21.A.131 Scope

Regulation (EU) No 748/2012

This Subpart establishes:

(a) the procedure for the issuance of a production organisation approval for a production organisation showing conformity of products, parts and appliances with the applicable design data;

(b) the rules governing the rights and obligations of the applicant for, and holders of, such approvals.

AMC-ELA No 1 to 21.A.131 Scope

ED Decision 2019/003/R

The AMC-ELA in this Subpart provide acceptable means of compliance for the issuance of a production organisation approval for organisations that produce

—      aeroplanes that are within the scope of CS-LSA, CS-VLA and CS-23 level 1;

—      sailplanes or powered sailplanes that are within the scope of CS-22; or

—      balloons, hot-air airships and gas airships that are ELA2 aircraft,

that are not classified as complex motor-powered aircraft, as well as products or parts used on these products.

GM-ELA No 1 to 21.A.131 Scope – General applicability of AMC-ELA and the use of AMC-ELA as a baseline outside its scope

ED Decision 2019/003/R

The AMC indicated with ‘AMC-ELA’ and the GM related to them (as indicated with ‘GM-ELA’), provide an alternative set of AMC and GM to the other available AMC and GM.

The AMC-ELA provide acceptable means to meet the requirements for small, non-complex organisations that produce aircraft as specified in AMC-ELA No 1 to 21.A.131.

If the AMC-ELA are not applicable (for instance for small, non-complex organisations that produce other low-risk products that are outside the scope of AMC-ELA No 1 to 21.A.131, e.g. light rotorcraft, CS-23 Level 2, etc.), the applicant is not obliged to use any other available AMC. Switching to those other available AMC will not necessarily provide a means of compliance that is proportionate. Since AMC are a means, but not the only means, of showing compliance, applicants and approval holders can also propose alternative means of compliance. These alternative means can use the AMC-ELA as a baseline, and complement them by additional or more stringent controls, processes or methods. This allows a gradual increase in the level of detail of the established procedures and the thoroughness of the implemented tools for POA approval. This enables the introduction of a proportionate approach that is commensurate with the kind of product and its associated risk or its production process risks, as a function of the complexity of the organisations and the risk and performance of the product. Using the AMC-ELA as a baseline for POA outside the applicability of the AMC-ELA is therefore considered to be an appropriate starting point.

Complementary elements need to be detailed, documented and recorded to a level at which the occurrence of repetitive non-conformities is mitigated. Applicants and approval holders need to demonstrate to the competent authority in such cases that those additional means meet the requirements that are appropriate for the products being produced.

GM-ELA No 2 to 21.A.131 Scope – AMC-ELA as a complete, self-contained set of AMC

ED Decision 2019/003/R

The AMC-ELA provide an alternative, complete and self-contained set of AMC. Applicants or POA holders that manufacture products or parts within the scope of AMC-ELA can use AMC-ELA instead of the existing AMC to Subpart G.

The AMC-ELA in full determine the acceptable means of compliance with Subpart G. The applicant should implement each of the means defined here on an individual basis. If the specific characteristics of the organisation render individual elements of AMC-ELA impracticable or not applicable, alternative means with a specific resolution should be agreed with the competent authority. A justification needs to be developed to show that the means that are applied meet the requirements of Part-21. A trustful relationship between the typically very compact team of the applicant and the competent authority should be developed. The applicant is strongly encouraged to ask the relevant contact person at the competent authority for mutual clarification of any questionable item, if there is any doubt.

GM-ELA No 3 to 21.A.131 Scope – Applicable design data

ED Decision 2019/003/R

GM 21.A.131 applies.

GM-ELA No 4 to 21.A.131 Scope – Explanation of terms used in AMC-ELA

ED Decision 2019/003/R

‘A method needs to be practised’.

When AMC-ELA applies the principle that ‘a method needs to be practised’, it means that the applicant can show what is actually done in order to comply with a requirement in a practical but systematic way. The applicant is not expected to have an excessively detailed documented procedure. As a baseline, documented procedures for such ‘practised methods’ can be limited to a declaration of the principles that are considered within the practised method. For example, a declaration such as ‘Document control is ensured by the workflow management as part of the IT-based Document Management System (DMS)’, may be provided. This is acceptable when evidence is provided by work results, by the demonstration of satisfactory conduct during surveillance activities, or by similar means. When the actions that are continuously performed show that they do not satisfy the needs of the AMC, a more detailed and documented procedure may need to be implemented to rectify the situation.

‘Delegation of tasks and responsibilities’

AMC-ELA differentiates between the delegation of tasks and the delegation of responsibilities. For small and simple organisations, the delegation of responsibilities to specific and separate organisational positions can create overly burdensome administrative processes that do not reflect the operational reality. The AMC-ELA accepts that tasks can be delegated, while the responsibility formally remains with the delegator. This can increase efficiency, and it offers the possibility for the applicant to simplify procedures. A typical example is when the accountable manager delegates tasks, while keeping the responsibility associated with these tasks. If this situation is identified with respect to the individual requirements, this may significantly reduce the effort required for documentation, and it allows streamlined methods to be practised.

‘Consolidated team’

AMC-ELA makes reference to companies working in a ‘consolidated team’, mainly in relation to coordination between the design and production activities. Companies are considered to be working in consolidated teams if the following criteria apply:

—      Even when a consolidated team spans across different legal entities, it acts as one organisation;

—      A consolidated team is expected to work within one consolidated setup, and under one management, so that a free flow of information is inherently ensured;

—      In a consolidated team, functions are not duplicated, so the same person(s) takes care of both the production and design aspects of any one function;

—      Responsibilities are defined at the level of the person or the position, not at the level of the legal entity;

—      Within consolidated teams, adequate coordination is expected to be present through ‘practised methods’, without any further written definitions of responsibilities beyond those elements that are explicitly described within AMC-ELA.

GM 21.A.131 Scope – Applicable design data

ED Decision 2019/018/R

Applicable design data is defined as all necessary drawings, specifications and other technical information provided by the applicant for, or holder of a design organisation approval, TC, STC, approval of repair or minor change design, or ETSO authorisation and released in a controlled manner to a production organisation approval holder. This should be sufficient for the development of production data to enable repeatable manufacture to take place in conformity with the design data.

Prior to issue of the TC, STC, approval of repair or minor change design or ETSO authorisation, or equivalent, design data is defined as ‘not approved’ but parts and appliances may be released with an EASA Form 1 as a certificate of conformity.

After issue of the TC, STC, approval of repair or minor change or ETSO authorisation, or equivalent, this design data is defined as ‘approved’ and items manufactured in conformity are eligible for release on an EASA Form 1 for airworthiness purposes.

For the purpose of Subpart G of Part 21, the term ‘applicable design data’ includes the information related to the applicable engine exhaust emissions and aeroplane CO₂ emissions production cut-off requirements.

21.A.133 Eligibility

Regulation (EU) No 748/2012

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 coordination between production and design.

GM 21.A.133(a) Eligibility – Approval appropriate for showing conformity

ED Decision 2012/020/R

‘Appropriate’ should be understood as follows:

—      The applicant produces or intends to produce aeronautical products, parts and/or appliances intended for airborne use as part of a type-certificated product (this excludes simulators, ground equipment and tools).

—      The applicant will be required to show a need for an approval, normally based on one or more of the following criteria:

1. Production of aircraft, engines or propellers (except if the competent authority considers a POA inappropriate)

2. Production of ETSO articles and parts marked EPA

3. Direct delivery to users such as owners or operators maintenance organisations with the need for exercising the privileges of issuing Authorised Release Certificates – EASA Form 1

4. Participation in an international co-operation program where working under an approval is considered necessary by the competent authority

5. Criticality and technology involved in the part or appliance being manufactured. Approval in this case may be found by the competent authority as the best tool to exercise its duty in relation to airworthiness control

6. Where an approval is otherwise determined by the competent authority as being required to satisfy the essential requirements of Annex I to the Regulation (EC) No 216/2008.

—      It is not the intent of the competent authority to issue approvals to manufacturing firms that perform only sub-contract work for main manufacturers of products and are consequently placed under their direct surveillance.

—      Where standard parts, materials, processes or services are included in the applicable design data (see guidance on applicable design data in GM 21.A.131) their standards should be controlled by the POA holder in a manner which is satisfactory for the final use of the item on the product, part or appliance. Accordingly, the manufacturer or provider of the following will not at present be considered for production organisation approval:

—      consumable materials

—      raw materials

—      standard parts

—      parts identified in the product support documentation as ‘industry supply’ or ‘no hazard’

—      non-destructive testing or inspection

—      processes (heat treatment, surface finishing, shot peening, etc.)

AMC No 1 to 21.A.133(b) and (c) Eligibility – Link between design and production organisations

ED Decision 2012/020/R

An arrangement is considered appropriate if it is documented and satisfies the competent authority that co-ordination is satisfactory.

To achieve satisfactory coordination the documented arrangements must at least define the following aspects irrespective of whether the two organisations are separate legal entities or not:

—      The responsibilities of a design organisation which assure correct and timely transfer of up-to-date airworthiness data (e.g., drawings, material specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.);

—      The responsibilities and procedures of a POA holder/applicant for developing, where applicable, its own manufacturing data in compliance with the airworthiness data package;

—      The responsibilities of a POA holder/applicant 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.);

—      The scope of the arrangements must cover Part 21 Subpart G requirements and associated AMC and GM, in particular: 21.A.145(b), 21.A.165(c), (f) and (g);

—      The responsibilities of a POA holder/applicant, in case of products prior to type certification to assist a design organisation in demonstrating compliance with CS (access and suitability of production and test facilities for manufacturing and testing of prototype models and test specimen);

—      The procedures to deal adequately with production deviations and non-conforming parts;

—      The procedures and associated responsibilities to achieve adequate configuration control of manufactured parts, to enable the production organisation to make the final determination and identification for conformity or airworthiness release and eligibility status;

—      The identification of the responsible persons/offices who control the above;

—      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 recognised as approved.

In many cases the production organisation may receive the approved design data through an intermediate production organisation. This is acceptable provided an effective link between the design approval holder and the production organisation can be maintained to satisfy the intent of 21.A.133.

When the design and production organisations are two separate legal entities a Direct Delivery Authorisation must 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 Direct Delivery Authorisation, specific permissions may be granted (refer to AMC 21.A.4).

AMC No 2 to 21.A.133(b) and (c) Eligibility – Link between design and production organisations

ED Decision 2012/020/R

In accordance with AMC No 1 to 21.A.133(b) and (c) the POA holder must demonstrate to the competent authority that it has entered into an arrangement with the design organisation. The arrangement must be documented irrespective of whether the two organisations are separate legal entities or not.

The documented arrangement must facilitate the POA holder to demonstrate compliance with the requirement of 21.A.133(b) and (c) by means of written documents agreed.

In the case where the design organisation and POA holder are part of the same legal entity these interfaces may be demonstrated by company procedures accepted by the competent authority.

In all other cases to define such a design/production interface the following sample format is offered:

Arrangement Sample Form

Instructions for completion:

Title: The title of the relevant document must clearly indicate that it serves the purpose of a design/production interface arrangement in accordance with 21.A.133(b) and (c).

Commitment: The document must include the basic commitments between the design organisation and the POA holder as addressed in AMC 21.A.4 and AMC No 1 to 21.A.133(b) and (c).

Relevant Procedures: Identify an entry point into the documentary system of the organisations with respect to the implementation of the arrangement (for example a contract, quality plan, handbooks, common applicable procedures, working plans etc.).

Scope of arrangement: The scope of arrangement must state by means of a list or reference to relevant documents those products, parts or appliances that are covered by the arrangement.

Transfer of applicable design data: Identify the relevant procedures for the transfer of the applicable design data required by 21.A.131 and GM 21.A.131 from the design organisation to the POA holder. The means by which the design organisation advises the POA holder whether such data is approved or not approved must also be identified (ref. 21.A.4/AMC 21.A.4).

Direct Delivery Authorisation: Where the design organisation and the POA holder are separate legal entities the arrangement must clearly identify whether authorisation for direct delivery to end users is permitted or not.

Where any intermediate production/design organisations are involved in the chain between the original design organisation and the POA holder evidence must be available that this intermediate organisation has received authority from the design organisation to grant Direct Delivery Authorisation.

Signature: AMC No 1 to 21.A.133(b) and (c) requests the identification of the responsible persons/offices who control the commitments laid down in the arrangement. Therefore the basic document must be signed mutually by the authorised representatives of the design organisation and the POA holder in this regard.

AMC-ELA No 1 to 21.A.133(c) Eligibility – Link between design and production

ED Decision 2019/003/R

The link between design and production is appropriately arranged when the organisation responsible for production and the one responsible for design both work within one consolidated team. The following documented arrangement may be used between the production organisation and the applicant for, or the holder of, a type design, in order to record their respective responsibilities.

AMC-ELA No 2 to 21.A.133(c) Eligibility – Link between design and production

ED Decision 2019/003/R

If the approval is held or is applied for by a different entity, and the work is not performed by one consolidated team, an arrangement in accordance with AMC-ELA No 1 to 21.A.133(c) is not sufficient. The roles and responsibilities for the coordination between the design and production staff (in both directions) need to be established. This may be achieved, for example, by simple flow chart definitions supported by strong, self‑explanatory forms, or by task descriptions of responsible functions in the organisation, or by equivalent means. IT-based enterprise resource planning (ERP) systems can be used to ensure and to demonstrate that there is a correct flow of information on the basis of defined and visible workflows with assigned roles and release gates, without any further need for written definitions. Further means with a comparable effect are possible. Internal and external audits can verify that the coordination functions properly.

21.A.134 Application

Regulation (EU) No 748/2012

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.

GM 21.A.134 Application – Application form and manner

ED Decision 2012/020/R

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.

GM-ELA No 1 to 21.A.134 Scope – Application

ED Decision 2019/003/R

GM 21.A.134 applies.

