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.
Regulation (EU) 2022/1358
Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart:
(a) in order to demonstrate compliance with points 21.A.14, 21.A.112B, 21.A.432B or 21.A.602B of this Annex ; or
(b) in order to demonstrate compliance with points 21L.A.23, 21L.A.83 or 21L.A.204 of Annex Ib (Part 21 Light); or
(c) for the purpose of obtaining privileges under point 21.A.263 regarding approval of minor changes or minor repair design, or issuing declarations of compliance regarding minor changes or minor repair design of aircraft for which design compliance has been declared in accordance with Subpart C of Section A of Annex Ib (Part 21 Light).
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.
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 management system
Regulation (EU) 2022/1358
(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; this system shall:
(i) include an airworthiness function responsible for managing that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, technical specifications concerning the making of declarations, the applicable operational suitability data certification basis and the environmental protection requirements;
(ii) ensure that it 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 of the demonstration of compliance on the basis of which the organisation declares compliance with the applicable airworthiness, operational suitability data and environmental protection requirements; and
3. specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subjects 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).
GM1 21.A.139, 21.A.239, 21.B.120, 21.B.140, 21.B.220, and 21.B.240 The use of information and communication technologies (ICT) for performing remote audits
ED Decision 2022/021/R
This GM provides technical guidance on the use of remote information and communication technologies (ICT) to support:
— competent authorities when overseeing regulated organisations;
— regulated organisations when conducting internal audits / monitoring compliance of their organisation with the relevant requirements, and when evaluating vendors, suppliers and subcontractors.
In the context of this GM:
— ‘remote audit’ means an audit that is performed with the use of any real-time video and audio communication tools in lieu of the physical presence of the auditor on-site; the specificities of each type of approval / letter of agreement (LoA) need to be considered in addition to the general overview (described below) when applying the ‘remote audit’ concept;
— ‘auditing entity’ means the competent authority or organisation that performs the remote audit;
— ‘auditee’ means the entity being audited/inspected (or the entity audited/inspected by the auditing entity via a remote audit);
It is the responsibility of the auditing entity to assess whether the use of remote ICT constitutes a suitable alternative to the physical presence of an auditor on-site in accordance with the applicable requirements.
The conduct of a remote audit
The auditing entity that decides to conduct a remote audit should describe the remote audit process in its documented procedures and should consider at least the following elements:
— The methodology for the use of remote ICT is sufficiently flexible and non-prescriptive in nature to optimise the conventional audit process.
— Adequate controls are defined and are in place to avoid abuses that could compromise the integrity of the audit process.
— Measures to ensure that the security and confidentiality are maintained throughout the audit activities (data protection and intellectual property of the organisation also need to be safeguarded).
Examples of the use of remote ICT during audits may include but are not limited to:
— meetings by means of teleconference facilities, including audio, video and data sharing;
— assessment of documents and records by means of remote access, in real time;
— recording, in real time during the process, of evidence to document the results of the audit, including non-conformities, by means of exchange of emails or documents, instant pictures, video or/and audio recordings;
— visual (livestream video) and audio access to facilities, stores, equipment, tools, processes, operations, etc.
An agreement between the auditing entity and the auditee should be established when planning a remote audit, which should include the following:
— determining the platform for hosting the audit;
— granting security and/or profile access to the auditor(s);
— testing platform compatibility between the auditing entity and the auditee prior to the audit;
— considering the use of webcams, cameras, drones, etc., when the physical evaluation of an event (product, part, process, etc.) is desired or is necessary;
— establishing an audit plan which will identify how remote ICT will be used and the extent of their use for the audit purposes to optimise their effectiveness and efficiency while maintaining the integrity of the audit process;
— if necessary, time zone acknowledgement and management to coordinate reasonable and mutually agreeable convening times;
— a documented statement of the auditee that they shall ensure full cooperation and provision of the actual and valid data as requested, including ensuring any supplier or subcontractor cooperation, if needed; and
— data protection aspects.
The following equipment and set-up elements should be considered:
— the suitability of video resolution, fidelity, and field of view for the verification being conducted;
— the need for multiple cameras, imaging systems, or microphones, and whether the person that performs the verification can switch between them, or direct them to be switched and has the possibility to stop the process, ask a question, move the equipment, etc.;
— the controllability of viewing direction, zoom, and lighting;
— the appropriateness of audio fidelity for the evaluation being conducted; and
— real-time and uninterrupted communication between the person(s) participating to the remote audit from both locations (on-site and remotely).
When using remote ICT, the auditing entity and the other persons involved (e.g. drone pilots, technical experts) should have the competence and ability to understand and utilise the remote ICT tools employed to achieve the desired results of the audit(s)/assessment(s). The auditing entity should also be aware of the risks and opportunities of the remote ICT used and the impacts they may have on the validity and objectivity of the information gathered.
Audit reports and related records should indicate the extent to which remote ICT have been used in conducting remote audits and the effectiveness of remote ICT in achieving the audit objectives, including any item that it has not been able to be completely reviewed.
AMC1 21.A.239(c) Design management system
ED Decision 2022/021/R
SAFETY MANAGEMENT ELEMENT
Demonstration of compliance with the international industry standard SM-0001 ‘Implementing a Safety Management System in Design, Manufacturing and Maintenance Organisations’, Issue B, 31 March 2022, is an acceptable means to demonstrate compliance with the safety management element of the design management system.
GM1 21.A.239(c) Design management system
ED Decision 2022/021/R
SAFETY MANAGEMENT ELEMENT
Safety management seeks to proactively identify hazards and mitigate the related safety risks before they result in aviation accidents and incidents. Safety management enables an organisation to manage its activities in a more systematic and focused manner. When an organisation has a clear understanding of its role in, and contribution to, aviation safety, this enables the organisation to prioritise safety risks and more effectively manage its resources for optimal results.
Safety should not be considered the responsibility of a single person or a limited group of people in the organisation. A safety culture should be developed throughout the organisation, which involves all the personnel as active contributors to the safety of the final product, part, or appliance, (see AMC1 21.A.239(c)(1)).
The principles of the requirements in points 21.A.3A, 21.A.5, 21.A.239, 21.A.245, and 21.A.247, and the related AMC constitute the EU design management system framework for aviation safety management. This framework addresses the core elements of the International Civil Aviation Organization (ICAO) safety management system (SMS) framework that is defined in ICAO Annex 19, Appendix 2, and facilitates the introduction of the additional safety management element.
This approach is intended to encourage organisations to embed safety management and risk‑based decision-making into all their activities, instead of superimposing another system onto their existing management system and governance structure. In addition, if the organisation holds multiple organisation certificates that are issued under Regulation (EU) 2018/1139, it may choose to implement a single management system to cover all of its activities. An integrated management system may be used not only to capture multiple management system requirements resulting from Regulation (EU) 2018/1139, but also to cover for other regulatory provisions requiring compliance with ICAO Annex 19 or for other business management systems, such as security, occupational health, and environmental management systems. Integration will remove duplication and exploit synergies by managing safety risks across multiple activities. Organisations may determine the best means to structure their management systems to suit their business and organisational needs.
It is important to recognise that safety management will be a continuous activity, as hazards, risks, as well as the effectiveness of safety risk mitigations, will change over time.
The safety management capability of an organisation should be commensurate with the safety risks to be managed, which can be at the product, part, and appliance level or at the organisational level.
The risks that are inherent in a complex structure require a robust safety risk management process (e.g. complex interfaces with different partners that participate in the design of a product may pose hazards that are complex to mitigate).
As a consequence, scalability and suitability of the safety management element should be a function of the inherent safety risk capability of the organisation. For instance, for organisations with a lower risk level:
(a) the risk assessment model that is used may be very simple in cases in which the identified hazards are easy to mitigate;
(b) expert judgement might be sufficient to measure the efficiency of safety barriers;
(c) the collection of data, safety information, and occurrences might be very limited;
(d) there might be no need for software or tools to manage the SMS; and
(e) the communication policy might be limited.
