ASD-STAN PREN 9107-2017 Aerospace series Quality systems - Direct Delivery Authorization - Guidance for Aerospace Companies (Edition P 2).pdf

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1、 ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM ASD-STAN prEN 9107:2017 Edition P2 2017-11 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer, 10/5 - B-1000 Brussels, Belgium - Tel +32 2 775 81 26 - Fax +32 2 775 81 31 - www.asd-stan.org ICS: Descr

2、iptors: ENGLISH VERSION Aerospace series - Quality systems Direct Delivery Authorization Guidance for Aerospace Companies Luft- und Raumfahrt Qualittsmanagement - Autorisierung fr Direktanlieferungen Richtlinie fr die Luft- und Raumfahrtindustrie Srie Arospatiale Systmes qualit Autorisation de livra

3、ison directe Recommandations pour les compagnies arospatiales This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aerospace Industry. I

4、t has been technically approved by the experts of 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 t

5、he standard. After examination and review by users and formal agreement of ASD-STAN, the ASD-STAN prEN 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 hav

6、e then to implement the EN at national level by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN for the needs of the European Aerospace Industry. The

7、 use of this standard is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is the sole responsibility of the user.” ASD-STAN reviews each standard and technical report at least every five years at which time it may

8、be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may arise. All rights reserved. No parts of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical

9、, photocopying, recording, or otherwise, without prior written permission of ASD-STAN. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication 1stNovember Comments should be sent within six months after the date of publication to ASD-STAN Qualit

10、y domain prEN 9107:2017 (E) 2 Contents Page Rationale . 3 Foreword 3 1 Scope 4 1.1 General 4 1.2 Purpose . 4 2 Applicable documents . 5 2.1 European Aviation Safety Agency publications 5 2.2 Federal Aviation Administration publications . 5 2.3 Transport Canada publications . 5 3 Terms and definition

11、s . 5 4 Direct Delivery Authorization requirements 7 4.1 General 7 4.2 Design Organisation . 7 4.2.1 Procedures. 7 4.2.2 Direct Delivery Authorization 8 4.2.3 Records . 8 4.3 Production Organisation 8 4.3.1 Procedures. 8 4.3.2 Direct Delivery Authorization 8 4.3.3 Records . 8 (informative) Acronym l

12、og . 10 Annex A(informative) Appropriate Arrangement 11 Annex BB.1 European Aviation Safety Agency regulatory requirements 11 B.2 Appropriate Arrangement template option I 13 B.3 Appropriate Arrangement template option II . 15 (informative) Direct Delivery Authorization template 16 Annex CC.1 Direct

13、 Delivery Authorization template option I 16 C.2 Direct Delivery Authorization template option II 17 (informative) Article listing . 18 Annex DD.1 Article listing template option I Direct Delivery Authorization defined by Approved Application . 18 D.2 Article listing template option II Direct Delive

14、ry Authorization defined by article and approval extended to constituent parts/items . 19 D.3 Article listing template option III Direct Delivery Authorization by article with approval limited to constituent parts/items . 20 Figures Figure 1 Direct delivery overview 4 Figure 2 Direct Delivery Author

15、ization process flow 7 prEN 9107:2017 (E) 3 Rationale This document was revised to coincide with European Union (EU) Commission Regulation No. 748/2012 of 3 August 2012 as amended by EU Commission Regulations No. 7/2013 of 8 January 2013 and No. 69/2014 of 27 January 2014, and the associated Accepta

16、ble Means of Compliance (AMC) and Guidance Material (GM) to Part 21 of EU Commission Regulation No. 748/2012. All other changes made to the document presented herein were editorial in nature. Foreword To assure customer satisfaction, the aviation, space, and defence industry organisations must produ

17、ce and continually improve safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization of the industry, and the resulting diversity of regional/national requirements and expectations, has complicated this objective. End-product organisations face the

18、 challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Industry suppliers and processors face the challenge of delivering product to multiple customers having varying quality expectations and requiremen

