AMC & GM to Part 21 — Issue 2, Amendment 14

Utgivare: Europeiska unionens byrå för luftfartssäkerhet
Antagen: 2022-12-19
Utfärdat genom: ED Decision 2022/021/R
Språk: engelska
Ämnesord: Part 21 - Airworthiness and Environmental Certification
Källa: www.easa.europa.eu

AMC and GM to Part 21

Issue 2, Amendment 14

ANNEX TO ED DECISION 2022/021/R

Acceptable Means of Compliance (AMC) and Guidance Material (GM) to Annex I (Part 21) to Commission Regulation (EU) No 748/2012 Issue 2, Amendment 14 Annex I to ED Decision 2012/020/R is amended as laid down in this Annex. The text of the amendment is arranged to show deleted text, new or amended text as shown below: — deleted text is struck through; — new or amended text is highlighted in blue; — an ellipsis ‘[…]’ indicates that the rest of the text is unchanged.

N o t e t o t h e re a d e r

In amended, and in particular in existing (that is, unchanged) text, ‘Agency’ is used interchangeably with ‘EASA’. The interchangeable use of these two terms is more apparent in the consolidated versions. Therefore, please note that both terms refer to the ‘European Union Aviation Safety Agency (EASA)’.

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ANNEX I (PART 21)

Issue 2, Amendment 14

Note 2: safety management training refers to specific training for the staff that are involved in safety management functions in accordance with points 21.A.139(c) and 21.A.239(c) of Part 21. Working days It refers to days between, and including, Monday and Friday, except public holidays.

GM2 Annex I Abbreviations

For the purpose of the AMC and GM to Part 21, the following abbreviations apply: AFM Aircraft flight manual AMC Acceptable means of compliance APU Auxiliary power unit CEO Chief executive officer CMR Certification maintenance requirement CofA Certificate of airworthiness CRI Certification review item CS Certification specification CS-CCD Certification Specifications for Cabin Crew Data CS-FCD Certification Specifications for Operational Suitability Data (OSD) Flight Crew Data CS-GEN-MMEL Certification Specifications for Generic Master Minimum Equipment List CS-MMEL Certification Specifications for Master Minimum Equipment List CS-MCSD Certification Specifications for Maintenance Certifying Staff Data CS-SIMD Certification Specifications for Simulator Data DAH Design approval holder DO Design organisation DOA Design organisation approval EDTO Extended diversion time operation ELOS Equivalent level of safety

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INVESTIGATION AND ANALYSIS

The ‘collection’, ‘investigation’ and ‘analysis’ functions of the system should include specific means to analyse the collected failures, malfunctions, defects or other occurrences, and the related available information, to identify adverse trends, to investigate the associated root cause(s), and to establish any necessary corrective action(s). It should also allow the determination of reportable occurrences as required under point 21.A.3A(b) — see GM 21.A.3A(b). In addition, for parts whose failure could lead to an unsafe condition, the ‘analysis’ function of the system should ensure that reports and information sent, or available, to the design approval holder are fully investigated so that the full nature of any damage, malfunction, or defect and its effect on continuing airworthiness is understood. This may then result in changes to the design, to the instructions for continued airworthiness (ICAs), and/or in establishing a mitigation plan to prevent or minimise such occurrences in the future, as necessary, and is not limited to those requiring the involvement of EASA under point 21.A.3A(c).

GM 21.A.3A(a) Failures, malfunctions and defects

GENERAL

The word ‘collection’ means the setting up of systems and procedures which will enable relevant failures, malfunctions and defects, or other occurrences, to be properly reported when they occur. Considerations for the collection of information related to failures, malfunctions and defects, or other occurrences, should include the analysis of failure rates, the early rejection of parts from service, and comparison with the certification assumptions.

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In the context of point 21.A.3A(a), the phrase ‘[…] or any other relevant approval deemed […]’ refers to ‘grandfathered’ design approvals under Part 21, as defined in Article 3 of Regulation (EU) No 748/2012. Approval holders of minor changes and minor repairs do not have to comply with the requirements in point 21.A.3A(a), since according to the classification criteria for design changes and repairs (see points 21.A.91 and 21.A.435), minor changes and minor repairs have no appreciable effect on the characteristics affecting the airworthiness of the product.

GM 21.A.3A(b) Failures, malfunctions and defects

OCCURRENCE REPORTING

For guidance on the reporting of failures, malfunctions, defects or other occurrences which have resulted or may result in an unsafe condition, refer to the latest edition of AMC 20-8. The GM available to determine an unsafe condition in accordance with 21.A.3B(b) could be considered to the extent that 21.A.3A(b)(1) also requires the reporting of occurrences that may result in an unsafe condition.

AMC 21.A.3A(b)(2) Reporting to the Agency

Within the overall limit of 72 hours the degree of urgency for submission of a report should be determined by the level of hazard judged to have resulted from the occurrence. Where an occurrence is judged by the person identifying the possible unsafe condition to have resulted in an immediate and particularly significant hazard the Agency (or the competent authority of the Member State as required) expects to be advised immediately and by the fastest possible means (telephone, fax, email, telex, etc.) of whatever details are available at that time. This initial report must be followed up by a full written report within 72 hours. A typical example would be an uncontained engine failure resulting in damage to aircraft primary structure. Where the occurrence is judged to have resulted in a less immediate and less significant hazard, report submission may be delayed up to the maximum of three days in order to provide more details

AMC1 21.A.5 Record-keeping

(a) The record-keeping system should ensure that all the records that are required by point 21.A.5 are accessible within a reasonable time. Those records should be organised in a manner that ensures their traceability and retrievability throughout the required retention period. (b) The records should remain legible throughout the required retention period and be protected against damage, alteration, and tampering. (c) The format of the records should be specified in the organisation’s procedures. (d) The organisation should ensure that copies of all the documents and supporting information that are developed: (1) under the privileges that are defined under points 21.A.163 and 21.A.263; or

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(2) for type certificates (TCs), restricted type certificates (RTCs), supplemental type certificates (STCs), major changes, and major repairs that are not issued under the privileges that are defined under point 21.A.263, are retained throughout the operational life of the product or part. (e) The retention period starts when the record is created or when it is last amended. If the organisation transfers a certificate or a letter of agreement to another natural or legal person, the records related to the certificate or to the letter of agreement should be transferred to the new holder.

GM1 21.A.5 Record-keeping

For organisations that hold or have applied for a type certificate (TC), restricted type certificate (RTC), supplemental type certificate (STC), a European technical standard order (ETSO) authorisation, a change to the TC approval, a repair design approval, a permit to fly, a production organisation approval (POA), or a letter of agreement under Part 21, the relevant design information/data includes at least the following, as applicable: — design data such as type design data, as defined in point 21.A.31, and changes to that data, ETSO design data, and repair design data; — drawings and test reports, including inspection records for the product tested; — the certification programme, including related certification basis data (certification review items (CRIs), special conditions (SCs), equivalent safety findings (ESFs)); and — compliance demonstration data. For production organisations (POs), the relevant records include at least: — conformity justification data; and — conformity attestation data (e.g. EASA Form 1 or EASA Form 52).

AMC1 21.A.5(a) and 21.A.433(b) Repair design and record-keeping

(a) The relevant substantiation data related to a new major repair design and record-keeping should include: (1) identification of the damage and of the source of the report; (2) the major repair design approval sheet that identifies the applicable specifications and the references of the justifications; (3) the repair drawing and/or instructions, and the scheme identifier; (4) any correspondence with the holder of the type certificate (TC), supplemental type certificate (STC), or auxilliary power unit (APU) European technical standard order (ETSO) authorisation, if their advice on the design was sought; (5) the structural justification (static strength, fatigue, damage tolerance, flutter, etc.) or references to that data;

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(6) the effect on the aircraft, engines and/or systems (performance, flight handling, etc., as appropriate); (7) the effect on the maintenance programme; (8) the effect on the airworthiness limitations, the flight manual, and the operating manual; (9) any change in the weight and moment; and (10) any special test requirements. (b) The relevant minor repair documentation includes points (a)(1) and (a)(3). Other elements of point (a) may be included, where necessary. If the repair is outside the approved data, a justification for the classification is required. (c) Special consideration should be given to repairs that impose subsequent limitations on the part, product or appliance (e.g. engine turbine segments that may only be repaired a finite number of times, the number of repaired turbine blades per set, the oversizing of fastener holes, etc.). (d) Special consideration should also be given to life-limited parts and critical parts, notably with the involvement of the TC or STC holder, when deemed necessary under point 21.A.433(a)(4). (e) Repairs to engines or to APU-critical parts would normally be accepted only with the involvement of the TC holder.

GM1 21.A.5(a) and (b) Record-keeping

RECORDING AND ARCHIVING SYSTEM

The main objective of record-keeping in design organisations (DOs) and production organisations (POs) is to ensure the retrievability of data that is required for the continued airworthiness of inservice products. In addition, records within the design environment are essential to ensure proper control of the configuration of the type design and of its compliance with the certification basis. In the production environment, records are also required, to ensure that products or parts are in conformity with the applicable data throughout the manufacturing cycle. In addition, certain records of milestones are needed, to subsequently provide objective evidence that all the prescribed stages of the production process have been satisfactorily completed. Therefore, the approved DO or PO (or a natural or legal person that is demonstrating their design capability through an agreement on alternative procedures or through the acceptance of the organisation’s certification programme, or a natural or legal person that produces products and parts under Part 21, Subpart F) are required to implement a system for the compilation and retention of records during all stages of design or production, which covers short-term and long-term records as appropriate to the nature of the product and its processes. The management of such information is subject to the appropriately documented procedures in the management system that is required by points 21.A.139 and 21.A.239 or to the manual/procedures that are required by points 21.A.14(b), 21.A.125A(b), or 21.A.602B(b)(2), as appropriate. This also applies in case of demonstrating the design capability through the acceptance of the certification programme under point 21.A.14(c).