AMC1 21.A.239(c)(1) Design management system
ED Decision 2022/021/R
SAFETY POLICY & OBJECTIVES
(a) The safety policy should:
(1) reflect organisational commitments regarding safety, and its proactive and systematic management, including the promotion of a positive safety culture;
(2) include internal reporting principles by fostering the reporting of organisational threats as well as events, as defined in AMC3 21.A.3A(a);
(3) be endorsed by the head of the design organisation (HDO);
(4) be communicated, with visible endorsement, throughout the organisation; and
(5) be periodically reviewed to ensure that it remains relevant and appropriate to the organisation.
(b) The safety policy should include the commitment:
(1) to comply with all the applicable legislation, meet all the applicable requirements, and adopt practices to improve safety standards;
(2) to provide the necessary resources for the implementation of the safety policy;
(3) to apply human factors (HF) principles;
(4) to enforce safety as a primary responsibility of all managers; and
(5) to apply ‘just culture’ principles and, in particular, not to make available or use the information on occurrences:
(i) to attribute blame or liability to personnel for actions, omissions, or decisions that are commensurate with their experience and training; or
(ii) for any purpose other than the improvement of aviation safety.
(c) Senior management should continuously promote the safety policy to all personnel, demonstrate their commitment to it, and provide the necessary human and financial resources for its implementation.
(d) Taking due account of its safety policy, the organisation should define safety objectives. The safety objectives should:
(1) form the basis for safety performance monitoring and measurement;
(2) reflect the organisation’s commitment to maintaining and continuously improving the overall effectiveness of safety management;
(3) be communicated throughout the organisation; and
(4) be periodically reviewed to ensure that they remain relevant and appropriate to the organisation.
GM1 21.A.239(c)(1) Design management system
ED Decision 2022/021/R
SAFETY POLICY
The safety policy is the means for the organisation to state its intention to maintain and, where practicable, to improve the safety levels of all its activities, and to minimise its contribution to the risk of an aircraft accident or serious incident occurring, as far as reasonably practicable. The safety policy reflects the management’s commitment to safety and the organisation’s philosophy of safety management. It is the foundation on which the organisation’s management system is built and serves as a reminder of ‘how we do business here’. The creation of a positive safety culture begins with issuing a clear, unequivocal policy statement.
The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules that describe how ‘just culture’ principles are guaranteed and implemented.
Regulation (EU) No 376/2014 defines the ‘just culture’ principles to be applied (refer, in particular, to Article 16(11) of that Regulation).
AMC1 21.A.239(c)(2) Design management system
ED Decision 2022/021/R
ORGANISATION AND ACCOUNTABILITY
(a) The management system should encompass safety by including a safety manager and a safety review board in the organisational structure. The functions of the safety manager are defined in AMC1 21.A.245(b).
(b) Safety review board
(1) The safety review board (the ‘board’), sometimes referred to as ‘high-level safety committee’, considers matters of strategic safety in support of the safety accountability of the head of the design organisation (HDO).
(2) The board should be normally chaired by the HDO and be generally composed of the person or group of persons nominated under point 21.A.245(b). Its composition can be adapted to its needs, considering point 21.A.245(b).
(3) The board should monitor:
(i) the organisation’s safety performance against its safety policy and objectives;
(ii) whether any safety action is taken in a timely manner; and
(iii) the effectiveness of the organisation’s management system processes.
(4) The board may also be tasked with:
(i) reviewing the results of compliance monitoring; and
(ii) monitoring the implementation of related corrective and preventive action.
(c) The board should ensure that appropriate resources are allocated to achieve the established safety objectives.
(d) Notwithstanding point (a), if justified by the size of the organisation and the nature and complexity of its activities, and subject to a risk assessment and/or mitigation measures, as well as the competent authority’s agreement, the organisation may not need to establish a board. In that case, the tasks that are normally allocated to the board should be allocated to the safety manager.
GM1 21.A.239(c)(2) Design management system
ED Decision 2022/021/R
SAFETY ACTION GROUP
(a) Depending on the size of the organisation and the nature and complexity of its activities, a safety action group may be established as a standing group or as an ad hoc group to assist, or act on behalf of, the safety manager or the safety review board.
(b) More than one safety action group may be established, depending on the scope of the task and the specific expertise that is required.
(c) The safety action group usually reports to, and takes strategic direction from, the safety review board, and may be composed of managers, supervisors, and personnel from operational areas.
(d) The safety action group may be tasked with or assist in the following:
(1) monitoring safety performance;
(2) defining action to control risks to an acceptable level;
(3) assessing the impact of organisational changes on safety;
(4) ensuring that safety action is implemented within the agreed timescales; and
(5) reviewing the effectiveness of previous safety action and safety promotion.
AMC1 21.A.239(c)(3) and (4) Design management system
ED Decision 2022/021/R
SAFETY MANAGEMENT KEY PROCESSES
(a) Hazard identification processes
(1) Hazard identification should be based on a combination of reactive and proactive methods.
(2) The organisation should focus in particular on hazards that may result from non‑compliance or errors in the design of a product, part, or appliance.
(b) Safety risk management processes
(1) The organisation should develop and maintain a safety risk management process that ensures a reactive, proactive, and predictive approach composed of the following elements:
(i) analysis (e.g. in terms of the probability or likelihood as well as severity of the consequences of hazards and occurrences)
(ii) assessment (in terms of tolerability); and
(iii) control (in terms of mitigation) of risks to an acceptable level.
(2) The organisation should specify, within the risk management process, who has the authority to make decisions, considering point (b)(1) of this AMC.
(c) Regardless of the approval status of the subcontracted organisations, the design organisation (DO) is responsible for ensuring that hazard identification and risk management activities are performed on subcontracted activities, as required by point 21.A.239(d)(3), as well as for the monitoring of their compliance and adequacy, as required by point 21.A.239(e).
(d) Internal investigation
(1) In line with ‘just culture’ as part of the safety policy, the organisation should define how to investigate events such as errors or near misses, in order to understand not only what happened, but also how it happened, as well as to prevent or reduce the probability and/or the consequences of any future recurrence.
(2) The scope of internal investigations should extend beyond the scope of the occurrences that are required to be investigated in accordance with point 21.A.3A.
(e) Safety performance monitoring and measurement
(1) Safety performance monitoring and measurement should be the processes through which the safety performance of the organisation is verified against the safety policy and the safety objectives.
(2) This process may include, as appropriate to the size, nature, and complexity of the organisation, the following elements:
(i) safety reporting that also addresses the status of compliance with the applicable requirements;
(ii) safety reviews, including trend reviews, which should be conducted during the introduction of new technologies, the implementation of new or changed procedures, or in cases of organisational changes that may have an impact on safety;
(iii) safety audits that focus on the integrity of the organisation’s management system, and that periodically assess the status of safety risk controls;
(iv) safety surveys that examine particular elements or procedures of a specific area, such as the following:
(A) the problem areas identified;
(B) bottlenecks in the daily design management activities,
(C) the perceptions and opinions of the design management personnel; and
(D) any areas of dissent or confusion; and
(v) other indicators relevant to safety performance.
(f) Management of change
Changes to the design management system may pose new hazards or decrease the effectiveness of existing safety risk controls. The organisation should manage any safety risks that are related to change in that organisation. The management of change should be a documented process to identify external or internal change that may have an adverse effect on safety. The management of change should use of the organisation’s existing processes for hazard identification, risk assessment, and risk mitigation.
(g) Continuous improvement
The organisation should continuously seek to improve its safety performance and the effectiveness of its design management system. Continuous improvement may be achieved through review of the following elements:
(1) compliance monitoring and audits;
(2) assessments, including assessments of the effectiveness of the safety culture and of the management system, to assess in particular the effectiveness of the safety risk management processes;
(3) staff surveys, including safety culture surveys, that can provide useful feedback on how engaged the staff are in the design management system;
(4) the monitoring of events and their recurrence;
(5) the evaluation of the safety performance indicators as well as reviews of all the available safety performance information; and
(6) the identification of lessons learned.
AMC1 21.A.239(c)(4)(ii) Design management system
ED Decision 2022/021/R
MANAGEMENT OF CHANGE
This AMC provides a means to consider organisational changes for their potential impact on safety. Organisational changes should also be evaluated for their significance, as required by point 21.A.247. In addition, necessary changes should be introduced into the handbook, as per point 21.A.243(c). The design management system should be designed such that all the above points are taken into account.
