21L.B.184 Oversight programme
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.