1、AECMA STANDARD NORME AECMA AECMA NORM prEN 9107 Edition P 1 August 2005 PUBLISHED BY THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES - STANDARDIZATION Gulledelle 94 - B-1200 Brussels - Tel. + 32 2 775 8110 - Fax. + 32 2 775 8111 - www.aecma-stan.orgICS: 49.060 Descriptors: ENGLISH VERSION Aerospace
2、 series Quality systems Direct Delivery Authorization Guidance for Aerospace Companies Srie arospatiale Systmes qualit Autorisation de Livraison Directe Recommandations pour compagnies arospatiales Luft- und Raumfahrt Qualittsmanagement Autorisierung fr direkt Anlieferungen Richtlinie fr die Luft- u
3、nd Raumfahrtindustrie This “Aerospace Series“ Prestandard has been drawn up under the responsibility of AECMA-STAN (The European Association of Aerospace Industries - Standardization). It is published for the needs of the European Aerospace Industry. It has been technically approved by the experts o
4、f the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physically or functionally, without re-identification of the standard. After examination and review by use
5、rs and formal agreement of AECMA-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN national members have then to implement the EN at national level by giving the EN
6、 the status of a national standard and by withdrawing any national standards conflicting with the EN. Edition approved for publication 31 August 2005 Comments should be sent within six months after the date of publication to AECMA-STAN Quality Domain Copyright 2005 by AECMA-STAN prEN 9107:2005 (E) 2
7、 Foreword This standard was reviewed by the Domain Technical Coordinator of AECMA-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of AECMA-STAN defined in AECMA-STANs General Process Manual, this standard has received approval for Publication. Contents Page 1
8、 Scope . 3 1.1 General. 3 1.2 Purpose . 3 2 Related material. 4 3 Acronyms 4 4 Terms and definitions . 5 5 Direct Delivery Authorization requirements 6 5.1 General. 6 5.2 Design Organization (DO). 7 5.2.1 Procedures 7 5.2.2 Direct Delivery Authorization . 7 5.2.3 Records . 7 5.3 Production Organizat
9、ion (PO) . 7 5.3.1 Procedures 7 5.3.2 Direct Delivery Authorization (DDA). 8 5.3.3 Records . 8 Annex A (normative) Appropriate Arrangement (AA). 9 A.1 EASA regulatory requirements. 9 A.2 Appropriate Arrangement Template Option I. 11 A.3 Appropriate Arrangement Template Option II . 12 Annex B (normat
10、ive) Article Listing 13 B.1 Article Listing Template Option I DDA defined by Approved Application. 13 B.2 Article Listing Template Option II DDA defined by Article and approval extended to component parts/items 14 B.3 Article Listing Template Option III DDA defined by Article with approval limited t
11、o constituent parts/items 15 Annex C (normative) Direct Delivery Authorization Template 16 C.1 Direct Delivery Authorization Template Option I 17 C.2 Direct Delivery Authorization Template Option II 18 prEN 9107:2005 (E) 1 Scope 1.1 General Limited to the Commercial Aerospace industry where a reques
12、t is made for a Production Organization (PO) to have Direct Delivery Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design Organization (DO). In this process the DO is responsible for ensuring the continuous updating of design and airworthiness data to the
13、 PO, whilst the PO is responsible for assurance that the manufactured article conforms to Approved Design and Airworthiness Data. The PO is responsible to provide airworthiness release documentation. 1.2 Purpose This document provides guidance to a Production Organization and a Design Organization o
14、n how to comply with the Direct Delivery Authorization, including Appropriate Arrangement, requirements as per the related material referenced in section 2. (see Figure 1) 3 Figure 1 Direct Delivery Overview Direct Delivery The Production Organization Is Responsible for Article Conformance Customer
15、Purchase Request *A/W Design Organization (DO) Production Organization (PO) Authorizes Direct Delivery *A/W = Airworthiness Release DocumentationprEN 9107:2005 (E) 4 2 Related material These include but are not limited to: a) EASA Publications 1) Commission Regulation No. 1702/2003, Annex Part 21A.1
16、33 Eligibility, paragraph (c) 2) AMC 21A.4 Transferring of information on eligibility and approval status from the design holder to production organisations 3) AMC No. 1 to 21A.133(b) and (c) Eligibility Link between design and production organizations 4) AMC No. 2 to 21A.133(b) and (c) Eligibility
17、Link between design and production organizations b) Transport Canada Publication 1) Civil Aviation CAR 561 c) FAA Publications 1) 14 CFR Part 21 - Certification Procedures for Products and Parts 3 Acronyms AMC Acceptable Means of Compliance AA Appropriate Arrangement CAR Canadian Aviation Regulation
