21.A.122 Eligibility

LINK BETWEEN DESIGN AND PRODUCTION An ‘arrangement’ is considered suitable if it is documented and satisfies the competent authority that coordination is satisfactory. To achieve satisfactory coordination, the documented arrangements must at least define the following aspects, irrespective of whether the design organisation (DO) and the organisation producing or intending to produce under Part 21, Subpart F are separate legal entities or not:

(a)the responsibilities of a DO, which assure correct and timely transfer of up-to-date applicable design data (e.g. drawings, material specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.);

(b)the responsibilities and procedures of the production organisation (PO) for receiving, managing, and using the applicable design data provided by the DO;

(c)the responsibilities and procedures of the PO for developing, where applicable, its own manufacturing data in compliance with the applicable design data package;

(d)the responsibilities of the PO to assist the DO in dealing with continuing airworthiness matters and for required actions (e.g. traceability of parts in case of direct delivery to users, retrofitting of modifications, traceability of processes’ outputs and approved deviations for individual parts as applicable, technical information and assistance, etc.);

(e)the scope of the arrangements covering Subpart F requirements, in particular, points 21.A.126(a)(4) and 21.A.129(d) and 21.A.3A and any associated GM or AMC;

(f)the responsibilities of the PO, in the case of products prior to type certification to assist a DO in demonstrating compliance with the CS (access and suitability of production and test facilities for manufacturing and testing of prototype models and test specimen);

(g)the procedures to deal adequately with production deviations and non-conforming parts;

(h)the means to achieve adequate configuration control of manufactured parts, to enable the PO to make the final determination and identification for conformity or airworthiness release and eligibility status;

(i)the identification of responsible persons that control the above; and

(j)the acknowledgment by the holder of the TC/STC/repair or change approval/ETSO authorisation that the approved design data that is provided, controlled and modified in accordance with the arrangement is recognised as approved. In many cases, the person producing or intending to produce under Part 21, Subpart F may receive the approved design data through an intermediate PO. This is acceptable, provided that an effective link between the design approval holder (DAH) and the PO can be maintained to satisfy the intent of point 21.A.122. When the DO and the PO are two separate legal entities, a direct delivery authorisation should be available for direct delivery to end users in order to guarantee continued airworthiness control of the released parts and appliances. Where there is no general agreement for direct delivery authorisation, specific permissions may be granted (see AMC 21.A.4).

LINK BETWEEN DESIGN AND PRODUCTION In accordance with AMC1 21.A.122 the person producing or intending to produce under Part 21 Subpart F should demonstrate to the authority that it has entered into an arrangement with the design organisation. The arrangement must be documented irrespective of whether the two organisations are separate legal entities or not. The documented arrangement must facilitate the person producing or intending to produce under Part 21 Subpart F to demonstrate compliance with the requirement of 21.A.122 by means of written documents agreed. In the case where the design organisation and the person producing or intending to produce under Part 21 Subpart F are part of the same legal entity these interfaces may be demonstrated by company procedures accepted by the competent authority. In all other cases to define such a design/production interface the following sample format is offered:

Arrangement Sample Form

Instructions for completion: Title: The title of the relevant document must clearly indicate that it serves the purpose of a design/production interface arrangement in accordance with 21.A.122. Commitment: The document must include the basic commitments between the design organisation and the manufacturer producing under Part 21 Subpart F as addressed in AMC 21.A.4 and AMC1 21.A.122. Relevant Procedures: Identify an entry point into the documentary system of the organisations with respect to the implementation of the arrangement (for example a contract, quality plan, handbooks, common applicable procedures, working plans etc.). Scope of arrangement: The scope of arrangement must state by means of a list or reference to relevant documents those products, parts or appliances that are covered by the arrangement. Transfer of approved design data: Identify the relevant procedures for the transfer of the applicable design data required by 21.A.122 and AMC1 21.A.122 from the design organisation to the person producing under Part 21 Subpart F. The means by which the design organisation advises the person producing under Part 21 Subpart F whether such data is approved or not approved must also be identified (ref. 21.A.4 / AMC 21.A.4). Direct Delivery Authorisation: Where the design organisation and the person producing under Part 21 Subpart F are separate legal entities the arrangement must clearly identify whether authorisation for direct delivery to end users is permitted or not. Where any intermediate production/design organisation is involved in the chain between the original design organisation and the person producing under Part 21 Subpart F, evidence must be available that this intermediate organisation has received authority from the design organisation to grant Direct Delivery Authorisation. Signature: AMC1 21.A.122 requests the identification of the responsible persons/offices who control the commitments laid down in the arrangement. Therefore the basic document must be signed mutually by the authorised representatives of the design organisation and the manufacturer producing under Part 21 Subpart F in this regard.