19、ts. The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG) for the purpose of achieving significant improvements in quality and safety, and reductions in cost, throughout the value stream. This organisation includes representation from companies in the

20、 Americas, Asia/Pacific, and Europe. This document standardizes requirements for the “direct delivery” of articles from a Production Organisation (PO); it was originally produced as a cooperative effort between the European Aviation Safety Agency (EASA) and the IAQG. The establishment of common expe

21、ctations, for use at all levels of the supply-chain by organisations, should result in improved quality and safety, and decreased costs, due to the elimination or reduction of organisation-unique requirements and the resultant variation inherent in these multiple expectations. prEN 9107:2017 (E) 4 1

22、 Scope 1.1 General Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design Organisation (DO). In this process the DO is responsible for ensuring the continu

23、ous updating of design and airworthiness data to the 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

24、 PO and DO on how to comply with the DDA, including AA requirements per the applicable documents referenced in clause 2 (see Figure 1). Key A/W Airworthiness Release Documentation Figure 1 Direct delivery overview prEN 9107:2017 (E) 5 2 Applicable documents These include, but are not limited to: 2.1

25、 European Aviation Safety Agency publications a) EU Commission Regulation No. 748/2012, Annex I, Subpart G Production Organisation Approval, Part 21.A.133, Eligibility, paragraph (c) b) EU Commission Regulation No. 748/2012, Annex I, Subpart G Production Organisation Approval, Part 21.A.165, Obligat

26、ions of the holder c) Acceptable Means of Compliance (AMC) 21.A.4, Transferring of information on eligibility and approval status from the design holder to production organisations d) AMC No. 1 to 21.A.133(b) and (c), Eligibility Link between design and production organisations e) AMC No. 2 to 21.A.

27、133(b) and (c), Eligibility Link between design and production organisations 2.2 Federal Aviation Administration publications a) 14 Code of Federal Regulations (CFR) Part 21, Certification Procedures for Products, Articles, Parts 2.3 Transport Canada publications a) Canadian Aviation Regulations (CA

28、Rs) Part V Airworthiness 3 Terms and definitions For the purposes of this document, the following terms and definitions given in Annex A and the following apply. 3.1 Appropriate Arrangement AA documented link between a DO and PO that describes the required coordination necessary to ensure airworthin

29、ess data and continuing airworthiness matters is satisfactory, and meets regulatory authority requirements 3.2 approved application designation of the product, part, appliance, etc. having design and airworthiness data approval by a regulatory authority for which an article is eligible for installat

30、ion 3.3 approved design and airworthiness data after issuance of the Type Certificate (TC), Supplemental Type Certificate (STC), Parts Manufacturer Approval (PMA), Technical Standard Order (TSO)/Joint Technical Standard Order (JTSO)/European Technical Standard Order (ETSO) Authorization or equivalen

31、t by the regulatory authority, design and airworthiness data is defined as “approved”. Items manufactured in conformity to this data are eligible to be released using Authorised/Authorized Release Certificates (ARCs) certifying airworthiness Note 1 to entry: The approved design and airworthiness dat

32、a typically consists of drawings, material specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc. prEN 9107:2017 (E) 6 3.4 article material, part, product, component, assembly, or appliance which is listed by the DO as eligible for installati

33、on in a type-certificated product or included in the design and airworthiness data approved by the regulatory authority; not inclusive of standard parts 3.5 Authorised/Authorized Release Certificate ARC document whose purpose is to detail an aeronautical product which has been manufactured or mainta

34、ined, the data to which it conforms or was maintained to, and who manufactured or performed the maintenance on it. In Canada, this document is known as the Transport Canada Authorized Release Certificate Form One; in the EASA system, it is known as the EASA Form 1; and the Federal Aviation Administr

35、ation (FAA) equivalent is the FAA Form 8130-3 3.6 constituent a part, component, or element of a larger unit/installation/assembly 3.7 Design Organisation DO organisation responsible for the design of articles or for changes thereto that is the holder of a design approval granted by a regulatory aut

