considered to be unforeseen if
the person or organisation has not assigned a suitable ‘independent qualified person’ to
that particular line station or shift.
(3) The certificate of release to service is issued after the task has been performed by the
‘authorised person’ and the reinspection has been carried out satisfactorily. The work
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card system used by the organisation should record the identification and the details of
the reinspection before the certificate of release to service for the task is issued.
[Back to implementing rule:
145.A.48 Performance of maintenance]
AMC1 145.A.48(c)(3) Performance of maintenance
The procedures should be aimed at:
(a) minimising multiple errors and preventing omissions. Therefore, the procedures should
specify:
(1) that every maintenance task is signed off only after completion;
(2) how the grouping of tasks for the purpose of sign-off allows critical steps to be clearly
identified; and
(3) that work performed by personnel under supervision (i.e. temporary staff, trainees) is
checked and signed off by an authorised person;
(b) minimising the possibility of an error being repeated in identical tasks and, therefore,
compromising more than one system or function. Thus, the procedures should ensure that no
person is required to perform a maintenance task involving removal/installation or
assembly/disassembly of several components of the same type fitted to more than one
system, a failure of which could have an impact on safety, on the same aircraft or component
during a particular maintenance check. However, in unforeseen circumstances when only one
person is available, the organisation may make use of reinspection as described in point (d) of
AMC4 145.A.48(b) AMC4 145.A.48(c)(2).
[Back to implementing rule:
145.A.48 Performance of maintenance]
GM1 145.A.48(c)(3) Performance of maintenance
To minimise the risk of multiple errors or errors being repeated, the organisation may implement:
procedures to plan the performance by different persons of the same task in different
systems;
duplicate independent inspection or re-inspection procedures.
[Back to implementing rule:
145.A.48 Performance of maintenance]
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GM1 145.A.48(c)(4) GM 145.A.48(d) Performance of maintenance
— critical design configuration control limitations (CDCCL)
The organisation should ensure that when performing maintenance, the CDCCL are not
compromised. The organisation should pay particular attention to possible adverse effects of any
change to the wiring of the aircraft, even of a change not specifically associated with the fuel tank
system. For example, it should be common practice to identify the segregation of fuel gauging
system wiring as a CDCCL. The organisation can prevent adverse effects associated with changes to
the wiring by standardising maintenance practices through training, and not through periodic
inspections. Training should be provided to avoid indiscriminate routing and splicing of wires, and to
provide comprehensive knowledge of critical design features of fuel tank systems that would be
controlled by a CDCCL. Guidance on the training of maintenance organisation personnel is provided
in Appendix IV to AMC3 145.A.35 145.A.30(e) and AMC2 145.B.200(a)(3) 145.B.10(3).
[Back to implementing rule:
145.A.48 Performance of maintenance]
GM1 AMC 145.A.50(a) Certification of maintenance
’Endangers the flight safety’ means any instances where safe operation could not be assured, or
which could lead to an unsafe condition. It typically includes, but is not limited to, significant
cracking, deformation, corrosion or failure of primary structure, any evidence of burning, electrical
arcing, significant hydraulic fluid or fuel leakage, and any emergency system or total system failure.
An airworthiness directive that is overdue for compliance is also considered to be a hazard to flight
safety.
However, the intent is not to require the maintenance organisation to find or become responsible
for hidden non-compliances which are not expected to be discovered during the ordered
maintenance.
A certificate of release to service issued by a maintenance organisation certifies that the performed
maintenance work has been completed in accordance with the applicable regulations and the
maintenance organisation’s approved procedures. In the case of aircraft maintenance, it does not
necessarily mean that the aircraft is in airworthy condition. Ensuring that the aircraft is airworthy
before each flight always remains the responsibility of the owner/operator/CAMO.
[Back to implementing rule:
145.A.50 Certification of maintenance]
AMC1 145.A.50(b) Certification of maintenance
1. The certificate of release to service should contain the following statement:
‘Certifies that the work specified, except as otherwise specified, was carried out in accordance
with Part-145 and in respect to that work, the aircraft/aircraft component is considered ready
for release to service’.
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Reference should also be made to the EASA Part-145 approval number and the identity of the
person who issued the release.
[…]
[Back to implementing rule:
145.A.50 Certification of maintenance]
AMC1 145.A.50(e) Certification of maintenance
1. Being unable to establish full compliance with point sub-paragraph Part- 145.A.50(a) means
that the maintenance required by the aircraft operator could not be completed due to either
to running out of available aircraft maintenance downtime for the scheduled check, or by
virtue of the condition of the aircraft, requiring additional maintenance downtime.
[…]
[Back to implementing rule:
145.A.50 Certification of maintenance]
AMC1 145.A.55 Record-keeping
GENERAL
(a) The record-keeping system should ensure that all records are accessible within a reasonable
time whenever they are needed. These records should be organised in a manner that ensures
their traceability and retrievability throughout the required retention period.
(b) Records should be kept in paper form, or in electronic format, or a combination of the two.
Records that are stored on microfilm or in optical disc formats are also acceptable. The
records should remain legible throughout the required retention period. The retention period
starts when the record is created or was last amended.
(c) Paper systems should use robust materials which can withstand normal handling and filing.
Computer record systems should have at least one backup system, which should be updated
within 24 hours of any new entry. Computer record systems should include safeguards to
prevent unauthorised personnel from altering the data.
(d) All computer hardware that is used to ensure the backup of data should be stored in a
different location from the one that contains the working data, and in an environment that
ensures that the data remains in good condition. When hardware or software changes take
place, special care should be taken to ensure that all the necessary data continues to be
accessible through at least the full period specified in the relevant provision. In the absence of
any such indications, all records should be kept for a minimum period of 3 years.
[Back to implementing rule:
145.A.55 Record-keeping]
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GM1 145.A.55 Record-keeping
RECORDS
Microfilming or optical storage of records may be carried out at any time. The records should be as
legible as the original record, and remain so for the required retention period.
[Back to implementing rule:
145.A.55 Record-keeping]
GM1 145.A.55(a)(1) Record-keeping Maintenance and
airworthiness review records
MAINTENANCE RECORDS
1. Properly executed and retained maintenance records provide owners, operators and
maintenance personnel with information essential in controlling unscheduled and scheduled
maintenance, and trouble-shooting troubleshooting to eliminate the need for re-inspection
and rework to establish airworthiness.
The prime objective is to have secure and easily retrievable records with comprehensive and
legible contents. The aircraft record should contain basic details of all serialised aircraft
components and all other significant aircraft components installed, to ensure traceability to
such installed aircraft component documentation and the associated maintenance data as
specified in point 145.A.45.
2. Some gas turbine engines are assembled from modules, and a true total time in service for a
total engine is not kept. When owners and operators wish to take advantage of the modular
design, then the total time in service and the maintenance records for each module is are to
be maintained. The maintenance records as specified are to be kept with the module and
should show compliance with any mandatory requirements pertaining to that module.
3. Reconstruction of lost or destroyed maintenance records can be done by reference to other
records which reflect the time in service, research of records maintained by repair facilities,
and reference to records maintained by individual mechanics etc. When these things have
been done and the record is still incomplete, the owner/operator may make a statement in
the new record describing the loss, and establishing the time in service based on the research
and the best estimate of time in service. The reconstructed records should be submitted to
the competent authority for acceptance.
Note: Additional maintenance may be required.
4. The maintenance record can be either a paper or computer system or any combination of
both.
5. Paper systems should use robust material which can withstand normal handling and filing. The
record should remain legible throughout the required retention period.
6. Computer systems may be used to control maintenance and/or record details of maintenance
work carried out. Computer systems used for maintenance should have at least one backup
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system which should be updated at least within 24 hours of any maintenance. Each terminal is
required to contain programme safeguards against the ability of unauthorised personnel to
alter the database.
[Back to implementing rule:
145.A.55 Record-keeping]
AMC1 145.A.55(a)(3) AMC 145.A.55(c) Record-keeping
Maintenance and airworthiness review records
MAINTENANCE RECORDS
’Associated maintenance data’ is specific information such as repair and modification data. This does
not necessarily require the retention of all Aircraft Maintenance Manuals, Component Maintenance
Manuals, IPC etc. issued by the TC holder or STC holder. Maintenance records should refer to the
revision status of the data used.
[Back to implementing rule:
145.A.55 Record-keeping]
AMC1 145.A.55(d) AMC 145.A.35(j) Certifying staff and support
staff Record-keeping
RECORDS OF CERTIFYING STAFF AND SUPPORT STAFF
1. The following minimum information, as applicable, should be kept on record in respect of
each certifying staff and or support staff:
(a) Name
(b) Date of Bbirth
(c) Basic Ttraining
(d) Type Ttraining
(e) Continuation Recurrent Ttraining
(f) Experience
(g) Qualifications relevant to the authorisation
(h) Scope of the authorisation
(i) Date of first issue of the authorisation
(j) If appropriate - expiry date of the authorisation
(k) Identification Nnumber of the authorisation
2. The record may be kept in any format but should be controlled by the organisation's
compliance monitoring function quality department. This does not mean that the compliance
monitoring manager quality department should run the record system.
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3. The number of Ppersons authorised to access the system should be maintained kept to at a
minimum to ensure that records cannot be altered in an unauthorised manner, or and that
such confidential records do not become accessible to any unauthorised persons.
4. The competent authority is an authorised person when investigating the records system for
initial certification and oversight continued approval or when the competent authority has
cause to doubt the competence competency of a particular person.
[Back to implementing rule:
145.A.55 Record-keeping]
AMC2 145.A.55(d) AMC 145.A.36 Record-keeping Records of
airworthiness review staff
RECORDS OF AIRWORTHINESS REVIEW STAFF
The following minimum information, as applicable, should be kept on record in respect of each
airworthiness review staff:
(a) nName;
(b) dDate of birth;
(c) cCertifying staff authorisation;
(d) eExperience as certifying staff on ELA1 aircraft covered by Part-ML;
(e) qQualifications relevant to the approval (knowledge of relevant parts of Part-ML and
knowledge of the relevant airworthiness review procedures);
(f) sScope of the airworthiness review authorisation and personal authorisation reference;
(g) dDate of the first issue of the airworthiness review authorisation; and
(h) iIf appropriate, expiry date of the airworthiness review authorisation.
[Back to implementing rule:
145.A.55 Record-keeping]
AMC 145.A.60(b) Occurrence reporting
1. The aim of occurrence reporting is to identify the factors contributing to incidents, and to
make the system resistant to similar errors.
2. An occurrence reporting system should enable and encourage free and frank reporting of any
(potentially) safety related occurrence. This will be facilitated by the establishment of a just
culture. An organisation should ensure that personnel are not inappropriately punished for
reporting or co-operating with occurrence investigations.
3. The internal reporting process should be closed-loop, ensuring that actions are taken
internally to address safety hazards.
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4. Feedback to reportees, both on an individual and more general basis, is important to ensure
their continued support for the scheme.
[Back to implementing rule:
145.A.60 Occurrence reporting]
AMC 145.A.65(a) Safety and quality policy, maintenance
procedures and quality system
The safety and quality policy should as a minimum include a statement committing the organisation
to:
Recognise safety as a prime consideration at all times.
Apply Human factors principles.
Encourage personnel to report maintenance related errors/incidents.
Recognise that compliance with procedures, quality standards, safety standards and
regulations is the duty of all personnel.
Recognise the need for all personnel to cooperate with the quality auditors.
[Back to implementing rule:
145.A.65 Maintenance procedures]
AMC1 145.A.65(b) Safety and quality policy, Maintenance
procedures and quality system
GENERAL
1. Maintenance procedures should be held current kept up to date such that they reflect the
best practices within the organisation. It is the responsibility of all the organisation’s
employees to report any differences via their organisation’s internal safety occurrence
reporting scheme mechanisms.
2. All procedures, and changes to those procedures, should be verified and validated before use
where practicable.
3. All technical procedures should be designed and presented in accordance with good human
factors principles.
[Back to implementing rule:
145.A.65 Maintenance procedures]
GM1 145.A.65 Maintenance procedures
HUMAN FACTORS PRINCIPLES
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The following key points should be considered when designing and presenting technical procedures
in accordance with good human factors principles:
(a) The design of procedures and changes should involve maintenance personnel who have a
good working knowledge of the tasks.
(b) Ensure that the procedures are accurate, appropriate and usable, and reflect best practices.
(c) Take account of the level of expertise and experience of the user; where appropriate, provide
an abbreviated version of the procedure for use by experienced technicians.
(d) Take account of the environment in which the procedures are to be used.
(e) Ensure that all the key information is included without the procedure being unnecessarily
complex.
(f) Where appropriate, explain the reasons for the procedure.
(g) The order of the tasks and the steps should reflect best practices, with the procedure clearly
stating where the order of steps is critical, and where the order is optional.
(h) Ensure consistency in the design of procedures and the use of terminology, abbreviations,
references, etc.
(i) For documents produced in the English language, use ‘simplified English’.
[Back to implementing rule:
145.A.65 Maintenance procedures]
GM2 145.A.65(b)(1) Safety and quality policy, Maintenance
procedures and quality system
Appendix V to AMC1 CAMO.A.315(c) Appendix XI to AMC M.A.708(c) provides guidance on the
elements that need to be considered for the maintenance contract between the CAMO and the
maintenance organisation. The Part-145 organisation should take into account these elements to
ensure that a clear contract or work order has been concluded before providing maintenance
services.
[Back to implementing rule:
145.A.65 Maintenance procedures]
AMC1 145.A.65(b)(2) Safety and quality policy, Maintenance
procedures and quality system
Specialised services include any specialised activity, such as, but not limited to non-destructive
testing, that require particular skills and/or qualification. Point 145.A.30(f) covers the qualifications
of personnel but, in addition, there is a need to establish maintenance procedures that cover the
control of any specialised process.
[Back to implementing rule:
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145.A.65 Maintenance procedures]
AMC1 145.A.70(a) Maintenance organisation exposition (MOE)
The following information should be included in the maintenance organisation exposition:
The information specified in point 145.A.70(a) subparagraphs points (6) and (12) to (16) (17)
inclusive, whilst a part of the MOE maintenance organisation exposition, may be kept as separate
documents or on separate electronic data files subject to the management part of said exposition
containing a clear cross-reference to such documents or electronic data files.
The MOE exposition should contain the information, as applicable, specified in this AMC. The
information may be presented in any subject order as long as all the applicable subjects are covered.
Where an organisation uses a different format, for example, to allow the exposition to serve for
more than one approval, then the exposition should contain a cross-reference Annex using this list
as an index with an explanation as to where the subject matter can be found in the exposition.
The exposition should contain information, as applicable, on how the maintenance organisation
complies with the Critical Design Configuration Control Limitations’ (CDCCL) instructions.
Small maintenance organisations may combine the various items to form a simple exposition that is
more relevant to their needs.
The operator may use electronic data processing (EDP) for the publication of the MOE maintenance
organisation exposition. The MOE maintenance organisation exposition should be made available to
the approving competent authority in a form that is acceptable to the competent authority.
Attention should be paid to the compatibility of EDP publication systems with the necessary
dissemination of the MOE maintenance organisation exposition, both internally and externally.
PART 0 GENERAL ORGANISATION (Operators within the European Union)
This section is reserved for those maintenance organisations approved under Part-145 who are also
operators within the European Union.
PART 1 MANAGEMENT GENERAL
1.1 Corporate commitment Statement by the accountable manager
1.2 Safety and quality policy and objectives
1.3 Management personnel
1.4 Duties and responsibilities of the management personnel
1.5 Management organisation chart
1.6 List of certifying staff, support staff and airworthiness review staff
1.7 Manpower resources
1.8 General description of the facilities at each address intended to be approved
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1.9 Organisations intended scope of work
1.10 Notification pProcedure for changes requiring prior approval to the competent authority
regarding changes to the organisation’s activities/approval/location/personnel
1.11 Procedure for Eexposition amendments procedures and changes not requiring prior approval
including, if applicable, delegated procedures
1.12 Procedure for alternative means of compliance (AltMoC)
PART 2 MAINTENANCE PROCEDURES
2.1 Supplier evaluation and subcontract control procedure
2.2 Acceptance/inspection of aircraft components and material from outside contractors
2.3 Storage, tagging and release of aircraft components and material to aircraft maintenance
2.4 Acceptance of tools and equipment
2.5 Calibration of tools and equipment
2.6 Use of tooling and equipment by staff (including alternate tools)
2.7 Cleanliness standards of maintenance facilities
2.8 Maintenance instructions and relationship to aircraft/aircraft component manufacturers’
instructions including updating and availability to staff
2.9 Repair procedure
2.10 Aircraft maintenance programme compliance
2.11 Airworthiness directives procedure
2.12 Optional modification procedure
2.13 Maintenance documentation in use and its completion
2.14 Technical record control
2.15 Rectification of defects arising during base maintenance
2.16 Release to service procedure
2.17 Records for the operator
2.18 Occurrence reporting of defects to the competent authority/operator/manufacturer
2.19 Return of defective aircraft components to store
2.20 Defective components to outside contractors
2.21 Control of computer maintenance record systems
2.22 Control of man-hour planning versus scheduled maintenance work
2.23 Critical maintenance tasks and error-capturing methods
2.24 Reference to specific maintenance procedures such as: -
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Engine running procedures
Aircraft pressure run procedures
Aircraft towing procedures
Aircraft taxiing procedures
2.25 Procedures to detect and rectify maintenance errors.
2.26 Shift/task handover procedures
2.27 Procedures for notification of maintenance data inaccuracies and ambiguities, to the type
certificate holder
2.28 Production planning procedures
2.29 Airworthiness review procedures and records for aircraft covered by Part-ML ELA1 aircraft not
involved in commercial operations
2.30 Development and approval processing for maintenance programmes for ELA2 aircraft not
involved in commercial operations
PART L2 ADDITIONAL LINE MAINTENANCE PROCEDURES
L2.1 Line maintenance control of aircraft components, tools, equipment, etc.