(a) Organisational changes should be proactively considered for their safety implications. The magnitude of a change, its safety criticality, and its potential impact on human performance (HP) should be assessed in any process for the management of change. Certain non-complex organisational changes may not require additional assessment.
(b) Special consideration, including human factors (HF) issues, should be given to the transition period during which the change becomes effective.
(c) During the process for the management of change, relevant previous risk assessments and existing hazards should be reviewed for their possible effects.
GM1 21.A.239(c)(4)(ii) Design management system
ED Decision 2022/021/R
MANAGEMENT OF CHANGE
Unless properly managed, changes in the organisational structure, facilities, scope of work, personnel, documentation, policies and procedures, etc. may result in inadvertently creating new hazards, which may expose the organisation to new or greater risks. Effective organisations seek to improve their processes, while being conscious of the fact that changes may expose the organisation to potential hazards and risks if they are not properly and effectively managed.
The process for the management of change typically provides principles and a structured framework for managing all aspects of changes. The disciplined implementation of management of change may maximise the effectiveness of change, engage staff, and minimise the risks that are inherent in change.
Change may have the potential to raise new HF issues, or to exacerbate existing ones. For example, changes in computer systems, equipment, technology, personnel changes (including changes in management personnel), procedures, the organisation of work, or work processes are likely to affect performance.
Effective management of change is supported by the following elements:
(a) the implementation of a process for hazard identification/risk analysis and assessment for major operational changes, major organisational changes, changes in key personnel, and changes that may affect the way in which design management is carried out;
(b) the identification of changes that may have a considerable impact on:
(1) resources (material and human);
(2) management direction (policies, processes, procedures, training); and
(3) management control;
(c) safety cases/risk assessments that are aviation-safety focused; and
(d) the involvement of key stakeholders in the process for the management of change, as appropriate.
AMC1 21.A.239(c)(5) Design management system
ED Decision 2022/021/R
SAFETY COMMUNICATION
(a) The organisation should establish communication to the staff, as appropriate to their safety responsibilities, regarding safety matters, which:
(1) ensures awareness of safety management activities;
(2) conveys safety-critical information, especially related to assessed risks and analysed hazards;
(3) explains why particular action is taken; and
(4) explains why safety procedures are established or changed.
(b) Regular meetings with staff, during which information, action, and procedures are discussed, may be used to communicate safety matters.
GM1 21.A.239(c)(5) Design management system
ED Decision 2022/021/R
SAFETY PROMOTION
(b) Safety promotion activities support the following:
(1) the organisation’s policies, encouraging a positive safety culture, thus creating an environment that is favourable to the achievement of the organisation’s safety objectives;
(2) organisational lessons learned; and
(3) the implementation of an effective safety reporting scheme and the development of a ‘just culture’.
(c) Depending on the particular safety issue, safety promotion may also constitute or complement risk mitigation action.
AMC1 21.A.239(c)(5)(i) Design management system
ED Decision 2022/021/R
SAFETY TRAINING
(a) The design management staff, as described in points 21.A.245(a) and (b), should receive initial and recurring safety training, as appropriate to their responsibilities, including in safety management principles and the associated safety objectives, to ensure their continued competency.
(b) The organisation should identify the category of other staff to which safety training should be provided, and define the initial and recurrent training programmes, including appropriate timelines.
(c) Adequate records of the safety training that is provided should be kept in accordance with point 21.A.5.
GM1 21.A.239(c)(5)(i) Design management system
ED Decision 2022/021/R
SAFETY TRAINING
(a) The main purpose of the safety training programme is:
(1) to support safety management policies and processes; and
(2) to ensure that personnel at all levels of the organisation develop and maintain their competency to fulfil their safety roles.
(b) Each organisation may adapt its syllabus to its own needs. Typically, depending on the targeted staff, to contribute to a positive safety culture, the following items may be included:
(1) the organisational roles and responsibilities related to safety, including the hazard identification and risk management processes;
(2) the safety objectives and the associated safety performance indicators;
(3) human factors (HF) principles, including human performance (HP) and limitations;
(4) legislation, where applicable;
(5) safety reporting systems and investigations; and
(6) safety issues.
(c) The purpose of the recurrent safety training is:
(1) primarily to ensure that staff are kept abreast notably of changes to safety management system (SMS) principles, processes, and procedures; and
(2) also to share feedback on safety issues that are relevant to the organisation or lessons learned.
(d) The training staff should have sufficient knowledge and experience to teach the topics at the required level, as well as the skills to influence attitudes and behaviours.
AMC1 21.A.239(d) Design management system
ED Decision 2022/021/R
DESIGN ASSURANCE ELEMENT
(a) Reserved
(b) Reserved
(c) Design assurance system
The complete design process, starting with the type certification basis, operational sutiability data (OSD) certification basis, as well as environmental protection requirements and product specifications, and culminating with the issuing of a type certificate (TC), is shown in Figure 1, which identifies the relationships between the design, the certification, and the design assurance processes.
Effective design assurance requires a continuing evaluation of all the factors that affect the adequacy of the design for the intended applications. In particular, it should be ensured that the product or part complies with the applicable type certification basis, OSD certification basis, and environmental protection requirements, and that it will continue to comply after any change to the TC or any repair.
Planned and systematic tasks should therefore be defined and performed from the very beginning of the design activities up to the continued-airworthiness activities.
Figure 1 — RELATIONSHIPS’ CONCEPT IN DESIGN AND CERTIFICATION
(1) Planned and systematic tasks
For design organisations that carry out the certification process of products, their planned and systematic tasks should cover the following, and the related procedures should be defined accordingly.
(i) General
(A) Issue or, where applicable, supplement, or amend the handbook in accordance with point 21.A.243, in particular to indicate the initiation of design activities on a product.
(B) Assure that all the instructions of the handbook are adhered to.
(C) Conduct the certification process.
(D) Nominate staff as ‘compliance verification engineers’ that are responsible for approving compliance documents as defined in point (c)(1)(iii).
(E) Nominate staff that belong to the Office of Airworthiness and are responsible as defined in point (c)(1)(iv).
(F) In the case of an applicant for an STC, obtain the agreement of the TC holder for the proposed supplemental type certificate (STC) to the extent that is defined in point 21.A.115.
(G) Ensure that there is full and complete liaison between the design organisation and the related organisations that have responsibility for the products and parts that are manufactured according to the type design.
(H) Provide assurance to EASA that any prototype models and test specimens adequately conform to the type design (see point 21.A.33(c).
(ii) Head of the design organisation (or deputy)
The head of the design organisation (HDO), or an authorised representative, should sign a declaration of compliance (see points 21.A.20(d) and 21.A.97(b)(3)) with the applicable type certification basis, OSD certification basis, and environmental protection requirements after verifying the satisfactory completion of the certification process. In accordance with point 21.A.20(e), the signature of the HDO on the declaration of compliance confirms that the procedures as specified in the handbook have been followed (see also GM 21.A.265(b)).
(iii) Compliance verification
(A) Approval through the signing of all the compliance documents, including test programmes and data that are necessary for the verification of compliance with the applicable type certification basis, OSD certification basis and environmental protection requirements, as defined in the certification programme.
(B) Approval of the technical content (completeness, technical accuracy, etc.), including any subsequent revisions of the manuals to be approved by EASA (aircraft flight manual (AFM), airworthiness limitations section of the instructions for continued airworthiness (ICA), and certification maintenance requirements (CMRs) document, where applicable).
