21L.A.1 Scope

Regulation (EU) 2022/1358

This Section establishes general rights and obligations that are applicable to:

(a) the applicant for, and holder of, any certificate issued or to be issued in accordance with this Annex;

(b) any declarant of design or production capability or of design compliance; and

(c) any natural or legal person issuing a statement of conformity for an aircraft, or an authorised release certificate (EASA Form 1) for an engine, propeller or part produced.

21L.A.2 Obligations and actions performed by a person other than the applicant for, or holder of, a certificate or the declarant of a declaration of design compliance

Regulation (EU) 2022/1358

The actions and obligations required to be undertaken by the applicant for, or holder of, a certificate for a product or part or by the declarant of a declaration of design compliance under this Section may be undertaken on its behalf by any other natural or legal person, provided that the applicant’s, holder’s or declarant’s obligations are and will be properly discharged.

21L.A.3 Reporting system

Regulation (EU) 2022/1358

(a) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council⁷⁰Regulation (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). and its delegated and implementing acts, any natural or legal person who holds or has applied for a type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, or who has declared the compliance of an aircraft design, or a design change or repair design to it under this Annex shall:

1. establish and maintain a system for collecting, investigatingand analysing occurrence reports in order to identify adverse trends or to address deficiencies, and to extract occurrences, whose reporting is mandatory in accordance with point (3) and those which are reported voluntarily. The reporting system shall include:

(i) reports of and information related to failures, malfunctions, defects or other events which cause or might cause adverse effects on the continuing airworthiness of the product or part covered by the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, or by the declaration of design compliance issued under this Annex;

(ii) reports of errors, near misses, and hazards that do not fall under point (i);

2. make available to known operators of the product or part, and, on request, to any person authorised under other associated implementing acts or delegated acts, the information about the system established in accordance with point (a)(1), and on how to provide such reports of and information related to failures, malfunctions, defects or other events referred to in point (a)(1)(i);

3. report to the Agency any failure, malfunction, defect or other event of which they are aware related to a product or part, covered by the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, or by a declaration of design compliance issued under this Annex, and which has resulted in or may result in an unsafe condition.

(b) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person who has declared their production capability under SUBPART G of this Annex, or who produces a product or part under SUBPART R of this Annex, shall:

1. establish and maintain a system for collecting and assessing internal occurrence reports, including reports on internal errors, near misses, and hazards, in order to identify adverse trends or to address deficiencies, and extract occurrences, whose reporting is mandatory in accordance with points (2) and (3) and those which are reported voluntarily;

2. report, to the responsible design approval holder or declarant of a declaration of design compliance, all cases in which products or parts have been released by them and subsequently identified to have possible deviations from the applicable design data, and investigate with the design approval holder or the declarant of a declaration of design compliance, to identify those deviations which could lead to an unsafe condition;

3. report to the Agency and the competent authority of the Member State responsible in accordance with point 21L.2, if any, the deviations which could lead to an unsafe condition that were identified according to point (2) of point 21L.A.3(b);

4. if acting as a supplier to another production organisation, report to that other organisation all the cases in which it has released products or parts to that organisation and subsequently identified them to have possible deviations from the applicable design data. 

The reporting obligations of point 21.A.3A(b) of Annex I of natural and legal persons who hold or have applied for a production organisation approval shall include occurrences related to products and parts produced in conformity with design data approved or declared in accordance with this Annex, and, where the design compliance was declared, reports shall be made to the declarant of design compliance.

(c) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person referred to in points (a) and (b) when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately safeguard the confidentiality of the reporter and of the persons mentioned in the report.

(d) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, any natural or legal person referred to in points (a) and (b) shall make the reports defined in points (a)(3) and (b)(3) in a form and manner established by the competent authority as soon as practicable, and in any case, dispatch the reports not later than 72 hours after the natural or legal person referred to in points (a) and (b) has identified the possible unsafe condition, unless exceptional circumstances prevent this.

(e) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, if an occurrence reported under point (a)(3) or under point (b)(3) results from a deficiency in the design, or a production deficiency, the holder of the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, the declarant of a declaration of design compliance or the production organisation referred to in point (b) as appropriate, shall investigate the reason for the deficiency and report to the Agency and to the competent authority of the Member State responsible in accordance with point 21L.2, if any, the results of its investigation and any action it is taking or proposes to take to correct that deficiency.

(f) If the competent authority finds that an action is required to correct the deficiency, the holder of the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, the declarant of a declaration of design compliance, or the production organisation referred to in point (b) as appropriate, shall submit the relevant data to the competent authority upon its request.

GM1 21L.A.3 Reporting system

ED Decision 2023/013/R

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

Regulation (EU) No 376/2014⁷¹ of the European Parliament and of the Council lays down requirements on the reporting, analysis and follow-up of occurrences in civil aviation. Compliance with point 21L.A.3 of Part 21 Light does not exempt organisations from compliance with Regulation (EU) No 376/2014. For each category of reporter, Regulation (EU) 2015/1018⁷² defines the nature of items to be mandatorily reported. Regulation (EU) No 376/2014 also considers voluntary reporting of other items that are perceived by the reporter as a threat to aviation safety.

Point 21L.A.3 lays down requirements for the mandatory reporting of events to the competent authority in view of performing the necessary activities linked to the continued airworthiness of products or parts.

For Part 21 Light design and production organisations and natural or legal persons that use Subpart R for production, the reportability criteria (i.e. potential unsafe condition) are the same as for Regulation (EU) No 376/2014.

Furthermore, compliance with Regulation (EU) No 376/2014 does not exempt organisations from compliance with point 21L.A.3. However, this should not give rise to two parallel reporting systems, and point 21L.A.3 and Regulation (EU) No 376/2014 should be seen as complementary in that respect.

In practice, this means that reporting obligations under point 21L.A.3 on one hand and reporting obligations under Regulation (EU) No 376/2014 on the other hand are compatible. These reporting obligations may be discharged using one reporting channel.

In addition, any natural or legal person that has more than one role subject to the obligation to report may discharge all those obligations through a single report. Natural or legal persons (organisations) are encouraged to properly describe this in their procedures, to address cases in which the responsibilities are discharged on behalf of the organisation.

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

ED Decision 2023/013/R

COLLECTION, INVESTIGATION AND ANALYSIS OF EVENTS

In the context of the following AMC and GM, the term ‘event’ refers to any failure, malfunction, defect, error, near miss, hazard identification, incident, accident or other occurrence that is subject to a reporting system.

The ‘collection’, ‘investigation’ and ‘analysis’ functions of the reporting system should include means to:

—      analyse events and related available information;

—      identify adverse trends;

—      investigate the associated root cause(s); and

—      determine any necessary corrective action(s).

It should also allow the determination of reportable occurrences as required under points 21L.A.3(a)(3) or 21L.A.3(b)(3), as applicable.

In addition, for parts whose failure could lead to an unsafe condition, the ‘analysis’ function of the reporting system should ensure that reports and information sent, or available, to the design approval holder or declarant of a declaration of design compliance are fully investigated so that the exact nature of any event and its effect on continuing airworthiness is understood. This may then result in changes to the design and/or to the instructions for continued airworthiness (ICAs), and/or in establishing a mitigation plan to prevent or minimise the possibility of such occurrences in the future, as necessary. The ‘analysis’ is not limited to those occurrences that require the involvement of the Agency under point 21L.A.3(e).

GM1 21L.A.3(a);(b) Reporting system

ED Decision 2023/013/R

GENERAL — SYSTEM FOR COLLECTING OCCURRENCE REPORTS

The term ‘collecting’ means the setting up of systems and procedures which should enable relevant failures, malfunctions and defects, or other occurrences, to be properly collected when they occur.

As the collection system needs to accept reports that originate outside the organisation (from operators, maintenance organisation, suppliers, etc.), it is necessary to inform possible reporters of the existence of the system and the appropriate means to introduce reports into it. This does not presume that direct access to the system is to be granted if other mechanisms are more appropriate.

The collection system should also ensure the collection, through an internal reporting scheme, of internal errors, near misses and hazards that are perceived by the reporter as an actual or potential aviation safety risk.

Considerations for the collection of information related to events should include the following:

—      grouping of events;

—      analysis of failure rates;

—      the early rejection of parts from service; and

—      comparison with the certification assumptions.

