21L.B.11 Oversight documentation
Regulation (EU) 2022/1361
The competent authority shall provide all the legislative acts, standards, rules, technical publications, and related documents to the relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities.
21L.B.12 Exchange of information
Regulation (EU) 2022/1361
(a) The competent authority of the Member State and the Agency shall share the information available to them through their investigation conducted and oversight performed in accordance with this Section, which is relevant for the other party when performing certification, oversight or enforcement tasks under this Section.
(b) The competent authority of the Member State and the Agency shall coordinate a product-focused investigation and oversight of the design and production of products and parts under this Annex, including, where necessary, conducting joint oversight visits.
GM1 21L.B.12 Exchange of information
ED Decision 2023/013/R
COORDINATION WITH OTHER RELATED ACTIVITIES
The purpose of coordination with other related activities is to:
(a) harmonise the effects of various approval and certification/oversight teams, especially when dealing with one organisation/applicant/declarant to prevent conflicts of conclusions;
(b) ensure efficient flow of information among the various approval and certification/oversight teams to facilitate the execution of their duties;
(c) optimise the use of EASA’s and the competent authorities’ resources to minimise disruption and cost.
Therefore, for a given organisation/applicant/declarant, the responsible Agency teams or staff or the competent authorities of a Member State should arrange for exchange of information with, and provide necessary assistance, as appropriate, to, the relevant competent authority of a Member State or EASA teams or staff — e.g.:
(a) the appropriate certification/oversight teams;
(b) the design organisation oversight team;
(c) the production organisation oversight team;
(d) the maintenance organisation approval team; or
(e) other approval or certification/oversight teams as appropriate.
This is considered vital for activities related to the critical design review / safety review prior to issuing the flight conditions for a permit to fly and also for the activities relating to the first-article inspection.
GM2 21L.B.12 Exchange of information
ED Decision 2023/013/R
COORDINATION
The exchange of information should be performed in accordance with Article 72 of Regulation (EU) 2018/1139 in particular when:
(a) the competent authority of a Member State immediately reacts to a safety problem;
(b) the competent authority of a Member State grants exemptions in accordance with Article 71(1) of Regulation (EU) 2018/1139 (for a period of more than 8 months or when the exemptions become repetitive, and their total duration exceeds 8 months).
21L.B.13 Information to the Agency
Regulation (EU) 2022/1361
(a) The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, within 30 days from the manifestation of such problems.
(b) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database as specified in Article 6(6) of Regulation No (EU) 376/2014.
AMC1 21L.B.13(b) Information to the Agency
ED Decision 2023/013/R
EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY
Each competent authority should appoint a coordinator to act as the point of contact for the exchange of safety-significant information between the competent authority and EASA.
GM1 21L.B.13(b) Information to the Agency
ED Decision 2023/013/R
MEANING OF SAFETY-SIGNIFICANT INFORMATION THAT STEMS FROM OCCURRENCE REPORTS
Safety-significant information that stems from occurrence reports means:
(a) a conclusive safety analysis which summarises individual occurrence data and provides an in-depth analysis of a safety issue, and which may be relevant for EASA’s safety action planning; and
(b) individual sets or pieces of occurrence data for cases for which EASA is the competent authority and which fulfils the reporting criteria of GM3 21L.B.13(b).
GM2 21L.B.13(b) Information to the Agency
ED Decision 2023/013/R
RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES
A conclusive safety analysis should contain the following:
(a) a detailed description of the safety issue, including the scenario in which the safety issue occurs; and
(b) an indication of the stakeholders that are affected by the safety issue, including types of operations and organisations;
and, as appropriate:
(c) a risk assessment establishing the severity and probability of all the possible consequences of the safety issue;
(d) information about the existing safety barriers that the aviation system has in place to prevent the likely consequences of the safety issue from occurring;
(e) any mitigating action that is already in place or developed to deal with the safety issue;
(f) recommendations for future actions to control the risk; and
(g) any other element the competent authority considers essential for EASA to properly assess the safety issue.
GM3 21L.B.13(b) Information to the Agency
ED Decision 2023/013/R
OCCURRENCES FOR WHICH THE AGENCY IS THE COMPETENT AUTHORITY
Occurrences that are related to natural or legal persons, organisations or products, which are certified or overseen by EASA, should be notified to EASA if:
(a) the occurrence is defined as a reportable occurrence in accordance with the applicable regulations;
(b) the natural or legal person or organisation responsible for addressing the occurrence is certified or overseen by EASA; and
(c) the competent authority of the Member State has come to the conclusion that:
(1) the natural or legal person or organisation certified or overseen by EASA to which the occurrence relates was not informed of the occurrence; or
(2) the occurrence has not been properly addressed or has been left unattended by the natural or legal person or organisation certified or overseen by EASA.
Such occurrence data should be reported in a format compatible with the European Co-ordination Centre for Accident and Incident Reporting Systems (ECCAIRS) and should provide all relevant information for its assessment and analysis, including necessary additional files in the form of attachments.
21L.B.14 Airworthiness directives received from non-Member States
Regulation (EU) 2022/1361
When the competent authority of a Member State receives an airworthiness directive from the competent authority of a non-Member State, that airworthiness directive shall be transferred to the Agency.
21L.B.15 Immediate reaction to a safety problem
Regulation (EU) 2022/1361
(a) Without prejudice to Regulation (EU) No 376/2014 and its delegated and implementing acts, the competent authority of the Member State shall implement a system to appropriately collect, analyse, and disseminate safety information.
(b) The Agency shall implement a system to appropriately analyse any relevant safety information received, and without undue delay, provide Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, persons or organisations that are subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
(c) Upon receiving the information referred to in points (a) and (b), the competent authority of the Member State shall take adequate measures to address the safety problem.
(d) Measures taken under point (c) of point 21L.B.15 shall immediately be notified to all persons or organisations that need to comply with them under Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.
Regulation (EU) 2022/1361
(a) The competent authority shall establish and maintain a management system, including as a minimum:
1. documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. The procedures shall be kept up to date, and serve as the basic working documents within that competent authority for all related tasks;
2. a sufficient number of personnel to perform its tasks and discharge its responsibilities. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks;
3. personnel who are qualified to perform their allocated tasks and who have the necessary knowledge, experience, initial and recurrent training to ensure continuing competency;
4. adequate facilities and office accommodation to perform the allocated tasks;
5. a function to monitor the compliance of the management system with the relevant requirements, and the adequacy of the procedures, including the establishment of an internal audit process, and a safety risk management process. The compliance monitoring function shall include a system to provide feedback about audit findings to the senior management of the competent authority to ensure the implementation of corrective actions as necessary;
6. a person or group of persons having a responsibility to the senior management of the competent authority for the compliance monitoring function.