21.A.134A Means of compliance

Regulation (EU) 2022/201

(a) An organisation may use any alternative means of compliance to establish compliance with this Regulation.

(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. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.

GM1 21.A.124A and 21.A.134A Means of compliance

ED Decision 2022/021/R

GENERAL

(a) Acceptable means of compliance (AMC), as referred to in Article 76(3) of Regulation (EU) 2018/1139²⁷, are a tool to standardise the demonstration of compliance with, and facilitate the verification activities of the competent authorities in relation to, that Regulation and its delegated and implementing acts. AMC are published by EASA to achieve those objectives. While competent authorities and regulated entities are not legally bound to use the AMC, applying them is recommended.

(b) If an organisation wishes to use other means to comply with Regulation (EU) 2018/1139 and its delegated and implementing acts, which are different from the AMC that are published by EASA, that organisation may need to demonstrate compliance by using alternative means of compliance (AltMoC) that are established:

(1) by its competent authority (see GM1 21.B.115 and GM1 21.B.215); or

(2) by that organisation and approved by its competent authority (see point (c)).

An AltMoC does not allow deviation from Regulation (EU) 2018/1139 and its delegated or implementing acts.

(c) AltMoC that are established by an organisation and approved by its competent authority

An organisation that wishes to use a different MoC than the one published by EASA can propose an AltMoC to the competent authority and use it only once the competent authority approves it. In that case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the regulation.

The approval of an AltMoC is granted to the organisation by its competent authority on an individual basis and is restricted to that specific organisation. Other organisations that wish to use the same AltMoC should go through the AltMoC process (i.e. demonstrate how that AltMoC establishes compliance with the regulation) and obtain individual approval from their competent authority.

GM2 21.A.124A and 21.A.134A Means of compliance

ED Decision 2022/021/R

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE IS NEEDED

When there is no EASA AMC to a certain point of a regulation, the means of compliance (MoC) that are proposed by the organisation to that point do not need to go through the AltMoC process. It is the responsibility of the competent authority to verify that compliance with the regulation is achieved. However, in certain cases, the organisation may propose, and the competent authority may agree, to have such MoC go through the AltMoC process.

When there is an EASA AMC, the AltMoC process is needed in the following cases (non-exhaustive list):

—      an AltMoC to the regulation is technically different to the AMC that is published by EASA; and

—      a Form is significantly different from the one that is included in the EASA AMC.

Note: a Form that is required by a delegated or implementing act cannot be modified.

Examples of issues that are not considered to require the AltMoC process include, but are not limited to:

—      editorial changes to an EASA AMC, as long as they do not change the intent of the AMC; and

—      incorporating an EASA AMC into the organisational structure, organisational processes, or standard operating procedures of an organisation with different wording and terminology that are customised to the organisation’s environment if it does not change the intent of the AMC and its associated level of safety.

AMC1 21.A.124A(b) and 21.A.134A(b) Means of compliance

ED Decision 2022/021/R

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE

(a) The description of the alternative means of compliance (AltMoC) should include:

(1) a summary of the AltMoC;

(2) the content of the AltMoC;

(3) a statement that compliance with the regulation is achieved; and

(4) in support of that statement, an assessment that demonstrates that the AltMoC reaches an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding EASA AMC.

(b) All these elements that describe the AltMoC are an integral part of the management system records, in accordance with point 21.A.5.

21.A.135 Issuance of production organisation approval

Regulation (EU) 2022/201

An organisation shall be entitled to have a production organisation approval issued by the competent authority when it has demonstrated compliance with the applicable requirements under this Subpart.

21.A.139 Production management system

Regulation (EU) 2022/201

(a) The production organisation shall establish, implement and maintain a production management system that includes a safety management element and a quality management element, with clearly defined accountability and lines of responsibility throughout the organisation.

(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 those activities;

2. be established, implemented and maintained under the direct accountability of a single manager appointed pursuant 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 in accordance with point 21.A.145(c)(2);

3. establish, implement and maintain a safety risk management process to identify safety hazards entailed by its aviation activities, evaluate them and manage associated risks, including taking actions to mitigate the risks and verify their effectiveness;

4. establish, implement and maintain a safety assurance process that includes:

(i) the measurement and monitoring of the organisation’s safety performance;

(ii) the management of changes in accordance with point 21.A.147;

(iii) the principles for the continuous improvement of the safety management element;

5. promote safety in the organisation through:

(i) training and education;

(ii) communication;

6. establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to the continuous improvement of safety.

(d) As part of the quality management element of the production management system, the production organisation shall:

1. 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, thus enabling the exercise of the privileges set out in point 21.A.163;

2. establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:

(i) document issue, approval or change;

(ii) vendor and subcontractor assessment audit and control;

(iii) verifying 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) the 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) the completion and retention of records;

(xi) the competence and 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 performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

(xvii) the issue of a permit to fly and approval of the associated flight conditions;

3. include specific provisions in the control procedures for any critical parts.

(e) The production organisation shall establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with and adequacy of the production management system. Monitoring shall include feedback to the person or group of persons referred to in point 21.A.145(c)(2) and to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action.

(f) If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate(s) held.

GM1 21.A.139, 21.A.239, 21.B.120, 21.B.140, 21.B.220, and 21.B.240 The use of information and communication technologies (ICT) for performing remote audits

ED Decision 2022/021/R

This GM provides technical guidance on the use of remote information and communication technologies (ICT) to support:

—      competent authorities when overseeing regulated organisations;

—      regulated organisations when conducting internal audits / monitoring compliance of their organisation with the relevant requirements, and when evaluating vendors, suppliers and subcontractors.

In the context of this GM:

—      ‘remote audit’ means an audit that is performed with the use of any real-time video and audio communication tools in lieu of the physical presence of the auditor on-site; the specificities of each type of approval / letter of agreement (LoA) need to be considered in addition to the general overview (described below) when applying the ‘remote audit’ concept;

—      ‘auditing entity’ means the competent authority or organisation that performs the remote audit;

—      ‘auditee’ means the entity being audited/inspected (or the entity audited/inspected by the auditing entity via a remote audit);

It is the responsibility of the auditing entity to assess whether the use of remote ICT constitutes a suitable alternative to the physical presence of an auditor on-site in accordance with the applicable requirements.

The conduct of a remote audit

The auditing entity that decides to conduct a remote audit should describe the remote audit process in its documented procedures and should consider at least the following elements:

—      The methodology for the use of remote ICT is sufficiently flexible and non-prescriptive in nature to optimise the conventional audit process.

—      Adequate controls are defined and are in place to avoid abuses that could compromise the integrity of the audit process.

—      Measures to ensure that the security and confidentiality are maintained throughout the audit activities (data protection and intellectual property of the organisation also need to be safeguarded).

Examples of the use of remote ICT during audits may include but are not limited to:

—      meetings by means of teleconference facilities, including audio, video and data sharing;

—      assessment of documents and records by means of remote access, in real time;

—      recording, in real time during the process, of evidence to document the results of the audit, including non-conformities, by means of exchange of emails or documents, instant pictures, video or/and audio recordings;

—      visual (livestream video) and audio access to facilities, stores, equipment, tools, processes, operations, etc.

An agreement between the auditing entity and the auditee should be established when planning a remote audit, which should include the following:

—      determining the platform for hosting the audit;

—      granting security and/or profile access to the auditor(s);

—      testing platform compatibility between the auditing entity and the auditee prior to the audit;

—      considering the use of webcams, cameras, drones, etc., when the physical evaluation of an event (product, part, process, etc.) is desired or is necessary;

—      establishing an audit plan which will identify how remote ICT will be used and the extent of their use for the audit purposes to optimise their effectiveness and efficiency while maintaining the integrity of the audit process;

—      if necessary, time zone acknowledgement and management to coordinate reasonable and mutually agreeable convening times;

—      a documented statement of the auditee that they shall ensure full cooperation and provision of the actual and valid data as requested, including ensuring any supplier or subcontractor cooperation, if needed; and

—      data protection aspects.

The following equipment and set-up elements should be considered:

—      the suitability of video resolution, fidelity, and field of view for the verification being conducted;

—      the need for multiple cameras, imaging systems, or microphones, and whether the person that performs the verification can switch between them, or direct them to be switched and has the possibility to stop the process, ask a question, move the equipment, etc.;

—      the controllability of viewing direction, zoom, and lighting;

—      the appropriateness of audio fidelity for the evaluation being conducted; and

—      real-time and uninterrupted communication between the person(s) participating to the remote audit from both locations (on-site and remotely).

When using remote ICT, the auditing entity and the other persons involved (e.g. drone pilots, technical experts) should have the competence and ability to understand and utilise the remote ICT tools employed to achieve the desired results of the audit(s)/assessment(s). The auditing entity should also be aware of the risks and opportunities of the remote ICT used and the impacts they may have on the validity and objectivity of the information gathered.

Audit reports and related records should indicate the extent to which remote ICT have been used in conducting remote audits and the effectiveness of remote ICT in achieving the audit objectives, including any item that it has not been able to be completely reviewed.

AMC1 21.A.139(c) Production management system

ED Decision 2022/021/R

SAFETY MANAGEMENT ELEMENT

Demonstration of compliance with the international industry standard SM-0001 ‘Implementing a Safety Management System in Design, Manufacturing and Maintenance Organisations’, Issue B, 31 March 2022, is an acceptable means to demonstrate compliance with the safety management element of the production management system.

GM1 21.A.139(c) Production management system

ED Decision 2022/021/R

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 in, and contribution to, aviation safety, this 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, which involves all the personnel as active contributors to the safety of the final product, part, or appliance (see AMC1 21.A.139(c)(1)).

The principles of the requirements 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 addresses the core elements of the International Civil Aviation Organization (ICAO) safety management system (SMS) framework that is defined in ICAO Annex 19, Appendix 2, and facilitates the introduction of the additional safety management element.

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 that are issued under Regulation (EU) 2018/1139, it may choose to implement a single management system to cover all of its activities. An integrated management system may be used not only to capture multiple management system requirements resulting from Regulation (EU) 2018/1139, but also to cover for other regulatory provisions requiring compliance with ICAO Annex 19 or for other business management systems, such as 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, as well as 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, part, and appliance level or at the organisational level.

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, may require more efficient safety barriers).

As a consequence, scalability and suitability of the safety management element should be a function of the inherent safety risk capability of the organisation. For instance, for organisations with a lower risk level:

(a) the risk assessment model that is used may be very simple in cases in which the identified hazards are easy to mitigate;

(b) expert judgement might be sufficient to measure the efficiency of safety barriers;

(c) the collection of data, safety information, and occurrences might be very limited;

(d) there might be no need for software or tools to manage the SMS; and

(e) the communication policy might be limited.

AMC1 21.A.139(c)(1) Production management system

ED Decision 2022/021/R

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 by fostering the reporting of organisational threats as well as events, as defined in AMC3 21.A.3A(a);

(3) be endorsed by the accountable manager (AM);

(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 the commitment:

(1) to comply with all the applicable legislation, meet all the applicable requirements, and adopt practices to improve safety standards;

(2) to provide the necessary resources for the implementation of the safety policy;

(3) to apply human factors (HF) principles;

(4) to enforce safety as a primary responsibility of all managers; and

(5) to apply ‘just culture’ principles and, in particular, not to make available or use the information on occurrences:

(i) to attribute blame or liability to personnel for action, omissions, or decisions 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, 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 maintaining or continuously improving the overall effectiveness of safety management;

(3) be communicated throughout the organisation; and

(4) be periodically reviewed to ensure that they remain relevant and appropriate to the organisation.

GM1 21.A.139(c)(1) Production management system

ED Decision 2022/021/R

SAFETY POLICY

The safety policy is the means for the organisation to state its intention to maintain and, where practicable, to improve the safety levels of all its activities, and to minimise its contribution to the risk of an aircraft accident or serious incident occurring, as far as reasonably practicable. The safety policy 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 issuing 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.

Regulation (EU) No 376/2014 defines the ‘just culture’ principles to be applied (refer, in particular, to Article 16(11) of that Regulation).

AMC1 21.A.139(c)(2) Production management system

ED Decision 2022/021/R

ORGANISATION AND ACCOUNTABILITY

(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 defined in AMC1 21.A.145(c)(2).

(b) Safety review board

(1) The safety review board (the ‘board’), sometimes referred to as ‘high-level safety committee’, considers matters of strategic safety in support of the safety accountability of the accountable manager.

(2) The board should be normally chaired by the accountable manager and be generally composed of the person or group of persons nominated under point 21.A.145(c)(2). Its composition can be adapted to its needs, considering point 21.A.245(c)(2).

(3) The board should monitor:

(i) the organisation’s safety performance against its safety policy and objectives;

(ii) whether any safety action is taken in a timely manner; and

(iii) the effectiveness of the organisation’s management system processes.

(4) The board may also be tasked with:

(i) reviewing the results of compliance monitoring; and

(ii) monitoring the implementation of any related corrective and preventive action.

(c) The board should ensure that appropriate resources are allocated to achieve the established safety objectives.

(d) Notwithstanding point (a), if justified by the size of the organisation and the nature and complexity of its activities, and subject to a risk assessment and/or mitigation measures, as well as the competent authority’s agreement, the organisation may not need to establish a board. In that case, the tasks that are normally allocated to the board should be allocated to the safety manager.

GM1 21.A.139(c)(2) Production management system

ED Decision 2022/021/R

SAFETY ACTION GROUP

(a) Depending on the size of the organisation and the nature and complexity of its activities, 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 that is 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 with or assist in the following:

(1) monitoring safety performance;

(2) defining action to control risks to an acceptable level;

(3) assessing the impact of organisational changes on safety;

(4) ensuring that safety action is implemented within the agreed timescales; and

(5) reviewing the effectiveness of previous safety action and safety promotion.

AMC1 21.A.139(c)(3) and (4) Production management system

ED Decision 2022/021/R

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 focus in particular on hazards that may generate nonconformity of a product, part, or appliance that is produced.

