23
MAY
2016

Opinion 07/2016

Embodiment of level of involvement requirements into Part-21

This Opinion addresses a systemic issue of introduction of safety management principles into the process of airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as changes and repairs thereto in accordance with Part-21 (Annex I to Regulation (EU) No 748/2012).

The Opinion is linked with the European Plan for Aviation Safety (EPAS) 2016-2020 action RMT.0262.

The main specific objective is to further strengthen the Part-21 certification processes performance in general, and the verification part of these processes by the European Aviation Safety Agency (hereinafter referred to as ‘the Agency’) in particular, so that their safety and environmental goals are consistently met in an effective and efficient manner. This will be achieved by introducing into Part-21 the new rules accommodating a risk-based approach to compliance verification through embodiment of the concept of level of involvement (LoI) of the Agency in the certification process. The risk-based LoI concept is in line with the safety risk management standards of International Civil Aviation Organization (ICAO) Annex 19, and will enable the Agency to better identify the areas of product certification more prone than others to risk with regard to safety and environmental protection. This will allow the Agency to focus its certification resources primarily on these areas that need a direct and high LoI in order to thoroughly verify that compliance has been demonstrated by applicants. In other certification areas, where the risk to product safety or environmental protection is assessed lower, the Agency may, when justified by their adequate performance, rely on approved design organisations. Moreover, this proposal will further enhance the oversight system of design organisations to become ‘performance-based’. Some design organisations may obtain new design organisation approval (DOA) privileges to certify certain major changes to type-certificates (TCs), supplemental type-certificates (STCs), and/or major repair designs without the Agency’s involvement, but only in technical domains where they demonstrate to the Agency their satisfactory experience and performance in compliance assurance.

The present opinion is the first step towards transposing the ICAO Annex 19 ‘Safety Management’ standards into Part-21. A further proposal to amend Part-21 in accordance with the ICAO safety management system (SMS) standards for design and production organisations, State Safety Programme (SSP) standards, and critical elements of a safety oversight system for the competent authorities (CAs), including the Agency, is being established by the Agency in a separate rulemaking task (RMT).

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