(b) The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).
(c) The competent authority shall establish procedures for participation in a mutual exchange of all the necessary information with any other competent authorities concerned and provide them with assistance, whether from within the Member State or in other Member States, including on:
1. all the findings raised and any follow-up actions taken as a result of the oversight of persons and organisations that carry out activities in the territory of a Member State, but certified by the competent authority of another Member State, or by the Agency;
2. any information stemming from mandatory and voluntary occurrence reporting as required by point 21L.A.3.
(d) A copy of the procedures related to the management system of the competent authority of the Member State and any amendments to those procedures shall be made available to the Agency for the purpose of standardisation.
AMC1 21L.B.16 Management system
ED Decision 2023/013/R
GENERAL
(a) In deciding upon the required airworthiness organisational structure, the competent authority should review:
(1) the number of certificates, approvals and their scope, declarations and authorisations to be issued;
(2) the number, complexity and size of the organisations under its oversight obligations;
(3) the possible use of qualified entities and of the resources of the competent authorities of other Member States to fulfil the continuing oversight obligations;
(4) the complexity of the aviation industry, taking into consideration the diversity of the products and parts; and
(5) the potential growth of activities in the field of civil aviation.
(b) The competent authority should retain effective control of the important surveillance functions and not delegate them in such a way that organisations, in effect, regulate themselves in airworthiness matters.
(c) The set-up of the organisational structure should ensure that the various tasks and obligations of the competent authority do not solely rely on individuals. The continuous and undisturbed fulfilment of these tasks and obligations of the competent authority should also be guaranteed in cases of illness, accidents or leave of individual employees.
AMC2 21L.B.16 Management system
ED Decision 2023/013/R
GENERAL
(a) The competent authority should be organised in such a way that:
(1) there is specific and effective management authority in the conduct of all the relevant activities;
(2) the functions and processes described in the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, acceptable means of compliance (AMC), certification specifications (CSs), detailed technical specifications and guidance material (GM) may be properly implemented;
(3) the competent authority policies, organisation and operating procedures for the implementation of the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, AMC, CSs and GM are properly documented and applied;
(4) all the personnel of the competent authority involved in the related activities are provided with training where necessary;
(5) specific and effective provision is made for the communication and interface as necessary with EASA and other competent authorities; and
(6) all the functions related to implementing the applicable requirements are adequately described.
(b) A general policy in respect to the activities related to the applicable requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on its basis should be developed, promoted and implemented by the manager at the highest appropriate level — for example, the manager at the top of the functional area of the competent authority that is responsible for such activities.
(c) Appropriate steps should be taken to ensure that the policy is known and understood by all the personnel involved, and all the necessary steps should be taken to implement and maintain the policy.
(d) The general policy should, in particular, take into account:
(1) the provisions of Regulation (EU) 2018/1139;
(2) the provisions of the applicable delegated and implementing acts and also the associated AMC, CSs and GM;
(3) the needs of industry; and
(4) the needs of EASA and of the other competent authorities.
(e) The policy should define specific objectives for the key elements of the competent authority’s organisation and processes for implementing the related activities, including the corresponding control procedures and the measurement of the achieved standard.
GM1 21L.B.16 Management system
ED Decision 2023/013/R
OVERSIGHT OF DECLARED ORGANISATIONS
The following are the activities which should be covered by the competent authority management system for the oversight of declared organisations (declared production organisations under Section A Subpart G, and declared design organisations under Section A Subpart J of Annex Ib (Part 21 Light)):
(a) appointment of the declared organisation team leader and the team;
(b) verification of the declaration received;
(c) registration of the declaration;
(d) establishment of an oversight programme;
(e) performance of oversight activities;
(f) follow-up of corrective actions;
(g) recommendation on the continuation of the activities conducted by the declared organisation;
(h) registration of the changes notified by the declared organisations under point 21L.A.128 or point 21L.A.178 respectively; and
(i) enforcement measures under point 21L.B.22.
AMC1 21L.B.16(a)(1) Management system
ED Decision 2023/013/R
DOCUMENTED POLICIES AND PROCEDURES
(a) The various elements of the organisation for the activities related to Regulation (EU) 2018/1139 and its delegated and implementing acts should be documented in order to establish a reference source for the establishment and maintenance of such organisation.
(b) The documented procedures should be established in a way that facilitates their use. They should be clearly identified, kept up to date and made readily available to all the personnel involved in the related activities.
(c) The documented procedures should cover, as a minimum, all the following aspects:
(1) policies and objectives;
(2) the organisational structure;
(3) responsibilities and the associated authority;
(4) processes and procedures;
(5) internal and external interfaces;
(6) internal control procedures;
(7) the training of personnel;
(8) cross references to associated documents; and
(9) assistance from other competent authorities or EASA (where required).
(d) It is likely that the information may be held in more than one document or series of documents, and suitable cross-referencing should be provided. For example, the organisational structure and the job descriptions are not usually in the same documentation as the detailed working procedures. In such cases, it is recommended that the documented procedures should include an index of cross references to all such other related information, and the related documentation should be readily available when required.
GM1 21L.B.16(a)(2) Management system
ED Decision 2023/013/R
SUFFICIENT PERSONNEL
(a) This GM on the determination of the required personnel is limited to the performance of certification and oversight tasks, excluding any personnel that are required to perform tasks subject to any national regulatory requirements.
(b) The elements to be considered when determining the required personnel and planning their availability may be divided into quantitative and qualitative elements, and there should be, at least:
(1) quantitative elements in accordance with AMC1 21L.B.16; and
(2) the following qualitative elements:
(i) the size, nature and complexity of the activities of overseen organisations, taking into account:
(A) the privileges of the organisation (if applicable);
(B) the type of the approval (if applicable) and the scope of the approval/declaration;
(C) possible certification to industry standards;
(D) the number of personnel; and
(E) the organisational structure and the existence of subcontractors;
(ii) the safety priorities identified;
(iii) the results of past oversight activities, including audits, inspections and reviews, in terms of risks and regulatory compliance, taking into account:
(A) the number and the levels of findings;
(B) the time frame for the implementation of corrective actions; and
(C) the maturity of the management systems implemented by the organisation, and their ability to effectively manage safety risks; and
(iv) the size and complexity of the Member States’ aviation industry, and the potential growth of activities in the field of civil aviation, which may be an indication of the number of new applications, and of changes to existing certificates, approvals, declarations, and authorisations to be expected.