L2.2 Line maintenance procedures related to servicing/fuelling/de-icing, including inspection
for/removal of de-icing/anti-icing fluid residues, etc.
L2.3 Line maintenance control of defects and repetitive defects
L2.4 Line procedure for completion of technical logs
L2.5 Line procedure for pooled parts and loaned parts
L2.6 Line procedure for return of defective parts removed from aircraft
L2.7 Line procedure for critical maintenance tasks and error-capturing methods
PART 3 QUALITY MANAGEMENT SYSTEM PROCEDURES
3.1 Hazard identification and safety risk management schemes
3.2 Internal safety reporting and investigations
3.3 Safety action planning
3.4 Safety performance monitoring
3.5 Management of changes (including organisational changes with regard to safety
responsibilities)
3.6 Safety training and promotion
3.7 Immediate safety action and coordination with the operator’s ERP
3.8 Compliance monitoring
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3.8.1 Quality aAudit plan and audit of organisation procedures
3.8.2 Quality Product audit of aircraft and inspections
3.8.3 Audit findings — corrective Quality audit remedial action procedure
3.94 Certifying staff and support staff qualifications and training procedures
3.105 Certifying staff and support staff records
3.116 Quality audit Compliance monitoring and safety management personnel
3.127 Qualifying inspectors
3.138 Qualifying mechanics
3.149 Aircraft or aircraft component maintenance tasks exemption process control Control of the
process for exemption from aircraft/aircraft component maintenance tasks
3.1510 Concession control for deviations from organisations’ procedures
3.1611 Qualification procedure for specialised activities such as NDT welding, etc.
3.1712 Management of Control of manufacturers’ and other maintenance external working teams
3.13 Human factors training procedure
3.1814 Competence Competency assessment of personnel
3.1915 Training procedures for on-the-job training as per Section 6 of Appendix III to Part-66 (limited
to the case where the competent authority for the Part-145 approval and for the Part-66
licence is the same).
3.2016 Procedure for the issue of a recommendation to the competent authority for the issue of a
Part-66 licence in accordance with 66.B.105 (limited to the case where the competent
authority for the Part-145 approval and for the Part-66 licence is the same).
PART 4 OPERATORS
4.1 Contracting operators
4.2 Operator procedures and paperwork
4.3 Operator record completion
PART 5 SUPPORTING DOCUMENTS
5.1 Sample of documents
5.2 List of Ssubcontractors as per point 145.A.75(b)
5.3 List of line maintenance locations as per point 145.A.75(d)
5.4 List of contracted organisations as per point 145.A.70(a)(16)
PART 6 OPERATORS MAINTENANCE PROCEDURES
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This section is reserved for those maintenance organisations approved under Part-145 who are also
operators.
PART 7 FAA SUPPLEMENTARY PROCEDURES FOR A FAR TITLE 14 CFR PART 145 REPAIR STATION
This section is reserved for those EASA Part-145 approved maintenance organisations approved
under EASA Part-145 who are also certificated as an FAA FAR Title 14 CFR Part 145 repair station.
The contents of this Part should be based on the Maintenance Annex Guidance (MAG) issued by
EASA and the FAA following the agreement between the United States of America and the European
Union on cooperation in the regulation of civil aviation safety.
PART 8 TRANSPORT CANADA CIVIL AVIATION (TCCA) SUPPLEMENTARY PROCEDURES FOR A CAR 573
MAINTENANCE ORGANISATION
This section is reserved for those EASA Part-145 approved maintenance organisations holding a
CAR 573 approval.
The content of this Part should be based on the Maintenance Annex Guidance (MAG) issued by EASA
and the TCCA following the agreement on civil aviation safety between the European Union and
Canada.
PART 9 ANAC SUPPLEMENTARY PROCEDURES FOR AN RBAC 145 MAINTENANCE ORGANISATION
This section is reserved for those EASA Part-145 approved maintenance organisations that hold an
RBAC 145 approval.
The contents of this Part should be based on the Maintenance Annex Guidance (MAG) issued by
EASA and ANAC following the agreement on civil aviation safety between the European Union and
Brazil.
[Back to implementing rule:
145.A.70 Maintenance organisation exposition (MOE)]
GM1 145.A.70(a) Maintenance organisation exposition (MOE)
1. The purpose of the maintenance organisation exposition (MOE) is to set forth the procedures,
means and methods of the organisation.
2. Compliance with its contents will assure compliance with the requirements of Part-145, which
is a prerequisite to obtaining and retaining a maintenance organisation approval certificate.
3. Points 145.A.70(a)(1) to (a)(11) constitutes the ‘general’ management’ part of the MOE and
therefore could be produced as one document and made available to the person(s) specified
under point 145.A.30(b) who should be reasonably familiar with its contents. The point
145.A.70(a)(6) list of certifying staff and B1 and B2 support staff may be produced as a
separate document.
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4. Point 145.A.70(a)(12) constitutes the working procedures of the organisation, and therefore
as stated in the requirement, may be produced as any number of separate procedures or
manuals. It should be remembered that these These documents should be cross-referenced
from the management MOE.
5. Personnel are expected to be familiar with those parts of the manuals that are relevant to the
maintenance work they carry out.
6. The organisation should specify in the MOE who should amend the exposition, manual
particularly in the case where there are several parts.
7. The organisation should define the responsibilities quality manager should be responsible for
monitoring and amending the amendment of the MOE, unless otherwise agreed by the
competent authority, including the associated procedures manuals and submission of the
proposed amendments to the competent authority in accordance with point 145.A.70(c).
However the competent authority may agree via a procedure stated in the amendment
section of the MOE that some defined class of amendments may be incorporated without
prior approval by the competent authority.
8. The MOE should cover four main parts:
(a) The general part of the management MOE covering the parts elements specified in
point (3) earlier;
(b) The maintenance procedures covering all aspects of how aircraft components may be
accepted from outside sources, and how aircraft will be maintained to the required
standard;
(c) The quality management system procedures, including the methods of qualifying
mechanics, inspectors ion, certifying staff, compliance monitoring and safety
management and quality audit personnel;
(d) Contracting operator procedures and paperwork.
[Back to implementing rule:
145.A.70 Maintenance organisation exposition (MOE)]
AMC1 145.A.70(a)(1) Maintenance organisation exposition (MOE)
ACCOUNTABLE MANAGER STATEMENT
Part 1 of the MOE should include a statement signed by the accountable manager (and
countersigned by the chief executive officer, if different), confirming that the MOE and any
associated manuals will be complied with at all times.
The accountable manager’s exposition statement as specified under point 145.A.70(a)(1) should
embrace the intent of the following paragraph, and in fact, this statement may be used without
amendment. Any modification to the statement should not alter the intent.
‘This exposition and any associated referenced manuals define the organisation and procedures upon
which the (competent authority*) Part-145 approval is based as required by 145.A.70.
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These procedures are approved by the undersigned and must should be complied with, as applicable,
when work orders are being progressed under the terms of the Part-145 approval.
It is accepted that these These procedures do not override the necessity of complying with any new or
amended regulation published by the (competent authority*) from time to time where these new or
amended regulations are in conflict with these procedures.
It is understood that the (competent authority*) will approve this organisation whilst the (competent
authority*) is satisfied that the procedures are being followed and work standards maintained. It is
further understood that the (competent authority*) reserves the right to suspend, limit or revoke the
approval of the organisation if the (competent authority*) has evidence that procedures are not
followed or standards not upheld.
It is understood that the approval of the organisation is based on the continuous compliance of the
organisation with Part-145, and with the organisation’s procedures described in this exposition. The
competent authority* is entitled to limit, suspend, or revoke the approval if the organisation fails to
fulfil the obligations imposed by Part-145 or any conditions according to which the approval was
issued.
Signed ........................................
Dated ..........................................
Accountable Manager and...... (quote position)........................
Chief Executive Officer …
For and on behalf of........ (quote organisation’s name)..................................................’
Note: Where it states (‘competent authority*’), please insert the actual name of the competent
authority, for example, EASA, the CAA-NL, the LBA, the DGAC, CAA, etc.
Whenever the accountable manager changes, it is important to ensure that the new accountable
manager signs the paragraph 9 statement at the earliest opportunity.
Failure to carry out this action could invalidate the Part-145 approval.
When an organisation is approved against any other Part containing a requirement for an exposition,
a supplement covering the differences will suffice to meet the requirements except that the
supplement should have an index showing where those parts missing from the supplement are
covered.
If the organisation holds one or more additional organisation certificates within the scope of
Regulation (EU) 2018/1139 containing a requirement for an exposition or manual, it may choose to
combine the MOE with that exposition or manual in order to avoid duplication. An index that shows
where each requirement is addressed should be kept up to date and made available to the
competent authority upon request.
[Back to implementing rule:
145.A.70 Maintenance organisation exposition (MOE)]
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AMC1 145.A.75(b) Privileges of the organisation
1. Working under the quality management system of an organisation appropriately approved
under Part-145 (sub contracting subcontracting) refers to the case of one organisation, not
itself appropriately whether or not it is approved to under Part-145, that carries out aircraft
line maintenance or minor engine maintenance or maintenance of other aircraft components
or a specialised service as a subcontractor for an organisation appropriately approved under
Part-145. To be appropriately approved to subcontract, the organisation should have a
procedure for the control of such subcontractors as described below. Any approved
maintenance organisation that carries out maintenance for another approved maintenance
organisation within its own approval scope is not considered to be subcontracting for the
purpose of this paragraph.
Note: For those organisations approved under Part-145 that are also certificated by the FAA
under FAR Part 145 it should be noted that FAR Part 145 is more restrictive in respect of
maintenance activities that can be contracted or sub-contracted to another maintenance
organisation. It is therefore recommended that any listing of contracted or sub-contracted
maintenance organisations should identify which meet the Part-145 criteria and which meet
the FAR Part 145 criteria.
2. Maintenance of engines or engine modules other than a complete workshop maintenance
check or overhaul, is intended to mean any maintenance that can be carried out without
disassembly of the core engine or, in the case of modular engines, without disassembly of any
core module.
3. FUNDAMENTALS OF SUBCONTRACTING SUB-CONTRACTING UNDER PART-145
3.1. The fundamental reasons for allowing an organisation approved under Part-145 to sub-
contract subcontract certain maintenance tasks are:
(a) To permit the acceptance of specialised maintenance services, such as, but not
limited to, plating, heat treatment, plasma spraying, fabrication of specified parts
for minor repairs / modifications, etc., by organisations without the need for
direct approval of those organisations by the competent authority in such cases.
(b) To permit the acceptance of aircraft maintenance up to but not including a base
maintenance check as specified in point 145.A.75(b) by organisations not
appropriately approved under Part-145 when it is unrealistic to expect direct
approval of those organisations by the competent authority. The competent
authority will determine when it is unrealistic, but in general, it is considered
unrealistic if only one or two organisations intend to use the subcontracted sub-
contract organisation.
(c) To permit the acceptance of component maintenance.
(d) To permit the acceptance of engine maintenance up to but not including a
workshop maintenance check or overhaul of an engine or engine module as
specified in point 145.A.75(b) by organisations not appropriately approved under
Part-145 when it is unrealistic to expect direct approval of those organisations by
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the competent authority. The determination of unrealistic is as per sub-paragraph
(b).
3.2. When maintenance is carried out under the sub-contract control management system,
it means that for the duration of such maintenance, the Part-145 approval has been
temporarily extended to include the sub-contractor subcontractor. It therefore follows
that those parts of the sub-contractor subcontractor’s facilities personnel and
procedures involved with the maintenance organisation’s products undergoing
maintenance should meet Part-145 requirements for the duration of that maintenance,
and it remains the organisation’s responsibility to ensure that such requirements are
satisfied.
3.3. For the criteria specified in sub-paragraph 3.1, the organisation is not required to have
complete facilities for the maintenance that it needs to subcontract, sub-contract but it
should have its own expertise to determine that whether the subcontractor sub-
contractor meets the necessary standards. However, an organisation cannot be
approved unless it has the in-house facilities, procedures and expertise to carry out the
majority of maintenance for which it wishes to be approved in terms of the number of
class ratings.
3.4. The organisation may find it necessary to include several specialist subcontractors sub-
contractors to enable it to be approved to completely certify the release to service of a
particular maintenance product. Examples could be specialist for welding, electro-
plating, painting, etc. To authorise the use of such subcontractors, the competent
authority will need to be satisfied that the organisation has the necessary expertise and
procedures to control such subcontractors sub-contractors.
3.5. An organisation working outside the scope of its approval schedule is deemed to be not
approved. Such an organisation may in this circumstance operate only under the sub-
contract subcontract control of another organisation approved under Part-145.
3.6. Authorisation to subcontract sub-contract is indicated by the competent authority
approving accepting the MOE maintenance organisation exposition containing a specific
procedure on the control of sub-contractors.
4. PRINCIPAL PART-145 PROCEDURES FOR THE CONTROL OF SUBCONTRACTORS SUB-
CONTRACTORS NOT APPROVED UNDER PART-145
4.1. A pre-audit procedure should be established whereby the maintenance organisations’
subcontract control section, which may also be the 145.A.65(c) quality system
independent audit section, should audit a prospective subcontractor to determine
whether those services of the subcontractor that it wishes to use meets the intent of
Part-145.
A pre-audit procedure should be established whereby the maintenance organisation
should audit a prospective subcontractor to determine whether those services of the
subcontractor that it wishes to use meet the intent of Part-145. This audit should be
performed under the responsibility of the compliance monitoring function.
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4.2. The organisation approved under Part-145 needs to assess to what extent it will use the
sub-contractor subcontractor`s facilities. As a general rule, the organisation should
require its own paperwork, approved data and material/spare parts to be used, but it
could permit the use of tools, equipment and personnel from the sub-contractor
subcontractor as long as such tools, equipment and personnel meet the requirement of
Part-145. In the case of sub-contractors subcontractors who provide specialised
services, it may for practical reasons be necessary to use their specialised services
personnel, approved data and materials, subject to acceptance by the organisation
approved under Part-145.
4.3. Unless the sub-contracted subcontracted maintenance work can be fully inspected on
receipt by the organisation approved under Part-145, it will be necessary for such
organisations to supervise the inspection and release from the subcontractor sub-
contractor. Such control activities should be fully described in the organisation’s
procedures. The organisation will need to consider whether to use its own staff or to
authorise the sub-contractor subcontractor's staff.
4.4. The certificate of release to service may be issued either at the subcontractor’s sub-
contractor or at the organisation’s facility by staff issued a certification authorisation in
accordance with point 145.A.30 as appropriate, by the organisation approved under
Part-145. Such staff would normally come from the organisation approved under Part-
145, but may otherwise be a person from the subcontractor sub-contractor who meets
the approved maintenance organisation certifying staff standard, which itself is
approved by the competent authority via the MOE maintenance organisation
exposition. The certificate of release to service and the EASA Form 1 will always be
issued under the maintenance organisation approval reference.
4.5. The sub-contract control procedure will need to record audits of the sub-contractor, to
have a corrective action follow up plan and to know when sub-contractors are being
used. The procedure should include a clear revocation process for sub-contractors who
do not meet the Part-145 approved maintenance organisation’s requirements.
The subcontract control procedure will need to address the relevant management
system key processes such as hazard identification, safety risk assessment and
management, internal safety reporting, and compliance monitoring (see point
145.A.205). The procedure should ensure that records of all subcontractor audits and
inspections, and the corresponding actions are kept, and provide information on when
subcontractors are used. The procedure should include a clear revocation process for
subcontractors who do not meet the Part-145 approved maintenance organisation’s
requirements.