GM1 21L.A.3(a);(e);(f) Reporting system

ED Decision 2023/013/R

GENERAL

Approval holders of minor changes and minor repairs or declarants of a design compliance for a minor change or minor repair other than the natural or legal person that submitted the declaration under Part 21 Light Subpart C do not have to comply with the requirements in point 21L.A.3(a), since according to the classification criteria for design changes and repairs (see points 21L.A.63 and 21L.A.203), minor changes and minor repairs have no appreciable effect on the characteristics affecting the airworthiness of a product. However, it should be noted that the obligations under Regulation (EU) No 376/2014 and its implementing acts still apply.

GM2 21L.A.3(a);(e);(f) Reporting system

ED Decision 2023/013/R

GENERAL

A certificate is ‘deemed to have been issued under this Annex’ if a certificate holder has elected to use Article 2a of Regulation (EU) No 748/2012 and that certificate is now governed by the provisions of Annex Ib (Part 21 Light) to Regulation (EU) No 748/2012 as detailed in the type-certificate data sheet or supplemental type-certificate data sheet.

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

ED Decision 2023/013/R

EVENTS REPORTED VOLUNTARILY TO THE ORGANISATION

Any natural person or legal person may voluntarily report to an organisation any event that is perceived by that person as posing an actual or potential hazard to aviation safety.

Voluntary reports may be originated by:

(a) persons that are not listed in Article 4(6) of Regulation (EU) No 376/2014; or

(b) persons that are listed in Article 4(6) of Regulation (EU) No 376/2014, even though such events are not included in Regulation (EU) 2015/2018;

(c) an organisation, if such organisation cannot determine whether the event should be mandatorily reported.

Example:

A maintenance staff member in a maintenance organisation reports to their maintenance organisation a perceived aircraft design issue that is not covered by Regulation (EU) 2015/2018. The maintenance organisation should make a final assessment on the voluntary report and if it assesses that the reported event ‘may involve an actual or potential aviation safety risk’, then it should mandatorily report it to the type-certificate holder or declarant, the competent authority, etc., as per point 145.A.60 ‘Occurrence reporting’ of Annex II (Part‑145) to Regulation (EU) No 1321/2014⁷³. If the maintenance organisation cannot determine whether a safety risk exists (due to a lack of competence, lack of data, etc.), it could voluntarily report it to the type-certificate holder or declarant for further assessment.

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

ED Decision 2023/013/R

INTERNAL SAFETY REPORTING SCHEME

The internal safety reporting scheme is part of the overall collection system. The objective of this GM is to provide specific guidance on the internal safety reporting scheme only.

(a) The overall objectives of the internal safety reporting scheme are to:

—       collect information that is reported by the organisation’s staff; and

—       use that reported information to improve the safety of operations.

Each internal safety reporting scheme should include provisions for confidentiality and enable and encourage free and frank reporting of events as those listed in point 21L.A.3(a)(1)(i) and (ii). This is facilitated by the establishment of a just culture.

(b) The specific objectives of the internal safety reporting scheme are to:

(1) enable an assessment of the safety implications of each relevant event that is reported, including previous similar events, so that any necessary action can be initiated; and

(2) ensure that lessons from relevant events are shared so that other persons and other entities within the organisation may learn from them.

(c) The internal safety reporting scheme is an essential part of the overall management system or the production control system and should be complementary to the routine procedures and control systems; it is not intended to duplicate or supersede any of them. The internal safety reporting scheme is a tool to identify those instances in which routine procedures have failed or may fail.

(d) All safety-related reports should be retained, as the significance of such reports may only become obvious later.

(e) The collection and analysis of timely, appropriate and accurate data will allow the organisation to react to the information that it receives, and to take the necessary action.

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

ED Decision 2023/013/R

REPORTING TO THE COMPETENT AUTHORITY

Within the overall limit of 72 hours, the degree of urgency for the submission of a report should be determined by the level of risk that is judged to have resulted from the occurrence.

If an occurrence is judged by the person identifying the possible unsafe condition to have resulted in an immediate and particularly significant hazard, the Agency (or the competent authority of the Member State as required) should be advised immediately and by the fastest possible means (telephone, fax, email, telex, etc.) of whatever details are available at the time. The initial report must be followed up by a full written report within 72 hours. An example would be an uncontained engine failure resulting in damage to the aircraft’s primary structure.

In all other cases, the submission of the report may be delayed up to a maximum of 72 hours after determination of the possible unsafe condition, in order to provide more details.

GM1 21L.A.3(a)(3);(b)(3) Reporting system

ED Decision 2023/013/R

REPORTING TO THE COMPETENT AUTHORITY — GENERAL

(a) The reference to ‘aware of’ an occurrence implies that the organisation identifies the event as one that falls into the category of occurrences to be reported — usually when the organisation determines that the event is reportable. The 72‑hour period starts when the possible unsafe condition is identified.

(b) Regulation (EU) 2015/1018 lays down a generic ‘list classifying occurrence in civil aviation to be mandatorily reported’. This list should not be understood as being an exhaustive collection of all issues that may pose a significant risk to aviation safety and, therefore, reporting should not be limited to the items listed in that Regulation.

(c) AMC‑20 ‘General Acceptable Means of Compliance for Airworthiness of Products, Parts and Appliances’ provides further details on occurrence reporting (AMC 20‑8).

(d) Point 21L.A.3(a)(3) requires the reporting of occurrences that may result in an unsafe condition. AMC1 21L.B.23(b) may be used to assist in the determination of an unsafe condition.

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

ED Decision 2023/013/R

FOLLOW-UP AND CLOSURE OF REPORTED OCCURRENCES

(a) The organisation should transmit the following information to the competent authority within 30 days from the date of notification of the occurrence to the competent authority:

(1) the latest position of the organisation responsible for design as to whether an unsafe condition is confirmed;

(2) the results of the analysis and of the first investigation — including the cause(s) of the occurrence, if known; and

(3) the measures it has taken, intends to take or proposes to be taken, including:

(i) containment measures that have already been defined by the reporting organisation and put in place (if any); and

(ii) in the case of reports made by the organisation responsible for design, for unsafe conditions, a risk assessment supporting that the product can be operated safely until the corrective action is defined and implemented, or that immediate mitigation measures need to be implemented until a more refined risk assessment can be provided.

Organisations are encouraged to provide a complete analysis and follow-up as soon as available and, in principle, no later than 3 months after the occurrence notification. It is recognised that analysing an occurrence may take longer than 3 months, especially if the investigation is complex or where the services of a specialist investigator are required.

The requirements for follow-up are not intended to jeopardise the quality and thoroughness of an occurrence analysis. It may be detrimental to safety if the analysis is completed in a rush within the encouraged 3‑month period without properly establishing the root cause(s), making a risk assessment and determining whether remedial action is required.

The designer (any natural or legal person that holds a type certificate, supplemental type certificate, major repair design approval, or that has declared the compliance of an aircraft design, or a design change or repair design to it under this Annex) and the production organisation (any natural or legal person that has declared their production capability under Subpart G of this Annex, or that produces a product or part under Subpart R) should cooperate, as necessary, to ensure that any corrective action can be implemented. In addition, affected organisations are expected to cooperate under their respective regulatory framework from the reporting of an occurrence until its closure, to ensure complete results.

The final (close-out) report should include:

—      the final designer position as to whether an unsafe condition exists;

—      the results of the occurrence analysis and of the final investigation, including the cause(s) of the occurrence;

—      any corrective and preventive action by the reporting organisation; and

—      in the case of reports made by the organisation responsible for the design, a risk assessment supporting that those corrective and preventive measures allow the product to be operated safely.

(b) Notwithstanding point (a), when the organisation identifies that no unsafe condition exists as a result of its analysis of a voluntarily reported occurrence, it can delay further communication to the competent authority up to the issue of the final report and report the occurrence as closed upon issue (data exchange). In such cases, no follow-up report should be submitted. The final report to EASA should include confirmation and justification that no unsafe condition exists. The organisation is requested to provide information on the cause(s) of the occurrence and on the corrective or preventive action that was taken by the organisation.

This way of reporting should not be understood as an accepted deviation from the requirements of Part 21 Light. If at any stage during the investigation, the organisation identifies that a possible unsafe condition exists, it should communicate it to EASA by means of a mandatory report within 72 hours.