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All forms of recording media are acceptable (paper, film, magnetic, etc.), including the use of electronic records, provided that they can meet the required duration for archiving under the given conditions and that the continued readability of the records is ensured. The related procedures are required to: — identify the records to be kept; — describe the organisation of, and responsibility for, the archiving system (its location, compilation, format) and the conditions for access to the information (e.g. by product, subject, etc.); — control access to the data and provide effective protection from deterioration or accidental damage, alteration, and tamperering; — ensure the continued readability of the records; — demonstrate to the competent authority the proper functioning of the record system; and — define an archiving period for each type of data as follows: — production data that supports the conformity of a product, part, or appliance is kept for not less than 3 years from the issue date of the related statement of conformity or authorised release certificate; and — design data, including data that supports the compliance of a product, part, or appliance with the certification basis (see GM1 21.A.5), as well as data that is considered essential for continuing airworthiness, is kept throughout the operational life of the product, part, or appliance; such continued airworthiness data may include, but are not limited to, in-service occurrence reports and mandatory continuing-airworthiness information; — for organisations that are approved according to Part 21, Subparts G and J and organisations that demonstrate their design capability through an agreement on alternative procedures or acceptance of their certification programme by EASA, ensure that the recording and record-keeping systems that are used by the partners, suppliers, and subcontractors meet the record-keeping objectives with the same level of confidence as they do for their own system;. in each case, it should be defined who should retain the data record (organisation, partner, supplier, or subcontractor), as well as the method of surveillance of the recording/record-keeping system of the partners, suppliers, or subcontractors; and — for natural or legal persons that produce items under Part 21, Section A, Subpart F, the data on supplied parts may be retained by the supplier if the supplier has a system that is agreed by the competent authority under Part 21, Section A, Subpart F; in each case, the PO is required to define the archiving period and satisfy itself and the competent authority that the recording media are acceptable. Related to electronic records, the following definitions apply: — electronic record: electronic or digital data that is created, generated, sent, communicated, received, or stored by electronic means; — electronic data: it is typically in the form of documentation that is statically stored in a computer file that is not modifiable (e.g. pdf of a scanned document with wet ink signatures); and

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— digital data: it is typically in the form of computer-generated bytes of information that is stored in a computer workable file (e.g. MS Word file, MS Excel file, 3D CAD file).

Block 7: The information to be entered here should reflect the number of staff or in the case of an initial approval, the intended number of staff for the manufacturing activities under this application, and therefore, it should also include any associated administrative staff. Block 8: State the name of the person that is authorised to sign the application.

GM 21.A.124(a) Application – Application form

EASA Form 60 (see AMC 21.B.120(c)(1)) should be obtained from the competent authority and completed by the applicant. An application may be accepted from: — An individual applying on his or her own behalf, or — In the case of an organisation, an individual with the authority to make agreements on behalf of the organisation. The completed form should be forwarded to the competent authority.

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

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.

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

GENERAL

(a) Acceptable means of compliance (AMC), as referred to in Article 76(3) of Regulation (EU) 2018/1139 , are a tool to standardise the demonstration of compliance with, and facilitate the

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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

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

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— 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.

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

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

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.

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

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.

GM1 21.A.126(b)(5) Production inspection system –— Engineering and manufacturing review procedure

1.(a) The procedure should permit to record the deviation, to present it to the design approval holder (DAH)Design holder under the provisions of point 21.A.122, and to record the results of the review and actions taken consequently as regards the part/product. 2.(b) Any unintentional deviation from the manufacturing/inspection data should be recorded and handled in accordance with Part 21, Section A, Subpart D or E as changes to the approved design.

GM 21.A.126(b)(6) Production inspection system – Recording and record keeping

1. Records within a production environment satisfy two purposes. Firstly, they should, during the production process to ensure that products, parts, or appliances are in conformity with the controlling data throughout the manufacturing cycle. Secondly, certain records of milestone events are needed to subsequently provide objective evidence that all prescribed stages of the production process have been satisfactorily completed and that compliance with the applicable design data has been achieved. Therefore, the person producing under Part 21 Subpart F should implement a system for the compilation and retention of records during all stages of manufacture, covering short-term and long-term records appropriate to the nature of the product and its production processes. The management of such information should be subject to appropriate documented procedures in the Manual required by 21.A.125A(b). All forms of recording media are acceptable (paper, film, magnetic ...) provided they can meet the required duration for archiving under the conditions provided. 2. The related procedures should: 2.1 Identify records to be kept.

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2.2 Describe the organisation of and responsibility for the archiving system (location, compilation, format) and conditions for access to the information (e.g., by product, subject). 2.3 Control access and provide effective protection from deterioration or accidental damage. 2.4 Ensure continued readability of the records. 2.5 Demonstrate to the competent authority proper functioning of the records system. 2.6 Clearly identify the persons involved in conformity determination. 2.7 Define an archiving period for each type of data taking into account importance in relation to conformity determination subject to the following: a) Data which supports conformity of a product, part, or appliance should be kept for not less than three years from the issue date of the related Statement of Conformity or Authorised Release Certificate. b) Data considered essential for continuing airworthiness should be kept throughout the operational life of the product, part or appliance. 2.8 Data related to supplied parts may be retained by the supplier if the supplier has a system agreed under Part 21 Section A Subpart F by the competent authority. The manufacturer should, in each case, define the archiving period and satisfy himself or herself and the competent authority that the recording media are acceptable.

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SUBPART G — PRODUCTION ORGANISATION APPROVAL GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design data

An uncontrolled non-compliance with applicable design data is a non-compliance: — that cannot be discovered through systematic analysis; or — that prevents identification of affected products, parts, appliances, or material.

GM No 2 to 21.A.158(a) Examples of level one findings

Examples of level one findings are non-compliances with any of the following points, that could affect the safety of the aircraft: 21.A.139, 21.A.145, 21.A.147, 21.A.148, 21.A.151, 21.A.163, 21.A.165(b), (c), (d), (e), (f) and (g). It should be anticipated that a non-compliance with these points is only considered a level one finding when objective evidence has been found that this finding is an uncontrolled non-compliance that could affect the safety of the aircraft. In addition, the failure to arrange for investigations under 21.A.157, in particular to obtain access to facilities, after denial of one written request should be classified as a level one finding.

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

Issue 2, Amendment 14

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

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

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

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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.

Issue 2, Amendment 14

As part of the workflow, it should be defined that the production organisation can only issue flight conditions and PtFs for this case, and as long as this flight test plan and flight conditions can be fully adhered to. When the production organisation issues flight conditions and PtFs for a purpose other than the production flight testing of new production aircraft, a flight test operations manual (FTOM) needs to be put in place, which should define the relevant workflows. For companies that work as one consolidated team, it is sufficient to have one set of flight test procedures that have been established on the basis of an FTOM within either the design or the production organisation.

GM-ELA No 1 to 21.A.139(b)(1) Quality system – Control procedures

The documentation of the quality system, and the associated training, is limited to what is necessary to demonstrate that the products that are produced conform to the relevant design definition, and are in a condition for safe operation. If products are repeatedly found that do not conform, or if evidence is available that the products may be or may become unsafe, then enhanced procedures and documentation that go beyond the AMC-ELA may be one of the means, but not the only possible means, to rectify that situation. The control procedures of a quality system can be defined by flow charts, process cards, or similar means. If enterprise resource planning (ERP) systems or other IT systems that manage workflows are applied, then separate workflow documentation is not necessary, as long as the workflow can be demonstrated on the basis of the IT system that is applied. The quality system methods should cover those aspects for which a failure to control these elements is expected to have a direct impact on the safe operation of the aircraft.

GM-ELA No 2 to 21.A.139(b)(1) Conformity of supplied parts or appliances

The organisation is responsible for ensuring that the delivered product conforms to the type design. This includes components that are used on the product and that are obtained from outside. To discharge this responsibility, the organisation needs to implement practised methods that ensure that non-conforming products are detected at a suitable point in time, prior to the declaration of conformity of the final product or the delivery of spare parts to the customer. Organisations that apply AMC-ELA No 1 to 21.A.139(b)(1) should ensure, as a minimum, the conformity of supplied parts to a level that is defined as part of the approved type design by using one or more of the following methods: — supplier control; — the inspection of incoming goods; — inspections conducted at a suitable stage of the production and verification flow; — verification of the performance and the characteristics of the completed product; or — other means that have an equivalent purpose.

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If methods for the verification of conformity are defined as part of the approved type design, the organisation does not need to go beyond these verification methods in their extent, method or frequency. If the type design does not determine the conformity criteria, the organisation may need to extend reasonable quality assurance methods to the related supplier if non-conformities of the parts would create a hazard.

AMC1GM 21.A.139(d)(2)(b)(1) Quality system – Elements of the quality systemProduction management system

accordance with an aviation standard (e.g. EN 9104 series of requirements) that describes the requirements for the OP certification, the items (ii), (iv), and (v) shallshould be deemed to be complied with.: (4) A definition that states to what scopeextent the OP will conduct supplierssupplier surveillance on behalf of the POA holder. If the OP partly replaces surveillance by the POA holderin part, the POA holder should identify the functions that will continue to be surveyed by the POA holder. (5) The pProcedures that ensure that the POA is aware of the loss of an existing certification. (6) The pProcedures that ensure that the POA holder is aware of any non-conformityies and has access to detailed information ofon theseany non-conformityies. (7) The pProcedures to evaluate the consequences of non-conformityies and take appropriate actions. (d) The POA should make arrangements that allow the competent authority to make investigationinvestigations in accordance with point 21.A.9,21.A.157 to include OP activities.