4.6. The Part-145 quality audit compliance monitoring staff will need to audit the
subcontract sub-contract control function section and sample audit sub-contractors
subcontractors unless this task is already carried out by the quality audit compliance
monitoring staff as stated in sub-paragraph 4.1.
4.7. The contract between the Part-145 approved maintenance organisation and the sub-
contractor subcontractor should contain a provision to grant access to the
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subcontractor to any person authorised by the authorities specified in point 145.A.140
for the competent authority and EASA standardisation team staff to have right of access
to the sub-contractor.
[Back to implementing rule:
145.A.75 Privileges of the organisation]
GM1 145.A.75(b) Privileges of the organisation
SUBCONTRACTING TO A PART-145 APPROVED ORGANISATION
It is not the intent of the rule to prevent a Part-145 organisation from subcontracting certain
maintenance activities to another Part-145 approved organisation. In this case, although it is
approved under Part-145, such a subcontracted organisation would work under the management
system of the contracting Part-145 organisation.
The rule does also not foresee a Part-145 approved organisation working solely as a subcontractor of
other Part-145 organisations, such that it would refrain from exercising its privileges.
[Back to implementing rule:
145.A.75 Privileges of the organisation]
AMC1 145.A.85 Changes to the organisation
APPLICATION TIME FRAMES
(a) The application for the amendment of an organisation certificate should be submitted at least
30 working days before the date of the intended changes.
(b) In the case of a planned change of a nominated person, the organisation should inform the
competent authority at least 20 working days before the date of the proposed change.
(c) Unforeseen changes should be notified at the earliest opportunity, in order to enable the
competent authority to determine whether there is continued compliance with the applicable
requirements, and to amend, if necessary, the organisation certificate and the related terms
of approval.
[Back to implementing rule:
145.A.85 Changes to the organisation]
AMC2 145.A.85 Changes to the organisation
MANAGEMENT OF CHANGES
The organisation should manage the safety risks related to any changes to the organisation in
accordance with AMC1 145.A.200(a)(3) point (e). For changes requiring prior approval, it should
conduct a safety risk assessment and provide it to the competent authority upon request.
[Back to implementing rule:
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145.A.85 Changes to the organisation]
GM1 145.A.85 Changes to the organisation
CHANGES TO THE MOE
Point 145.A.85 also covers changes to the MOE, as explained in point 145.A.70(c).
[Back to implementing rule:
145.A.85 Changes to the organisation]
GM1 145.A.85(a)(1) Changes to the organisation
CHANGES THAT MAY AFFECT THE SCOPE OF THE CERTIFICATE OR THE TERMS OF APPROVAL
Typical examples of such changes are listed below:
(1) the name of the organisation;
(2) the organisation’s principal place of business;
(3) the organisation’s scope of work;
(4) the accountable manager referred to in point 145.A.30(a);
(5) the safety policy;
(6) the facilities.
[Back to implementing rule:
145.A.85 Changes to the organisation]
GM2 145.A.85(a)(1) Changes to the organisation
CHANGE OF THE NAME OF THE ORGANISATION
A change of the name requires the organisation to submit a new application as a matter of urgency.
If this is the only change to report, the new application can be accompanied by a copy of the
documentation that was previously submitted to the competent authority under the previous name,
as a means of demonstrating that the organisation complies with the applicable requirements.
[Back to implementing rule:
145.A.85 Changes to the organisation]
GM1 145.A.85(b) Changes to the organisation
CHANGES REQUIRING PRIOR APPROVAL
This GM is a non-exhaustive list of items that require prior approval from the competent authority
(other than covered by point 145.A.85(a)) as specified in the applicable implementing rules:
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(a) Alternative means of compliance [145.A.120(b)];
(b) The MOE procedure for the use of alternative tooling or equipment [145.A.40(a)(i)];
(c) The use of component maintenance data by an A-rated organisation for the maintenance of
components fitted to the aircraft [Appendix II point (d)];
(d) The MOE procedure to allow an A-rated organisation to temporarily remove a component for
maintenance, in order to improve access to that component [Appendix II point (d)];
(e) The use of component maintenance data by a B-rated organisation for the maintenance of
components fitted to the engine and/or APU [Appendix II point (f)];
(f) The MOE procedure to allow a B-rated organisation to carry out maintenance on an installed
engine during ‘base’ and ‘line’ maintenance [Appendix II point (f)];
(g) The MOE procedure to allow a C-rated organisation to carry out maintenance on an installed
component (other than a complete engine/APU) during ‘base’ and ‘line’ maintenance or at an
engine/APU maintenance facility [Appendix II point (g)];
(h) The Airworthiness Review Staff (ARS) nominated by the organisation [145.A.37(b)];
(i) The procedures and standards to establish and control the competency of personnel
[145.A.30(e)];
(j) An effective and continuous system for reporting to the competent authority on the safety
performance and regulatory compliance of the organisation [145.B.305(d)].
[Back to implementing rule:
145.A.85 Changes to the organisation]
GM1 145.A.85(c) Changes to the organisation
CHANGES NOT REQUIRING PRIOR APPROVAL
The intention of point 145.A.85(c) is to allow the competent authority to accept certain changes to
the organisation (other than where the implementing rule explicitly requires an approval) to be
implemented without prior approval, depending on the compliance and safety performance of the
organisation, and in particular, on its capability to manage the safety risks related to changes.
[Back to implementing rule:
145.A.85 Changes to the organisation]
AMC1 145.A.95 Findings
GENERAL
The action plan defined by the organisation should address the effects of the non-compliance, as
well as its root cause(s) and contributing factor(s).
Depending on the issues, the action plan should address the correction/containment of the issue,
corrective action and preventive action.
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145.A.95 Findings]
GM1 145.A.95 Findings
CAUSAL ANALYSIS
(a) It is important that the analysis does not primarily focus on establishing who or what caused
the non-compliance, but on why it was caused. Establishing the root cause or causes of a
non-compliance often requires an overarching view of the events and circumstances that led
to it, to identify all the possible systemic and contributing factors (regulatory, human factors,
organisational factors, technical, etc.) in addition to the direct factors.
(b) A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault
tree, to identify the chain of events that led to the non-compliance, may not properly reflect
the complexity of the issue, and therefore there is a risk that important factors that must be
addressed in order to prevent a reoccurrence will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only
address the symptoms of the non-conformity. A peer review of the results of the causal
analysis may increase its reliability and objectivity.
(c) A system description of the organisation that considers the organisational structures,
processes and their interfaces, procedures, staff, equipment, facilities and the environment in
which the organisation operates, will support both effective causal (reactive) and hazard
(proactive) analyses.
[Back to implementing rule:
145.A.95 Findings]
AMC1 145.A.120 Means of compliance
DEMONSTRATION OF COMPLIANCE
(a) In order to demonstrate that the implementing rules are met, a risk assessment should be
completed and documented.
(b) The result of the risk assessment forms an integral part of the management system records to
be managed in accordance with point 145.A.55.
[Back to implementing rule:
145.A.120 Means of compliance]
GM1 145.A.200 Management system
GENERAL
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Safety management seeks to proactively identify hazards and to mitigate the related safety risks
before they result in aviation accidents and incidents. Safety management enables an organisation
to manage its activities in a more systematic and focused manner. When an organisation has a clear
understanding of its role and contribution to aviation safety, it can prioritise safety risks and more
effectively manage their resources and obtain optimal results.
The principles of the requirements in points 145.A.200, 145.A.202, 145.A.205 and the related AMC
constitute the EU management system framework for aviation safety management. This framework
addresses the core elements of the ICAO safety management system (SMS) framework defined in
Appendix 2 to Annex 19, and it promotes an integrated approach to the management of an
organisation. It facilitates the introduction of the additional safety management components,
building upon the existing management system, rather than adding them as a separate framework.
This approach is intended to encourage organisations to embed safety management and risk-based
decision-making into all their activities, instead of superimposing another system onto their existing
management system and governance structure. In addition, if the organisation holds multiple
organisation certificates within the scope of Regulation (EU) 2018/1139, it may choose to implement
a single management system to cover all of its activities. An integrated management system may not
only be used to capture multiple certification requirements, but also to cover other business
management systems such as quality, security, occupational health and environmental management
systems. Integration will remove any duplication and exploit synergies by managing safety risks
across multiple activities. Organisations may determine the best means to structure their
management systems to suit their business and organisational needs.
The core part of the management system framework (145.A.200) focuses on what is essential for
safety management, by mandating the organisation to:
(a) clearly define responsibilities and accountabilities;
(b) establish a safety policy and the related safety objectives,
(c) implement safety reporting procedures in line with just culture principles;
(d) ensure the identification of aviation safety hazards entailed by its activities, ensure their
evaluation, and the management of the associated risks, including:
(1) taking actions to mitigate the risks;
(2) verifying the effectiveness of the actions taken to mitigate the risks;
(e) monitor compliance, while considering any additional requirements that are applicable to the
organisation;
(f) keep their personnel trained, competent, and informed about significant safety issues; and
(g) document all the key management system processes.
Compared with the previous Part-145 quality system ‘framework’, the new elements that are
introduced are, in particular, those addressed under points (b) to (d). Points (c) and (d)(1) address
component 2 ‘Safety Risk Management’ of the ICAO SMS framework. Points (d)(2) and (e) address
component 3 ‘Safety Assurance’ thereof.
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Point 145.A.200 defines the following as key safety management processes; these are further
specified in the related AMC and GM:
Hazard identification;
Safety risk management;
Internal investigation;
Safety performance monitoring and measurement;
Management of change;
Continuous improvement;
Immediate safety action and coordination with the aircraft operator’s Emergency Response
Plan (ERP).
It is important to recognise that safety management will be a continuous activity, as hazards, risks
and the effectiveness of safety risk mitigations will change over time.
These key safety management processes are supported by a compliance monitoring function as an
integral part of the management system for safety. Most aviation safety regulations constitute
generic safety risk controls established by the ‘regulator’. Therefore, ensuring effective compliance
with the regulations during daily operations and independent monitoring of compliance are
fundamental to any management system for safety. The compliance monitoring function may, in
addition, support the follow-up of safety risk mitigation actions. Moreover, where non-compliances
are identified through internal audits, the causes will be thoroughly assessed and analysed. Such an
analysis in return supports the risk management process by providing insights into causal and
contributing factors, including human factors, organisational factors and the environment in which
the organisation operates. In this way, the outputs of compliance monitoring become some of the
various inputs to the safety risk management functions. On the other hand, the safety risk
management processes may be used to determine focus areas for compliance monitoring. In this
way, internal audits will inform the organisation’s management of the level of compliance within the
organisation, whether safety risk mitigation actions have been implemented, and where corrective
or preventive action is required. The combination of safety risk management and compliance
monitoring should lead to an enhanced understanding of the end-to-end process and the process
interfaces, exposing opportunities for increased efficiencies, which are not limited to safety aspects.
As aviation is a complex system with many organisations and individuals interacting together, the
primary focus of the key safety management processes is on the organisational processes and
procedures, but it also relies on the humans in the system. The organisation and the way in which it
operates can have a significant impact on human performance. Therefore, safety management
necessarily addresses how humans can contribute both positively and negatively to an organisation’s
safety outcomes, recognising that human behaviour is influenced by the organisational
environment.
The effectiveness of safety management largely depends on the degree of commitment of the senior
management to create a working environment that optimises human performance and encourages
personnel to actively engage in and contribute to the organisation’s management processes.
Similarly, a positive safety culture relies on a high degree of trust and respect between the personnel
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and the management, and it must therefore be created and supported at the senior management
level. If the management does not treat individuals who identify hazards and report adverse events
in a consistently fair and just way, those individuals are unlikely to be willing to communicate safety
issues or to work with the management to effectively address the safety risks. As with trust, a
positive safety culture takes time and effort to establish, and it can be easily lost.
It is further recognised that the introduction of processes for hazard identification and risk
assessment, mitigation and verification of the effectiveness of such mitigation actions will create
immediate and direct costs, while related benefits are sometimes intangible, and may take time to
materialise. Over time, an effective management system will not only address the risks of major
occurrences, but also identify and address production inefficiencies, improve communication, foster
a better organisational culture, and lead to a more effective control of contractors and suppliers. In
addition, through an improved relationship with the authority, an effective management system
may result in a reduced oversight burden.
Thus, by viewing safety management and the related organisational policies and key processes as
items that are implemented not only to prevent incidents and accidents, but also to meet the
organisation’s strategic objectives, any investment in safety should be seen as an investment in
productivity and organisational success.
[Back to implementing rule:
145.A.200 Management system]
AMC1 145.A.200(a)(1) Management system
ORGANISATION AND ACCOUNTABILITIES
(a) The management system should encompass safety by including a safety manager and a safety
review board in the organisational structure. The functions of the safety manager are those
defined in AMC1 145.A.30(c);(ca).
(b) Safety review board
(1) The safety review board should be a high-level committee that considers matters of
strategic safety in support of the accountable manager’s safety accountability.
(2) The board should be chaired by the accountable manager and composed of the heads
of the functional areas.
(3) The safety review board should monitor:
(i) safety performance against the safety policy and objectives;
(ii) that any safety action is taken in a timely manner; and
(iii) the effectiveness of the organisation’s management system processes.
(4) The safety review board may also be tasked with:
(i) reviewing the results of compliance monitoring;
(ii) monitoring the implementation of related corrective and preventive actions.
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(c) The safety review board should ensure that appropriate resources are allocated to achieve the
established safety objectives.
(d) The safety manager or any other relevant person may attend, as appropriate, safety review
board meetings. He or she may communicate to the accountable manager all information, as
necessary, to allow decision-making to be based on safety data.
(e) Notwithstanding point (a), where justified by the size of the organisation and the nature and
complexity of its activities and subject to a risk assessment and agreement by the competent
authority, the organisation may not need to establish a formal safety review board. In this
case, the tasks normally allocated to the safety review board should be allocated to the safety
manager.
[Back to implementing rule:
145.A.200 Management system]
GM1 145.A.200(a)(1) Management system
SAFETY ACTION GROUP
(a) A safety action group may be established as a standing group or as an ad hoc group to assist,
or act on behalf of the safety manager or the safety review board.
(b) More than one safety action group may be established, depending on the scope of the task
and the specific expertise required.
(c) The safety action group usually reports to, and takes strategic direction from, the safety
review board, and may be composed of managers, supervisors and personnel from
operational areas.
(d) The safety action group may be tasked or assist with:
(1) monitoring safety performance;
(2) defining actions to control risks to an acceptable level;
(3) assessing the impact on safety of organisational changes;
(4) ensuring that safety actions are implemented within agreed timescales;
(5) reviewing the effectiveness of previous safety actions and safety promotion.
[Back to implementing rule:
145.A.200 Management system]
GM2 145.A.200(a)(1) Management system
MEANING OF THE TERMS ‘ACCOUNTABILITY’ AND ‘RESPONSIBILITY’
In the English language, the notion of accountability is different from the notion of responsibility.
Whereas ‘accountability’ refers to an obligation which cannot be delegated, ‘responsibility’ refers to
an obligation that can be delegated.
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[Back to implementing rule:
145.A.200 Management system]
AMC1 145.A.200(a)(2) Management system
SAFETY POLICY & OBJECTIVES
(a) The safety policy should:
(1) reflect organisational commitments regarding safety, and its proactive and systematic
management, including the promotion of a positive safety culture;
(2) include internal reporting principles, and encourage personnel to report
maintenance-related errors, incidents and hazards;
(3) recognise the need for all personnel to cooperate with the compliance monitoring and
internal investigations referred to under point (c) of AMC1 145.A.200(a)(3);
(4) be endorsed by the accountable manager;
(5) be communicated, with visible endorsement, throughout the organisation; and
(6) be periodically reviewed to ensure it remains relevant and appropriate for the
organisation.
(b) The safety policy should include a commitment to:
(1) comply with all the applicable legislation, to meet all the applicable requirements, and
adopt practices to improve safety standards;
(2) provide the necessary resources for the implementation of the safety policy;
(3) apply human factors principles;
(4) enforce safety as a primary responsibility of all managers; and
(5) apply ‘just culture’ principles to internal safety reporting and the investigation of
occurrences and, in particular, not to make available or use the information on
occurrences:
(i) to attribute blame or liability to front-line personnel or other persons for actions,
omissions or decisions taken by them that are commensurate with their
experience and training; or
(ii) for any purpose other than the maintenance or improvement of aviation safety.
(c) Senior management should continually promote the safety policy to all personnel,
demonstrate its commitment to it, and provide necessary human and financial resources for
its implementation.
