AMC2 21.A.122 Eligibility

CAA ORS9 Decision No. 40

Link between design and production

In accordance with AMC No 1 to 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 CAA.

In all other cases to define such a design/production interface the following sample format is offered:

Arrangement Sample Form

ARRANGEMENT in accordance with 21.A.122
The undersigned agree on the following commitments:	Relevant interface procedures
The design organisation [NAME] takes responsibility to: — 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.) to the person producing under Part 21 Subpart F [NAME] — provide visible statement(s) of approved design data.
The person producing under Part 21 Subpart F [NAME] takes responsibility to — assist the design organisation [Name] in dealing with continuing airworthiness matter and for required actions — assist the design organisation [NAME] in case of products prior to type certification in demonstrating compliance with certification specifications — develop, where applicable, its own manufacturing data in compliance with the airworthiness data package.
The design organisation [NAME] and the person producing under Part 21 Subpart F [NAME] take joint responsibility to: — deal adequately with production deviations and non-conforming parts in accordance with the applicable procedures of the design organisation and the manufacturer producing under Part 21 Subpart F. — achieve adequate configuration control of manufactured parts, to enable the manufacturer producing under Part 21 Subpart F to make the final determination and identification for conformity.
The scope of production covered by this arrangement is detailed in [DOCUMENT REFERENCE/ATTACHED LIST]
[When the design organisation is not the same legal entity as the manufacturer producing under Part 21 Subpart F] Transfer of approved design data: The TC/STC/UKTSO authorisation holder [NAME] acknowledges that the approved design data provided, controlled and modified in accordance with the arrangement are recognised as approved by the CAA and therefore the parts and appliances manufactured in accordance with these data and found in a condition for safe operation may be released certifying that the item was manufactured in conformity to approved design data and is in a condition for safe operation.
[When the design organisation is not the same legal entity as the manufacturer producing under Part 21 Subpart F] Direct Delivery Authorisation: This acknowledgment includes also [OR does not include] the general agreement for direct delivery to end users in order to guarantee continued airworthiness control of the released parts and appliances.
For the [NAME of the design organisation/DOA holder] [DOA/ADOA number] Signature: ([NAME in block letters]) Date: xx.xx.xxxx	For the [NAME of the person producing under Part 21 Subpart F] [POA holder] [POA number] Signature: ([NAME in block letters]) Date: xx.xx.xxxx

ARRANGEMENT

in accordance with 21.A.122

The undersigned agree on the following commitments:

Relevant interface procedures

The design organisation [NAME] takes responsibility to:

— 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.) to the person producing under Part 21 Subpart F [NAME]

— provide visible statement(s) of approved design data.

The person producing under Part 21 Subpart F [NAME] takes responsibility to

— assist the design organisation [Name] in dealing with continuing airworthiness matter and for required actions

— assist the design organisation [NAME] in case of products prior to type certification in demonstrating compliance with certification specifications

— develop, where applicable, its own manufacturing data in compliance with the airworthiness data package.

The design organisation [NAME] and the person producing under Part 21 Subpart F [NAME] take joint responsibility to:

— deal adequately with production deviations and non-conforming parts in accordance with the applicable procedures of the design organisation and the manufacturer producing under Part 21 Subpart F.

— achieve adequate configuration control of manufactured parts, to enable the manufacturer producing under Part 21 Subpart F to make the final determination and identification for conformity.

The scope of production covered by this arrangement is detailed in [DOCUMENT REFERENCE/ATTACHED LIST]

[When the design organisation is not the same legal entity as the manufacturer producing under Part 21 Subpart F]

Transfer of approved design data:

The TC/STC/UKTSO authorisation holder [NAME] acknowledges that the approved design data provided, controlled and modified in accordance with the arrangement are recognised as approved by the CAA and therefore the parts and appliances manufactured in accordance with these data and found in a condition for safe operation may be released certifying that the item was manufactured in conformity to approved design data and is in a condition for safe operation.

[When the design organisation is not the same legal entity as the manufacturer producing under Part 21 Subpart F]

Direct Delivery Authorisation:

This acknowledgment includes also [OR does not include] the general agreement for direct delivery to end users in order to guarantee continued airworthiness control of the released parts and appliances.

For the [NAME of the design organisation/DOA holder] [DOA/ADOA number]

Signature:

([NAME in block letters])

Date:

xx.xx.xxxx

For the [NAME of the person producing under Part 21 Subpart F] [POA holder] [POA number]

Signature:

([NAME in block letters])

Date:

xx.xx.xxxx

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 AMC No 1 to 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 AMC No 1 to 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: AMC No 1 to 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.