36、hority (i.e., TC, STC, PMA, TSO/JTSO/ETSO Authorization, or equivalent) 3.8 Direct Delivery Authorization DDA written endorsement granted by a DO to a PO that allows the PO to deliver articles to end-users, installers, or customers; and for this purpose to use the DOs approved design and airworthine

37、ss data to declare an article in conformance to the regulatory approved data in order to guarantee continued airworthiness control of the released articles 3.9 product aircraft, aircraft engine, or propeller 3.10 Production Organisation PO organisation, approved by an applicable regulatory authority

38、, which is responsible for the manufacture of aeronautical articles 3.11 standard part parts for which the design, manufacturing, inspection data, and marking requirements necessary to demonstrate conformity of the part are in the public domain, and published or established as part of officially rec

39、ognized standards prEN 9107:2017 (E) 7 4 Direct Delivery Authorization requirements 4.1 General The DDA process involves a DO and a PO. In a logical flow, a request for DDA is generated, an AA is verified to have been established between the DO and PO, the DO validates airworthiness eligibility (app

40、roved design), and the DO informs the PO of DDA approval or denial status (see Figure 2). Figure 2 Direct Delivery Authorization process flow 4.2 Design Organisation 4.2.1 Procedures A DO that intends to issue DDA to a PO shall develop internal procedures that, as a minimum, address: a) The decision

41、 whether to grant or deny the PO DDA. b) The determination of whether an AA (see Annex B) already exists with the PO, and if one does not exist, the DO initiates the process to establish an AA that is agreed to by the PO. c) The process used to determine an article is suitable for ultimate airworthi

42、ness certification by ensuring the article is a constituent of a regulatory approved design (e.g., TC, STC, PMA, TSO, JTSO, ETSO). prEN 9107:2017 (E) 8 d) The process used and the type of documentation to transmit DDA approval or denial status to the PO. e) The process used to modify an existing DDA

43、 in whole or in part, and when required by the DOs regulatory authority to notify the DOs regulatory authority of such modification. f) Transmission of DDA approval or denial status to the PO. 4.2.2 Direct Delivery Authorization The DO shall provide DDA (see Annex C), for article(s) described in acc

44、ordance with Annex D, to a PO when: a) A DO receives a DDA application. b) The decision has been made by the DO to grant aftermarket rights to the PO for the article(s). c) An AA in accordance with Annex B has been agreed to by the DO and the PO. d) Determination has been made that the article(s) is

45、 a constituent of a regulatory approved design and is eligible for airworthiness certification. 4.2.3 Records The DO shall issue and maintain records of DDAs, and make them available to regulatory authorities, upon request. 4.3 Production Organisation 4.3.1 Procedures A PO that intends to apply for

46、DDA to a DO shall develop internal procedures that, as a minimum, address: a) The process to establish an AA is in existence between the DO and the PO. b) The process to apply to the DO for DDA. c) The process to receive the approved design and airworthiness data and plan appropriate manufacturing,

47、assembly, and inspection processes sufficient to establish and declare that the produced article is complete, conforms to the approved design and airworthiness data, and is in condition for safe operation. d) The process to implement granted DDAs. e) The process to act upon modified DDAs. 4.3.2 Dire

48、ct Delivery Authorization The PO shall make application for DDA to a DO in accordance with Annex C. 4.3.3 Records The PO shall maintain records and make the following available, upon request: prEN 9107:2017 (E) 9 a) AAs between the DO and PO (see Annex B). b) DDAs granted by the DO (see Annex C). c)

49、 Article listings reflecting granted DDA (see Annex D). prEN 9107:2017 (E) 10 Annex A(informative) Acronym log AA Appropriate Arrangement AMC Acceptable Means of Compliance ARC Authorised/Authorized Release Certificate CARs Canadian Aviation Regulations CFR Code of Federal Regulations DDA Direct Delivery Authorization DO Design Organisation EASA European Aviation Safety Agency ETSO European Technical Standard Order FAA Federal Aviation Administration GM Guidance Material IAQG International Aerospace Quality Group JTSO Joint Technical Standar