(d) Taking due account of its safety policy, the organisation should define safety objectives. The
safety objectives should:
(1) form the basis for safety performance monitoring and measurement;
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(2) reflect the organisation’s commitment to maintain or continuously improve the overall
effectiveness of the management system;
(3) be communicated throughout the organisation; and
(4) be periodically reviewed to ensure they remain relevant and appropriate for the
organisation.
[Back to implementing rule:
145.A.200 Management system]
GM1 145.A.200(a)(2) Management system
SAFETY POLICY
(a) The safety policy is the means whereby the organisation states its intention to maintain and,
where practicable, improve safety levels in all its activities and to minimise its contribution to
the risk of an aircraft accident or serious incident as far as is reasonably practicable. It reflects
the management’s commitment to safety, and should reflect the organisation’s philosophy of
safety management, as well as being the foundation on which the organisation’s management
system is built. It serves as a reminder of ‘how we do business here’. The creation of a positive
safety culture begins with the issuance of a clear, unequivocal policy.
(b) The commitment to apply ‘just culture’ principles forms the basis for the organisation’s
internal rules describing how ‘just culture’ principles are guaranteed and implemented.
(c) For organisations that have their principal place of business in a Member State, Regulation
(EU) No 376/2014 defines the ‘just culture’ principles to be applied (refer in particular to
Article 16(11) of that Regulation).
[Back to implementing rule:
145.A.200 Management system]
AMC1 145.A.200(a)(3) Management system
SAFETY MANAGEMENT KEY PROCESSES
(a) Hazard identification processes
(1) Reactive and proactive schemes for hazard identification should be the formal means of
collecting, recording, analysing, acting on, and generating feedback about hazards and
the associated risks that may affect safety.
(2) The organisation should in particular focus on:
(i) hazards that may be generated from limitations in human performance; and
(ii) hazards that may stem from the organisational set-up or the existence of
complex operational and maintenance arrangements (such as when multiple
organisations are contracted, or when multiple levels of
contracting/subcontracting are included).
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(b) Risk management processes
(1) A formal safety risk management process should be developed and maintained that
ensures that there is:
(i) analysis (in terms of the probability and severity of the consequences of hazards
and occurrences);
(ii) assessment (in terms of tolerability); and
(iii) control (in terms of mitigation) of risks to an acceptable level.
(2) The levels of management who have the authority to make decisions regarding the
tolerability of safety risks, in accordance with (b)(1)(ii), should be specified.
(c) Internal investigation
(1) In line with its just culture policy, the organisation should define how to investigate
incidents such as errors or near misses, in order to understand not only what happened,
but also how it happened, to prevent or reduce the probability and/or consequence of
future recurrences (refer to AMC1 145.A.202).
(2) The scope of internal investigations should extend beyond the scope of the
occurrences required to be reported to the competent authority in accordance with
point 145.A.60.
(d) Safety performance monitoring and measurement
(1) Safety performance monitoring and measurement should be the processes by which
the safety performance of the organisation is verified in comparison with the safety
policy and the safety objectives.
(2) These processes may include, as appropriate to the size, nature and complexity of the
organisation:
(i) safety reporting, addressing also the status of compliance with the applicable
requirements;
(ii) safety reviews, including trend reviews, which would be conducted during the
introduction of new products and their components, new
equipment/technologies, the implementation of new or changed procedures, or
in situations of organisational changes that may have an impact on safety;
(iii) safety audits that focus on the integrity of the organisation’s management
system, and on periodically assessing the status of safety risk controls; and
(iv) safety surveys, examining particular elements or procedures in a specific area,
such as identified problem areas, or bottlenecks in daily maintenance activities,
perceptions and opinions of maintenance management personnel, and areas of
dissent or confusion.
(e) Management of change
The organisation should manage the safety risks related to a change. The management of
change should be a documented process to identify external and internal changes that may
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have an adverse effect on safety. It should make use of the organisation’s existing hazard
identification, risk assessment and mitigation processes.
(f) Continuous improvement
The organisation should continuously seek to improve its safety performance and the
effectiveness of its management system. Continuous improvement may be achieved through:
(1) audits carried out by external organisations;
(2) assessments, including assessments of the effectiveness of the safety culture and
management system, in particular to assess the effectiveness of the safety risk
management processes;
(3) staff surveys, including cultural surveys, that can provide useful feedback on how
engaged personnel are with the management system;
(4) monitoring the recurrence of incidents and occurrences;
(5) evaluation of safety performance indicators and reviews of all the available safety
performance information; and
(6) the identification of lessons learned.
(g) Immediate safety action and coordination with the operator’s Emergency Response Plan (ERP)
(1) Procedures should be implemented that enable the organisation to act promptly when
it identifies safety concerns with the potential to have an immediate effect on flight
safety, including clear instructions on who to contact at the owner/operator/CAMO,
and how to contact them, including outside of normal business hours. These provisions
are without prejudice to the occurrence reporting required by point 145.A.60.
(2) If applicable, procedures should be implemented to enable the organisation to react
promptly if the ERP is triggered by the operator and it requires the support of the
Part-145 organisation.
[Back to implementing rule:
145.A.200 Management system]
GM1 145.A.200(a)(3) Management system
SAFETY RISK MANAGEMENT — INTERFACES BETWEEN ORGANISATIONS
(a) Safety risk management processes should specifically address the planned implementation of,
or participation of the organisation in, any complex operational and maintenance
arrangements (such as when multiple organisations are contracted, or when multiple levels of
contracting/subcontracting are included).
(b) Hazard identification and risk assessment start with the identification of all the parties
involved in the arrangement, including independent experts and non-approved organisations.
This identification process extends to cover the overall control structure, and assesses in
particular the following elements across all subcontract levels and all parties within such
arrangements:
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(1) coordination and interfaces between the different parties;
(2) applicable procedures;
(3) communication between all the parties involved, including reporting and feedback
channels;
(4) task allocation, responsibilities and authorities; and
(5) the qualifications and competency of key personnel with reference to point 145.A.30.
(c) Safety risk management should focus on ensuring the following aspects:
(1) clear assignment of accountability and allocation of responsibilities;
(2) that only one party is responsible for a specific aspect of the arrangement, with no
overlapping or conflicting responsibilities, in order to eliminate coordination errors;
(3) the existence of clear reporting lines, both for occurrence reporting and progress
reporting;
(4) the possibility for staff to directly notify the organisation of any hazard that suggests an
obviously unacceptable safety risk as a result of the potential consequences of this
hazard.
(d) The safety risk management processes should ensure that there is regular communication
between all the parties involved to discuss work progress, risk mitigation actions, and changes
to the arrangements, as well as any other significant issues.
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145.A.200 Management system]
GM2 145.A.200(a)(3) Management system
MANAGEMENT OF CHANGE
(a) Unless they are properly managed, changes in organisational structure, facilities, the scope of
work, personnel, documentation, policies and procedures, etc. can result in the inadvertent
introduction of new hazards, and expose the organisation to new or increased risk. Effective
organisations seek to improve their processes, with conscious recognition that changes can
expose the organisation to potentially latent hazards and risks if they are not properly and
effectively managed.
(b) Regardless of the magnitude of a change, large or small, its safety implications should always
be proactively considered. This is primarily the responsibility of the team that proposes and/or
implements the change. However, a change can only be successfully implemented if all the
personnel affected by the change are engaged, are involved and participate in the process.
The magnitude of a change, its safety criticality, and its potential impact on human
performance should be assessed in any change management process.
(c) The process for the management of change typically provides principles and a structured
framework for managing all aspects of the change. Disciplined application of the management
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of change can maximise the effectiveness of the change, engage the staff, and minimise the
risks that are inherent in a change.
(d) The introduction of a change is the trigger for the organisation to perform their hazard
identification and risk management processes.
Some examples of change include, but are not limited to:
(1) changes to the organisational structure;
(2) the inclusion of a new aircraft type in the terms of approval;
(3) the addition of aircraft of the same or a similar type;
(4) significant changes in personnel (affecting key personnel and/or large numbers of
personnel, high turn-over);
(5) new or amended regulations;
(6) competition (e.g. new competitor);
(7) changes to the customer base (e.g. loss of major customer);
(8) changes to the security arrangements;
(9) changes in the financial status of an organisation;
(10) new schedule(s), location(s), equipment, and/or operational procedures; and
(11) the addition of new subcontractors.
(e) A change may have the potential to introduce new, or to exacerbate pre-existing, human
factor issues. For example, changes in computer systems, equipment, technology, personnel
changes, including changes in management personnel, procedures, work organisation, or work
processes are likely to affect performance.
(f) The purpose of integrating human factors (HF) into the management of change is to minimise
potential risks by specifically considering the impact of the change on the people within a
system.
(g) Special consideration, including any HF issues, should be given to the ‘transition period’. In
addition, the activities utilised to manage these issues should be integrated into the change
management plan.
(h) Effective management of change should be supported by the following:
(1) Implementation of a process for formal hazard identification/risk assessment for major
operational changes, major organisational changes, changes in key personnel, and
changes that may affect the way maintenance is carried out;
(2) Identification of changes that are likely to occur in business which would have a
noticeable impact on:
(i) resources — material and human;
(ii) management direction — policies, processes, procedures, training; and
(iii) management control.
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(3) Safety cases/risk assessments that are aviation-safety focused.
(4) The involvement of key stakeholders in the change management process, as
appropriate.
(i) During the management of change process, previous risk assessments and existing hazards are
reviewed for possible effect.
[Back to implementing rule:
145.A.200 Management system]
AMC1 145.A.200(a)(4) Management system
COMMUNICATION ON SAFETY
(a) The organisation should establish communication regarding safety matters that:
(1) ensures that all personnel are aware of the safety management activities, as
appropriate for their safety responsibilities;
(2) conveys safety-critical information, especially related to assessed risks and analysed
hazards;
(3) explains why particular actions are taken; and
(4) explains why safety procedures are introduced or changed.
(b) Regular meetings with personnel, at which information, actions, and procedures are
discussed, may be used to communicate safety matters.
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145.A.200 Management system]
GM1 145.A.200(a)(4) Management system
SAFETY PROMOTION
(a) Safety training, combined with safety communication and information sharing, forms part of
safety promotion.
(b) Safety promotion activities should support:
(1) the organisation’s policies, encouraging a positive safety culture, creating an
environment that is favourable to the achievement of the organisation’s safety
objectives;
(2) organisational learning; and
(3) the implementation of an effective safety reporting scheme and the development of a
just culture.
(c) Depending on the particular safety issue, safety promotion may also constitute or
complement risk mitigation actions.
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(d) Qualifications and training aspects are further specified in the AMC and the GM to point
145.A.30.
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145.A.200 Management system]
GM1 145.A.200(a)(5) Management system
MANAGEMENT SYSTEM DOCUMENTATION
(a) The organisation may document its safety policy, safety objectives and all its key management
system processes in a separate manual (e.g. a Safety Management Manual or Management
System Manual), or in its MOE (see AMC1 145.A.70(a), Part 3 ‘Management system
procedures’). Organisations that hold multiple organisation certificates within the scope of
Regulation (EU) 2018/1139 may prefer to use a separate manual in order to avoid duplication.
That manual or the MOE, depending on the case, should be the key instrument for
communicating the approach to management system for the whole of the organisation.
(b) The organisation may also choose to document some of the information that is required to be
documented in separate documents (e.g. policy documents, procedures). In that case, it
should ensure that the manual or the MOE contains adequate references to any document
that is kept separately. Any such documents are to be considered as integral parts of the
organisation’s management system documentation.
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145.A.200 Management system]
AMC1 145.A.200(a)(6) Management system
COMPLIANCE MONITORING — GENERAL
(a) The primary objectives of compliance monitoring are to provide an independent monitoring
function on how the organisation ensures compliance with the applicable requirements,
policies and procedures, and to request action where non-compliances are identified.
(b) The independence of the compliance monitoring should be established by always ensuring
that audits and inspections are carried out by personnel who are not responsible for the
functions, procedures or products that are audited or inspected.
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AMC2 145.A.200(a)(6) AMC 145.A.65(c)(1) Management system
COMPLIANCE MONITORING — INDEPENDENT AUDIT
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1. The primary objectives of the quality system are to enable the organisation to ensure that it
can deliver a safe product and that organisation remains in compliance with the requirements.
1.2. An essential element of the quality system compliance monitoring is the independent audit.
2.3. The independent audit is should be an objective process of routine sample checks of all
aspects of the organisation’s ability to carry out all maintenance to the required standards
required by this Regulation. and It should includes some product sampling, as this is the end
result of the maintenance process.
3. It represents The independent audit should provide an objective overview of the complete set
of maintenance-related activities and is intended to complement the 145.A.50(a) requirement
for certifying staff to be satisfied that all required maintenance has been properly carried out
before issue of the certificate of release to service. Independent audits It should include a
percentage of random unannounced audits carried out on a sample basis when while
maintenance is being carried out. This means that some audits should be carried out during
the night for those organisations that work at night.
3a. The organisation should establish an audit plan to show when and how often the activities as
required by this Regulation will be audited.
4. Except as specified in sub-paragraphs points 7 and 9, the independent audit plan should
ensure that all aspects of Part-145 compliance are verified every year checked every 12
months, including all the subcontracted activities, and the auditing may be carried out as a
complete single exercise or subdivided over the 12 month annual period in accordance with a
scheduled plan. The independent audit should does not require each procedure to be verified
checked against each product line when it can be shown that the particular procedure is
common to more than one product line and the procedure has been verified checked every
year 12 months without resultant findings. Where findings have been identified, the particular
procedure should be verified rechecked against other product lines until the findings have
been rectified, after which the independent audit procedure may revert back to a 1-year
interval 12 monthly for the particular procedure.
5. Except as specified otherwise in subparagraphs 7, the independent audit should sample check
one product on each product line every year 12 months as a demonstration of the
effectiveness of compliance with the maintenance procedures compliance. It is recommended
that Procedures and product audits may be combined by selecting a specific product example,
such as an aircraft or engine or instrument component, and sample checking all the
procedures and requirements associated with the specific product example to ensure that the
end result should be an airworthy product.
For the purpose of the independent audit, a product line includes any product under an
Appendix II approval class rating as specified in the terms of approval schedule issued to the
particular organisation.
It therefore follows, for example, that a maintenance organisation approved under Part-145
with a capability to maintain aircraft, repair engines, brakes and autopilots would need to
carry out four complete product audits sample checks each year, except as specified
otherwise in subparagraphs points 5, 7 or 9.
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6. The sample check of a product audit means to witness any relevant testing and visually
inspect the product and the associated documentation. The sample check product audit
should not involve repeated disassembly or testing unless the sample check product audit
identifies findings that requireing such an action.
7. Except as specified otherwise in sub-paragraph point 9, where the smallest organisation, that
is an organisation with a maximum of 10 personnel actively engaged in maintenance, chooses
to contract the independent audit element of the compliance monitoring, quality system in
accordance with 145.A.65(c)(1) it is conditional on the audit being carried out twice in every
year 12 month period.
8. Except as specified otherwise in sub-paragraph point 9, where the organisation has line
stations listed as per point 145.A.75(d), the compliance monitoring documentation quality
system should include a describe description of how these line stations are integrated into the
function, system and include a plan to audit each listed line station at a frequency consistent
with the extent of flight activity at the particular line station and the related safety hazards
identified. Except as specified otherwise in sub-paragraph point 9, the maximum period
between audits of a particular line station should not exceed 2 years 24 months.
9. Except as specified otherwise in sub-paragraph point 5, provided that there are no safety-
related findings, the audit planning cycle specified in this AMC may be increased by up to
100 %, subject to a risk assessment and agreement by the competent authority the competent
authority may agree to increase any of the audit time periods specified in this AMC
145.A.65(c)(1) by up to 100% provided that there are no safety related findings and subject to
being satisfied that the organisation has a good record of rectifying findings in a timely
manner.
10. A report should be issued raised each time an audit is carried out describing what was
checked and the resulting non-compliance findings against applicable requirements, and
procedures and products.
11. The independence of the audit should be established by always ensuring that audits are
carried out by personnel not responsible for the function, procedure or products being
checked.
It therefore follows that a large maintenance organisation approved under Part-145, being an
organisation with more than about 500 maintenance staff should have a dedicated quality
audit group whose sole function is to conduct audits, raise finding reports and follow up to
check that findings are being rectified. For the medium sized maintenance organisation
approved under Part-145, being an organisation with less than about 500 maintenance staff, it
is acceptable to use competent personnel from one section/department not responsible for
the production function, procedure or product to audit the section/department that is
responsible subject to the overall planning and implementation being under the control of the
quality manager. Organisations with a maximum of 10 maintenance staff actively engaged in
carrying out maintenance may subcontract the independent audit element of the quality
system compliance monitoring function to another organisation or contract a qualified and
competent person approved by, with the agreement of the competent authority.