(c) Based on existing data from previous oversight planning cycles, and taking into account the situation within the Member States’ aviation industry, the competent authority may estimate:
(1) the standard working time required for processing applications for new certificates, approvals and authorisations, or registration of declarations;
(2) the number of new certificates and approvals to be issued, or registrations of declarations for each oversight planning period; and
(3) the number of changes to existing certificates, approvals, authorisations and declarations to be processed for each oversight planning period.
(d) In line with the competent authority’s oversight policy, the following planning data should be determined:
(1) the standard number of audits to be performed per oversight planning cycle;
(2) the standard duration of each audit;
(3) the standard working time for audit preparation, on-site auditing, reporting, and follow‑up, per inspector;
(4) the standard number of unannounced inspections to be performed;
(5) the standard duration of inspections, including the preparation, reporting, and follow-up, per inspector; and
(6) the minimum number and required qualifications of inspectors for each audit/inspection.
(e) Standard working time could be expressed either in working hours per inspector, or in working days per inspector. All planning calculations should, then, be based on the same units (hours or working days).
(f) It is recommended to use a spreadsheet application to process the data defined under points (c) and (d) to assist in determining the total number of working hours/days per oversight planning cycle required for certification, oversight and enforcement activities. This application could also serve as a basis for implementing a system for planning the availability of personnel.
(g) The number of working hours/days per planning period for each qualified inspector that may be allocated for certification, oversight and enforcement activities should be determined, taking into account:
(1) purely administrative tasks not directly related to certification and oversight;
(2) training;
(3) participation in other projects;
(4) planned absences; and
(5) the need to include a reserve for unplanned tasks or unforeseeable events.
(h) The determination of working time available for certification, oversight and enforcement activities should also consider, if applicable:
(1) the use of qualified entities;
(2) cooperation with other competent authorities for approvals that involve more than one Member State; and
(3) oversight activities under a bilateral aviation safety agreement.
(i) Based on the elements listed above, the competent authority should be able to:
(1) monitor the dates when audits and inspections are due, and when they were carried out;
(2) implement a system to plan the availability of personnel; and
(3) identify possible gaps between the number and the qualifications of personnel and the required volume of certification and oversight.
Care should be taken to keep planning data up to date in line with changes in the underlying planning assumptions, with a particular focus on risk-based oversight principles.
AMC1 21L.B.16(a)(3) Management system
ED Decision 2023/013/R
QUALIFICATIONS AND TRAINING — GENERAL
(a) It is essential for the competent authority to have the full capability to adequately assess the compliance and performance of an organisation by ensuring that the whole range of activities is assessed by appropriately qualified personnel.
(b) For each inspector, the competent authority should:
(1) define the competencies required to perform the allocated certification and oversight tasks;
(2) define the associated minimum qualifications that are required;
(3) establish initial and recurrent training programmes in order to maintain and to enhance the competency of inspectors at the level that is necessary to perform the allocated tasks; and
(4) ensure that the training provided meets the established standards and is regularly reviewed and updated as necessary.
(c) The competent authority should ensure that training is provided by qualified trainers with appropriate training skills.
AMC2 21L.B.16(a)(3) Management system
ED Decision 2023/013/R
QUALIFICATIONS AND TRAINING — INSPECTORS
(a) Competent authority inspectors should have:
(1) practical experience and expertise in the application of aviation safety standards and safe operating practices;
(2) comprehensive knowledge of:
(i) the relevant parts of Regulation (EU) 2018/1139 and its delegated and implement acts and the related AMC, CSs and GM;
(ii) the competent authority’s procedures;
(iii) their rights and obligations of an inspector;
(iv) systems based on the EU management system requirements (including compliance monitoring) and on ICAO Annex 19;
(v) design or production standards, as applicable; and
(vi) design- or production- (as applicable) related human-factors and human-performance principles;
(3) training in auditing techniques and assessing and evaluating management systems and safety-related processes and procedures;
(4) relevant work experience to be allowed to work without supervision as an inspector;
this may include experience gained during training to obtain the qualifications described in following point (5); and
(5) a relevant engineering degree with additional education; ‘relevant engineering degree’ means an engineering degree from aeronautical, mechanical, electrical, electronic, avionics or other studies relevant to the design and production of aircraft / aircraft components.
(b) In addition to their technical competency, inspectors should have a high degree of integrity, be impartial in carrying out their tasks, be tactful, and have a good understanding of human nature.
(c) A programme for recurrent training should be developed to ensure that inspectors remain competent to perform their allocated tasks; as a general policy, it is not desirable for inspectors to obtain technical qualifications from those entities that are under their direct regulatory oversight.
AMC3 21L.B.16(a)(3) Management system
ED Decision 2023/013/R
INITIAL AND RECURRENT TRAINING FOR INSPECTORS
(a) Initial training programme
The initial training programme for inspectors should include, to an extent appropriate to their role, current knowledge, experience and skills, at least all the following:
(1) aviation legislation, organisation, and structure;
(2) the Chicago Convention, the relevant ICAO annexes and documents;
(3) Regulation (EU) No 376/2014 on the reporting, analysis and follow-up of occurrences in civil aviation;
(4) an overview of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on its basis, and the related AMC, CSs and GM;
(5) specific knowledge of Regulation (EU) No 748/2012 as well as of any other applicable requirements;
(6) management systems, including the assessment of the effectiveness of a management system, in particular hazard identification and risk assessment, and non-punitive reporting techniques in the context of the implementation of a just culture;
(7) auditing techniques;
(8) procedures of the competent authority that are relevant to the inspector’s tasks;
(9) human-factors principles;
(10) the rights and obligations of inspecting personnel of the competent authority;
(11) on-the-job training relevant to the inspector’s tasks; and
(12) technical training appropriate to the role and tasks of the inspector, in particular for those areas that require approvals.
Note: The duration of the on-the-job training should take into account the scope and complexity of the inspector’s tasks. The competent authority should assess whether the required level of competence has been achieved before an inspector is authorised to perform a task without supervision.
(b) Recurrent training programme
Once qualified, the inspector should receive training periodically, as well as whenever it is deemed necessary by the competent authority, in order to remain competent to perform their allocated tasks. The recurrent training programme for inspectors should include, as appropriate to their role, at least the following topics:
(1) changes in aviation legislation, the operational environment and technologies;
(2) procedures of the competent authority that are relevant to the inspector’s tasks;
(3) technical training that is appropriate to the role and tasks of the inspector; and
(4) results from past oversight activities.
(c) Assessments of an inspector’s competency should take place at regular intervals that do not exceed 3 years. The results of these assessments, as well as any actions taken following these assessments, should be recorded.
