Regulation (EU) 2022/1361
(a) The competent authority shall oversee the natural or legal person issuing statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) under Subpart R of Section A of this Annex in order to verify the continuous compliance of the natural or legal person 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 that is produced for the first time for which the natural or legal person has issued a statement of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1), and, as determined by the oversight programme in accordance with point 21L.B.252, inspections of further aircraft, engines, propellers and parts produced by that natural or legal person.
ED Decision 2023/013/R
FIRST-ARTICLE INSPECTION FOR A NEW AIRCRAFT, ENGINE, PROPELLER OR PART PRODUCED FOR THE FIRST TIME
(a) Purpose
The purpose of first-article inspection when a new aircraft, engine, propeller or part is produced and released for the first time is for the competent authority to:
(1) ensure the conformity of the aircraft, engine, propeller or part with the applicable design data;
(2) conduct an oversight visit to the natural or legal person that uses Subpart R in order to ensure that the natural or legal is capable of consistently producing, or controlling the production of, aircraft, products and parts that conform with the declared design data;
(3) ensure that the natural or legal person that uses Subpart R is able to discharge its obligations and responsibilities for production.
(b) Methodology and evidence
The first-article inspection should be conducted by the competent authority at an appropriate location(s) selected by the natural or legal person that uses Subpart R. This (these) location(s) should:
(1) be at the physical location of the aircraft, engine, propeller or part under inspection;
(2) be in the principal place of business (which in accordance with Article 8(2) of Regulation (EU) No 748/2012 must be in an EU Member State); and
(3) be in a location that enables the competent authority to conduct the oversight stated in points (a)(2) and (3) above; this location should include the actual production and manufacture of new aircraft, engine, propeller or parts of the aircraft to enable the competent authority to determine that the legal or natural person is in compliance with Subpart R.
Note: The principal place of business is defined as follows: ‘The head office or registered office of the organisation within which the principal financial functions and operational control of the activities referred to in this Regulation are exercised.’
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 for which a statement of conformity has been issued or the engine, propeller or part for which an authorised release certificate has been issued.
Additional sources of evidence during the visit to the 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 production organisation has:
(1) misunderstood, misinterpreted or not achieved conformity with the applicable design data;
(2) not discharged its production obligations;
(3) not followed good production practices to ensure conformity or control of a product or 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 natural or legal person that uses Subpart R at the time of the visit by the competent authority to the facilities of the production organisation. Key production personnel should be made available to the competent authority 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 (a), an appropriate finding may be raised. 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.
(f) Duration and schedule
First-article inspection relating to the initial declaration of design compliance for an aircraft (including engines and propellers).
The natural or legal person that uses Subpart R should coordinate with the competent authority so that the first-article-inspection activities to be conducted under point 21L.B.251(b) are conducted at the same time as the first-article-inspection activities conducted under point 21L.B.62(b). If this is not appropriate (due to the fact that a partial first-article inspection would be beneficial at an earlier stage of production), then it is possible that the declarant arrange this with the competent authority.
Note: For a modified or repaired product, when determined under points 21L.B.121(b) or 21L.B.221(b) 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 natural or legal person that uses Subpart R, 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.121(b) or 21L.B.221(b), 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.251. This oversight programme shall take into account the specific nature of the natural or legal person, the complexity of their activities and the results of past 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) production control system assessments and process audits;
(ii) product audits of a relevant sample of the products and parts that are under the scope of the natural or legal person;
(iii) sampling of the work performed; and
(iv) unannounced inspections;
2. meetings convened between the legal or natural person 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 natural or legal person has demonstrated that they can effectively identify aviation safety hazards and manage the associated risks;
2. the natural or legal person has continuously demonstrated compliance with point 21L.A.273 and that they have 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 natural or legal person 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 natural or legal person themselves.
(f) The oversight planning cycle may be reduced if there is evidence that the safety performance of the natural or legal person 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 natural or legal person, reflecting the results of the oversight.
CONTENTS
The oversight programme should be built around conformity inspections of products and parts (performed during manufacture and on the final product).
The oversight programme should consist of:
(a) planned inspections of each new aircraft produced for the first time and for which a permit to fly has been requested (see point 21L.B.241(a));
(b) planned first-article inspections of every new aircraft, engine, propeller or part that is produced for the first time for which the natural or legal person has issued a statement of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) (see point 21L.B.251(b));
(c) inspections of further aircraft, engines, propellers and parts produced by that natural or legal person; for this to be performed 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 activities of the natural or legal person; this sampling plan should be flexible to accommodate changes in the production rate, and consider the results from other samples or investigation activities; and
(d) specific assessments and audits; these might be triggered by the results of the above inspections of products and parts, and the feedback on in-service products received from other competent authorities’ and EASA teams.
Note: For the planned inspections of a new aircraft, engine and propeller produced for the first time (see points (a) and (b) above), the competent authority should coordinate as much as possible the related activities with the EASA team(s) involved in the investigation of the respective aircraft’s declaration of design compliance.
GM1 21L.B.252(d);(e) Oversight programme
ED Decision 2023/013/R
EXTENSION OF THE OVERSIGHT PROGRAMME PLANNING CYCLE
Compliance with the conditions for the extension of the oversight programme planning cycle in point 21L.B.252(d) and (e) would normally be demonstrated using a safety management system. However, it is not expected that the natural or legal person that produces under Subpart R would implement such a system. Consequently, that natural or legal person is not expected to meet the conditions for the extension of the oversight programme planning cycle
21L.B.253 Oversight activities
Regulation (EU) 2022/1361
(a) When the competent authority verifies the compliance of the natural or legal person in accordance with point 21L.B.251 and the oversight programme established in accordance with point 21L.B.252, 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 point 21L.B.21 and 21L.B.22;
4. inform the natural or legal person about the results of the oversight activities.
(b) If the facilities of the natural or legal person 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 natural or legal person who 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 natural or legal person 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 natural or legal person issuing statements of conformity (EASA Form 52B) or authorised release certificates (EASA Form 1) 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.