21.B.435 Changes in the design management system

APPLICATION FOR SIGNIFICANT CHANGES OR CHANGE OF TERMS OF APPROVAL OF THE DOA

(a)The competent authority should review any changes in the personnel specified in points 21.A.245 (a) and (b).

(b)When an organisation submits the application for a significant change for any of the personnel positions specified in points 21.A.245 (a) and (b), the competent authority should require the organisation to produce a résumé of the proposed person. The competent authority may interview the nominee or request additional evidence of their suitability before deciding upon the nominee being acceptable.

(c)For changes requiring prior approval, in order to verify the organisation’s compliance with the applicable requirements, the competent authority should determine the necessary activities to verify continued compliance of the organisation, limited to the extent of the changes, and determine whether the organisation needs to provide a safety risk assessment.

(d)If required for verification, the activities may include interviews and inspections carried out at the organisation’s facilities.

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.