21L.B.141 Initial oversight investigation
Regulation (EU) 2022/1361
(a) Upon receiving a declaration from an organisation declaring their production capability, the competent authority shall verify that:
1. the declarant is eligible to declare their production capability in accordance with point 21L.A.122;
2. the declaration contains all the information specified in point (c) of point 21L.A.123; and
3. the declaration does not contain information that indicates a non-compliance with the requirements of Subpart G of Section A of this Annex.
(b) The competent authority shall acknowledge the receipt of the declaration, including the assignment of an individual declared production organisation reference number to the declarant.
AMC1 21L.B.141 Initial oversight investigation
ED Decision 2023/013/R
Upon receiving a declaration from an organisation that declares its production capability, the competent authority should appoint a suitable member of its technical staff as the team leader (i.e. focal point) to be in charge of the verification and registration of the declaration and, subsequently, the oversight of the organisation. If needed, the team leader should be supported by one or more team members.
The competent authority should perform sufficient verification activities to be satisfied that the declarant is compliant with the requirements of Subpart G of Section A of this Annex.
21L.B.142 Registration of a declaration of production capability
Regulation (EU) 2022/1361
The competent authority shall register the declaration of production capability on a suitable database, including the declared scope of work, provided that:
(a) the declarant has declared their capability in accordance with point 21L.A.123;
(b) the declarant has made a commitment that the obligations in accordance with point 21L.A.127 will be undertaken;
(c) there are no unresolved issues in accordance with point 21L.B.141.
AMC1 21L.B.142 Registration of a declaration of production capability
ED Decision 2023/013/R
REGISTRATION NUMBER
The competent authority should assign a unique and consecutive declared production organisation (DPO) reference number to the declarant.
The reference number should have the following format: commencing with the UN country code of the State of the competent authority to which the declaration is submitted, followed by the term ‘.DPO.’ and a consecutive numbering (example: ‘AT.DPO.001’).
Regulation (EU) 2022/1361
(a) The competent authority shall oversee the declared production organisation in order to verify the continuous compliance of the declared production organisation with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15.
(b) The oversight shall include a first article inspection of every new aircraft, engine, propeller or part design that is produced for the first time and, as determined by the oversight programme in accordance with point 21L.B.144, inspections of further produced aircraft, engines, propellers and parts that are produced by the declared production organisation.
ED Decision 2023/013/R
FIRST-ARTICLE INSPECTION FOR A NEW AIRCRAFT, ENGINE, PROPELLER OR PART PRODUCED FOR THE FIRST TIME
The purpose of first-article inspection (of the article that is in conformance with the proposed type design for certification) when a new aircraft, engine, propeller or part is produced and released for the first time is for the competent authority to:
— ensure the conformity of the aircraft, engine, propeller or part with the applicable design data;
— conduct an oversight visit to the declared production organisation in order to ensure that the declared production organisation is capable of consistently producing, or controlling the production of, aircraft, products and parts that conform with the applicable design data;
— ensure that the declared production organisation is able to discharge its obligations and responsibilities as regards production.
(b) Methodology and evidence
The first-article inspection should be conducted by the competent authority at an appropriate location(s) selected by the declared production organisation. This (these) location(s) should include the physical location of the aircraft, engine, propeller or part under inspection and should be in the principal place of business (which in accordance with Article 9(2) of Regulation (EU) No 748/2012 must be in an EU Member State).
The main focus of the activities to gather evidence to ensure the objectives mentioned in point (a) are satisfied should be through a physical inspection of the aircraft, engine, propeller or part that has been produced in accordance with the approved design data.
Additional sources of evidence during the visit to the declared production organisation’s facilities may include:
(1) the review of supporting conformity documentation and test reports;
(2) the review of applicable design data and how it is used;
(3) discussions with key production personnel;
(4) the review of production processes and procedures.
The above list of additional sources of evidence is not exhaustive.
It is possible that during the first-article inspection the competent authority may discover ‘evidence’ that indicates that the declared production organisation has:
(1) misunderstood, misinterpreted or not achieved conformity with the applicable design data;
(2) not discharged its production obligations as a declared production organisation;
(3) not followed good production practices to ensure conformity or control of a product or a part it has produced.
If such ‘evidence’ is discovered, the competent authority may perform a more in-depth investigation into the production practices of the production organisation to determine the root cause(s) and to establish corrective actions to prevent a reoccurrence of the issue.
(c) Condition and conformity of the aircraft, engine, propeller or part to be inspected
The aircraft, engine, propeller or part presented to the competent authority for inspection should be in the final condition for release and in conformity with the applicable design data.