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

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

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;

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(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.

AMC-ELA No 1 to 21.A.139(b)(2) Quality system – Independent quality assurance function

The responsibility for the independent checking that the quality system functions in accordance with point 21.A.139(b)(1)(xiv) is specified within the organisation. The responsible person(s) establish(es) a schedule, which verifies all the elements of the quality system at least once a year. The schedule can be complemented by unplanned audits if needed. The person(s) responsible obtain(s) direct monitoring results and ensure(s) that corrective actions are taken when necessary.

GM-ELA No 1 to 21.A.139(b)(2) Quality system – Independent quality assurance function

The term ‘adequacy of procedures’ means that the quality system, through the use of the practised methods or procedures as documented, is capable of meeting the conformity objectives identified in point 21.A.139(a). This can be shown with the results from the implemented quality system, carried

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out in accordance with point 21.A.139(b)(1)(xiv). Independent quality assurance monitoring can be accomplished by structured experience exchanges, regular quality meetings, brainstorming or lessons-learned sessions, project reviews at appropriate phases of the development, or by other similar means. The adequacy of the quality system should be assessed on the basis of the continued conformity of the product with the approved type design. If the practised methods and the level of documentation of procedures are not found to be adequate, a more detailed documented procedure may need to be implemented to rectify the situation.

GM No 1 to 21.A.139(b)(2) Quality System – Independent quality assurance function

The quality assurance function which is part of the organisation is required to be independent from the functions being monitored. This required independence relates to the lines of reporting, authority and access within the organisation and assumes an ability to work without technical reliance on the monitored functions.

GM1 No 2 to 21.A.139(f)(b)(2) Production management systemQuality System – Adequacy of procedures and monitoring function

ADEQUACY OF PROCEDURES AND OF THE MONITORING FUNCTION

‘Adequacy of procedures’ means that the production management system, through the use of the procedures as set forth defined, is capable of meeting the conformity objectives that are identified in point 21.A.139(d)(1)(a). The quality assurance function to ensure the above should perform planned continuing and systematic evaluations or audits of factors that affect the conformity (and, where required, safe operation) of the products, parts or appliances to the applicable design. This evaluation should include all elements of the quality system in order to demonstrate compliance with Part 21 Subpart G.

AMC-ELA No 1 to 21.A.139(b)(2) Quality system – Independent quality assurance function

The responsibility for the independent checking that the quality system functions in accordance with point 21.A.139(b)(1)(xiv) is specified within the organisation. The responsible person(s) establish(es) a schedule, which verifies all the elements of the quality system at least once a year. The schedule can be complemented by unplanned audits if needed. The person(s) responsible obtain(s) direct monitoring results and ensure(s) that corrective actions are taken when necessary.

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(a) The purpose of the production organisation exposition (POE) is to set forthstate in a concise documentdocumented 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 instructioninstructions, 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.The competent authority requires the POE to be an accurate definition and description of the production organisation. The document does not require approval in itself, but it will be considered as such by virtue of the approval of the organisation. (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.Significant changes to the organisation (as defined in GM 21.A.147(a)) should be approved by the competent authority prior to update of the POE. When an organisation is approved against any other implementing rule containing a requirement for an exposition, a supplement covering the differences may suffice to meet the requirements of Part 21

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(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.

AMC-ELA No 1 to 21.A.143(a)(13) Exposition – Policies and procedures related to flight test

The objective of this AMC is to identify the items that need to be considered for a safe flight test, that need to be practised, and, if necessary, defined in the flight test operations manual (FTOM) or related procedures, templates or checklists. Those items are the following: — A flight test plan, completed flight conditions, and the related Forms 18a and 20b for the purpose of conducting the production flight testing of a new production aircraft that are provided as part of the approved type design. These define: — a crewing policy, including its composition, and any competence, currency and flight time limitations; — procedures for the carriage of persons other than crew members, and for flight test training; — a policy for risk and safety management, and associated methodologies that are adequate for the purpose of the flight; — a definition of the instruments and equipment to be carried on board during this test flight; and — a list of the records that need to be produced when conducting this flight test. — This flight test plan constitutes the FTOM for this limited purpose.

GM1 21.A.145(c)(1) ResourcesApproval Requirements – Accountable manager

ACCOUNTABLE MANAGER

‘Accountable manager’ refers tomeans the manager thatwho is responsible, and has corporate authority for ensuring that all production work is carried out to the required standard. This function may be performedcarried out by the Chief Executivechief executive officer (CEO) or by another person in the organisation, nominated by him or herthe CEO to fulfil the function, provided that thehis or her position and authority of that person in the organisation permitsallows that person to discharge the associatedattached responsibilities. The manager is responsible for ensuring that all necessary resources are available and properly used in order to produce under the production approval in accordance with Part 21, Section A, Subpart G. The manager needs to have sufficient knowledge and authority to enable him or her to respond to the competent authority regarding major issues of the production approval and implement necessary improvements. The manager needs to be able to demonstrate that he or she is fully aware of and supports the quality policy and maintains adequate li with the quality manager.

AMC1GM 21.A.145(c)(2) ResourcesApproval Requirements – Responsible managers

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 GSection A Subpart G. It therefore follows that, dependingDepending on the size of the Part 21 Section A Subpart Gapproved 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).

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Certifying staff (CS) are nominated by the production organisation to ensure that products qualify for statements of conformity or release certificates. The number of CS and their positions within the organisation should be adequate to perform their duties and commensurate with the complexity of the product and the production rate. The nomination of the CS is based on their knowledge, background and experience, and specific training (or testing) is established by the organisation to ensure that the CS members are appropriately qualified for the product, part, or appliance to be released. This can be ensured by utilising appropriately qualified Part-66 licence holders as inspectors, or inspectors who are qualified to comparable standards that are agreed with the relevant competent authority. The training of personnel who support CS at the subcomponent level may be ensured by on-the-job training. For the release of products, parts or appliances, the responsibilities for issuing statements of conformity or release certificates (EASA Form 52, EASA Form 1), or PtFs and approvals of flight conditions (if applicable), are allocated under the responsibility of the AM to individuals that are nominated as CS.

AMC 21.A.145(d)(2) Approval requirements – Record of certifying staff

1. The following is the minimum information to be recorded in respect of each certifying person: (a) Name (b) Date of Birth (c) Basic Training and standard attained (d) Specific Training and standard attained (e) If appropriate – Continuation Training (f) Experience

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(g) Scope of the authorisation (h) Date of first issue of the authorisation (i) If appropriate – expiry date of the authorisation (j) Identification Number of the authorisation 2. The record may be kept in any format and must be controlled by an internal procedure of the organisation. This procedure forms part of the quality system. 3. Persons authorised to access the system must be maintained at a minimum to ensure that records cannot be altered in an unauthorised manner and that confidential records cannot become accessible to unauthorised persons. 4. The certifying person must be given reasonable access on request to his or her own records. 5. Under the provision of 21.A.157 the competent authority has a right of access to the data held in such a system. 6. The organisation must keep the record for at least two years after the certifying person has ceased employment with the organisation or withdrawal of the authorisation, whichever is the sooner.

AMC-ELA No 1 to 21.A.145(d)(2) Approval requirements – Records of certifying staff

The following data shoI be recorded for each certifying staff (CS) member: (a) name; (b ate of birth; (c) basItraining and the standard attained; (d) specific training and thtandard attained; (e) if appropriate, continuation training; (f) experience; (g) scope of the authorisation; (h) date of first issue of the authorisation; (i) if applicable, the expiry date of the authorisation; (j) identification (number) of the authorisation; (k) documented acceptance of the nomination. The above information is deemed to be sufficient to provide the CS with evidence of their scope of authorisation. The record of this data may be kept in any format. Each CS member should be given reasonable access on request to his or her own records.

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The organisation should keep these records for at least 2 years after the CS member has ceased to be employed by the organisation, or 2 years after the withdrawal of their authorisation, whichever occurs first.

AMC1 21.A.145(d)(2)(3) ResourcesApproval requirements – Evidence of authorisation

EVIDENCE OF AUTHORISATION

(1.a) The certifying staff should be provided with evidence of their authorisation. This should be done through an internal authorisation document. That document mustshould be in a style that makes its scope clear to the certifying staff and any entitledauthorised person thatwho 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. (2.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 followingof a request from an entitledauthorised person. Authorised persons, which includes the competent authority.

AMC-ELA No 1 to 21.A.145(d)(3) Approval requirements – Evidence of authorisation

Evidence of the scope of the authorisation may be provided in a reasonably accessible way within the company, so that a staff member that needs to be aware of the authorisation can verify their status whenever needed. This can be achieved by the provision of accessible listings of the nominated CS members, or by other means. The issuing of individual badges or passes is not required.

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

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— changes in the placement or control of significant subcontracted work or supplied parts; — relocation of the major place of activities to a different geographic location, city, airfield or similar; — changes in the scope of approval; and — changes in ownership.