21L.A.4 Airworthiness directives

Regulation (EU) 2022/1358

When an airworthiness directive has to be issued by the Agency in accordance with point 21L.B.23 to correct an unsafe condition, or to require the performance of an inspection, the holder of the type certificate, supplemental type certificate, major repair design approval, or any other relevant certificate deemed to have been issued under this Annex, as well as the declarant of a declaration of design compliance, as applicable, shall:

(a) propose the appropriate corrective action or required inspections, or both, and submit details of these proposals to the Agency for approval;

(b) following the approval by the Agency of the proposals referred to under point (a), make available to all known operators or owners of the product or part, and, on request, to any person required to comply with the airworthiness directive, appropriate descriptive data and accomplishment instructions.

21L.A.5 Collaboration between design and production

Regulation (EU) 2022/1358

The holder of a type certificate, supplemental type certificate, approval of a change to type certificate or approval of a repair design, the declarant of a declaration of design compliance, and the organisation or the natural or legal person producing products or parts of that specific design shall collaborate so as to ensure that the product or part are in conformity to that design and to ensure the continued airworthiness of the product or part.

AMC1 21L.A.5 Collaboration between design and production

ED Decision 2023/013/R

TRANSFER OF INFORMATION ON ELIGIBILITY AND STATUS FROM THE DESIGNER TO A PRODUCTION ORGANISATION

Where there is a need to provide (normally outside the organisation or entity responsible for design) a visible statement of approved or declared design data or airworthiness, or environmental protection data associated with the approved or declared design data, the following minimum information should be provided. The need for a visible statement may be in relation to an organisation that holds a production organisation approval (POA) in relation to point 21.A.163(c) or a registered declaration of production capability (declared production organisation) or a natural or legal person using Subpart R.

Information to be provided:

Company name: the name of the responsible organisation (or natural or legal person) for design (type certificate, supplemental type certificate, approval of repair or minor change design, declarant of a declaration of design compliance) that issues the information.

Date: the date at which the information is released.

Eligibility: indicate the specific products for which data has been approved or declared.

Identification: the part number of the part. Preference should be given to the use of the Illustrated Parts Catalogue (IPC) designation. Alternatively, the reference to the instructions for continued airworthiness (e.g. service bulletins (SBs), aircraft maintenance manual (AMM), etc.) could be stated. Marking requirements of Part 21 Light Section A Subpart Q should be taken into account.

Description: the name or description of the part or document should be given. In the case of a part, preference should be given to the use of the IPC designation. The description should include reference to any applicable European Parts Approval (EPA) marking, or previous national approvals still valid.

Purpose of data: the reason for the provision of the information should be stated by the organisation responsible for design.

Examples:

(a) Provision of approved or declared design data to a production organisation to permit manufacture (AMC1 21L.A.122(c), AMC1 21L.A.272 or AMC No 1 to 21.A.133(b) and (c)).

(b) Information regarding eligibility for installation (replacement parts, repair, modification, etc.).

(c) Direct Delivery Authorisation (AMC1 21L.A.122(c), AMC1 21L.A.272 or AMC No 1 to 21.A.133(b) and (c)).

If the data is in support of a change or repair, then reference to the aircraft level approval or declarations should be given (make reference to the approved supplemental type certificate, declaration, change or repair).

Limitations/remarks: state any information, either directly or by reference to supporting documentation, which identifies any particular data or limitations (including specific importing requirements) needed by a production organisation to complete Block 12 of the EASA Form 1.

Approval/declaration: provide reference information related to the approval or declaration of the data (EASA document / DOA privilege / registered declaration).

Authorised signature: name and handwritten or electronic signature of the person who has written authority from the organisation responsible for design, as indicated in the procedures overseen by EASA.

21L.A.6 Marking

Regulation (EU) 2022/1358

(a) The holder of a type certificate, supplemental type certificate, approval of a change to type certificate or approval of a repair design, or the declarant of a declaration of design compliance shall specify the marking for products or parts in accordance with Subpart Q of this Annex.

(b) The organisation or the natural or legal person producing products or parts shall mark these products and parts in accordance with Subpart Q of this Annex.

21L.A.7 Record-keeping

Regulation (EU) 2022/1358

All natural or legal persons who hold or who have applied for a type certificate, supplemental type certificate, repair design approval, or permit to fly, who have declared design compliance, who have issued a declaration of design or production capability, or who produce products or parts under this Regulation shall:

(a) when designing a product or part or changes or repairs thereto, establish a record-keeping system that incorporates the requirements imposed on its partners and subcontractors and maintain the relevant design information/data and hold it at the disposal of the Agency in order to provide the information necessary to ensure their continued airworthiness and compliance with the applicable environmental protection requirements;

(b) when producing a product or part, establish a record-keeping system and record the details of the work relevant to the conformity of the products or parts, and the requirements imposed on its partners and suppliers, and hold them at the disposal of the competent authority in order to provide the information necessary to ensure the continuing airworthiness of the product and part;

(c) with regard to permits to fly, in addition to the record-keeping requirements established in point 21.A.5(c) of Annex I, record any documents produced to demonstrate compliance with the additional requirements established in point 21L.A.241(b), and hold them at the disposal of the Agency and the competent authority;

(d) retain records of competence and the qualifications of personnel who are involved in design or production and in the independent function to monitor the compliance, if required by points 21L.A.125(c), 21L.A.175(b) or 21L.A.175(e).

AMC1 21L.A.7 Record-keeping

ED Decision 2023/013/R

(a) The record-keeping system should ensure that all the records required by point 21L.A.7 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 of Annex I (Part 21); or

(2) under the design and production activities conducted under points 21L.A.126, 21L.A.176 or 21L.A.274;

(3) for type certificates, supplemental type certificates, major changes and major repair design approvals that are not issued under the privileges defined under point 21.A.263 of Annex I (Part 21),

or

(4) for declarations of design compliance in accordance with Subpart C, F or N,

are retained throughout the operational life of the product or part.

(e) The retention period starts when the record is created or when it was last amended.

If the organisation transfers a certificate to another natural or legal person, the records related to the certificate should be transferred to the new holder.

GM1 21L.A.7 Record-keeping

ED Decision 2023/013/R

For organisations that hold or have applied for a type certificate, supplemental type certificate, change to the type-certificate approval, repair design approval, permit to fly or have submitted a declaration of design compliance or a declaration of design or production capability under Part 21 Light or produces (or intends to) using Subpart R, the relevant design information/data should include at least, as applicable:

—      design data such as type design data as defined in points 21L.A.26 and 21L.A.46 and changes to that data, and repair design data;

—      drawings and test reports, including inspection records for the product tested;

—      the certification demonstration plan, including related certification basis data (certification review items (CRIs), special conditions (SCs), equivalent safety findings (ESFs)); and

—      compliance-demonstration data.

For production organisations, the relevant records should include at least:

—      conformity justification data; and

—      conformity attestation data (e.g. EASA Form 1, EASA Form 52B).

AMC1 21L.A.7(a) Record-keeping

ED Decision 2023/013/R

REPAIR DESIGN AND RECORD-KEEPING

(a) The relevant substantiation data associated with a new major repair design and record‑keeping should include:

(1) identification of the damage and the source of the report;

(2) the major repair design approval/declaration sheet, identifying the applicable specifications and the references of the justifications;

(3) the repair drawing and/or instructions, and the scheme identifier;

(4) any correspondence with the type-certificate holder, supplemental type-certificate holder or declarant, if their advice on the design was sought;

(5) the structural justification (static strength, fatigue, damage tolerance, flutter, etc.) or references to that data;

(6) the effect on the aircraft, engines and/or systems (performance, flight handling, etc., as appropriate);

(7) the effect on the maintenance programme;

(8) the effect on the airworthiness limitations, the flight manual and the operating manual;

(9) any change in the weight and moment;

(10) any special test requirements; and

(11) the justification that the certified or declared noise or emissions level remain unchanged after the repair.

(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 or declared data, a justification for the classification is required.

(c) Special consideration should be given to repairs that impose subsequent limitations on the part or product (e.g. 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 type-certificate or supplemental type-certificate holder, when deemed necessary under point 21.A.208(c).

(e) Repairs to engines and/or propeller critical parts would normally only be accepted with the involvement of the type-certificate holder or the declarant if compliance of the engine has been included within the aircraft declaration of compliance.

GM1 21L.A.7(a);(b) Record-keeping

ED Decision 2023/013/R

RECORD-KEEPING AND ARCHIVING SYSTEM

The main purpose of record-keeping for organisations responsible for design and production is to ensure the retrievability of data required for the continued airworthiness of in-service products.