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145.A.200 Management system]
AMC3 145.A.200(a)(6) Management system
COMPLIANCE MONITORING — CONTRACTING OF THE INDEPENDENT AUDIT
(a) If external personnel are used to perform independent audits:
(1) any such audits are performed under the responsibility of the compliance monitoring
manager; and
(2) the organisation remains responsible for ensuring that the external personnel have the
relevant knowledge, backgrounds, and experience that are appropriate to the activities
being audited, including knowledge and experience in compliance monitoring.
(b) The organisation retains the ultimate responsibility for the effectiveness of the compliance
monitoring function, in particular for the effective implementation and follow-up of all
corrective actions.
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145.A.200 Management system]
AMC4 145.A.200(a)(6) AMC 145.A.65(c)(2) Safety and quality policy,
maintenance procedures and quality system Management system
COMPLIANCE MONITORING — FEEDBACK SYSTEM
1. An essential element of the quality system compliance monitoring is the quality feedback
system.
2. The quality feedback system may should not be contracted to external outside persons or
organisations.
2a. When a non-compliance is found, the compliance monitoring function should ensure that the
root cause(s) and contributing factor(s) are identified (see GM1 145.A.95), and that corrective
actions are defined. The feedback part of the compliance monitoring function should define
who is required to address any non-compliance in each particular case, and the procedure to
be followed if the corrective action is not completed within the defined time frame. The
principal functions of the quality feedback system is are to ensure that all findings resulting
from the independent quality audits of the organisation are properly investigated and
corrected in a timely manner, and to enable the accountable manager to be kept informed of
any safety issues and the extent of compliance with Part-145.
3. The independent quality audit reports referred to referenced in AMC 145.A.65(c)(1) AMC2
145.A.200(a)(6) sub-paragraph 10 should be sent to the relevant department(s) for corrective
rectification action, giving target rectification dates. Rectification These target dates should be
discussed with the relevant such department(s) before the quality department or nominated
quality auditor compliance monitoring function confirms such the dates in the report. The
relevant department(s) are required by 145.A.65(c)(2) to implement the corrective action
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rectify findings and inform the compliance monitoring function quality department or
nominated quality auditor of the status of the implementation of the action such rectification.
4. The accountable manager should hold regular meetings with staff to check progress on
rectification except that in the large organisations such meetings may be delegated on a day
to day basis to the quality manager subject to the accountable manager meeting at least twice
per year with the senior staff involved to review the overall performance and receiving at least
a half yearly summary report on findings of non-compliance.
Unless the review of the results from compliance monitoring is the responsibility of the safety
review board (ref. AMC1 145.A.200(a)(1) point (b)(4)), the accountable manager should hold
regular meetings with staff to check the progress of any corrective actions. These meetings
may be delegated to the compliance monitoring manager on a day-to-day basis, provided that
the accountable manager:
(1) meets the senior staff involved at least twice per year to review the overall
performance of the compliance monitoring function; and
(2) receives at least a half-yearly summary report on non-compliance findings.
5. All records pertaining to the independent quality audit and the quality feedback system
should be retained for the period specified in point 145.A.55(c) at least 2 years after the date
of closure clearance of the finding to which they refer or for such periods as to support
changes to the audit planning cycle in accordance with AMC2 145.A.200(a)(6) AMC
145.A.65(c)(1) sub-paragraph 9 audit time periods, whichever is the longer.
[Back to implementing rule:
145.A.200 Management system]
GM1 145.A.200(a)(6) Management system
COMPLIANCE MONITORING FUNCTION
The compliance monitoring function is one of the elements that is required to ‘ensure’ compliance
with the applicable requirements. This means that the compliance monitoring function itself should
be subject to independent monitoring of compliance in accordance with 145.A.200(a)(6).
[Back to implementing rule:
145.A.200 Management system]
GM2 145.A.200(a)(6) GM 145.A.65(c)(1) Safety and quality policy,
maintenance procedures and quality system Management system
COMPLIANCE MONITORING — AUDIT PLAN
(a)1. The purpose of this GM is to give guidance on just one acceptable working audit plan to meet
part of the needs of point 145.A.200(a)(6) 145.A.65(c)1. There is any number of other
acceptable working audit plans.
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(b) The audits described in the audit plan are intended to monitor compliance with the applicable
requirements, and at the same time to review all areas of the organisation to which those
requirements are applicable.
(c) In order to achieve this objective, as a first element, the organisation needs to identify all the
regulatory requirements that are applicable to the activity and the scope of work under
consideration, to allow the audit plan to focus on the relevant topics. Each topic (e.g. facilities,
personnel, etc.) should be cross-referred with the relevant requirement and the related
procedure of the organisation in the exposition that describes the particular topic. If an
organisation applies an AMC to demonstrate compliance with the rule, that information may
also be stated.
(d) As a second element, all the functional areas of the organisation in which Part-145 functions
are intended to be carried out, including subcontracting, need to be listed in order to identify
the applicability of any topic to each functional area.
(e) A matrix can be used, as shown in the example below, to capture the two elements
mentioned above. This matrix is intended to be a living document to be customised by each
particular organisation depending on its scope of work and its structure. This matrix should
represent the overall compliance of the audit system and needs to be amended, as necessary,
based upon any change to the applicable regulations, the procedures of the organisation or
the functional areas of the organisation (e.g. a change in the scope of work to include line
maintenance, etc.)
Example (to be further completed) of an audit matrix for an organisation involved in aircraft
base maintenance that does not hold airworthiness review privilege:
Topic Requirement Exposition Functional areas
Base Compliance Component …
Subcontracting
maintenance monitoring workshop
Facilities 145.A.25(a)(1 …
1.8 X N/A X X
)
AMC …
2.22 X N/A N/A X
145.A.25(a)
… … … … … … …
Personnel … … … … … … …
145.A.30(c) 1.4 N/A X N/A N/A …
145.A.30(d) 1.7, 2.22 X X X X …
… … … … … … …
145.A.37 N/A N/A N/A N/A N/A …
… … … … … … … …
Record- 145.A.55 … … … … … …
keeping … … … … … … …
… … … … … … … …
(f) The audit plan can be presented as a simplified schedule (see below), showing the operational
areas of the organisation against a timetable to indicate when each particular area was
scheduled for audit and when the audit was completed. The audit plan should include a
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number of product audits (depending on the number of product lines), some of which should
be unannounced (see AMC2 145.A.200(a)(6)).
Example (to be further completed) of an audit plan for an organisation, mentioned in point
(e), that has 2 base maintenance hangars, and hydraulic and electrical workshops:
Operational area Functional area Planned Completed Remarks
Base maintenance hangar 1 Base maintenance mmm yyyy dd mmm yyyy
Base maintenance hangar 2 Base maintenance mmm yyyy dd mmm yyyy
Hydraulic workshop Component workshop mmm yyyy dd mmm yyyy
Electrical workshop Component workshop mmm yyyy dd mmm yyyy
Subcontractor 1 Subcontracting mmm yyyy dd mmm yyyy
Product audit 1 Base maintenance mmm yyyy dd mmm yyyy
Product audit 2 Component workshop unannounced dd mmm yyyy
… … … …
(g) The audit of each operational area will review all the topics that are applicable to the relevant
functional area. For each topic, the audit should check that the particular Part-145
requirement is documented in the corresponding procedure in the exposition and that the
procedure is effectively implemented in the operational area that is being audited. In addition,
the audit should also identify any practice/process implemented in the operational area which
has not been documented in any procedure in the exposition.
2. The proposed plan lists the subject matter that should be covered by the audit and attempts
to indicate applicability in the various types of workshops and aircraft facilities. The list should
therefore be tailored for the particular situation and more than one list may be necessary.
Each list should be shown against a timetable to indicate when the particular item is
scheduled for audit and when the audit was completed.
PARA Comment HANGAR ENGINE MECH AVIONIC
Workshop Workshop Workshop
145.A.25 Yes Yes Yes Yes
145.A.30 Yes Yes Yes Yes
145.A.35 Yes Yes Yes Yes
145.A.36 Yes No No No
145.A.40 Yes Yes Yes Yes
145.A.42 Yes Yes Yes Yes
145.A.45 Yes Yes Yes Yes
145.A.47 Yes Yes Yes Yes
145.A.48 Yes Yes if appl if appl
145.A.50 Yes Yes Yes Yes
145.A.55 Yes Yes Yes Yes
145.A.60 Yes Yes Yes Yes
145.A.65 Yes Yes Yes Yes
2.1 MOE Yes Yes Yes Yes
2.2 MOE Yes Yes Yes Yes
2.3 MOE Yes Yes Yes Yes
2.4 MOE Yes Yes Yes Yes
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PARA Comment HANGAR ENGINE MECH AVIONIC
2.5 MOE Yes Yes Yes Yes
2.6 MOE Yes Yes Yes Yes
2.7 MOE Yes Yes Yes Yes
2.8 MOE Yes Yes Yes Yes
2.9 MOE Yes Yes Yes Yes
2.10 MOE Yes No No No
2.11 MOE Yes Yes Yes Yes
2.12 MOE Yes Yes Yes Yes
2.13 MOE Yes Yes Yes Yes
2.14 MOE Yes Yes Yes Yes
2.15 MOE Yes No No No
2.16 MOE Yes Yes Yes Yes
2.17 MOE if appl if appl if appl if appl
2.18 MOE Yes Yes Yes Yes
2.19 MOE Yes Yes Yes Yes
2.20 MOE Yes Yes Yes Yes
2.21 MOE if appl if appl if appl if appl
2.22 MOE Yes Yes No No
2.23 MOE Yes Yes if appl if appl
2.24 MOE Yes Yes Yes Yes
2.25 MOE Yes Yes Yes Yes
2.26 MOE Yes Yes Yes Yes
2.27 MOE Yes Yes Yes Yes
2.28 MOE Yes Yes Yes Yes
2.29 MOE Yes No No No
2.30 MOE Yes No No No
L2.1 MOE if appl No No No
L2.2 MOE if appl No No No
L2.3 MOE if appl No No No
L2.4 MOE if appl No No No
L2.5 MOE if appl No No No
L2.6 MOE if appl No No No
L2.7 MOE if appl No No No
3.9 MOE if appl if appl if appl if appl
3.10 MOE if appl if appl if appl if appl
3.11 MOE if appl if appl if appl No
3.12 MOE Yes Yes No No
3.13 MOE Yes Yes Yes Yes
3.14 MOE Yes Yes Yes Yes
145.A.70 Yes Yes Yes Yes
145.A.75 Yes Yes Yes Yes
145.A.80 Yes Yes Yes Yes
145.A.85 Yes Yes Yes Yes
145.A.95 if appl if appl if appl if appl
Note 1: ‘if appl’ means ‘if applicable or relevant’.
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Note 2: In the case of line stations, all line stations should be audited at the frequency
agreed with the competent authority within the limits of AMC 145.A.65(c)(1).
[Back to implementing rule:
145.A.200 Management system]
AMC1 145.A.202 Internal safety reporting scheme
(a) Each internal safety reporting scheme should be confidential and enable and encourage free
and frank reporting of any potentially safety-related occurrence, including incidents such as
errors or near misses, safety issues and identified hazards. This will be facilitated by the
establishment of a just culture.
(b) The internal safety reporting scheme should contain the following elements:
(1) clearly identified aims and objectives with demonstrable corporate commitment;
(2) a just culture policy as part of the safety policy, and related just culture implementation
procedures;
(3) a process to:
(i) identify those reports which require investigation; and
(ii) when so identified, investigate all the causal and contributing factors, including
any technical, organisational, managerial, or human factors issues, and any other
contributing factors related to the occurrence, incident, error or near miss that
was identified;
(iii) if adapted to the size and complexity of the organisation, analyse the collective
data showing the trends and frequencies of the contributing factors;
(4) appropriate corrective actions based on the findings of investigations;
(5) initial and recurrent training for staff involved in internal investigations;
(6) where relevant, the organisation should cooperate with the owner, operator or CAMO
on occurrence investigations by exchanging relevant information to improve aviation
safety.
(b) The internal safety reporting scheme should:
(1) ensure the confidentiality of the reporter;
(2) be closed-loop, to ensure that actions are taken internally to address any safety issues
and hazards; and
(3) feed into the recurrent training as defined in AMC5 145.A.30(e) whilst maintaining
appropriate confidentiality.
(c) Feedback should be given to staff both on an individual and a more general basis to ensure
their continued support of the safety reporting scheme.
[Back to implementing rule:
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145.A.202 Internal safety reporting scheme]
GM1 145.A.202 Internal safety reporting scheme
GENERAL
(a) The overall purpose of the internal safety reporting scheme is to use the reported information
to improve the level of the safety performance of the organisation, and not to attribute
blame.
(b) The objectives of the scheme are to:
(1) enable an assessment to be made of the safety implications of each relevant incident
(errors, near miss), safety issue and hazard reported, including previous similar issues,
so that any necessary action can be initiated; and
(2) ensure that knowledge of relevant incidents, safety issues and hazards is shared so that
other persons and organisations may learn from them.
(c) The scheme is an essential part of the overall monitoring function and should be
complementary to the normal day-to-day procedures and ‘control’ systems; it is not intended
to duplicate or supersede any of them. The scheme is a tool to identify those instances in
which routine procedures have failed or may fail.
(d) All safety reports that are judged to be reportable by the person submitting the report should
be retained, as the significance of such reports may only become obvious at a later date.
(e) Typical occurrences to be reported are those in which aviation safety was, or could have been
endangered, or which could have led to an unsafe condition. If, in the view of the reporter, an
occurrence did not endanger aviation safety but, if it was repeated in different but likely
circumstances, would create an unsafe situation that could lead to an accident or serious
incident, then a report should be made. What is judged to be reportable on one class of
product, part, or appliance may not be the same for another, and the absence or presence of
a single factor, organisational, human, or technical, can transform an occurrence into an
accident or serious incident.
(f) The collection and analysis of timely, appropriate and accurate data will allow the organisation
to react to the information that it receives, and to take the necessary action.
[Back to implementing rule:
145.A.202 Internal safety reporting scheme]
GM1 145.A.205 Contracting and subcontracting
RESPONSIBILITY WHEN CONTRACTING OR SUBCONTRACTING MAINTENANCE
(a) Regardless of the approval status of the subcontracted organisations, a Part-145 organisation
is responsible for ensuring that all subcontracted activities are subject to hazard identification
and risk management, as required by point 145.A.200(a)(3), and to compliance monitoring, as
required by point 145.A.200(a)(6).
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(b) A Part-145 organisation is responsible for identifying hazards that may stem from the
existence of complex maintenance arrangements (such as when multiple organisations are
contracted, or when multiple levels of contracting/subcontracting are included) with due
regard to the organisations’ interfaces (see GM1 145.A.200(a)(3)). In addition, the compliance
monitoring function should at least check that the approval of the contracted maintenance
organisation(s) effectively covers the contracted activities, and that it is still valid.
(c) A Part-145 organisation is responsible for ensuring that interfaces and communication
channels are established with the contracted maintenance organisation for occurrence
reporting. This does not replace the obligation of the contracted organisation to report to the
competent authority in accordance with Regulation (EU) No 1321/2014.
For subcontracted activities, interfaces and communication channels are also needed for the
purpose of the internal safety reporting scheme (145.A.202).
[Back to implementing rule:
145.A.205 Contracting and subcontracting]
GM2 145.A.205 Contracting and subcontracting
DIFFERENCE BETWEEN ‘CONTRACTING MAINTENANCE’ AND ‘SUBCONTRACTING MAINTENANCE’
(a) ‘Subcontracting maintenance’ means subcontracting to a third party under the maintenance
organisation management system.
This is the case when a third party carries out certain maintenance tasks on behalf of the
Part-145 organisation, and the responsibility remains within the Part-145 organisation (this
Part-145 organisation must have the tasks within its scope of approval). Whether the third
party is approved or not is not relevant for the designation of subcontracting, since the third
party will be working under the management system of the Part-145 organisation and the
maintenance will be released under the approval of this organisation. See also GM1
145.A.75(b).
(b) ‘Contracting maintenance’ means contracting to another maintenance organisation which will
release the maintenance under its own approval.
This is the case when a Part-145 organisation, contracted to carry out maintenance by an
owner/operator/CAMO, further contracts certain maintenance tasks to another approved
Part-145 organisation, and transfers the responsibility for the release of such tasks to the
second Part-145 organisation.
Contracting should only be foreseen when it is allowed by the person or organisation that
requests the maintenance.