GM1 21.A.147(a) Changes to the approved production management systemorganisation – Significant changes

SIGNIFICANT CHANGES

1 Changes to be approved by the competent authority include: — Ssignificant changes to the production capacity or methods;. — Cchanges in the organisation’s structure, especially those parts of the organisation in charge of quality and safety;. — a change of the accountable manager or of any other person that is nominated under point 21.A.145(c)(2);. — Cchanges in the production or qualitymanagement systems that may have an important impact on the conformity/ or airworthiness of anyeach 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. — Cchanges in the placement or control of significant sub-contractedsubcontracted work or supplied parts. 2. To ensure that changes do not result in non-compliance with Part 21, Section A Subpart G it is in the interest of both the competent authority and the approval holder to establish a relationship and exchange information that will permit the necessary evaluation work to be conducted before the implementation of a change. This relationship should also permit agreement on the need for variation of the terms of approval (refer to point 21.A.143(a)(9)). 3. Where a change of name or ownership results in the issue of a new approval, the investigation will normally take account of the competent authority’s knowledge and information from the preceding approval. 4. Changes of location are addressed in point 21.A.148, and changes of ownership in point 21.A.149, and the change of scope of the approval in point 21.A.153.

Issue 2, Amendment 14

GM1 21.A.139, 21.A.157, 21.A.239, 21.A.257, 21.B.120, 21.B.140, 21.B.220, 21.B.235 and 21.B.240 The use of information and communication technologies (ICT) for performing remote audits

[...]

GM-ELA No 1 to 21.A.157 Investigations – Arrangements

The production organisation is encouraged to coordinate with the competent authority on any investigations that focus on issues that could result in unsafe conditions. The production organisation grants to the competent authority full and free access to the facilities and to any information that is relevant to demonstrate the conformity of the product to the approved type design, and it provides assistance (personnel support, records, reports, computer data, etc., as necessary) to the competent authority during the investigation. In this context, assistance to the competent authority includes providing all the appropriate means that are necessary to allow the competent authority to perform these investigations, such as making available a meeting room, office and personnel support, documentation and data, and communication facilities, which should all be properly and promptly made available as necessary.

Issue 2, Amendment 14

AMC-ELA No 1 to 21.A.165(g) Obligations of the holder – Continuing airworthiness assistance

The production organisation should actively communicate with and assist the holder of the type certificate or the design approval when dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced. Compliance with this requirement can be shown by effective coordination regarding the corrective actions. If the design and production entities both work within one consolidated team, assistance to the type design holder is expected to be provided as an intrinsic function of the cooperation, and no further evidence of the assistance needs to be provided.

AMC-ELA No 1 to 21.A.165(d);(h) Obligations of the holder – Recording and archiving system

Records of production that have been Id to determine conformity with the type design, such as those records mentioned in relation to point 21.A.165(c) and (d), should be archived and preserved using an adequate archiving method that should be defined within the company manual. Those records need to be held at the disposal of the competent authority, and need to be retained in order to provide the information necessary to ensure the continuing airworthiness of the products, parts or appliances. All forms of recording media are acceptable (paper, database, etc.), provided that the preservation of the records for the retention period for archiving can be ensured. The production organisation should: — define the records to be retained. If the type design defines which data needs to be recorded, the production organisation is not required to go beyond this data; — implement a structured method of archiving. If IT-based ERP systems with workflow management are used, a detailed description of the system is not required; — ensure that there is effective protection of the records from deterioration or accidental damage, e.g. by holding hard and soft copies in separate locations; — ensure the continued readability of the records by selecting an adequate method of archiving; — define a retention period for each type of data, taking into account that the determination of conformity is subject to the following: — data which supports the conformity of a product, part or appliance should be kept for not less than 3 years from the issue date of the related statement of conformity or authorised release certificate; — data considered to be essential for continuing airworthiness should be kept throughout the operational life of the product, part or appliance. If the production organisation has decided that the records of any partner, supplier or subcontractor do not need to be supplied to the production organisation, then the production organisation should extend its requirements for recoIkeeping to that partner, supplier or subcontractor.

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SUBPART J — DESIGN ORGANISATION APPROVAL AMC1 21.A.239(c) Design management system

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 design management system.

GM1 21.A.239(c) Design management system

SAFETY MANAGEMENT ELEMENT

Safety management seeks to proactively identify hazards and mitigate the related safety risks before they result in aviation accidents and incidents. Safety management enables an organisation to manage its activities in a more systematic and focused manner. When an organisation has a clear understanding of its role 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.239(c)(1)). The principles of the requirements in points 21.A.3A, 21.A.5, 21.A.239, 21.A.245, and 21.A.247, and the related AMC constitute the EU design management system framework for aviation safety management. This framework 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.

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The risks that are inherent in a complex structure require a robust safety risk management process (e.g. complex interfaces with different partners that participate in the design of a product may pose hazards that are complex to mitigate). 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.239(c)(1) Design management system

SAFETY POLICY & OBJECTIVES

(a) The safety policy should: (1) reflect organisational commitments regarding safety, and its proactive and systematic management, including the promotion of a positive safety culture; (2) include internal reporting principles by fostering the reporting of organisational threats as well as events, as defined in AMC3 21.A.3A(a); (3) be endorsed by the head of the design organisation (HDO); (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 actions, omissions, or decisions that are commensurate with their experience and training; or (ii) for any purpose other than the improvement of aviation safety.

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(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 and 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.239(c)(1) Design management system

SAFETY POLICY

The safety policy is the means for the organisation to state its intention to maintain and, where practicable, 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.239(c)(2) Design management system

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.245(b). (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 head of the design organisation (HDO). (2) The board should be normally chaired by the HDO and be generally composed of the person or group of persons nominated under point 21.A.245(b). Its composition can be adapted to its needs, considering point 21.A.245(b).

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(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(i) reviewing the results of compliance monitoring; and (ii) monitoring the implementation of 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.239(c)(2) Design management system

AMC1 21.A.239(c)(4)(ii) Design management system

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.247. In addition, necessary changes should be introduced into the handbook, as per point 21.A.243(c). The design 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.239(c)(4)(ii) Design management system

MANAGEMENT OF CHANGE

Unless properly managed, changes in the organisational structure, facilities, scope of work, personnel, documentation, policies and procedures, etc. 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 changes. 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 design 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

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

AMC1 21.A.239(c)(5) Design management system

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.239(c)(5) Design management system

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.239(c)(5)(i) Design management system

SAFETY TRAINING

(a) The design management staff, as described in points 21.A.245(a) and (b), should receive initial and recurring safety training, as appropriate to their responsibilities, including in safety management principles and the associated safety objectives, to ensure their continued competency.

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(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.239(c)(5)(i) Design management system

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.

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— ensuring that a design organisation handbook (DOH) is prepared and updated as required; — ensuring that there is adequate and timely interaction with the authorities and internally on all relevant matters with respect to type certification, changes to type certificates, the approval of repairs and the approval of the design organisation. This includes the coordination that the required documentation (type design documents, compliance documentation and service documents including manuals/ICA and the MMEL, if applicable) is adequately established; — ensuring that the continued airworthiness activities are properly performed; — accepting the certification programme and the approval of the classification of changes/repairs, minor changes/repairs, major repairs, and flight conditions and the issue of PtFs under the relevant privileges; — providing verification to the HDO that all the activities required for the type investigation have been properly completed. — Independent system monitoring (ISM): — monitoring that the implemented DAS is adequate, and that it is complied with, by using structured experience exchanges, regular quality meetings, brainstorming or lessonslearned sessions, project reviews at appropriate phases of the development, planned and unplanned audits, or other similar means; — conducting independent ISM activities and directly reporting any observations to the HDO.

AMC-ELA No 4 to 21.A.239(a) Design assurance system – Independent system monitoring

Monitoring that the implemented design assurance system (DAS) is adequate, and that it is complied with, is done by systematic means. The systematic means of monitoring may include structured experience exchanges, regular design meetings, brainstorming or lessons-learned sessions, project reviews at appropriate phases of the development, or by other similar means. Audits may be one element of monitoring. When implemented, audits should be conducted as combined process/product (project) audits that focus on the implemented key processes or methods practised according to the DOH (or the equivalent document), and the audits should also allow the design organisation to find ways to become more efficient by continuous improvement. Systematic means of monitoring are coordinated by the ISM, under the responsibility of the HDO, and with a direct reporting line to the HDO. If the ISM is not independent of the activity that is monitored, especially if the HDO also fulfills the role of the head of ISM, the HDO may involve auditors that have adequate knowledge of the applicable requirements and of the implemented DAS. The system monitoring function may be undertaken by the existing quality assurance organisation, provided that it has adequate reporting lines to the HDO.

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GM1 21.A.239(d)(a) Design assurancemanagement system

DESIGN ASSURANCE ELEMENT

(a)1. Purpose This GM outlines some basic principles and objectives of 21.A.239(a).the design assurance element. (b)2. Definitions 2.(1) The design assurance element includessystem is the organisational structure, responsibilities, procedures, and resources to ensure the proper functioning of the design organisation. 2.(2) The design‘Design assurance’ refers tomeans all those planned and systematic actions necessary to provide adequate confidence that the organisation has the capability to: — to design products or parts in accordance with the applicable type certification basis, the operational suitability data (OSD) certification basis,CS and the environmental protection requirements;, — to demonstrate and verify the compliance with these type certification basis, the OSD certification basis,CS and the environmental protection requirements,; and — to demonstrate to the AgencyEASA thatis compliance. 2.(3) The ‘Type Iinvestigation’ meansrefers to the tasks of the organisation in support of the type- certificate (TC), supplemental type- certificate (STC), or other design approval processes necessary to demonstrate, and verify, and to maintain compliance with the applicable type certification basis, OSD certification basis,CS and environmental protection requirements. 3. Design Assurance The complete process, starting with the CS and environmental protection requirements and product specifications and culminating with the issuing of a type-certificate, is shown in the diagram on Figure 1. This identifies the relationship between the design, the Type Investigation and design assurance processes. Effective design assurance demands a continuing evaluation of factors that affect the adequacy of the design for intended applications, in particular that the product, or part, complies with applicable CS and environmental protection requirements and will continue to comply after any change. Two main aspects should therefore be considered: — How the planned and systematic actions are defined and implemented, from the very beginning of design activities up to continued airworthiness –ctivities; — How these actions are regularly evaluated and corrective actions implemented as necessary.