AMC1 21L.B.16(a)(5) Management system
ED Decision 2023/013/R
SAFETY RISK MANAGEMENT PROCESS
(a) The safety risk management process required by point 21L.B.16 should be documented. The following should be defined in the related documentation:
(1) the means used for hazard identification and the related data sources, taking into account data that comes from other competent authorities with which the competent authority interfaces in the State or from the competent authorities of other Member States;
(2) risk management steps including:
(i) analysis (in terms of the probability and severity of the consequences of hazards and occurrences);
(ii) assessment (in terms of the tolerability); and
(iii) control (in terms of the mitigation) of risks to an acceptable level;
(3) who has the responsibility for hazard identification and risk management;
(4) who has the responsibility for the follow-up of risk-mitigation actions;
(5) the levels of management that have the authority to make decisions regarding the tolerability of risks;
(6) the means to assess the effectiveness of risk-mitigation actions; and
(7) the link with the compliance-monitoring function.
(b) To demonstrate that the safety risk management process is operational, competent authorities should be able to provide evidence that:
(1) the persons involved in internal safety risk management activities are properly trained;
(2) hazards that could impact on the authority’s capabilities to perform its tasks and discharge its responsibilities have been identified, and the related risk assessment is documented;
(3) regular meetings take place at appropriate levels of management of the competent authority to discuss the risks identified and to decide on the risk tolerability and possible risk-mitigation actions;
(4) in addition to the initial hazard identification exercise, the risk management process is triggered as a minimum whenever changes occur that may affect the competent authority’s capability to perform any of the tasks required by Part 21 Light;
(5) a record of the actions taken to mitigate risks is maintained, showing the status of each action and the owner of the action;
(6) there is follow-up on the implementation of all risk-mitigation actions;
(7) risk-mitigation actions are assessed for their effectiveness;
(8) the results of risk assessments are periodically reviewed to check whether they remain relevant.
GM1 21L.B.16(a)(5) Management system
ED Decision 2023/013/R
SAFETY RISK MANAGEMENT PROCESS
The purpose of safety risk management, as part of the management system framework for competent authorities, is to ensure the effectiveness of the management system. As for any organisation, hazard identification and risk management are expected to contribute to effective decision-making, to guide resource allocation and contribute to organisational success.
The safety risk management process required by point 21L.B.16 is intended to address safety risks that are directly related to the competent authority’s organisation and processes, and which may affect its capability to perform its tasks and discharge its responsibilities. This process is not intended to be a substitute for the State safety risk management Standards and Recommended Practices (SARPs) defined in ICAO Annex 19 Chapter 3. This does not mean, however, that the competent authority may not use information and data obtained through its State Safety Programme (SSP), including oversight data and information, for the purpose of safety risk management as part of its management system.
The safety risk management process is also to be applied to the management of changes (point 21L.B.18), which is intended to ensure that the management system remains effective whenever changes occur.
AMC1 21L.B.16(d) Management system
ED Decision 2023/013/R
PROCEDURES AVAILABLE TO THE AGENCY
(a) Copies of the procedures related to the competent authority’s management system, and their amendments, which should be made available to EASA for the purpose of standardisation, should provide at least the following information:
(1) The competent authority’s organisational structure for the continuing oversight functions that it undertakes, with a description of the main processes. This information should demonstrate the allocation of responsibilities within the competent authority, and that the competent authority is capable of carrying out the full range of tasks regarding the size and complexity of a particular Member State’s aviation industry. It should also consider the overall proficiency and the scope of authorisation of the competent authority’s personnel;
(2) For personnel that are involved in oversight activities, the minimum required professional qualification and level of experience, and the principles that guide their appointment (e.g. assessment);
(3) How the following are carried out: assessments of applications and evaluations of compliance; the issuance of certificates, approvals, and authorisations; continuing oversight activities; the follow-up of findings; enforcement measures; and the resolution of safety concerns;
(4) The principles used to manage exemptions and derogations;
(5) The processes that are in place to distribute applicable safety information for timely reaction to a safety problem;
(6) The criteria for planning continuing oversight activities (i.e. an oversight programme), including the management of interfaces when conducting continuing oversight activities; and
(7) An outline of the initial training of newly recruited oversight personnel (taking future activities into account), and the basic framework for the recurrent training of oversight personnel.
(b) As part of the continuous monitoring of a competent authority, EASA may request details of the working methods used, in addition to a copy of the procedures of the competent authority’s management system (and of any amendments to it). These additional details are the procedures and related guidance material that describe the working methods for the personnel of the competent authority that conduct oversight activities.
(c) Information related to the competent authority’s management system may be submitted in an electronic format.
21L.B.17 Allocation of tasks to qualified entities
Regulation (EU) 2022/1361
(a) A competent authority may allocate the tasks related to the initial certification or to the continuing oversight of products and parts, and of natural or legal persons subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, to qualified entities. When allocating tasks, the competent authority shall ensure that it has:
1. put a system in place to initially and continuously assess whether the qualified entity complies with Annex VI ‘Essential requirements for qualified entities’ to Regulation (EU) 2018/1139. This system and the results of the assessments shall be documented;
2. established a documented agreement with the qualified entity, approved by both parties at the appropriate management level, which defines:
(i) the tasks to be performed;
(ii) the declarations, reports, and records to be provided;
(iii) the technical conditions to be met in performing such tasks;
(iv) the related liability coverage;
(v) the protection given to the information acquired in carrying out such tasks.
(b) The competent authority shall ensure that the internal audit process and the safety risk management process required by point (a)(5) of point 21L.B.16 cover all the certification and continuing oversight tasks performed on its behalf by the qualified entity.
GM1 21L.B.17 Allocation of tasks to qualified entities
ED Decision 2023/013/R
CERTIFICATION TASKS
The tasks that may be performed by a qualified entity on behalf of the competent authority include those that are related to the initial certification and the continuing oversight of persons and organisations as defined in Regulation (EU) No 748/2012.
21L.B.18 Changes in the management system
Regulation (EU) 2022/1361
(a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. This system shall enable it to take the action necessary to ensure that its management system remains adequate and effective.
(b) The competent authority shall update its management system to reflect any change to Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof in a timely manner, so as to ensure its effective implementation.
(c) The competent authority of the Member State shall notify the Agency of any changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof.
21L.B.19 Resolution of disputes
Regulation (EU) 2022/1361
The competent authority of the Member State shall establish a process for the resolution of disputes within its documented procedures.