(b) Safety risk management processes

(1) The organisation should develop and maintain a safety risk management process that ensures a reactive, proactive, and predictive approach composed of the following elements:

(i) analysis (e.g. in terms of the probability or likelihood as well as 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 organisation should specify, within the risk management process, who has the authority to make decisions, considering point (b)(1) of this AMC.

(c) Regardless of the approval status of the subcontracted organisations, the production organisation (PO) is responsible for ensuring that hazard identification and risk management activities are performed on subcontracted activities, as required by point 21.A.139(d)(2)(ii), as well as for the monitoring of their compliance and adequacy, as required by point 21.A.139(e).

(d) Internal investigation

(1) In line with ‘just culture’ as part of the safety policy, the organisation should define how to investigate events such as errors or near misses, in order to understand not only what happened, but also how it happened, as well as to prevent or reduce the probability and/or the consequences of any future recurrence.

(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) Safety performance monitoring and measurement should be the processes through which the safety performance of the organisation is verified against the safety policy and the safety objectives.

(2) This process may include, as appropriate to the size, nature, and complexity of the organisation, the following elements:

(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, parts, or new equipment/technologies, the implementation of new or changed procedures, or in cases 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 that periodically assess the status of safety risk controls;

(iv) safety surveys that examine particular elements or procedures of a specific area, such as the following:

(A) the problem areas identified;

(B) bottlenecks in the daily production management activities;

(C) the perceptions and opinions of the production management personnel; and

(D) any areas of dissent or confusion; and

(v) other indicators relevant to safety performance.

(f) Management of change

Changes to the production management system may pose new hazards or decrease the effectiveness of existing safety risk controls. The organisation should manage any safety risks that are related to change in that organisation. The management of change should be a documented process to identify external or internal change that may have an adverse effect on safety. The management of change should use the organisation’s existing processes for hazard identification, risk assessment, and risk mitigation.

(g) Continuous improvement

The organisation should continuously seek to improve its safety performance and the effectiveness of its production management system. Continuous improvement may be achieved through review of the following elements:

(1) compliance monitoring and audits;

(2) assessments, including assessments of the effectiveness of the safety culture and of the management system, to assess in particular the effectiveness of the safety risk management processes;

(3) staff surveys, including safety culture surveys, that can provide useful feedback on how engaged the staff are in the production management system;

(4) the monitoring of events and their recurrence;

(5) the evaluation of the safety performance indicators as well as reviews of all the available safety performance information; and

(6) the identification of lessons learned.

AMC1 21.A.139(c)(4)(ii) Production management system

ED Decision 2022/021/R

MANAGEMENT OF CHANGE

This AMC provides a means to consider organisational changes for their potential impact on safety. Organisational changes should also be evaluated for their significance, as required by point 21.A.147. In addition, necessary changes should be introduced into the production organisation exposition (POE), as per point 21.A.143(c). The production management system should be designed such that all the above points are taken into account.

(a) Organisational changes should be proactively considered for their safety implications. The magnitude of a change, its safety criticality, and its potential impact on human performance (HP) should be assessed in any process for the management of change. Certain non-complex organisational changes may not require additional assessment.

(b) Special consideration, including human factors (HF) issues, should be given to the transition period during which the change becomes effective.

(c) During the process for the management of change, relevant previous risk assessments and existing hazards should be reviewed for their possible effects.

GM1 21.A.139(c)(4)(ii) Production management system

ED Decision 2022/021/R

MANAGEMENT OF CHANGE

Unless properly managed, changes in the organisational structure, facilities, scope of work, personnel, documentation, policies and procedures, etc. may result in inadvertently creating new hazards, which may expose the organisation to new or greater risks. Effective organisations seek to improve their processes, while being conscious of the fact that changes may expose the organisation to potential 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 change. The disciplined implementation of management of change may maximise the effectiveness of change, engage staff, and minimise the risks that are inherent in change.

Change may have the potential to raise new HF issues, or to exacerbate existing ones. For example, changes in computer systems, equipment, technology, personnel changes (including changes in management personnel), procedures, the organisation of work, or work processes are likely to affect performance.

Effective management of change is supported by the following elements:

(a) the implementation of a process for 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;

(b) the identification of changes that may have a considerable impact on:

(1) resources (material and human);

(2) management direction (policies, processes, procedures, training); and

(3) management control;

(c) safety cases/risk assessments that are aviation-safety-focused; and

(d) the involvement of key stakeholders in the process for the management of change, as appropriate.

AMC1 21.A.139(c)(5) Production management system

ED Decision 2022/021/R

SAFETY COMMUNICATION

(a) The organisation should establish communication to the staff, as appropriate to their safety responsibilities, regarding safety matters, which:

(1) ensures awareness of safety management activities;

(2) conveys safety-critical information, especially related to assessed risks and analysed hazards;

(3) explains why particular action is taken; and

(4) explains why safety procedures are established or changed.

(b) Regular meetings with staff, during which information, action, and procedures are discussed, may be used to communicate safety matters.

GM1 21.A.139(c)(5) Production management system

ED Decision 2022/021/R

SAFETY PROMOTION

(a) Safety training, combined with safety communication and information sharing, is part of safety promotion.

(b) Safety promotion activities support the following:

(1) the organisation’s policies, encouraging a positive safety culture, thus creating an environment that is favourable to the achievement of the organisation’s safety objectives;

(2) organisational lessons learned; 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 action.

AMC1 21.A.139(c)(5)(i) Production management system

ED Decision 2022/021/R

SAFETY TRAINING

(a) The production management staff, as described in points 21.A.145(c)(1) and (2), should receive initial and recurring safety training, as appropriate to their responsibilities, including in safety management principles and the associated safety objectives, to ensure their continued competency.

(b) The organisation should identify the category of other staff to which safety training should be provided, and define the initial and recurrent training programmes, including appropriate timelines.

(c) Adequate records of the safety training that is provided should be kept in accordance with point 21.A.5.

GM1 21.A.139(c)(5)(i) Production management system

ED Decision 2022/021/R

SAFETY TRAINING

(a) The main purpose of the safety training programme is:

(1) to support safety management policies and processes; and

(2) to ensure that personnel at all levels of the organisation develop and maintain their competency to fulfil their safety roles.

(b) Each organisation may adapt its syllabus to its own needs. Typically, depending on the targeted staff, to contribute to a positive safety culture, the following items may be included:

(1) the organisational roles and responsibilities related to safety, including the hazard identification and risk management processes;

(2) the safety objectives and the associated safety performance indicators;

(3) human factors (HF) principles, including human performance (HP) and limitations;

(4) legislation, where applicable;

(5) safety reporting systems and investigations; and

(6) safety issues.

(c) The purpose of the recurrent safety training is:

(1) primarily to ensure that staff are kept abreast notably of changes to safety management system (SMS) principles, processes, and procedures; and

(2) also to share feedback on safety issues that are relevant to the organisation or lessons learned.

(d) The training staff should have sufficient knowledge and experience to teach the topics at the required level, as well as the skills to influence attitudes and behaviours.

AMC1 21.A.139(d) Production management system

ED Decision 2022/021/R

QUALITY SYSTEM ELEMENT

The quality system element is an organisational structure, included in the production management system, with responsibilities, procedures, processes, and resources that 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) are available in a written form;

—      distribution of relevant procedures to offices/persons is made in a controlled manner,

—      procedures which identify persons responsible for the prescribed actions are established; and

—      the updating process is clearly described.

The competent authority will verify on the basis of the exposition and by appropriate investigations that the production organisation (PO) has established and can maintain their documented quality system.

GM1 21.A.139(d)(1) Production management system

ED Decision 2022/021/R

CONFORMITY OF SUPPLIED PARTS OR APPLIANCES

The production organisation approval (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 AMC1 21.A.139(d)(2)(ii) or AMC2 21.A.139(d)(2)(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 the supplier's 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 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 inspections/tests performed by the supplier if it can establish that:

—      the personnel responsible 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 POA holder retains direct responsibility for inspections/tests that are performed either at its own facilities or at the supplier’s facilities.

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, which is released in accordance with the supplier’s privileges that are defined in point 21.A.163.

A supplier who does not hold a POA is considered to be a subcontractor under the direct control of the POA quality system.

GM2 21.A.139(d)(1) Production management system

ED Decision 2022/021/R

QUALITY SYSTEM ELEMENT — PARTNER AND SUBCONTRACTOR ARRANGEMENTS

When defining the arrangements between the production organisation (PO) and its partners and subcontractors, both elements of the production management system should be taken into account, i.e. the safety management element and the quality system element. The following guidance should therefore be considered applicable to both elements.

(a) When the PO subcontracts activities, the arrangements should consider the safety risk management process that is part of the PO’s safety management element (see point 21.A.139(c)(3)). When the subcontractor does not have a safety management element, the subcontractor should be integrated into the safety management element of the PO; when the subcontractor has implemented a safety management system (such as for design organisation approval (DOA) or production organisation approval (POA)), the two safety management systems, i.e. of the PO and of the subcontractor, should be harmonised.

(b) Depending on the complexity and criticality of those arrangements, the following elements within the arrangements should be addressed:

(1) coordination and interfaces between all the parties involved;

(2) applicable procedures;

(3) safety culture, including internal safety reporting schemes (see point 21.A.3A);

(4) communication between all the parties involved, including reporting, regular meetings, and feedback channels;

(5) allocation of tasks, of clear accountability, and of responsibilities; and

(6 the qualifications and competency of key personnel with reference to point 21.A.145.

(c) The safety risk management should focus on the need to exchange safety data and safety information that are deemed significant for the determination of relevant risks in terms of likelihood, severity, impact, and acceptability, such as, wherever appropriate, but not limited to the following:

(1) (at product level) failure, malfunction, defect, or other occurrences, non-conformity or outcome of the compliance monitoring function, quality escape, process failure, foreign object damage (FOD), deviation (e.g. calibration of tools), component failure analysis, in‑service event, etc.;

(2) (at documentation level) key processes (e.g. airworthiness directives, production documentation, production processes); and

(3) (at organisational level) organisational changes, disruptive events, resources’ issues, human performance (HP) issues.

(d) Regular communication should be ensured between all the parties involved, to discuss work progress, risk mitigation measures, changes to the arrangements, as well as any other significant issues.

AMC1 21.A.139(d)(2) Production management system   

ED Decision 2022/021/R

QUALITY SYSTEM — ELEMENTS OF THE QUALITY SYSTEM

(1) The control procedures covering the elements of point 21.A.139(d)(2) should document the standards to which the production organisation intends to work.

(2) An organisation having a quality 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:

—      mandatory and voluntary occurrence reporting, as required by points 21.A.3A and 21.A.139(c) and continued airworthiness as required by point 21.A.165(e);

—      control of work occasionally performed (outside the POA facility by POA personnel);

—      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; and

—      personnel training and qualification procedures especially for certifying staff as required in 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 Part 21. In all cases, the competent authority will still need to be satisfied that compliance with Part 21 is established.

AMC2 21.A.139(d)(2)(ii) Production management system

ED Decision 2022/021/R

VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT, AND CONTROL — PRODUCTION ORGANISATION APPROVAL HOLDER THAT USES OTHER PARTIES SUPPLIER CERTIFICATION

(1) General

Other party (OP) supplier certification is a method whereby a supplier contracts an appropriately recognised or accredited OP for the purpose of obtaining a certification from that OP. Certification indicates that the supplier has satisfactorily demonstrated 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 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 production organisation approval (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 holder. 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.

(2) Reserved

(3) Conditions and criteria for using supplier certification for 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 that are required for use of supplier certification for the supplier assessment and surveillance should be consistent the with other procedures of the POA holders’ quality system.

(c) The procedures of the POA holder that uses supplier certification for the supplier assessment and surveillance should include the following:

(1) A listing of the OPs 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 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 is including on-site surveillance activities that are conducted 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; and

(vii) verification that the OP has access to the applicable proprietary data to the level of detail necessary to survey the suppliers’ functions.

Where the POA holder uses an OP accredited by a signatory to the European cooperation for Accreditation (EA) Multilateral Agreement and works in accordance with an aviation standard (e.g. EN 9104 series of requirements) that describes the requirements for the OP certification, items (ii), (iv), and (v) should be deemed to be complied with.

(4) A definition that states to what extend the OP will conduct supplier surveillance on behalf of the POA holder. If the OP partly replaces surveillance by the POA holder, the POA holder should identify the functions that will continue to be surveyed by the POA holder.

(5) the procedures that ensure that the POA is aware of the loss of an existing certification.

(6) the procedures that ensure that the POA holder is aware of any non-conformity and has access to detailed information on any non-conformity.

(7) the procedures to evaluate the consequences of non-conformity and take appropriate actions.

(d) The POA should make arrangements that allow the competent authority to make investigations in accordance with point 21.A.9  to include OP activities.

GM1 21.A.139(d)(2)(ii) Production management system

ED Decision 2022/021/R

ASSESSMENT, AUDIT, AND CONTROL OF VENDOR AND SUBCONTRACTOR

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’,whether they hold production organisation approvals (POAs) or not; audit and control are hereinafter referred to as ‘surveillance’. Implementing or significantly 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.

AMC1 21.A.139(d)(2)(ii)(b)(1)(ii) Production management system

ED Decision 2022/021/R

VENDOR AND SUBCONTRACTOR ASSESSMENT, AUDIT AND CONTROL — PRODUCTION ORGANISATION APPROVAL HOLDER THAT USES DOCUMENTED ARRANGEMENTS WITH OTHER PARTIES FOR THE ASSESSMENT AND SURVEILLANCE OF A SUPPLIER

(1) General

The production organisation is required by 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 other parties (OPs), such as a consulting firm or quality assurance company, for supplier assessment and surveillance does not exempt the production organisation approval (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 OPs.

The purpose of using an OP cannot be to replace the assessment, audit and control of the POA holder. 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 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 assessin’ and/or surveying a ‘OA’s supplier.