(iv) Airworthiness function
The airworthiness function is commonly performed by the Office of Airworthiness and should cover the following tasks as relevant*:
(A) liaison between the design organisation (DO) and EASA with respect to all aspects of the certification programme;
(B) ensuring that a handbook and the flight test operations manual, when relevant, are prepared and updated as required by point 21.A.243;
(C) cooperation with EASA in developing procedures to be used for the type certification process;
(D) issuing of guidelines for documenting compliance;
(E) cooperation in issuing guidelines for the preparation of the manuals that are required by the applicable requirements, service bulletins (SBs), drawings, specifications, and standards;
(F) ensuring procurement and distribution of the applicable type certification basis, OSD certification basis, as well as environmental protection requirements and other specifications;
(G) cooperating with EASA in proposing the type certification basis, OSD certification basis, and environmental protection requirements;
(H) the interpretation of the type certification basis, OSD certification basis, and environmental protection requirements, and requesting EASA to take decisions in case of doubt;
(I) advising all the departments of the DO on any question regarding airworthiness, operational suitability, environmental protection approvals, and certification;
(J) the preparation of the certification programme, including a proposal for EASA involvement in the verification of compliance demonstration activities and data, and coordination of all the tasks related to the certification process in agreement with EASA;
(K) regular reporting to EASA about the progress of the certification process, including any difficulty or event that may necessitate a change of the previously notified EASA level of involvement, and announcing scheduled activities (e.g. tests) in due time;
(L) ensuring cooperation in preparing the inspection and test programmes needed for demonstration of compliance;
(M) establishing the compliance checklist and updating it with any changes;
(N) checking that all the compliance documents that are necessary to demonstrate compliance with the type certification basis, OSD certification basis, and environmental protection requirements are prepared and complete, and signing the documents for release;
(O) checking the required type design definition documents that are described in point 21.A.31 and ensuring that they are provided to EASA for approval when required;
(P) preparation, if necessary, of a draft of a type certification data sheet (TCDS) and/or a modification to a TCDS;
(Q) providing verification to the HDO that all the activities that are required for the certification process have been properly completed;
(R) managing the exercise of the DO privileges in accordance with point 21.A.263(c);
(S) monitoring significant events on other aeronautical products, as far as they are relevant, to determine their effect on the airworthiness or operational suitability of the products that are designed by the DO;
(T) ensuring that there is cooperation in preparing SBs and the structural repair manual, and any subsequent revisions, with special attention to the manner in which the contents affect airworthiness and environmental protection, and granting the approval on behalf of EASA;
(U) ensuring the initiation of activities in response to a failure (accident/incident/in-service occurrence) evaluation and to complaints from the operation, and providing information to EASA if airworthiness or operational suitability are impaired (continuing airworthiness and continued operational suitability);
(V) advising EASA on the issuing of airworthiness directives in general based on SBs; and
(W) ensuring that the manuals that are approved by EASA, including any subsequent revisions, (AFM, airworthiness limitations section of the ICA, and CMR document, where applicable) are checked, to determine whether they meet their respective requirements, and that they are provided to EASA for approval.
* Some of the above tasks may be carried out through a different organisational function.
(v) Maintenance and operating instructions
(A) Ensuring the preparation and updating of all the maintenance and operating instructions (including ICA and SBs) that are needed to maintain airworthiness (i.e. continuing airworthiness) in accordance with the relevant certification specifications (CSs). For that purpose, the applicant should:
(a) establish the list of all the documents they produce to comply with CS 2X.1581 (CS 23.2620) and with the Appendix that is referred to in CS 2X.1529, CS‑E 20/25, or CS‑P 30/40, or CS 23.2625;
(b) establish a system to collect in-service experience to be used for the improvement of the instructions; and
(c) define the procedures and the organisation for producing and issuing those documents, taking into account the obligation of point 21.A.265(h); those procedures should cover the following elements:
(1) preparation, including format and language (available industrial standards can be referred to and used);
(2) proofreading (checking for clarity, readability, typos, etc.);
(3) verification of technical consistency with the corresponding approved change(s), repair(s), or approved data, including effectivity, description, effects on airworthiness and environmental protection, especially when limitations are changed;
(4) verification of feasibility in practical applications, when relevant and feasible; and
(5) responsibilities and authorised signatories.
Note: Compliance verification, as described in point (c)(1)(iii) of this AMC, applies to the manuals that are approved by EASA (AFM, airworthiness limitations section of the ICA, and CMR document, where applicable); for the other ICA or other maintenance instructions, the procedure that is required by (c)(1)(v) of this AMC provides a sufficient level of verification and does not require specific compliance verification unless, as per point 21.A.90C, additional work to demonstrate compliance is required; in that case, where additional compliance demonstration is required, points 21.A.91 to 21.A.109, as well as the independent checking function of compliance demonstration as per point 21.A.239(b), apply.
(B) In accordance with points 21.A.6 and 21.A.7 and, where applicable, point 21.A.609, ensuring that those documents are made available as per point 21.A.7(b).
(vi) Operational suitability data
(A) Ensuring the preparation and updating of all OSD in accordance with the relevant CSs. For that purpose, the applicant should:
(a) establish the list of all the documents that they produce to comply with CS-MMEL or CS-GEN-MMEL, CS-FCD, CS-CCD, CS-SIMD, and CS‑MCSD, as applicable; and
(b) define the procedures and the organisation for producing and issuing those documents, taking into account the obligation of point 21.A.265(h); those procedures should cover the aspects that are described in (c)(1)(v)(A).
(B) In accordance with points 21.A.6, 21.A.62, 21.A.108, and 21.A.120B, ensuring that those documents are provided to all the affected operators and training organisations, as well as to all the authorities involved.
AMC2 21.A.239(d) Design management system
ED Decision 2022/021/R
DESIGN ASSURANCE ELEMENT FOR MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
(a) Purpose
This AMC outlines some basic principles and objectives in order to comply with the design assurance element for organisations designing only minor changes to type design or minor repairs to products.
(b) Design assurance system
— The design assurance system should include the following:
— an organisational structure:
— to control the design;
— to demonstrate compliance with the applicable type certification basis, operational suitability data (OSD) certification basis, and environmental protection requirements;
— to independently check demonstrations of compliance;
— to liaise with EASA;
— to continuously evaluate the design organisation; and
— To control subcontractors; and
— procedures and responsibilities associated with the functions listed above, taking due account of Part 21 requirements applicable to design and approval of minor changes to type design or minor repairs to products.
GM1 21.A.239(d) Design management system
ED Decision 2022/021/R
DESIGN ASSURANCE ELEMENT
(a) Purpose
This GM outlines some basic principles and objectives of the design assurance element.
(b) Definitions
1 The design assurance element includes the organisational structure, responsibilities, procedures, and resources to ensure the proper functioning of the design organisation.
2 ‘Design assurance’ refers to all planned and systematic action necessary to provide adequate confidence that the organisation has the capability to:
— design products or parts in accordance with the applicable type certification basis, the operational suitability data (OSD) certification basis, and the environmental protection requirements;
— demonstrate and verify compliance with the type certification basis, the OSD certification basis, and the environmental protection requirements; and
— demonstrate to EASA that compliance.
3 ‘Type investigation’ refers to the tasks of the organisation in support of the type certificate (TC), supplemental type certificate (STC) or other design approval processes necessary to demonstrate, verify and maintain compliance with the applicable type certification basis, OSD certification basis, and environmental protection requirements.
AMC1 21.A.239(d)(2) Design management system
ED Decision 2022/021/R
INDEPENDENT VERIFICATION FUNCTION OF THE DEMONSTRATION OF COMPLIANCE
(a) The independent verification function of the demonstration of compliance should consist of the verification by a person that did not create the compliance data. Such a person may work in conjunction with the individuals that prepare compliance data.
(b) The verification should be shown by signing compliance documents, including test programmes and data.
(c) For a product, there is normally only one compliance verification engineer that is nominated for each relevant subject. A procedure should cover the non-availability of nominated persons and their replacement, when necessary.
(d) For STC cases, when compliance statement and associated documentation are produced by the TC holder, and when this data is approved under the system of the authority of TC holder, then the STC applicant does not need to provide, within its own DOA, the independent verification function that is required in point 21.A.239(d)(2) for that data.
GM1 21.A.239(d)(3) Design management system
ED Decision 2022/021/R
DESIGN ASSURANCE ELEMENT — PARTNERS AND SUBCONTRACTORS
In meeting the requirements of point 21.A.239(d)(3), the applicant for a design organisation approval under Subpart J may adopt the following policy:
(a) The satisfactory integration of the partner and subcontractor and applicant’s design assurance systems is demonstrated for the activities that are covered under the applicant’s terms of approval.