(c) In case (a), the subcontracted organisation works under the approval of the contracting
organisation, whereas in case (b), the contracted organisation works under its own approval.
[Back to implementing rule:
145.A.205 Contracting and subcontracting]
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[AMC/GM to Section B are replaced by:]
SECTION B — AUTHORITY REQUIREMENTS
GM1 145.B.120 Means of compliance
ALTERNATIVE MEANS OF COMPLIANCE
Alternative means of compliance that are used by a competent authority, or by a person or
organisations under its oversight, may be used by other competent authorities, persons, or
organisations only if they are processed again in accordance with points 145.B.120(d) and (e).
[Back to implementing rule:
145.B.120 Means of compliance]
AMC1 145.B.120(e) Means of compliance
DEMONSTRATION OF COMPLIANCE
In order to demonstrate that the implementing rules are met, a risk assessment should be
completed and documented.
[Back to implementing rule:
145.B.120 Means of compliance]
AMC1 145.B.200 Management system
ORGANISATIONAL STRUCTURE
(a) In deciding upon the required organisational structure, the competent authority should
review:
(1) the number of certificates to be issued, and the number and size of the potential
Part-145 approved maintenance organisations within that Member State;
(2) the possible use of qualified entities and of the resources of the competent authorities
of other Member States to fulfil the continuing oversight obligations;
(3) the level of civil aviation activity, the number and complexity of the aircraft and the size
of the Member State’s aviation industry; and
(4) the potential growth of activities in the field of civil aviation.
(b) The competent authority should retain effective control of the important surveillance
functions and should not delegate them in such a way that Part-145 organisations, in effect,
regulate themselves in airworthiness matters.
(c) The set-up of the organisational structure should ensure that the various tasks and obligations
of the competent authority do not solely rely on individuals. The continuous and undisturbed
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fulfilment of these tasks and obligations of the competent authority should also be
guaranteed in case of illness, accidents or leave of individual employees.
[Back to implementing rule:
145.B.200 Management system]
AMC2 145.B.200 Management system
GENERAL
(a) The competent authority designated by each Member State should be organised in such a way
that:
(1) there is specific and effective management authority in the conduct of all the relevant
activities;
(2) the functions and processes described in the applicable requirements of Regulation (EU)
2018/1139 and its delegated and implementing acts, AMC, Certification Specifications
(CSs), and Guidance Material (GM) may be properly implemented;
(3) the competent authority’s policy, organisation and operating procedures for the
implementation of the applicable requirements of Regulation (EU) 2018/1139 and and
its delegated and implementing acts are properly documented and applied;
(4) all the competent authority’s personnel who are involved in the related activities are
provided with training where necessary;
(5) specific and effective provision is made for communicating and interfacing as necessary
with EASA and the competent authorities of other Member States; and
(6) all the functions related to implementing the applicable requirements are adequately
described.
(b) A general policy in respect of the activities related to the applicable requirements of
Regulation (EU) 2018/1139 and its delegated and implementing acts should be developed,
promoted, and implemented by the manager at the highest appropriate level; for example,
the manager at the top of the functional area of the competent authority that is responsible
for such activities.
(c) Appropriate steps should be taken to ensure that the policy is known and understood by all
the personnel involved, and all the necessary steps should be taken to implement and
maintain the policy.
(d) The general policy, whilst also satisfying the additional national regulatory responsibilities,
should, in particular, take into account:
(1) the provisions of Regulation (EU) 2018/1139;
(2) the provisions of the applicable implementing rules and their AMC, CSs, and GM;
(3) the needs of industry; and
(4) the needs of EASA and of the competent authority.
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(e) The policy should define specific objectives for the key elements of the organisation and
processes for implementing the related activities, including the corresponding control
procedures and the measurement of the achieved standard.
[Back to implementing rule:
145.B.200 Management system]
AMC1 145.B.200(a)(1) Management system
DOCUMENTED POLICIES AND PROCEDURES
(a) The various elements of the organisation involved with the activities related to Regulation
(EU) 2018/1139 and its delegated and implementing acts should be documented in order to
establish a reference source for the establishment and maintenance of this organisation.
(b) The documented procedures should be established in a way that facilitates their use. They
should be clearly identified, kept up to date, and made readily available to all the personnel
who are involved in the related activities.
(c) The documented procedures should cover, as a minimum, all of the following aspects:
(1) policies and objectives;
(2) the organisational structure;
(3) responsibilities and the associated authority;
(4) procedures and processes;
(5) internal and external interfaces;
(6) internal control procedures;
(7) the training of personnel;
(8) cross-references to associated documents;
(9) assistance from other competent authorities or EASA (where required).
(d) It is likely that the information may be held in more than one document or series of
documents, and suitable cross-referencing should be provided. For example, the
organisational structure and job descriptions are not usually in the same documentation as
the detailed working procedures. In such cases, it is recommended that the documented
procedures should include an index of cross references to all such other related information,
and the related documentation should be readily available when required.
[Back to implementing rule:
145.B.200 Management system]
GM1 145.B.200(a)(2) Management system
SUFFICIENT PERSONNEL
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(a) This GM on the determination of the required personnel is limited to the performance of
certification and oversight tasks, excluding any personnel who are required to perform tasks
that are subject to any national regulatory requirements.
(b) The elements to be considered when determining who are the required personnel and
planning their availability may be divided into quantitative and qualitative elements:
(1) Quantitative elements
(i) the estimated number of initial certificates to be issued;
(ii) the number of organisations to be certified by the competent authority;
(iii) the estimated number of subcontracted organisations used by certified
organisations.
(2) Qualitative elements
(i) the size, nature, and complexity of the activities of certified organisations, taking
into account:
(A) the privileges of each organisation;
(B) the types of approval and the scopes of approval;
(C) possible certification to industry standards;
(D) the number of personnel; and
(E) the organisational structure and the existence of subsidiaries;
(ii) the safety priorities identified;
(iii) the results of past oversight activities, including audits, inspections and reviews,
in terms of risks and regulatory compliance, taking into account:
(A) the number and the levels of findings;
(B) the time frame for implementation of corrective actions; and
(C) the maturity of the management systems implemented by organisations,
and their ability to effectively manage safety risks; and
(iv) the size and complexity of the Member State’s aviation industry, and the
potential growth of activities in the field of civil aviation, which may be an
indication of the number of new applications and changes to existing certificates
to be expected.
(c) Based on the existing data from previous oversight planning cycles, and taking into account
the situation within the Member State’s aviation industry, the competent authority may
estimate:
(1) the standard working time required for processing applications for new certificates;
(2) the number of new certificates to be issued for each planning period; and
(3) the number of changes to existing certificates to be processed for each planning period.
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(d) In line with the competent authority’s oversight policy, the following planning data should be
determined:
(1) the standard number of audits to be performed per oversight planning cycle;
(2) the standard duration of each audit;
(3) the standard working time for audit preparation, on-site audit, reporting, and follow-up
per inspector;
(4) the standard number of unannounced inspections to be performed;
(5) the standard duration of inspections, including preparation, reporting, and follow-up
per inspector; and
(6) the minimum number and the required qualifications of the inspectors for each
audit/inspection.
(e) The standard working time could be expressed either in working hours per inspector, or in
working days per inspector. All planning calculations should then be based on the same unit
(hours or working days).
(f) It is recommended to use a spreadsheet application to process the data defined under (c) and
(d), to assist in determining the total number of working hours/days per oversight planning
cycle required for certification, oversight and enforcement activities. This application could
also serve as a basis for implementing a system for planning the availability of personnel.
(g) The number of working hours/days per planning period for each qualified inspector that may
be allocated for certification, oversight and enforcement activities should be determined,
taking into account:
(1) purely administrative tasks that are not directly related to certification and oversight;
(2) training;
(3) participation in other projects;
(4) planned absence; and
(5) the need to include a reserve for unplanned tasks or unforeseeable events.
(h) The determination of the working time available for certification, oversight and enforcement
activities should also consider, as applicable:
(1) the use of qualified entities;
(2) cooperation with other competent authorities for approvals that involve more than one
Member State;
(3) oversight activities under a bilateral aviation safety agreement.
(i) Based on the elements listed above, the competent authority should be able to:
(1) monitor the dates when audits and inspections are due, and when they were carried
out;
(2) implement a system to plan the availability of personnel; and
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(3) identify possible gaps between the number and the qualifications of personnel and the
required volume of certification and oversight.
Care should be taken to keep planning data up to date in line with changes in the underlying
planning assumptions, with particular focus on risk-based oversight principles.
[Back to implementing rule:
145.B.200 Management system]
AMC1 145.B.200(a)(3) Management system
QUALIFICATION AND TRAINING — GENERAL
(a) It is essential for the competent authority to have the full capability to adequately assess the
compliance and performance of an organisation by ensuring that the whole range of activities
is assessed by appropriately qualified personnel.
(b) For each inspector, the competent authority should:
(1) define the competencies required to perform the allocated certification and oversight
tasks;
(2) define the associated minimum qualifications that are required;
(3) establish initial and recurrent training programmes in order to maintain and to enhance
the competency of inspectors at the level that is necessary to perform the allocated
tasks; and
(4) ensure that the training provided meets the established standards, and is regularly
reviewed and updated whenever necessary.
(c) The competent authority may provide training through its own training organisation with
qualified trainers, or through another qualified training source.
(d) If training is not provided through an internal training organisation, adequately experienced
and qualified persons may act as trainers, provided that their training skills have been
assessed. If required, an individual training plan should be established that covers specific
training skills. Records should be kept of such a training, and of the assessment, as
appropriate.
[Back to implementing rule:
145.B.200 Management system]
AMC2 145.B.200(a)(3) Management system
QUALIFICATION AND TRAINING — INSPECTORS
(a) Competent authority inspectors should have:
(1) practical experience and expertise in the application of aviation safety standards and
safe operating practices;
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(2) comprehensive knowledge of:
(i) the relevant parts of the implementing rules, certification specifications and
guidance material;
(ii) the competent authority’s procedures;
(iii) the rights and obligations of an inspector;
(iv) safety management systems based on the EU management system requirements
(including compliance monitoring) and ICAO Annex 19;
(v) continuing airworthiness management;
(vi) operational procedures that affect the continuing airworthiness management of
the aircraft or its maintenance;
(vii) maintenance-related human factors and human performance principles;
(3) training on auditing techniques and assessing and evaluating management systems and
safety risk management processes;
(4) 5 years of relevant work experience for them to be allowed to work independently as
inspectors. This may include experience gained during training to obtain the
qualifications mentioned below in point (a)(5);
(5) a relevant engineering degree or an aircraft maintenance technician qualification with
additional education. ‘Relevant engineering degree’ refers to an engineering degree
from aeronautical, mechanical, electrical, electronic, avionic or other studies that are
relevant to the maintenance and continuing airworthiness of aircraft/aircraft
components.
(6) knowledge of a relevant sample of the type(s) of aircraft or components, gained
through a formalised training course. Aircraft/engine type training courses should be at
least at a level equivalent to a Part-66 Appendix III Level 1 General Familiarisation.
‘Relevant sample’ refers to courses that cover the typical aircraft or components that
are within the scope of work;
(7) knowledge of maintenance standards, including fuel tank safety (FTS) training as
described in Appendix IV to AMC3 145.A.30(e) and AMC2 145.B.200(a)(3).
(b) In addition to technical competency, inspectors should have a high degree of integrity, be
impartial in carrying out their tasks, be tactful, and have a good understanding of human
nature.
(c) A programme for recurrent training should be developed that ensures that the inspectors
remain competent to perform their allocated tasks. As a general policy, it is not desirable for
the inspectors to obtain technical qualifications from those entities that are under their direct
regulatory oversight.
[Back to implementing rule:
145.B.200 Management system]
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AMC3 145.B.200(a)(3) Management system
INITIAL AND RECURRENT TRAINING — INSPECTORS
(a) Initial training programme
The initial training programme for inspectors should include, as appropriate to their role,
current knowledge, experience and skills in at least all of the following:
(1) aviation legislation, organisation, and structure;
(2) the Chicago Convention, the relevant ICAO annexes and documents;
(3) Regulation (EU) No 376/2014 on the reporting, analysis and follow-up of
occurrences in civil aviation;
(4) overview of Regulation (EU) 2018/1139 and its delegated and implementing acts and
the related AMC, CS, and GM;
(5) Regulation (EU) No 1321/2014 as well as any other applicable requirements;
(6) management systems, including the assessment of the effectiveness of a management
system, in particular hazard identification and risk assessment, and non-punitive
reporting techniques in the context of the implementation of a ‘just culture’;
(7) auditing techniques;
(8) procedures of the competent authority that are relevant to the inspectors’ tasks;
(9) human factors principles;
(10) the rights and obligations of inspecting personnel of the competent authority;
(11) on-the-job training that is relevant to the inspector’s tasks;
(12) technical training that is appropriate to the role and tasks of the inspector, in particular
for those areas that require approvals.
NOTE: the duration of the on-the-job training should take into account the scope and
complexity of the inspector’s tasks. The competent authority should assess whether the
required competency has been achieved before an inspector is authorised to perform a
task without supervision.
(b) Recurrent training programme
Once qualified, the inspector should undergo training periodically, as well as whenever
deemed necessary by the competent authority, in order to remain competent to perform the
allocated tasks. The recurrent training programme for inspectors should include, as
appropriate to their role, at least the following topics:
(1) changes in aviation legislation, the operational environment and technologies;
(2) procedures of the competent authority that are relevant to the inspector’s tasks;
(3) technical training that is appropriate to the role and tasks of the inspector; and
(4) results from past oversight.
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(c) Assessments of an inspector’s competency should take place at regular intervals that do not
exceed 3 years. The results of these assessments, as well as any actions taken following the
assessments, should be recorded.
[Back to implementing rule:
145.B.200 Management system]
AMC1 145.B.200(a)(5) Management system
SAFETY RISK MANAGEMENT PROCESS
(a) The safety risk management process required by point 145.B.200 should be documented. The
following should be defined in the related documentation:
(1) means for hazard identification, and the related data sources, taking into account data
that comes from other competent authorities with which the competent authority
interfaces in the State, or from the competent authorities of other Member States;
(2) risk management steps including:
(i) analysis (in terms of the probability and the severity of the consequences of
hazards and occurrences);
(ii) assessment (in terms of tolerability); and
(iii) control (in terms of mitigation) of risks to an acceptable level;
(3) who holds the responsibilities for hazard identification and risk management;
(4) who holds the responsibilities for the follow-up of risk mitigation actions;
(5) the levels of management who have the authority to make decisions regarding the
tolerability of risks;
(6) means to assess the effectiveness of risk mitigation actions; and
(7) the link with the compliance monitoring function.
(b) To demonstrate that the safety risk management process is operational, competent
authorities should be able to provide evidence that:
(1) the persons involved in internal safety risk management activities are properly trained;
(2) hazards that could impact the authority’s capabilities to perform its tasks and discharge
its responsibilities have been identified and the related risk assessment is documented;
(3) regular meetings take place at appropriate levels of management of the competent
authority to discuss the risks identified, and to decide on the tolerability of risks and
possible risk mitigations;
(4) in addition to the initial hazard identification exercise, the risk management process is
triggered as a minimum whenever changes occur that may affect the competent
authority’s capability to perform any of the tasks required by Part-145;
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(5) a record of the actions taken to mitigate risks is maintained, showing the status of each
action and the owner of the action;
(6) there is a follow-up on the implementation of all risk mitigation actions;
(7) risk mitigation actions are assessed for their effectiveness;
(8) the results of risk assessments are periodically reviewed to check whether they remain
relevant. (Are the assumptions still valid? Is there any new information?).
[Back to implementing rule:
145.B.200 Management system]
GM1 145.B.200(a)(5) Management system
SAFETY RISK MANAGEMENT PROCESS
The purpose of safety risk management as part of the management system framework for
competent authorities is to ensure the effectiveness of the management system. As for any
organisation, hazard identification and risk management are expected to contribute to effective
decision-making, to guide the allocation of resources and contribute to organisational success.
The safety risk management process required by point 145.B.200 is intended to address the safety
risks that are directly related to the competent authority’s organisation and processes, and which
may affect its capability to perform its tasks and discharge its responsibilities. This process is not
intended to be a substitute for the State safety risk management SARPs defined in ICAO Annex 19,
Chapter 3, component 3.3. This does not mean, however, that the competent authority may not use
information and data that is obtained through its State Safety Programme (SSP), including oversight
data and information, for the purposes of safety risk management as part of its management
system.
The safety risk management process is also to be applied to the management of changes
(145.B.210), which is intended to ensure that the management system remains effective whenever
changes occur.