GM1 21L.B.19 Resolution of disputes
ED Decision 2023/013/R
PRINCIPLES FOR THE RESOLUTION OF DISPUTES
It is essential for the efficient accomplishment of the activities related to Part 21 Light of the competent authority of the Member State that all decisions regarding the resolution of disputes be taken at as low a level as possible. In addition, the documented procedures for the resolution of disputes should clearly identify the chain of escalation.
Regulation (EU) 2022/1361
(a) The competent authority shall establish a system of record-keeping that allows the adequate storage, accessibility, and reliable traceability of:
1. the management system’s documented policies and procedures;
2. the training, qualifications, and authorisation of its personnel;
3. the allocation of tasks covering the elements required by point 21L.B.17, as well as the details of the tasks allocated;
4. certification processes and the continuing oversight of certified and declared organisations, including:
(i) applications for a certificate;
(ii) declarations of capability;
(iii) declarations of design compliance;
(iv) the competent authority’s continuing oversight programme, including all assessments, audits and inspection records;
(v) the certificates issued, including any changes to them;
(vi) a copy of the oversight programme listing the dates when audits are due and when audits were carried out;
(vii) copies of all formal correspondence;
(viii) recommendations for the issue or continuation of a certificate or continuation of the registration of a declaration, details of findings, and actions taken by organisations to close these, including the date of closure of each item, enforcement actions, and observations;
(ix) any assessment, audit or inspection report issued by another competent authority;
(x) copies of all organisation handbooks, procedures and processes or manuals and amendments to them;
(xi) copies of any other documents approved by the competent authority;
5. statements of conformity of aircraft (EASA Form 52B) or authorised release certificates (EASA Form 1) for engines, propellers or parts that it has inspected according to Subpart R of this Annex.
(b) The competent authority of the Member State shall include in the record-keeping:
1. the evaluation and notification to the Agency of any alternative means of compliance proposed by organisations, and the assessment of any alternative means of compliance used by the competent authority itself;
2. safety information in accordance with point 21L.B.13 and follow-up measures;
3. the use of safeguard and flexibility provisions in accordance with Articles 71(1) and 76(4) of Regulation (EU) 2018/1139.
(c) The competent authority shall maintain a list of all the certificates that it has issued and any declarations that it has registered.
(d) All the records referred to in points (a), (b) and (c) shall be kept for a minimum period of 5 years, subject to the applicable data protection law.
(e) All the records referred to in points (a), (b) and (c) shall be made available upon request to the competent authorities of another Member State or the Agency.
AMC1 21L.B.20(a) Record-keeping
ED Decision 2023/013/R
GENERAL
(a) The record-keeping system should ensure that all records are accessible within a reasonable time whenever they are needed. Those records should be organised in a manner that ensures their traceability and retrievability throughout the required retention period.
(b) All records that contain sensitive data on applicants, declarants or organisations should be stored in a secure manner with controlled access, to ensure their confidentiality.
(c) The records should be kept in paper form, or in an electronic format, or a combination of both. Records that are stored on microfilm or optical discs are also acceptable. The records should remain legible and accessible throughout the required retention period. The retention period starts when the record is created.
(d) Paper record systems should use robust material that can withstand normal handling and filing. Computer record systems should have at least one backup system that should be updated within 24 hours of any new entry. Computer record systems should include safeguards to prevent unauthorised personnel from altering the data.
(e) All the computer hardware that is used to ensure the backup of data should be stored in a different location from the one that contains the working data and in an environment that ensures that the data remains in a good condition. When hardware or software changes take place, special care should be taken that all the necessary data continues to be accessible throughout at least the full period that is specified in point 21L.B.20(d).
AMC1 21L.B.20(a)(1);(a)(2) Record-keeping
ED Decision 2023/013/R
COMPETENT AUTHORITY MANAGEMENT SYSTEM
The records that are related to the competent authority’s management system should include, as a minimum and as applicable:
(a) the documented policies and procedures;
(b) the files of the competent authority’s personnel, with the supporting documents related to their training and qualifications;
(c) the results of the competent authority’s internal audits and safety risk management processes, including audit findings, as well as any corrective, preventive, and risk-mitigation action; and
(d) the contracts that are established with the qualified entities that perform certification or oversight tasks on behalf of the competent authority.
21L.B.21 Findings and observations
Regulation (EU) 2022/1361
(a) When the competent authority, during investigation or oversight or by any other means, detects a non-compliance with the applicable requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, of a procedure or manual required by those Regulations, or of a certificate or declaration issued in accordance with those Regulations, it shall, without prejudice to any additional action required by those Regulations, raise a finding.
(b) The competent authority shall have a system to analyse findings for their safety significance.
A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected which lowers safety or seriously endangers flight safety, or in the case of design organisations may lead to an uncontrolled non-compliance and to a potential unsafe condition as per point 21L.B.23; level 1 findings shall also include but not be limited to the following:
1. any failure to grant the competent authority access to the organisation’s or natural or legal person’s facilities as defined in point 21L.A.10 during normal operating hours and after two written requests;
2. providing wrong information or falsification of documentary evidence;
3. any evidence of malpractice or of fraudulent use of a certificate, declaration or statement issued in accordance with this Annex;
4. the lack of an accountable manager or head of the design organisation, as applicable.
A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, of a procedure or manual required by those Regulations, or of a declaration issued in accordance with those Regulations, which is not classified as a level 1 finding.
(c) The competent authority shall communicate the finding to the organisation or the natural or legal person in writing, and request corrective action to address the non‑compliance(s) identified.
(d) If there are any level 1 findings, the competent authority shall take immediate and appropriate action in accordance with point 21L.B.22, unless the finding is on a design organisation which has declared its design capabilities, in which case the Agency shall first grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, which in any case shall not be more than 21 working days. The period shall commence from the date of the written communication of the finding to the organisation, requesting corrective action to address the non‑compliance identified. If the level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.
(e) For level 2 findings, the competent authority shall grant the organisation or the natural or legal person a corrective action implementation period that is appropriate to the nature of the finding. The period shall commence from the date of the written communication of the finding to the organisation or the natural or legal person, requesting corrective action to address the non‑compliance identified. At the end of this period, and subject to the nature of the finding, the competent authority may extend the period, provided that a corrective action plan has been agreed by the competent authority.
The competent authority shall assess the corrective action and the implementation plan proposed by the organisation or the natural or legal person, and if the assessment concludes that they are sufficient to address the non-compliance(s), accept these.
If an organisation or natural or legal person fails to submit an acceptable corrective action plan, or to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to a level 1 finding, and action shall be taken as laid down in point (d).
(f) The competent authority may issue observations for those cases not requiring level 1 or level 2 findings:
1. for any item the performance of which has been assessed to be ineffective;
2. when it has been identified that an item has the potential to cause a non-compliance; or
3. when suggestions or improvements are of interest for the overall safety performance of the organisation.
