21.A.231 Scope

Regulation (EU) 2019/897

This Subpart establishes the procedure for the approval of design organisations and rules governing the rights and obligations of applicants for, and holders of, such approvals. In this Subpart, the references to type-certificates include type-certificates and restricted type-certificates.

AMC-ELA No 1 to 21.A.231 Scope

ED Decision 2019/003/R

The AMC-ELA in this Subpart provides acceptable means of compliance for a design organisation approval for organisations that design:

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

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

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

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

GM-ELA No 1 to 21.A.231 Scope

ED Decision 2019/003/R

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

The AMC-ELA provide acceptable means to meet the requirements of Subpart J for small, non-complex organisations that make designs for aircraft as specified in AMC-ELA No 1 to 21.A.231.

If the AMC-ELA are not applicable (for instance, for small, non-complex organisations that make designs for other low-risk products outside the scope of AMC-ELA No 1 to 21.A.231, e.g. light rotorcraft, CS 23 Level 2, etc.), the applicant is not obliged to use any other available AMC. Switching to those other available AMC will not necessarily provide a means of compliance that is proportionate. Since AMC are a means, but not the only means of showing compliance, applicants and approval holders can also propose alternative means of compliance. These alternative means may use the AMC ELA as a baseline, and complement them with additional or more stringent controls, processes or methods. This allows a gradual increase in the level of detail of the established procedures and the thoroughness of the implemented tools for DOA approval. This enables the introduction of a proportionate approach that is commensurate with the kind of product and its associated risk as a function of the complexity of the organisation and the risk and performance of the product. The use of AMC-ELA as a baseline for DOA outside the applicability of that AMC-ELA is therefore considered to be an appropriate starting point.

Complementing elements need to be detailed, documented and recorded to a level where the occurrence of any repetitive non-conformities is mitigated. Applicants and approval holders need to demonstrate to the competent authority in such cases that those additional means meet the requirements that are appropriate for the complexity of these designs.

GM-ELA No 2 to 21.A.231 Scope – AMC-ELA as a complete, self-contained set of AMC

ED Decision 2019/003/R

The AMC-ELA provide an alternative, complete and self-contained set of AMC. Small, non-complex organisations that design products or articles within the scope of AMC-ELA can use AMC-ELA instead of the existing AMC to Subpart J.

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

GM-ELA No 3 to 21.A.231 Scope – Explanation of terms used in AMC-ELA

ED Decision 2019/003/R

‘A method needs to be practised’

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

Delegation of tasks and responsibilities

AMC-ELA differentiates between the delegation of tasks, and the delegation of responsibilities. For small and simple organisations, the delegation of responsibilities to specific and separate organisational positions can create overly burdensome administrative processes that do not reflect the operational reality.

The AMC-ELA accepts that tasks can be delegated, while the responsibility formally stays with the delegator. This can increase efficiency, and it offers the possibility to simplify procedures. A typical example is when the head of the design organisation (HDO) delegates tasks, while keeping the responsibility associated with this task.

If this situation is identified with respect to the individual requirements, this may significantly reduce the effort required for documentation, and it allows streamlined methods to be practised.

21.A.233 Eligibility

Regulation (EU) No 748/2012

Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart

(a) in accordance with points 21.A.14, 21.A.112B, 21.A.432B or 21.A.602B; or

(b) for approval of minor changes or minor repair design, when requested for the purpose of obtaining privileges under point 21.A.263.

21.A.234 Application

Regulation (EU) No 748/2012

Each application for a design organisation approval shall be made in a form and manner established by the Agency and shall include an outline of the information required by point 21.A.243, and the terms of approval requested to be issued under point 21.A.251.

AMC-ELA No 1 to 21.A.234  Application

ED Decision 2019/003/R

EASA Form 80 should be obtained from the EASA website and completed by the head of the design organisation (HDO). The completed form should be submitted to EASA, accompanied by a copy of the company’s registration.

21.A.235 Issue of design organisation approval

Regulation (EU) No 748/2012

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

21.A.239 Design assurance system [applicable until 6 March 2023] / 21.A.139 Design management system [applicable from 7 March 2023 - Regulation (EU) 2022/201]

Regulation (EU) No 69/2014

(a) The design organisation shall demonstrate that it has established and is able to maintain a design assurance system for the control and supervision of the design, and of design changes, of products, parts and appliances covered by the application. This design assurance system shall be such as to enable the organisation:

1. to ensure that the design of the products, parts and appliances or the design change thereof, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and environmental protection requirements; and

2. to ensure that its responsibilities are properly discharged in accordance with:

(i) the appropriate provisions of this Annex I (Part 21); and

(ii) the terms of approval issued under point 21.A.251;

3. to independently monitor the compliance with, and adequacy of, the documented procedures of the system. This monitoring shall include a feed‑back system to a person or a group of persons having the responsibility to ensure corrective actions.

(b) The design assurance system shall include an independent checking function of the showings of compliance on the basis of which the organisation submits compliance statements and associated documentation to the Agency.

(c) The design organisation shall specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances designed or the tasks performed by partners or subcontractors according to methods which are the subject of written procedures.

[applicable until 6 March 2023]

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

(b) The design management system shall:

1. correspond to the size of the organisation and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities;

2. be established, implemented and maintained under the accountability of a single manager appointed pursuant to point 21.A.245(a).

(c) As part of the safety management element of the design management system, the design organisation shall:

1. establish, implement and maintain a safety policy and the corresponding related safety objectives;

2. appoint key safety personnel in accordance with point 21.A.245(b);

3. establish, implement and maintain a safety risk management process that includes the identification of aviation safety hazards entailed by its activities, their evaluation and the management of the associated risks, including taking actions to mitigate the risks and verify their effectiveness;

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

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

(ii) the management of changes in accordance with points 21.A.243(c) and 21.A.247;

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

5. promote safety in the organisation through:

(i) training and education;

(ii) communication;

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

(d) As part of the design assurance element of the design management system, the design organisation shall:

1. establish, implement and maintain a system for the control and supervision of the design, and of design changes and repairs, of products, parts and appliances covered by the terms of approval; that system shall:

(i) include an airworthiness function responsible for ensuring that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements;

(ii) ensure that the design organisation properly discharges its responsibilities in accordance with this Annex and with the terms of approval issued under point 21.A.251;

2. establish, implement and maintain an independent verification function on the basis of which the design organisation demonstrates compliance with the applicable airworthiness, operational suitability data and environmental protection requirements;

3. specify the manner in which the design management system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subject of written procedures.

(e) The design organisation shall establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with and adequacy of the design management system. Monitoring shall include feedback to the person or the group of persons referred to in point 21.A.245(b) and to the manager referred to in point 21.A.245(a) to ensure, where necessary, the implementation of corrective action.

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

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

AMC-ELA No 1 to 21.A.239(a)  Design assurance system – Definition

ED Decision 2019/003/R

The term ‘design assurance system (DAS)’, in the context of the AMC-ELA to Subpart J, refers to those elements of product development and certification that ensure the control and supervision of the initial design, of changes or repairs to the design, and its continued airworthiness with respect to the applicable type certification basis, the operational suitability data certification basis and the environmental protection requirements. Therefore, elements to be considered as part of the DAS are:

      the generation, iteration, EASA acceptance and maintenance of the certification programme;

      the demonstration of compliance and its verification within the design organisation;

      the declaration of compliance provided by the design organisation to EASA;

      monitoring functions to ensure the continued airworthiness of the certified product, including the resulting activities;

      independent system monitoring of the compliance with, and the adequacy of, the documented procedures of this system.

A typical development process will include a number of additional activities, such as preliminary design, project management elements (a PDR, CDR, etc.), or development activities (test platforms, demonstrators, feasibility studies), etc., that are not part of the DAS, even when elements of the DAS form specific milestones in the development path. In the context of this Subpart, those other activities are consequently excluded from the assessment of the DAS, even when elements of the DAS are also applied to those activities.

AMC-ELA No 2 to 21.A.239(a) Design assurance system – Ensuring compliance

ED Decision 2019/018/R

An acceptable design assurance system (DAS) contains the elements of the DAS that are described in AMC-ELA No 1 to 21.A.239(a), and which are further broken down below into the following activities:

      The generation, iteration, EASA acceptance and maintenance of the certification programme:

      ensure that adequate product, change or repair specifications have been generated and are available to support a meaningful certification programme;

      generate a certification programme that is tailored to the product, or change, or repair specified, and that identifies:

      the product and the kinds of operations envisaged, or the changes to them;

      the proposed certification basis;

      a description of how compliance will be demonstrated, with the proposed means of compliance and any selected guidance material, if this is not clearly visible from the compliance/means of compliance (MOC) checklist;

      a compliance checklist, together with the means of compliance that is intended to be used, and any guidance material;

      the relevant CVE to be used on the project;

      the programme milestones for interaction with EASA;

      iteration of the certification programme, until EASA acceptance is reached;

      monitoring of the workflow in line with the certification programme:

      updating the certification programme and seeking a new acceptance by EASA, if necessary;

      ensuring that the relevant staff members adhere to the certification programme when they conduct certification activities;

      structured methods for the classification of changes, repairs or deviations by using an adequate process flow, or by following adequate decision forms (matrices) if there are major changes that directly support the change-related certification programme.

      Demonstration of compliance and its verification within the design organisation:

      ensure that a complete set of data has been developed in order to form a complete and concise definition of the type design;

      ensure that the selected method for defining the type design allows for adequate configuration management, for the purposes of design and design variant management, and for the later management of production;

      ensure that the handling of changes within the type investigation process and post-TC/-STC is controlled, coordinated and repeatable;

      ensure that analyses and tests have been conducted by using methods that are adequate to support the means of compliance that was defined, and that they are documented to allow their use for showing compliance;

      ensure that the formal demonstration of compliance for the intended type design, change design or repair design, including the generation of compliance statements with respect to any relevant certification requirement, is provided;

      conduct the formal verification of compliance for the intended type design, change design or repair design, including the verification of compliance statements with respect to any relevant certification requirement by an independent person nominated within the design organisation (i.e. a compliance verification engineer (CVE));

      ensure that the applicable product-relevant documentation, such as the AFM, ICA or MMEL, is established and provided;

      ensure that prototypes or test specimens, produced by a connected production organisation, or by any prototyping facilities of the design organisation itself, are used on the basis of an adequate configuration verification against the design definitions specified for the relevant test;

      ensure that coordinated flight test activities with adequate risk mitigations are performed.

      Monitoring functions to ensure the continued airworthiness of the certified product:

      conduct monitoring of any significant events;

      ensure that all reported occurrences and events are investigated and classified;

      ensure that there is occurrence reporting for events that are classified as ‘safety-critical’ and that constitute unsafe or potentially unsafe conditions;

      ensure that information and instructions are generated and published, as applicable, and that information or instructions and any related design activity are verified by following the same principles as for any type design, change design or repair design activity/documentation.

      Declaration of compliance by the design organisation to EASA:

      verification of the completeness of the compliance verification and type design documentation as defined within the certification programme by the head of airworthiness (HoA);

      issuing of the declaration of compliance by the head of the design organisation (HDO) to EASA, subsequent to the satisfactory completion of the verification of compliance against all the applicable certification requirements.

AMC-ELA No 3 to 21.A.239(a) Design assurance system – Discharge of responsibilities

ED Decision 2019/018/R

As part of the design assurance system (DAS), at least the following responsibilities have to be allocated:

      Head of the design organisation (HDO):

      control of budget and staffing to ensure the completion of the development and certification tasks of the design organisation approval (DOA) within reasonable time frames and workload. The HDO is ultimately responsible for providing the necessary resources for the proper functioning of the design organisation;

      issuing the declaration of compliance (see points 21.A.15(b), 21.A.15(c), 21.A.20(c) and 21.A.20(d)) with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements after verifying the satisfactory completion of the type investigation;

      ensuring that adequate and timely information is provided to EASA in matters that affect the DOA.

      Compliance verification engineer (CVE):

      conducting the verification that compliance has been demonstrated with the applicable type certification basis, the applicable operational suitability data certification basis and the environmental protection requirements and its technical content within its subject matter of nomination. Verification of a compliance demonstration implicitly includes the approval of all the referenced and supporting documents. The applicant may elect to separately document the approval of the individual supporting documents, e.g. by having a cover sheet with the supporting documents in the attachment.

      Head of airworthiness (HoA):

      ensuring the verification of compliance with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements by adequately qualified staff and that the activities that are necessary to demonstrate compliance are complete;

      ensuring that a design organisation handbook (DOH) is prepared and updated as required;

      ensuring that there is adequate and timely interaction with the authorities and internally on all relevant matters with respect to type certification, changes to type certificates, the approval of repairs and the approval of the design organisation. This includes the coordination that the required documentation (type design documents, compliance documentation and service documents including manuals/ICA and the MMEL, if applicable) is adequately established;

      ensuring that the continued airworthiness activities are properly performed;

      accepting the certification programme and the approval of the classification of changes/repairs, minor changes/repairs, major repairs, and flight conditions and the issue of PtFs under the relevant privileges;

      providing verification to the HDO that all the activities required for the type investigation have been properly completed.

      Independent system monitoring (ISM):

      monitoring that the implemented DAS is adequate, and that it is complied with, by using structured experience exchanges, regular quality meetings, brainstorming or lessons-learned sessions, project reviews at appropriate phases of the development, planned and unplanned audits, or other similar means;

      conducting independent ISM activities and directly reporting any observations to the HDO.

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

ED Decision 2019/003/R

Monitoring that the implemented design assurance system (DAS) is adequate, and that it is complied with, is done by systematic means. The systematic means of monitoring may include structured experience exchanges, regular design meetings, brainstorming or lessons‑learned sessions, project reviews at appropriate phases of the development, or by other similar means.

Audits may be one element of monitoring. When implemented, audits should be conducted as combined process/product (project) audits that focus on the implemented key processes or methods practised according to the DOH (or the equivalent document), and the audits should also allow the design organisation to find ways to become more efficient by continuous improvement.

Systematic means of monitoring are coordinated by the ISM, under the responsibility of the HDO, and with a direct reporting line to the HDO. If the ISM is not independent of the activity that is monitored, especially if the HDO also fulfills the role of the head of ISM, the HDO may involve auditors that have adequate knowledge of the applicable requirements and of the implemented DAS. The system monitoring function may be undertaken by the existing quality assurance organisation, provided that it has adequate reporting lines to the HDO.

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

ED Decision 2021/007/R

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

      competent authorities when overseeing regulated organisations;

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

In the context of this GM:

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

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

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

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

The conduct of a remote audit

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

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

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

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

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

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

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

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

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

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

      determining the platform for hosting the audit;

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

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

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

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

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

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

      data protection aspects.

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

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

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

      the controllability of viewing direction, zoom, and lighting;

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

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

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

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

GM1 21.A.239(a) Design assurance system

ED Decision 2021/007/R

1. Purpose

This GM outlines some basic principles and objectives of 21.A.239(a).

2. Definitions

2.1 The design assurance system is the organisational structure, responsibilities, procedures and resources to ensure the proper functioning of the design organisation.

2.2 The design assurance means all those planned and systematic actions necessary to provide adequate confidence that the organisation has the capability

       to design products or parts in accordance with the applicable CS and environmental protection requirements,

       to demonstrate and verify the compliance with these CS and environmental protection requirements, and

       to demonstrate to the Agency this compliance.

2.3 The ‘Type Investigation’ means the tasks of the organisation in support of the type-certificate, supplemental type-certificate or other design approval processes necessary to demonstrate and verify and to maintain compliance with the applicable CS and environmental protection requirements.

3. Design Assurance

The complete process, starting with the CS and environmental protection requirements and product specifications and culminating with the issuing of a type-certificate, is shown in the diagram on Figure 1. This identifies the relationship between the design, the Type Investigation and design assurance processes.

Effective design assurance demands a continuing evaluation of factors that affect the adequacy of the design for intended applications, in particular that the product, or part, complies with applicable CS and environmental protection requirements and will continue to comply after any change.

Two main aspects should therefore be considered:

      How the planned and systematic actions are defined and implemented, from the very beginning of design activities up to continued airworthiness activities;

      How these actions are regularly evaluated and corrective actions implemented as necessary.

Figure 1 - RELATIONSHIPS BETWEEN DESIGN, DESIGN ASSURANCE AND TYPE INVESTIGATION

3.1 Planned and Systematic Actions

For design organisations carrying out Type Investigation of products, the planned and systematic actions should cover the following tasks and procedures should be defined accordingly:

3.1.1 General

a. To issue or, where applicable, supplement or amend the handbook in accordance with 21.A.243, in particular to indicate the initiation of design activities on a product.

b. To assure that all instructions of the Handbook are adhered to.

c. To conduct Type Investigation.

d. To nominate staff as ‘compliance verification engineers’ responsible to approve compliance documents as defined in paragraph 3.1.3.

e. To nominate personnel belonging to the Office of Airworthiness responsible as defined in paragraph 3.1.4.

f. In the case of an applicant for a supplemental type-certificate, to obtain the agreement of the type-certificate holder for the proposed supplemental type-certificate to the extent defined in 21.A.115.

g. To ensure full and complete liaison between the type design organisation and related organisations having responsibility for products manufactured to the type-certificate.

h. To provide the assurance to the Agency that prototype models and test specimens adequately conform to the type design (see 21.A.33(b)(1)).