In addition, the records within a design environment are essential to ensure a proper control of the configuration of type design and its compliance with the certification basis or applicable technical specifications.

In the production environment, the records are 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, organisations responsible for design or production 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 required by points 21L.A.124, 21L.A.174 or in the manual/procedures required by point 21L.A.273 as appropriate.

All forms of recording media (paper, film, magnetic, etc.) are acceptable, including the use of electronic records*, provided they can meet the required duration for archiving under the conditions provided 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 against deterioration or accidental damage;

—      ensure the continued readability of the records;

—      demonstrate to the competent authority the proper functioning of the records system;

—      define an archiving period for each type of data subject as follows:

—      production data that supports the conformity of a product or part, 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 which supports the compliance of a product or part with the certification basis or applicable technical specifications, as well as data that is considered essential for continuing airworthiness is kept throughout the operational life of the product or part; such continued airworthiness data may include but are not limited to in-service occurrence reports and mandatory continuing airworthiness information;

—      organisations responsible for design or production should ensure that the recording and record-keeping system used by the partners, suppliers and subcontractors meet the record-keeping objectives with the same level of confidence as for their own system; in each case, it should be defined who 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.

* In relation 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);

—      ‘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 21L.A.7(d) Record-keeping

ED Decision 2023/013/R

RECORDS OF PERSONNEL INVOLVED IN DESIGN OR PRODUCTION

(a) The following should be the minimum information to be recorded for personnel that are involved in design or production and in the independent function to monitor the compliance, if required by points 21L.A.125(c), 21L.A.125(d), 21L.A.175(b) or 21L.A.175(e):

(b) 

(1) first name and surname;

(2) date of birth;

(3) basic training received and qualifications attained;

(4) specific training received and qualifications attained;

(5) continuation training (if appropriate);

(6) experience gained;

(7) scope of the authorisation;

(8) date of first issue of the authorisation;

(9) expiry date of the authorisation (if appropriate);

(10) identification number of the authorisation (or equivalent means to identify the link between the authorisation and the individual that holds the authorisation);

(11) changes to the data.

(c) The record may be kept in any format and should be controlled by an internal procedure of the organisation. That procedure is part of the management system of the organisation.

(d) Staff members should be given reasonable access, on request, to their own records as per Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Regulation) (OJ L 119, 4.5.2016, p. 1).

(e) A design or production organisation should keep the record of a particular staff member for at least 3 years after the staff member is no longer employed by the organisation or has changed their position in the organisation, or after the withdrawal of the authorisation, whichever occurs first.

21L.A.8 Manuals

Regulation (EU) 2022/1358

The holder of a type certificate or supplemental type certificate or the declarant of a declaration of design compliance shall produce, maintain and update master copies of all the manuals or variations in the manuals required by the applicable type-certification basis, the applicable detailed technical specifications and the applicable environmental protection requirements for the product or part, and provide copies, on request, to the Agency.

21L.A.9 Instructions for continued airworthiness

Regulation (EU) 2022/1358

(a) The holder of a type certificate, supplemental type certificate, design change or repair design approval or the declarant of a declaration of design compliance shall establish the information which is necessary for ensuring that the airworthiness of the aircraft type and any associated part, conforming to that design, is maintained throughout the operational life.

(b) The holder of a type certificate, supplemental type certificate, design change or repair design approval or the declarant of a declaration of design compliance shall provide the information established in (a) before that design is released to service.

(c) The instructions for continued airworthiness shall be provided by:

1. the holder of a type certificate or by the declarant of a declaration of design compliance to each known owner of one or more products upon its delivery or upon the issuance of the first certificate of airworthiness or restricted certificate of airworthiness, as applicable, for the affected aircraft, whichever occurs later;

2. the holder of a type certificate, supplemental type certificate or minor change approval or by the declarant of a declaration of design compliance for a design change to all known operators of the product affected by the change upon the release to service of the modified product;

3. the holder of a repair design approval or by the declarant of a declaration of design compliance for a repair design to all known operators of the product affected by the repair upon the release to service of the product in which the repair design is embodied. The repaired product or part may be released into service before the related instructions for continued airworthiness have been completed, but this shall be for a limited service period, and in agreement with the Agency.

Thereafter, these certificate holders or declarants shall make this information available on request to any other person required to comply with those instructions for continued airworthiness.

(d) By way of derogation from point (b), the type-certificate holder or declarant of a declaration of design compliance may delay the availability of a part of the instructions for continued airworthiness, dealing with long lead accomplishment instructions of a scheduled nature, until after the product or modified product has entered into service, but shall make those instructions available before the use of this data is required for the product or modified product.

(e) The design approval holder or declarant of a declaration of design compliance who is required to provide instructions for continued airworthiness in accordance with point (b) shall also make available all the changes to those instructions to all the known operators of the product affected by the change, and, on request, to any other person required to comply with those changes.

AMC1 21L.A.9(a) Instructions for continued airworthiness

ED Decision 2023/013/R

INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs) — CONTENTS

(a) The ICAs should identify the following, in accordance with the applicable certification specifications or applicable technical specifications:

(1) any limitations that are necessary for the continued airworthiness of the product or article;

(2) the means to determine when the product or article has deteriorated to the extent that it is no longer airworthy;

(3) the minimum actions required to restore the airworthiness of the product or article before the limitations (as per point (1)) have been exceeded or before their deterioration (as per point (2)), as an alternative to the withdrawal of the product or part from service.

(b) The ICAs should, therefore, include, in accordance with the applicable certification specifications or applicable technical specifications:

(1) any limitations determined through the certification or demonstration of compliance resulting in a declaration of compliance of the product or article, and instructions on how to determine that the limitations have been exceeded;

(2) any inspection, servicing or maintenance actions determined to be necessary by the certification process or demonstration of compliance resulting in a declaration of compliance;

(3) any inspection or troubleshooting actions determined to be necessary to establish the nature of faults and the necessary remedial actions;

(4) sufficient general information on the operation of the product or article to enable the understanding of the instructions in points (a)(1) to (a)(3) above.

AMC2 21L.A.9(a) Instructions for continued airworthiness

ED Decision 2023/013/R

IDENTIFICATION OF THE INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs)

The ICAs may be provided together with other, additional or optional, maintenance information, or in another acceptable format as per GM1 21L.A.9(a), with the following conditions:

(a) The information that is necessary for the continued airworthiness is clearly identified (refer to AMC1 21L.A.9(b)).

(b) The ICAs may reference additional instructions for continued airworthiness in separate publications, where necessary (for example, those produced by suppliers).

If the product’s ICAs reference the use of supplier data (e.g. component maintenance manual (CMM) or section of it) as the appropriate location for the ICAs, those applicable instructions are incorporated by reference and become part of the complete set of the ICAs for the particular product.

(c) Additional or optional maintenance information that is not considered ICAs but referenced by the design approval holder (DAH) or declarant together with the ICAs should be evaluated appropriately by the DAH or declarant in order to ensure that its use will not compromise the continued airworthiness of the product or article.

(d) If the maintenance data made available by a DAH or declarant includes data from an operator (i.e. in order to customise the data for the operator, and created under the authority of the operator), the operator data should be identified as such, and the DAH or declarant is not required to additionally evaluate it.

AMC3 21L.A.9(a) Instructions for continued airworthiness

ED Decision 2023/013/R

DESIGN APPROVAL HOLDER (DAH) OR DECLARANT RESPONSIBILITY TO CHECK THE SUPPLIER DATA WHICH IS PART OF THE ICAs OR REFERENCED TOGETHER WITH THE ICAs

The DAH or declarant may carry out a complete check of the supplier data, or may choose to rely, in whole or in part, on the supplier’s process for ensuring the accuracy and completeness of the data. In the latter case, the DAH or declarant will propose a means to validate the supplier’s process. Supplier data may also be issued by the supplier to the DAH or declarant under a contract or an arrangement, addressing the following:

(a) the accuracy and the adequacy of the technical documentation, which should be checked through a verification process (e.g. component workshop verification);

(b) evidence showing that workshop verification has been performed should be kept by the supplier and a clear statement should be given in the introduction to the supplier data as a confirmation that component verification is complete;

(c) evidence that the supplier has taken into account all justified feedback and changes to data requested by any person required to use the ICAs; typical examples would be the correction of reported errors, or mistakes.

In addition, some validation activities may be decided by the DAH or declarant, depending on the articles and the capability level of the supplier.