(2) Reserved

(3) Conditions and criteria for the use of OPs to perform supplier assessment and surveillance

(a) The POA holder should include the use of OPs for supplier assessment and surveillance in the POA holders’ quality system to demonstrate compliance with the applicable requirements of Part 21.

(b) The procedures that are required for using OPs for supplier assessment and surveillance should be consistent with other procedures of the POA holders’ quality systeI(c) The procedures of the POA holder that uses 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 has sufficient knowledge, experience, and training to perform it's allocated tasks;

(iii) verification that the frequency with which the OP carry out surveillance 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 is including on-site surveillance activities that are conducted by the OP; and

(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 works in accordance with an aviation standard (e.g. EN 9104 series of requirements) that describes requirements for the assessment and surveillance by the other party, items (ii) and (iv) shall be deemed to be complied with.

(4) A definition that states to what extend the OP will conduct surveillance of the suppliers on behalf of the POA holder. If the OP partly replaces surveillance by the POA holder, 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-conformity that is discovered at the supplier's facility, and of the corrective action and follow-up.

(d) The POA should make arrangements that allow the competent authority to make investigations in accordance with point 21.A.9 to include OP activities.

AMC1 21.A.139(e) and 21.A.139(d)(2)(xiv) Production management system

ED Decision 2022/021/R

INDEPENDENT MONITORING FUNCTION

(a) The independent monitoring function should ensure that:

(1) the activities of the production organisation (PO) are monitored for their compliance with the applicable requirements and with any additional requirements as established by the organisation, and that those activities are properly performed under the supervision of the nominated persons that are referred to in point 21.A.145(c)(2); furthermore, compliance with, and the adequacy of, the production management system should be monitored;

(2) all subcontracted production activities are monitored for compliance and adequacy with the applicable arrangements;

(3) an objective review of the complete set of production-management-related activities is provided through independent monitoring activities, such as audits, inspections, reviews;

(4) the independence of the monitoring activities is established by always ensuring that those activities and inspections are performed by staff that are not involved in the function, procedure, or products that they monitor, and that are independent from the operating managers of the function(s) being monitored; however, this should not exclude support by domain experts during monitoring;

(5) a monitoring plan is established to show when and how often the activities that are required by Part 21 will be audited;

(6) the monitoring cycle should not exceed the applicable oversight planning cycle that is established according to point 21.B.222; the determination of the monitoring plan should consider at least the following aspects:

(i) the criticality of the items checked; and

(ii) the safety performance of the organisation, including any previous findings and root causes;

(7) when non-compliance is found, the root cause(s) and contributing factor(s) are identified, and corrective action is defined and followed up;

(8) feedback is provided to the management of the PO; and

(9) the above elements perform 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 to demonstrate compliance with Part 21.

(b) The staff performing an independent monitoring function should have access to all the parts of the PO and, as necessary, to any subcontracted organisations.

GM1 21.A.139(f) Production management system

ED Decision 2022/021/R

ADEQUACY OF PROCEDURES AND OF THE MONITORING FUNCTION

‘Adequacy of procedures’ means that the quality system, through the use of the procedures as defined, is capable of meeting the conformity objectives that are identified in 21.A.139 (d)(1).

21.A.143 Production organisation exposition

Regulation (EU) 2022/201 (EU) 2022/201

(a) The production organisation shall establish and maintain a production organisation exposition (POE) that provides directly or by cross reference the following information related to the production management system as described in point 21.A.139:

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 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 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 associated chains of responsibility of the managers as required by point 21.A.145(c)(1) and (2);

5. a list of certifying staff as referred to in point 21.A.145(d);

6.  a general description of 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 production management system, the policy, processes and procedures as provided for in point 21.A.139(c);

12. a list of the outside parties referred to in point 21.A.139(d)(1);

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;

(vi) a list of documents that need to be produced for flight test.

(b) The initial issue of the POE shall be approved by the competent authority.

(c) The POE shall be amended as necessary so that it remains an up-to-date description of the organisation. Copies of any amendments shall be supplied to the competent authority.

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)

ED Decision 2017/024/R

1. General

a. Scope: The FTOM covers flight test operations.

The FTOM complexity should be proportionate to the aircraft and the organisation complexity.

b. Format

The FTOM may:

—      be included in the Design Organisation Approval (DOA)/Production Organisation Approval (POA)/Alternative Procedure to DOA (APDOA) documents, or

—      be a separate manual.

The FTOM may make reference to other documents to cover the contents listed below, e.g. for record-keeping.

c. Use by contractors or sub-contractors:

When flight tests are performed by contractors or sub-contractors, they should comply with the FTOM of the primary organisations, unless they have established an FTOM in compliance with Part-21, the use of which has been agreed between the two organisations.

2. The FTOM should contain the following elements:

a. Exposition (not applicable in the case of APDOA):

 If the FTOM is presented as a separate document, it should include a chart indicating the structure of the organisation and, more specifically, the functional links of the people in charge of flight test activities. It should also mention the coordination between all departments affecting flight test, e.g. Design Office, Production and Maintenance, in particular coordination for the establishment and update of a Flight Test Programme.

b. Risk and safety management:

 The FTOM should describe the organisation’s policy in relation to risk and safety assessment, mitigation and associated methodologies.

c. Crew members:

According to the flight test category, the FTOM should describe the organisation’s policy on the composition of the crew (including the need to use a Lead Flight Test Engineer (LFTE)) and the competence and currency of its flight test crew members, including procedures for appointing crew members for each specific flight.

All crew members should be listed in the FTOM.

A flight time limitation policy should be established.

d. Carriage of persons other than crew members:

According to the flight test category, the FTOM should describe the organisation’s policy in relation to the presence and safety on-board, of people other than crew members (i.e. with no flying duties).

People other than crew members should not be allowed on board for Category 1 flight tests.

e. Instruments and equipment:

 The FTOM should list, depending on the nature of the flight, the specific safety-related instruments and equipment that should be available on the aircraft or carried by people on board.

 The FTOM should contain provisions to allow flights to take place in case of defective or missing instruments or equipment.

f. Documents:

The FTOM should list the documents to be produced for flight test, and include (or refer to) the procedures for their issue, update and follow-up to ensure the documents’ configuration control:

(i) documents associated with a Flight Test Programme:

—      Flight Order for a given flight, which should include:

—      a list of the tests to be performed and associated conditions;

—      safety considerations relevant to the flight;

—      category of the flight (e.g. Category 1);

—      composition of the crew;

—      names of persons other than crew members;

—      aircraft configuration items relevant to the test to be highlighted to the crew;

—      loading of the aircraft;

—      reference to approved flight conditions; and

—      restrictions relevant to the flight to be highlighted to the crew.

—      Flight crew report.

(ii) documentation and information to be carried on the aircraft during flight test;

(iii) record-keeping: the FTOM should describe the policy relative to record-keeping.

g. Permit to fly:

The FTOM should describe the involvement of the flight test organisation or flight test team (as appropriate) in the process for the approval of flight conditions and the issue of permits to fly in accordance with Subpart P.

h. Currency and training:

 The FTOM should describe how training for flight test is organised.

 Currency of the flight test crew may be ensured either through recent experience or refresher training.

For aircraft for which Appendix XII is applicable, minimum flight experience by year should be:

—      for pilots: 50 hours. In addition:

—      for pilots with a flight test rating, the 50 hours should include 20 flight test hours in any flight test category.

—      for pilots performing a Category 3 flight test, the flight test experience should be expressed in terms of a number of flights leading to the issue of a Certificate of Airworthiness (CofA) (e.g. first flights).

—      for pilots performing a Category 4 flight test, the minimum flight test experience should be proportionate to the activity envisaged.

—      for LFTEs: 10 flight test hours in any flight test category.

The FTOM should specify the requirements for a refresher training in order to ensure that crew members are sufficiently current to perform the required flight test activity.

A system should be established to record the currency of the flight test crew’s training.

A valid national document (i.e. licence), issued by an EASA Member State under its national regulations and ensuring compliance with the agreed currency requirements, is an acceptable means of compliance to demonstrate currency for a pilot that holds a flight test rating and for an LFTE.

GM1 21.A.143 Production organisation exposition

ED Decision 2022/021/RDecision 2022/021/R

GENERAL

(a) The purpose of the production organisation exposition (POE) is to state in a concise 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 instructions, the POE should provide a summary of the information and an appropriate cross-reference.

(b) Point 21.A.143(b) requires that the initial issued of the POE is approved by the competent authority. Revisions of the POE are subject to the process that is described in point (c) below.

(c) When changes to the organisation occur, according to point 21.A.143(c), the POE is required to be kept up to date. This should be done as per a procedure that is laid down in the POE. If the changes are significant, the organisation should not amend the POE before the competent authority approves the change in accordance with point 21.A.147.

AMC1 21.A.143(a)(1) Production organisation exposition

ED Decision 2022/021/R

CONTENT OF THE PRODUCTION ORGANISATION EXPOSITION

(a) All staff should be familiar with those production organisation exposition (POE) parts that are relevant to their tasks.

(b) A paragraph in the POE should provide a description of the organisation, as well as the safety policy and the corresponding 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 senior company manager, if different), which confirms that the POE and any associated manuals are complied with at all times.

This statement should read as follows, or embrace the intent of the following text:

‘This exposition defines the organisation and the procedures upon which the competent authority’s* production organisation approval (POA) is based.

These procedures are approved by the undersigned, and must be complied with, as applicable, to ensure that all production activities are performed on time and to an approved standard.

It is understood that the approval of the production organisation (PO) is based on the organisation’s continuous compliance with the applicable requirements of Part 21, and with the organisation’s procedures that are described in this exposition. The competent authority* is entitled to limit, suspend, or revoke the approval if the organisation fails to fulfil the obligations that are imposed by Part 21, or any conditions according to which the approval was issued.

Signed ......................................

Dated ......................................

Accountable manager and ...................................... (quote the position of the signatory)

Senior company manager ......................................

For and on behalf of ...................................... (quote the organisation’s name)’

*Where ‘competent authority’ is stated, please insert the actual name of the approving competent-authority organisation or administration that grants the POA.

The statement should be reissued at the earliest opportunity when the accountable manager changes.

(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) The POE should include the safety management procedures (including identification of safety hazards, evaluation, and associated risks management), safety assurance procedures, and safety promotion processes.

(f) If the organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139 and the delegated and implementing acts that are adopted on the basis thereof, so that the organisation is required to establish another exposition, the organisation may combine the documents by producing a separate manual or supplement that covers the differences between the POE and the other exposition. In that case, the manual or supplement should identify where in the other exposition the remaining information on the production organisation (PO) is covered. That remaining information then formally becomes part of the exposition.

(g) The organisation may document its safety policy, safety objectives, and all the safety management system key processes (as required by point 21.A.139(c)) in a separate manual (e.g. a safety management manual or management system manual) or in its POE. Organisations that hold multiple organisation approvals, which are issued under Regulation (EU) 2018/1139 and the delegated and implementing acts that are adopted on the basis thereof, may prefer to have a separate manual to avoid duplication.

21.A.145 Resources

Regulation (EU) 2022/201

The production organisation shall demonstrate that:

(a) the facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21.A.165;

(b) with regard to all the necessary airworthiness and environmental protection data:

1. the production organisation holds all data it needs to determine conformity with the applicable design data. Such data may originate from the Agency and from the holder of, or applicant for, the type-certificate, restricted type-certificate or design approval, and may include any exemption granted from the environmental protection requirements;

2. the production organisation has established a procedure to ensure that the airworthiness and environmental protection data are correctly incorporated in its production data;

3. such data are kept up to date and made available to all personnel that need access to such data to perform their duties;

(c) with regard to management and staff:

1. an accountable manager has been appointed by the production organisation with the authority to ensure that, within the organisation, all production is performed to the required standards and that the production organisation is continuously in compliance with the requirements of the production management system referred to in point 21.A.139, and the data and procedures identified in the POE referred to in point 21.A.143;

2. a person or group of persons has/have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Annex, and are identified, together with the extent of their authority; such person or group of persons shall be responsible to the accountable manager and have direct access to him. The person or group of persons shall have the appropriate knowledge, background and experience to discharge their responsibilities;

3. staff at all levels have been given the 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 and environmental protection data matters;

(d) with regard to certifying staff authorised by the production organisation to sign the documents issued under point 21.A.163 within the scope of the terms of approval:

1. they have the appropriate knowledge, background (including other functions in the organisation) and experience to discharge their allocated responsibilities;

2. they are provided with evidence of the scope of their authorisation.

AMC1 21.A.145(a) Resources

ED Decision 2022/021/R

EQUIPMENT AND TOOLS

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 that affect the dimensions and values of products should demonstrate compliance with, and be traceable to, national or international standards.

AMC2 21.A.145(a) Resources

ED Decision 2022/021/R

STAFF NUMBER AND COMPETENCY

(a) Sufficient personnel means that, for each function, according to the nature of the work and the production rate, the organisation has a sufficient number of qualified staff to accomplish all the specified manufacturing tasks and to attest the conformity of such task. The number of staff should be such that the relevant airworthiness considerations may be applied in all areas without any undue pressure.

(b) 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 organisation’s terms of approval.

(c) The organisation should establish and control the competency of the staff that is involved in activities of the organisation, as detailed in the organisation’s terms of approval, in accordance with documented procedures. In addition to the necessary expertise that is related to the job function, the competency of the staff should include an understanding of safety management and human factors (HF) principles, which is appropriate to the staff member’s function and responsibilities in the organisation.

(d) The competency evaluation should include verification, where appropriate, that specific qualification standards have been applied, for example, welding for non-destructive testing (NDT), etc.

(e) To assist in the assessment of competency and to perform the analysis of the training needs, job (job family) descriptions are recommended, which should contain sufficient criteria to enable the required competency assessment throughout the duration of the employment/contract.