3.1.2 Chief Executive and Head of design organisation (or his or her Deputy)

a. The Chief Executive should provide the necessary resources for the proper functioning of the design organisation.

b. The Head of the design organisation, or an authorised representative, should sign a declaration of compliance (see 21.A.20(d) and 21.A.97(a)(3)) with the applicable CS and environmental protection requirements after verification of satisfactory completion of the Type Investigation. In accordance with 21.A.20(e) and 21.A.97(a)(4), his or her signature on the declaration of compliance confirms that the procedures as specified in the handbook have been followed (see also GM 21.A.265(b)).

c. The functions of Chief Executive and Head of the design organisation may be performed by the same person.

3.1.3 Compliance Verification

a. Approval by signing of all compliance documents, including test programmes and data, necessary for the verification of compliance with the applicable CS and environmental protection requirements as defined in the certification programme.

b. Approval of the technical content (completeness, technical accuracy...), including any subsequent revisions, of the manuals approved by the Agency (Aircraft Flight Manual, the Airworthiness Limitations section of the Instructions for Continued Airworthiness and the Certification Maintenance Requirements (CMR) document, where applicable).

3.1.4 Office of Airworthiness

a. Liaison between the design organisation and the Agency with respect to all aspects of the certification programme.

b. Ensuring that a handbook is prepared and updated as required in 21.A.243.

c. Co-operation with the Agency in developing procedures to be used for the type certification process.

d. Issuing of guidelines for documenting compliance.

e. Co-operation in issuing guidelines for the preparation of the manuals required by the applicable implementing rules, Service Bulletins, drawings, specifications, and standards.

f. Ensuring procurement and distribution of applicable CS and environmental protection requirements and other specifications.

g. Co-operating with the Agency in proposing the type-certification basis

h. Interpretation of CS and environmental protection requirements and requesting decisions of the Agency in case of doubt.

i. Advising of all departments of the design organisation in all questions regarding airworthiness, operational suitability, environmental protection approvals and certification.

j. Preparation of the certification programme and co-ordination of all tasks related to Type Investigation in concurrence with the Agency.

k. Regular reporting to the Agency about Type Investigation progress and announcement of scheduled tests in due time.

l. Ensuring co-operation in preparing inspection and test programmes needed for demonstration of compliance.

m. Establishing the compliance checklist and updating for changes.

n. Checking that all compliance documents are prepared as necessary to demonstrate compliance with all CS and environmental protection requirements, as well as for completeness, and signing for release of the documents.

o. Checking the required type design definition documents described in 21.A.31 and ensuring that they are provided to the Agency for approval when required.

p. Preparation, if necessary, of a draft for a type-certificate data sheet and/or type-certificate data sheet modification.

q. Providing verification to the head of the design organisation that all activities required for Type Investigation have been properly completed.

r. Approving the classification of changes in accordance with 21.A.91 and granting the approval for minor changes in accordance with 21.A.95(b).

s. Monitoring of significant events on other aeronautical products as far as relevant to determine their effect on airworthiness or operational suitability of products being designed by the design organisation.

t. Ensuring co-operation in preparing Service Bulletins and the Structural Repair Manual, and subsequent revisions, with special attention being given to the manner in which the contents affect airworthiness and environmental protection and granting the approval on behalf of the Agency.

u. Ensuring the initiation of activities as a response to a failure (accident/incident/in-service occurrence) evaluation and complaints from the operation and providing of information to the Agency in case of airworthiness or operational suitability impairment (continuing airworthiness and continued operational suitability).

v. Advising the Agency with regard to the issue of airworthiness directives in general based on Service Bulletins.

w. Ensuring that the manuals approved by the Agency, including any subsequent revisions (the Aircraft Flight Manual, MMEL, the Airworthiness Limitations section of the Instructions for Continued Airworthiness and the Certification Maintenance Requirements (CMR) document, where applicable) are checked to determine that they meet the respective requirements, and that they are provided to the Agency for approval.

3.1.5 Maintenance and Operating Instructions

(a) Ensuring the preparation and update of all maintenance and operating/installation instructions (including instructions for continued airworthiness and service bulletins) needed to maintain airworthiness (continuing airworthiness) in accordance with the relevant CSs. For that purpose, the applicant should:

      establish the list of all documents it produces to comply with CS 2X.1581 and with the Appendix referred to in CS 2X.1529, CS‑E 20/25 or CS-P 30/40;

      establish a system to collect in-service experience to be used for the improvement of the instructions;

      define its procedures and the organisation to produce and issue these documents, under the obligation of point 21.A.265(h); the procedures should cover:

      preparation, including the format and language (available industrial standards can be referred to and used);

      proofreading (checking for clarity, readability, typos, etc.);

      verification of technical consistency with the corresponding approved change(s), repair(s) or approved data, including the effectivity, description, effects on airworthiness and environmental protection, especially when limitations are changed;

      verification of feasibility in practical applications when relevant and feasible; and

      responsibilities and authorised signatories.

Note: The compliance verification, as described in 3.1.3(b) of this GM, applies to the manuals approved by EASA (aircraft flight manual, the Airworthiness Limitations section of the Instructions for Continued Airworthiness (ICA) and the Certification Maintenance Requirements (CMR) document, where applicable). For the other ICA or other maintenance instructions, the procedure required by 3.1.5(a) provides a sufficient level of verification and does not require specific compliance verification unless, in line with 21.A.90C, additional work to demonstrate compliance is required. In this case, where additional showing of compliance is required, points 21.A.91 to 21.A.109 apply and then the independent checking function of the showings of compliance as per 21.239(b) applies.

(b) In accordance with points 21.A.6, 21.A.7 and, where applicable, 21.A.609, ensuring that these documents are made available in accordance with point 21.A.7(b).

3.1.6 Operational Suitability Data (OSD)

(a) Ensuring the preparation and update of all OSD in accordance with the relevant CSs. For that purpose, the applicant should:

      establish the list of all the documents it produces to comply with CS‑MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD and CS-MCSD, as applicable;

      define its procedures and the organisation to produce and issue these documents under the obligation of point 21.A.265(h); these procedures should cover the aspects described in 3.1.5(a) above.

(b) In accordance with points 21.A.6 and 21.A.7, ensuring that these documents are provided to all affected operators and training organisations and all involved authorities.

3.2 Continued effectiveness of the design assurance system. The organisation should establish the means by which the continuing evaluation (system monitoring) of the design assurance system will be performed in order to ensure that it remains effective.

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

ED Decision 2012/020/R

1. Purpose

This GM outlines some basic principles and objectives in order to comply with 21.A.239(a) for organisations designing only minor changes to type design or minor repairs to products.

2. Design assurance system

The design assurance system should include the following:

      an organisational structure to:

      control the design

       demonstrate compliance with applicable CS and environmental protection requirements

       independently check demonstrations of compliance

       liaise with the Agency

       continuously evaluate the design organisation

       control sub-contractors

       procedures and responsibilities associated with the functions listed above, taking due account of Part 21 requirements applicable to design and approval of minor changes to type design or minor repairs to products.

AMC 21.A.239(a)(3) Design assurance system – Independent system monitoring

ED Decision 2012/020/R

The system monitoring function required by 21.A.239(a)(3) may be undertaken by the existing quality assurance organisation when the design organisation is part of a larger organisation.

AMC 21.A.239(b) Design assurance system – Independent checking function of the demonstration of compliance

ED Decision 2012/020/R

1. The independent checking function of the demonstration of compliance should consist of the verification by a person not creating the compliance data. Such person may work in conjunction with the individuals who prepare compliance data.

2. The verification should be shown by signing compliance documents, including test programmes and data.

3. For a product, there is normally only one compliance verification engineer nominated for each relevant subject. A procedure should cover the non-availability of nominated persons and their replacement when necessary.

4. For STC cases, when compliance statement and associated documentation are produced by the TC holder, and when these data are approved under the system of the authority of TC holder, then the STC applicant does not need to provide, within its own DOA, the independent checking function required in 21.A.239(b) for these data.

AMC-ELA No 1 to 21.A.239(b)  Design assurance system – Independent checking function

ED Decision 2019/003/R

The design assurance system (DAS) defines methods to ensure there is an independent verification of the compliance demonstration on the basis of which the organisation submits compliance statements and associated documentation to EASA.

Compliance verification therefore means the approval of all those compliance documents that are necessary for the verification of compliance with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements, as defined in the certification programme. This shall include all the relevant aspects that ultimately lead to the showing of compliance, and therefore, for example, it may need to be extended to test programmes or data analysis reports if the higher-level compliance report itself does not adequately cover all the necessary levels of detail.

Compliance verification is provided by the approval of documented information by a person who did not create the approved data, and who acts as a compliance verification engineer (CVE). Approval is given after the completeness and technical accuracy of the report and the correctness of the derived statement of compliance have been verified. The approval must be documented in such a way that the date and the person who gives approval can be identified.

CVEs are nominated for specific scopes of responsibility. The structure of these scopes is defined by the applicant, and it should follow a logical structure, commensurate with the type of product, such as, for example, by disciplines (e.g. structures, flight, electrical system, etc.), by a set of CS requirements (Subpart B, Subpart C, etc.), by a (set of) ATA chapters (ATA 27 Flight Controls, ATA 32 Landing Gear, ATA 51 Structures, etc.), or by any other appropriate logic. For the kind of product addressed by this AMC, it is explicitly acceptable for the scope of the CVE to be broken down into only a few different disciplines, commensurate with the kind of product.

Compliance verification as part of the DAS is the only task within the DOA in which the creation and the CVE check of documents is mandatorily performed by different persons. It is acceptable for one person to hold multiple CVE nominations. For small companies, it is acceptable for persons who hold other functions, such as the CE, HDO and HOA, to also be nominated as design engineers and CVEs, provided they have the proper competence.

AMC-ELA No 1 to 21.A.239(c)  Design assurance system – Acceptability of tasks performed by external parties

ED Decision 2019/003/R

The organisation is responsible for ensuring that the type design of the product complies with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements. This includes the determination that components designed by, or tasks performed by, external parties are acceptable. To discharge this responsibility, the DO has to implement documented methods that ensure the compliance of the final product, and that make use of these components or task results, prior to making the final declaration of compliance.

One acceptable means to ensure this is whether the CVE(s) of the applicant conducts (conduct) the verification of compliance, in line with the definitions of the DAS of the applicant. As the verification of compliance remains with the applicant, no specific qualification measures are required other than to pragmatically verify the capabilities of the external party, and to ensure that the required level of detail is supplied to enable the work results to be adequately verified. The capability of an external party should be verified if more complex activities are subcontracted.

If a DOA subcontracts the CVE function to an external party that conducts the task, but does not hold its own DOA, then the same requirements for the qualification, nomination and documentation of qualification and nomination apply to the person who is nominated as a CVE as are defined in the design organisation handbook (DOH) of the contracting DOA. The availability of all the relevant information for the subcontracted CVE to perform their duties is ensured by the applicant. The relevant contract defines that when acting as a CVE, the external person acts on behalf of, and with direct reporting to, the applicant’s head of airworthiness (HoA). The person who acts as a CVE is named in this contract, or in an attachment to it.

Alternatively, if an organisation with a DOA obtains design substantiation data from a subcontractor that also holds a DOA, and the work that is conducted is within the approved scope of this subcontractor DOA, the subcontractor’s design data becomes acceptable when the contracting DOA has verified that the results adequately meet the needs of the product under development. Additional formal compliance verification by the contracting DOA is not required if the CVE of the contracted DOA signs and approves the document under its DOA.

GM 21.A.239(c) Design assurance system

ED Decision 2012/020/R

In meeting the requirements of 21.A.239(c) the applicant for a design organisation approval under Subpart J may adopt the following policy:

1. The satisfactory integration of the Partner/Sub-contractor and applicant’s design assurance systems should be demonstrated for the activities covered under the applicant’s terms of approval.

2. In the event that a Partner/Sub-contractor holds a design organisation approval (DOA), then in accordance with 21.A.239(c), the applicant may take this into account in demonstrating the effectiveness of this integrated system.

3. When any Partner/Sub-contractor does not hold a DOA then the applicant will need to establish to its own satisfaction and the satisfaction of the Agency, the adequacy of that partner’s/sub-contractor’s design assurance system in accordance with 21.A.243(b).

21.A.243 Data [applicable until 6 March 2023] / 21.A.243 Handbook [applicable from 7 March 2023 - Regulation (EU) 2022/201]

Regulation (EU) 2015/10399

(a) The design organisation shall furnish a handbook to the Agency describing, directly or by cross-reference, the organisation, the relevant procedures and the products or changes to products to be designed. If flight tests are to be conducted, a flight test operations manual defining the organisation’s policies and procedures in relation to flight test shall be furnished. The flight test operations manual shall include:

(i) a description of the organisation’s processes for flight test, including the flight test organisation involvement into the permit to fly issuance process;

(ii) crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII to this Annex I (Part 21), where applicable;

(iii) procedures for the carriage of persons other than crew members and for flight test training, when applicable;

(iv) a policy for risk and safety management and associated methodologies;

(v) procedures to identify the instruments and equipment to be carried;

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

(b) Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to give, for all parts and appliances, the assurance of compliance required by point 21.A.239(b), and shall contain, directly or by cross‑reference, descriptions and information on the design activities and organisation of those partners or subcontractors, as necessary to establish this statement.

(c) The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of amendments shall be supplied to the Agency.

(d) The design organisation shall furnish a statement of the qualifications and experience of the management staff and other persons responsible for making decisions affecting airworthiness and environmental protection in the organisation.

[applicable until 6 March 2023]

(a) As part of the design management system, the design organisation shall create and furnish to the Agency a handbook that describes, directly or by cross reference, the organisation, its relevant policies, processes and procedures, the type of design work, and the categories of products, parts and appliances for which the design organisation holds a design organisation approval, as identified in the terms of approval issued in accordance with point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.

If flight tests are to be conducted, a flight test operations manual that defines the organisation’s policies and procedures in relation to flight tests shall also be created and furnished to the Agency. The flight test operations manual shall include:

1. a description of the organisation’s processes for flight tests, including its involvement in the process for issuing a permit to fly;

2. crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII, where applicable;

3. procedures for the carriage of persons other than the crew members and for flight test training, where applicable;

4. a policy for the risk and safety management and associated methodologies;

5. procedures to identify the instruments and equipment to be carried on board;

6. a list of documents that need to be produced for the flight test.

(b) Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to demonstrate, for all parts and appliances, the compliance in accordance with point 21.A.239(d)(2), and shall contain, directly or by cross reference, descriptions of and information on the design activities and the organisation of those partner organisations or subcontractors, as necessary to establish the statement.

(c) The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of the amendments shall be provided to the Agency.

(d) The design organisation shall establish and maintain a statement of the qualifications and experience of the management staff and of other persons in the organisation that are responsible for making decisions that affect airworthiness, operational suitability data and environmental protection matters. It shall submit that statement to the competent authority.

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

AMC to 21.A.143, 21.A.243, 21.A.14(b), 21.A.112B(b) and 21.A.432B(b) Flight Test Operations Manual (FTOM)

ED Decision 2017/024/R

1. General

a. Scope: The FTOM covers flight test operations.

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

b. Format

The FTOM may:

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

      be a separate manual.

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

c. Use by contractors or sub-contractors:

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

2. The FTOM should contain the following elements:

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

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

b. Risk and safety management:

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

c. Crew members:

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

All crew members should be listed in the FTOM.

A flight time limitation policy should be established.

d. Carriage of persons other than crew members:

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

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

e. Instruments and equipment:

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

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

f. Documents:

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

(i) documents associated with a Flight Test Programme:

      Flight Order for a given flight, which should include:

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

      safety considerations relevant to the flight;

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

      composition of the crew;

      names of persons other than crew members;

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

      loading of the aircraft;

      reference to approved flight conditions; and

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

      Flight crew report.

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

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

g. Permit to fly:

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

h. Currency and training:

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

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

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

      for pilots: 50 hours. In addition:

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

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

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

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

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

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

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

AMC1 21.A.243(a) Data requirements

ED Decision 2021/007/R

HANDBOOK CONTENT

The handbook should provide the following information for each product covered by the design organisation approval.

1. A description of the tasks which can be performed under the approval, according to the following classification:

a. General areas, like subsonic turbojet aeroplanes, turbopropeller aeroplanes, small aeroplanes, rotorcraft.

b. Technologies handled by the organisation (composite, wood or metallic construction, electronic systems, etc.)

c. A list of types and models for which the design approval has been granted and for which privileges may be exercised, supported by a brief description for each product.

d. For repair design, classification and (if appropriate) approval activities it is necessary to specify the scope of activity in terms of structures, systems, engines, etc.

2. A general description of the organisation, its main departments, their functions and the names of those in charge; a description of the line management and of functional relationships between the various departments.

3. A description of assigned responsibilities and delegated authority of all parts of the organisation which, taken together, constitute the organisation’s design assurance system together with a chart indicating the functional and hierarchical relationship of the design assurance system to Management and to other parts of the organisation; also the chains of responsibilities within the design assurance system, and the control of the work of all partners and sub-contractors.