For articles subject to an ETSO authorisation, the validation of the supplier’s process for ensuring the accuracy and completeness of the data is not needed. This is also valid for other national TSO authorisations (e.g. FAA TSOs) accepted by EASA as stipulated in related bilateral agreements.

GM1 21L.A.9(a) Instructions for continued airworthiness

ED Decision 2023/013/R

SCOPE OF THE INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs), THEIR PUBLICATION FORMAT AND TYPICAL ICA DATA

(a) The ICAs may be published in documents or in a manner other than the traditional understanding of a document — for example, as a series of web pages, or Information Technology (IT) tools, or in a publishing format linked to tasks or data modules rather than pages.

(b) The design approval holder (DAH) or declarant may decide, within the framework provided by point 21L.A.9 and its acceptable means of compliance and guidance material, to publish the ICAs in the most suitable location as part of all the information published to support the airworthiness of a given aircraft.

(c) The requirement for ICAs is not intended to ensure that all products or articles may be restored to an airworthy condition. A certain level of deterioration may require a product or an article to be permanently withdrawn from service, and restoration may not be reasonably achievable.

Certain deteriorations or levels of deterioration may require specific instructions (e.g. inspection or restoration) that will only be developed and provided on a case-by-case basis, as needed, for a given product or article, and as such, will not be included in the ICAs.

In some exceptional cases, ICAs for products may ultimately instruct the user to contact the DAH or declarant in order to define the specific instructions on a case-by-case basis. This typically happens when the definition of generic instructions covering all possible cases is not possible. For example, following an aircraft hard landing, a detailed analysis may have to be carried out by the DAH or declarant to determine the specific instructions to be followed, which depend on the touchdown loads.

GM2 21L.A.9(a) Instructions for continued airworthiness

ED Decision 2023/013/R

DETERMINATION OF WHICH SUPPLIER DATA IS PART OF THE INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs)

Note 1: For the purposes of this GM, the term ‘supplier data’ also applies to similar types of data when issued directly by the DAH or declarant (e.g. component maintenance manuals (CMMs) issued by the DAH or declarant).

Note 2: For the purposes of this GM, the term ‘supplier data’ should be understood as data coming from the supplier and related to either a full CMM or to part of a CMM.

Note 3: The link between the aircraft ICAs and the engine/propeller CMM, as detailed below, is similar to the link between engine/propeller ICAs and the CMM of equipment fitted to the engine/propeller.

Note 4: If the supplier is also the DAH (for instance, an engine or propeller manufacturer), then the ICAs for these items will be made available by virtue of the DAH obligations as type-certificate holder (TCH) and need not be included in the aircraft ICAs.

Note 5: If the supplier is an engine or propeller manufacturer, then the ICAs for these items will be made available by virtue of the DAH obligations as type-certificate holder (TCH) and need not be included in the aircraft ICAs. If the supplier is an engine or propeller manufacturer that is not the TCH due to the aircraft TC or declaration of design compliance also including the compliance of the engine or propeller, then the supply of ICAs from the engine or propeller manufacturer will need to be subject to a suitable arrangement.

(a) When determining whether a supplier data is part of the ICAs, the following should be considered:

(1) Supplier data related to the Airworthiness Limitations Section (ALS) of the ICAs is part of the ICAs.

(2) Supplier data related to instructions on how to accomplish the scheduled maintenance part of the aircraft ICAs are part of the aircraft ICAs. A typical case is the periodical removal of a component to perform a workshop task.

(3) Supplier data related to scheduled maintenance on the component should be endorsed by the DAH or declarant before becoming part of the aircraft ICAs, to define and confirm that the supplier data is applicable and effective.

(4) If the ICAs are defined at aircraft level, the following principles apply to the other supplier data that is not related to the ALS nor to scheduled maintenance:

(i) If the supplier data includes a maintenance instruction for an action identified in the aircraft-level ICAs, including an engine or propeller, this supplier data should be referenced in the aircraft-level ICAs and should be made available like any other ICAs.

As an alternative to linking such supplier data to the aircraft-level ICAs (e.g. with cross references), it is possible to include the relevant data directly into the aircraft ICAs. In such a case, the supplier data is not part of the aircraft ICAs since the aircraft ICAs already contain all the required information.

(ii) If an aircraft ICAs’ task only requires a replacement task for an engine, propeller or part (i.e. ‘remove and replace’ or ‘discard’) and does not refer to the supplier data for further maintenance of the removed engine, propeller or part, this means that the aircraft airworthiness may only be maintained by replacement action, and that the supplier data is not part of the ICAs for the particular aircraft. In such cases, the supplier data does not need to be referenced in the aircraft ICAs.

Example: If supplier data provides off-aircraft maintenance instructions for an engine, propeller, or other article (i.e. workshop maintenance), then this data may not be considered as part of the complete set of the ICAs for the aircraft, but may be considered as part of the complete set of the ICAs for the engine or propeller. However, the procedure for removal from / installation on the aircraft is necessarily part of the aircraft ICAs.

(b) However, for the above cases, aircraft-level ICAs can provide, as additional or optional maintenance information, the references to the supplier data even if it is not considered part of the ICAs. In such cases, it should be made clear that the supplier data references are provided as additional or optional maintenance information and is not part of the product ICAs. Besides, it should be ensured that the use of additional or optional maintenance information not considered as ICAs but referenced together with the ICAs will not compromise the continued airworthiness of the product or article.

(c) For the supplier data identified as part of the ICAs, the DAH or declarant should:

(1) identify the supplier data that is part of the ICAs; this can be achieved either by creating a listing or by any other acceptable means that allow to identify which data is part of the ICAs and which data is not part of the ICAs (refer to AMC1 21L.A.9(b));

(2) just as for any other ICAs, ensure the publication of the supplier data;

(3) ensure the accuracy and the adequacy of the technical content of the supplier data.

GM3 21L.A.9(a) Instructions for continued airworthiness

ED Decision 2023/013/R

NON-ICAs SUPPLIER DATA (e.g. COMPONENT MAINTENANCE MANUALS (CMMs))

(a) Non-ICAs supplier data referenced together with the ICAs

Supplier data, or parts of the supplier data, which is not considered part of the ICAs but is additional or optional maintenance information referenced together with the product-level ICAs may be issued by the supplier to the DAH or declarant under a contract or an arrangement, using the methodology proposed in AMC3 21L.A.9(a).

(b) Other non-ICAs supplier data

Non-ICAs supplier data, which is not referenced together with the ICAs, but which can be used for the maintenance of components approved for installation by the DAH or declarant, should be acceptable to the DAH or declarant. This non-ICAs supplier data may be documented in a list.

AMC1 21L.A.9(b) Instructions for continued airworthiness

ED Decision 2023/013/R

IDENTIFICATION OF A COMPLETE SET OF INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs)

The design approval holder (DAH) or declarant should identify the complete set of ICAs according to point 21L.A.9(b) in such a way that the complete set can be:

(a) directly listed in the product’s type certificate data sheet (TCDS) or airworthiness data sheet; or

(b) indirectly referenced in the TCDS or airworthiness data sheet through other means, which allow the complete list of the ICAs to be obtained (e.g. a complete listing of ICAs contained in a ‘principal manual’ or a reference to the DAH’s or declarant’s website); or

(c) directly listed in the product’s supplemental type certificate (STC); or

(d) indirectly referenced in the STC through other means, which allow the obtainment of the complete list of the ICAs; or

(e) if direct reference is made to the ICAs in the product’s TCDS or the STC or airworthiness data sheet, no reference to the revision level of the ICAs should be made; in this case, the revision level should be available elsewhere (e.g. on the DAH’s or declarant’s website).

For design changes and repairs to type certified or declared aircraft, the identification of ‘a complete set of the changes to the instructions for continued airworthiness’ should be performed by the DAH or declarant by a statement to provide this information, or by confirmation that there are no changes to the ICAs. This statement may also be made in the accomplishment document (e.g. embodiment instructions).

For products and articles for which the DAH or declarant holds a design organisation approval (DOA), the ICAs are considered to have been issued under the authority of the DOA and, therefore, the approval of the ICAs should be made explicit to the reader in accordance with point 21.A.265(h) of Annex I (Part 21) to this Regulation, unless otherwise agreed with EASA.