(b) In the event that a partner and subcontractor holds a design organisation approval (DOA), then in accordance with point 21.A.239(d)(3), the applicant may take this into account in demonstrating the effectiveness of that integrated system.
(c) When any partner and subcontractor does not hold a DOA, then the applicant will need to establish to its own satisfaction and the satisfaction of EASA, the adequacy of that partner’s/subcontractor’s design assurance system in accordance with point 21.A.243(b).
GM2 21.A.239(d)(3) Design management system
ED Decision 2022/021/R
DESIGN ASSURANCE ELEMENT — PARTNER AND SUBCONTRACTOR ARRANGEMENTS
When defining the arrangements between the design organisation (DO) and its partners and subcontractors, both elements of the design management system should be taken into account, i.e. the safety management element and the design assurance element. The following guidance should therefore be considered applicable to both elements.
(a) When the DO subcontracts activities, the arrangements should consider the safety risk management process that is part of its safety management element (see point 21.A.239(c)(3)). When the subcontractor does not have a safety management element, the subcontractor should be integrated into the safety management element of the DO; when the subcontractor has implemented a safety management system (such as for design organisation approval (DOA) or production organisation approval (POA)), the two safety management systems, i.e. of the DO and of the subcontractor, should be harmonised.
(b) Depending on the complexity and criticality of those arrangements, the following elements within the arrangements should be addressed:
(1) coordination and interfaces between all the parties involved;
(2) applicable procedures;
(3) safety culture, including internal safety reporting scheme (see point 21.A.3A).
(4) communication between all the parties involved, including reporting, regular meetings, and feedback channels;
(5) allocation of tasks, of clear accountability, and of responsibilities; and
(6) the qualifications and competency of key personnel with reference to point 21.A.245.
(c) The safety risk management should focus on the needs to exchange safety data and safety information that are deemed significant for the determination of relevant risks in terms of likelihood, severity, impact, and acceptability, such as, wherever appropriate, but not limited to the following:
(1) (at product level) failure, malfunction, defect, or other occurrences, non-conformity or outcome of the compliance monitoring function, component failure analysis, in-service event, etc.;
(2) (at documentation level) key processes (e.g. airworthiness directives, design and certification documentation, design processes); and
(3) (at organisation level) changes, disruptive events, resources’ issues, human performance (HP) issues.
(d) Regular communication should be ensured between all the parties involved, to discuss work progress, risk mitigation measures, changes to the arrangements, as well as any other significant issues.
AMC1 21.A.239(e) Design management system
ED Decision 2022/021/R
INDEPENDENT MONITORING FUNCTION
(a) The independent monitoring function should ensure that:
(1) the activities of the design organisation (DO) are monitored for their compliance with the applicable requirements and with any additional requirements as established by the organisation, and that those activities are properly performed under the supervision of the nominated persons that are referred to in point 21.A.245(b); furthermore, compliance with, and the adequacy of, the design management system should be monitored;
(2) all subcontracted design activities are monitored for adequacy and compliance with the applicable arrangements;
(3) an objective review of the complete set of design-management-related activities is provided through independent monitoring activities, such as audits, inspections, reviews;
(4) the independence of the monitoring activities is established by always ensuring that those activities and inspections are performed by staff that are not involved in the function, procedure, or products that they monitor, and that are independent from the operating managers of the function(s) being monitored; however, this should not exclude support by domain experts during monitoring;
(5) a monitoring plan is established to show when and how often the activities that are required by Part 21 will be audited;
(6) the monitoring cycle should not exceed the applicable oversight planning cycle that is established according to point 21.B.432; the determination of the monitoring plan should consider at least the following aspects:
— the criticality of the items checked; and
— the safety performance of the organisation, including any previous findings and root causes;
(7) when non-compliance is found, the root cause(s) and contributing factor(s) are identified, and corrective action is defined and followed up; and
(8) feedback is provided to the management of the DO.
(b) The independent monitoring function that is required by point 21.A.239(e) may be undertaken by the existing quality assurance organisation if the DO is part of a larger organisation.
(c) The staff performing an independent monitoring function should have access to all the parts of the DO and, as necessary, to any subcontracted organisations.
21.A.239A Information security management system
Regulation (EU) 2022/1645
In addition to the design management system required by point 21.A.239, the design organisation shall establish, implement and maintain an information security management system in accordance with Commission Delegated Regulation (EU) 2022/1645 in order to ensure the proper management of information security risks which may have an impact on aviation safety.
[applicable from 16 October 2025 – Regulation (EU) 2022/1645]
Regulation (EU) 2022/201
(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.
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.
ED Decision 2023/014/R
GENERAL
(a) All personnel should be familiar with those parts of the handbook that are relevant to their tasks.
(b) The handbook should provide the following information for each product that is covered by the design organisation approval (DOA).
(1) A description of the tasks that can be performed under the approval, according to the following classification:
(i) general areas, like subsonic turbojet aeroplanes, turboprop aeroplanes, small aeroplanes, rotorcraft, etc.;
(ii) technologies handled by the organisation (composite, wood or metallic construction, electronic systems, etc.);
(iii) 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; and
(iv) for repair design, classification and (if appropriate) approval activities. it is necessary to specify the scope of activity in terms of structures, systems, engines, etc.
(2) A general description of the organisation, its main departments, their functions and the names of those in charge; a description of the line management and of the functional relationships between the various departments.
(3) A description of the assigned responsibilities and delegated authority of all parts of the organisation, which, taken together, constitute the organisation’s design management system, together with a chart indicating the functional and hierarchical relationship of the design management system to the management and to other parts of the organisation; also the chains of responsibilities within the design management system, and the control of the work of all partners and subcontractors.
(4) A general description of the way in which the organisation performs all the design functions in relation to airworthiness, operational suitability and environmental protection approvals, including:
(i) the procedures followed and forms used in the certification process to ensure that the design of, or the change to the design of, the product as applicable, is identified and documented, and complies with the applicable type certification basis, operational suitability data (OSD) certification basis, and the environmental protection requirements, including specific requirements for import by importing authorities;
(ii) the procedures for classifying design changes as ‘major’ or ‘minor’ and for the approval of minor changes;
(iii) the procedures for classifying and approving unintentional deviations from the applicable design data occurring in production (concessions or non-conformity); and
(iv) 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 cooperation with the production organisation when dealing with any continuing airworthiness action that is related to the production of the product, part, or appliance, as applicable.
(6) A description of the human resources, facilities, and equipment, which constitutes the means for design and, where appropriate, for ground and flight testing.
(7) An outline of a system for controlling and informing the personnel of the organisation of current changes in engineering drawings, specifications, and design management procedures.
(8) A description of the recording system for:
(i) the type design, including relevant design information, drawings and test reports, including inspection records of test specimens;
(ii) the means of compliance; and
(iii) the compliance documentation (compliance checklist, reports, etc.).
(9) A description of the record-keeping system to comply with point 21.A.5.
(10) A description of the means by which the organisation collects, monitors, analyses and responds to reports of problems that 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 AMC1 21.A.239(d)).
(11) The names of the design organisation (DO)-authorised signatories. Nominated persons with specific responsibilities such as those mentioned in points 21.A.33 and 21.A.35 should be listed as well.
(12) (Reserved).
(13) A clear definition of the tasks, competency, and areas of responsibility of the Office of Airworthiness.
(14) A description of the procedures for the establishment and the control of the manuals and instructions for continued airworthiness (ICA) (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 management 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 OSD (see points 21.A.5, 21.A.62, 21.A.108, and 21.A.120B).
(17) A description of the organisation’s safety policy and objectives, as required by point 21.A.239(c)(1).
(18) A description of the internal safety reporting scheme, as required by point 21.A.3A(a)(1).
(19) A description of the safety management procedures (including identification of safety hazards, evaluation, and associated risks management), safety assurance procedures, and safety promotion processes.
(20) A statement, signed by the head of the design organisation (HDO) (and countersigned by the senior company manager, if different), which confirms that the design management handbook and any associated manuals are complied with at all times.