4. A general description of the way in which the organisation performs all the design functions in relation to airworthiness, operational suitability and environmental protection approvals including:

a. The procedures followed and forms used in the Type Investigation process to ensure that the design of, or the change to the design of, the product as applicable is identified and documented, and complies with the applicable CS and environmental protection requirements, including specific requirements for import by importing authorities

b. The procedures for classifying design changes as ‘major’ or ‘minor’ and for the approval of minor changes.

c. The procedures for classifying and approving unintentional deviations from the approved design data occurring in production (concessions or non-conformance’s).

d. The procedure for classifying and obtaining approval for repairs.

5. A general description of the way in which the organisation performs its functions in relation to the continuing airworthiness and continued operational suitability of the product it designs, including co-operation with the production organisation when dealing with any continuing airworthiness actions that are related to production of the product, part or appliance, as applicable.

6. A description of the human resources, facilities and equipment, which constitutes the means for design, and where appropriate, for ground and flight testing.

7. An outline of a system for controlling and informing the Staff of the organisation of current changes in engineering drawings, specifications and design assurance procedures.

8. A description of the recording system for:

a. The type design, including relevant design information, drawings and test reports, including inspection records of test specimens.

b. The means of compliance.

c. The compliance documentation (compliance check list, reports...).

9. A description of the record-keeping system to comply with 21.A.5.

10. A description of the means by which the organisation collects, monitors, analyses and responds to reports of problems which cause or might cause an adverse effect on the airworthiness or operational suitability of its product, part or appliance during design, production and in service, in particular to comply with point 21.A.3A (see also AMC3 21.A.3A(a) and GM No 1 to 21.A.239(a), points 3.1.4(s) and (u)). These collected reports should include both mandatory and voluntary occurrence reports from organisations and natural persons involved in the operation and maintenance of the product, part or appliance.

11. The names of the design organisation authorised signatories.  Nominated persons with specific responsibilities such as mentioned in 21.A.33 and 21.A.35 should be listed.

12. (Reserved).

13. A clear definition of the tasks, competence and areas of responsibility of the Office of Airworthiness.

14. A description of the procedures for the establishment and control of the maintenance and operating instructions (see points 21.A.6, 21.A.7 and, where applicable, 21.A.609).

15. A description of the means by which the continuing evaluation (system monitoring) of the design assurance system will be performed in order to ensure that it remains effective.

16. A description of the procedures for the establishment and control of the operational suitability data (see 21.A.5, 21.A.62, 21.A.108, and 21.A.120B).

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

ED Decision 2012/020/R

Part 1. Organisation

1.1 Objective of handbook and binding statement

1.2 Responsible person for administration of handbook

1.3 Amendment procedure

1.4 List of effective pages

1.5 Distribution list

1.6 Presentation of design organisation (including locations)

1.7 Scope of work (with identification of type and models of products)

1.8 Organisation charts

1.9 Human resources

1.10 Management staff

1.11 Certifying personnel (see GM No 2 to 21.A.243(d), paragraph 2)

1.12 Independent system monitoring

Part 2. Procedures

2.1 Management of changes to type design and design of repairs

      configuration control

       classification

       approval of minor changes to type design and minor repairs

2.2 Control of design sub-contractors

2.3 Collecting/Investigating of failures, malfunctions and defects 

2.4 Co-ordination with production

2.5 Documentation control

       in relations with the changes and repairs

       in relation with failures/malfunctions and defects (i.e. Services  Bulletins)

2.6 Record keeping

AMC-ELA No 1 to 21.A.243  Data – Design organisation handbook

ED Decision 2019/003/R

The organisation is responsible for ensuring that the type design complies with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements. This includes components that are part of the product, but are designed by external parties, and that are not covered by the applicable and individual parts-related (ETSO) approvals or (type) certificates.

To discharge this responsibility, the DOA implements practised methods to ensure that there are adequate means to positively establish and verify the compliance of the design and the associated documentation that is generated. The completeness of those methods is documented within the design organisation handbook (DOH), together with the required supporting and company-specific definitions.

The extent of the documentation, and the associated training, is mandated only to the extent that is required to be able to demonstrate that the generated type designs, design changes or repair designs comply with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements, and that the continued airworthiness activities are properly conducted. If evidence is found that the system described is not effective, then enhanced documentation may be one of the means, but not the only possible means, to rectify that situation.

The documentation of the elements within the DOH may be limited to workflow definitions (e.g. flow charts, process cards, or similar items) or to forms that are sufficiently process-oriented. If ERP systems or other IT systems that manage workflows are used, separate workflow documentation is not necessary, as long as the workflow can be demonstrated during surveillance activities on the basis of the IT system that is applied.

The ‘practising of methods’ is confirmed by observing that the methods are practised in an organised and repeatable manner on several examples. Those methods do not automatically require detailed documentation if they are otherwise defined. Nevertheless, ‘practised methods’ should be at least identified with a declarative statement.

The documentation at least covers the relevant items in the list below:

1. A unique identifier for the DOH, and a means to identify and record its revision status.

2. The name of the organisation and the address of its major place of activity, including any side offices where DAS functions as per AMC-ELA No 2 to 21.A.239(a) are performed under the DOA. If this location differs from the legal place of business, both addresses should be provided. Floor plans, or similar data, are not required.

3. A statement signed by the head of the design organisation (HDO) confirming that the DOH will be complied with at all times, and that it is used as a basic working document (i.e. a binding declaration).

4. A statement of the scope of the DOA (refer to GM-ELA No 1 to 21.A.251), which lists the key technologies used for airframe design and propulsion concepts on the projects in that scope.

5. The title and the name of the HDO, HoA and ISM, with statements of their accountability per AMC-ELA No 1 to 21.A.239(a). The delegation of tasks without responsibility does not affect accountability, and it is not required to be mentioned within the DOH.

6. The identification of the formal position and the reporting lines of the HDO, HoA and ISM within the company, possibly, but not necessarily, by means of an organisational chart.

7. A statement that the HDO assumes all the duties and responsibilities associated with the DOA, unless delegation of responsibility, beyond the delegation of tasks, is applied. In such a case, the allocation of responsibilities should be shown along with this statement.

8. A statement that the HoA is the formal point of contact for EASA.

9. Definitions of the required competences and qualifications that are necessary for the HDO and the HoA (which may be consolidated if both functions are provided by one person), and for design engineers, CVEs and ISMs.

10. A listing of the CVEs, either directly in the DOH or in a separate source (a document, listing, the intranet, etc.) that is linked to the DOH, and this data should be easily accessible to everyone concerned within the company. This list should be made available to EASA in its current version.

11. The approximate size of the company in full-time equivalent staff members, accurate enough to determine the related fees and charges that are laid down in Commission Regulation (EU) No 319/2014 (the Fees and Charges Regulation). This should include a declaration that the company ensures that the numbers and the qualifications of the staff involved in the design activities are adequate, that the company monitors these aspects, and that it takes action if necessary.

12. A confirmation that any significant changes to the DO, and any changes to the organisation that affect the contents of the DOH, will be notified to EASA in a timely manner by the responsible person defined in the DOH.

13. A confirmation that, when changes to the organisation occur that affect the documentation required here, the DOH is kept up to date by the responsible person defined in the DOH, but under the responsibility of the HDO, or their delegate. Amendments to the DOH should be released by the HDO, or by their delegate, and distributed according to the implemented method for the control of documented information, to locations that are identified in a generic or document-specific distribution list, including the responsible design organisation approval team leader (DOATL).

14. A definition of the methods that are practised to verify the effectiveness of the elements of the DAS that are stated in this listing. The main targets of Subpart J are to ensure that the type design of the product complies with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements, and that the continued airworthiness activities are properly conducted. The surveillance mechanisms that are used may include structured experience exchanges, regular quality meetings, brainstorming or lessons learned sessions, project reviews at appropriate phases of the development, planned and unplanned audits, or other similar means. Corrective actions that are identified should be followed up, and the means of resolution should be recorded. The DOH should define how this is accomplished.

15. A declaration that control methods are practised, and that the general principles of the applied document revision and access management processes ensure the use of current information.

16. A general identification of the documentation that is the result of all the design functions in relation to the airworthiness, operational suitability and environmental protection approvals, and continued airworthiness, each one of which should be commensurate with the complexity of the product and the risk level in terms of its content, style and format, including:

a. a listing of the document types that form the type design, such as, for example, specifications, drawings, bills of materials, instructions, and other documents;

b. a listing of the document types that form the compliance documentation, such as, for example, compliance reports, compliance summary documents, compliance checklists, means of compliance checklists, manuals, instructions for continued airworthiness (ICAs), master minimum equipment lists (MMELs) (if required), and others;

c. a listing of the document types that form the change and repair design-specific documentation, such as classification matrices and approvals of minor changes, repairs, or production deviations;

d. a listing of the documents related to continued airworthiness activities (information and instructions such as, for example, service bulletins/service instructions), if not already listed to address point a.

17. A declaration and a definition of the principles that are applied, and the accepted related duties, of the key elements of the DAS, as defined in AMC-ELA No 2 to 21.A.239(a). The definition of the elements can be provided by various means, such as precise forms that guide the user through the process, workflow modelling in IT-based design or document management systems, process charts, flow diagrams, classical process definition documents, or other comparable means that are commensurate with the complexity and the criticality of the products. If references are made to other documents that are outside the DOH, the DOH should contain a listing of those documents.

18. A confirmation that methods are practised that enable adequate airworthiness coordination with the applicant for, or the holder of, the production approval. Dedicated procedures and/or DO–PO agreements for the purpose of airworthiness coordination with the production approval holder are not required if the design and the production entities work within one consolidated team, or if the control of airworthiness-related information is conducted by the same group of persons for both design and production. However, it should be described how any occurrences, and any unintentional deviations from the approved design data that occur in production (i.e. concessions or non-conformances) are handled within the design organisation, and when a concession process or a direct approval of such non conformities under the DOA is sought, for example by using the change process. In addition, the methods/processes that are required by other AMC-ELA and GM-ELA should be defined, either directly in the DOH or in a document that is linked to it.

19. A declaration and a definition of the method applied to accept design work that is conducted by external parties, in line with AMC-ELA No 1 to 21.A.239(c).

20. The identification of the design subcontractors and satellite locations that operate under the DAS of the design organisation, and that fulfil functions required by the DAS, or are directly involved in critical aspects of compliance demonstration, such as, for example, flutter investigations and analyses. This identification may be an integral part of the DOH, or it may be provided in a separate listing that is only identified from within the DOH.

21. A reference to a flight test operations manual (FTOM) that is adequate for the flight test activities of the design organisation. If both the design and the manufacturing entities work within one consolidated team, it is sufficient to have FTOM procedures defined for only one of the entities. The FTOM shall then identify the workflow that defines how to issue flight conditions and PtFs for the purpose of conducting factory acceptance test flights.

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

ED Decision 2019/003/R

In order to conduct flight test activities, the DOA is required to implement policies and procedures for conducting these activities that include a proportionate and efficient risk and safety management system. This approach is documented either within a separate flight test operations manual (FTOM) or as an integral part of any other valid manual of the organisation, such as the DOH, or any other relevant quality manual. The FTOM, or its equivalent, should be proportionate to the risk of the product and the complexity of the organisation.

The risk and safety management system, documented within the FTOM, or its equivalent, covers the following aspects:

      The definition of the key qualifications, responsibilities and accountabilities of the staff involved in conducting the flight tests, which covers at least:

      the head of flight test (HoFT), who coordinates all the activities related to flight test and assumes responsibility for flight testing (this can be shared with other management positions within the DO);

      the flight test engineer, who manages individual flight tests (or test campaigns);

      the test pilot, who conducts any flight tests;

      the flight test mechanic, who conducts all maintenance tasks and configuration changes to the test aircraft.

One person who has adequate qualifications may act in more than one role. The HoFT should have a direct reporting line to the HDO.

      A method that provides practical guidance on conducting a hazard assessment to classify flight tests according to the risk involved. At least two categories should be identified: Category 1 for high-risk flight tests, and Category 2 for medium- and low-risk flight tests.

      Definitions of generic risk mitigation strategies such as the use of minimum and maximum altitudes or airspeed safety margins, and safety rules to be obeyed for the typical major test phases and missions.

      Identification of the aircraft-related safety equipment that needs to be available, including references to the maintenance requirements of this equipment.

      A policy on how to alert and involve rescue services, such as the fire brigade or emergency physicians, in order to allow sufficiently short reaction times.

      Crew qualifications, including requirements for the qualifications to be current and for crew (refresher) training, as adequate.

      For aircraft with MTOMs of 2 000 kg or more:

      the provisions of EASA Part-21 Appendix XII apply.

      the minimum flight experience per year should be:

      for pilots: 50 hours. In addition:

      for pilots who have flight test ratings, the 50 hours should include 20 flight test hours in any flight test category;

      for pilots to perform Category 3 flight tests, their flight test experience should be expressed in terms of the number of flights that led to the issuing of a certificate of airworthiness (CofA) (e.g. first flights);

      for pilots to perform Category 4 flight tests, their minimum flight test experience should be proportionate to the activity envisaged.

      Crew composition and duty time limitations that are adequate for the kind of testing and the risk category of the flight tests conducted by the DOA.

The procedural aspects, documented within the FTOM, or its equivalent, should cover the following aspects:

      The initiation and planning of a flight test activity, including, for example, but not limited to:

      hazard analysis;

      detailed flight test planning;

      the generation and approval of flight conditions;

      the definition and verification of the test-aircraft configuration;

      preparation of the aircraft;

      the integration, calibration and verification of any flight test equipment;

      verification of the fitness of the aircraft for flight;

      issuing or obtaining a PtF;

      the preflight briefing, and conducting the flight test; and

      debriefing and data reporting.

The FTOM, or its equivalent, identifies all the documents and records that are required to be generated or maintained in relation to the flight test, including the definitions for the authority to sign.

The FTOM, or its equivalent, identifies how training for flight tests is organised.

The definition of the methods required may be provided in different ways, including but not limited to flow charts, process descriptions, forms that are detailed enough to enforce adherence to the required workflow, workflow implementation in IT-based ERP systems, or similar means.

The implementation of the standard FTOM, including its associated process definitions and forms, ensures adherence to this AMC, and hence that there will be compliance with the relevant requirements of Part-21.

Any flight tests that are subcontracted to a third party should comply with the FTOM of the DOA, unless the third party has established an FTOM that is in compliance with Part-21, and its use has been agreed between the two organisations.

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

ED Decision 2019/003/R

Evidence of their qualifications and experience is documented for the persons who accept the duties defined for the following roles:

      head of the design organisation (HDO);

      head of airworthiness (HoA);

      independent system monitoring (ISM);

      compliance verification engineer (CVE).

The credentials of the HDO, HoA and ISM are provided to EASA using EASA Form 4-DOA. The form is published on the EASA webpage.

For the CVE, no individual statement is needed. CVEs are selected by the applicant/approval holder on the basis of their knowledge, background and experience as defined in the DOH. When necessary, complementary training should be established to ensure that CVEs have sufficient background and knowledge in the scope of their authorisation.

The organisation maintains a record of the CVE personnel, which includes details of the scopes of their authorisations. The CVE personnel are given reasonable access on request to their own records. As part of its investigations, EASA has the right to access the data held in such a system.

The following minimum information on each of the CVEs should be kept on record:

a) name,

b) date of birth,

c) experience and training,

d) position in the organisation,

e) scope of the authorisation,

f) date of the first issue of the authorisation,

g) if applicable, the date of expiry of the authorisation,

h) identification number of the authorisation,

i) documented acceptance of the nomination by the CVE.

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

The organisation should keep the records of a CVE for at least 2 years after the CVE has ceased to be employed by the organisation, or 2 years after the withdrawal of the CVE’s authorisation, whichever occurs first.

GM No 1 to 21.A.243(d) Statement of qualifications and experience

ED Decision 2014/007/R

1. Purpose

This GM provides guidelines on the following points:

       Who are the persons covered by 21.A.243(d)?

       What is requested from the applicant for these persons?

2. Who are the persons?

Three different types of functions are named or implicitly identified in the requirements of Part 21 Subpart J or in associated AMC and GM, using qualified and experienced personnel:

       the Chief Executive [see GM No 1 to 21.A.239(a), para. 3.1.2, GM 21.A.249, GM 21.A.265(b)]

       the other management staff:

      the Head of the design organisation [see GM No 1 to 21.A.239(a), para.3.1.2, GM No 1 21.A.245, para.4.1, GM 21.A.265(b)]

       the Chief of the Office of Airworthiness, or [see GM No 1 to 21.A.245, para. 4.2]

       the Chief of the independent monitoring function of the design assurance system [see 21.A.239(a)(3) and AMC No 1 to 21.A.243(a), para.2]

       the personnel making decisions affecting airworthiness, operational suitability and environmental protection:

       compliance verification engineers [see GM No 1 to 21.A.239(a), para.3.1.3; AMC 21.A.239(b)]

       personnel of the Office of Airworthiness making decisions affecting airworthiness, operational suitability and environmental protection, especially those linked with the 21.A.263 privileges (signing documents for release, approving classification of changes and repairs, and granting the approval of minor changes and minor repairs, granting the approval of SBs, and minor revisions to the aircraft flight manual) [see GM No 1 to 21.A.239(a), para. 3.1.4]

3. Kind of statement

3.1 Chief Executive

The Chief Executive should provide the necessary resources for the proper functioning of the design organisation.