GM1 21L.A.9(b) Instructions for continued airworthiness

ED Decision 2023/013/R

ANY OTHER PERSONS REQUIRED TO COMPLY

For the purposes of this GM, ‘any other person required to comply’ means:

(a) any independent certifying staff that performs maintenance on a product or article, in accordance with Regulation (EU) No 1321/2014, in the framework of a contract (or work order) with the person or organisation responsible for the aircraft continuing airworthiness;

(b) any maintenance organisation approved to maintain a product or article, in accordance with Regulation (EU) No 1321/2014, in the framework of a contract (or work order) with the owner of the engine or article, or the person or organisation responsible for the aircraft continuing airworthiness;

(c) any organisation approved to manage the aircraft continuing airworthiness in accordance with Regulation (EU) No 1321/2014, in the framework of a contract with the aircraft owner or aircraft operator.

GM2 21L.A.9(b) Instructions for continued airworthiness

ED Decision 2023/013/R

INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs) — FORMAT

The ICAs may be furnished or made available by various means (including paper copies, electronic documents, or web-based access). Regardless of the format, the design approval holder (DAH) or declarant is expected to furnish or make the ICAs available in a means that is readily accessible for and useable by the owner and any other person required to comply with the ICAs. Service documents, such as service information letters, may be used for transmitting ICAs information and updates.

(a) Formatting standards

DAHs or declarants may use the latest ATA, AECMA/ASD or GAMA formatting standards such as:

(1) AeroSpace and Defence Industries Association of Europe (ASD), ASD-S1000D, International Specification for Technical Publications Utilizing a Common Source Data Base, version 4 or higher;

(2) the Air Transport Association’s (ATA) iSpec 2200, Information Standards for Aviation Maintenance, latest edition (ATA is now known as Airlines for America (A4A) but the standard is still listed as ATA); or

(3) General Aviation Manufacturers Association (GAMA) Specification No. 2, Specification for Manufacturers Maintenance Data, latest edition.

With regard to scheduled maintenance, DAHs or declarants may also refer to the glossary of the ATA MSG‑3 standard, latest revision, for standardised task definitions and designations.

(b) General considerations

The ICAs should be easy to read and to follow. All ICAs should include a means to identify their applicability (model, type, etc.), and the associated revision status. Refer to sample formats in the Air Transport Association’s iSpec 2200, Information Standards for Aviation Maintenance, latest edition, or AECMA/ASD standards. There is no requirement for any specific format or arrangement of the ICAs in a document or documents. However, the specific format selected by the DAH or declarant should be used and applied in a uniform manner. Empty pages in a document should contain the statement ‘Intentionally left blank’ or similar.

At the beginning of each procedure, the ICAs should contain cautions and warnings regarding possible mistakes that can be made when following the instructions.

Abbreviations, acronyms and symbolisation should be either avoided or explained as part of the ICAs documentation.

The ICAs contain units of measurement. Measurements could be, for instance, instrument readings, temperatures, pressures, torque values with tolerances, limits, and ranges when applicable. If the ICAs contain units of measurement of a system other than the metric, the ICAs should include a conversion to the metric system for each measurement, tolerance, or torque value. A general conversion table alone should not be provided, as it may introduce an additional source of error.

The DAH or declarant should use a means to indicate changes to the ICAs directly in relation to each item of the information/data of the ICAs, e.g. using a vertical change bar in the margin next to the line.

(c) Publication of the ICAs in multiple documents

DAHs or declarants may prepare ICAs as a document, or several documents, depending on how much data is necessary to provide a complete set of ICAs.

If there are multiple documents, there should be a principal document that describes the general scope of all other documents, in order to provide an overview of the multiple document structure.

According to different standards, the Airworthiness Limitations Section (ALS) needs to be included in the principal document as a dedicated section. However, EASA may also accept a separate Airworthiness Limitations document when it is at least referenced as such in the principal document.

DAHs or declarants that decide to segregate information dedicated to a specific subject from a principal document into a separate document, e.g. ‘Fuel Pipe Repair Manual’, ‘Cable Fabrication Manual’, ‘Duct Repair Manual’ or ‘Instrument Display Manual’, should declare these documents to be ICAs.

DAHs or declarants may decide to integrate certain information in a principal document (as, for example, troubleshooting information as part of the aircraft maintenance manual (AMM) instead of a separate troubleshooting manual (TSM)).

(d) Language

The ICAs should be provided in any of the official language(s) of the European Union which is (are) acceptable to the competent authority.

Note: In certain countries, such as the USA, English is required for ICAs. EASA, therefore, recommends that DAHs or declarants include a version of the ICAs in simplified technical English (e.g. in accordance with ASD Specification STE100).

(e) Electronic media

The ICAs may be provided in an electronic format (e.g. CDs, via the internet, etc.) instead of paper copies or microfilms (refer to AMC1 21L.A.9(b)).

When electronic format is used, the DAH or declarant should consider aspects such as the traceability of updates, keeping previous versions (record-keeping), data security and the obligations of the person(s) or organisation(s) responsible for the aircraft continuing airworthiness, considering that the ICAs form the basis of the data used for continuing airworthiness activities.

GM3 21L.A.9(b) Instructions for continued airworthiness

ED Decision 2023/013/R

APPROVAL STATUS OF THE MANUAL FOR A COMPONENT OR ARTICLE

When the ICAs refer to a document for a specific component or article, it is possible that this document is used for products from more than one DAH. In such cases, instead of placing approval statements from each DAH in the same manual, it may be more practical to identify the approved status of the relevant document through its inclusion in lists managed by the DAH in accordance with AMC1 21L.A.9(b).

GM4 21L.A.9(b) Instructions for continued airworthiness

ED Decision 2023/013/R

INTEGRATION OF THE INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs) BETWEEN PRODUCTS (AIRCRAFT, ENGINES, PROPELLERS)

The aircraft/engine/propeller type-certificate holder (TCH) and, if applicable, the declarant, should ensure the availability of ICAs to allow maintenance of the aircraft, including engines/propellers when installed on the aircraft.

When referring to engine/propeller ICAs directly in the aircraft ICAs, the aircraft TCH or declarant should not perform additional verification and validation. However, the integration and interface aspects between the aircraft and the engine/propeller are still under the responsibility of the aircraft TCH or declarant.

If the ICAs published by the aircraft TCH or declarant include some engine/propeller ICAs developed by the engine/propeller TCH, the engine/propeller TCH should make an arrangement with the aircraft TCH setting out engine/propeller TCH and aircraft TCH or declarant shared responsibilities with respect to the ICAs under point 21L.A.9.

This arrangement should:

—      define the part of the engine/propeller ICAs which is published in the aircraft ICAs; and

—      address the development, publication and update processes of these ICAs, including completeness and timely availability aspects.

—      The incorporated engine/propeller data content remains under the responsibility of the engine/propeller TCH, and the publication is under the responsibility of the aircraft TCH or declarant. Therefore, the aircraft TCH or declarant should coordinate with the engine/propeller TCH regarding any modification or alteration of the incorporated data.

AMC1 21L.A.9(d) Completeness and timely availability of the Instructions for Continued Airworthiness

ED Decision 2023/013/R

COMPLETENESS AND TIMELY AVAILABILITY OF THE INSTRUCTIONS FOR CONTINUED AIRWORTHINESS (ICAs) FOR TYPE-CERTIFICATE (TC) APPLICANTS OR DECLARATION OF DESIGN COMPLIANCE

(a) An applicant or declarant may wish to choose among the three options described below. Once the certification programme or demonstration of compliance for a declaration starts, it may be necessary to modify the initially selected option to accommodate programme changes. All such changes should be coordinated with EASA.

(1) Option 1: Complete ICAs are available at the time of the design approval (type certificate (TC)) or submission of a declaration of design compliance

(i) The ICAs will be made available at the time of the design approval or submission of the declaration of design compliance. This option minimises the risk of incomplete ICAs, especially for changes.

(ii) With all ICAs available at the time of the design approval or submission of the declaration of design compliance, they should also be furnished / made available to the aircraft operator / aircraft owner and made available to any other person required to comply with any of those instructions in accordance with point 21L.A.9, without using the provision to delay certain parts of the ICAs after the entry into service of the product.

(iii) Frequently, there is only a short period of time between the design approval or submission of the declaration of design compliance and the entry into service. Nevertheless, applicants/DAHs or declarants may still wish to apply Option 2 or 3 for a part of their ICAs as stated below.