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DESIGN ASSURANCE ELEMENT

(a) Reserved (b) Reserved (c) Design assurance system The complete design process, starting with the type certification basis, operational sutiability data (OSD) certification basis, as well as environmental protection requirements and product specifications, and culminating with the issuing of a type certificate (TC), is shown in Figure 1, which identifies the relationships between the design, the certification, and the design assurance processes. Effective design assurance requires a continuing evaluation of all the factors that affect the adequacy of the design for the intended applications. In particular, it should be ensured that the product or part complies with the applicable type certification basis, OSD certification basis, and environmental protection requirements, and that it will continue to comply after any change to the TC or any repair. Planned and systematic tasks should therefore be defined and performed from the very beginning of the design activities up to the continued-airworthiness activities.

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AMC2GM No 2 to 21.A.239(d)(a) Design management systemDesign assurance system for minor changes to type design or minor repairs to products

GM1 21.A.239(d)(3)(c) Design management systemDesign assurance system

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The statement should be reissued at the earliest opportunity when the HDO changes. (c) The organisation may document its safety policy, safety objectives, and all the safety management system key processes (as required by point 21.A.239(c)) in a separate manual (e.g. a safety management manual or management system manual) or in its handbook. 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.

AMC2 No 2 to 21.A.243(a) Data requirements – Model content of handbook for organisations designing minor changes to type design or minor repairs to productsHandbook

TYPICAL CONTENT OF HANDBOOK FOR ORGANISATIONS THAT DESIGN MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS

The following is a typical table of contents for the handbook: Part 1. Organisation 1.1 Objective of the handbook and binding statement 1.2 Responsible person for the administration of the handbook 1.3 Amendment procedure 1.4 List of effective pages 1.5 Distribution list 1.6 Presentation of the design organisation (DO) (including locations) 1.7 Scope of work (with identification of type and models of products) 1.8 Organisation charts 1.9 Human resources 1.10 Management staff 1.11 Certifying personnel (see GM No2 to 21.A.243(d), paragraphpoint 2) 1.12 Independent system monitoring 1.13 Safety management system Part 2. Procedures 2.1 Management of changes to type design and design of repairs: — configuration control, — classificationl, and — approval of minor changes to type design and minor repairs

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2.2 Control of design sub-contractorssubcontractors 2.3 Collecting/Investigating of failures, malfunctions, and defects 2.4 Co-ordinationCoordination with production 2.5 Documentation control — in relationsrelation towith the changes and repairs, and — in relation towith failures/malfunctions and defects (i.e. Sservices Bbulletins) 2.6 Record-keeping

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persons for both design and production. However, it should be described how any occurrences, and any unintentional deviations from the approved design data that occur in production (i.e. concessions or non-conformances) are handled within the design organisation, and when a concession process or a direct approval of such non conformities under the DOA is sought, for example by using the change process. In addition, the methods/processes that are required by other AMC-ELA and GM-ELA should be defined, either dire€y in the DOH or in a document that is linked to it. 19. A declaration and a definition of the method applied to accept design work that is conducted by external parties, in line with AMC-ELA No 1 to 21.A.239(c). 20. The identification of the design subcontractors and satellite locations that operate under the DAS of the design organisation, and that fulfil functions required by the DAS, or are directly involved in critical aspects of compliance demonstration, such as, for example, flutter investigations and analyses. This identification may be an integral part of the DOH, or it may be provided in a separate listing that is only identified from within the DOH. 21. A reference to a flight test operations manual (FTOM) that is adequate for the flight test activities of the design organisation. If both the design and the manufacturing entities work within one consolidated team, it is sufficient to have FTOM procedures defined for only one of the entities. The FTOM shall then identify the workflow that defines how to issue flight conditions and PtFs for the purpose of conducting factory acceptance test flights.

AMC-ELA No 2 to 21.A.243 Data – Policies and procedures in relation to flight tests

In order to conduct flight test activities, the DOA is required to implement policies and procedures for conducting these activities that include a proportionate and efficient risk and safety management system. This approach is documented either within a separate flight test operations manual (FTOM) or as an integral part of any other valid manual of the organisation, such as the DOH, or any other relevant quality manual. The FTOM, or its equivalent, should be proportionate to the risk of the product and the complexity of the organisation. The risk and safety management system, documented within the FTOM, or its equivalent, covers the following aspects: — The definition of the key qualifications, responsibilities and accountabilities of the staff involved in conducting the flight tests, which covers at least: — the head of flight test (HoFT), who coordinates all the activities related to flight test and assumes responsibility for flight testing (this can be shared with other management positions within the DO); — the flight test engineer, who manages individual flight tests (or test campaigns); — the test pilot, who conducts any flight tests; — the flight test mechanic, who conducts all maintenance tasks and configuration changes to the test aircraft.

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One person who has adequate qualifications may act in more than one role. The HoFT should have a direct reporting line to the HDO. — A method that provides practical guidance on conducting a hazard assessment to classify flight tests according to the risk involved. At least two categories should be identified: Category 1 for high-risk flight tests, and Category 2 for medium- and low-risk flight tests. — Definitions of generic risk mitigation strategies such as the use of minimum and maximum altitudes or airspeed safety margins, and safety rules to be obeyed for the typical major test phases and missions. — Identification of the aircraft-related safety equipment that needs to be available, including references to the maintenance requirements of this equipment. — A policy on how to alert and involve rescue services, such as the fire brigade or emergency physicians, in order to allow sufficiently short reaction times. — Crew qualifications, including requirements for the qualifications to be current and for crew (refresher) training, as adequate. — For aircraft with MTOMs of 2 000 kg or more: — the provisions of EASA Part-21 Appendix XII apply. — the minimum flight experience per year should be: — for pilots: 50 hours. In addition: — for pilots who have flight test ratings, the 50 hours should include 20 flight test hours in any flight test category; — for pilots to perform Category 3 flight tests, their flight test experience should be expressed in terms of the number of flights that led to the issuing of a certificate of airworthiness (CofA) (e.g. first flights); — for pilots to perform Category 4 flight tests, their minimum flight test experience should be proportionate to the activity envisaged. — Crew composition and duty time limitations that are adequate for the kind of testing and the risk category of the flight tests conducted by the DOA. The procedural aspects, documented within the FTOM, or its equivalent, should cover the following aspects: — The initiation and planning of a flight test activity, including, for example, but not limited to: — hazard analysis; — detailed flight test planning; — the generation and approval of flight conditions; — the definition and verification of the test-aircraft configuration; — preparation of the aircraft; — the integration, calibration and verification of any flight test equipment;

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— verification of the fitness of the aircraft for flight; — issuing or obtaining a PtF; — the preflight briefing, and conducting the flight test; and — debriefing and data reporting. The FTOM, or its equivalent, identifies all the documents and records that are required to be generated or maintained in relation to the flight test, including the definitions for the authority to sign. The FTOM, or its equivalent, identifies how training for flight tests is organised. The definition of the methods required may be provided in different ways, including but not limited to flow charts, process descriptions, forms that are detailed enough to enforce adherence to the required workflow, workflow implementation in IT-based ERP systems, or similar means. The implementation of the standard FTOM, including its associated process definitions and forms, ensures adherence to this AMC, and hence that there will be compliance with the relevant requirements of Part-21. Any flight tests that are subcontracted to a third party should comply with the FTOM of the DOA, unless the third party has established an FTOM that is in compliance with Part-21, and its use has been agreed between the two organisations.

AMC-ELA No 1 to 21.A.243(d) Data – Statement of qualifications and experience

Evidence of their qualifications and experience is documented for the persons who accept the duties defined for the following roles: — head of the design organisation (HDO); — head of airworthiness (HoA); — independent system monitoring (ISM); — compliance verification engineer (CVE). The credentials of the HDO, HoA and ISM are provided to EASA using EASA Form 4-DOA. The form is published on the EASA webpage. For the CVE, no individual statement is needed. CVEs are selected by the applicant/approval holder on the basis of their knowledge, background and experience as defined in the DOH. When necessary, complementary training should be established to ensure that CVEs have sufficient background and knowledge in the scope of their authorisation. The organisation maintains a record of the CVE personnel, which includes details of the scopes of their authorisations. The CVE personnel are given reasonable access on request to their own records. As part of its investigations, EASA has the right to access the data held in such a system. The following minimum information on each of the CVEs should be kept on record: a) name,

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b) date of birth, c) experience and training, d) position in the organisation, e) scope of the authorisation, f) date of the first issue of the authorisation, g) if applicable, the date of expiry of the authorisation, h) identification number of the authorisation, i) documented acceptance of the nomination by the CVE. Evidence of the authorisation is provided in a reasonably accessible way within the company, so that a staff member who needs to be aware of the authorisation can verify their status whenever needed. This can be achieved by the provision of accessible listings of the nominated staff members, or by other means. The issuing of individual badges or passes is not required. The organisation should keep the records of a CVE for at least 2 years after the CVE has ceased to be employed by the organisation, or 2 years after the withdrawal of the CVE’s authorisation, whichever occurs first.