This statement should read as follows, or embrace the intent of the following text:
‘This handbook defines the organisation and procedures upon which EASA’s DOA is based.
These procedures are approved by the undersigned, and must be complied with, as applicable, to ensure that all design activities are performed on time and to an approved standard.
It is understood that the approval of the DO is based on the organisation’s continuous compliance with the applicable requirements of Part 21, and with the organisation’s procedures that are described in this handbook. EASA is entitled to limit, suspend, or revoke the approval if the organisation fails to fulfil the obligations that are imposed by Part 21, or any conditions according to which the approval was issued.
Signed .....................................
Dated ......................................
HDO and ...................................... (quote the position of the signatory)
Senior company manager
For and on behalf of ..................................... (quote the organisation’s name)’
The statement should be reissued at the earliest opportunity when the HDO changes.
(c) The organisation may document its safety policy, safety objectives, and all the safety management system key processes (as required by point 21.A.239(c)) in a separate manual (e.g. a safety management manual or management system manual) or in its handbook. Organisations that hold multiple organisation approvals, which are issued under Regulation (EU) 2018/1139 and the delegated and implementing acts that are adopted on the basis thereof, may prefer to have a separate manual to avoid duplication.
AMC2 21.A.243(a) Handbook
ED Decision 2022/021/R
TYPICAL CONTENT OF HANDBOOK FOR ORGANISATIONS THAT DESIGN MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
The following is a typical table of contents for the handbook:
Part 1. Organisation
1.1 Objective of the handbook and binding statement
1.2 Responsible person for the administration of the handbook
1.3 Amendment procedure
1.4 List of effective pages
1.5 Distribution list
1.6 Presentation of the design organisation (DO) (including locations)
1.7 Scope of work (with identification of type and models of products)
1.8 Organisation charts
1.9 Human resources
1.10 Management staff
1.11 Certifying personnel (see GM2 21.A.243(d), point 2)
1.12 Independent system monitoring
1.13 Safety management system
Part 2. Procedures
2.1 Management of changes to type design and design of repairs:
— configuration control,
— classification, and
— approval of minor changes to type design and minor repairs
2.2 Control of design subcontractors
2.3 Collecting/Investigating of failures, malfunctions, and defects
2.4 Coordination with production
2.5 Documentation control
— in relation to the changes and repairs, and
— in relation to failures/malfunctions and defects (i.e. services bulletins)
2.6 Record-keeping
ED Decision 2022/021/R
STATEMENT OF QUALIFICATIONS AND EXPERIENCE
(a) The following statements should be provided:
(1) Other management staff as defined in GM1 21.A.243(d)
For each nominated manager, the organisation should provide this data to EASA to show that the nominated managers are suitable in terms of their relevant knowledge and satisfactory experience related to the nature of the design activities that are performed by the organisation.
(2) The staff that make decisions that affect airworthiness, operational suitability, and environmental protection
For that staff, no individual statements are required. The organisation should demonstrate that there is an internal authorisation system that allows it to select, train, maintain, and identify them for all the tasks for which they are needed.
(b) The staff that is defined in point (a) should be identified in the handbook or linked to it. This, together with the corresponding procedures, should enable that staff to carry out the assigned tasks and to properly discharge the associated responsibilities.
AMC2 21.A.243(d) Handbook
ED Decision 2022/021/R
STATEMENT OF THE QUALIFICATION AND EXPERIENCE — ORGANISATIONS THAT DESIGN MINOR CHANGES TO TYPE DESIGN OR MINOR REPAIRS TO PRODUCTS
For organisations that design minor changes to type design or minor repairs to products, the statement of the qualifications and experience that is required by point 21.A.243(d) should be addressed as follows:
(a) The nominated managers should be identified and their relevant knowledge and satisfactory experience related to the nature of the design activities that they perform should be demonstrated. For each nominated manager, the organisation should provide evidence of competency so that they may be considered to be appropriate in terms of relevant knowledge and satisfactory experience related to the nature of the design activities as performed by the organisation.
(b) The persons responsible for:
— classifying changes to type design or repairs (point 21.A.263(c)(1));
— verifying compliance (point 21.A.239(d)(2));
— approving minor changes to type design and minor repairs (point 21.A.263(c)(2));
— issuing information or instructions (point 21.A.265(h)),
should be selected by the organisation in accordance with a procedure and criteria agreed by EASA.
GM1 21.A.243(d) Handbook
ED Decision 2023/014/R
STATEMENT OF QUALIFICATIONS AND EXPERIENCE
Three different types of functions are named or implicitly identified in the requirements of Part 21, Subpart J or in the associated AMC and GM, when using qualified and experienced personnel:
the senior company manager (see AMC1 21.A.245(a), GM1 21.A.249, GM 21.A.265(b));
the other management staff:
— the head of the design organisation (HDO) (see points 21.A.239(b)(2) and 21.A.245(a));
— the chief of the airworthiness function (see point 21.A.245(b)(1));
— the chief of the independent monitoring function (see point 21.A.245(b)(2));
— the safety manager (see GM1 21.A.239(c)(2), AMC1 21.A.239(c)(2) and AMC1 21.A.245(b), point (g)); and
— when a safety review board is established, the chairperson of that board, if different from the HDO (see AMC1 21.A.239(c)(2)); and
the staff making decisions affecting airworthiness, operational suitability, and environmental protection:
— compliance verification engineers (see AMC1 21.A.239(d), point (c)(1)(iii) and AMC1 21.A.239(c)(2));and
— staff of the Office of Airworthiness making decisions affecting airworthiness, operational suitability, and environmental protection, especially those that are linked with the 21.A.263 privileges (signing documents for release, approving classification of changes and repairs, and granting the approval of minor/major changes, supplemental type certificates (STCs) and minor/major repairs, granting the approval of service bulletins (SBs), and minor revisions to the aircraft flight manual) (see AMC1 21.A.239(d), point (c)(1)(iv)).
A statement of the qualifications and experience of the senior company manager is not required. For the other two categories that are identified above, a statement of qualifications and experience should be provided (see AMC1 21.A.243(d) and AMC2 21.A.243(d) respectively).
Regulation (EU) 2022/201
(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.
ED Decision 2023/014/R
HEAD OF THE DESIGN ORGANISATION
(a) The head of the design organisation (HDO) should:
(1) have sufficient knowledge and authority to be able to respond to the competent authority regarding major issues concerning the design organisation (DO) and the product design approval, and to carry out any necessary improvements;
(2) promote the safety policy that is specified in AMC1 21.A.239(c)(1); and
(3) demonstrate a Part 21 understanding that is sufficient to discharge the relevant responsibilities.
(b) The handbook that is submitted in accordance with point 21.A.243 should show that the HDO has the direct or functional responsibility for all the departments of the organisation which are responsible for the design of the product. If the departments responsible for design are functionally linked, the HDO still has the ultimate responsibility for compliance of the DO with Part 21.
NOTE: When the HDO has no direct control on the resources necessary for the proper functioning of the design organisation, then a senior company manager should provide these resources. To confirm such commitment, the senior company manager should sign, along with the HDO, the binding statement (see AMC1 21.A.243(a), point (b)(20) and GM 21.A.265(b)).
ED Decision 2022/021/R
NOMINATED MANAGERS
(a) The person or group of persons nominated in accordance with point 21.A.245(b) should represent the management structure of the organisation and be responsible for all the functions as specified in Part 21, Subpart J.
(b) The nominated managers should be identified (see GM1 21.A.243(d)).
(c) The responsibilities and the duties of each individual manager should be defined.
(d) The independent monitoring function should be independent from the design and airworthiness functions. As such, the chief of the independent monitoring function should not be at the same time one of the other persons that are referred to in point 21.A.245(b)(1) or (b)(3), except for the safety manager. If the same person is designated to manage both the independent monitoring function and safety-management-related processes and tasks, the head of the design organisation (HDO), in order to discharge their safety accountability, should ensure that sufficient resources are allocated to both functions, taking into account the size of the organisation, and the nature and complexity of its activities.