(d) Availability of supporting documentation and key personnel
The supporting documentation and conformity data should be made available by the declared production organisation at the time of the visit by the competent authority to the facilities of the declared production organisation. Key production personnel should be made available to the competent authority by the declared production organisation in case of need.
(e) Findings and resolution
If a non-compliance is discovered by the competent authority in the process of the activities mentioned in point (b), an appropriate finding may be raised against the declared production organisation in accordance with point 21L.B.21 and enforcement actions implemented in accordance with point 21L.B.22. Depending upon its nature, such finding may need to be resolved before the initial and subsequent aircraft, engine(s), propeller(s) or part(s) can be released or the first certificate of airworthiness (or restricted certificate of airworthiness in the case of a declared aircraft) is issued.
(f) Duration and schedule
First-article inspection relating to the initial type certificate of a product
The declared production organisation should coordinate with the competent authority so that, as far as practicable, the first-article-inspection activities to be conducted under point 21L.B.143(b) are conducted at the same time as the first-article inspection activities conducted under point 21L.B.46(c) or point 21L.B.62(b). If this is not appropriate or practicable (for example, because a partial first-article inspection would be beneficial at an earlier stage of production (e.g. for major assemblies)), then the applicant may arrange this with the competent authority.
Note: For a modified or repaired product, when determined under points 21L.B.83(c), 21L.102(c) or 21L.B.203(c) respectively, EASA may require and coordinate with the competent authority on the need for a first-article inspection.
First-article inspection relating to a part that is produced for the first time by the production organisation
For the first-article inspection of every part that is produced for the first time by the declared production organisation, it is possible that this is arranged without the need for coordination with EASA.
If such a part relates to a major change/repair for which EASA has determined the need for a first-article inspection under points 21L.B.83(c), 21L.102(c) or 21L.B.203(c), then EASA may require and coordinate with the competent authority on the need for a first-article inspection.
Regulation (EU) 2022/1361
(a) The competent authority shall establish and maintain an oversight programme in order to ensure compliance with point 21L.B.143. This oversight programme shall take into account the specific nature of the organisation, the complexity of its activities and the results of past certification and/or oversight activities, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:
1. assessments, audits and inspections, including as appropriate:
(i) management system assessments and process audits;
(ii) product audits of a relevant sample of the products and parts that are under the scope of the organisation;
(iii) sampling of the work performed; and
(iv) unannounced inspections;
2. meetings convened between the accountable manager and the competent authority to ensure that they both remain informed of any significant issues.
(b) The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out.
(c) An oversight planning cycle that does not exceed 24 months shall be applied.
(d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the competent authority has established that during the previous 24 months:
1. the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks;
2. the organisation has continuously demonstrated compliance with point 21L.A.128 and that it has full control over all changes to the management system for production;
3. no level 1 findings have been issued;
4. all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as defined in point 21L.B.21.
(e) Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions provided in point (d), the organisation has established, and the competent authority has approved, an effective continuous system for reporting to the competent authority on the safety performance and regulatory compliance of the organisation itself.
(f) The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased.
(g) At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the activities conducted by the declared production organisation based on its declaration of production capability, reflecting the results of the oversight.
AMC1 21L.B.144 and 21L.B.184 Oversight programme
ED Decision 2023/013/R
ANNUAL REVIEW
The oversight planning cycle and the related oversight programme for each organisation should be reviewed annually to ensure they remain adequate regarding any changes in the nature, complexity or performance of the organisation.
When reviewing the oversight programme, the competent authority should also consider any relevant information collected in accordance with points 21L.A.3 and 21L.B.12.
AMC1 21L.B.144(a) and 21L.B.184(a) Oversight programme
ED Decision 2023/013/R
SPECIFIC NATURE AND COMPLEXITY OF THE ORGANISATION — RESULTS OF PAST OVERSIGHT ACTIVITIES
When determining the oversight programme, including for product audits, the relevant sample of products and parts that are within the scope of the organisation, the competent authority should consider in particular the following elements, as applicable:
(a) the effectiveness of the organisation’s management system in identifying and addressing non‑compliances;
(b) the implementation by the organisation of any industry standards that are directly relevant to the organisation’s activities subject to Part 21 Light;
(c) any specific procedures implemented by the organisation that are related to any alternative means of compliance used (see point 21L.B.24(b));
(d) the number of locations and the activities performed at each location;
(e) the number and type of any subcontractors which perform production or design tasks as appropriate;
(f) the volume of activity for each product or part; and
(g) the number and nature of significant changes notified under points 21L.A.128 or 21L.A.178, as relevant.