A statement of the qualification and experience of the Chief Executive is normally not required.

3.2 Other management staff

The person or persons nominated should represent the management structure of the organisation and be responsible through the Head of design organisation to the Chief Executive for the execution of all functions as specified in Part 21, Subpart J. Depending on the size of the organisation, the functions may be subdivided under individual managers.

The nominated managers should be identified and their credentials furnished to the Agency on EASA Form 4-DOA (see EASA website:

http://easa.europa.eu/certification/application-forms.php) in order that they may be seen to be appropriate in terms of relevant knowledge and satisfactory experience related to the nature of the design activities as performed by the organisation.

The responsibilities and the tasks of each individual manager should be clearly defined, in order to prevent uncertainties about the relations, within the organisation. Responsibilities of the managers should be defined in a way that all responsibilities are covered.

3.3 Personnel making decisions affecting airworthiness, operational suitability and environmental protection

For these personnel, no individual statement is required. The applicant should show to the Agency that there is a system to select, train, maintain and identify them for all tasks where they are necessary.

The following guidelines for such a system are proposed:

       These personnel should be identified in the handbook, or in a document linked to the handbook. This, and the corresponding procedures, should enable them to carry out the assigned tasks and to properly discharge associated responsibilities.

       The needs, in terms of quantity of these personnel to sustain the design activities, should be identified by the organisation.

       These personnel should be chosen on the basis of their knowledge, background and experience.

       When necessary, complementary training should be established, to ensure sufficient background and knowledge in the scope of their authorization. The minimum standards for new personnel to qualify in the functions should be established. The training should lead to a satisfactory level of knowledge of the procedures relevant for the particular role.

       Training policy forms part of the design assurance system and its appropriateness forms part of investigation by the Agency within the organisation approval process and subsequent surveillance of persons proposed by the organisation.

       This training should be adapted in response to experience gained within the organisation

       The organisation should maintain a record of these personnel which includes details of the scope of their authorisation. The personnel concerned should be provided with evidence of the scope of their authorisation.

       The following minimum information should be kept on record:

a) Name

b) Date of birth

c) Experience and training

d) Position in organisation

e) Scope of the authorisation

f) Date of first issue of the authorisation

g) If appropriate, date of expiry of the authorisation

h) Identification number of the authorisation.

The record may be kept in any format and should be controlled.

       Persons authorised to access the system should be maintained at a minimum to ensure that records cannot be altered in an unauthorised manner or that such confidential records do not become accessible to unauthorised persons.

       Personnel should be given access to their own record.

       Under the provision of 21.A.257 the Agency has a right of access to the data held in such a system.

       The organisation should keep the record for at least two years after a person has ceased employment with the organisation or withdrawal of the authorisation, whichever is the sooner.

GM No 2 to 21.A.243(d)  Data requirements – Statement of the qualification and experience – Organisations that design minor changes to type designs or minor repairs to products

ED Decision 2019/018/R

For organisations that design minor changes to type design or minor repairs to products, the statement of the qualifications and experience required by 21.A.243(d) should be addressed as follows:

1. The nominated managers should be identified and their credentials submitted to EASA on EASA Form 4 - DOA (see EASA website: http://easa.europa.eu/certification/application-forms.php) in order that they may be seen to be appropriate in terms of relevant knowledge and satisfactory experience related to the nature of the design activities as performed by the organisation.

2. The persons responsible for:

       classifying changes to type designs or repairs;

      verifying compliance (21.A.239(b));

      approving minor changes to type design and minor repairs (21.A.263(c)(2));

      issuing information or instructions (21.A.265(h)),

should be selected by the organisation in accordance with a procedure and criteria agreed with EASA.

21.A.245 Approval requirements [applicable until 6 March 2023] / 21.A.245 Resources [applicable from 7 March 2023 - Regulation (EU) 2022/201]

Regulation (EU) No 69/2014

The design organisation shall demonstrate, on the basis of the information submitted in accordance with point 21.A.243 that, in addition to complying with point 21.A.239:

(a) the staff in all technical departments are of sufficient numbers and experience and have been given appropriate authority to be able to discharge their allocated responsibilities and these, together with the accommodation, facilities and equipment, are adequate to enable the staff to achieve the airworthiness, operational suitability and environmental protection objectives for the product;

(b) there is full and efficient coordination between departments and within departments in respect of airworthiness, operational suitability and environmental protection matters.

[applicable until 6 March 2023]

(a) The organisation shall appoint a head of the design organisation with the authority to ensure that, within the organisation, all design activities are performed to the required standards and that the design organisation is continuously in compliance with the requirements of the design management system referred to in point 21.A.239 and the procedures specified in the handbook referred to in point 21.A.243.

(b) The head of the design organisation shall nominate and specify the extent of authority of:

1. a chief of the airworthiness function;

2. a chief of the independent monitoring function;

3. depending on the size of the organisation and the nature and complexity of its activities, any other person or group of persons that are required to ensure that the organisation complies with the requirements of this Annex.

(c) By way of derogation from point 21.A.245(b)(1), the airworthiness function referred to in point 21.A.239(d)(1)(i) may be performed under the direct supervision of the head of the design organisation in either of the following cases:

1. where the scope of activities of/of work of the design organisation, as identified in the terms of approval issued under point 21.A.251, is limited to minor changes and/or minor repairs;

2. for a limited period of time when the design organisation does not have a nominated chief of the airworthiness function and the exercise of that function under the direct supervision of the head of the design organisation is commensurate with the scope and level of the organisation’s activities.

(d) The person or group of persons nominated pursuant to point (b) shall:

1. be answerable to the head of the design organisation and have direct access to them;

2. have the appropriate knowledge, background and experience to discharge their responsibilities.

(e) The design organisation shall ensure that:

1. the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and the facilities, equipment and accommodation that are adequate to enable the staff to fulfil the airworthiness, operational suitability data and environmental protection requirements as regards the product;

2. there is full and efficient coordination between the departments and within the departments in respect of airworthiness, operational suitability data and environmental protection matters.

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

AMC-ELA No 1 to 21.A.245  Approval requirements

ED Decision 2019/003/R

The organisation demonstrates adequate staffing, infrastructure, access to facilities and discharge of responsibilities by means of the continued ability to certify type designs after it has ensured that there is positive compliance with the applicable type-certification basis, the operational suitability data certification basis and the environmental protection requirements. Adequate staffing is observed on the basis of reasonable workload, working time and project completion times.

The applicant should have access to:

      workshops and production facilities that are suitable for manufacturing prototype models and test specimens; and

      accommodation and test facilities that are suitable for carrying out the tests and measurements needed to demonstrate compliance with the certification specifications and the environmental protection requirements. The test facilities may be subject to additional technical conditions related to the nature of the tests performed.

The HDO for which an application for approval has been made has the direct or functional responsibility for all the departments of the organisation that are responsible for the design of the product. If the departments responsible for the design are functionally linked, the HDO still has the ultimate responsibility for the compliance of the organisation with Subpart J.

The function of the head of airworthiness (HoA) should be established with a direct reporting line to the HDO, and the person who fulfils this function is required to have a direct contract with the DO.

Responsibilities for all the tasks related to type investigations should be assigned in such a way that there are no gaps in authority.

Combinations of responsibilities are acceptable where:

      the role of the HDO may be fulfilled by the chief executive (CE) of the legal entity, who may also fill the role of the AM within a parallel POA;

      the HDO and the HoA are the same person, provided that the person has the competence to fulfil both functions;

      the HoA and the ISM are the same person, provided that the ISM assessment of working activities that directly affect the person in their second role is conducted by another independent person, on behalf of the ISM;

      the HDO and the ISM are the same person, provided that the auditing activity is conducted by another independent person, under the responsibility of the ISM;

      external persons are acceptable for all or for parts of the role of the ISM;

      a part-time HoA is acceptable, provided that the person is directly involved in the DOA, and not by an agreement between two DOAs, and provided that the availability of the person ensures that response times will be adequate;

      a CVE may also hold any of the other nominations, as long as there is an independent check of compliance per AMC-ELA No 1 to 21.A.239(b).

Due to the typically small size of the design organisations and the low complexity and criticality of the products within the scope of AMC-ELA, no specific provisions are required to ensure that there is full and efficient coordination between departments and within departments in respect of airworthiness, operational suitability and environmental protection matters, provided that evidence of this coordination can be observed during the surveillance activities.

GM No 1 to 21.A.245 Requirements for approval

ED Decision 2014/007/R

See 21.A.245

1. General. The data submitted in accordance with 21.A.243 should show that sufficient skilled personnel are available and suitable technical and organisational provisions have been made for carrying out the Type Investigation defined by GM No 1 to 21.A.239(a), paragraph 2.3.

2. Personnel. The applicant should show that the personnel available to comply with 21.A.245(a) are, due to their special qualifications and number, able to provide assurance of the design or modification of a product, as well as the compilation and verification of all data needed to meet the applicable CS and environmental protection requirements while taking into account the present state of the art and new experience.

3. Technical. The applicant should have access to:

a. Workshops and production facilities which are suitable for manufacturing prototype models and test specimens.

b. Accommodation and test facilities which are suitable for carrying out tests and measurements needed to demonstrate compliance with the CS and environmental protection requirements. The test facilities may be subjected to additional technical conditions related to the nature of tests performed.

4. Organisation. The data submitted in accordance with 21.A.243 should show that:

4.1 The Head of the design organisation for which an application for approval has been made, has the direct or functional responsibility for all departments of the organisation which are responsible for the design of the product. If the departments responsible for design are functionally linked, the Head of the design organisation still carries the ultimate responsibility for compliance of the organisation with Part 21 Subpart J.

4.2 An Office of Airworthiness, or equivalent function, has been established and staffed on a permanent basis to act as the focal point for co-ordinating airworthiness, operational suitability and environmental protection matters (see GM No 1 to 21.A.239(a) paragraph 3.1.4); it reports directly to the Head of the design organisation or is integrated into an independent quality assurance organisation reporting to the Head of the design organisation.

4.3 [Reserved]

4.4 Responsibilities for all tasks related to Type Investigations are assigned in such a way that gaps in authority are excluded.

4.5 The responsibility for a number of tasks as in paragraph 4.4 may be assigned to one person especially in the case of simple projects.

4.6 Co-ordination between technical departments and the persons in charge of the system monitoring required by 21.A.239(a)(3) has been established:

a. to ensure quick and efficient reporting and resolution of difficulties encountered using the handbook and associated procedures

b. to maintain the design assurance system

c. to optimise auditing activities.

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

ED Decision 2014/007/R

The data submitted in accordance with 21.A.243 should show that:

1. The manager responsible for design has the direct or functional responsibility for all departments of the organisation which are involved in the design of minor changes to type design or minor repairs to products.

2. Person(s) have been nominated to liaise with the Agency and to co-ordinate airworthiness, operational suitability and environmental protection matters. Their position in the organisation should allow direct report to the manager responsible for design.

3. Responsibilities for all tasks related to the design and approval of minor changes to type design or minor repairs to products are assigned to ensure that all areas are covered

4. The responsibility for a number of tasks as in paragraph 3 may be assigned to one person especially in the case of simple projects.

21.A.247 Changes in design assurance system [applicable until 6 March 2023] / 21.A.247 Changes in the design management system [applicable from 7 March 2023 - Regulation (EU) 2022/201]

Regulation (EU) No 69/2014

After the issue of a design organisation approval, each change to the design assurance system that is significant to the showing of compliance or to the airworthiness, operational suitability and environmental protection of the product, shall be approved by the Agency. An application for approval shall be submitted in writing to the Agency and the design organisation shall demonstrate to the Agency, on the basis of submission of proposed changes to the handbook, and before implementation of the change, that it will continue to comply with this Subpart after implementation.

[applicable until 6 March 2023]

After the issue of a design organisation approval, each change to the design management system that is significant to the demonstration of compliance or to the airworthiness, operational suitability and environmental protection of the product, part or appliance shall be approved by the Agency before being implemented. The design organisation shall submit to the Agency an application for approval demonstrating, on the basis of the proposed changes to the handbook, that it will continue to comply with this Annex.

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

GM 21.A.247 Significant changes in the design assurance system

ED Decision 2019/018/R

In addition to a change in ownership (see 21.A.249), the following changes to the design assurance system should be considered to be ‘significant’ to the demonstration of compliance or to the airworthiness, operational suitability or environmental protection of the products:

1. Organisation

      Relocation to new premises (see also GM 21.A.249);

       Change in the industrial organisation (partnership, suppliers, design work sharing), unless it can be shown that the independent checking function of the demonstration of compliance is not affected;

       Change in the parts of the organisation that contribute directly to the airworthiness, operational suitability or environmental protection (independent checking function, office of airworthiness (or equivalent));

      Change to the independent monitoring principles (see 21.A.239(a)(3)).

2. Responsibilities

       Change of the management staff;

       the Head of the design organisation (GM No 1 to 21.A.239(a), para.3.1.2; GM No 1 to 21.A.245, para.4.1; GM 21.A.265(b));

       the Chief of the Office of Airworthiness (GM No 1 to 21.A.245, para. 4.2);

       the Chief of the independent monitoring function of the design assurance system (21.A.239(a)(3) and AMC No 1 to 21.A.243(a), para.2).

       New distribution of responsibilities affecting airworthiness, operational suitability or environmental protection;

       For organisations that design minor changes to type design or minor repairs to products, change of the persons identified in GM No 2 to 21.A.243(d).

3. Procedures

Change to the principles of procedures related to:

       the type certification;

       the classification of changes and repairs as ‘major’ or ‘minor’ (21.A.263(c)(1));

       the treatment of major changes and major repairs;

      the approval of the design of minor changes and minor repairs (21.A.263(c)(2));

      the approval of the design of certain major repairs (21.A.435(b) or 21.A.263(c)(5));

      the approval of the conditions under which a permit to fly can be issued (21.A.263(c)(6));

      the issue of a permit to fly (21.A.263(c)(7));

      the approval of certain major changes to a type certificate (21.A.263(c)(8));

      the approval of certain supplemental type certificates (21.A.263(c)(9));

      the approval of certain major changes to certain supplemental type certificates; (21.A.263(c)(9));

       continued airworthiness or continued operational suitability (see 21.A.3);

       the configuration control, when airworthiness, operational suitability or environmental protection is affected;

      the acceptability of design tasks undertaken by partners or subcontractors (21.A.239(c));

      the issue of data and information under the obligation of 21.A.265(h).

4. Resources

      A substantial reduction in the number and/or experience of staff (see 21.A.245(a)).

GM-ELA No 1 to 21.A.247 Changes in design assurance system

ED Decision 2019/003/R

The following changes are considered to be significant:

      Changes in ownership:

      relocation of the major place of activity to a different geographic location, city, airfield or similar. Relocation within one building, or to a neighbouring building on the same premises, or a similar move, does not require prior approval, as long as there is no negative effect on the interface with or the access to the related production organisation;

      Changes in the scope of approval;

      Changes in the nomination of, or the allocation of responsibilities to, the HDO, the HoA, or the ISM; or

      Changes in the parts of the organisation that contribute directly to the airworthiness, operational suitability or environmental protection functions, such as changes to the principles or to the procedures related to:

      type certification;

      the classification of changes and repairs as ‘major’ or ‘minor’;

      the handling of major changes and major repairs;

      the approval of the design of minor changes and minor repairs;

      the issue of information and instructions under the DOA privileges;

      the approval of minor revisions to the aircraft flight manual;

      the approval of the designs of major repairs;

      continued airworthiness or continued operational suitability; or

      configuration control if airworthiness, operational suitability or environmental protection is affected.

Significant changes require EASA approval prior to their implementation. The organisation should submit the application for approval of a significant change to the DOA, using EASA Form 82, to EASA sufficiently ahead of time, stating the nature of any significant change, and supported by a draft of the updated version of the DOH, so that the required extent of the investigation can be agreed upon and conducted in a reasonable way. The focus of the assessment is the continued ability to comply with the provisions of Subpart J.

Any other changes to the approved organisation do not require prior EASA approval, and will be addressed as part of the regular DOA surveillance.

To ensure that changes do not result in non-compliance with the applicable requirements of Subpart J, it is in the interest of both EASA and the approval holder to establish a relationship and to exchange data during the implementation of a change. As part of this relationship, the company should consider informing EASA sufficiently ahead of the next regular surveillance activity of any non significant changes.

21.A.249 Transferability

Regulation (EU) No 748/2012

Except as a result of a change in ownership, which is deemed significant for the purposes of point 21.A.247, a design organisation approval is not transferable.

GM 21.A.249 Transferability

ED Decision 2012/020/R

1.  Transfer of the approval would normally only be agreed in cases where the organisation itself remains substantially unchanged.

2.  An acceptable transfer situation could be for example a change of company name (supported by the appropriate certificate from the National Companies Registration Office or equivalent) but with no changes to site address or Chief Executive.  However, if the same legal entity were to relocate to new premises with a new Chief Executive and/or new departmental heads, then a substantial investigation by the Agency would be necessary such that the change would be classified as a re-approval.