[Back to implementing rule:
145.B.200 Management system]
AMC1 145.B.200(d) Management system
PROCEDURES AVAILABLE TO EASA
(a) Copies of the procedures related to the competent authority’s management system, and their
amendments, that should be made available to EASA for the purpose of standardisation,
should provide at least the following information:
(1) the competent authority’s organisational structure for the continuing oversight
functions that it undertakes, with a description of the main processes. This information
should demonstrate the allocation of responsibilities within the competent authority,
and that the competent authority is capable of carrying out the full range of tasks for
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the size and complexity of the Member State’s aviation industry. It should also consider
the overall proficiency and the scope of authorisation of the competent authority’s
personnel;
(2) for personnel who are involved in oversight activities, the minimum required
professional qualifications and amount of experience, and the principles that are used
to guide their appointment (e.g. assessment);
(3) how the following are carried out: assessments of applications and evaluations of
compliance, the issuing of certificates, continuing oversight activities, the follow-up of
findings, enforcement measures and the resolution of safety concerns;
(4) the principles used for the management of exemptions and derogations;
(5) the processes that are in place to distribute the applicable safety information to enable
a timely reaction to a safety problem;
(6) the criteria for planning continuing oversight activities (i.e. an oversight programme),
including the management of interfaces when conducting continuing oversight activities
(of air operations and of continuing airworthiness management, for example);
(7) an outline of the initial training of newly recruited oversight personnel (taking future
activities into account), and the basic framework for the recurrent training of oversight
personnel.
(b) As part of the continuous monitoring of a competent authority, EASA may request details of
the working methods used, in addition to a copy of the procedures of the competent
authority’s management system (and any amendments). These additional details are the
procedures and the related guidance material that describes the working methods for the
personnel of the competent authority who conduct oversight activities.
(c) Information related to the competent authority’s management system may be submitted in
an electronic format.
[Back to implementing rule:
145.B.200 Management system]
GM1 145.B.205 Allocation of tasks to qualified entities
CERTIFICATION TASKS
The tasks that may be performed by a qualified entity on behalf of the competent authority include
those that are related to the initial certification and to the continuing oversight of persons and
organisations as defined in Regulation (EU) No 1321/2014.
[Back to implementing rule:
145.B.205 Allocation of tasks to qualified entities]
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AMC1 145.B.220(a) Record-keeping
GENERAL
(a) The record-keeping system should ensure that all records are accessible within a reasonable
time whenever they are needed. These records should be organised in a manner that ensures
their traceability and retrievability throughout the required retention period.
(b) All records that contain sensitive data regarding applicants or organisations should be stored
in a secure manner with controlled access to ensure their confidentiality.
(c) Records should be kept in paper form, or in an electronic format, or a combination of the two.
Records that are stored on microfilm or optical discs are also acceptable. The records should
remain legible and accessible throughout the required retention period. The retention period
starts when the record is created.
(d) Paper systems should use robust material which can withstand normal handling and filing.
Computer record systems should have at least one backup system, which should be updated
within 24 hours of any new entry. Computer record systems should include safeguards against
any unauthorised personnel from altering the data.
(c) All computer hardware that is used to ensure the backup of data should be stored in a
different location from the one that contains the working data, and in an environment that
ensures that the data remains in a good condition. When hardware or software changes take
place, special care should be taken to ensure that all the necessary data continues to be
accessible throughout at least the full period specified in point 145.B.220(c).
[Back to implementing rule:
145.B.220 Record-keeping]
AMC1 145.B.220(a)(1) Record-keeping
COMPETENT AUTHORITY MANAGEMENT SYSTEM
Records that are related to the competent authority’s management system should include, as a
minimum, and as applicable:
(a) the documented policies and procedures;
(b) the personnel files of the competent authority’s personnel, with the supporting documents
related to their training and qualifications;
(c) the results of the competent authority’s internal audits and safety risk management
processes, including audit findings, and corrective, preventive and risk mitigation actions; and
(d) the contract(s) established with any qualified entities that perform certification or oversight
tasks on behalf of the competent authority.
[Back to implementing rule:
145.B.220 Record-keeping]
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AMC1 145.B.300(a);(b);(c) Oversight principles
ASSESSMENT OF THE MANAGEMENT SYSTEM
As part of the initial certification of an organisation, the competent authority should assess the
organisation’s management system and processes to make sure that all the required enablers of a
functioning management system are present and suitable.
As part of its continuing oversight activities, the competent authority should verify that the required
enablers remain present, and assess the effectiveness of the organisation’s management system and
processes.
When significant changes take place in the organisation, the competent authority should determine
whether there is a need to review the existing assessment to ensure that it is still appropriate.
[Back to implementing rule:
145.B.300 Oversight principles]
AMC1 145.B.300(f) Oversight principles
INFORMATION DEEMED USEFUL FOR OVERSIGHT
This information should include, as a minimum:
(a) any occurrence reports received by the competent authority;
(b) the reports received following the issuing of any one-off certification authorisations as defined
in point 145.A.30(j)(5);
(c) the results of the following types of inspections and surveys if they indicate an issue that
originates from a Part-145 organisation:
(i) ramp inspections performed in accordance with Subpart RAMP of Annex II (Part-ARO)
to Commission Regulation (EU) No 965/2012 ‘Air Operations’;
(ii) product surveys of aircraft, pursuant to M.B.303 or ML.B.303;
(iii) any aircraft sample surveys conducted pursuant to CAMO.B.305(b)(1); and
(iv) any physical surveys or partial airworthiness reviews performed by the competent
authority in line with M.B.901.
[Back to implementing rule:
145.B.300 Oversight principles]
AMC1 145.B.305(a);(b) Oversight programme
ANNUAL REVIEW
(a) The oversight planning cycle and the related oversight programme for each organisation
should be reviewed annually to ensure that they remain adequate regarding any changes in
the nature, complexity or the safety performance of the organisation.
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(b) When reviewing the oversight planning cycle and the related oversight programme, the
competent authority should also consider any relevant information collected in accordance
with points 145.A.60 and 145.B.300(f).
[Back to implementing rule:
145.B.305 Oversight programme]
AMC1 145.B.305(b) Oversight programme
SPECIFIC NATURE AND COMPLEXITY OF THE ORGANISATION — RESULTS OF PAST OVERSIGHT
When determining the oversight programme, including the relevant sample of maintenance carried
out by the organisation for the product audits, the competent authority should consider in particular
the following elements, as applicable:
(1) the effectiveness of the organisation’s management system in identifying and addressing
non-compliances and safety hazards;
(2) the implementation by the organisation of any industry standards that are directly relevant to
the organisation’s activities subject to this Regulation;
(3) the procedure applied for and the scope of changes not requiring prior approval;
(4) any specific procedures implemented by the organisation that are related to any alternative
means of compliance used;
(5) the number of approved locations and the activities performed at each location;
(6) the number and type of any subcontractors who perform maintenance tasks; and
(7) the volume of activity for each A, B, C and D class rating, as applicable.
[Back to implementing rule:
145.B.305 Oversight programme]
AMC2 145.B.305(b) Oversight programme
SUBCONTRACTED ACTIVITIES
If a Part-145 organisation subcontracts maintenance tasks, the competent authority should
determine whether the subcontracted organisation needs to be audited and included in the
oversight programme, taking into account the specific nature and complexity of the subcontracted
activities, the results of previous oversight activities of the approved organisation, and the
assessment of the associated risks.
For such audits, the competent authority inspector should ensure that he or she is accompanied
throughout the audit by a senior technical member of the Part-145 organisation.
NOTE: if a Part-145 organisation subcontracts maintenance tasks, the competent authority should
ensure that the Part-145 organisation manages the risks related to, and that it has sufficient control
over, the subcontracted activities (see GM1 145.A.205 and AMC1 145.A.75(b)).
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[Back to implementing rule:
145.B.305 Oversight programme]
AMC1 145.B.305(b)(1) Oversight programme
AUDIT
(a) The oversight programme should indicate which aspects of the approval will be covered by
each audit.
(b) Part of each audit should concentrate on the audit reports produced by the organisation’s
compliance monitoring function, to determine whether the organisation has been identifying
and correcting its problems.
(c) At the conclusion of the audit, the auditing inspector should complete an audit report that
identifies the areas and processes that were audited, and includes all the findings that were
raised.
(d) At the completion of each oversight planning cycle, a new EASA Form 6 should be issued.
[Back to implementing rule:
145.B.305 Oversight programme]
AMC1 145.B.305(c) Oversight programme
OVERSIGHT PLANNING CYCLE — AUDIT AND INSPECTION
(a) When determining the oversight planning cycle and defining the oversight programme, the
competent authority should assess the risks related to the activity of each organisation, and
adapt the oversight to the level of risk identified and to the effectiveness of the organisation’s
management system, in particular its ability to effectively manage safety risks.
(b) The competent authority should establish a schedule of audits and inspections that is
appropriate to each organisation. The planning of audits and inspections should take into
account the results of the hazard identification and the risk assessment conducted and
maintained by the organisation as part of the organisation’s management system. Inspectors
should work in accordance with the schedule provided to them.
(c) When the competent authority, having regard to the level of risk identified and the
effectiveness of the organisation’s management system, varies the frequency of an audit or
inspection, it should ensure that all aspects of the organisation’s activity are audited and
inspected within the applicable oversight planning cycle.
[Back to implementing rule:
145.B.305 Oversight programme]
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AMC2 145.B.305(c) Oversight programme
OVERSIGHT PLANNING CYCLE — AUDIT
(a) For each organisation certified by the competent authority, all processes should be completely
audited at periods that do not exceed the applicable oversight planning cycle. The beginning
of the first oversight planning cycle is normally determined by the date of issue of the first
certificate. If the competent authority wishes to align the oversight planning cycle with the
calendar year, it should shorten the first oversight planning cycle accordingly.
(b) The interval between two audits for a particular process should not exceed the interval of the
applicable oversight planning cycle.
(c) Audits should include at least one on-site audit within each oversight planning cycle. For
organisations who carry out their regular activities at more than one site, the determination of
the sites to be audited should consider the results of past oversight activities and the volume
of activities at each site, as well as main risk areas identified.
(d) For organisations that hold more than one certificate, the competent authority may define an
integrated oversight schedule that includes all the applicable audit items. In order to avoid any
duplication of audits, credit may be granted for specific audit items that have already been
completed during the current oversight planning cycle, provided that:
(1) the specific audit item is the same for all the certificates under consideration;
(2) there is satisfactory evidence on record that those specific audit items were carried out,
and that all the related corrective actions have been implemented to the satisfaction of
the competent authority;
(3) the competent authority is satisfied that there is no evidence that standards have
deteriorated regarding those specific audit items for which credit is granted;
(4) the interval between two audits for the specific item for which credit is granted does
not exceed the applicable oversight planning cycle.
[Back to implementing rule:
145.B.305 Oversight programme]
AMC1 145.B.305(d) Oversight programme
EXTENSION OF THE OVERSIGHT PLANNING CYCLE BEYOND 24 MONTHS
(a) If the competent authority applies an oversight planning cycle that exceeds 24 months, it
should, at a minimum, perform one inspection of the organisation within each 12-month
segment of the applicable oversight planning cycle to validate the oversight programme.
(b) If the results of this inspection indicate a decrease in the safety performance of the
organisation, the competent authority should revert back to a 24-month (or less) oversight
planning cycle and review the oversight programme accordingly.
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(c) In order to be able to apply an oversight planning cycle of up to 36 months, the competent
authority should determine the format and contents of the regular reports to be made by the
organisation on its safety performance.
(d) To enable the competent authority to apply an oversight planning cycle of up to 48 months,
the competent authority should establish, implement and maintain a methodology to
evaluate the safety performance of the organisation, focusing on the organisation’s ability to
effectively identify aviation safety hazards and manage the associated risks.
[Back to implementing rule:
145.B.305 Oversight programme]
AMC1 145.B.310 Initial certification procedure
VERIFICATION OF COMPLIANCE
(a) In order to verify the organisation’s compliance with the applicable requirements, the
competent authority should conduct an audit of the organisation, including interviews of the
personnel, and inspections carried out at the organisation’s facilities.
(b) The competent authority should only conduct such an audit if it is satisfied that the
application and the supporting documentation, including the results of the pre-audit
performed by the organisation, are in compliance with the applicable requirements.
(c) The audit should focus on the following areas:
(1) the detailed management structure, including the names and qualifications of
personnel as required by points 145.A.30(a), (b), (c) and (ca), and the adequacy of the
organisation and its management structure;
(2) the personnel:
(i) the adequacy of the number of staff, and of their qualifications and experience
with regard to the intended terms of approval and the associated privileges;
(ii) the validity of any licences and/or authorisations, as applicable;
(3) the processes used for safety risk management and compliance monitoring;
(4) the facilities and their adequacy regarding the organisation’s scope of work;
(5) the documentation based on which the certificate should be granted (i.e. the
documentation required by Part-145):
(i) verification that the procedures specified in the MOE comply with the applicable
requirements; and
(ii) verification that the accountable manager has signed the exposition statement.
(d) If an application for an organisation certificate is refused, the applicant should be informed of
the right of appeal that exists under national law.
[Back to implementing rule:
145.B.310 Initial certification procedure]
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AMC1 145.B.310(a) Initial certification procedure
(a) The competent authority should determine how and by whom the audit shall be conducted.
For example, it will be necessary to determine whether one large team audit, a short series of
small team audits, or a long series of single inspector audits is most appropriate for the
particular situation.
(b) The audit may be structured so as to verify the organisation’s processes related to a product
line. For example, in the case of an organisation with Airbus A310 and A320 ratings, the audit
should concentrate on the maintenance processes of one type only for a full compliance
check, and depending upon the result, the second type may only require a sample check
against those aspects that were seen to be weak regarding compliance for the first type.
(c) In determining the scope of the audit and which activities of the organisation will be assessed
during the audit, the privileges of the approved organisation should be taken into account,
e.g. their approval to carry out airworthiness reviews.
(d) The competent authority auditing inspector should always ensure that he or she is
accompanied throughout the audit by a senior member of the organisation, who is normally
the compliance monitoring manager. The reason for being accompanied is to ensure that the
organisation is fully aware of any findings made during the audit.
(e) At the end of the audit, the auditing inspector should inform the senior member of the
organisation of all the findings that were raised during the audit.
[Back to implementing rule:
145.B.310 Initial certification procedure]
AMC1 145.B.310(c) Initial certification procedure
(a) There may be occasions when the competent authority inspector is unsure about the
compliance of some aspects of the applicant's organisation. If this occurs, the inspector should
inform the organisation about the possible non-compliance at the time, and about the fact
that the situation will be reviewed within the competent authority before a decision is made.
If the review concludes that there is no finding, then a verbal confirmation to the organisation
should suffice.
(b) Any findings should be recorded on the audit report form, each with a provisional
categorisation as a level 1 or 2 finding. Subsequent to the on-site audit that identified the
particular findings, the competent authority should review the provisional finding levels,
adjusting them if necessary, and should change the categorisation from ‘provisional‘ to
‘confirmed‘.
[Back to implementing rule:
145.B.310 Initial certification procedure]
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AMC2 145.B.310(c) Initial certification procedure
(a) The audit should be recorded using the audit report EASA Form 6 (Appendix II to
AMC2 145.B.310(c)).
(b) A review of the EASA Form 6 audit report form should be carried out by a competent
independent person nominated by the competent authority. The review should take into
account the relevant points of Part-145, the categorisation of the findings levels and the
closure action that was taken. A satisfactory review of the audit report should be indicated by
a signature on the EASA Form 6.
(c) The audit reports should include the date when each finding was closed, together with a
reference to the competent authority report or letter that confirmed the closure.
[Back to implementing rule:
145.B.310 Initial certification procedure]
AMC1 145.B.310(d) Initial certification procedure
All findings should be confirmed in writing to the applicant organisation within 2 weeks of the on-
site audit.
[Back to implementing rule:
145.B.310 Initial certification procedure]
AMC1 145.B.310(e)(2) Initial certification procedure
(a) The competent authority should indicate its approval of the MOE in writing.
(b) Approval of the MOE constitutes the formal acceptance of the personnel specified in points
145.A.30(b), 145.A.30(c), 145.A.30(ca) and 145.A.30(k).
(c) The competent authority may reject an accountable manager if there is clear evidence that
this person previously held a senior position in any organisation that was approved in
accordance with Regulation (EU) 2018/1139 and its delegated and implementing acts, and
that the person abused that position by not complying with the applicable requirements.
[Back to implementing rule:
145.B.310 Initial certification procedure]
AMC1 145.B.330 Changes — organisations
(a) The competent authority should have adequate control over any changes to the personnel
specified in points 145.A.30(a), (b), (c), (ca) and (k). Such changes in personnel will require an
amendment to the exposition.