AMC2 21L.B.144(a) and 21L.B.184(a) Oversight programme
ED Decision 2023/013/R
SUBCONTRACTED ACTIVITIES
If a declared production or design organisation subcontracts some of its tasks, the competent authority should determine whether the subcontracted organisations need to be audited and included in the oversight programme, taking into account the specific nature and complexity of the subcontracted activities, the results of previous oversight activities of the declared production or design organisation, and based on the assessment of the associated risks.
For such an audit, the competent authority inspector should ensure that they are accompanied throughout the audit by a representative of the declared production or design organisation.
GM1 21L.B.144(a) Oversight programme
ED Decision 2023/013/R
CONTENTS
An oversight programme typically consists of the elements detailed in this GM.
(a) Planned continued surveillance
In the planned continued surveillance, the total surveillance actions are split into several audits that are carried out at planned intervals during the oversight cycle. One aspect may be audited once or several times, depending on its importance. All relevant aspects are audited at least once within an oversight cycle.
(b) Planned inspections of produced aircraft, engines, propellers and parts
For the first-article inspection (of a new product or part produced for the first time), refer to AMC1 21L.B.143(b).
For serial production, in order to perform the inspections effectively and efficiently, the competent authority should integrate a sampling plan, as part of the planning of the continued surveillance activities, which is appropriate to the scope and size of the declared production organisation. A flexible sampling plan allows to accommodate changes in the production rate and consider the results obtained from other samples or investigation activities.
(c) Unplanned reviews
Unplanned reviews are specific additional investigations of a declared production organisation related to surveillance findings or external needs. The competent authority is responsible for deciding when a review is necessary, taking into account any changes in the scope of work, changes in personnel, reports on the organisation’s performance submitted by other EASA or competent authorities’ teams, and reports on the in-service products.
AMC1 21L.B.144(d);(e) and 21L.B.184(d);(e) Oversight programme
ED Decision 2023/013/R
EXTENSION OF THE OVERSIGHT PLANNING CYCLE BEYOND 24 MONTHS
(a) Part 21 Light Subparts G and J do not require the implementation of a safety management system by the respective declared organisations. However, a declared production organisation or a declared design organisation may decide to introduce certain elements of a safety management system as defined in Part 21 points 21.A.139 and 21.A.239 (e.g. safety risk management, safety performance monitoring and measurement). When such elements are voluntarily introduced, the competent authority may consider them to substantiate an extension of the oversight planning cycle beyond 24 months, as specified in points 21L.B.144(d) and (e) and in points 21L.B.184(d) and (e).
(c) If the results of the annual review indicate a decrease in the safety performance of the organisation, the competent authority should revert to a 24‑month (or shorter) oversight planning cycle and review the oversight programme accordingly.
21L.B.145 Oversight activities
Regulation (EU) 2022/1361
(a) When the competent authority verifies the compliance of the declared production organisation in accordance with point 21L.B.143 and the oversight programme established in accordance with point 21L.B.144, it shall:
1. provide the personnel responsible for oversight with guidance to perform their functions;
2. conduct assessments, audits, inspections, and, if needed, unannounced inspections;
3. collect the evidence needed in case further action is required, including the measures provided for in points 21L.B.21 and 21L.B.22;
4. inform the declared production organisation about the results of the oversight activities.
(b) If the facilities of the declared production organisation are located in more than one State, the competent authority identified in point 21L.2 may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where other facilities are located, or by the Agency for facilities that are located in a non-Member State. Any declared production organisation that is subject to such an agreement shall be informed of its existence and of its scope.
(c) For any oversight activities that are performed by the competent authority at facilities located in a Member State other than where the organisation has its principal place of business, the competent authority shall inform the competent authority of that Member State before performing any on-site audit or inspection of the facilities.
(d) The competent authority shall collect and process any information deemed necessary for conducting oversight activities.
(e) If the competent authority detects a non-compliance of the declared production organisation with the applicable requirements of Section A and the implementation of safety measures mandated according to points (c) and (d) of point 21L.B.15, the competent authority shall act in accordance with points 21L.B.21 and 21L.B.22.
21L.B.146 Changes to declarations
Regulation (EU) 2022/1361
(a) Upon receiving a notification of changes in accordance with point 21L.A.128, the competent authority shall verify the completeness of the notification in accordance with point 21L.B.141.
(b) The competent authority shall update its oversight programme established according to point 21L.B.144 and investigate whether it is necessary to establish any conditions under which the organisation may operate during the change.
(c) When the change affects any aspect of the declaration that is registered in accordance with point 21L.B.142, the competent authority shall update the register.
(d) Upon completion of the activities required by points (a) to (c), the competent authority shall acknowledge the receipt of the notification to the declared production organisation.