(e) Chief of the airworthiness function
If more than one team, including their management, are designated for the airworthiness function as defined in point 21.A.239(d)(1)(i), the HDO should identify the person that acts as the unique focal point for the entire design organisation (DO), i.e. the ‘chief of the airworthiness function’.
The need to designate more than one team may be triggered by the specific scope and volume of activity of the DO. For example:
— managing several lines of products (separate airworthiness representative per line of product); and
— division between initial and continued airworthiness activities.
The tasks for which the chief of the airworthiness function should be responsible are presented in AMC1 21.A.239(d), point (c)(1)(iv).
(f) Chief of the independent monitoring function
The role of the chief of the independent monitoring function should be to ensure that:
(1) the activities of the organisation are monitored for compliance with the applicable requirements and any additional requirements as established by the organisation, and that those activities are performed properly under the supervision of the nominated persons that are referred to in point 21.A.245(b);
(2) an audit plan is properly implemented, maintained, and continually reviewed and improved; and
(3) corrections and corrective action are requested, as necessary.
If more than one person is designated for the development, administration, and maintenance of effective safety management processes as defined in point 21.A.239(c)(2), the HDO should identify the ‘safety manager’ as the unique focal point.
The role of the safety manager should be:
(1) to facilitate hazard identification, as well as risk assessment and management;
(2) to monitor the implementation of action taken to mitigate risks, as listed in the safety action plan, unless action follow-up is addressed by the independent monitoring function;
(3) to provide periodic reports on safety performance to the safety review board (the functions of the safety review board are defined in AMC1 21.A.239(c)(2));
(4) to ensure the maintenance of safety management documentation;
(5) to ensure that there is safety training available, and that it meets acceptable standards;
(6) to provide advice on safety matters; and
(7) to ensure the initiation and follow-up of internal investigations of occurrences.
ED Decision 2022/021/R
DIRECT SUPERVISION OF THE AIRWORTHINESS FUNCTION BY THE HEAD OF THE DESIGN ORGANISATION
To cope with unexpected circumstances, for a period of time, it is possible for the head of the design organisation (HDO) to directly supervise the airworthiness function activities. This period of time should be limited and should typically not exceed 6 months.
Such a situation should be discussed with EASA and may be subject to certain limitations (e.g. only continued airworthiness activities may be allowed).
ED Decision 2022/021/R
MANAGEMENT REPORTING LINES AND COMPETENCIES
(a) Managers that are nominated in accordance with point 21.A.245(b) should report directly to the HDO through either a hierarchical or a formal functional link.
(b) All prospective members of the design management staff and staff that is nominated in accordance with point 21.A.245(b) should:
(1) be assessed for their competency, qualifications, and capabilities that are related to their intended duties;
(2) be able to demonstrate their knowledge of, and compliance with, the design management organisation procedures that are applicable to their tasks; and
(3) be able to demonstrate an understanding of the safety management principles, as well as human factors (HF) issues and human performance (HP) issues that are related to their tasks.
(c) The chief of the airworthiness function should be able to demonstrate relevant knowledge, background, and appropriate experience that are related to the product certification and continued airworthiness, including knowledge of, and experience in, managing the design assurance system.
(d) The chief of the independent monitoring function should be able to demonstrate relevant knowledge, background, and appropriate experience that are related to the activities of the organisation, including knowledge of, and experience in, independent system monitoring.
(e) The competency of the person that assumes (or the persons that assume) the function of the safety manager should include, but not be limited to, the following:
(1) knowledge of the International Civil Aviation Organization (ICAO) standards and EU requirements for safety management;
(2) an understanding of management systems, including compliance monitoring systems;
(3) an understanding of risk management;
(4) an understanding of safety investigation techniques;
(5) an understanding of HF, including HP and limitations;
(6) an understanding of a positive safety culture and of its promotion; and
(7) operational experience related to the activities of the organisation.
ED Decision 2022/021/R
STAFF, FACILITIES, AND COORDINATION
(a) General
The handbook that is submitted in accordance with point 21.A.243 should show that sufficient skilled personnel are available, and that suitable technical and organisational provisions are made for carrying out the type investigation that is defined in GM1 21.A.239(d), point (b)(3).
(b) Personnel
The organisation should show that the personnel that is available to comply with point 21.A.245(e)(1) are able, based on their special qualifications and numbers, to provide assurance of the design or modification of a product, as well as of the compilation and verification of all the data that is needed to meet the applicable type certification basis, operational suitability data (OSD) certification basis, and environmental protection requirements, while taking into account the state of the art and new experience.
The organisation should have a system in place to plan the availability of staff to ensure that the organisation has sufficient appropriately qualified staff to plan, perform, supervise, inspect, and monitor the organisation’s activities in accordance with the organisation’s terms of approval.
(c) Technical
The organisation should have access to:
(1) workshops and production facilities that are suitable for manufacturing prototype models and test specimens; and
(2) accommodation and test facilities that are suitable for carrying out the tests and measurements that are needed to demonstrate compliance with the type certification basis, OSD certification basis, and environmental protection requirements; the test facilities may be subject to additional technical conditions that are related to the nature of the tests performed.
(d) Organisation
The handbook that is submitted in accordance with point 21.A.243 should show that:
(1) the responsibilities for all the tasks that are related to the certification process are assigned in such a way that gaps in authority are excluded;
(2) the responsibility for a number of tasks as in point (d)(1) may be assigned to one person, especially in cases of simple projects; and
(3) coordination between technical departments and the persons in charge of the system monitoring that is required by point 21.A.239(e) is established:
(i) to ensure the quick and efficient reporting and resolution of difficulties that are encountered using the handbook and associated procedures;
(ii) to maintain the design management system; and
(iii) to optimise auditing activities.
(e) Competency and training
(1) The organisation should establish and control the competency of the staff that is involved in the activities of the organisation, as detailed in the organisation’s terms of approval, in accordance with documented procedures. In addition to the necessary expertise that is related to the job function, the competency of the staff should include an understanding of safety management and human factors (HF) principles, which is appropriate to the staff member’s function and responsibilities in the organisation.
(2) To assist in the assessment of competency and to perform the analysis of the training needs, job (job family) descriptions are recommended, which should contain sufficient criteria to enable the required competency assessment throughout the duration of the employment/contract.
(3) The organisation should develop a procedure that describes the process for assessing the competency of the staff. The procedure should specify:
(i) the staff that are responsible for that process;
(ii) the means and methods for the initial assessment;
(iii) the means and methods for the continuous control of the competency of the personnel, including feedback on their performance;
(iv) the action to be taken if the assessment is not satisfactory; and
(v) how to record assessment results.
(4) Adequate initial and recurrent training should be provided in relation to the job function to ensure that staff remain competent. This training should be adapted based on experience that is gained within the organisation (for safety training, refer also to AMC1 21.A.239(c)(5)(i)).
(5) The organisation should record the training that is provided as described in point (e)(4).
21.A.247 Changes in the design management system
Regulation (EU) 2022/201
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.
AMC1 21.A.247 Changes to the design management system
ED Decision 2022/021/R
APPLICATION FOR APPROVAL OF SIGNIFICANT CHANGES OR CHANGES IN THE TERMS OF APPROVAL OF A DESIGN ORGANISATION
An application for approval of significant changes or changes in the terms of approval of a design organisation (DO) should be submitted in writing to EASA. The design organisation (DO) should demonstrate to EASA, on the basis of the submission of any proposed changes to the handbook or the DOA, and before the implementation of the changes, that it will continue to comply with Part 21 after the implementation.
GM1 21.A.247 Significant changes to the design management system
ED Decision 2022/021/R
In addition to a change in ownership (see point 21.A.249), the following changes to the design management system should be considered to be ‘significant’ for the demonstration of compliance, or for the airworthiness, operational suitability, or environmental protection of the products:
(a) Organisation
— Relocation to new premises (see also GM 21.A.249);
— A change in the industrial organisation (partnership, subcontractors, design work sharing), unless it can be shown that the independent verification function of the demonstration of compliance is not affected;
— A change in the parts of the organisation that contribute directly to the airworthiness, operational suitability, or environmental protection (independent verification function, airworthiness function (or equivalent));
— A change to the independent monitoring principles of compliance and adequacy (see point 21.A.239(e).