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(b) When an organisation submits the name of a new nominee for any of the personnel specified
in points 145.A.30(a), (b), (c), (ca) and (k), the competent authority may require the
organisation to produce a written résumé of the proposed person's qualifications. The
competent authority should reserve the right to interview the nominee or to call for additional
evidence of his or her suitability before deciding upon him or her being acceptable.
(c) For changes requiring prior approval, in order to verify the organisation's compliance with the
applicable requirements, the competent authority should conduct an audit of the
organisation, limited to the extent of the changes, and determine whether a safety risk
assessment needs to be provided by the organisation.
(d) If a safety risk assessment is deemed to be necessary, the competent authority should inform
the organisation accordingly.
(e) If the competent authority considers that it is necessary to review the safety risk assessment
performed by the organisation, it should request the organisation to provide it, and assess its
results.
(f) If required, the audit may include interviews and inspections carried out at the organisation’s
facilities.
(g) The applicable part(s) of the EASA Form 6 should be used to document the assessment of any
changes to the Part-145 approval.
[Back to implementing rule:
145.B.330 Changes – organisations]
GM1 145.B.330 Changes — organisations
CHANGE OF THE NAME OF THE ORGANISATION
(a) On receipt of the application and the amendment to the relevant parts of the MOE, the
competent authority should reissue the certificate.
(b) A change of only the name does not require the competent authority to audit the organisation
unless there is evidence that other aspects of the organisation have changed.
[Back to implementing rule:
145.B.330 Changes – organisations]
GM1 145.B.350(b);(c) Findings and corrective actions
The following is an example of a level 1 finding:
The calibration control of the equipment specified in point 145.A.40(b) had previously failed
on a particular type product line such that most of the ‘calibrated’ equipment was suspect
from that time onwards.
A complete product line is defined as all the aircraft, engines or components of a particular type.
For such a level 1 finding, it may be necessary for the competent authority to ensure that:
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further maintenance and re-certification of all the affected products is accomplished,
dependent upon the nature of the finding;
further training by the organisation is carried out and audited by the competent authority
before the activity is resumed, dependent upon the nature of the finding.
In practical terms, if a competent authority inspector finds a non-compliance with Part-145 against
one product, it is deemed to be a level 2 finding.
The following are examples of level 2 findings:
There was a one-time use of a component that did not have a serviceable tag.
The training documents of the certifying staff are not complete.
[Back to implementing rule:
145.B.350 Findings and corrective actions]
AMC1 145.B.355(c) Suspension, limitation and revocation
INFORMATION ON THE SECURITY SITUATION
(a) The European Commission Security Directorate generally advises against any non-essential
travel to a country where hostile conditions, or a combination of the following conditions,
reduce the level of security, and pose a high level of threat to personnel, as follows:
(1) international or internal armed conflict with frequent armed confrontation taking place,
numerous casualties, and/or serious damage to infrastructure;
(2) a situation that could lead to war, or characterised by high internal or external tension
that could escalate into instability in the short term; very poorly functioning institutions;
(3) relatively frequent terrorist attacks due to the presence of active terrorist groups, either
domestic or transnational, and state authorities that are unable to ensure a satisfactory
level of security; and
(4) frequent criminal violence that also targets non-nationals. State authorities have a
limited ability to counter criminal activities and ensure security.
(b) Countries where the above conditions apply should not be considered to be compatible with
the performance of on-site audits by the competent authority.
[Back to implementing rule:
145.B.355 Suspension, limitation and revocation]
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APPENDICES TO AMC TO ANNEX II (PART-145)
Appendix I to AMC 145.B.20(1) EASA Form 4
The provisions of Appendix X to AMC M.B.602(a) and AMC M.B.702(a) EASA Form 4 apply.
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Appendix II to AMC2 145.B.310(c) AMC 145.B.20(5) EASA Form 6
Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 1: General
Name of organisation:
Approval reference:
Requested approval rating:
EASA Form 3 dated*:
FAA FAR Title 14 CFR Part 145 Certificate No (if applicable):
TCCA CAR 573 Certificate (if applicable):
ANAC RBAC 145 Certificate (if applicable):
Address of facility audited:
Audit period: From to
Date(s) of audit:
Audit reference(s):
Persons interviewed:
Competent authority inspector(s) surveyor(s): Signature(s):
Competent authority office: Date of EASA Form 6 Part 1 completion:
*delete as appropriate
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Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 2: Part-145 Compliance Aaudit Rreview
The five columns may be labelled and used as necessary to record the approval class and/or product line
reviewed. Against each column used of the following Part-145 points, please either tick () the box if
satisfied with compliance or cross (X) the box if not satisfied with compliance, and specify the reference of
the Part 4 finding next to the box, or enter N/A where if an item is not applicable, or N/R when if it is
applicable but it was not reviewed.
ParaPoint Subject
145.A.25 Facility requirements
145.A.30 Personnel requirements
145.A.35 Certifying Sstaff and support
staff
145.A.376 Records of Aairworthiness
review staff
145.A.40 Equipment, and Ttools and
material
145.A.42 Acceptance of Components
145.A.45 Maintenance Ddata
145.A.47 Production Pplanning
145.A.48 Performance of maintenance
145.A.50 Certification of Mmaintenance
145.A.55 Record-keeping
Maintenance Records
145.A.60 Occurrence Rreporting
145.A.65 Safety and Quality Policy,
Maintenance procedures and
Quality System
145.A.70 Maintenance Oorganisation
Eexposition (MOE) (see Part 3)
145.A.75 Privileges of the organisation
145.A.80 Limitations on the
organisation
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Proposed amendments to Part-145
145.A.85 Changes to the organisation
145.A.95 Findings
145.A.120 Means of compliance
145.A.140 Access
145.A.155 Immediate reaction to a
safety problem
145.A.200 Management system
145.A.202 Internal safety reporting
scheme
145.A.205 Contracting, subcontracting
and procurement
Competent inspector(s) surveyor(s): Signature(s):
Competent authority office: Date of EASA Form 6 Part 2 completion:
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Proposed amendments to Part-145
Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 3: Compliance with 145.A.70 Maintenance organisation exposition
Please either tick () the box if satisfied with compliance; or cross (X) if not satisfied with compliance, and
specify the reference of the Part 4 finding; or enter N/A where if an item is not applicable; or N/R when if it
is applicable but it was not reviewed.
PART 1 General Management
1.1 Corporate commitment Statement by the accountable manager
1.2 Safety and Quality policy and objectives
1.3 Management personnel
1.4 Duties and responsibilities of the management personnel
1.5 Management Oorganisation Cchart
1.6 List of Ccertifying staff, support staff and airworthiness review staff (Note: a separate
document may be referenced)
1.7 Manpower resources
1.8 General description of the facilities at each address intended to be approved
1.9 Organisations intended scope of work
1.10 Notification pProcedure for changes requiring prior approval to the competent
authority regarding changes to the organisation’s
activities/approval/location/personnel
1.11 Procedure for Eexposition amendments procedures and changes not requiring prior
approval
1.12 Procedure for alternative means of compliance
PART 2 Maintenance Pprocedures
2.1 Supplier evaluation and subcontract control procedure
2.2 Acceptance/inspection of aircraft components and material from outside contractors
2.3 Storage, tagging, and release of aircraft components and material to aircraft
maintenance
2.4 Acceptance of tools and equipment
2.5 Calibration of tools and equipment
2.6 Use of tooling and equipment by staff (including alternate tools)
2.7 Cleanliness standards of maintenance facilities
2.8 Maintenance instructions and relationship to aircraft/aircraft component
manufacturers’ instructions including updating and availability to staff
2.9 Repair procedure
2.10 Aircraft maintenance programme compliance
2.11 Airworthiness Directives procedure
2.12 Optional modification procedure
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Proposed amendments to Part-145
Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 3: Compliance with 145.A.70 Maintenance organisation exposition
2.13 Maintenance documentation in use and its completion
2.14 Technical records control
2.15 Rectification of defects arising during base maintenance
2.16 Release to service procedure
2.17 Records for the operator
2.18 Occurrence Rreporting of defects to the competent authority/Operator/Manufacturer
2.19 Return of defective aircraft components to store
2.20 Defective components to outside contractors
2.21 Control of computer maintenance record systems
2.22 Control of man-hour planning versus scheduled maintenance work
2.23 Critical maintenance tasks and error-capturing methods
2.24 Reference to specific maintenance procedures
2.25 Procedures to detect and rectify maintenance errors
2.26 Shift/task handover procedures
2.27 Procedures for notification of maintenance data inaccuracies and ambiguities to the
type certificate holder
2.28 Production planning procedures
2.29 Airworthiness review procedures and records for aircraft covered by Part-ML ELA1
aircraft not involved in commercial operations
2.30 Development and approval processing for maintenance programmes for ELA2 aircraft
not involved in commercial operations
PART L2 Additional Lline Mmaintenance Pprocedures
L2.1 Line maintenance control of aircraft components, tools, equipment, etc.
L2.2 Line maintenance procedures related to servicing/fuelling/de-icing, etc.
L2.3 Line maintenance control of defects and repetitive defects
L2.4 Line procedure for completion of technical log
L2.5 Line procedure for pooled parts and loaned parts
L2.6 Line procedure for return of defective parts removed from aircraft
L2.7 Line procedure for critical maintenance tasks and error-capturing methods
PART 3 Quality Management Ssystem Pprocedures
3.1 Hazard identification and safety risk management schemes
3.2 Internal safety reporting and investigations
3.3 Safety action planning
3.4 Safety performance monitoring
3.5 Management of change (including organisational changes with regard to safety
responsibilities)
3.6 Safety training and promotion
3.7 Immediate safety action and coordination with the operator’s ERP
3.8 Compliance monitoring
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Proposed amendments to Part-145
3.8.1 Quality aAudit plan and audit of organisation procedures
3.8.2 Quality Product audit of aircraft and inspections
3.8.3 Audit findings — corrective Quality audit remedial action procedure
3.94 Certifying staff and support staff qualifications and training procedures
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Proposed amendments to Part-145
Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 3: Compliance with 145.A.70 Maintenance organisation exposition
3.105 Certifying staff records
3.116 Quality audit Compliance monitoring and safety management personnel
3.127 Qualifying inspectors
3.138 Qualifying mechanics
3.149 Aircraft/aircraft component maintenance tasks exemption process control Control of
the process for exemption from aircraft/aircraft component maintenance tasks
3.1510 Concession control for deviation from organisation’s procedures
3.1611 Qualification procedure for specialised activities such as NDT, welding, etc.
3.1712 Management of Control of manufacturers’ and other external maintenance working
teams
3.13 Human Factors training procedure
3.1814 Competence Competency assessment of personnel
3.1915 Training procedures for on-the-job training as per Section 6 of Appendix III to Part-66
(limited to the case where the competent authority for the Part-145 approval and for
the Part-66 licence is the same).
3.2016 Procedure for the issue of a recommendation to the competent authority for the issue
of a Part-66 licence in accordance with 66.B.105 (limited to the case where the
competent authority for the Part-145 approval and for the Part-66 licence is the same).
PART 4 Operators
4.1 Contracting operators
4.2 Operator procedures/paperwork
4.3 Operator record completion
PART 5 Appendices Supporting documents
5.1 Sample Ddocuments
5.2 List of subcontractors
5.3 List of Lline maintenance locations
5.4 List of contracted Part-145 organisations
MOE Rreference: MOE Aamendment:
Competent authority audit staff: Signature(s):
Competent authority office: Date of EASA Form 6 Part 3 completion:
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Proposed amendments to Part-145
Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 4: Findings — Part-145 Compliance status
Each level 1 and 2 finding should be recorded, whether it has been rectified or not, and should be identified
by a simple cross-reference to the Part 2 requirement. All non-rectified findings should be copied in writing
to the organisation for them to take the necessary corrective action.
Part Audit reference(s): L Corrective action
2 or 3 E
reference Findings V Date Date Reference
E Due Closed
L
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Proposed amendments to Part-145
Part-145 APPROVAL RECOMMENDATION REPORT EASA FORM 6
Part 5: Part-145 Approval or continued approval or change recommendation*
Name of organisation:
Approval reference:
Audit reference(s):
The following Part-145 scope terms of approval are is recommended for this organisation:
Or, it is recommended that the Part-145 scope terms of approval specified in EASA Form 3 referenced
...................................................... should be continued.
Name of recommending competent authority inspector surveyor:
Signature of recommending competent authority inspector surveyor:
Competent authority office:
Date of recommendation:
EASA Form 6 review (quality check): Date:
*delete as appropriate
[Back to implementing rule:
145.B.310 Initial certification procedure]
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Proposed amendments to Part-145
Appendix III to AMC1 145.A.15 EASA Form 2
The provisions of Appendix IX to AMC M.A.602 and AMC M.A.702 EASA Form 2 apply.
[Back to implementing rule:
145.A.15 Application for an organisation certificate]
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Proposed amendments to Part-145
Appendix IV to AMC3 145.A.30(e) and AMC2 145.B.200(a)(3)
145.B.10(3) Fuel Ttank Ssafety Ttraining
This appendix includes general instructions for providing training on Ffuel Ttank Ssafety issues.
A. Effectivity:
Large aeroplanes as defined in Decision 2003/11/RM of the Executive Director of the
Agency (CS-25) and certified after 1 January 1958 with a maximum type certified
passenger capacity of 30 or more or a maximum certified payload capacity of 7 500 lbs
(3 402 kg) cargo or more, and
Large aeroplanes as defined in Decision 2003/11/RM of the Executive Director of the
Agency (CS-25), which contains have CS-25 aAmendment 1 or later in their certification
basis.
B. Affected organisations:
Part-145 approved maintenance organisations that are involved in the maintenance of
the aeroplanes specified in paragraph A), and fuel system components installed on such
aeroplanes when the maintenance data is are affected by CDCCL.
Competent authorities that are responsible as per 145.B.30 for the oversight of the
Part-145 approved organisations specified in this paragraph B).
C. Persons from affected organisations who should receive training:
Phase 1 only:
The group of persons who representing the maintenance management structure of the
organisation, the quality compliance monitoring manager, the safety manager and the
staff who are directly involved in required to quality monitoring the compliance of the
organisation.
The Ppersonnel of the competent authorities who are responsible as per 145.B.30 for
the oversight of the Part-145 approved maintenance organisations specified in
paragraph B).
Phase 1 + Phase 2 + Continuation recurrent training:
The Ppersonnel of the Part-145 approved maintenance organisation who are required
to plan, perform, supervise, inspect and certify the maintenance of the aircraft and fuel
system components specified in paragraph A).
D. General requirements of the training courses
Phase 1 – Awareness:
The training should be carried out before the person starts to work without supervision, but
not later than 6 months after joining the organisation. The persons who have already
attended the Level 1 Familiarisation course in compliance with ED Decision 2007/002/R
Appendix IV is are already in compliance with Phase 1.
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Type: It sShould provide be an awareness of course with the principal elements of the subject.
It may take the form of a training bulletin, or any other self-study or informative
session. The Ssignature of the reader trainer is required to ensure that the person has
passed the training.
Level: It should be a course at the level of familiarisation with the principal elements of the
subject.
Objectives: The trainee should, after the completion of the training:
1. Bbe familiar with the basic elements of the fuel tank safety issues.;
2. Bbe able to give a simple description of the historical background and the
elements requiring a safety consideration, using common words and showing
examples of non-conformities.;
3. Bbe able to use typical terms.
Content: The course should include:
a short background showing examples of FTS accidents or incidents,;
the description of the concept of fuel tank safety and CDCCL,;
some examples of manufacturers documents showing CDCCL items,;
typical examples of FTS defects,;
some examples of TC holders repair data;
some examples of maintenance instructions for inspection.
Phase 2 — Detailed training
A flexible period may be allowed by the competent authorities to allow organisations to set up
the necessary courses and impart provide the training to the personnel, taking into account
the organisation’s training schemes/means/practices. This flexible period should not extend
beyond 31 December 2010.
The persons who have already attended the Level 2 Detailed training course in compliance
with ED dDecision 2007/002/R Appendix IV either from a Part-145 maintenance organisation
or from a Part-147 training organisation are already in compliance with Phase 2 with the
exception of recurrent continuation training.
Staff should have received Phase 2 training by 31 December 2010 or within 12 months of
joining the organisation, whichever comes later.
Type: It sShould be a more in-depth internal or external course. It should not take the form of
a training bulletin, or any other form of self-study. At the end of the course, the trainees
should be required to take Aan examination should be required at the end, which
should be in the form of a multi choice questions, and the pass mark of the examination
should be 75 %.
[…]
[Back to implementing rule:
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Proposed amendments to Part-145
145.A.30 Personnel requirements
145.B.200 Management system]
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