3.  In the event of receivership there may be good technical justification for continuation of the approval provided that the company continues to function in a satisfactory manner.  It is likely that at a later stage the approval might be surrendered by the receiver or transferred to another legal entity in which case the former paragraphs apply.

GM 21.A.149 and 21.A.249 Transferability

ED Decision 2021/001/R

GENERAL

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

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

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

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

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

21.A.251 Terms of approval

Regulation (EU) 2019/897

The terms of approval shall identify the types of design work, the categories of products, parts and appliances for which the design organisation holds a design organisation approval, and the functions and duties that the organisation is approved to perform with regard to the airworthiness, operational suitability and environmental characteristics of the products. For design organisation approvals covering type-certification or European Technical Standard Order (ETSO) authorisation for auxiliary power units (APUs), the terms of approval shall contain in addition the list of products or APUs. Those terms shall be issued as part of a design organisation approval.

GM No 1 to 21.A.251 Terms of approval

ED Decision 2012/020/R

1. The terms of approval are stated on the certificate of approval issued by the Agency. The certificate states the scope of work and the products, changes or repairs thereof, with the appropriate limitations for which the approval has been granted. For design organisation approval covering type certification or ETSO authorisation for APU, the list of product types covered by the design assurance system should be included.

2. Approval of a change in the terms of approval in accordance with 21.A.253 will be confirmed by an appropriate amendment of the certificate of approval.

3. The certificate references the handbook of the approved design organisation, provided in accordance with 21.A.243. This handbook defines the tasks which may be performed under the approval.

4. Scopes of work are, for example, ‘subsonic turbojet aeroplanes’, ‘turbopropeller aeroplanes’, ‘small aeroplanes’, ‘rotorcraft’... Technologies are quoted in the scope of work when it is considered by the Agency as a limitation for the design organisation approval.

5. For repair design activities, the certificate states the scope of work with the appropriate limitations for which the approval has been granted.

GM No 2 to 21.A.251  Terms of approval – Organisations that design minor changes to type design or minor repairs to products

ED Decision 2019/018/R

Terms of approval issued for organisations designing minor changes to type design or minor repairs to products should contain:

1. Scope of work

This design organisation approval has been granted for:

      designing minor changes to type design or minor repairs to [aircraft, engine, propeller] in accordance with the applicable CS and environmental protection requirements,

      demonstrating and verifying the compliance with these CS and environmental protection requirements.

2. Category of products

Any other indication if the Agency has found a limitation related to aircraft systems or technologies and reducing the scope as defined in paragraph 1.

3. Privileges

The holder of this approval is entitled to list the privileges granted with the approval, pursuant to 21.A.263(c)(1) and (2).

GM-ELA No 1 to 21.A.251 Terms of approval

ED Decision 2019/003/R

1. The terms of approval are stated on the certificate issued by EASA. The certificate states the scope of work and the products, changes or repairs to them, with the appropriate limitations for which the approval has been granted. For a design organisation approval (DOA) that covers a type certification, the list of product types covered by the design assurance system (DAS) is included.

2. A change to the terms of approval in accordance with point 21.A.253 will lead to an amendment of the certificate of approval.

3. The certificate of approval references the design organisation handbook (DOH), which has been provided in accordance with point 21.A.243. This handbook defines the tasks that may be performed under the approval.

4. Scopes of work are defined, for example, by ‘small aeroplanes’, ‘VLA’, ‘LSA’, ‘Balloons’, ‘Airships’, etc. If the product within the framework defined in AMC-ELA No 1 to 21.A.231 is a subset of that term (for example, not for all small aeroplanes), corresponding limitations are incorporated into the terms of approval for the product category. Technologies are quoted in the scope of work when they are considered by EASA to be limitations for the DOA.

5. For repair design activities, the certificate of approval states the scope of work, along with the appropriate limitations for which the approval has been granted.

21.A.253 Changes to the terms of approval

Regulation (EU) No 748/2012

Each change to the terms of approval shall be approved by the Agency. An application for a change to the terms of approval shall be made in a form and manner established by the Agency. The design organisation shall comply with the applicable requirements of this Subpart.

AMC-ELA No 1 to 21.A.253  Changes to the terms of approval

ED Decision 2019/003/R

An application for an approval of changes to the terms of approval should be filed by the applicant using EASA Form 82.

21.A.257 Investigations

Regulation (EU) No 748/2012

(a) The design organisation shall make arrangements that allow the Agency to make any investigations, including investigations of partners and subcontractors, necessary to determine compliance and continued compliance with the applicable requirements of this Subpart.

(b) The design organisation shall allow the Agency to review any report and make any inspection and perform or witness any flight and ground test necessary to check the validity of the compliance statements submitted by the applicant under point 21.A.239(b).

[applicable until 6 March 2023 – Regulation (EU) 2022/201]

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

ED Decision 2021/007/R

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

      competent authorities when overseeing regulated organisations;

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

In the context of this GM:

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

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

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

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

The conduct of a remote audit

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

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

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

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

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

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

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

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

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

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

      determining the platform for hosting the audit;

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

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

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

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

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

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

      data protection aspects.

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

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

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

      the controllability of viewing direction, zoom, and lighting;

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

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

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

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

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

ED Decision 2019/003/R

Investigations by EASA may include enquiries, questions, discussions, explanations and inspections of products that are developed under the scope of approval of the DOA.

The design organisation should assist EASA in its investigations by providing appropriate means to allow EASA to perform these inspections and audits, such as meeting rooms and office support.

If design partners or subcontractors fulfil nominated functions within the DO, for example as CVEs, the organisation should coordinate access to the subcontractor, when it is explicitly requested by EASA on a specific subject.

Any failure to allow EASA access to facilities to conduct investigations will be classified as a level 1 finding.

GM 21.A.257(a) Investigations

ED Decision 2012/020/R

Arrangements that allow the Agency to make investigations include the complete design organisation including partners, sub-contractors and suppliers, whether they are in the State of the applicant or not, assisting and co-operating with the Agency in performing inspections and audits conducted during initial assessment and subsequent surveillance.

Assistance to the Agency includes all appropriate means associated with the facilities of the design organisation to allow the Agency to perform these inspections and audits, such as a meeting room and office support.

21.A.258 Findings [applicable until 6 March 2023] / 21.A.258 Findings and observations [applicable from 7 March 2023 - Regulation (EU) 2022/201]

Regulation (EU) 2019/897

(a) When, during the investigations referred to in points 21.A.257 and 21.B.100, objective evidence is found demonstrating non-compliance of the holder of a design organisation approval with the applicable requirements of this Annex, the finding shall be classified as follows:

1. a “level 1” finding is any non-compliance with the requirements of this Annex that may lead to uncontrolled non-compliances with applicable requirements and affect the safety of the aircraft;

2. a “level 2” finding is any non-compliance with the requirements of this Annex that is not classified as a “level 1” finding.

(b) A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under point (a).

(c) After receipt of notification of findings under the applicable administrative procedures established by the Agency:

1. in the case of a “level 1” finding, the holder of a design organisation approval shall demonstrate to the satisfaction of the Agency that it has taken adequate corrective action within a period of no more than 21 working days after written confirmation of the finding;

2. in the case of a “level 2” findings, the holder of a design organisation approval shall demonstrate to the satisfaction of the Agency that it has taken adequate corrective action within a time period set by the Agency which is appropriate to the nature of the finding and is initially no longer than three months. The Agency may extend that initial time period where it considers that the nature of the finding allows such extension and where the applicant has submitted a corrective action plan which the Agency finds satisfactory; and

3. a “level 3” finding shall not require immediate action by the holder of a design organisation approval.

(d) In cases of “level 1” or “level 2” findings, the design organisation approval may be subject to a partial or full suspension or revocation under the applicable administrative procedures established by the Agency. In that case, the holder of a design organisation approval shall provide confirmation of receipt of the notice of suspension or revocation of the design organisation approval in a timely manner.

[applicable until 6 March 2023]

(a) After the receipt of the notification of findings in accordance with point 21.B.433, the holder of the design organisation approval shall:

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

2. establish a corrective action plan;

3. demonstrate the implementation of the corrective action to the satisfaction of the Agency.

(b) The actions referred to in point (a) shall be performed within the period agreed by the Agency in accordance with point 21.B.433.

(c) The observations received in accordance with point 21.B.433(e) shall be given due consideration by the holder of the design organisation approval. The organisation shall record the decisions taken in respect of those observations.

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

21.A.259 Duration and continued validity

Regulation (EU) No 748/2012

(a) A design organisation approval shall be issued for an unlimited duration. It shall remain valid unless:

1. the design organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or

2. the Agency is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with point 21.A.257; or

3. there is evidence that the design assurance system cannot maintain satisfactory control and supervision of the design of products or changes thereof under the approval; or

4. the certificate has been surrendered or revoked under the applicable administrative procedures established by the Agency.

(b) Upon surrender or revocation, the certificate shall be returned to the Agency.

[applicable until 6 March 2023]

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

1. the design organisation continues to comply with Regulation (EU) 2018/1139 and its delegated and implementing acts; taking into account the provisions of point 21.B.433 of this Annex related to the handling of findings;

2. the holder of the design organisation approval or any of its partners or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9;

3. the design organisation is able to provide the Agency with evidence showing that the design management system of the organisation maintains satisfactory control and supervision of the design of products, repairs and changes thereto under the approval;

4. the certificate has not been revoked by the Agency under point 21.B.65, or surrendered by the design organisation.

(b) Upon surrender or revocation, the certificate shall be returned to the Agency.

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

21.A.263 Privileges

Regulation (EU) 2019/897

(a) (Reserved)

(b) (Reserved)

(c) A holder of a design organisation approval shall be entitled, within the scope of its terms of approval, as established by the Agency, and under the relevant procedures of the design assurance system:

[applicable until 6 March 2023]

(c) The holder of a design organisation approval shall be entitled, within the scope of its terms of approval issued under point 21.A.251 and under the relevant procedures of the design management system:

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

1. to classify changes to a type-certificate or to a supplemental type-certificate and repair designs as “major” or “minor”;

2. to approve minor changes to a type-certificate or to a supplemental type-certificate and minor repair designs;

3. (Reserved);

4. (Reserved);

5. to approve certain major repair designs under Subpart M to products or auxiliary power units (APUs);

6. to approve for certain aircraft the flight conditions under which a permit to fly can be issued in accordance with point 21.A.710(a)(2), except for permits to fly to be issued for the purpose of point 21.A.701(a)(15);

7. to issue a permit to fly in accordance with point 21.A.711(b) for an aircraft it has designed or modified, or for which it has approved, in accordance with point 21.A.263(c)(6), the flight conditions under which the permit to fly can be issued, and where the holder of a design organisation approval itself:

(i)  controls the configuration of the aircraft, and

(ii)  attests conformity with the design conditions approved for the flight;

8.  to approve certain major changes to a type-certificate under Subpart D; and

9.  to issue certain supplemental type-certificates under Subpart E and approve certain major changes to those certificates.

AMC-ELA1 to 21.A.263 Privileges and
AMC-ELA1 to 21.A.265(h) Obligations of the holder

ED Decision 2021/001/R

(a) The privilege to classify minor/major changes and repairs is granted in accordance with 21.A.263(c)(1) on the basis of the application of the method defined in response to AMC-ELA No 2 to 21.A.239(a).

The defined method should cover the following points:

      the identification of changes to a type design or repairs, including the applicable requirements as per the type certification data sheet (TCDS);

      the classification of changes as major if additional work is required to demonstrate compliance with the applicable requirements;

      the classification of changes as minor if no additional work is required to demonstrate compliance with the applicable requirements;

      the recording of the classification, and documented justification of the classification, for those cases that are not straightforward;

      approval of the classification by the authorised signatories.

It is acceptable to use the same classification process for repairs as for changes. Nevertheless, GM 21.A.435(a) should be taken into consideration when classifying repairs.

(b) The privilege to approve minor changes and minor repairs is granted together with the privilege of classification, on the basis of the application of the method defined in response to AMC-ELA No 2 to 21.A.239(a).

The defined method should cover the following points:

      the identification of whether additional work is required to demonstrate compliance with the applicable requirements;

      determination of the required compliance documentation and the verification by following the same workflow as the one applied for the initial design and certification;

      approving the repair under the DOA privileges by using a formalised approach. This may be, for example, defined by an adequately structured form that provides:

      adequate identification of the change;

      the identification of the applicable requirements;

      reference to compliance documents;

      the identification of the effects on limitations and approved documentation (if any);

      evidence that independent checking has been conducted;

      the date and evidence of the approval given by the relevant nominated staff.

      identification of the authorised signatories for the approval of minor changes and minor repairs;

      a statement that the design of minor changes/repairs is conducted using the same provisions as those defined for the design work during the initial design and certification.

It is acceptable to use the same approval process for minor repairs as the one used for minor changes.

(c) Instructions required by the certification specifications, such as the maintenance manual, the MMEL, etc., are usually prepared within the type investigation process to comply with the certification requirements. These documents are covered by the type investigation process. The generation and publication of information or instructions related to continued airworthiness, including updates to the above-mentioned ICA and MMEL and to any related design activity, are handled according to the same principles as any type design, change design or repair design activity/documentation if no separate method/process as per GM 21.A.265(h) is defined. The DOH should state how documents under this obligation are issued and distributed to the aircraft owner and to other interested parties. Using the change/repair process would be the simplest way for small companies to do this.

(d) The approval of minor revisions to the AFM and its supplements should contain the following statement: ‘The technical content of this document is approved under the authority of the DOA, ref.: EASA.21J.[XXXX]. Such a change is treated as a change to the type certificate, as the AFM is formally a part of the type certificate, and it is consequently classified on the basis of the application of the method defined in response to AMC-ELA No 2 to 21.A.239(a), and identified as being related to a ‘minor’ design change. Administrative revisions to the AFM are also expected to be classified as ‘minor’. The following revisions to the AFM are defined as ‘minor’ revisions:

1. editorial revisions or corrections to the AFM;

2. changes to parts of the AFM that are not required to be approved by EASA;

3. changes to limitations or procedures that are achieved without altering or exceeding the certification data;

4. conversions of units of measurement that were previously approved by the FAA or by EASA, and that are added to the AFM in a previously approved manner;

5. the addition of aircraft serial numbers to an existing AFM if the aircraft configuration, as related to the AFM, is identical to the configuration of the aircraft already in that AFM;

6. the removal of references to aircraft serial numbers that are no longer applicable to that AFM;

7. the translation of an EASA-approved AFM into the language of the State of Design or the State of Registration;

8. AFM revisions as part of minor changes to a type design.

(e) In order to be granted a privilege to approve flight conditions (FC) and to issue PtFs, the design organisation should have in place an adequate FTOM in accordance with AMC-ELA No 2 to 21.A.243 that is limited to the products designed and produced by the company, and over which the company has full configuration control. Authorised signatories shall be defined within the FTOM, or its equivalent.

In such a case, the FTOM (or another document) should contain a defined method that addresses the following points if the (FC) are approved under the DOA privileges:

      FC that must be complied with to safely perform a flight must be determined in accordance with point 21.A.708;

      management of the aircraft configuration, including the handling of changes to the aircraft configuration operated under a PtF;

      the documentation of substantiations of flight conditions;

      approval under the privilege using EASA Form 18A defined in AMC 21.A.263(c)(6), and the definition of the authorised signatories.

For a PtF that is issued under the privilege, a method should be defined that addresses the following points:

      how conformity with the approved conditions is established, documented and attested;

      the issue of the PtF under the DOA privilege (form), and the authorised signatories;

      the interface with the local authority for the flight.

Further guidance is provided in AMC 21.A.263(c)(6) and (c)(7), as well as in the GM and AMC related to Subpart P.

AMC1 21.A.263(c)(1) Privileges

ED Decision 2021/001/R

PROCEDURE FOR THE CLASSIFICATION OF CHANGES TO A TYPE CERTIFICATE (TC) OR TO A SUPPLEMENTAL TYPE CERTIFICATE (STC), AND OF REPAIR DESIGNS AS ‘MINOR’ OR ‘MAJOR’

1. INTENT

This AMC provides the means to develop a procedure for the classification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs.

Each design organisation approval (DOA) applicant should develop its own internal classification procedure following this AMC in order to obtain the associated privilege under 21.A.263(c)(1).

2. PROCEDURE FOR THE CLASSIFICATION OF CHANGES TO A TC, APU ETSO, OR TO THAT PART OF THE PRODUCT COVERED BY AN STC, AND REPAIR DESIGNS

2.1 Content

The procedure should address the following points:

      the identification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs;

      classification;

      justification of the classification;

      acceptance of the classification by authorised signatories; and

      supervision of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs initiated by subcontractors.