(2) Option 2: Complete ICAs are available at entry into service (TC or submission of the declaration of design compliance)

If an applicant or declarant plans to make part of the ICAs available to EASA upon entry into service, the following approach is acceptable:

(i) For the Airworthiness Limitations Section (ALS), as part of the type design, notwithstanding the selection of Option 2: the applicant or declarant submits the ALS prior to the design approval or submission of the declaration of design compliance. Any ALS content that is incomplete, not yet demonstrated for compliance, or delayed beyond the design approval or submission of the declaration of design compliance, requires to be compensated through an interim limitation to establish compliance within this limitation. The interim limitation is notified to the aircraft operator(s) concerned as a temporary operational limitation in a manner agreed with EASA.

In this context, ALS content is understood as the task method (e.g. a detailed inspection), including its reference, title and applicability, and the associated threshold / interval / life-limit. The accomplishment procedure itself, i.e. how to carry out the task, is usually described in other parts of the ICAs (e.g. in the aircraft maintenance manual (AMM) or the non-destructive testing (NDT) manual). However, a feasibility study of the accomplishment procedure is required for compliance with specific requirements.

(A) This may typically apply when the aircraft’s structural full-scale fatigue testing required for compliance with the fatigue- and damage-tolerance requirements, considering the expected operational life, will not be completed prior to the type certificate being issued. In this case, a temporary operational limitation is assigned and stated in the ALS, dependent on the aircraft’s full-scale fatigue testing progress. The ALS is effectively incomplete beyond this temporary operational limitation, as the required justification and the resulting ICAs are not yet available to support the safe operation of the aircraft beyond this limitation.

(B) A type certificate data sheet (TCDS) or airworthiness data sheet notation is not necessary since the product is provided with complete ALS content up to the established temporary operational limitation.

(ii) A compliance plan identifying those parts of the ICAs that are only to be made available upon entry into service is produced, submitted to EASA and agreed between the applicant/declarant and EASA prior to the design approval or registration of the declaration of design compliance (refer also to point (iv) for the ICAs considered necessary at the time of the design approval/registration of a declaration of design compliance).

(iii) A commitment is made to produce, verify and, when requested, submit to EASA the relevant ICAs prior to entry into service. This commitment should be provided in a compliance document (e.g. the compliance plan). If the respective organisation responsible for design has not previously exercised the practice of delaying the ICAs beyond the design approval or submission of a declaration of design compliance, the required procedure should be agreed with EASA.

(iv) The ICAs considered necessary at the time of design approval or submission of the declaration of design compliance are provided or made available in a format that adequately defines the data. Furthermore, the way the data is presented at the time of the design approval or submission of the declaration of design compliance offers the same understanding of the data as the final published format does.

The applicant or declarant should agree with EASA, in a compliance plan, on all ICAs necessary at the time of the design approval or registration of the declaration of design compliance. The Agency investigation may vary from no involvement or evaluating a limited sample of the ICAs to performing a thorough review of specific parts of the ICAs.

(v) In cases where EASA has doubts as to whether the applicant/holder or declarant can fulfil the applicable requirements of point 21L.A.9 to control and support delaying the ICAs beyond the design approval, or type certificate (TC), or submission of the declaration of design compliance and until entry into service, EASA may decide to assign a condition for entry into service for non-ALS ICAs or withhold the registration of the declaration of design compliance.

As a condition for the entry into service, a note should be included in the type certificate data sheet (TCDS) or airworthiness data sheet as a result of these pending issues under the ICAs paragraph as follows:

‘Note: The ICAs are not complete. As per point 21L.A.9 of Annex Ib (Part 21 Light) to Commission Regulation (EU) No 748/2012, they must be completed before the entry into service of the aircraft. Contact EASA for information on the status.’

The decision to assign a condition may be based on the applicant’s or declarant’s performance, e.g. if the applicant or declarant has already demonstrated in previous projects that it has provided the complete set of ICAs before the entry into service, if the applicant or declarant has already experienced difficulties in providing the ICAs considered necessary at the time of the design approval or submission of the declaration of design compliance, or has previously failed on a different project to meet its commitment to complete the ICAs prior to entry into service, or if the applicant/holder or declarant has no previous experience with the practice of delaying the ICAs beyond the design approval or submission of the declaration of design compliance.

(vi) Post-TC action or the submission of the declaration of design compliance is established together with EASA (if EASA requests such a review) to review the ICAs’ status upon entry into service.

(vii) If all ICAs are made available to EASA at the time of entry into service, they should also be furnished at that time to the aircraft operator / aircraft owner and made available to any other person(s) required to comply with any of those instructions in accordance with point 21.A.7, without using the provision to delay certain parts of the ICAs beyond the entry into service.

(3) Option 3: Complete ICAs are available after the entry into service (TC or registration of declaration of design compliance)

As per point 21L.A.9(d), certain ICAs dealing with the ‘overhaul or other forms of heavy maintenance’ may be delayed until after the aircraft entry into service. Although there is no definition of what is meant by ‘overhaul or other forms of heavy maintenance’, the intention of the requirement is to provide flexibility to applicants/holders or declarants for long-lead ICAs of a scheduled nature.

If an applicant or declarant plans to make part of the ICAs available only after the entry into service, the following is acceptable for the complete set of ICAs:

(i) For the ALS, as it cannot be delayed until after the entry into service, point (i) of Option 2 applies.

(ii) For ICAs considered necessary at the time of the design approval or submission of the declaration of design compliance, point (iv) of Option 2 applies.

(iii) A detailed compliance plan identifying those parts of the ICAs that are to be provided prior to and after the entry into service. For ICAs made available after the entry into service, the plan should account for when the ICAs are needed so that they can be complied with. This approach may only be used for scheduled maintenance accomplishment procedures, where threshold / interval / life-limit requirements of the related scheduled tasks are established. In that respect, the following aspects should be considered:

(A) The majority of the ICAs are of an unscheduled nature; therefore, these items should be available at entry into service at the latest.

(B) Consideration should be given to the fact that a number of tasks are used for both scheduled and unscheduled maintenance (e.g. an operational check of a system is planned as a scheduled task at a certain point in time, but is also required as part of the installation procedure to determine the operational status of the system).

(C) For ICAs to be made available after entry into service, the detailed plan should contain threshold(s) controlled by the applicant/holder, stating the maximum value in flight hours (FHs) / flight cycles (FCs) or calendar time (CT), or a combination of them as applicable, by which point in time the delayed ICAs should be made available.

(D) This detailed plan should be available prior to the time of the design approval or submission of the declaration of design compliance and should be either directly integrated or cross-referenced in a compliance plan.

(E) Information on the format in which the ICAs delayed until after entry into service will be made available in time (e.g. regular revisions or temporary revisions (TRs) or service information (SBs, SIL, etc.).

(iv) A procedure/programme that ensures a detailed plan is produced and implemented in the applicant’s or declarant’s organisation in order to ensure the timely availability (to the aircraft operator / aircraft owner and to any other person(s) required to comply with any of those instructions and to EASA, if involved and when requested).

(v) A commitment is made to produce, verify and provide the relevant ICAs in accordance with the established detailed plan. This commitment should be provided in an appropriate document (e.g. a compliance plan). If the respective organisation responsible for design has not previously exercised the practice of delaying the ICAs beyond the design approval or submission of the declaration of design compliance, the required procedure should be agreed with EASA.

(vi) In order to ensure that the applicant/holder or declarant can meet their obligations as set out in point 21L.A.9 to control and support delaying the ICAs, EASA may decide:

(A) for ICAs delayed until entry into service, to assign a condition/notation for the entry into service to be included in the TCDS or airworthiness data sheet as a result of these pending issues under the ICAs paragraph, as per point (v) of Option 2;

(B) for ICAs delayed until after entry into service, to assign an interim limitation to be published and included in the ALS as a temporary operational limitation, also for non-ALS ICAs, to compensate for the delayed ICAs; this approach may only be used for scheduled maintenance accomplishment procedures, where task and interval requirements are available.

The decision to assign a condition/limitation may be based on the applicant’s or declarant’s performance, e.g. if the applicant or declarant has already demonstrated in previous projects that it has provided the complete set of ICAs before the entry into service, if the applicant or declarant had already difficulties in providing the ICAs considered necessary at the time of the design approval or submission of the declaration of design compliance, or has failed before in a different project to control and support delaying the ICAs, or if the applicant/holder or declarant has not previously exercised the practice of delaying the ICAs beyond the design approval or submission of the declaration of design compliance.