AMC1 21.A.243(d) Handbook

STATEMENT OF QUALIFICATIONS AND EXPERIENCE

(a) The following statements should be provided: (1) Other management staff as defined in GM1 21.A.243(d) For each nominated manager, the organisation should provide this data to EASA to show that the nominated managers are suitable in terms of their relevant knowledge and satisfactory experience related to the nature of the design activities that are performed by the organisation. (2) The staff that make decisions that affect airworthiness, operational suitability, and environmental protection For that staff, no individual statements are required. The organisation should demonstrate that there is an internal authorisation system that allows it to select, train, maintain, and identify them for all the tasks for which they are needed. (b) The staff that is defined in point (a) should be identified in the handbook or linked to it. This, together with the corresponding procedures, should enable that staff to carry out the assigned tasks and to properly discharge the associated responsibilities.

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GM No AMC2 to 21.A.243(d) HandbookData requirements – Statement of the qualification and experience – Organisations that design minor changes to type designs or minor repairs to products

STATEMENT OF THE QUALIFICATION AND EXPERIENCE — ORGANISATIONS THAT DESIGN MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS

For organisations that designing minor changes to type design or minor repairs to products, the statement of the qualifications and experience that is required by point 21.A.243(d) should be addressed as follows: (a)1. The nominated managers should be identified and their relevant knowledge and satisfactory experience related to the nature of the design activities that they perform should be demonstrated. For each nominated manager, the organisation should provide evidence of competencycredentials submitted to on EASA Form 4 - DOA (see http://easa.europa.eu/certification/application-forms.php) in orderso that they may be seenconsidered to be appropriate in terms of relevant knowledge and satisfactory experience related to the nature of the design activities as performed by the organisation. (b)2. The persons responsible tofor: — classifyclassifying changes to type designs or repairs (point 21.A.263(c)(1)); — verifyverifying compliance (point 21.A.239(b)(d)(2)); — approveapproving minor changes to type design and minor repairs (point 21.A.263(c)(2)); and — issueissuing information or instructions (point 21.A.265(h)), should be selected by the onisation in accordance with a procedure and criteria that are agreed with by the AgencyEASA.

GM1 No 1 to 21.A.243(d) HandbookStatement of qualifications and experience

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c) Experience and training d) Position in organisation e) Scope of the authorisation f) Date of first issue of the authorisation g) If appropriate, date of expiry of the authorisation h) Identification number of the authorisation. The record may be kept in any format and should be controlled. — Persons authorised to access the system should be maintained at a minimum to ensure that records cannot be altered in an unauthorised manner or that such confidential records do not become accessible to unauthorised persons. — Personnel should be given access to their own record. — Under the provision of 21.A.257 the Agency has a right of access to the data held in such a system. — The organisation should keep the record for at least two years after a person has ceased employment with the organisation or withdrawal of the authorisation, whichever is the sooner.

AMC1 21.A.245(a) Resources

HEAD OF THE DESIGN ORGANISATION

(a) The head of the design organisation (HDO) should: (1) have sufficient knowledge and authority to be able to respond to the competent authority regarding major issues concerning the design organisation (DO) and the product design approval, and to carry out any necessary improvements; (2) promote the safety policy that is specified in AMC1 21.A.239(c)(1); and (3) demonstrate a Part 21 understanding that is sufficient to discharge the relevant responsibilities. (b) The handbook that is submitted in accordance with point 21.A.243 should show that the HDO has the direct or functional responsibility for all the departments of the organisation which are responsible for the design of the product. If the departments responsible for design are functionally linked, the HDO still has the ultimate responsibility for compliance of the DO with Part 21.

AMC1 21.A.245(b) Resources

NOMINATED MANAGERS

(a) The person or group of persons nominated in accordance with point 21.A.245(b) should represent the management structure of the organisation and be responsible for all the functions as specified in Part 21, Subpart J.

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(b) The nominated managers should be identified (see GM1 21.A.243(d)). (c) The responsibilities and the duties of each individual manager should be defined. (d) The independent monitoring function should be independent from the design and airworthiness functions. As such, the chief of the independent monitoring function should not be at the same time one of the other persons that are referred to in point 21.A.245(b)(1) or (b)(3), 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 head of the design organisation (HDO), 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. (e) Chief of the airworthiness function If more than one team, including their management, are designated for the airworthiness function as defined in point 21.A.239(d)(1)(i), the HDO should identify the person that acts as the unique focal point for the entire design organisation (DO), i.e. the ‘chief of the airworthiness function’. The need to designate more than one team may be triggered by the specific scope and volume of activity of the DO. For example: — managing several lines of products (separate airworthiness representative per line of product); and — division between initial and continued airworthiness activities. The tasks for which the chief of the airworthiness function should be responsible are presented in AMC1 21.A.239(d), point (c)(1)(iv). (f) Chief of the independent monitoring function The role of the chief of the independent monitoring function 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.245(b); (2) an audit plan is properly implemented, maintained, and continually reviewed and improved; and (3) corrections and corrective action are requested, as necessary. (g) Safety manager If more than one person is designated for the development, administration, and maintenance of effective safety management processes as defined in point 21.A.239(c)(2), the HDO should identify the ‘safety manager’ as the unique focal point. The role of the safety manager should be: (1) to facilitate hazard identification, as well as risk assessment and management;

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(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.239(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.

GM1 21.A.245(c)(2) Resources

DIRECT SUPERVISION OF THE AIRWORTHINESS FUNCTION BY THE HEAD OF THE DESIGN ORGANISATION

To cope with unexpected circumstances, for a period of time, it is possible for the head of the design organisation (HDO) to directly supervise the airworthiness function activities. This period of time should be limited and should typically not exceed 6 months. Such a situation should be discussed with EASA and may be subject to certain limitations (e.g. only continued airworthiness activities may be allowed).

AMC1 21.A.245(d) Resources

MANAGEMENT REPORTING LINES AND COMPETENCIES

(a) Managers that are nominated in accordance with point 21.A.245(b) should report directly to the HDO through either a hierarchical or a formal functional link. (b) All prospective members of the design management staff and staff that is nominated in accordance with point 21.A.245(b) 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 design management organisation procedures that are applicable to their tasks; 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 chief of the airworthiness function should be able to demonstrate relevant knowledge, background, and appropriate experience that are related to the product certification and continued airworthiness, including knowledge of, and experience in, managing the design assurance system.

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(d) The chief of the independent monitoring function 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. (e) 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.245(e) Resources

STAFF, FACILITIES, AND COORDINATION

(a) General The handbook that is submitted in accordance with point 21.A.243 should show that sufficient skilled personnel are available, and that suitable technical and organisational provisions are made for carrying out the type investigation that is defined in GM1 21.A.239(d), point (b)(3). (b) Personnel The organisation should show that the personnel that is available to comply with point 21.A.245(e)(1) are able, based on their special qualifications and numbers, to provide assurance of the design or modification of a product, as well as of the compilation and verification of all the data that is needed to meet the applicable type certification basis, operational suitability data (OSD) certification basis, and environmental protection requirements, while taking into account the state of the art and new experience. 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) Technical The organisation should have access to: (1) workshops and production facilities that are suitable for manufacturing prototype models and test specimens; and (2) accommodation and test facilities that are suitable for carrying out the tests and measurements that are needed to demonstrate compliance with the type certification

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GM No 2 to 21.A.245 Requirements for approval – Organisations designing minor changes to type design or minor repairs to products

The data submitted in accordance with 21.A.243 should show that: 1. The manager responsible for design has the direct or functional responsibility for all departments of the organisation which are involved in the design of minor changes to type design or minor repairs to products. 2. Person(s) have been nominated to liaise with the Agency and to co-ordinate airworthiness, operational suitability and environmental protection matters. Their position in the organisation should allow direct report to the manager responsible for design. 3. Responsibilities for all tasks related to the design and approval of minor changes to type design or minor repairs to products are assigned to ensure that all areas are covered 4. The responsibility for a number of tasks as in paragraph 3 may be assigned to one person especially in the case of simple projects.

AMC1 21.A.247 Changes to the design management system

APPLICATION FOR APPROVAL OF SIGNIFICANT CHANGES OR CHANGES IN THE TERMS OF APPROVAL OF A DESIGN ORGANISATION

An application for approval of significant changes or changes in the terms of approval of a design organisation (DO) should be submitted in writing to EASA. The design organisation (DO) should demonstrate to EASA, on the basis of the submission of any proposed changes to the handbook or the DOA, and before the implementation of the changes, that it will continue to comply with Part 21 after the implementation.