18、s CFR Code of Federal Regulations DO Design Organization DDA Direct Delivery Authorization EASA European Aviation Safety Agency ETSO European Technical Standard Order FAA Federal Aviation Administration GM Guidance Material JTSO Joint Technical Standard Order PMA Parts Manufacturer Approval PO Produ
19、ction Organization STC Supplemental Type Certificate TSO Technical Standard Order TC Type Certificate prEN 9107:2005 (E) 5 4 Terms and definitions For the purposes of this document, the following terms and definitions apply. 4.1 appropriate arrangement (AA) a documented link between Design and Produ
20、ction Organizations that describes the required co-ordination necessary to ensure airworthiness data and continuing airworthiness matters is satisfactory and meets regulatory authority requirements 4.2 approved design/airworthiness data after issue of the TC, STC, PMA, or TSO/JTSO/ETSO Authorization
21、, or equivalent, by the regulatory authority, design data is defined as approved. Items manufactured in conformity to this data are eligible to be released using authorized release certificates certifying airworthiness. (The Approved Design/Airworthiness Data typically consists of drawings, material
22、 specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.) 4.3 approved application designation of the product, part, appliance, etc having Approved Design Data approval by a regulatory authority and for which an Article is eligible for install
23、ation 4.4 article material, part, product, component, assembly, or appliance which is listed by the DO as eligible for installation in a type certificated product or included in the design data approved by the regulatory authority, not inclusive of standard parts 4.5 design organization (DO) an orga
24、nization responsible for the design of articles or for changes thereto that is the holder of a Design Approval granted by a regulatory authority i.e. TC, STC, PMA, or TSO/JTSO/ETSO Authorization, or equivalent. 4.6 direct delivery authorization (DDA) the written endorsement granted by a DO to a PO t
25、hat allows the PO to deliver articles to end users or installers, and for this purpose, to use the DOs approved design data to declare an article is in conformance to that regulatory approved design data in order to guarantee continued airworthiness control of the released articles 4.7 production or
26、ganization (PO) an organization, approved by an applicable regulatory authority, that is responsible for the manufacture of aeronautical articles 4.8 product an aircraft, aircraft engine, or propeller 4.9 standard part parts for which the design, manufacturing, inspection data, and marking requireme
27、nts necessary to demonstrate conformity of the part are in the public domain and published or established as part of officially recognized Standards prEN 9107:2005 (E) 5 Direct Delivery Authorization requirements 5.1 General The Direct Delivery Authorization (DDA) process involves a Design Organizat
28、ion (DO) and a Production Organization (PO). In a logical flow, a request for DDA is generated, an Appropriate Arrangement is verified to have been established between the DO The determination of whether an A ppropriate Arrangement exists with the PO, and if one does not exist, the DO process to est
29、ablish an AA that is agreed to by the PO; The process used to determine article for ultimate ai rworthiness certification by ensuring the article is a constituent of a regulatory approved design (TC, STC, PMA, TSO, JTSO, ETSO, etc.); The process used and the type of doc umentation to transmit DDA ap
30、proval or denial status to the PO; The process used to modify an existing DDA in whol e or in part and when required by the DOs regulatory authority, notify the DOs regulatory authority of such modification; Transmission of DDA approval or denial status to the PO. 5.2.2 Direct Delivery Authorization
31、 The DO shall provide DDA in accordance with Annex C, for article(s) described in accordance with Annex B, to a PO when: DO receives DDA application; The decision has been made by the DO to grant a ftermarket rights to the PO for the article(s); An appropriate arrangement in accordance with Annex A
32、has been agreed to by the DO and the PO; Determination has been made that the article(s) is (are) a constituent of a regulatory approved design and is (are) eligible for airworthiness certification. 5.2.3 Records The DO shall issue and maintain records of direct delivery authorizations and make them
33、 available to regulatory authorities upon request. 5.3 Production Organization (PO) 5.3.1 Procedures A PO that intends to apply for DDA to a DO shall develop internal procedures that, as a minimum, address: The process to establish an appropriate arrangement is in existence between the DO and the PO