Observations issued under this point shall be communicated to the organisation or the natural or legal person in writing and recorded by the competent authority.
AMC1 21L.B.21(c) Findings and corrective actions
ED Decision 2023/013/R
NOTIFICATION OF FINDINGS
In the case of a level 1 finding, confirmation should be obtained in a timely manner that the accountable manager has taken note of the finding and its details.
Level 1 and level 2 findings require timely and effective oversight by the competent authority to ensure the completion of the corrective action. That oversight may include intermediate communication, such as letters, as necessary, to remind the natural or legal person to verify that the corrective action plan is followed.
GM1 21L.B.21(f) Findings and observations
ED Decision 2023/013/R
DIFFERENCE BETWEEN A ‘LEVEL 2 FINDING’ AND AN ‘OBSERVATION’
‘Findings’ are issued for a non-compliance with the applicable regulation, whereas ‘observations’ may be issued to a natural or legal person (‘organisation’) that remains compliant with the applicable regulation while additional input to the organisation may be considered for continuous improvement (see points (1), (2) and (3) of point 21L.B.21(f)).
However, the competent authority may decide to issue a ‘level 2’ finding when the ‘observations’ process is not managed correctly or is overlooked.
Regulation (EU) 2022/1361
(a) The competent authority shall:
1. suspend a certificate if the competent authority considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety;
2. issue an airworthiness directive under the conditions of point 21L.B.23;
3. suspend, revoke or limit a certificate if such action is required pursuant to point (d) of point 21L.B.21;
4. suspend or revoke a certificate of airworthiness or a restricted certificate of airworthiness when the conditions specified in point (b) of point 21L.B.163 are met;
5. suspend or revoke a noise certificate or a restricted noise certificate when the conditions specified in point (b) of point 21L.B.173 are met;
6. take immediate and appropriate action necessary to limit or prohibit the activities of an organisation or natural or legal person if the competent authority considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety;
7. limit or prohibit the activities of an organisation or a natural or legal person that have declared their capabilities to design or produce products or parts in accordance with Section A or that issue statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) in accordance with Subpart R of Section A of this Annex pursuant to point (d) of point 21L.B.21;
8. not register a declaration of design compliance as long as there are unresolved findings from the initial oversight investigation;
9. temporarily or permanently de-register a declaration of design compliance or a declaration of capability pursuant to point (d) of point 21L.B.21;
10. take any further enforcement measures necessary in order to ensure the termination of a non‑compliance with the essential requirements set out in Annex II to Regulation (EU) 2018/1139 and with this Annex, and, where necessary, remedy the consequences thereof.
(b) Upon taking an enforcement measure in accordance with point (a), the competent authority shall notify it to the addressee, state the reasons for it, and inform the addressee of their right to appeal.
GM1 21L.B.22 Enforcement measures
ED Decision 2023/013/R
LINK BETWEEN FINDINGS AND LIMITATION OR SUSPENSION
It is expected that any natural or legal person will move quickly to re-establish compliance with Part 21 Light and will not risk the possibility of their approval or the registration of their declaration of design compliance or declaration of design or production capability being suspended.
Level 1 findings are those which may lead, if not properly addressed, to limitation, suspension or revocation of the approval. If appropriate, these negative decisions on the approval may be taken immediately or after the organisation fails to comply within the time period agreed by the competent authority.
The type of the negative decision (i.e. limitation, suspension or revocation) should depend upon the contents and the extent of the level 1 finding. Normally, a limitation or a suspension should be considered first.
GM1 21L.B.22 Enforcement measures
ED Decision 2023/013/R
(a) GENERAL
Decisions on the suspension or revocation of a certificate, approval, and registration and deregistration of a declaration of design compliance or declaration of design or production capability will always be actioned in such a way as to comply with any applicable national laws or regulations related to appeal rights and the conduct of appeals.
In case of Agency decisions, as competent authority, the rules for appeal are included in Regulation (EU) 2018/1139.
(b) LIMITATION
A limitation is an amendment to a certificate, approval, or to a registration of a declaration of design compliance or declaration of design or production capability that partially limits the activities of the organisation.
(c) SUSPENSION OF CERTIFICATES AND APPROVALS
A suspension is a temporary withdrawal of a natural or legal person’s (‘organisation’s’) ability to conduct their activities under a certificate or an approval. No activities that invoke the certificate or approval may take place while the suspension is in force. The normal activities of the natural or legal person may be reinstated when the circumstances that caused the suspension are corrected and the natural or legal person can once again demonstrate full compliance with the applicable requirements.
(d) DEREGISTRATION OF DECLARATIONS
In the case of declarations, point 21L.B.22 provides that a declaration may be temporarily or permanently deregistered. No activities that invoke the declaration may take place while the declaration is deregistered. The normal activities of the natural or legal person may be reinstated when the circumstances that caused the deregistration are corrected and the natural or legal person can once again demonstrate full compliance with the applicable requirements.
21L.B.23 Airworthiness directives
Regulation (EU) 2022/1361
(a) An airworthiness directive means a document issued or adopted by the Agency which mandates actions to be performed on an aircraft to restore an acceptable level of safety when evidence shows that the safety level of this aircraft may otherwise be compromised.
(b) The Agency shall issue an airworthiness directive when:
1. an unsafe condition has been determined by the Agency to exist in an aircraft as a result of a deficiency in the aircraft, or an engine, propeller or part installed on this aircraft; and
2. that condition is likely to exist or develop in other aircraft.
(c) An airworthiness directive shall contain at least information identifying:
1. the unsafe condition;
2. the affected aircraft;
3. the action(s) required;
4. the compliance time for the required action(s);
5. the date of entry into force.
AMC1 21L.B.23(b) Airworthiness directives
ED Decision 2023/013/R
UNSAFE CONDITION
An unsafe condition exists if there is factual evidence (from in-service experience, analysis or tests) that:
(a) an event may occur that would result in fatalities, usually with the loss of the aircraft, or reduce the capability of the aircraft or the ability of the crew to cope with adverse operating conditions to the extent that there would be:
(i) a large reduction in safety margins or functional capabilities; or
(ii) physical distress or excessive workload such that the flight crew cannot be relied upon to perform their tasks accurately or completely; or
(iii) serious or fatal injury to one or more occupants,
unless it is shown that the probability of such an event is within the limit defined by the applicable certification specifications; or
(b) there is an unacceptable risk of serious or fatal injury to persons other than occupants; or
(c) design features intended to minimise the effects of survivable accidents do not perform their intended function.