(f) The organisation should develop a procedure that describes the process for assessing the competency of the staff. The procedure should specify:

(1) the staff that are responsible for that process;

(2) the means and methods for the initial assessment;

(3) the means and methods for the continuous control of the competency of the personnel, including feedback on their performance;

(4) the action to be taken if the assessment is not satisfactory; and

(5) how to record assessment results.

(g) Adequate initial and recurrent training should be provided in relation to the job function to ensure that staff remain competent. That training should be adapted based on experience that is gained within the organisation (for safety training, refer also to AMC1 21.A.139(c)(5)(i)).

(h) The organisation should record the training that is provided as described in point (g).

GM1 21.A.145(a) Resources

ED Decision 2022/021/R

FACILITIES

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.

GM1 21.A.145(b)(2) Resources

ED Decision 2022/021/R

PRODUCTION DATA

When a production organisation approval (POA) holder or an applicant for a POA is developing its own manufacturing data, such as computer-based data, from the design data package that is delivered by a design organisation, procedures are required to demonstrate the correct transcription of the original design data.

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 should 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 of issuing a statement of conformity or EASA Form 1.

AMC1 21.A.145(c)(1) Resources

ED Decision 2022/021/R

ACCOUNTABLE MANAGER

(a) The accountable manager (AM) should:

(1) have sufficient knowledge and authority to be able to respond to the competent authority regarding major issues concerning the production organisation approval (POA), and to carry out any necessary improvements;

(2) promote the safety policies and objectives that are specified in AMC1 21.A.139(c)(1); and

(3) demonstrate a Part 21 understanding that is sufficient to discharge the relevant responsibilities.

(b) The production organisation exposition (POE) that is submitted in accordance with point 21.A.143 should show that the AM has the direct or functional responsibility for all the departments of the organisation which are involved in the POA. If any of those departments are functionally linked, the AM still has the ultimate responsibility for compliance of the PO with Part 21.

GM1 21.A.145(c)(1) Resources

ED Decision 2022/021/R

ACCOUNTABLE MANAGER

‘Accountable manager’ refers to the manager that is responsible and has corporate authority for ensuring that all production work is performed to the required standard. This function may be carried out by the chief executive officer (CEO) or by another person in the organisation, nominated by the CEO to fulfil the function, provided that the position and authority of that person in the organisation allows that person to discharge the associated responsibilities.

The manager is responsible for ensuring that all necessary resources are available and properly used under the production approval in accordance with Part 21, Section A, Subpart G.

AMC1 21.A.145(c)(2) Resources

ED Decision 2022/021/R

NOMINATED MANAGERS

(a) The person or group of persons nominated in accordance with point 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, Subpart G. Depending on the size of the approved production organisation (PO), 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 that are responsible for:

(1) the independent monitoring function as defined in point 21.A.139(e); and

(2) ensuring the development, administration, and maintenance of effective safety risk management processes as defined in point 21.A.139(c)(3).

(c) If more than one person is designated for the management of the independent monitoring function, the AM should identify a unique focal point, typically known as the ‘quality manager’.

(d) If more than one person is designated for the development, administration, and maintenance of effective safety risk management processes as defined in point 21.A.139(c)(3), the AM should identify a ‘safety manager’ as the unique focal point.

(e) Each nominated manager should be identified and their credentials submitted to the competent authority as a significant change 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 approved PO.

(f) The responsibilities and the duties of each individual manager should be clearly defined in such a way that all the responsibilities are covered.

(g) Where an approved PO chooses to appoint managers for all or for any combination of functions that are the identified in Part 21 because of the size of the undertaking, those managers should ultimately report to the accountable manager. When a manager does not directly report to the accountable manager, that manager should have a direct access to the accountable manager formally established.

(h) The independent monitoring function should be independent from other functions. As such, the quality manager should not be at the same time one of the other persons that are referred to in point 21.A.145(c)(2), except for the safety manager. If the same person is designated to manage both the independent monitoring function and safety-management-related processes and tasks, the accountable manager, in order to discharge their safety accountability, 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.

(i) Quality manager

The role of the quality manager should be to 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 those activities are performed properly under the supervision of the nominated persons that are referred to in point 21.A.145(c)(2);

(2) an audit plan is properly implemented, maintained, and continually reviewed and improved; and

(3) corrections and corrective action are requested, as necessary.

(j) Safety manager

The role of the safety manager should be:

(1) to facilitate hazard identification, as well as risk assessment and management;

(2) to monitor the implementation of action taken to mitigate risks, as listed in the safety action plan, unless action follow-up is addressed by the independent monitoring function;

(3) to provide periodic reports on safety performance to the safety review board (the functions of the safety review board are defined in AMC1 21.A.139(c)(2));

(4) to ensure the maintenance of safety management documentation;

(5) to ensure that there is safety training available, and that it meets acceptable standards;

(6) to provide advice on safety matters; and

(7) to ensure the initiation and follow-up of internal investigations of occurrences.

(k) Subject to a risk assessment and the competent authority’s agreement, 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 performed by the accountable manager, provided that the accountable manager has demonstrated the related level of competency.

AMC2 21.A.145(c)(2) Resources

ED Decision 2022/021/R

MANAGEMENT STAFF COMPETENCIES

(a) The organisation should provide initial and recurrent training to the persons or group of persons that are nominated in accordance with point 21.A.145(c)(2), which is adequate to their job function and ensures that their continued competency is maintained throughout the duration of their employment/contract.

(b) All prospective members of the production management staff and staff that is nominated in accordance with point 21.A.145(c)(2) should:

(1) be assessed for their competency, qualifications, and capabilities that are related to their intended duties;

(2) be able to demonstrate their knowledge of, and compliance with, the production management organisation procedures that are applicable to their job function; and

(3) be able to demonstrate an understanding of the safety management principles, as well as human factors (HF) issues and human performance (HP) issues that are related to their tasks.

(c) The quality manager should be able to demonstrate relevant knowledge, background, and appropriate experience that are related to the activities of the organisation, including knowledge of, and experience in, independent system monitoring.

(d) The competency of the person that assumes (or the persons that assume) the function of the safety manager should include, but not be limited to, the following:

(1) knowledge of the International Civil Aviation Organization (ICAO) standards and EU 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 HF, including HP and limitations;

(6) an understanding of a positive safety culture and of its promotion; and

(7) operational experience related to the activities of the organisation.

AMC1 21.A.145(d)(1) Resources

ED Decision 2022/021/R

CERTIFYING STAFF

(a) Certifying staff should be nominated by the production organisation to ensure that each of their products, parts, and/or appliances qualifies for a statement of conformity or a release certificate. The position and number of certifying staff should be appropriate to the complexity of the product and the production rate.

(b) The qualifications of certifying staff should be based on their knowledge, background and experience and on specific training (or testing) that is established by the organisation to ensure that it is appropriate to the product, part, or appliance to be released.

(c) Training should be given to certifying staff to develop a satisfactory level of knowledge of product/part specifications, the organisation’s procedures, production management systems (including compliance monitoring), aviation legislation, and the associated regulations, AMC and GM, that are relevant to their particular role. Training should include on-the-job training, as relevant.

(d) For that purpose, in addition to the general training policy, the organisation should define its own standards for training, including pre-qualification standards, for personnel to be identified as certifying staff.

(e) A feedback system to ascertain that the required standards are being maintained should be put in place to ensure the continuing compliance of personnel with authorisation requirements.

(f) For the release of products, parts, or appliances, the responsibilities to issue statements of conformity or release certificates (EASA Form 1) or permits to fly, including the approval of flight conditions, are allocated to the certifying staff that is identified in point 21.A.145(d)(2).

AMC1 21.A.145(d)(2) Resources

ED Decision 2022/021/R

EVIDENCE OF AUTHORISATION

(a) The certifying staff should be provided with evidence of their authorisation. This should be done through an internal authorisation document. That document should be in a style that makes its scope clear to the certifying staff and any entitled person that may require to examine the authorisation. It should include the privileges that are granted to the certifying staff and the category of products upon which they may exercise those privileges. Where codes are used to define the scope, an interpretation document should be readily available.

(b) 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 following a request from an entitled person, which includes the competent authority.

21.A.147 Changes in the production management system

Regulation (EU) 2022/201

After the issue of a production organisation approval certificate, each change in the production management system that is significant for the demonstration of conformity or the airworthiness and environmental protection characteristics of the product, part or appliance, shall be approved by the competent authority before being implemented. The production organisation shall submit an application for approval to the competent authority demonstrating that it will continue to comply with this Annex.

AMC1 21.A.147 Changes to the production management system

ED Decision 2022/021/R

APPLICATION FOR APPROVAL OF SIGNIFICANT CHANGES OR VARIATIONS IN THE SCOPE OR TERMS OF A PRODUCTION ORGANISATION APPROVAL

(a) An application for approval of significant changes or variations in the scope or terms of a production organisation approval (POA) should be submitted in writing to the competent authority. The production organisation (PO) should demonstrate to the competent authority, on the basis of the submission of any proposed changes to the production organisation exposition (POE), and before the implementation of the changes, that it will continue to comply with Part 21 after the implementation.

(b) The approved PO should submit to the competent authority an application for any significant change(s), or for a variation in the scope or terms of its POA, using an EASA Form 51 (see below).

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’ 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 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’ if no change is anticipated.

Block 5: This block should state the changes to the organisation as it is defined in the current POE, 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). State ‘not applicable’ if no change is anticipated.

Block 6: State the position and name of the accountable manager. Where there is a change in the nomination of the accountable manager, the information should refer to the nominee for that position. State ‘not applicable’ 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 that position. In all other cases, EASA Form 51 should be signed by the accountable manager.

GM1 21.A.147 Changes to the production management system

ED Decision 2022/021/R

SIGNIFICANT CHANGES

Changes to be approved by the competent authority include:

—      significant changes to the production capacity or methods;

—      changes in the organisation's structure, especially those parts of the organisation in charge of quality and safety;

—      a change of the accountable manager or of any other person that is nominated under point 21.A.145(c)(2);

—      changes in the production management system that may have an important impact on the conformity orairworthiness of any product, part, or appliance, including in the reporting lines between the personnel that is nominated in accordance with point 21.A.145(c)(2) and the accountable manager; and

—      changes in the placement or control of significant subcontracted work or supplied parts.

To ensure that changes do not result in non-compliance with Part 21, 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)).

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.

Changes of location are addressed in point 21.A.148, changes of ownership in point 21.A.149, and the change of scope of the approval in point 21.A.153.

21.A.148 Changes of location

Regulation (EU) No 748/2012

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.

AMC 21.A.148 Changes of location – Management during change of location

ED Decision 2012/020/R

1. The relocation of any work, to an unapproved location, or a location with inappropriate scope of approval, constitutes a change of significance to the organisation and requires approval by the competent authority as prescribed in 21.A.147. An unapproved relocation will invalidate the production organisation approval, and may necessitate re-application for any similar approval required at the new location. However, suitable transitional arrangements may be agreed with the competent authority, in advance of the relocation, which can allow continuation of the approval.

2. When an organisation expands its facility to include a new production location or moves parts of its production to a new location the production organisation approval may continue in force, but the approval does not include the new location until the competent authority has indicated its satisfaction with the arrangements.

3. For a change in location, taking an extended period of time, suitable transitional arrangements would require preparation of a co-ordination plan for the removal. The plan must, at least, identify the following:

(a) A clearly identified person, or group of persons, responsible for co-ordinating the removal and acting as focal point for communication with all parties, including the competent authority.

(b) The basis of the co-ordination plan, e.g., whether by product or area.

(c) Planned timing of each phase of relocation.

(d) Arrangements for maintaining the standards of the approval up to the point where the production area is closed down.

(e) Arrangements for verifying continued production quality upon resumption of work at the new location.

(f) Arrangements for check and/or re-calibration of inspection aids or production tools and jigs before resuming production.

(g) Procedures which ensure that goods are not released from the new location until their associated production and quality systems have been verified.

(h) Arrangements for keeping the competent authority informed of progress with the relocation.

4. From the co-ordination plan, the competent authority can determine the points at which it wishes to conduct investigation.

5. If an agreed co-ordination plan is in operation, the competent authority will normally allow the existing approval to remain in force and will, where appropriate, grant an additional approval to cover the new address for the duration of the move.

GM-ELA No 1 to 21.A.148  Changes of location

ED Decision 2019/003/R

A change of location of the major place of activities to a different geographic location, city, airfield or similar is deemed to be of significance, and is treated in line with GM-ELA No 1 to 21.A.147.

No other changes related to the location of the company, including a relocation within one building, or to a neighbouring building on the same premises, or similar, are considered to be of significance, as long as the parameters that are critical to the environment, infrastructure or equipment remain the same, and are under the responsibility of the accountable manager (AM). Any other alterations will be addressed during the subsequent periodical authority oversight.

21.A.149 Transferability

Regulation (EU) No 748/2012

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.

GM1 21.A.149 and 21.A.249 Transferability

ED Decision 2022/021/R

GENERAL

A transfer of approval to another production or design organisation is, by default, excluded by points 21.A.149 or 21.A.249 respectively. These points only allow it exceptionally if it is a direct consequence of a transfer of ownership in an approved production or design organisation, which is then considered a significant change to the existing approval (to which point 21.A.147 or 21.A.247 applies).

As a consequence, and in order to apply this exception, the production or design organisation has to demonstrate to the competent authority the existence of a change in ownership which resulted in the fact that a different legal entity is now conducting the approved production or design functions while remaining effectively unchanged.

An example of such an exception is a change of ownership that leads to a re-registration of the organisation (supported by the appropriate certificate from the National Companies Registration Office or equivalent). In order to demonstrate that the organisation remains effectively unchanged, the organisation needs to demonstrate that there are no changes affecting the initial demonstration of compliance of the organisation with Subpart G or Subpart J. If, for instance, the change of ownership would, in addition, lead to a change of address, facilities, type of work, staff, accountable manager or persons nominated under points 21.A.145 or 21.A.245, then it is not an acceptable transfer situation; the exception does not apply in this case. A new investigation by the competent authority would be necessary. The new organisation would have to apply for its own approval. In such a case where the organisation applies for a new approval, the demonstration of compliance in accordance with points 21.A.135 or 21.A.235 may be limited to the demonstration that the changes in the organisation comply with the Subpart G or Subpart J requirements, while referring for the rest to the compliance demonstration of the previous approval holder.

