ASD-STAN PREN 9117-2016 Aerospace series Delegated Product Release Verification (Edition P 1).pdf

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1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9117 Edition P 1 April 2016 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer 10 - 1000 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 775 8131 - www.asd-stan.orgICS: Descriptors: Note Technically

2、 equivalent writings published in all IAQG sectors ENGLISH VERSION Aerospace series Delegated Product Release Verification Srie arospatiale Dlgation de linspection du produit avant livraison Luft- und Raumfahrt bertragung der Produktfreigabeprfung This “Aerospace Series“ Prestandard has been drawn u

3、p 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. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to th

4、e 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 users and formal agreement of ASD-STAN, it will be submitted as a dra

5、ft 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 the status of a national standard and by withdrawing any national s

6、tandards 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 use of this standard is entirely voluntary, and its applicability and suitability for any particular use, including any patent i

7、nfringement 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 be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may a

8、rise. 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, photocopying, recording, or otherwise, without prior written permission of ASD-STAN. Order details: E-mail: salesasd-stan.org W

9、eb address: http:/www.asd-stan.org/ Edition approved for publication 1stApril 2016 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2016 ASD-STAN prEN 9117:2016 (E) 2 prEN 9117:2016(E) RATIONALE The process for Delegated Product Release Ver

10、ification (DPRV) varies from one organization to another. Implementation of a standard process reduces the risk of escapes in the aviation, space, and defence industry supply chain, when the organizations product release verification has been delegated to a supplier. FOREWORD To assure customer sati

11、sfaction, the aviation, space, and defence industry organizations must produce 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 expe

12、ctations, has complicated this objective. End-product organizations face the challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Furthermore, suppliers and processors, within the industry, face the ch

13、allenge of delivering product to multiple customers having varying quality expectations and requirements. 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

14、 in cost, throughout the value stream. This organization includes representation from companies in the Americas, Asia/Pacific, and Europe. This document defines the minimum requirements for delegation of product release to a supplier within the aviation, space, and defence industry. The establishmen

15、t of common requirements should result in improved quality, safety, and reduced costs by minimizing customer specific requirements and the resultant variation inherent in these multiple expectations. While primarily developed for the aviation, space, and defence industry, this standard can also be u

16、sed in other industry sectors where a DPRV process may be of benefit. prEN 9117:2016 (E) 3 Contents Page 1 Scope . 4 1.1 General 4 1.2 Application 4 2 Normative references . 4 3 Terms and definitions 5 4 Requirements . 5 4.1 System requirements for delegating organization . 5 4.2 Supplier responsibi

17、lities 6 4.3 Qualification / Requalification of delegated product release verification personnel 6 4.4 Review of product by delegated product release verification personnel 7 4.5 Records retention . 7 5 Notes . 8 Appendix A (informative) Delegated Product Release Verification Checklist (Example). 9

18、Foreword This standard was reviewed by the Domain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. prEN 9117:2016 (E) 4 p

19、rEN 9117:2016(E) 1 Scope 1.1 General This standard specifies requirements for DPRV to establish common product/service requirements for use at all levels of the supply chain. This standard shall apply when an organization elects to delegate product release verification by contractual flow down to th

20、eir supplier (reference 9100 and 9110 standards); to perform product acceptance on their behalf. The delegating organization shall use this standard as the baseline for establishing a DPRV process, although they may include additional contract requirements to meet their specific needs. 1.2 Applicati

21、on This standard is intended for use by organizations that produce and/or provide aviation, space, and defence products, including organizations providing maintenance, spare parts, materials, and services. It is emphasized that the requirements specified in this standard are complementary, not alter

22、native, to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable contractual, statutory, or regulatory requirements, the latter shall take precedence. 2 Normative references The following documents, in wh

23、ole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. The following documents support the a

24、pplication/use of this standard. When a conflict in requirements between this standard and the referenced documents exist, the requirements of this document shall take precedence. EN 9100, Quality Management Systems Requirement for Aviation, Space and Defence Organization EN 9102, Quality Management

25、 Systems Aerospace First Article Inspection Requirement EN 9107, Quality Systems Direct Delivery Authorization Guidance for Aerospace Companies 1) EN 9110, Quality Management Systems Requirements for Aviation Maintenance Organizations EN 9114, Quality Systems Direct Ship Guidance for Aerospace Compa

26、nies 1) NOTE Equivalent versions (e.g., AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published internationally in each IAQG sector. ISO 9000, Quality Management Systems Fundamentals and Vocabulary 2) 1) Published as ASD-STAN Prestandard at the date of publication of this standard.