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GM1 21.A.247 Significant Changes toin the design managementassurance system

In addition to a change in ownership (see point 21.A.249), the following changes to the design assurancemanagement system should be considered to be ‘significant’ tofor the demonstration of compliance, or tofor the airworthiness, operational suitability, or environmental protection of the products: (a)1. Organisation — Relocation to new premises (see also GM 21.A.249).; — A changeChange in the industrial organisation (partnership, subcontractorssuppliers, design work sharing), unless it can be shown that the independent verificationchecking function of the demonstration of compliance is not affected.; — A changeChange in the parts of the organisation that contribute directly to the airworthiness, operational suitability, or environmental protection (independent verificationchecking function, airworthiness functionoffice of airworthiness (or equivalent)).; — A changeChange to the independent monitoring principles of compliance and adequacy (see point 21.A.239(e)(a)(3)). (b)2. Responsibilities — Change of the management personnelstaff.: — the Hhead of the design organisation (HDO) (see point 21.A.245(a))(GM No 1 to 21.A.239(a), para.3.1.2; GM No 1 to 21.A.245, para.4.1; GM 21.A.265(b)); — the Cchief of the Office of Aairworthiness function (see point 21.A.245(b))(GM No 1 to 21.A.245, para. 4.2); and — the Cchief of the independent monitoring function of compliance and adequacy of the design managementassurance system (see point 21.A.245(b)(2))(21.A.239(a)(3) and AMC No 1 to 21.A.243(a), para.2).; and — the safety manager (see point 21.A.239(c)(2)). — Reporting lines between the personnel that is nominated in accordance with point 21.A.245(b) and the HDO. — New distributionAllocation of responsibilities that affecting safety, airworthiness, operational suitability, or environmental protection.; — For organisations designing minor changes to type designor minor repairs to products, change of the persons identified in GM No 2 to 21.A.243(d). (c)3. Procedures Change to the principles of procedures related to: — the type certification;

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— the classification of changes and repairs as ‘major’ or ‘minor’ (see point 21.A.263(c)(1)); — the treatmenthandling of major changes and major repairs; — the approval of the design of minor changes and minor repairs (see point 21.A.263(c)(2)); — the approval of the design of certain major repairs (see point 21.A.435(b) or 21.A.263(c)(5)); — the approval of the conditions under which a permit to fly can be issued (see point 21.A.263(c)(6)); — the issue of a permit to fly (see point 21.A.263(c)(7)); — the approval of certain major changes to a type certificate (TC) (see point 21.A.263(c)(8)); — the approval of certain supplemental type certificates (STCs) (see point 21.A.263(c)(9)); — the approval of certain major changes to certain STCssupplemental type certificates; (see point 21.A.263(c)(9)); — continued airworthiness or continued operational suitability (see point 21.A.3B); — the configuration control, when airworthiness, operational suitability, or environmental protection is affected; — the acceptability of design tasks that are undertaken by partners or subcontractors (see point 21.A.239(d)(3)(c)); — the issue of data and information under the obligation of point 21.A.265(h).; and — the safety risk management process (see point 21.A.239(c)(3)). (d)4. Resources — A substantialSubstantial reduction in the number and/or experience of personnelstaff (see point 21.A.245(d)(1)(a)).

GM-ELA No 1 to 21.A.247 Changes to thein design managementassurance system

[…]

GM-ELA No 1 to 21.A.257 Investigations – Arrangements

Investigations by EASA may include enquiries, questions, discussions, explanations and inspections of products that are developed under the scope of approval of the DOA. The design organisation should assist EASA in its investigations by providing appropriate means to allow EASA to perform these inspections and audits, such as meeting rooms and office support. If design partners or subcontractors fulfil nominated functions within the DO, for example as CVEs, the organisation should coordinate access to the subcontractor, when it is explicitly requested by EASA on a specific subject.

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When the competent authority of a Member State receives an airworthiness directive from the competent authority of a non-Member State, that airworthiness directive should be transferred to EASA for dissemination in accordance with Article 76 of Regulation (EU) 2018/1139.

AMC2 21.B.15(b) Information to the Agency

EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH EASA

Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and EASA.

GM1 21.B.15(b) Information to the Agency

MEANING OF SAFETY-SIGNIFICANT INFORMATION THAT STEMS FROM OCCURRENCE REPORTS

Safety-significant information that stems from occurrence reports means: (a) a conclusive safety analysis that summarises individual occurrence data and provides an in-depth analysis of a safety issue, and that may be relevant for EASA’s safety action planning; and (b) individual occurrence data for the cases in which EASA is the competent authority and which fulfils the reporting criteria of GM3 21.B.15(b).

GM2 21.B.15(b) Information to the Agency

A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders that are affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment that establishes the severity and probability of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely consequences of the safety issue from occurring;

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GM No 2 to 21.B.45 Co-ordination

An exchange of information should especially take place in accordance with Article 15 of the Regulation (EC) No 216/2008: (a) an immediate reaction of a competent authority of the Member State to a safety problem (b) granting of exemptions by the competent authority of the Member State from the substantive requirements of the Regulation (EC) No 216/2008 and its implementing rules (for a period of more than two months or when the exemptions become repetitive)

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(c) granting of approvals on an equivalent level of protection by the competent authority of the Member State by derogation from the Part 21 requirements

GM No 3 to 21.B.45 Reporting – Information relevant to registers established by the Agency

When so requested by the Agency, the competent authority of the Member State should notify any certificate or approval issued, changed or revoked including details of the scope of that certificate or approval to the Agency for inclusion in a central register managed by the Agency.

AMC1 21.B.55(a) Record-keeping

GENERAL

(a) The record-keeping system should ensure that all the records are accessible within a reasonable time whenever they are needed. Those records should be organised in a manner that ensures their traceability and retrievability throughout the required retention period. (b) All the records that contain sensitive data on applicants or organisations should be stored in a secure manner with controlled access, to ensure their confidentiality. (c) The records should be kept in paper form, or in an electronic format, or a combination of both. Records that are stored on microfilm or optical discs are also acceptable. The records should remain legible and accessible throughout the required retention period. The retention period starts when the record is created. (d) Paper record systems should use robust material that can withstand normal handling and filing. Computer record systems should have at least one backup system that should be updated within 24 hours of any new entry. Computer record systems should include safeguards to prevent unauthorised personnel from altering the data. (e) All the computer hardware that is used to ensure the backup of data should be stored in a different location from the one that contains the working data and in an environment that ensures that the data remains in a good condition. When hardware or software changes take place, special care should be taken that all the necessary data continues to be accessible throughout at least the full period that is specified in point 21.B.55(d).

AMC1 21.B.55(a)(1) and (a)(2) Record-keeping

COMPETENT AUTHORITY MANAGEMENT SYSTEM

The records that are related to the competent authority’s management system should include, as a minimum, and as applicable: (a) the documented policies and procedures; (b) the personnel files of the competent authority personnel, with the supporting documents related to their training and qualifications;

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(c) the results of the competent authority’s internal audits and safety risk management processes, including audit findings, as well as any corrective, preventive, and risk mitigation action; and (d) the contracts that are established with the qualified entities that perform certification or oversight tasks on behalf of the competent authority.

GM1 21.B.55(e) Record-keeping

TRACEABILITY OF RELEASE CERTIFICATES

The record-keeping of those EASA Forms 52 and 1 that are validated by the competent authority should allow the verification of that validation by the parties concerned, including the recipients of the release certificates.

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GM 21.B.130(b) Issue of the letter of agreement

The agreement should include or reference a pre-defined plan of inspection points established as part of the production inspection system and agreed with the competent authority to be used as a basis for the inspections described in 21.A.129 and 21.B.120(c)(5) and its associated CS and GM. The plan should clearly identify inspection point, places, inspection subjects (materials, process, tooling documentation, human resources, etc.), as well as the focal points and the method of communication between the manufacturer and the competent authority. The competent authority should detail a method how it will assure itself that the manufacturer is working in accordance with the manual and the agreed inspection procedures during the validity period of the agreement. For renewal of this validity period the procedure as defined in 21.B.140 should be used. Any conditions under which the agreement will expire (such as termination date and/or number of units to produce), should be clearly stated in the letter of agreement.

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GM 21.B.150(d) Record keeping – Traceability of release certificates

The recordkeeping for those EASA Forms 52 and 1 that have been validated by the competent authority should allow verification of such validation by concerned parties including the recipients of the release certificates.

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SUBPART G — PRODUCTION ORGANISATION APPROVAL AMC No 1 to 21.B.230 Issue of the certificate

— have a properly operating feedback system to their national authorities organisation for POA and the manufacturer — maintain an effective working relationship with the manufacturer and his staff — be able to communicate effectively

GM 21.B.235(b) Maintenance of the POA - Work allocation within the competent authority

After issue of the approval the competent authority should appoint a suitable member of its technical staff as the POATL to be in charge of the approval for the purpose of continued surveillance. Where the POA holder facilities are located in more than one Member State the competent authority of the State of manufacture will liaise with the competent authorities of the various partners/members to ensure appropriate continued surveillance.

GM 21.B.235(b) and (c) Continued surveillance

Continued surveillance consists of: 1. Planned continued surveillance, in which the total surveillance actions are split into several audits, which are carried out at planned intervals during the validity period of the production organisation approval. Within the continued surveillance one aspect may be audited once or several times depending upon its importance. 2. Unplanned POA reviews, which are specific additional investigation of a POA holder related to surveillance findings or external needs. The competent authority is responsible for deciding when a review is necessary taking into account changes in the scope of work, changes in personnel, reports on the organisation performance submitted by other EASA or national authorities teams, reports on the in service product.

AMC 21.B.235(c) Continuation of POA

At the end of the 24 months continued surveillance cycle the POATL responsible for the POA should complete an EASA Form 56 (see GM No 2 to 21.B.220(c)) as a summary report for the continued surveillance including the recommendation for continuation of the POA as applicable. The EASA Form 56 should be countersigned by the person responsible within the competent authority for his acceptance. At this stage there is no limitation to the number of level two findings that may be open, provided they are within the time limits of the respective corrective action plans.

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AMC No 1 to 21.B.240 Application for significant changes or variation of scope of terms of the POA

The competent authority must receive an application for significant changes or variation of scope and terms of the POA on an EASA Form 51 (see below) completed by the applicant.