2.2 Identification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs

The procedure should indicate how the following are identified:

      items (consisting of areas, systems, parts, or appliances) to be affected by the change or repair following the definitions provided in paragraph 3.9 of GM 21.A.101;

      airworthiness directives which have, or might have, an impact on any of the identified items affected by the change or repair;

      other constituents of the TC and of the pre-existing change(s) to the TC as applicable to the affected items (for instance, operating limitations, OSD constituents, manuals — see also point 21.A.90A and the associated GM) to be affected by the change or repair;

      the existing type-certification basis of the affected items containing, as applicable, the certification specifications, special conditions, deviations from the applicable certification specifications and the equivalent level of safety findings incorporated by reference in the TC of the product to be changed;

      the existing OSD certification basis;

      the definition of the change or repair to the affected items and to the other affected constituents of the TC and of the pre-existing change(s) to the TC, if applicable, in accordance with the provisions of points 21.A.31 and 21.A.91;

      the certification basis of the change or repair determined in accordance with point 21.A.101 with the support of GM 21.A.101 (point 21.A.433 for repairs); this might lead to preclassification of the change as ‘major significant’ as per the associated definitions
(see point 2.3 below).

The procedure should request the applicant to record a justification that the information, on which those identifications are based, is adequate. This may be done either by using the DOA holder’s own resources, or through an arrangement with the TC holder, or any other design approval holder as relevant.

The procedure should address cases where the pre-existing configuration of the type design is the result of multiple changes or repairs applied to the same areas, systems, parts, equipment or appliances.

2.3 Classification

The procedure should show how the effects on airworthiness, operational suitability and environmental protection are analysed, from the very beginning, by reference to the specific applicable requirements of the affected items.

If no specific CSs or environmental protection requirements are applicable to the affected items, the above review should be carried out at the level of the part or system where the affected items are integrated and where specific CSs or environmental protection requirements are applicable.

For changes to a TC, the criteria used for the classification should be in compliance with point 21.A.91 and follow the guidelines provided in GM 21.A.91.

For repairs, the criteria used for the classification should be in compliance with point 21.A.435 and follow the guidelines provided in GM 21.A.435(a).

The procedure should define provisions to contact EASA in case of doubts regarding the classification.

The procedure should take into consideration that a change to a TC may have been found to be significant according to point 21.A.101 and following the definitions provided in GM 21.A.101. Therefore, it is already preclassified at the stage of the determination of the certification basis (see point 2.2 above).

2.4 Justification of the classification

All decisions on the classification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs classified as ‘major’ or ‘minor’ should be recorded, and, for those which are not straightforward, also justified according to the procedure and criteria in point 2.3 above. These records should be easily accessible to EASA for sample checking.

2.5 Acceptance of the classification by the authorised signatories

All classifications of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs should be accepted by an appropriately authorised signatory, belonging to or tasked by the office of airworthiness, as explained in GM No 1 to 21.A.239(a)(3.1.4)(r).

The procedure should indicate the authorised signatories for the various products listed in the terms of approval.

For those changes or repairs that are handled by subcontractors, as described under point 2.6, a description should be provided of how the DOA holder manages its classification responsibility.

The final classification may be:

      major changes significant to a TC;

      major changes not significant to a TC or major repairs;

      minor changes to a TC or minor repairs where additional work is necessary to demonstrate compliance with the certification basis, the operational suitability data certification basis, where applicable, and the environmental protection requirements; or

      minor changes to a TC or minor repairs requiring no further demonstration of compliance.

The procedure should indicate how the above four classes of changes/repairs are identified, taking into consideration the requirements laid down in point 21.A.31.

2.6 Supervision of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs initiated by subcontractors

The procedure should indicate, directly or by cross reference to written procedures, how changes to a TC, or to that part of the product covered by an STC, and repair designs may be initiated and classified by subcontractors, and are controlled and supervised by the DOA holder, taking into consideration the requirements laid down in point 21.A.239(c) and the associated GM 21.A.239(c).

AMC2 21.A.263(c)(1) Privileges

ED Decision 2021/001/R

ORGANISATIONS THAT DESIGN MINOR CHANGES TO A TYPE CERTIFICATE (TC) OR A SUPPLEMENTAL TYPE CERTIFICATE (STC), AND MINOR REPAIRS TO PRODUCTS: CLASSIFICATION PROCEDURE

1. Content

The procedure should address the following points:

      the configuration control rules, especially the identification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs;

      the classification in compliance with point 21.A.91 and considering GM 21.A.91 for changes and GM 21.A.435(a) for repairs;

      the justification of the decisions for the classification; and

      the acceptance of the classification by authorised signatories.

2. Identification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs

The procedure should indicate how the following are identified:

      the items (consisting of areas, systems, parts, or appliances) to be affected by the change or repair as per the definitions provided in paragraph 3.9 of GM 21.A.101; these include the parts, appliances, systems or areas affected, and also the other TC constituents (see definitions in GM to 21.A.90A; for instance, operating limitations, OSD constituents, manuals, etc.);

      airworthiness directives which have, or might have, an impact on any of the identified items affected by the change or repair;

      the existing type-certification basis of the affected items containing, as applicable, the certification specifications, special conditions, deviations from the applicable certification specifications and the equivalent level of safety findings incorporated by reference in the TC of the product to be changed;

      the existing OSD certification basis;

      the definition of the change or repair to the affected items in accordance with the provisions of point 21.A.31;

      the certification basis of the change or repair determined in accordance with point 21.A.101 with the support of GM 21.A.101 (point 21.A.433 for repairs); this might lead to preclassification of the change as ‘major significant’ as per the associated definitions
(see paragraph 3 below).

3. Classification

The procedure should show how the effects on airworthiness, operational suitability and environmental protection are analysed, from the very beginning, by reference to the specific applicable requirements of the affected items.

If no specific CSs or environmental protection requirements are applicable to the affected items, the above review should be carried out at the level of the part or system where the affected items are integrated and where specific CSs or environmental protection requirements are applicable.

For repairs, the criteria used for the classification should be in compliance with point 21.A.435 and follow the guidelines provided in GM 21.A.435(a).

The procedure should define provisions to contact EASA in case of doubts regarding the classification.

4. Justification of the classification

All decisions on the classification of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs classified as ‘minor’, should be recorded, and, for those which are not straightforward, also justified according to the procedure and the criteria defined in paragraph 3 above.

These records should be easily accessible to EASA for sample checking.

The justification may be in the format of meeting notes or a register.

5. Acceptance of the classification by the authorised signatories

All classifications of changes to a TC, APU ETSO or to that part of the product covered by an STC, and repair designs should be accepted by an appropriately authorised signatory.

The procedure should indicate the authorised signatories for the various products listed in the terms of approval.

The final classification may be:

      minor changes to a TC or minor repairs where additional work is necessary for the demonstration of compliance with the certification basis, the operational suitability data certification basis (where applicable), and the environmental protection requirements; or

      minor changes to a TC or minor repairs that require no further demonstration of compliance.

AMC1 21.A.263(c)(2) Privileges

ED Decision 2021/001/R

PROCEDURE FOR THE APPROVAL OF MINOR CHANGES AND MINOR REPAIRS TO A TYPE CERTIFICATE (TC), AN AUXILIARY POWER UNIT EUROPEAN TECHNICAL STANDARD ORDER (APU ETSO) OR A SUPPLEMENTAL TYPE CERTIFICATE (STC)

1. INTENT

This AMC provides the means to develop a procedure for the approval of minor changes to a TC, APU ETSO or to that part of the product covered by an STC, and minor repairs.

Each design organisation approval (DOA) applicant should develop its own internal procedures following this AMC in order to obtain the associated privilege under 21.A.263(c)(2).

2. PROCEDURE FOR THE APPROVAL OF MINOR CHANGES TO A TC, AN APU ETSO OR TO THAT PART OF THE PRODUCT COVERED BY AN STC, AND MINOR REPAIRS

2.1 Content

The procedure should address the following points:

      compliance documentation;

      approval under the DOA privilege;

      authorised signatories; and

      supervision of minor changes to a TC, an APU ETSO or to that part of the product covered by an STC or minor repairs handled by subcontractors.

2.2 Compliance documentation

For those minor changes to a TC, an APU ETSO or to that part of the product covered by an STC, and minor repairs where additional work to demonstrate compliance with the applicable CSs and environmental protection requirements is necessary, compliance documentation should be established and independently checked as required by point 21.A.239(b).

The procedure should describe how the compliance documentation is produced and checked. For compliance documentation, see also AMC 21.A.20(c).

2.3 Approval under the DOA privilege

2.3.1 For those minor changes to a TC, an APU ETSO or to that part of the product covered by an STC, and minor repairs where additional work to demonstrate compliance with the applicable CSs and environmental protection requirements is necessary, the procedure should define a document to formalise the approval under the DOA privilege.

This document should include at least:

      a brief description of the change or repair and the reasons for the change or repair;

      identification of the initial configuration of the affected area and other items (which determines the eligibility for installation of the change or repair into an aircraft);

      identification of the final configuration of the affected area, and of supplements to manuals and to OSD constituents;

      the applicable CSs or environmental protection requirements and methods of compliance;

      references to the compliance documents;

      the effects, if any, on the limitations and on the approved documentation;

      evidence of the independent checking function of the demonstration of compliance;

      evidence of the approval under the privilege of point 21.A.263(c)(2) by an authorised signatory; and

      the date of the approval.

For repairs, see AMC 21.A.433(b) and 21.A.447.

2.3.2 For the other minor changes to a TC, APU ETSO or to that part of the product covered by an STC, and minor repairs, the procedure should define a means to identify the change or repair and the reasons for the change or repair, and to formalise its approval by the appropriate engineering authority under an authorised signatory. This function may be delegated by the Office of Airworthiness but should be controlled by the Office of Airworthiness, either directly or through appropriate procedures of the DOA holder’s design assurance system.

2.4 Authorised signatories

The persons authorised to sign for the approval under the privilege of point 21.A.263(c)(2) should be identified (name, signature and scope of authority) in appropriate documents that may be linked to the handbook.

2.5 Supervision of minor changes to a TC, APU ETSO or to that part of the product covered by an STC, and minor repairs handled by subcontractors

For the minor changes to a TC, APU ETSO or to that part of the product covered by an STC, and minor repairs described in 2.3.2 which are handled by subcontractors, the procedure should indicate, directly or by cross reference to written procedures, how these minor changes to a TC, APU ETSO or to that part of the product covered by an STC, and minor repairs are approved at the subcontractor level and the arrangements made for the control and supervision by the DOA holder.

AMC2 21.A.263(c)(2) Privileges

ED Decision 2021/001/R

ORGANISATIONS THAT DESIGN MINOR CHANGES TO A TYPE CERTIFICATE (TC), AN AUXILIARY POWER UNIT EUROPEAN TECHNICAL STANDARD ODER (APU ETSO) OR A SUPPLEMENTAL TYPE CERTIFICATE (STC) AND MINOR REPAIRS TO PRODUCTS: PROCEDURE FOR THE APPROVAL OF MINOR CHANGES TO A TC, AN APU ETSO OR MINOR REPAIRS

1. Content

The procedure should address the following points:

      compliance documentation;

      approval under the DOA privilege; and

      authorised signatories.

2. Compliance documentation

For those minor changes to a TC, an APU ETSO or to that part of the product covered by an STC, and minor repairs where additional work to demonstrate compliance with the applicable CSs and environmental protection requirements is necessary, compliance documentation should be established and independently checked as required by point 21.A.239(b).

The procedure should describe how the compliance documentation is produced and checked. For compliance documentation, see also AMC 21.A.20(c).

3. Approval under the DOA privilege

3.1. For those minor changes to a TC, an APU ETSO or to that part of the product covered by an STC, and minor repairs where additional work to demonstrate compliance with the applicable CSs or environmental protection requirements is necessary, the procedure should define a document to formalise the approval under the DOA privilege.

This document should include at least:

(a) a brief description of the change or the repair and the reason for change or repair;

(b) identification of the initial configuration of the affected area and other items (which determines the eligibility for installation of the change or repair into an aircraft);

(c) identification of the final configuration of the affected area, and of supplements to manuals and to OSD constituents;

(d) the applicable CSs or environmental protection requirements and methods of compliance;

(e) references to the compliance documents;

(f) the effects, if any, on the limitations and on the approved documentation;

(g) evidence of the independent checking function of the demonstration of compliance;

(h) evidence of the approval under the privilege of point 21.A.263(c)(2) by an authorised signatory; and

(i) the date of the approval.

For repairs, see also AMC 21.A.433(b) and 21.A.447.

3.2. For the other minor changes to a TC, APU ETSO or to that part of the product covered by an STC, and minor repairs, the procedure should define a means to identify the change or repair and the reasons for the change or repair, and to formalise its approval by the appropriate engineering authority under an authorised signatory. This function should be controlled through appropriate procedures of the DOA holder’s design assurance system.

4. Authorised signatories

The persons authorised to sign for the approval under the privilege of 21.A.263(c)(2) should be identified (name, signature and scope of authority) in appropriate documents that may be linked to the handbook.

AMC No 3 to 21.A.263(c)(2)  Procedure for the approval of minor changes to a type certificate (TC) which affect the aircraft flight manual (AFM)

ED Decision 2019/018/R

1. Intent

This AMC provides additional guidance for developing a procedure for the approval of minor changes to a TC which affect the aircraft flight manual (AFM).

Each design organisation approval (DOA) applicant/holder should develop its own internal procedure, based on these guidelines. For guidance on the classification of changes to a TC which affect the AFM, see GM 21.A.91.

2. Procedure for the approval of minor changes to a TC which affect the AFM

2.1 Content

The procedure should address the following points:

      assessment of any change to a TC for the impact of the change on the AFM;

      preparation of revisions or supplements to the AFM;

      classification of the change to a TC, taking into account the impact on the AFM;

      classification of stand-alone revisions or supplements to the AFM;

      control of the configuration of the AFM;

      approval of the revisions or supplements to the AFM; and

      the approval statement.

2.2 Assessment of a change for its impact on the AFM The procedure should include an assessment of whether or not the AFM is impacted by the change.

2.3 Preparation

The procedure should indicate how revisions or supplements to the AFM are prepared and how the coordination among the persons in charge of design changes is performed.

2.4 Classification

The procedure should indicate how changes to a TC which affect the AFM are classified, in accordance with the criteria of GM 21.A.91 Section 3.4.

The procedure should indicate how classification decisions are recorded, documented and signed.

Easy accessibility of these records to EASA for sample checking should be ensured. All classifications should be accepted by an appropriately authorised signatory. The procedure should indicate the authorised signatories for the various products listed in the terms of approval.

2.5 Configuration control of the AFM

The procedure should explain the traceability of changes in order to understand who has approved what. Especially if a given page or data module has been revised several times, it should be traceable which part(s) of the page or data module has (have) been approved directly by EASA under which approval, and which part(s) has (have) been approved under the privilege of a DOA holder.

2.6 Approval

The procedure should indicate how the approval under the privilege of point 21.A.263(c)(2) is formalised.

The authorised signatories should be identified (name, signature), together with the scope of the authorisation, in a document that is linked to the DOA handbook.

2.7 Approval statement

The amended AFM, or the supplement to the AFM, approved under the privilege of point 21.A.263(c)(2) should be issued under the obligation of point 21.A.265(h) (see point 21.A.265(h) and the related GM) with a respective statement in the log of revisions.

AMC1 21.A.263(c)(6) Privileges

ED Decision 2021/001/R

PROCEDURE FOR THE APPROVAL OF THE CONDITIONS FOR THE ISSUE OF A PERMIT TO FLY (PtF)

1. INTENT

      This AMC provides the means to develop a procedure to determine that an aircraft can fly, under the appropriate restrictions compensating for non-compliance with the certification specifications applicable to the specific aircraft category.

      Each DOA applicant or DOA holder should develop its own internal procedure following this AMC, in order to obtain the privilege to make this determination and approve the associated conditions without EASA’s involvement, under point 21.A.263(c)(6). When the privilege does not apply, the DOA applicant or the DOA holder will prepare all the necessary data required for the determination in accordance with the same procedure required for the privilege, and will apply for EASA’s approval.

      The establishment of flight conditions may include conditions related to engines/propellers without a type certificate or with unapproved changes that are fitted to the aircraft, for which a permit to fly (PtF) is requested. These conditions (i.e. the installation, operating limitations, maintenance conditions or limitations) should be defined by the organisation responsible for the design of the engine/propeller and provided to the organisation responsible for the design of the aircraft.

      These conditions should be established and substantiated under an arrangement between the organisation responsible for the design of the aircraft and the organisation responsible for the design of the engine/propeller. However, the establishment and substantiation of the flight conditions for the aircraft, including its engine(s), is ultimately the responsibility of the organisation responsible for the design of the aircraft.

2. PROCEDURE FOR THE APPROVAL OF THE CONDITIONS FOR THE ISSUE OF A PERMIT TO FLY (PtF)

2.1 Content

The procedure should address the following points:

      the decision to exercise the privilege;

      management of the aircraft configuration;

      determination of the conditions that should be complied with to safely perform a flight;

      documentation of substantiations of flight conditions;

      approval under the DOA privilege, when applicable; and

      the authorised signatories.

2.2 Decision to exercise the privilege of point 21.A.263(c)(6)

The procedure should include a decision to determine the flights for which the privilege of point 21.A.263(c)(6) will be exercised.

2.3 Management of the aircraft configuration

The procedure should indicate:

      how the aircraft, for which an application for a permit to fly is made, is identified; and

      how changes to the aircraft will be managed.