Note 1: Non-compliance with the applicable certification specifications or technical specifications is generally considered as an unsafe condition, unless it is shown that possible events resulting from this non-compliance do not constitute an unsafe condition as defined under points (a), (b) and (c).
Note 2: An unsafe condition may exist even though applicable airworthiness requirements are complied with.
Note 3: The definition in points (a), (b) and (c) covers the majority of cases where EASA considers there is an unsafe condition. There may be other cases where overriding safety considerations may lead EASA to issue an airworthiness directive.
Note 4: There may be cases where events can be considered as an unsafe condition if they occur too frequently (significantly beyond the applicable safety objectives) and could eventually lead to the consequences listed in point (a) in specific operating environments. Although having less severe immediate consequences than those listed in point (a), the referenced events may reduce the capability of the aircraft or the ability of the crew to cope with adverse operating conditions to the extent that there would be, for example, a significant reduction in safety margins or functional capabilities, a significant increase in crew workload, or in conditions impairing crew efficiency, or discomfort to occupants, possibly including injuries.
GM1 21L.B.23(b) Airworthiness directives
ED Decision 2023/013/R
DETERMINATION OF AN UNSAFE CONDITION
It is important to note that these guidelines are not exhaustive. However, this material is intended to provide guidelines and examples that will cover most cases, taking into account the applicable certification requirements or technical specifications.
1. INTRODUCTION
The certification, approval or declaration of a product is a demonstration of compliance with the applicable requirements which are intended to ensure an acceptable level of safety. This demonstration, however, includes certain accepted assumptions and predicted behaviours, such as:
— fatigue behaviour is based on analysis supported by test;
— modelling techniques are used for aircraft flight manual (AFM) performance calculations;
— the systems’ safety analyses give predictions of what the systems’ failure modes, effects and probabilities may be;
— the system components’ reliability figures are predicted values derived from general experience, tests or analyses;
— the crew is expected to have the skills to apply the procedures correctly; and
— the aircraft is assumed to be maintained in accordance with the prescribed instructions for continued airworthiness (ICAs) (or maintenance programme).
In-service experience, additional testing, further analysis, etc., may show that certain initially accepted assumptions are not correct. Thus, certain conditions initially demonstrated as safe, are revealed by experience as unsafe. In this case, it is necessary to mandate corrective actions in order to restore a level of safety consistent with the applicable certification requirements or technical specifications.
To support the determination of an unsafe condition, the investigation may need to include examinations of worn, damaged and time-expired parts / analysis / demonstrations / tests / statistical analysis, and comparison with the design assumptions.
See AMC1 21L.B.23(b) for the definition of ‘unsafe condition’ used in point 21L.A.3(a)(3) and (b)(3).
2. GUIDELINES FOR ESTABLISHING WHETHER A CONDITION IS UNSAFE
The following points give general guidelines for analysing the reported events and determining whether an unsafe condition exists, and are provided for each type of product subject to a specific airworthiness approval (type certificates (TCs) or supplemental type certificates (STCs)) for aircraft, engines or propellers or a declaration of design compliance for an aircraft.
This analysis may be qualitative or quantitative, i.e. formal and quantitative safety analyses may not be available. In such cases, the level of analysis should be consistent with that required by the certification specifications or technical specifications and may be based on engineering judgement supported by in-service experience data.
2.1 Analysis method for aircraft
2.1.1 Accidents or incidents without any aircraft, engine, system, propeller or part malfunction or failure
When an accident/incident does not involve any component malfunction or failure but when a human factor of the crew has been a contributing factor, this should be assessed from a man–machine interface standpoint to determine whether the design is adequate or not. Point 2.5 gives further details on this aspect.
2.1.2 Events involving an aircraft, engine, system, propeller or part failure, malfunction or defect
The general approach for analysis of in-service events caused by malfunctions, failures or defects will be to analyse the actual failure effects, taking into account previously unforeseen failure modes or improper or unforeseen operating conditions revealed by in-service experience.
These events may have occurred in service, or have been identified during maintenance, or have been identified as a result of subsequent tests, analyses or quality control.
They may result from a design or production deficiency (non-conformity with the applicable design data), or from improper maintenance. In this case, it should be determined whether improper maintenance is limited to one aircraft, in which case an airworthiness directive may not be issued, or if it is likely to be a general problem due to improper design and/or maintenance procedures, as detailed in point 2.5.
2.1.2.1 Flight
An unsafe condition exists if:
— there is a significant shortfall of the actual performance compared to the approved or declared performance (taking into account the accuracy of the performance calculation method); or
— the handling qualities, although having been found to comply with the applicable certification specifications at the time of initial approval or declared as being compliant with the applicable technical specifications, are subsequently shown by in-service experience not to comply.
2.1.2.2 Structural or mechanical systems
An unsafe condition exists if the deficiency may lead to a structural or mechanical failure which could exist in a principal structural element. Principal structural elements are those which contribute significantly to carrying flight, ground, and pressurisation loads, and whose failure could result in a catastrophic failure of the aircraft.
They could reduce the structural stiffness to such an extent that the required flutter, divergence or control reversal margins are no longer achieved.
They could result in the loss of a structural piece that could damage vital parts of the aircraft, cause serious or fatal injuries to persons other than occupants.
They could, under ultimate load conditions, result in the liberation of items of mass that may injure the aircraft occupants.
They could jeopardise the proper operation of systems and may lead to hazardous or catastrophic consequences, if this effect has not been taken adequately into account in the initial certification safety assessment.
2.1.2.3 Systems
The consequences of reported system components’ malfunctions, failures or defects should be analysed.
For this analysis, the certification or design data may be used as supporting material, in particular systems’ safety analyses (if applicable).
The general approach for analysis of in-service events caused by systems’ malfunctions, failures or defects will be to analyse the actual failure effects.
As a result of this analysis, an unsafe condition will be assumed if it cannot be shown that the safety objectives for hazardous and catastrophic failure conditions are still achieved, taking into account the actual failure modes and rates of the components affected by the reported deficiency.
The failure probability of a system component may be affected by:
— a design deficiency (the design does not meet the specified reliability or performance);
— a production deficiency (non-conformity with the certified type design or declared design data) that affects either all components, or a certain batch of components;
— improper installation (for instance, insufficient clearance of pipes to surrounding structure);
— susceptibility to adverse environment (corrosion, moisture, temperature, vibrations etc.);
— ageing effects (component failure rate increases when the component ages);
— improper maintenance.
When the failure of a component is not immediately detectable (hidden or latent failures), it is often difficult to have a reasonably accurate estimation of the component failure rate since the only data available are usually results of maintenance or flight crew checks. This failure probability should, therefore, be conservatively assessed.