(b) Responsibilities
— Change of the management personnel:
— the head of the design organisation (HDO) (see point 21.A.245(a))
— the chief of the airworthiness function (see point 21.A.245(b)); and
— the chief of the independent monitoring function of compliance and adequacy of the design management system (see point 21.A.245(b)(2)); and
— the safety manager (see point 21.A.239(c)(2)).
— Reporting lines between the personnel that is nominated in accordance with point 21.A.245(b) and the HDO.
— Allocation of responsibilities that affect safety, airworthiness, operational suitability, or environmental protection.
(c) Procedures
Change to the principles of procedures related to:
— the type certification;
— the classification of changes and repairs as ‘major’ or ‘minor’ (see point 21.A.263(c)(1));
— the handling of major changes and major repairs;
— the approval of the design of minor changes and minor repairs (see point 21.A.263(c)(2));
— the approval of the design of certain major repairs (see point 21.A.435(b) or 21.A.263(c)(5));
— the approval of the conditions under which a permit to fly can be issued (see point 21.A.263(c)(6));
— the issue of a permit to fly (see point 21.A.263(c)(7));
— the approval of certain major changes to a type certificate (TC) (see point 21.A.263(c)(8));
— the approval of certain supplemental type certificates (STCs) (see point 21.A.263(c)(9));
— the approval of certain major changes to certain STCs; (see point 21.A.263(c)(9));
— continued airworthiness or continued operational suitability (see point 21.A.3B);
— the configuration control, when airworthiness, operational suitability or environmental protection is affected;
— the acceptability of design tasks that are undertaken by partners or subcontractors (see point 21.A.239(d)(3));
— the issue of data and information under the obligation of point 21.A.265(h); and
— the safety risk management process (see point 21.A.239(c)(3)).
(d) Resources
— A substantial reduction in the number and/or experience of personnel (see point 21.A.245(d)(1)).
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.
ED Decision 2023/014/R
GENERAL
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 senior company manager. However, if the same legal entity were to relocate to new premises with a new senior company manager and/or new departmental heads, then a substantial investigation by EASA 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.
GM1 21.A.149 and 21.A.249 Transferability
ED Decision 2022/021/R
GENERAL
A transfer of approval to another production or design organisation is, by default, excluded by points 21.A.149 or 21.A.249 respectively. These points only allow it exceptionally if it is a direct consequence of a transfer of ownership in an approved production or design organisation, which is then considered a significant change to the existing approval (to which point 21.A.147 or 21.A.247 applies).
As a consequence, and in order to apply this exception, the production or design organisation has to demonstrate to the competent authority the existence of a change in ownership which resulted in the fact that a different legal entity is now conducting the approved production or design functions while remaining effectively unchanged.
An example of such an exception is a change of ownership that leads to a re-registration of the organisation (supported by the appropriate certificate from the National Companies Registration Office or equivalent). In order to demonstrate that the organisation remains effectively unchanged, the organisation needs to demonstrate that there are no changes affecting the initial demonstration of compliance of the organisation with Subpart G or Subpart J. If, for instance, the change of ownership would, in addition, lead to a change of address, facilities, type of work, staff, accountable manager or persons nominated under points 21.A.145 or 21.A.245, then it is not an acceptable transfer situation; the exception does not apply in this case. A new investigation by the competent authority would be necessary. The new organisation would have to apply for its own approval. In such a case where the organisation applies for a new approval, the demonstration of compliance in accordance with points 21.A.135 or 21.A.235 may be limited to the demonstration that the changes in the organisation comply with the Subpart G or Subpart J requirements, while referring for the rest to the compliance demonstration of the previous approval holder.
A pure name change, where the ownership does not change, does not require a transfer of the approval. In this case, the natural or legal person that holds the approval remains the same. However, as a consequence of the name change, the approval document needs to be amended to reflect the new company name. This is a significant change, to which point 21.A.147 or 21.A.247 applies.
Another example of a transfer of ownership, which may be exceptionally accepted under points 21.A.149 or 21.A.249, may be the event of receivership (bankruptcy, insolvency or another equivalent legal process). In this case, there is no change to the production or design organisation, except that the custodial responsibility for its property, including its tangible and intangible assets and rights, is transferred to a receiver or insolvency administrator. The receivership aims to continue the business of the same organisation.
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).
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.
21.A.258 Findings and observations
Regulation (EU) 2022/201
(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.
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings and observations
ED Decision 2022/021/R
ROOT CAUSE ANALYSIS
(a) It is important that the analysis does not primarily focus on establishing who or what caused the non-compliance, but on why it was caused. Establishing the root cause(s) of non‑compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (human factors (HF), regulatory, organisational, technical factors, etc.) in addition to the direct factors.
(b) A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree, to identify the chain of events that led to the non-compliance, may not properly reflect the complexity of the issue, and therefore, there is a risk that important factors that must be considered to prevent reoccurrence will be ignored.
Such an inappropriate or partial root cause analysis often leads to applying ‘quick fixes’ that only address the symptoms of the non-compliance. A peer review of the results of the root cause analysis may increase its reliability and objectivity.
AMC1 21.A.125B(a)(3), 21.A.158(a)(3) and 21.A.258(a)(3) Findings and observations
ED Decision 2022/021/R
FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION
After receipt of notification of findings, the organisation should identify and define the action for all findings, to address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s).
Depending on the issues identified, the organisation may need to take immediate corrective action.
The corrective action plan should:
— include the correction of the issue, corrective and preventive action, as well as the planning to implement them; and
— be timely submitted to the competent authority for acceptance before it is effectively implemented.
After receiving the competent authority’s acceptance of the corrective action plan, the organisation should implement the associated action.
Within the agreed period, the organisation should inform the competent authority that the corrective action plan has been implemented and should send the associated pieces of evidence, on request from the competent authority.
AMC1 21.A.125B(c), 21.A.158(c), 21.A.258(c) Findings and observations
ED Decision 2022/021/R
DUE CONSIDERATION TO OBSERVATIONS
For each observation that is notified by the competent authority, the organisation should analyse the related issues and determine when action is needed.
The handling of the observations may follow a process similar to the handling of the findings by the organisation.
The organisation should record the analysis and the related outputs, such as action taken, or the reasons why no action was taken.
21.A.259 Duration and continued validity
Regulation (EU) 2022/201
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.
Regulation (EU) 2022/1358
(a) (Reserved)
(b) (Reserved)
(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:
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 under this Annex (Part 21) or under Annex Ib (Part 21 Light);
3. to declare the compliance of a minor change or minor repair to the design of an aircraft for which design compliance has been declared by the declarant under point 21L.A.43 of Subpart C of Section A of Annex Ib (Part 21 Light;)
4. to declare compliance of a changed aircraft design, in accordance with point 21L.A.43 of Annex Ib (Part 21 Light), in the event that the natural or legal person who originally made a declaration of design compliance with respect to that aircraft under point 21L.A.43 of Annex Ib (Part 21 Light) is no longer active or is unresponsive to requests for the declaration of compliance of design changes;
5. to approve certain major repair designs under Subpart M of this Annex 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 of this Annex or under Subpart D of Section A of Annex Ib (Part 21 Light); and
9. to issue certain supplemental type certificates under Subpart E of this Annex or under Subpart E of Section A of Annex Ib (Part 21 Light) and approve certain major changes to those certificates.
AMC1 21.A.263(c)(1) Privileges
ED Decision 2023/014/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 the airworthiness function, as explained in AMC1 21.A.239(d).
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(d)(3) and its associated guidance material.
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 2023/014/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 verified as required by point 21.A.239(d)(2).
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 AMC1 21.A.5 and AMC1 21.A.433(b).
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 2023/014/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 verified as required by point 21.A.239(d)(2).
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 99133 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) 2022/1358
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;
(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;
(i) comply with Subpart A of this Section.
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.
GM1 21.A.265(b) Obligations of the holder
ED Decision 2023/014/R
USE OF THE HANDBOOK
1. The handbook should be signed by the senior company manager 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.
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.