2.4 Determination of the conditions that should be complied with to safely perform a flight

The procedure should describe the process used by the DOA holder to justify that the aircraft can perform the intended flight(s) safely. This process should include:

      with reference to point 21.A.701(a), identification of the applicable airworthiness requirements which the aircraft does not meet, or has not been shown to meet, if applicable, and of the purpose of the flight(s); for flight conditions raised to cover unapproved changes, the identification of the applicable airworthiness requirements which the aircraft does not meet, or has not been shown to meet, can be fulfilled by referring to the certification programme of the unapproved changes;

      the analysis, calculations, tests or other means used to determine under which conditions or restrictions the aircraft can safely perform a flight (the flights);

      the establishment of specific maintenance instructions and conditions to perform these instructions;

      an independent technical verification of the analysis, calculations, tests or other means used to determine under which conditions or restrictions the aircraft can perform the intended flight(s) safely;

      a statement by the office of airworthiness (or equivalent), that the determination has been made in accordance with the related procedure and that the aircraft has no features and characteristics that render it unsafe for the intended operation(s) under the identified conditions and restrictions; and

      approval by an authorised signatory.

2.5 Documentation of flight conditions substantiations

1.  The analysis, calculations, tests, or other means used to determine under which conditions or restrictions the aircraft can safely perform a flight (or the flights) should be compiled in compliance documents. These documents should be signed by the author and by the person performing the independent technical verification.

2.  Each compliance document should have a number and an issue date. The various issues of a document should be controlled.

3.  The data submitted and approved by the TC holder can be used as substantiations. In that case, the independent technical verification referred to in 2.4 is not required.

2.6 Approval under the DOA privilege

2.6.1 Initial approval

The procedure should include the following EASA Form 18A (as an alternative, the DOA holder should provide an equivalent template containing the same level of information) to support the approval under the DOA privilege:

FLIGHT CONDITIONS FOR A PERMIT TO FLY — APPROVAL FORM

1. Applicant:

 Approval No:

[Name and organisation approval number of the organisation providing the flight conditions and associated substantiations]

2. Approval form No:

 Issue:

[Number and issue, for traceability purposes]

3. Aircraft manufacturer/type

 

4. Serial number(s)

 

5. Purpose

[Purpose in accordance with point 21.A.701(a)]

6. Aircraft configuration

The above aircraft, for which a permit to fly is requested, is defined in [add reference to the document(s) identifying the detailed configuration of the aircraft]

[For change(s) affecting the initial approval form: a description of the change(s). This form must be reissued]

7. Substantiations

[References to the document(s) justifying that the aircraft (as described in block 6) can perform the intended flight(s) safely under the defined conditions or restrictions.]

[For change(s) affecting the initial approval form: reference(s) to additional substantiation(s). This form must be reissued]

8. Conditions/Restrictions

The above aircraft must be used with the following conditions or restrictions:

[Details of these conditions/restrictions, or a reference to the relevant document, including specific maintenance instructions and conditions to perform these instructions.]

9. Statement

The determination of the flight conditions has been made in accordance with the relevant DOA procedure agreed by EASA.

The aircraft, as defined in block 6 above, has no features or characteristics that render it unsafe for the intended operation(s) under the identified conditions and restrictions.

[strike through what is not applicable]

10a. Approved under the authority of DOA EASA.21J.xyz [when the privilege of point 21.A.263(c)(6) applies]

10b. Submitted under the authority of DOA EASA.21J.xyz [when the privilege of point 21.A.263(c)(6) does not apply]

11. Date of issue

 

12. Name and signature

[Authorised signatory]

13. EASA approval and date

[when the privilege of point 21.A.263(c)(6) does not apply]

EASA Form 18A — Issue 4

When the privilege of point 21.A.263(c)(6) is not applicable, the signed form should be presented by the office of airworthiness (or equivalent) to EASA.

2.6.2 Approval of changes

Except for changes that do not affect the conditions approved for the issue of the permit to fly, the procedure should specify how changes will be approved by the DOA holder. The EASA Form 18A should be updated.

2.7 Authorised signatories

The person(s) authorised to sign the approval form should be identified (name, signature and scope of authority) in the procedure, or in an appropriate document linked to the DOA handbook.

AMC 21.A.263(c)(7) Procedure for the issue of a permit to fly

ED Decision 2012/020/R

1. INTENT

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

Each DOA applicant or holder must develop its own internal procedure following this AMC, in order to obtain the privilege of 21.A.263(c)(7) to issue permits to fly for aircraft it has designed or modified, or for which it has approved under 21.A.263(c)(6) the conditions under which the permit to fly can be issued, and when the design organisation itself is controlling under its DOA the configuration of the aircraft and is attesting conformity with the design conditions approved for the flight.

2. PROCEDURE FOR THE ISSUE OF A PERMIT TO FLY

2.1 Content

 The procedure must address the following points:

      conformity with approved conditions;

       issue of the permit to fly under the DOA privilege;

       authorised signatories;

       interface with the local authority for the flight.

2.2 Conformity with approved conditions

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

2.3 Issue of the permit to fly under the DOA privilege

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

2.4 Authorised signatories

The person(s) authorised to sign the permit to fly under the privilege of 21.A.263(c)(7) must be identified (name, signature and scope of authority) in the procedure, or in an appropriate document linked to the DOA handbook.

2.5 Interface with the local authority for the flight

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

AMC No 1 to 21.A.263(c)(5), (8) and (9)  Scope and criteria

ED Decision 2019/018/R

1. Definition of ‘certain major repairs’

‘Certain major repairs’ for which privileges may be granted as per point 21.A.263(c)(5) are:

(a) major repairs to products or auxiliary power units (APUs) for which the design organisation approval (DOA) holder holds the type certificate (TC) or the supplemental type certificate (STC) or the European technical standard order authorisation (ETSOA); or

(b) major repairs to products or APUs for which the DOA holder does not hold the TC or the STC or ETSOA and that meet the criteria of 3(a), (b) and (c) below.

1.1 Criteria for limitations on eligibility

An EASA approval may be required in cases of major repairs proposed by DOA holders who are the TC, STC or APU ETSOA holders if the major repair is:

(a) related to a new interpretation of any item of the certification basis as used for the type certification (such as the certification specifications (CSs), certification review items (CRIs) for special conditions, equivalent safety findings, deviations or ‘elect to comply’); and

(b) related to the application of a CS that is different from the one used for type certification. Note: This should be established at the time of granting the privilege to the DOA holder, or later through an EASA-agreed procedure.

2. Definition of ‘certain major changes’ and ‘certain supplemental type certificates’

‘Certain major changes’ and ‘certain supplemental type certificates’ for which privileges may be granted as per point 21.A.263(c)(8) and (9) are changes similar to those that have been previously approved by EASA for the same DOA holder.

The similarity of the changes is to be seen in terms of the design, the installation, and the operational characteristics, whereas their repetitiveness is seen in terms of the applicable requirements and the compliance demonstration.

In this context, a ‘requirement’ means any element of the type-certification basis as specified in point 21.B.80, or the operational suitability data (OSD) certification basis as specified in point 21.B.82, or the environmental protection requirements as specified in point 21.B.85.

2.1 Criteria for limitations on eligibility

The following types of changes are not eligible:

(a) changes that require a revision to a type certificate data sheet (TCDS) (e.g. the introduction of a derivative model or variant) or a type certificate data sheet for noise (TCDSN);

(b) changes that require an amendment to the existing certification basis by a special condition, equivalent safety finding, deviation or ‘elect to comply’;

(c) changes that revise airworthiness limitations or operating limitations, unless otherwise agreed with EASA;

(d) changes that are intended to be used as alternative method of compliance (AMOC) to an airworthiness directive (AD);

(e) changes that are made mandatory by an AD or that are the terminating action of an AD;

(f) changes that are classified as ‘significant’ in accordance with point 21.A.101;

(g) changes for which, in the affected area and for the operations for which the design is to be certified, more conservative certification requirements are applicable which were not used in the description of the EASA-approved procedure of the DOA holder, e.g. in the case of a type, model or modification with a later, more stringent certification basis;

(h) changes that affect the noise and/or emissions characteristics of the changed product, unless otherwise agreed with EASA;

(i) changes that affect a part or system, a single failure of which may have a catastrophic effect upon the product, and for which critical characteristics have been identified, which should be controlled to ensure the required level of integrity;

(j) changes to engines or propellers, a single failure of which may have a hazardous effect upon the product, and for which critical characteristics have been identified, which should be controlled to ensure the required level of integrity; and

(k) changes for which a non-compliance has been found in the referenced change during the continued-airworthiness process.

3 Criteria for major repairs, major changes and STCs for which the privileges of point 21.A.263(c)(5), (8) and (9) may be granted

The following criteria need to be met:

(a) Similarity

The installation on the product, the design, the operation, and the equipment qualification are basically the same as in projects for which EASA has already been involved and issued an approval for the same DOA holder.

(b) Repetitiveness of the certification process

The whole certification process is repetitive, i.e. identical to, or part of, an already approved referenced process. For a change or repair that is a part of the referenced ‘certain major repairs’, ‘certain major changes’ or ‘certain supplemental type certificates’, the certification process is still identical to the one for the affected change. This is the case when each compliance demonstration is performed to the same extent in accordance with the same requirements, GM, and content of the interpretative material, as well as with the same means and method of compliance (not only the same means-of-compliance (MoC) code).

Note: In this AMC, a ‘requirement’ means any element of the type-certification basis as specified in point 21.B.80, or OSD certification basis as specified in point 21.B.82, or an environmental protection requirement as specified in point 21.B.85.

(c) Performance and experience in previous projects

EASA should have classified as ‘medium’ or ‘high’ the level of performance of the organisation during at least the latest project referenced, to demonstrate ‘similarity’ and ‘repetitiveness’.

In addition, EASA should have classified as ‘low’ or ‘very low’ the likelihood of an unidentified non-compliance for all the included compliance demonstration items (CDIs) identified in at least the latest project referenced, to demonstrate ‘similarity’ and ‘repetitiveness’ (applying the criteria for the determination of EASA’s level of involvement (LoI) in product certification, see AMC 21.B.100(a) and 21.A.15(b)(6)).

The process to obtain and to use the privileges of point 21.A.263(c)(5), (8) and (9) is described in AMC No 2 to 21.A.263(c)(5), (8) and (9).

AMC No 2 to 21.A.263(c)(5), (8) and (9)  Procedure for the approval of a major repair, a major change to a type certificate (TC), or a supplemental type certificate (STC) by a design organisation approval (DOA) holder under their privileges

ED Decision 2019/018/R

This AMC describes the process to be followed in order to obtain and use the privilege to approve ‘certain major repairs’ and ‘certain major changes’ to a TC, and ‘certain supplemental type certificates’ as defined in points 1(b) and 2 of AMC No 1 to 21.A.263(c)(5), (8) and (9).

1. PROCESS FOR OBTAINING A PRIVILEGE

A DOA holder that applies for the privileges referred to in point 21.A.263(c)(5), (8) or (9) should do the following:

(a) Submit to EASA an application for a significant change in the design assurance system (see points 21.A.247 and 21.A.253).

(b) Establish internal procedures for the application of the privilege covering the following elements, and add them to the application:

(1) The definition of the ‘list associated with the privilege’ of certain major repairs/changes/STCs. The ‘list associated with the privilege’ is a list of all ‘certain major changes’, ‘certain STCs’ and ‘certain major repairs’ (or families thereof) plus the associated ‘justification document’ references for which the privileges as per point 21.A.263(c)(5), (8) and (9) have been granted.

(2) A ‘justification document’ for a ‘certain major repair’, ‘certain major change’ or a ‘certain STC’, as applicable. The ‘justification document’ should contain:

(i) The reference(s) to the EASA-approved major change(s), STC(s) and major repair(s), which is (are) used to demonstrate the DOA holder’s experience and performance.

Note: The number of already EASA-approved major change(s), STC(s) or major repair(s) used to demonstrate the DOA holder’s experience and performance is based on an assessment of the scope of the ‘certain major repairs’, ‘certain major changes’ or ‘certain supplemental type certificates’ which is requested to be added to the ‘list associated with the privilege’, as well as on the performance of the DOA holder during previous projects.

(ii) The certification programme(s) of the major change(s), STC(s), or major repair(s), accepted by EASA, used to demonstrate the applicant’s experience and performance.

(iii) The applicable product configuration(s).

The applicant should list the type(s) and model(s) to which the major change(s)/STC(s)/repair(s) applies (apply) or may apply. Exceptionally, this may be done for a dedicated product, system or equipment if the type or model has no technical influence on the major change(s)/STC(s)/repair(s), i.e. when the installation issues are negligible (e.g. the TCAS 7.1 software change for a certain equipment), such a listing is not mandatory, but it needs to be justified.

(iv) The list of ‘requirements’ for the demonstration of compliance, if not identical to the ones referenced in the certification programme.

(v) The certification process, if not identical to the one referenced in the certification programme.

(vi) A detailed description with all the technical data relevant to the installation of the product, the design, the operation and the qualification which ensures the proper use of the privilege for future major changes, major repairs or STCs. This description should include the criteria defining the conditions that should be met in order to apply the privileges.

(vii) Any other limits on the use of the privilege.

(3) The assessment of the acceptability of using the privilege for major repairs, major changes or STCs against the ‘list associated with the privilege’ and the ‘justification document’ of ‘certain major repairs’, ‘certain major changes’ or ‘certain STCs’.

(4) The approval process, including the templates to be used, the authorised signatories, records management and the provision of a ‘summary list’ of major changes, major repairs and STCs approved under the privilege of point 21.A.263(c)(5), (8) and (9). This process should clarify that the approval is issued under the DOA holder’s privilege.

The persons authorised under the privilege of point 21.A.263(c)(5), (8) and (9) should be identified by their names, signatures and scopes of authority in the appropriate documents and referenced in the procedure.

A ‘summary list’ of all the major changes, STCs and major repairs approved under a privilege should be provided to EASA on a regular basis, as agreed with EASA.

(5) Extension of the ‘list associated with the privilege’ after the privilege is granted.

After the granting of the privilege, the initial list of ‘certain major repairs’, ‘certain major changes’ and ‘certain STCs’ under the privilege may be further extended by an EASA agreement, as shown in Section 2 as well as in Figures 2 and 3 below.

(c) Identify in the ‘list associated with the privilege’ the eligible major changes, major repairs or STCs proposed for inclusion in the scope of the privilege (see also AMC No 1 to 21.A.263(c)(5), (8) and (9)).

(d) Provide a ‘justification document’ for each proposed certain major change, certain major repair or certain STC identified under (c) above.

Note: The ‘list associated to the privilege’ identifying all certain major repairs, certain major changes and certain STCs and the associated ‘justification document(s)’ are to be referenced in the DOA holder procedure mentioned under (b) above.

The process for obtaining the privilege, referred to in 21.A.263(c)(5), (8) and (9), is summarised in Figure 1 below:

Figure 1

The privilege referred to in point 21.A.263(c)(5), (8) and (9) may be used by a DOA holder for the approval of major repairs, major changes or STCs, as applicable, under the following conditions:

(a) the privilege has already been granted by EASA;

(b) the major repair/change/STC to be approved falls under the ‘List associated with the privilege’ agreed by EASA; and

(c) the criteria established in the relevant ‘Justification document’ are met and the relevant assessment is recorded.

If all the above conditions are met, the privilege may be used and the approval of major repairs, major changes or STCs, as applicable, can be obtained by the DOA holder without EASA’s involvement.

Note: If a DOA holder applies for a third-country validation after having approved a modification under its DOA holder privilege, EASA may review some of the compliance demonstration data in order to support the validation activity.

2. EXTENSION OF THE ‘PRIVILEGE LIST’ OF ‘CERTAIN MAJOR REPAIRS’, ‘CERTAIN MAJOR CHANGES’ OR ‘CERTAIN STCs’ AFTER THE PRIVILEGE IS GRANTED

When the DOA holder intends to update the ‘List associated with the privilege’, a ‘Justification document’ needs to be provided to EASA, as described in Section 1(b)(2) above. After EASA agrees with the updated ‘privilege list’ as part of the DOA holder’s procedure, the DOA holder may proceed as per Section 4 below.

Figure 2

Figure 3

3. TC, STC OR APU ETSOA HOLDER APPROVAL OF A MAJOR REPAIR UNDER A MAJOR REPAIR PRIVILEGE — SPECIFIC CONSIDERATIONS

TC, STC or APU ETSOA DOA holders that intend to approve a major repair design under the privilege of point 21.A.263(c)(5) should ensure that:

(a) the type-certification basis for the product, part or appliance to be repaired is identified, together with all the other relevant requirements;

(b) all the records and substantiation data, including the documents that demonstrate compliance with all the relevant requirements, are provided to EASA for review; and

(c) for repair designs created for a specific product serial number, an assessment is made as to whether or not the repair design is affected by the presence of any embodied STC, change or repair.

4. DOA HOLDER’S APPROVAL BASED ON THE PRIVILEGE FOR A MAJOR REPAIR, MAJOR CHANGE OR STC — SPECIFIC CONSIDERATIONS

For the approval of:

      major repairs by DOA holders that are not the TC, STC or APU ETSO authorisation holders;

      major changes; and

      STCs

by a DOA holder under the privilege of point 21.A.263(c)(5), (8) and (9), the following should be considered.