A pure name change, where the ownership does not change, does not require a transfer of the approval. In this case, the natural or legal person that holds the approval remains the same. However, as a consequence of the name change, the approval document needs to be amended to reflect the new company name. This is a significant change, to which point 21.A.147 or 21.A.247 applies.

Another example of a transfer of ownership, which may be exceptionally accepted under points 21.A.149 or 21.A.249, may be the event of receivership (bankruptcy, insolvency or another equivalent legal process). In this case, there is no change to the production or design organisation, except that the custodial responsibility for its property, including its tangible and intangible assets and rights, is transferred to a receiver or insolvency administrator. The receivership aims to continue the business of the same organisation.

21.A.151 Terms of approval

Regulation (EU) No 748/2012

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.

GM 21.A.151 Terms of approval – Scope and categories

ED Decision 2012/020/R

Terms of approval document(s) will be issued by the competent authority under 21.A.135 to identify the scope of work, the products, and/or categories for which the holder is entitled to exercise the privileges defined in 21.A.163.

The codes shown against each scope of work item are intended for use by the competent authority for purposes such as managing, administering and filing details of approvals. It may also assist in the production and publication of a list of approval holders.

The scope of work, the Products, Parts, or Appliances for which the POA holder is entitled to exercise the privileges defined in 21.A.163 will be described by the competent authority as follows:

FOR PRODUCTS:

1. General area, similar to the titles of the corresponding certification codes.

2. Type of Product, in accordance with the type-certificate.

FOR PARTS AND APPLIANCES:

1. General area, showing the expertise, e.g., mechanical, metallic structure.

2. Generic type, e.g., wing, landing gear, tyres.

21.A.153 Changes to the terms of approval

Regulation (EU) No 748/2012

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.

AMC 21.A.153 Changes to the terms of approval — Application for a change to the terms of approval

ED Decision 2022/021/R

EASA Form 51 (see AMC1 21.A.147) must be obtained from the competent authority and completed in accordance with the procedures of the production organisation exposition (POE).

The information entered on the form is the minimum required by the competent authority to assess the need for change of the production organisation approval.

The completed form and an outline of the changed POE, and details of the proposed change to POA terms of approval should be forwarded to the competent authority.

AMC-ELA No 1 to 21.A.153 Changes to the terms of approval — Application for a change to the terms of approval

ED Decision 2022/021/R

EASA Form 51 (see AMC1 21.A.147) should be obtained from the competent authority and completed in accordance with the instructions provided by the competent authority. The information entered on the form is needed by the competent authority in order to assess whether the production organisation approval (POA) is to be amended. The completed form should be forwarded to the competent authority. The applicant and the competent authority can agree on whether the assessment for a change in approval can be completed via a desktop audit or through a surveillance audit.

21.A.158 Findings and observations

Regulation (EU) 2022/201

(a) After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:

1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;

2. define a corrective action plan;

3. demonstrate the implementation of the corrective action to the satisfaction of the competent authority.

(b) The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.225.

(c) The observations received in accordance with 21.B.225(e) shall be given due consideration by the holder of the production organisation approval certificate. The organisation shall record the decisions taken in respect of those observations.

GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings and observations

ED Decision 2022/021/R

ROOT CAUSE 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(s) of 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 (human factors (HF), regulatory, organisational, technical factors, 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 considered to prevent reoccurrence will be ignored.

Such an inappropriate or partial root cause analysis often leads to applying ‘quick fixes’ that only address the symptoms of the non-compliance. A peer review of the results of the root cause analysis may increase its reliability and objectivity.

AMC1 21.A.125B(a)(3), 21.A.158(a)(3) and 21.A.258(a)(3) Findings and observations

ED Decision 2022/021/R

FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION

After receipt of notification of findings, the organisation should identify and define the action for all findings, to address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s).

Depending on the issues identified, the organisation may need to take immediate corrective action.

The corrective action plan should:

—      include the correction of the issue, corrective and preventive action, as well as the planning to implement them; and

—      be timely submitted to the competent authority for acceptance before it is effectively implemented.

After receiving the competent authority’s acceptance of the corrective action plan, the organisation should implement the associated action.

Within the agreed period, the organisation should inform the competent authority that the corrective action plan has been implemented and should send the associated pieces of evidence, on request from the competent authority.

AMC1 21.A.125B(c), 21.A.158(c), 21.A.258(c) Findings and observations

ED Decision 2022/021/R

DUE CONSIDERATION TO OBSERVATIONS

For each observation that is notified by the competent authority, the organisation should analyse the related issues and determine when action is needed.

The handling of the observations may follow a process similar to the handling of the findings by the organisation.

The organisation should record the analysis and the related outputs, such as action taken, or the reasons why no action was taken.

21.A.159 Duration and continued validity

Regulation (EU) 2022/201

(a) A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions:

1. the production organisation continues to comply with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts;

2. the competent authority is permitted by the production organisation or by any of its partners, suppliers or subcontractors to perform the investigations in accordance with point 21.A.9;

3. the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the approval;

4. the production organisation approval certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the production organisation.

(b) Upon surrender or revocation, the production organisation approval certificate shall be returned to the competent authority.

GM 21.A.159(a)(3) Evidence of a lack of satisfactory control

ED Decision 2012/020/R

A positive finding by the competent authority of:

1. an uncontrolled non-compliance with type design data affecting the airworthiness of product part or appliance

2. an incident/accident identified as caused by POA holder

3. non-compliance with the POE and its associated procedures which could affect conformity of manufactured items to design data

4. insufficient competence of certifying staff

5. insufficient resources in respect of facilities, tools and equipment

6. insufficient means to ensure good production work standards

7. a lack of effective and timely response to prevent a recurrence of any of point 1 to 6.

21.A.163 Privileges

Regulation (EU) No 748/2012

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) without further showing;

(d) maintain a new aircraft that it has produced and issue a certificate of release to service (EASA Form 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).

GM1 21.A.130, 21.A.163 and 21.A.165 Performance of tasks in real time for the issuance of an ‘EASA Form 1’ for prototype and new parts, appliances and products other than complete aircraft, using information and communication technologies (ICT)

ED Decision 2021/007/R

This GM provides technical guidance on the use of remote ICT to support the issuance of an ‘EASA Form 1’ for prototype and newly produced parts, appliances and products other than complete aircraft.

It is the responsibility of the production organisation to assess whether the use of remote ICT constitutes a suitable alternative to the physical inspection of the part, appliance or product in accordance with the applicable requirements. The production organisation that intends to use the remote ICT for such purposes should first discuss the feasibility aspects with its competent authority.

(a) Terminology

In the context of this GM, the following terminology is used:

—      ‘issue of an EASA Form 1’ means the issuance of an EASA Form 1 under Part 21 Subpart G by a certifying staff, raise an EASA Form 1 under Part 21 Subpart F by an authorised person, and the validation of an EASA Form 1 under Part 21 Subpart F by a competent authority inspector, except in the case of issuance of an EASA Form 1 for the correction of error(s) on a previously issued certificate and for the recertification of an item from ‘prototype’ to ‘new’ provided that the design data has not changed;

—      ‘authorised staff’ means certifying staff as defined in Part 21 Subpart G, and ‘authorised person’ and ‘competent authority inspector’ as defined in Part 21 Subpart F;

—      ‘item’ means any part, appliance or product other than a complete aircraft;

—      ‘applicable design data’ means non-approved design data for a prototype item and approved design data for a newly produced item;

—      ‘task’ means any inspection, test and/or verification, as described in a documented procedure, which is needed to be performed by an authorised staff before signing an EASA Form 1;

—      ‘remote ICT’ means any real-time video and audio communication tools using information and communication technologies (ICT) whose aim is to enable the performance of the task(s) by the authorised staff from a location different from that where the item is located (on-site).

(b) Regulatory context

The following entities may issue an EASA Form 1 for produced items in order to certify their conformity to the applicable design data and, for new items, their condition for safe operation:

—      the holder of a letter of agreement (LoA) that is issued in accordance with Part 21 Subpart F (refer to point 21.A.130(a));

—      the competent authority in the context of Part 21 Subpart F (refer to point 21.A.130(d));

—      the holder of a production organisation approval (POA) in accordance with Part 21 Subpart G (refer to point 21.A.163(c)).

An EASA Form 1 has to be issued by appropriately qualified authorised staff. Part 21 does not require authorised staff to be on-site when issuing an EASA Form 1, nor how the production organisation and the competent authority shall determine whether the part/appliance/product other than a complete aircraft conforms to the applicable design data and, for a new item, is in a condition for safe operation. These should be detailed in a documented procedure accepted by the competent authority.

Part 21 requires:

—      in point 21.A.130(d) that the competent authority validate the EASA Form 1 following inspections performed in accordance with 21.B.135(b) if it finds after the inspection that the product, part or appliance conforms to the applicable design data and is in condition for safe operation;

—      in point 21.A.165(c) that the POA holder has to 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;

—      other products, parts or appliances conform to the applicable data before issuing an EASA Form 1.

Typically, compliance with these requirements is ensured through the on-site presence of the authorised staff in order to guarantee they have appropriate access to the item, as needed.

However, compliance with these requirements may be also ensured in certain circumstances, determined as per the considerations described in point (c) below, by remotely conducting the tasks which are needed before the issuance of an EASA Form 1 by the use of remote ICT. The following considerations should be used as guidelines when the on-site presence of the authorised staff is to be replaced by virtual presence, using remote ICT.

(c) The use of remote ICT to support the issuance of an EASA Form 1

Remote ICT may have limitations that could render it unsuitable for some applications. Accordingly, careful consideration and risk management should be applied when determining when to use remote ICT. These considerations, listed below, are however not exhaustive and should not be treated as a checklist.

(1) General considerations

—      As an overarching principle, it needs to be determined whether the nature of the tasks to be performed by the authorised staff allows the use of remote ICT.

—      The facility where the item is located:

—      should be referred to in EASA Form 65 or EASA Form 55, directly or indirectly by reference to the corresponding section of the manual or production organisation exposition (POE); or

—      for a POA, should be a facility from where a POE procedure related to point 21.A.139(b)(1)(xv) authorises the issuance of an EASA Form 1.

—      The complexity, novelty and safety criticality of the item to be released with the EASA Form 1 should be taken into account.

—      The level of competence and experience of the personnel in the use of the particular procedures and equipment that will be used to perform the tasks before issuing EASA Form 1.

—      Previous experience of the organisation / confidence in the organisation’s inspection system / quality system / management system.

—      The appropriateness of the inspection and test instruments and/or equipment, especially if used to evaluate qualitative aspects of a product, part or appliance.

(2) Equipment and set-up considerations

—      The suitability of video resolution, fidelity, and field of view for the task being performed.

—      The need for multiple cameras, imaging systems or microphones, and whether the person that performs or witnesses the tasks can switch between them, or direct them to be switched, and has the possibility to stop the process, ask a question, move the equipment, etc.

—      The controllability of viewing direction, zoom, and lighting.

—      The appropriateness of audio fidelity for the evaluation being conducted.

—      Whether real-time, uninterrupted communication between the person(s) authorised to remotely witness the activity (authorised staff) and the personnel performing it exists at the location where the item is located.

—      The need for unique testing devices or equipment (for example, fast-frame cameras, special lighting conditions, sensitive listening devices, mobile phones with cameras for HD video calls).

—      Whether personnel have been adequately trained in the proper set-up, validation and use of the technology, tools and/or equipment to be used.

—      The need for the recording of audio and video data, as well for its retention or for the retention of other information.

(3) Cybersecurity considerations

There are cases where the facilities where the tasks have to be performed are subject to strict security limitations. When using remote ICT for the tasks needed before issuing an EASA Form 1, it is the responsibility of the organisation to provide an equivalent level of security, therefore the person that is responsible for IT security within the organisation should concur to the ICT technology before proceeding.

(4) Documenting the use of the remote ICT

The documented processes (procedures) developed by the holder of a letter of agreement (LoA) or a POA should be accepted by the competent authority, and should describe the following:

—      the risk assessment process required to determine the appropriateness of the remote ICT taking into account the above-mentioned considerations;

—      the tasks to be performed, including preparation activities, inspections, tests, verifications to be done, personnel involved in the remote ICT activities and their level of competence;

—      that it is necessary to guarantee that authorised staff have access to all necessary data (e.g. drawings, schematics, datasheets, etc.) they require in order to determine that the item conforms to the applicable design data, and how this can be ensured;

—      how remote ICT will be used in real time (not pre-recorded) so that authorised staff may direct the performance of the tasks as if it were conducted in-person, on-site, with the aid of the equipment or the personnel supporting the activity at the remote location;

—      the procedures for conducting a reinspection in case the equipment malfunctions or the process fails to yield acceptable results; a reinspection using remote ICT may be accomplished after correcting the malfunction or process, or by an actual on‑site inspection;

—      how authorised staff should record and communicate any difficulties or concerns regarding the process so that the organisation can improve its programme;

—      how the use of the remote ICT will be documented in the required records; and

—      how the organisation’s IT security is ensured throughout the remote ICT process (data protection and intellectual property of the organisation also need to be safeguarded).

AMC No 1 to 21.A.163(c) Computer generated signature and electronic exchange of the EASA Form 1

ED Decision 2012/020/R

1. Submission to the competent authority

Any POA holder/applicant intending to implement an electronic signature procedure to issue EASA Form 1 and/or to exchange electronically such data contained on the EASA Form 1, should document it and submit it to the competent authority as part of the documents attached with its exposition.

