21L.B.181 Initial oversight investigation
Regulation (EU) 2022/1358
(a) Upon receiving a declaration from an organisation declaring their design capability, the Agency shall verify that:
1. the declarant is eligible to declare their design capability in accordance with point 21L.A.172;
2. the declaration contains all the information specified in point (c) of point 21L.A.173; and
3. the declaration does not contain information that indicates a non-compliance with the requirements of Subpart J of Section A of this Annex.
(b) The Agency shall acknowledge the receipt of the declaration, including the assignment of an individual declared design organisation reference number to the declarant.
AMC1 21L.B.181 Initial oversight investigation
ED Decision 2023/013/R
Upon receiving a declaration from an organisation that declares its design capability, EASA 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.
EASA should perform sufficient verification activities to be satisfied that the declarant is compliant with the requirements of Subpart J Section A of this Annex.
21L.B.182 Registration of a declaration of design capability
Regulation (EU) 2022/1358
The Agency shall register the declaration of design 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.173;
(b) the declarant has made a commitment that the obligations in accordance with point 21L.A.177 will be undertaken;
(c) there are no unresolved issues in accordance with point 21L.B.181.
AMC1 21L.B.182 Registration of a declaration of production capability
ED Decision 2023/013/R
REGISTRATION NUMBER
EASA should assign a unique and consecutive declared design organisation (‘DDO’) reference number to the declarant.
EASA should publish an up-to-date list of the registered declarations of design capability. This list should include the declared scope of work of those declared design organisations.
Regulation (EU) 2022/1358
(a) The Agency shall oversee the declared design organisation in order to verify the continuous compliance of the organisation with the applicable requirements of Section A.
(b) The oversight shall include a product critical design review or physical inspection, and a first article inspection of every new design of the declared design organisation.
ED Decision 2023/013/R
CRITICAL DESIGN REVIEW, PHYSICAL INSPECTION AND FIRST-ARTICLE INSPECTION
The oversight of a declared design organisation should be built around the product design and the investigations performed by EASA during the certification or the registration of a declaration of design compliance.
These investigations are performed as follows:
(a) for the certification of design compliance:
(1) a critical design review is performed, as applicable, before the approval of the flight conditions (see point 21L.B.242(a)(1) and (a)(3));
(2) a physical inspection is performed, as applicable, before the approval of the flight conditions (see point 21L.B.242(a)(1) and (a)(3)); and
(3) a physical inspection of the first article (first-article inspection) is performed, as applicable, after receiving the declaration of compliance and before the issuance of the respective product design certificate or approval (see points 21L.B.46(c), 21L.B.83(c), 21L.B.102(c) and 21L.B.203(c));
(b) for a declaration of design compliance:
(1) a physical inspection is performed, as applicable, before the approval of the flight conditions (see point 21L.B.242(a)(2) and (a)(4)); and
(2) a physical inspection of the first article (first-article inspection) is performed, as applicable, after receiving the declaration of design compliance and before the registration of the respective declaration (see points 21.B.62(b), 21.B.121(b) and 21L.B.221(b)).
Note: The physical inspections mentioned above are:
— for a certified product: compliance inspections during which EASA verifies that the product is compliant with the applicable type-certification basis and the applicable environmental protection requirements;
— for a declared aircraft: safety inspections during which EASA ensures that the aircraft is capable of safe flight and environmentally compatible; these physical inspections may include ground, functional and flight tests, as relevant.
For the contents and methodology to perform critical design reviews, physical inspections and first-article inspections, refer to AMC2 21L.B.46(c), AMC1 21L.B.62(b), AMC1 21L.B.241(a)(1) and point 21L.B.242(a)(1), and AMC 21L.B.241(a)(2) and point 21L.B.242(a)(2).
Regulation (EU) 2022/1358
(a) The Agency shall establish and maintain an oversight programme in order to ensure compliance with point 21L.B.183. The 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 design and certification of the products, and parts that are under the scope of the organisation;
(iii) sampling of the work performed;
(iv) unannounced inspections;
2. meetings convened between the head of the design organisation and the Agency to ensure that 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 Agency 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.178 and that it has full control over all changes to the design management system;
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 Agency 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 Agency has approved, an effective continuous system for reporting to the Agency 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 Agency shall issue a recommendation report on the continuation of the activities conducted by the declared design organisation based on its declaration of design capability, reflecting the results of the oversight.
AMC1 21L.B.144 and 221L.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 each organisation.
When reviewing the oversight programme and the oversight planning cycle, 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 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; and
(f) the volume of activity for each product or part.
(g) the number and nature of significant changes notified under point 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 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 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.184(a) Oversight programme
ED Decision 2023/013/R
CONTENTS
The 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 critical design reviews, physical inspections and first-article inspections as defined for each new product design.
(c) Unplanned reviews
Unplanned reviews are specific additional investigations of a declared design organisation related to surveillance findings or external needs. EASA 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 include requirements for the implementation of a safety management system. 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).
(b) If the competent authority applies an extended oversight planning cycle (i.e. that exceeds 24 months), it should perform, at a minimum, one annual review (see AMC1 21L.B.144 and point 21L.B.184 ‘Oversight programme’) to validate the oversight programme.
(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.185 Oversight activities
Regulation (EU) 2022/1358
(a) When the Agency verifies the compliance of the declared design organisation in accordance with point 21L.B.183 and the oversight programme established in accordance with point 21L.B.184, 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 declared design organisation about the results of the oversight activities.
(b) The Agency shall collect and process any information deemed necessary for conducting oversight activities.
(c) If the Agency detects a non-compliance of the declared design organisation with the applicable requirements of Section A, with a procedure or manual required by Section A, or with the declaration submitted, the Agency shall act in accordance with points 21L.B.21 and 21L.B.22.
21L.B.186 Changes to declarations
Regulation (EU) 2022/1358
(a) Upon receiving a notification of changes in accordance with point 21L.A.178, the Agency shall verify the completeness of the notification in accordance with point 21L.B.181.
(b) The Agency shall update its oversight programme established according to point 21L.B.184 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.182, the Agency shall update the register.
(d) Upon completion of the activities required by points (a) to (c), the Agency shall acknowledge the receipt of the notification to the declared design organisation.