4.1 Eligibility of the proposed major repair, major change or STC

The DOA holder should assess the proposed major repair, major change or STC against the ‘list associated with the privilege’ and the ‘justification document’ of ‘certain major repairs’, ‘certain major changes’ or ‘certain supplemental type certificates’ in order to determine whether the criteria of AMC No 1 to 21.A.263(c)(5), (8) and (9), Section 2.2, are met.

4.2 Forms for approval certificates

The DOA holder should use the following forms for the issuance of an approval under their privilege:

      EASA Form 99128 https://www.easa.europa.eu/easa-and-you/aircraft-products/design-organi… for an STC;

      EASA Form 9931 for a major change; and

      EASA Form 9941 for a major repair.

If the DOA holder chooses to use their own forms, it must be ensured that at least the same information as requested on the EASA forms is presented.

For the numbering of major changes to TCs, STCs, as well as of major repairs approved under the privilege of point 21.A.263(c)(5), (8) or (9), please refer to GM 21.A.263(c)(5), (8) and (9).

4.3 Approval under the DOA holder’s privilege

When the DOA holder makes use of the privilege of point 21.A.263(c)(5), (8) or (9), they should include the following in the certification data package:

      a record of the assessment as described in 4.1 above;

      the reference to the ‘justification document’;

      the applicable product configuration;

      the applicable CSs or environmental protection requirements and methods of compliance;

      the compliance documents;

      the effects, if any, on limitations and on the approved documentation;

      the evidence of the independent checking of the compliance demonstration;

      the approval document containing the statement of the approval under the privilege of point 21.A.263(c)(5), (8) and (9) by an authorised signatory; and

      the date of approval.

In any case, before the major change, STC or major repair is approved under the DOA privilege, the DOA holder should ensure that the Part 21 requirements, in particular points 21.A.97, 21.A.115 and 21.A.433, are met.

4.4 Authorised signatories

An authorised person that is identified and authorised as described in Section 1(b)(4) above should sign the approval under the privilege of point 21.A.263(c)(5), (8) and (9).

4.5 Summary list

The DOA holder should add to the ‘summary list’ as described in Section 1(b)(4) above the major change, STC or major repair approved under the privilege of point 21.A.263(c)(5), (8) and (9).

GM 21.A.263(c)(5), (8) and (9)  Numbering system for supplemental type certificates (STCs), major changes and major repairs issued by design organisation approval (DOA) holders, and information to EASA

ED Decision 2019/018/R

STCs, major changes and major repairs issued by a DOA holder under their privilege of point 21.A.263(c)(5), (8) and (9) should each be given a unique and consecutive reference number.

The following numbering system may be considered:

DOA holder reference

Type of certificate

Year of approval

Dash

Sequential number

Issue reference

21Jxxx

STC or MCH or MRE

17

001

A

Example: 21J999STC17—001A

Note: ‘MCH’ refers to ‘major changes’, ‘MRE’ to ‘major repairs’.

With reference to STCs only, after the STC approval, the DOA holder should send a copy of the STC to EASA in a timely manner (as agreed with EASA).

21.A.265 Obligations of the holder

Regulation (EU) 2019/897

The holder of a design organisation approval shall, within the scope of its terms of approval, as established by the Agency:

(a) maintain the handbook required under point 21.A.243 in conformity with the design assurance system;

(b) ensure that this handbook or the relevant procedures included by cross-reference are used as a basic working document within the organisation;

(c) determine that the design of products, or changes or repairs thereto comply with the applicable specifications and requirements and have no unsafe features;

[applicable until 6 March 2023]

(c) determine that the design of the products, or of the changes or repairs thereto, complies with the applicable type-certification basis, operational suitability data certification basis, and the environmental protection requirements, and have no unsafe features;

[applicable from 7 March 2023 - Regulation (EU) 2022/201]

(d) provide the Agency with statements and associated documentation confirming compliance with point (c), except for approval processes carried out in accordance with point 21.A.263(c);

(e) provide to the Agency data and information related to the actions required under point 21.A.3B;

(f) determine, in accordance with point 21.A.263(c)(6), the flight conditions under which a permit to fly can be issued;

(g) establish, in accordance with point 21.A.263(c)(7), compliance with points (b) and (e) of point 21.A.711 before issuing a permit to fly to an aircraft;

(h) designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the Agency with the following statement: “The technical content of this document is approved under the authority of the DOA ref. EASA. 21J.[XXXX]”.

[point (h) applicable until 6 March 2023]

(h) designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the Agency with the following statement: “The technical content of this document is approved under the authority of the DOA ref. EASA. 21J [XXXX]”;’

(i) comply with Subpart A of this Section.

[points (h) and (i) applicable from 7 March 2023 - Regulation (EU) 2022/201]

AMC1 21.A.265(a) Obligations of the holder

ED Decision 2021/001/R

ADMINISTRATION OF THE HANDBOOK

1. The handbook of the applicant must be in the language which will permit the best use of it by all personnel charged with the tasks performed for the purpose of the design organisation. The applicant may be requested to provide an English translation of the handbook and other supporting documents as necessary for the investigation.

2. The handbook must be produced in a concise form with sufficient information to meet 21.A.243 relevant to the scope of approval sought by the applicant. The handbook must include the following:

a. Organisation name, address, telephone, telex and facsimile numbers.

b. Document title, and company document reference No (if any).

c. Amendment or revision standard identification for the document.

d. Amendment or revision record sheet.

e. List of effective pages with revision/date/amendment identification for each page.

f. Contents list or index.

g. A distribution list for the Handbook.

h. An introduction, or foreword, explaining the purpose of the document for the guidance of the organisation’s own personnel. Brief general information concerning the history and development of the organisation and, if appropriate, relationships with other organisations which may form part of a group or consortium, must be included to provide background information for the Agency.

i. The certificate of approval must be reproduced in the document.

j. Identification of the department responsible for administration of the Handbook.

Note: In the case of an initial or revised approval it is recognised that certificate will be issued after EASA agreement to the handbook content in draft form.  Arrangements for formal publication in a timely manner must be agreed before the certificate of approval is issued.

3. An updating system must be clearly laid down for carrying out required amendments and modifications to the handbook.

4. The handbook may be completely or partially integrated into the company organisation manual. In this case, identification of the information required by 21.A.243 must be provided by giving appropriate cross-references, and these documents must be made available, on request, to the Agency.

AMC2 21.A.265(a) Obligations of the holder

ED Decision 2021/001/R

HANDBOOK FORMAT AND PUBLICATION MEANS

The term ‘handbook’ is meant to describe a means to document the design organisation’s processes and procedures. This may be in an electronic or paper format, as a stand-alone document or integrated in a management system. It may consist of:

      an online integrated management system with flowcharts and descriptions embedded in it;

      an online system referring to single documents;

      a classic handbook with references to online procedures;

      or any other combination of the above.

In any case, as required by point (c) of point 21.A.243, independently of the system chosen by the design organisation, the relevant content and the means to update the system should be clearly identified.

AMC-ELA No 1 to 21.A.265(a)  Obligations of the holder – Administration of the design organisation handbook

ED Decision 2019/003/R

The design organisation handbook (DOH) of the applicant should be in a language that will permit the best use of it by all the personnel who perform tasks for the design organisation. The DOH may be completely or partially integrated into the company’s organisation manual. Refer also to AMC-ELA No 1 to 21.A.243 for the required content.

AMC-ELA No 1 to 21.A.265(b) Obligations of the holder – Use of the design organisation handbook as a basic working document

ED Decision 2019/003/R

It is the responsibility of the HDO to ensure that the design organisation handbook (DOH) is used as a basic working document within the design organisation. In this sense, the HDO should include a statement to the DOH that the information provided within the DOH is binding.

The organisation should ensure that personnel have access to, and are familiar with, that part of the content of the DOH that covers their activities. This may be done, for example, by distributing the information that updates of the documentation are available, and by making the documentation available at a location where the information is accessible to all affected persons.

Staff at the design organisation who are involved in the demonstration of compliance of products under the DOA approval should be able to demonstrate their awareness of the definitions provided within the DOH. This can be achieved by any suitable means, and it does not necessarily require training sessions to be provided. Regular internal monitoring should be conducted to verify that the relevant staff members are aware of the relevant definitions.

Monitoring of compliance with this documentation should be done by systematic means. These means do not need to be limited to, or to even include auditing, but they can be accomplished by structured experience exchanges, regular quality meetings, brainstorming or lessons-learned sessions, project reviews at appropriate phases of the product development, or other similar means accepted by EASA.

GM 21.A.265(b) Obligations of the holder

ED Decision 2021/001/R

USE OF THE HANDBOOK

1. The handbook should be signed by the chief executive and the head of the design organisation and declared as a binding instruction for all personnel charged with the development and type investigation of products. This binding statement should be provided independently of the means chosen by the design organisation to document its processes and procedures.

2. All procedures referenced in the handbook are considered as parts of the handbook and therefore as basic working documents.

AMC-ELA No 1 to 21.A.265(c)  Obligations of the holder – Determination of compliance

ED Decision 2019/003/R

The organisation should apply the methods detailed in AMC-ELA No 2 to 21.A.239(a) to determine whether the design of the product, or changes or repairs to them, comply with the applicable requirements, and to ensure that the design of the product contains no unsafe features.

AMC-ELA No 1 to 21.A.265(e)  Obligations of the holder – Providing information in response to airworthiness directives

ED Decision 2019/003/R

The design organisation handbook (DOH) should contain a declaration to ensure that the proposal of appropriate corrective actions/required inspections is submitted to EASA in cases where EASA has issued airworthiness directives in response to potentially unsafe conditions of a product under the responsibility of the approved DO. In addition, the provisions in the DOH should ensure that following the approval by EASA of any proposals referred to under this point, the DO makes appropriate descriptions and procedures for the corrective actions/required inspections available to all known operators or owners of the product and, upon request, to any person that is required to comply with the airworthiness directive.

GM 21.A.265(h) Designation of data and information issued under the authority of a design organisation approval (DOA) holder

ED Decision 2021/007/R

1. INTENT

This GM provides guidance for complying with the obligation of 21.A.265(h), and addresses the various aspects that the DOA holder should cover in order to have a comprehensive procedure for the designation of data and information.

2. SCOPE

The term ‘data and information’ as used in point 21.A.265(h) also includes instructions.

Data and information referred to in point 21.A.265(h) are issued by a DOA holder and cover the following:

      embodiment instructions for design changes or repairs (usually in the form of a service bulletin, a modification bulletin, repair instructions or engineering order, etc.);

      manuals required by Part 21 or the applicable CSs (such as the aircraft flight manual (AFM), rotorcraft flight manual, instructions for continuing airworthiness (ICAs), etc.);

      operation suitability data (OSD);

      continued-airworthiness instructions (usually in the form of service bulletins) which may be covered by airworthiness directives (ADs);

      additional data to be defined by the DOA holder (e.g. alternative maintenance instructions that are not, per se, ICAs).

Note: This data and information may be issued in a digital or paper format.

The obligation does not apply to, and the statement provided with the data and information should not be used on, the following documents:

      certification documents (e.g. the certification programme, compliance checklist, etc.);

      compliance documents;

      design data transferred to production organisations; and

      production deviations (also referred to as ‘unintended deviations’ or ‘concessions’).

3. RATIONALE

The purpose of this obligation is to give certainty to the end users about the approval status of the data and information issued by the DOA holder.

4. PROCEDURE

For the information and instructions issued under point 21.A.265(h), the DOA holder should establish a procedure that addresses the following aspects:

      their preparation;

      verification of their technical consistency with the corresponding approved change(s), repair(s) or approved data, including their effectivity, description, effects on airworthiness and environmental protection, especially when limitations are changed;

      verification of their feasibility in practical applications, when relevant and feasible;

      the authorised signatories.

The procedure should include the information or the instructions prepared by suppliers, and declared applicable to its products by the DOA holder.

5. STATEMENT

The statement provided with the data and information should also cover those items prepared by subcontractors or vendors that the DOA holder has declared as applicable to their products. The technical content of the statement is related to the type certificate data and information.

The approval included in the statement means that:

      the type certificate data has been appropriately approved; and

      the information contains practical and well-defined installation or inspection methods, and, when those methods are implemented, the product is in conformity with the approved type certificate data.

Note: Data and information related to the measures required by point 21.A.3B(b) (airworthiness directives (ADs)) are submitted to EASA to ensure their compatibility with the content of an AD (see point 21.A.265(e)), and contain a statement that they are, or will be, subject to an AD issued by EASA.

AMC-ELA1 to 21.A.263 Privileges and
AMC-ELA1 to 21.A.265(h) Obligations of the holder

ED Decision 2021/001/R

(a) The privilege to classify minor/major changes and repairs is granted in accordance with 21.A.263(c)(1) on the basis of the application of the method defined in response to AMC-ELA No 2 to 21.A.239(a).

The defined method should cover the following points:

      the identification of changes to a type design or repairs, including the applicable requirements as per the type certification data sheet (TCDS);

      the classification of changes as major if additional work is required to demonstrate compliance with the applicable requirements;

      the classification of changes as minor if no additional work is required to demonstrate compliance with the applicable requirements;

      the recording of the classification, and documented justification of the classification, for those cases that are not straightforward;

      approval of the classification by the authorised signatories.

It is acceptable to use the same classification process for repairs as for changes. Nevertheless, GM 21.A.435(a) should be taken into consideration when classifying repairs.

(b) The privilege to approve minor changes and minor repairs is granted together with the privilege of classification, on the basis of the application of the method defined in response to AMC-ELA No 2 to 21.A.239(a).

The defined method should cover the following points:

      the identification of whether additional work is required to demonstrate compliance with the applicable requirements;

      determination of the required compliance documentation and the verification by following the same workflow as the one applied for the initial design and certification;

      approving the repair under the DOA privileges by using a formalised approach. This may be, for example, defined by an adequately structured form that provides:

      adequate identification of the change;

      the identification of the applicable requirements;

      reference to compliance documents;

      the identification of the effects on limitations and approved documentation (if any);

      evidence that independent checking has been conducted;

      the date and evidence of the approval given by the relevant nominated staff.

      identification of the authorised signatories for the approval of minor changes and minor repairs;

      a statement that the design of minor changes/repairs is conducted using the same provisions as those defined for the design work during the initial design and certification.

It is acceptable to use the same approval process for minor repairs as the one used for minor changes.

(c) Instructions required by the certification specifications, such as the maintenance manual, the MMEL, etc., are usually prepared within the type investigation process to comply with the certification requirements. These documents are covered by the type investigation process. The generation and publication of information or instructions related to continued airworthiness, including updates to the above-mentioned ICA and MMEL and to any related design activity, are handled according to the same principles as any type design, change design or repair design activity/documentation if no separate method/process as per GM 21.A.265(h) is defined. The DOH should state how documents under this obligation are issued and distributed to the aircraft owner and to other interested parties. Using the change/repair process would be the simplest way for small companies to do this.

(d) The approval of minor revisions to the AFM and its supplements should contain the following statement: ‘The technical content of this document is approved under the authority of the DOA, ref.: EASA.21J.[XXXX]. Such a change is treated as a change to the type certificate, as the AFM is formally a part of the type certificate, and it is consequently classified on the basis of the application of the method defined in response to AMC-ELA No 2 to 21.A.239(a), and identified as being related to a ‘minor’ design change. Administrative revisions to the AFM are also expected to be classified as ‘minor’. The following revisions to the AFM are defined as ‘minor’ revisions:

1. editorial revisions or corrections to the AFM;

2. changes to parts of the AFM that are not required to be approved by EASA;

3. changes to limitations or procedures that are achieved without altering or exceeding the certification data;

4. conversions of units of measurement that were previously approved by the FAA or by EASA, and that are added to the AFM in a previously approved manner;

5. the addition of aircraft serial numbers to an existing AFM if the aircraft configuration, as related to the AFM, is identical to the configuration of the aircraft already in that AFM;

6. the removal of references to aircraft serial numbers that are no longer applicable to that AFM;

7. the translation of an EASA-approved AFM into the language of the State of Design or the State of Registration;

8. AFM revisions as part of minor changes to a type design.

(e) In order to be granted a privilege to approve flight conditions (FC) and to issue PtFs, the design organisation should have in place an adequate FTOM in accordance with AMC-ELA No 2 to 21.A.243 that is limited to the products designed and produced by the company, and over which the company has full configuration control. Authorised signatories shall be defined within the FTOM, or its equivalent.

In such a case, the FTOM (or another document) should contain a defined method that addresses the following points if the (FC) are approved under the DOA privileges:

      FC that must be complied with to safely perform a flight must be determined in accordance with point 21.A.708;

      management of the aircraft configuration, including the handling of changes to the aircraft configuration operated under a PtF;

      the documentation of substantiations of flight conditions;

      approval under the privilege using EASA Form 18A defined in AMC 21.A.263(c)(6), and the definition of the authorised signatories.

For a PtF that is issued under the privilege, a method should be defined that addresses the following points:

      how conformity with the approved conditions is established, documented and attested;

      the issue of the PtF under the DOA privilege (form), and the authorised signatories;

      the interface with the local authority for the flight.

Further guidance is provided in AMC 21.A.263(c)(6) and (c)(7), as well as in the GM and AMC related to Subpart P.