2. Characteristics of the electronic system generating the EASA Form 1

The electronic system should:

—      guarantee secure access for each certifying staff;

—      ensure integrity and accuracy of the data certified by the signature of the Form and be able to show evidence of the authenticity of the EASA Form 1 (recording and record keeping) with suitable security, safeguards and backups;

—      be active only at the location where the part is being released with an EASA Form 1;

—      not permit to sign a blank form;

—      provide a high degree of assurance that the data has not been modified after signature (if modification is necessary after issuance, i.e. re-certification of a part), a new form with a new number and reference to the initial issuance should be made); and

—       provide for a ‘personal’ electronic signature, identifying the signatory. The signature should be generated only in the presence of the signatory.

An electronic signature means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication and should meet the following criteria:

—      it is uniquely linked to the signatory;

—      it is capable of identifying the signatory;

—      it is created using means that the signatory can maintain under their sole control.

The electronic signature is defined as an electronically generated value based on a cryptographic algorithm and appended to data in a way to enable the verification of the data’s source and integrity.

POA holders/applicants are reminded that additional national and/or European requirements may need to be satisfied when operating electronic systems. ‘Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures’, as last amended may constitute a reference.

The electronic system should be based on a policy and management structure (confidentiality, integrity and availability), such as:

—      administrators, signatories;

—       scope of authorisation, rights;

—       password and secure access, authentication, protections, confidentiality;

—       track changes;

—       minimum blocks to be completed, completeness of information;

—       archives;

—       etc.

The electronic system generating the EASA Form 1 may contain additional data such as:

—       manufacturer code;

—       customer identification code;

—       workshop report;

—       inspection results;

—       etc.

3. Characteristics of the computer generated signature

To facilitate understanding and acceptance of the EASA Form 1 released with an electronic signature, the following statement should be in Block 13b: ‘Electronic Signature on File’.

In addition to this statement, it is accepted to print or display a signature in any form such as a representation of the hand-written signature of the person signing (i.e. scanned signature) or their name.

When printing the electronic form, the EASA Form 1 should meet the general format as specified in Appendix I to Part 21. A watermark-type ‘PRINTED FROM ELECTRONIC FILE’ should be printed on the document.

When the electronic file contains a hyperlink to data, required to determine the airworthiness of the item(s), the data associated to the hyperlink, when printed, should be in a legible format and be identified as a reference from the EASA Form 1.

Additional information not required by the EASA Form 1 completion instructions may be added to the printed copies of EASA Form 1 as long as the additional data do not prevent a person from filling out, issuing, printing, or reading any portion of the EASA Form 1. This additional data should be provided only in block 12 unless it is necessary to include it in another block to clarify the content of that block.

4. Electronic exchange of the electronic EASA Form 1

The electronic exchange of the electronic EASA Form 1 should be accomplished on a voluntary basis. Both parties (issuer and receiver) should agree on electronic transfer of the EASA Form 1.

For that purpose, the exchange needs to include:

—       all data of the EASA Form 1, including data referenced from the EASA Form 1;

—       all data required for authentication of the EASA Form 1.

In addition, the exchange may include:

—       data necessary for the electronic format;

—       additional data not required by the EASA Form 1 completion instructions, such as manufacturer code, customer identification code.

The system used for the exchange of the electronic EASA Form 1 should provide:

—      a high level of digital security; the data should be protected, unaltered or uncorrupted;

—      traceability of data back to its source should be possible.

Trading partners wishing to exchange EASA Form 1 electronically should do so in accordance with these means of compliance stated in this document. It is recommended that they use an established, common, industry method such as Air Transport Association (ATA) Spec 2000 Chapter 16.

The applicant(s) is/are reminded that additional national and/or European requirements may need to be satisfied when operating the electronic exchange of the electronic EASA Form 1.

The receiver should be capable of regenerating the EASA Form 1 from the received data without alteration; if not the system should revert back to the paper system.

When the receiver needs to print the electronic form, refer to the subparagraph 3 above.

AMC2 21.A.163(c) Completion of EASA Form 1

ED Decision 2021/011/R

EASA Form 1 Block 8 ‘Part Number’

The part number as it appears on the item, is usually defined in the design data; however in the case of a kit of parts, media containing software or any other specific condition of supply may be defined in production data developed from design data. Information about the contents of the kit or media may be given in block 12 or in a separate document cross-referenced from block 12.

EASA Form 1 Block 12 ‘Remarks’

Examples of conditions which would necessitate statements in Block 12 are:

—      When the certificate is used for prototype purposes the following statement must be entered at the beginning of block 12:

‘NOT ELIGIBLE FOR INSTALLATION ON IN-SERVICE TYPE-CERTIFICATED AIRCRAFT’.

—      Re-certification of items from ‘prototype’ (conformity only to non-approved data) to ‘new’ (conformity to approved data and in a condition for safe operation) once the applicable design data is approved.

The following statement must be entered in block 12:

RE-CERTIFICATION OF ITEMS FROM ‘PROTOTYPE’ TO ‘NEW’:

THIS DOCUMENT CERTIFIES THE APPROVAL OF THE DESIGN DATA [insert TC/STC number, revision level], DATED [insert date if necessary for identification of revision status], TO WHICH THIS ITEM (THESE ITEMS) WAS (WERE) MANUFACTURED.

—      When a new certificate is issued to correct error(s) the following statement must be entered in block 12:

‘THIS CERTIFICATE CORRECTS THE ERROR(S) IN BLOCK(S) [enter block(s) corrected] OF THE CERTIFICATE [enter original tracking number] DATED [enter original issuance date] AND DOES NOT COVER CONFORMITY/ CONDITION/RELEASE TO SERVICE’.

Examples of data to be entered in this block as appropriate:

—      For complete engines, a statement of compliance with the applicable emissions requirements current on the date of manufacture of the engine.

—      For ETSO articles, state the applicable ETSO number.

—      Modification standard.

—      Compliance or non-compliance with airworthiness directives or service bulletins.

—      Details of repair work carried out, or reference to a document where this is stated.

—      Shelf-life data, manufacture date, cure date, etc.

—      Information needed to support shipment with shortages or reassembly after delivery.

—      References to aid traceability, such as batch numbers.

—      In the case of an engine, if the competent authority has granted an exemption from the applicable engine environmental protection requirements, the record: ‘Engine exempted from [reference to the type of emission] emissions environmental protection requirement’.

AMC-ELA No 1 to 21.A.163(c)  Privileges to issue authorised release certificates

ED Decision 2019/003/R

Block 12 on any issued EASA Form 1 is filled with the following statement:

‘ELIGIBLE ONLY FOR INSTALLATION ON AIRCRAFT THAT ARE NOT CLASSIFIED AS COMPLEX MOTOR POWERED AIRCRAFT, AND THAT ARE EITHER AEROPLANES WITHIN THE SCOPE OF CS-LSA, CS VLA OR CS-23 LEVEL 1, OR SAILPLANES OR POWERED SAILPLANES WITHIN THE SCOPE OF CS-22, OR BALLOONS, HOT AIR AIRSHIPS OR GAS AIRSHIPS THAT ARE ELA2 AIRCRAFT.’

AMC1 21.A.163(d) Privileges

ED Decision 2021/001/R

MAINTENANCE

The applicant may apply for terms of approval, which cover maintenance of a new aircraft that it has manufactured, as necessary to keep it in an airworthy condition, but not beyond the point at which the applicable operational rules require maintenance to be performed by an approved maintenance organisation. If the production organisation intends to maintain the aircraft beyond that point, it would have to apply for and obtain an appropriate maintenance approval.

When the competent authority is satisfied that the procedures required by 21.A.139 are satisfactory to control maintenance activities so as to ensure that the aircraft is airworthy, this capability will be stated in the terms of approval.

MAINTENANCE OF AIRCRAFT

Examples of such maintenance activities are:

—      Preservation, periodic inspection visits, etc.

—      Embodiment of a Service Bulletin.

—      Application of airworthiness directives.

—      Repairs.

—      Maintenance tasks resulting from special flights.

—      Maintenance tasks to maintain airworthiness during flight training, demo flights and other non-revenue flights.

Any maintenance activities must be recorded in the Aircraft Log Book. It must be signed by certifying staff for attesting the conformity of the work to the applicable airworthiness data.

In some cases the Aircraft Log Book is not available, or the production organisation prefers to use a separate form (for instance for a large work package or for delivery of the aircraft to the customer). In these cases, production organisations must use EASA Form 53 which must subsequently become part of the aircraft maintenance records.

MAINTENANCE OF COMPONENTS OUTSIDE THE POA CAPABILITY

Such a maintenance activity outside the capability of the aircraft POA holder may still be accomplished under the production approval of the original release organisation. In such circumstances, the engine(s), propeller(s), parts and appliances will require re-release in accordance with point 21.A.163(c) (EASA Form 1).

Records relevant to continued airworthiness or retirement lives, such as engine runs, flight hours, landings, etc., which affect part retirement of maintenance schedules must be specified on any re-release.

As an alternative the engine, propeller, part or appliance may be maintained by the holder of an approval in accordance with Part 145, classified and released as ‘used’.

AMC 21.A.163(e) Procedure for the issue of a permit to fly including approval of the flight conditions

ED Decision 2012/020/R

1. INTENT

This acceptable means of compliance provides means to develop a procedure for the issue of a permit to fly including approval of the flight conditions.

Each POA applicant or holder must develop its own internal procedure following this AMC, in order to obtain the privilege of 21.A.163(e) to issue permits to fly for an aircraft under procedures agreed with its competent authority for production, 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.

2.  PROCEDURE FOR THE ISSUE OF A PERMIT TO FLY

2.1  Content

The procedure must address the following points:

—      as relevant, in accordance with 21.A.710(b), the approval of flight conditions;

—      conformity with approved conditions;

—      issue of the permit to fly under the POA privilege;

—      authorised signatories;

—      interface with the local authority for the flight.

2.2 Approval of the flight conditions (when relevant)

The procedure must include the process to establish and justify the flight conditions, in accordance with 21.A.708 and how compliance with 21.A.710(c) is established, and include the EASA Form 18B as defined in AMC 21.A.709(b) for the approval under the POA privilege.

2.3 Conformity with approved conditions

The procedure must indicate how conformity with approved conditions is made, documented and attested by an authorised person.

2.4  Issue of the permit to fly under the POA privilege

The procedure must describe the process to prepare the EASA Form 20b and how compliance with 21.A.711(c) and (e) is established before signature of the permit to fly.

2.5  Authorised signatories

The person(s) authorised to sign the permit to fly under the privilege of 21.A.163(e) must be identified (name, signature and scope of authority) in the procedure, or in an appropriate document linked to the Production Organisation Exposition.

2.6  Interface with the local authority for the flight

The procedure must include provisions describing the communication with the local authority for compliance with the local requirements which are outside the scope of the conditions of 21.A.708(b) (see 21.A.711(e)).

21.A.165 Obligations of the holder

Regulation (EU) 2022/201

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 condition for safe operation;

3. Additionally, in the case of environmental requirements determine that:

(i) the completed engine is in compliance with the applicable engine exhaust emissions requirements on the date of manufacture of the engine; and

(ii) the completed aeroplane is in compliance with the applicable CO₂ emissions requirements on the date its first certificate of airworthiness is issued.

4. determine that other products, parts or appliances conform to the applicable data before issuing an EASA Form 1 as a conformity certificate.

(d) provide assistance to the holder of the type-certificate or other design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;

(e) where, under its terms of approval, the holder of a production organisation approval intends to issue a certificate of release to service, determine, prior to issuing the certificate, that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation;

(f) where applicable, under the privilege set out in point 21.A.163(e), determine the conditions under which a permit to fly can be issued;

(g) where applicable, under the privilege set out in point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing an aircraft with a permit to fly;

(h) comply with Subpart A of this Section.

GM1 21.A.130, 21.A.163 and 21.A.165 Performance of tasks in real time for the issuance of an ‘EASA Form 1’ for prototype and new parts, appliances and products other than complete aircraft, using information and communication technologies (ICT)

ED Decision 2021/007/R

This GM provides technical guidance on the use of remote ICT to support the issuance of an ‘EASA Form 1’ for prototype and newly produced parts, appliances and products other than complete aircraft.

It is the responsibility of the production organisation to assess whether the use of remote ICT constitutes a suitable alternative to the physical inspection of the part, appliance or product in accordance with the applicable requirements. The production organisation that intends to use the remote ICT for such purposes should first discuss the feasibility aspects with its competent authority.

(a) Terminology

In the context of this GM, the following terminology is used:

—      ‘issue of an EASA Form 1’ means the issuance of an EASA Form 1 under Part 21 Subpart G by a certifying staff, raise an EASA Form 1 under Part 21 Subpart F by an authorised person, and the validation of an EASA Form 1 under Part 21 Subpart F by a competent authority inspector, except in the case of issuance of an EASA Form 1 for the correction of error(s) on a previously issued certificate and for the recertification of an item from ‘prototype’ to ‘new’ provided that the design data has not changed;

—      ‘authorised staff’ means certifying staff as defined in Part 21 Subpart G, and ‘authorised person’ and ‘competent authority inspector’ as defined in Part 21 Subpart F;

—      ‘item’ means any part, appliance or product other than a complete aircraft;

—      ‘applicable design data’ means non-approved design data for a prototype item and approved design data for a newly produced item;

—      ‘task’ means any inspection, test and/or verification, as described in a documented procedure, which is needed to be performed by an authorised staff before signing an EASA Form 1;

—      ‘remote ICT’ means any real-time video and audio communication tools using information and communication technologies (ICT) whose aim is to enable the performance of the task(s) by the authorised staff from a location different from that where the item is located (on-site).

(b) Regulatory context

The following entities may issue an EASA Form 1 for produced items in order to certify their conformity to the applicable design data and, for new items, their condition for safe operation:

—      the holder of a letter of agreement (LoA) that is issued in accordance with Part 21 Subpart F (refer to point 21.A.130(a));

—      the competent authority in the context of Part 21 Subpart F (refer to point 21.A.130(d));

—      the holder of a production organisation approval (POA) in accordance with Part 21 Subpart G (refer to point 21.A.163(c)).