27、 http:/www.asd-stan.org/ 2) Published by: ISO International Organization for Standardization. http:/www.iso.ch/ prEN 9117:2016 (E) 5 3 Terms and definitions For the purposes of this standard, the following terms and definitions apply. 3.1 Delegate Product Release Verification (DPRV) a process whereb

28、y a supplier is delegated the authority to act on behalf of the delegating organization to verify and release products/services. 3.2 final inspection the verification of product features and documentation to validate that the completed product conforms to all customer requirements. 3.3 organization

29、group of people and facilities with an arrangement of responsibilities, authorities, and relationships (reference ISO 9000). 3.4 supplier organization or person that provides a product or service (reference ISO 9000). 4 Requirements 4.1 System requirements for delegating organization 4.1.1 The deleg

30、ating organization shall have a documented process defining their delegation requirements, including the organizations responsibilities and authority for selection, qualification, maintenance, removal, suspension, and limitation of the delegation. 4.1.2 DPRV supplier selection criteria shall include

31、 the following: a. The supplier shall be approved on the delegating organizations supplier register. b. The delegating organization shall provide documented authorization of the suppliers participation in their DPRV program. c. During selection of suppliers for DPRV, the delegating organization shal

32、l review the suppliers quality performance. Supplier performance criteria shall be defined and documented by the delegating organization. The data reviewed shall include a measure of product/process conformance and responsiveness to corrective action requests. d. The delegating organization shall ve

33、rify that the supplier is knowledgeable of its requirements and expectations associated to product quality. 4.1.3 The delegating organization shall define and document the scope and limitations of the delegation. Documentation stating the scope and limitations of delegation shall be provided to and

34、acknowledged by the supplier. 4.1.4 The delegating organization shall define change notification requirements to the supplier. These requirements shall include the type of changes requiring notification and process for communicating these changes. prEN 9117:2016 (E) 6 prEN 9117:2016(E) 4.1.5 The del

35、egating organizations maintenance process for DPRV shall, at a minimum, include the following: a. A periodic review of the suppliers quality performance. b. A periodic inspection and/or validation of product. c. A periodic review of the suppliers DPRV process. d. Actions to address poor supplier per

36、formance. e. Criteria to remove, suspend, and limit the delegation to the supplier and/or DPRV personnel. 4.2 Supplier responsibilities 4.2.1 The supplier shall maintain their QMS approval. 4.2.2 The suppliers QMS shall have a documented process detailing the requirements for the DPRV, including the

37、 establishment of process controls and monitoring for process effectiveness. 4.2.3 The supplier shall keep a list of authorized DPRV personnel, including the associated scope of approval. 4.2.4 The supplier is responsible for assuring that the authorized DPRV personnel have prerequisites, including

38、but not limited to those listed below, sufficient to be able to perform their duties. a. Access to product-related documentation. b. Access to necessary facilities and equipment to be able to perform DPRV activities. c. Sufficient time allotted to adequately perform the associated product verificati

39、on activities. d. The authority to suspend the release of products, until all open issues associated with the product being released are addressed. e. Documented and demonstrable proficiency and training, including appropriate product knowledge. 4.2.5 The supplier shall provide the delegating organi

40、zation notification of changes affecting the DPRV process (see section 4.1.4). 4.2.6 Suppliers shall obtain documented approval from the delegating organization, if they intend to use a sub-tier supplier to verify and release the final product, in accordance with the delegating organizations process

41、 requirements. 4.2.7 The supplier shall monitor DPRV personnel performance and have defined criteria to disqualify/suspend the DPRV personnel, including notification to the delegating organization. 4.3 Qualification / Requalification of delegated product release verification personnel 4.3.1 DPRV per

42、sonnel shall be qualified by the supplier. 4.3.2 The selection of DPRV personnel shall be based on their background, experience, and product knowledge. Specific training and/or testing shall be established by the supplier. The supplier shall ensure training and qualification is appropriate for the p

43、roduct being released. 4.3.3 The DPRV personnel shall have a periodic vision assessment to a recognized standard, unless waived by the delegating organization. prEN 9117:2016 (E) 7 4.3.4 DPRV personnel shall be subject to periodic requalification and training by the supplier. 4.3.5 The supplier shal

44、l meet additional requirements for DPRV personnel contractually imposed by the delegating organization (e.g., delegating organization approval of DPRV personnel). 4.4 Review of product by delegated product release verification personnel 4.4.1 The DPRV shall be performed on each release of product. D

45、PRV shall be performed after final inspection, as close to shipment as practical; conducted as an independent process by someone other than the person who performed the final inspection, unless waived by the delegating organization. 4.4.2 The DPRV shall consist of but, not limited to: a. Contract /

46、purchase order review. b. Supplier documentation review. Verification that all required product realization operations and inspections are complete. When applicable, verification that product nonconformance has been properly documented and processed, in accordance with the delegating organizations c

47、ontractual requirements. Verification that the delegating organizations requirements for first article inspection (reference 9102 standard) have been satisfied. c. Physical product verification, including verification of product marking/identification and visual examination. DPRV shall validate spec

48、ial requirements, critical items, and key characteristics when contractually required by the delegating organization. d. Shipping / release documentation. 4.4.3 DPRV personnel shall validate and record the completion of the verification activity. NOTE An example of a template for recording the DPRV

49、activity can be found in Appendix A (Delegated Product Release Verification Checklist). This template can be adapted to satisfy the delegating organizations and/or suppliers DPRV process criteria. 4.4.4 Specific stamps, signatures, identification numbers, etc. shall be used for product release when contractually required by the delegating organization. 4.4.5 Sampling plans for product verification may be used with approval from the delegating organization. 4.4.6 Product and/or documentation nonconformances detected, during the DPRV process, s