EASA Form 51 Application for significant changes or a variation of the scope or terms of a Part 21 POA Competent authority of an EU Member State or EASA 1. Name and address of the POA holder: 2. Approval reference number: 3. Location(s) for which changes in the terms of approval are requested: 4. Brief summary of the proposed changes to the activities at the item 3 addresses: a) General: b) Scope of approval: c) Nature of privileges: 5. Description of organisational changes: 6. Position and name of the accountable manager or nominee: _ ____ Date Signature of the accountable manager (or nominee)

EASA Form 51

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Block 1: the name should be entered as written on the current approval certificate. If a change in the name is to be announced, state the old name and address here, while using Block 5 for the information about the new name and address. The change of name and/or address should be supported by evidence, e.g. by a copy of the entry in the register of commerce. Block 2: state the current approval reference number. Block 3: state the location(s) for which changes in the terms of approval are requested, or state ‘not applicable’ here if no change is anticipated. Block 4: this block should include further details for the variation of the scope of approval for the addresses indicated in Block 3. The ‘General’ block should include overall information for the change (including changes e.g. in workforce, facilities, etc.), while the ‘Scope of approval’ block should address the change in the scope of work and products/categories following the principles laid down in GM 21.A.151. The ‘nature of privileges’ block should indicate a change in the privileges as defined in points 21.A.163(b)- (d). State ‘not applicable’ here if no change is anticipated. Block 5: this block should state the changes to the organisation as it is defined in the current production organisation exposition, including changes to the organisational structure, functions and responsibilities. This block should therefore also be used to indicate a change in the accountable manager in accordance with point 21.A.145(c)(1) or a change in the nomination of the responsible managers in accordance with point 21.A.145(c)(2). A change in the nomination of the responsible managers should be accompanied by the corresponding EASA Forms 4. State ‘not applicable’ here if no change is anticipated. Block 6: state the position and name of the accountable manager here. Where there is a change in the nomination of the accountable manager, the information should refer to the nominee for this position. State ‘not applicable’ here if no change is anticipated. In case of an application for a change of the accountable manager, EASA Form 51 should be signed by the new nominee for this position. In all other cases, EASA Form 51 should be signed by the accountable manager.

GM 21.B.245 Continued validity

1. GENERAL Decisions on restriction, surrender, suspension or revocation of POA will always be actioned in such a way as to comply with any applicable national laws or regulations relating to appeal rights and the conduct of appeals, unless the decision has been taken by the Agency. In such case, the Agency appeal procedures will apply. 2. RESTRICTION is temporary withdrawal of some of the privileges of a POA under 21.A.163. 3. SURRENDER is a permanent cancellation of a production organisation approval by the competent authority upon formal written request by the accountable manager of the organisation concerned. The organisation effectively relinquishes its rights and privileges granted under the approval and, after cancellation, may not make certifications invoking the approval and must remove all references to the approval from its company documentation. 4. SUSPENSION is temporary withdrawal of all the privileges of a production organisation approval under 21.A.163. The approval remains valid but no certifications invoking the approval may be made while the suspension is in force. Approval privileges may be re-instated when the

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circumstances causing the suspension are corrected and the organisation once again can demonstrate full compliance with the Requirements. 5. REVOCATION is a permanent and enforced cancellation of the whole of an approval by the competent authority. All rights and privileges of the organisation under the approval are withdrawn and, after revocation, the organisation may not make any certifications or other statements invoking the approval and must remove all references to the approval from its company documentation.

AMC 21.B.245 Corrective action plan

It is expected that any established POA holder will move quickly to re-establish compliance with Part 21 and not risk the possibility of approval suspension. Therefore, the corrective action period granted by the competent authority must be appropriate to the nature of the finding but in any case initially must not be more than six months. In certain circumstances and subject to the nature of the finding the competent authority can vary the six months period subject to a satisfactory corrective action plan agreed by the competent authority. Failure to comply within time scale agreed by the competent authority means that provisional suspension of the POA in whole or in part must proceed.

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Fotnoter

1 ICAO Document 10151 ‘Manual on Human Performance (HP) for Regulators’, First Edition, 2021. 2 Ibid. Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18) (https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX%3A32014R0376&qid=1669377456448).
4 Commission Implementing Regulation (EU) 2015/1018 of 29 June 2015 laying down a list classifying occurrences in civil aviation to be mandatorily reported according to Regulation (EU) No 376/2014 of the European Parliament and of the Council (OJ L 163, 30.6.2015, p. 1) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32015R1018&qid=1669631925416).
5 Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R1321&qid=1669641196734).
6 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1) (https://eurlex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri=CELEX:32018R1139).

ANNEX TO ED DECISION 2022/021/R

ANNEX I (PART 21)

GM1 Annex I Definitions

Note 2: safety management training refers to specific training for the staff that are involved in safety management functions in accordance with points 21.A.139(c) and 21.A.239(c) of Part 21. Working days It refers to days between, and including, Monday and Friday, except public holidays.

GM2 Annex I Abbreviations

GM1 21.1 Competent authority

RESPONSIBILITY FOR THE IMPLEMENTATION OF PART 21

GM1 21.1(e) Competent authority

PERMIT TO FLY

SECTION A — TECHNICAL REQUIREMENTS SUBPART A — GENERAL PROVISIONS GM1 21.A.3A Reporting system

LINK BETWEEN POINT 21.A.3A AND REGULATION (EU) No 376/2014

AMC1 21.A.3A(a) Reporting system

COLLECTION, INVESTIGATION, AND ANALYSIS OF EVENTS

GM1 21.A.3A(a) and 21.A.3A(b) Reporting system

GENERAL — COLLECTING SYSTEM

AMC2 21.A.3A(a) Reporting system

COLLECTION, INVESTIGATION, AND ANALYSIS OF DATA RELATED TO FLAMMABILITY REDUCTION MEANS (FRM) RELIABILITY

AMC3 21.A.3A(a) Reporting system

COLLECTION, INVESTIGATION, AND ANALYSIS OF DATA RELATED TO EDTO-SIGNIFICANT OCCURRENCES

GM1 21.A.3A(a), 21.A.3A(e), and 21.A.3A(f) Reporting system

GENERAL

on the characteristics that affect the airworthiness of the product. However, it should be noted that the obligations under Regulation (EU) No 376/2014 and its implementing acts still apply.

GM1 21.A.3A(a)(1) and (b)(1) Reporting system

EVENTS REPORTED VOLUNTARILY TO THE ORGANISATION

GM2 21.A.3A(a)(1) and (b)(1) Reporting system

INTERNAL SAFETY REPORTING SCHEME

AMC1 21.A.3A(a)(3), 21.A.3A(b)(3), 21.A.3A(d) Reporting system

REPORTING TO THE COMPETENT AUTHORITY

GM1 21.A.3A(a)(3), 21.A.3A(b)(3) and 21.A.3A(d) Reporting system

REPORTING TO THE COMPETENT AUTHORITY — GENERAL

AMC1 21.A.3A(e) Reporting system

FOLLOW-UP TO, AND CLOSURE OF, REPORTED OCCURRENCES

AMC No 1 to 21.A.3A(a) Collection, investigation and analysis of data related to Flammability Reduction Means (FRM) reliability

AMC No 2 to 21.A.3A(a) Collection, investigation and analysis of data related to ETOPS significant occurrences

AMC3 21.A.3A(a) Failures, malfunctions and defects

INVESTIGATION AND ANALYSIS

GM 21.A.3A(a) Failures, malfunctions and defects

GENERAL

GM 21.A.3A(b) Failures, malfunctions and defects

OCCURRENCE REPORTING

AMC 21.A.3A(b)(2) Reporting to the Agency

AMC1 21.A.5 Record-keeping

GM1 21.A.5 Record-keeping

AMC1 21.A.5(a) and 21.A.433(b) Repair design and record-keeping

GM1 21.A.5(a) and (b) Record-keeping

RECORDING AND ARCHIVING SYSTEM

— digital data: it is typically in the form of computer-generated bytes of information that is stored in a computer workable file (e.g. MS Word file, MS Excel file, 3D CAD file).

AMC1 21.A.5 (d) & (e) Record-keeping

RECORD OF STAFF INVOLVED IN DESIGN OR PRODUCTION

GM1 21.A.9 Access and investigations

ARRANGEMENTS

SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL AMC1 No 1 to 21.A.122 Eligibility —– Link between design and production

LINK BETWEEN DESIGN AND PRODUCTION

AMC1 21.A.124 Application

6. Links/arrangements with design approval holder(s) (DAHs)/ design organisation(s) (DO(s)), where different from Block 1: 7. Human resources: 8. Name of the person signing the application: ______________________________ ___________________________________ Date Signature

GM 21.A.124(a) Application – Application form

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

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE

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

GENERAL

(a) Acceptable means of compliance (AMC), as referred to in Article 76(3) of Regulation (EU) 2018/1139 , are a tool to standardise the demonstration of compliance with, and facilitate the

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

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE IS NEEDED

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

ROOT CAUSE ANALYSIS

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

FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION

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

DUE CONSIDERATION TO OBSERVATIONS

GM1 21.A.126(b)(5) Production inspection system –— Engineering and manufacturing review procedure

GM 21.A.126(b)(6) Production inspection system – Recording and record keeping

SUBPART G — PRODUCTION ORGANISATION APPROVAL GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design data

An uncontrolled non-compliance with applicable design data is a non-compliance: — that cannot be discovered through systematic analysis; or — that prevents identification of affected products, parts, appliances, or material.

GM No 2 to 21.A.158(a) Examples of level one findings

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

SAFETY MANAGEMENT ELEMENT

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

SAFETY MANAGEMENT ELEMENT

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

SAFETY POLICY & OBJECTIVES

6. Links/arrangements with design approval holder(s) (DAHs)/ design organisation(s) (DO(s)), where different from Block 1: 7. Human resources: 8. Name of the person signing the application: _____ Date Signature