(vii) Post-TC action or the submission of the declaration of design compliance should be established with EASA to regularly review the ICAs’ status, if EASA requests such a review, taking into account other oversight activities.

(viii) An applicant/holder or declarant should provide visibility, regarding the ICAs that are delayed beyond entry into service, to the aircraft operator / aircraft owner and to any other person(s) required to comply with any of those instructions. This can be achieved by providing this information, for example, on a website or in a document, such as a maintenance planning document (MPD) or an aircraft maintenance manual (AMM), preferably in the principal ICAs manual. This visibility information is then itself considered ICAs information.

(ix) It is assumed that for those ICAs that are made available to EASA at the time of entry into service, they are also at the same time furnished to the aircraft operator / aircraft owner and made available to any other person(s) required to comply with any of those instructions in accordance with point 21L.A.9.

This is to satisfy EASA that such a delayed publication will not have an adverse effect on the continuing airworthiness of any given aircraft.

To allow the timely review and incorporation of a delayed part of the ICAs into continuing airworthiness activities and processes (e.g. amendment of the aircraft maintenance programme) by the person or organisation responsible for the aircraft continuing airworthiness or for performing maintenance, EASA considers that the delayed ICAs should typically be made available 2 years before the actual ICAs have to be used, when using normal revisions as a format. However, shorter time margins may be acceptable, provided that the format used ensures the prompt notification of the availability of the delayed ICAs or the ICAs itself, but they should not be shorter than 1 year before the ICAs have to be used.

(b) Completeness and timely availability of changes to the ICAs (TC or declaration of design compliance)

Point 21L.A.9(e) regulates the distribution of changes to the ICAs required from the TC holder or declarant. Those changes to the ICAs could result from the design change process (minor and major changes), in-service experience, corrections, and others.

A programme showing how changes to the ICAs are distributed is part of the respective procedures (e.g. design organisation procedures, or other procedures used to demonstrate design capabilities). For changes to the ICAs triggered by design changes, typically these procedures follow the same principles as those available for TCs or the initial declaration of design compliance (Options 1 to 3), while taking into account the relevant privileges, e.g. that a DOA may approve minor changes in accordance with point 21.A.263(c)(2) of Annex I (Part 21).

21L.A.10 Access and investigation

Regulation (EU) 2022/1358

All natural or legal persons who hold or who have applied for a type certificate, supplemental type certificate, major repair design approval, permit to fly, certificate of airworthiness, restricted certificate of airworthiness, noise certificate or restricted noise certificate, who have declared design compliance, who have declared their design or production capability or who produce aircraft, engines, propellers or parts under Subpart R of this Annex, shall:

(a) grant the competent authority access to any facility, product, part, document, record, data, processes, procedures or any other material, and permit the review of any report and make any inspection and perform or witness any test that is necessary to verify the compliance and the continued compliance with the applicable requirements of this Section;

(b) if the natural or legal person uses partners, suppliers or subcontractors, make arrangements with them to ensure that the competent authority has access and can investigate as described in point (a).

GM1 21L.A.10 Access and investigation

ED Decision 2023/013/R

ARRANGEMENTS

Natural or legal persons that hold or that have applied for a type certificate (TC), a supplemental type certificate (STC), a major repair design approval, a permit to fly, a certificate of airworthiness, a restricted certificate of airworthiness, a noise certificate or a restricted noise certificate, that have declared design compliance, that have declared their design or production capability or that produce aircraft, engines, propellers or parts under Subpart R are required to allow the competent authority to make investigations that include the complete organisation including its partners, subcontractors and suppliers, whether they are in the State of the natural or legal person or not.

The investigations may include audits, enquiries, questions, discussions and explanations, monitoring, witnessing, inspections, checks, flight and ground tests, and inspections of completed products or parts that are either designed or produced.

In order to maintain its confidence in the standards achieved by the natural or legal person, the competent authority may conduct an investigation of a sample product or part and of its associated records, reports and certifications/declarations.

The arrangements are required to enable the natural or legal person to assist the competent authority and cooperate with it in conducting the investigation during the initial assessment and for the subsequent surveillance.

‘Cooperation in performing investigations’ means the competent authority has been granted full and free access to the facilities and to any information relevant to demonstrating compliance with the Part 21 Light requirements, and has provided assistance as necessary.

‘Assistance to the competent authority’ includes all the appropriate means regarding the facilities of the natural or legal person to allow the competent authority to conduct the investigation, such as meeting rooms, offices, support personnel, records, documentation, computer data, and communication facilities, all properly and promptly made available as necessary.

The competent authority seeks to have a good working relationship with the natural or legal person, and suitable liaison staff are required to be nominated to facilitate this, including one or more suitable representative(s) to accompany competent authority staff during visits, not only at the natural or legal person’s own facilities, but also with subcontractors, partners or suppliers.

21L.A.11 Findings and observations

Regulation (EU) 2022/1358

(a) After the receipt of the notification of findings, the natural or legal person who holds or who has applied for a type certificate, supplemental type certificate, major repair design approval, permit to fly, certificate of airworthiness, restricted certificate of airworthiness, noise certificate or restricted noise certificate, who has declared design compliance, who has declared their design or production capability or who produces aircraft, engines, propellers or parts under Subpart R of this Annex, shall take the following steps within the time period determined by the competent authority in accordance with point (d) or (e) of point 21L.B.21:

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

2. define a corrective action plan and propose it to the competent authority;

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

(b) An observation notified by the competent authority in accordance with point (f) of point 21L.B.21 shall be given due consideration. The natural or legal person shall record the decision taken in respect of those observations.

GM1 21L.A.11(a) Findings and observations

ED Decision 2023/013/R

ROOT-CAUSE ANALYSIS

(a) It is important that the analysis does not primarily focus on establishing who or what caused the non-compliance, but on why it was caused. Establishing the root cause(s) of non‑compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (human factors (HFs), 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 21L.A.11(a) Findings and observations

ED Decision 2023/013/R

FINDINGS — CORRECTIVE ACTION PLAN AND IMPLEMENTATION

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

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

The respective corrective action plan should:

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

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

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

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

AMC1 21L.A.11(b) Findings and observations

ED Decision 2023/013/R

DUE CONSIDERATION TO OBSERVATIONS

For each observation that is notified by the competent authority, the natural or legal person (‘organisation’) should analyse the related issues and determine when action is needed.

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

21L.A.12 Means of compliance

Regulation (EU) 2022/1358

(a) A legal or natural person may use any alternative means of compliance to the acceptable means of compliance (AMC) to establish compliance with this Regulation.

(b) If a natural or legal person wishes to use an alternative means of compliance, they shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

(c) The natural or legal person may use those alternative means of compliance subject to prior approval from the competent authority.

AMC1 21L.A.12(b) Means of compliance

ED Decision 2023/013/R

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE (AltMoC)

(a) The description of the AltMoC should include:

(1) a summary of the AltMoC;

(2) the content of the AltMoC;

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

(4) in support of that statement, an assessment which demonstrates that the AltMoC reach(es) an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding Agency’s AMC.

(b) All these elements that describe the AltMoC are an integral part of the management system records, in accordance with point 21L.A.7.

GM1 21L.A.12 Means of compliance

ED Decision 2023/013/R

GENERAL

(a) Acceptable means of compliance (AMC), as referred to in Article 76(3) of Regulation (EU) 2018/1139⁷⁴, are a tool to standardise the demonstration of compliance with, and facilitate the verification activities of the competent authorities in relation to, that Regulation and its delegated and implementing acts. AMC are published by EASA to achieve those objectives. While competent authorities and regulated entities are not legally bound to use the AMC, applying them is recommended.

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

(1) by its competent authority (see GM1 21L.B.24); or

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 means of compliance than the one published by EASA may propose an AltMoC to the competent authority and use it only once the competent authority has approved it. In that case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the relevant 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 relevant regulation) and obtain an individual approval from their competent authority.

GM2 21L.A.12 Means of compliance

ED Decision 2023/013/R

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE (AltMoC) IS REQUIRED

When there is no Agency AMC to a certain point of a given regulation, the means of compliance that are proposed by an 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 a given regulation is achieved. However, in certain cases, the organisation may propose, and the competent authority may agree, to have such means of compliance go through the AltMoC process.

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

—      an AltMoC to a given regulation is technically different from 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 Agency AMC, as long as they do not change the intent of the AMC; and

—      incorporating an Agency 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.