34、; The process to apply to the DO for DDA; The process to receive the approved design data and plan appropriate manufacturing, assembly, and inspection processes sufficient to establish and declare that the produced article is complete, conforms to the approved design data, and is in condition for sa
35、fe operation; The process to implement granted DDAs; The process to act upon modified DDAs. prEN 9107:2005 (E) 8 5.3.2 Direct Delivery Authorization (DDA) The PO shall make application for DDA to a DO in accordance with Annex C. 5.3.3 Records The PO shall maintain records of and make them available
36、upon request: Appropriate Arrangements between the DO and PO (Annex A); Article listings reflecting granted DDA (Annex B); DDAs granted by the DO (Annex C). prEN 9107:2005 (E) 9 Annex A (normative) Appropriate Arrangement (AA) Annex A is comprised of: EASA regulatory requirements in order to comply
37、with Part 21A.133 and associated AMC/GM requirements, when achieved via a contractual agreement, and Two versions of an Appropriate Arrangement Temp late when the arrangement is not achieved via a contractual agreement. A.1 EASA regulatory requirements a) In compliance with EASA regulation Part 21A.
38、133 requirements and associated AMC/GM requirements, the Design Organization (DO) and the Production Organization (PO) must ensure, through an Appropriate Arrangement, an approval of the specific design, satisfactory coordination between production and design. b) When the DO and the PO are part of t
39、he same legal entity, the appropriate arrangement or interfaces may be demonstrated by company procedures accepted by the National Aviation Authority. c) The appropriate arrangement is achieved by contractual agreement or by a separate agreement, see attached template. d) The appropriate arrangement
40、 must satisfy the intent and the spirit of the referenced regulations as stated below. e) An arrangement is considered appropriate if it is documented and satisfies the National Aviation Authority that co-ordination is satisfactory. f) To achieve satisfactory coordination the documented arrangements
41、 must at least define the following aspects irrespective of whether the two organizations are separate legal entities or not: 1) The responsibilities of a DO, which assure correct and timely transfer of up-to-date airworthiness data (e.g., drawings, material specifications, dimensional data, process
42、es, surface treatments, shipping conditions, quality requirements, etc.); 2) The responsibilities and procedures of a PO for developing, where applicable, its own manufacturing data in compliance with the airworthiness data package; 3) The responsibilities of a PO to assist the DO in dealing with co
43、ntinuing 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.); 4) The s
44、cope of the arrangements must cover EASA Part 21 Subpart G requirements and associated AMC and GM, in particular: 21A.145(b), 21A.165(c), (f) and (g); 5) The procedures to deal adequately with production deviations and non conforming parts; prEN 9107:2005 (E) 10 6) The procedures and associated resp
45、onsibilities 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; 7) The identification of the responsible persons/offices who control the above; 8) The ack
46、nowledgment by the holder of the TC/STC or change approval/ETSO authorization that the approved design data provided, controlled and modified in accordance with the arrangement are recognized as approved. g) In many cases the PO may receive the approved design data through an intermediate PO. This i
47、s acceptable provided an effective link between the DO and the PO can be maintained to satisfy the intent of 21A.133. h) When the DO and PO are two separate legal entities a Direct Delivery Authorization must be available for direct delivery to end users in order to guarantee continued airworthiness
48、 control of the released parts and appliances, refer to Annex C of this writing. NOTE A Direct Delivery Authorization may be achieved by contractual agreement or necessitate a separate authorization for parts and appliances, including sub-components thereof, produced by the PO, in accordance with An
49、nex B of this writing. prEN 9107:2005 (E) 11 A.2 Appropriate Arrangement Template Option I Date: MM DD YYYY Ref: XXXYYYZZZ Appropriate Arrangement between insert Design Organization Name and insert Production Organization Name in accordance with Annex Part 21A.133 1 Scope 1.1 The European Aviation Safety Agency (EASA) requires a documented arrangement and satisfactory co-ordination between insert Design Organization Name (the Design Organization) and insert Production Organization Name (the Production Organization) for all