An EASA Form 1 has to be issued by appropriately qualified authorised staff. Part 21 does not require authorised staff to be on-site when issuing an EASA Form 1, nor how the production organisation and the competent authority shall determine whether the part/appliance/product other than a complete aircraft conforms to the applicable design data and, for a new item, is in a condition for safe operation. These should be detailed in a documented procedure accepted by the competent authority.

Part 21 requires:

—      in point 21.A.130(d) that the competent authority validate the EASA Form 1 following inspections performed in accordance with 21.B.135(b) if it finds after the inspection that the product, part or appliance conforms to the applicable design data and is in condition for safe operation;

—      in point 21.A.165(c) that the POA holder has to 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;

—      other products, parts or appliances conform to the applicable data before issuing an EASA Form 1.

Typically, compliance with these requirements is ensured through the on-site presence of the authorised staff in order to guarantee they have appropriate access to the item, as needed.

However, compliance with these requirements may be also ensured in certain circumstances, determined as per the considerations described in point (c) below, by remotely conducting the tasks which are needed before the issuance of an EASA Form 1 by the use of remote ICT. The following considerations should be used as guidelines when the on-site presence of the authorised staff is to be replaced by virtual presence, using remote ICT.

(c) The use of remote ICT to support the issuance of an EASA Form 1

Remote ICT may have limitations that could render it unsuitable for some applications. Accordingly, careful consideration and risk management should be applied when determining when to use remote ICT. These considerations, listed below, are however not exhaustive and should not be treated as a checklist.

(1) General considerations

—      As an overarching principle, it needs to be determined whether the nature of the tasks to be performed by the authorised staff allows the use of remote ICT.

—      The facility where the item is located:

—      should be referred to in EASA Form 65 or EASA Form 55, directly or indirectly by reference to the corresponding section of the manual or production organisation exposition (POE); or

—      for a POA, should be a facility from where a POE procedure related to point 21.A.139(b)(1)(xv) authorises the issuance of an EASA Form 1.

—      The complexity, novelty and safety criticality of the item to be released with the EASA Form 1 should be taken into account.

—      The level of competence and experience of the personnel in the use of the particular procedures and equipment that will be used to perform the tasks before issuing EASA Form 1.

—      Previous experience of the organisation / confidence in the organisation’s inspection system / quality system / management system.

—      The appropriateness of the inspection and test instruments and/or equipment, especially if used to evaluate qualitative aspects of a product, part or appliance.

(2) Equipment and set-up considerations

—      The suitability of video resolution, fidelity, and field of view for the task being performed.

—      The need for multiple cameras, imaging systems or microphones, and whether the person that performs or witnesses the tasks can switch between them, or direct them to be switched, and has the possibility to stop the process, ask a question, move the equipment, etc.

—      The controllability of viewing direction, zoom, and lighting.

—      The appropriateness of audio fidelity for the evaluation being conducted.

—      Whether real-time, uninterrupted communication between the person(s) authorised to remotely witness the activity (authorised staff) and the personnel performing it exists at the location where the item is located.

—      The need for unique testing devices or equipment (for example, fast-frame cameras, special lighting conditions, sensitive listening devices, mobile phones with cameras for HD video calls).

—      Whether personnel have been adequately trained in the proper set-up, validation and use of the technology, tools and/or equipment to be used.

—      The need for the recording of audio and video data, as well for its retention or for the retention of other information.

(3) Cybersecurity considerations

There are cases where the facilities where the tasks have to be performed are subject to strict security limitations. When using remote ICT for the tasks needed before issuing an EASA Form 1, it is the responsibility of the organisation to provide an equivalent level of security, therefore the person that is responsible for IT security within the organisation should concur to the ICT technology before proceeding.

(4) Documenting the use of the remote ICT

The documented processes (procedures) developed by the holder of a letter of agreement (LoA) or a POA should be accepted by the competent authority, and should describe the following:

—      the risk assessment process required to determine the appropriateness of the remote ICT taking into account the above-mentioned considerations;

—      the tasks to be performed, including preparation activities, inspections, tests, verifications to be done, personnel involved in the remote ICT activities and their level of competence;

—      that it is necessary to guarantee that authorised staff have access to all necessary data (e.g. drawings, schematics, datasheets, etc.) they require in order to determine that the item conforms to the applicable design data, and how this can be ensured;

—      how remote ICT will be used in real time (not pre-recorded) so that authorised staff may direct the performance of the tasks as if it were conducted in-person, on-site, with the aid of the equipment or the personnel supporting the activity at the remote location;

—      the procedures for conducting a reinspection in case the equipment malfunctions or the process fails to yield acceptable results; a reinspection using remote ICT may be accomplished after correcting the malfunction or process, or by an actual on‑site inspection;

—      how authorised staff should record and communicate any difficulties or concerns regarding the process so that the organisation can improve its programme;

—      how the use of the remote ICT will be documented in the required records; and

—      how the organisation’s IT security is ensured throughout the remote ICT process (data protection and intellectual property of the organisation also need to be safeguarded).

AMC-ELA No 1 to 21.A.165(a);(b)  Obligations of the holder – Basic working document

ED Decision 2019/003/R

The organisation should ensure that its personnel have access to, and are familiar with, the parts of the organisation’s procedures that are applicable to their activities. This may be done, for example, by providing information to the personnel when updates of the documentation become available, or by making the changed documentation available at a location where the information is accessible to all the affected personnel.

Staff members of the production organisation who are involved in the production of products under the POA should be able to demonstrate their awareness of the information that is provided within the POE and the company manual. This can be achieved by any suitable means, and it does not necessarily require training sessions to be provided. Regular internal monitoring should be used to internally verify that the relevant staff members are aware of the relevant definitions.

The organisation should systematically conduct monitoring for compliance with this documentation. This monitoring can be via auditing, structured experience exchanges, regular quality meetings, brainstorming or lessons-learned sessions, project reviews at appropriate phases of the development, or other similar means.

GM 21.A.165(a) Obligations of the holder – Basic working document

ED Decision 2012/020/R

Compliance with the production organisation exposition (POE) is a prerequisite for obtaining and retaining a production organisation approval.

The organisation should make the POE available to its personnel where necessary for the performance of their duties. A distribution list should therefore be established. Where the POE mainly refers to separate manuals or procedures, the distribution of the POE could be limited.

The organisation should ensure that personnel have access to and are familiar with that part of the content of the POE or the referenced documents, which covers their activities.

Monitoring of compliance with the POE is normally the responsibility of the quality assurance function.

GM-ELA No 1 to 21.A.165(c) Obligations of the holder

ED Decision 2019/003/R

GM No 1 to 21.A.165(c) is applicable.

GM No 2 to 21.A.165(c) is applicable.

GM No 3 to 21.A.165(c) is applicable.

GM No 4 to 21.A.165(c) is applicable.

GM No 1 to 21.A.165(c) Obligations of the holder – Conformity of prototype models and test specimens

ED Decision 2012/020/R

21.A.33 requires determination of conformity of prototype models and test specimens to the applicable design data. The EASA Form 1 may be used as a conformity certificate as part of the assistance a POA holder provides to a design approval holder/applicant.

GM No 2 to 21.A.165(c) Obligations of holder – Conformity with type design

ED Decision 2012/020/R

Individual configurations are often based on the needs of the customer and improvements or changes which may be introduced by the type-certificate holder. There are also likely to be unintentional divergencies (concessions or non-conformances) during the manufacturing process. All these changes should have been approved by the design approval holder, or when necessary by the Agency.

GM No 3 to 21.A.165(c) Obligations of the holder – Condition for safe operation

ED Decision 2012/020/R

Before issue of the Statement of Conformity to the competent authority of the Member State of registry, the holder of a production organisation approval should make an investigation so as to be satisfied in respect of each of the items listed below. The documented results of this investigation should be kept on file by the POA holder. Certain of these items may be required to be provided (or made available) to the operator or owner of the aircraft (and in some cases the competent authority of the Member State of registry):

1. Equipment or modifications which do not meet the requirements of the State of manufacture but have been accepted by the competent authority of the importing country.

2. Identification of products, parts or appliances which:

a) are not new;

b) are furnished by the buyer or future operator (including those identified in 21.A.801 and 21.A.805).

3. Technical records which identify the location and serial numbers of components that have special traceability requirements for continued airworthiness purposes including those identified in 21.A.801 and 21.A.805.

4. Log book and a modification record book for the aircraft as required by the Agency.

5. Log books for products identified in 21.A.801 installed as part of the type design as required by the Agency.

6. A weight and balance report for the completed aircraft.

7. A record of missing items or defects which do not affect airworthiness these for example could be furnishing or BFE (Items may be recorded in a technical log or other suitable arrangement such that the operator and Agency are formally aware).

8. Product support information required by other implementing rules and associated CS or GM, such as a Maintenance Manual, a Parts Catalogue, or MMEL all of which are to reflect the actual build standard of the particular aircraft. Also an Electrical load analysis and a wiring diagram.

9. Records which demonstrate completion of maintenance tasks appropriate to the test flight flying hours recorded by the aircraft. These records should show the relationship of the maintenance status of the particular aircraft to the manufacturers recommended maintenance task list and the MRB document/report.

10. Details of the serviceability state of the aircraft in respect of a) the fuel and oil contents, b) provision of operationally required emergency equipment such as life rafts, etc.

11. Details of the approved interior configuration if different from that approved as part of the type design.

12. An approved Flight Manual which conforms to the build standard and modification state of the particular aircraft shall be available.

13. Show that inspections for foreign objects at all appropriate stages of manufacture have been satisfactorily performed.

14. The registration has been marked on the exterior of the aircraft as required by national legislation. Where required by national legislation fix a fireproof owners nameplate.

15. Where applicable there should be a certificate for noise and for the aircraft radio station.

16. The installed compass and or compass systems have been adjusted and compensated and a deviation card displayed in the aircraft.

17. Software criticality list.

18. A record of rigging and control surface movement measurements.

19. Details of installations which will be removed before starting commercial air transport operations (e.g., ferry kits for fuel, radio or navigation).

20. Where maintenance work has been performed under the privilege of 21.A.163(d) issue a release to service that includes a statement that the aircraft is in a condition for safe operation.

21. List of all applicable Service Bulletins and airworthiness directives that have been implemented.

GM No 4 to 21.A.165(c) Airworthiness Release or Conformity Certificate

ED Decision 2012/020/R

The EASA Form 1, when used as a release certificate as addressed in 21.A.165(c)(2) and (3), may be issued in two ways:

—      As an airworthiness release, only when by virtue of the arrangement described in 21.A.133(b) and (c), it can be determined that the part conforms to the approved design data and is in a condition for safe operation.

—      As a conformity certificate, only when by virtue of the arrangement described in 21.A.133(b) and (c), it can be determined that the part conforms to applicable design data which is not (yet) approved, for a reason that is indicated in Block 12. Parts released with an EASA Form 1 as a conformity certificate are not eligible for installation in a type-certificated aircraft.

The EASA Form 1 should only be used for conformity release purposes when it is possible to indicate the reason that prevents its issue as for airworthiness release purposes.

AMC1 21.A.165(c)(3) Applicable engine exhaust emissions requirements

ED Decision 2021/011/R

This determination is made according to the data provided by the engine type-certificate holder. It should be noted that the competent authority has the possibility to grant exemptions from these requirements as noted in Chapter 2, paragraph 2.1.1 and Chapter 4, paragraph 4.1.1 of Part III of Volume II of Annex 16 to the Chicago Convention.

When such an exemption is granted, the competent authority:

—      takes into account the number of exempted engines that will be produced and their impact on the environment;

—      considers imposing a time limit on the production of such engines; and

—      issues an exemption document.

The Agency establishes and maintains a register, containing at least the engine serial number, and makes it publicly available.

ICAO Doc 9501 ‘Environmental Technical Manual’ Volume II provides guidance on the issuing of exemptions.

GM1 21.A.165(c)(3) Definitions of engine type certification date and production date

ED Decision 2021/011/R

Volume II of Annex 16 to the Chicago Convention contains three different references to applicability dates:

1. the ‘date of manufacture for the first individual production model’, which refers to the date when the type certificate is issued for the engine type or model;

2. the ‘date of application for a type certificate’, which refers to the application date to the certificating authority of the State of Design of the engine type certification; and

3. the ‘date of manufacture for the individual engine’, which refers to the production date of a specific engine serial number (date of EASA Form 1).

The third reference refers to the date of the first engine EASA Form 1 issued after the completion of the engine production pass-off test.

The third reference is used in the application of engine emissions production cut-off requirement which specifies a date after which all in-production engine models must meet a certain emissions standard.

21.A.165(c)(3) includes the production requirements for engine exhaust emissions.

ICAO Doc 9501 ‘Environmental Technical Manual’ Volume II provides guidance on these applicability dates.

AMC1 21.A.165(c)(4) Applicable aeroplane CO₂ emissions requirements

ED Decision 2021/011/R

This determination is made according to the data provided by the aeroplane type-certificate holder. This data should allow the determination of whether the aeroplane complies with the CO₂ emissions applicability requirements in Chapter 2, paragraph 2.1.1 of Part II of Volume III of Annex 16 to the Chicago Convention.

It should be noted that the competent authority has the possibility to grant exemptions as noted in Chapter 1, paragraph 1.11 and Chapter 2, paragraph 2.1.3 of Part II of Volume III of Annex 16 to the Chicago Convention.

When such an exemption is granted, the competent authority:

—      takes into account the number of exempted aeroplanes that will be produced and their impact on the environment; and

—      issues an exemption document.

The Agency establishes and maintains a register, containing at least the aeroplane serial number, and makes it publicly available.

ICAO Doc 9501 ‘Environmental Technical Manual’ Volume III provides guidance on the issuing of exemptions.