21.B.430 Initial certification procedure

VERIFICATION OF COMPLIANCE — INITIAL CERTIFICATION AUDITS

(a)In order to verify the organisation’s compliance with the applicable requirements, the investigation by the competent authority should include one or more audit(s) of the organisation, together with interviews of the personnel, typically carried out at the organisation’s facilities.

(b)The competent authority should only conduct such an audit if it is satisfied that the application and supporting documentation are in compliance with the applicable requirements.

(c)The audit(s) should address the following areas:

(1)the organisation’s core processes;

(2)the detailed management structure, notably its adequacy;

(3)the personnel: the adequacy of the number of staff, and of their qualifications and experience with regard to the intended terms of approval and the associated privileges;

(4)the processes used for safety risk management and compliance monitoring (independent monitoring function);

(5)the facilities and their adequacy regarding the organisation’s intended terms of approval including its scope of work; and

(6)the documentation based on which the approval should be granted.

INVESTIGATION TEAM AND PROCEDURES

(a)The competent authority should appoint a design organisation investigation team for each applicant for a DOA. This team is responsible for conducting all the relevant tasks related to the initial certification. The team should consist of a team leader to manage and lead the team and, if needed, one or more team members. The team leader should report to the manager who is responsible for the activities of the competent authority as defined in point 21.B.25(b).

(b)The competent authority should perform sufficient investigation activities for an applicant for a DOA to justify the recommendations for the issuance of the approval.

(c)The competent authority should prepare procedures for the investigation of a design organisation as part of the documented procedures that cover at least the following elements:

(1)evaluation of the application received;

(2)appointment of the investigation team;

(3)preparation and planning of the investigation;

(4)evaluation of the documentation (design organisation handbook, procedures, etc.);

(5)auditing;

(6)follow-up of corrective actions;

(7)recommendation for the issuance of a design organisation approval; and

(8)oversight.

ALTERNATIVE MEANS OF COMPLIANCE The competent authority should have a procedure for formally recording the proposal, discussion and disposition of alternative means of compliance (deviations from existing AMC). This procedure is necessary to record satisfaction by the competent authority that the use of alternative means provides for compliance with the applicable requirements. The alternative means of compliance should only be allowed to be used by the organisation once agreement has been found with the competent authority. For those alternative means of compliance where previously no formal satisfaction was recorded, a pragmatic approach should be followed on both organisation and competent authority side as to the need to formally record acceptance of such an alternative means of compliance. Note: EASA Management Board Decisions 03-2004 (Section 2, Article 2, Paragraph 2) and 12-2007 (Section 2, Article 3, Paragraph 2) already required a formal process on the handling of deviations from AMC.

INVESTIGATION TEAM SELECTION

(a)Team leader selection The team leader should satisfy all of the criteria for a team member and will be selected by considering the following additional criteria:

(1)the capability to lead and manage a team;

(2)the capability to prepare reports and be diplomatic;

(3)experience in investigations (not necessarily only Part 21 Section A, Subpart J); and

(4)a knowledge of design management systems.

(b)Team member selection The competent authority should determine the size of the team and the specialisations to be covered, taking into account the scope of work and the characteristics of the applicant. Team members should be selected by considering the following criteria:

(1)training for Part 21;

(2)education and experience, to cover the appropriate aviation knowledge, investigation practices; and

(3)the ability to verify that an applicant’s organisation conforms to its own procedures, and that its key personnel are competent.

ISSUE OF THE CERTIFICATE

(a)The competent authority should base its decision to issue a DOA on the recommendation in the DOA investigation report submitted by the DOA team leader. The report includes a proposal by the DOA team for the certificate and terms of approval that define the products, technical scope and privileges for which the approval is to be granted, with appropriate limitations.

(b)When the competent authority issues the approval, a final controlled copy of an acceptable handbook for the organisation should be supplied to the competent authority. Alternatively, when no physical handbook exists, the organisation should provide access to equivalent data.

(c)In some cases, it may be acceptable for some actions to not be fully closed because work is still in progress. The competent authority may decide according to the following principles:

(1)Actions may not represent a non-compliance with the rule. Such non-compliances should be findings and need to be resolved before the approval can be issued.

(2)Actions still to be taken by the organisation which do not prevent the design organisation from working properly in the period when the action is open, can remain open at the time of the approval when an action plan, including timescales, is found to be acceptable.

(3)Recommendations only need acknowledgement of receipt by the organisation at the time of the approval.