As it is difficult to justify that the safety objectives for the following systems are still met, a deficiency that affect these types of systems may often lead to a mandatory corrective action:
— backup emergency systems; or
— fire detection and protection systems (including shut-off means).
Deficiencies that affect the systems used during an emergency evacuation (emergency exits, evacuation assist means, emergency lighting system, etc.) and to locate the site of a crash (emergency locator transmitter (ELT)) will also often lead to mandatory corrective action.
2.1.2.4 Others
In addition to the above, the following conditions are considered unsafe:
— There is a deficiency in certain components which are involved in fire protection or which are intended to minimise/retard the effects of fire/smoke in a survivable crash, preventing them to perform their intended function (for instance, deficiency in cargo liners or cabin material leading to non-compliance with the applicable flammability requirements).
— There is a deficiency in the lightning or the high-intensity radiated field (HIRF) protection of a system which may lead to hazardous or catastrophic failure conditions.
— There is a deficiency which could lead to a total loss of power or thrust due to common mode failure.
2.2 Engines
The consequences and probabilities of engine failures should be assessed at the aircraft level in accordance with point 2.1, and also at the engine level for those failures considered as 'hazardous’ in CS E‑510, CS E‑210, CS‑22 Subpart H or the applicable technical specifications.
The latter will be assumed to constitute unsafe conditions, unless it can be shown that the consequences at the aircraft level do not constitute an unsafe condition for a particular aircraft installation.
2.3 Propellers
The consequences and probabilities of propeller failures should be assessed at the aircraft level in accordance with point 2.1, and also at the propeller level for those failures considered as ‘hazardous’ in CS P‑150, CS‑22 Subpart J or the applicable technical specifications.
The latter will be assumed to constitute unsafe conditions, unless it can be shown that the consequences at the aircraft level do not constitute an unsafe condition for a particular aircraft installation.
2.4 Parts
The consequences and probabilities of equipment failures should be assessed at the aircraft level in accordance with point 2.1.
2.5 Human-factors aspects in establishing and correcting unsafe conditions
This point provides guidance on the way to treat an unsafe condition that results from a maintenance or crew error observed in service.
It is recognised that human-factors techniques are under development. However, the following is a preliminary guidance on the subject.
Systematic review should be used to assess whether the crew or maintenance error raises issues that require regulatory action (whether in design or other areas) or should be noted as an isolated event without intervention. This may need the establishment of a multidisciplinary team (designers, crews, human-factors experts, maintenance experts, aircraft operators, etc.).
The assessment should include at least the following:
— Characteristics of the design intended to prevent or discourage incorrect assembly or operation.
— Characteristics of the design that allow or facilitate incorrect operation.
— Unique characteristics of a design feature differing from established design practices.
— The presence of indications or feedback that alerts the operator to an erroneous condition.
— The existence of similar previous events, and whether or not they resulted (on those occasions) in unsafe conditions.
— Complexity of the system, associated procedures and training (has the crew a good understanding of the system and its logic after a standard crew qualification programme?).
— Clarity/accuracy/availability/currency and practical applicability of manuals and procedures.
— Any issues arising from interactions among personnel, such as shift changeover, dual inspections, team operations, supervision (or lack of it), or fatigue.
Apart from a design change, the corrective actions, if found necessary, may consist of modifications of the manuals, inspections, training programmes, and/or information to the operators about particular design features. The Agency may decide to make mandatory such corrective action if necessary.
Regulation (EU) 2022/1361
(a) The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.
(b) Alternative means of compliance may be used to establish compliance with this Regulation.
(c) Competent authorities shall inform the Agency of any alternative means of compliance used by natural or legal persons under their oversight for establishing compliance with this Regulation.
GM1 21L.B.24 Means of compliance
ED Decision 2023/013/R
ALTERNATIVE MEANS OF COMPLIANCE — GENERAL
(a) A competent authority may establish alternative means to comply with the Regulation, which are different from the AMC that are established by EASA.
In that case, the competent authority is responsible for demonstrating how those alternative means of compliance (AltMoC) establish compliance with the Regulation.
(b) AltMoC that are used by a competent authority, or by an organisation under its oversight, may be used by other competent authorities, or another organisation, only if they are processed by those authorities in accordance with point 21L.B.24, and by that organisation in accordance with point 21L.A.12.
(c) AltMoC that are issued by the competent authority may cover the following cases:
(1) AltMoC to be used by organisations under the oversight of the competent authority and which are made available to those organisations; and
(2) AltMoC to be used by the authority itself to discharge its responsibilities.
AMC1 21L.B.24(a);(b) Means of compliance
ED Decision 2023/013/R
PROCESSING THE ALTERNATIVE MEANS OF COMPLIANCE
To meet the objectives of points (b) and (c) of point 21L.B.24:
(a) the competent authority should establish the means to consistently evaluate over time that all the AltMoC that are used by itself or by organisations under its oversight allow for the establishment of compliance with the Regulation;
(b) if the competent authority issues AltMoC for itself or for the organisations under its oversight, it should:
(1) make them available to all relevant organisations; and
(2) notify EASA of the AltMoC as soon as they are issued, including the information that is described in point (d) of this AMC;
(c) the competent authority should evaluate the AltMoC that are proposed by an organisation by analysing the documentation provided and, if considered necessary, by inspecting the organisation; when the competent authority finds that the AltMoC are in accordance with the Regulation, it should:
(1) notify the applicant that the AltMoC are approved;
(2) indicate that those AltMoC may be implemented, and agree when the organisation’s processes and procedures are to be amended accordingly; and
(3) notify EASA of the AltMoC approval as soon as they are approved, including the information that is described in point (d) of this AMC; and
(d) the competent authority should provide EASA with the following information:
(1) a summary of the AltMoC;
(2) the content of the AltMoC;
(3) a statement that compliance with the Regulation is achieved; and
(4) in support of that statement, an assessment that demonstrates that the AltMoC reach an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding Agency’s AMC.
(e) All these elements that describe the AltMoC are an integral part of the records to be kept, which are managed in accordance with point 21L.B.20.
GM1 21L.B.24(b);(c) Means of compliance
ED Decision 2023/013/R
CASES IN WHICH THERE IS NO CORRESPONDING AGENCY AMC
When there is no Agency AMC to a certain requirement in the Regulation, the competent authority may choose to develop national guides or other types of documents to assist the organisations under its oversight in compliance demonstration. The competent authority may inform EASA so that such guides or other types of documents may be later considered for incorporation into an AMC that is published by EASA using the EASA rulemaking process.