EN 9117-2017 en Aerospace series - Delegated Product Release Verification.pdf

1、Aerospace series - Delegated Product Release VerificationBS EN 9117:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9117 October 2017 ICS 49.020 English Version Aerospace series - Delegated Product Release Veri

2、ficationSrie arospatiale - Dlgation de linspection du produit avant livraison Luft- und Raumfahrt - bertragene Produktfreigabeprfung This European Standard was approved by CEN on 16 July 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions fo

3、r giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in thre

4、e official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bod

5、ies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slo

6、venia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserve

7、d worldwide for CEN national Members. Ref. No. EN 9117:2017 ENational forewordThis British Standard is the UK implementation of EN 9117:2017.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of organiz

8、ations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017I

9、SBN 978 0 580 86716 3ICS 49.020Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2017.Amendments/corrigenda issued since publicationDate Text affectedBR

10、ITISH STANDARDBS EN 9117:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9117 October 2017 ICS 49.020 English Version Aerospace series - Delegated Product Release VerificationSrie arospatiale - Dlgation de linspection du produit avant livraison Luft- und Raumfahrt - bertragene Produktfreiga

11、beprfung This European Standard was approved by CEN on 16 July 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographic

12、al references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility

13、of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of M

14、acedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMAL

15、ISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9117:2017 EBS EN 9117:2017EN 9117:2017 (E) 2 Contents Page European forewo

16、rd . 3 1 Scope 5 1.1 General 5 1.2 Application 5 2 Normative references 5 3 Terms and definitions . 6 4 Requirements . 6 4.1 System requirements for delegating organization . 6 4.2 Supplier responsibilities 7 4.3 Qualification / Requalification of delegated product release verification personnel . 8

17、 4.4 Review of product by delegated product release verification personnel 8 4.5 Records retention . 9 (informative) Delegated Product Release Verification Checklist (Example) . 11 BS EN 9117:2017EN 9117:2017 (E) 3 European foreword This document (EN 9117:2017) has been prepared by the Aerospace and

18、 Defence Industries Association of Europe - Standardization (ASD-STAN). After enquiries and votes carried out in accordance with the rules of this Association, this Standard has received the approval of the National Associations and the Official Services of the member countries of ASD, prior to its

19、presentation to CEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2018, and conflicting national standards shall be withdrawn at the latest by April 2018. Attention is drawn to the possib

20、ility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to imple

21、ment this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

22、 Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9117:2017EN 9117:2017 (E) 4 Rationale The process for Delegated Product Release Verification (DPRV) varies from one organization to another. Implementation of a standard process reduces the risk of escapes

23、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 satisfaction, the aviation, space, and defence industry organizations must produce and continually improve safe, reliable produ

24、cts 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 organizations face the challenge of assuring the quality of, and in

25、tegrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Furthermore, suppliers and processors, within the industry, face the challenge of delivering product to multiple customers having varying quality expectations and requirements. The aviation, s

26、pace, 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 organization includes representation from companies in the Americas, Asia / P

27、acific, and Europe. This document defines the minimum requirements for delegation of product release to a supplier within the aviation, space, and defence industry. The establishment of common requirements should result in improved quality, safety, and reduced costs by minimizing customer specific r

28、equirements and the resultant variation inherent in these multiple expectations. While primarily developed for the aviation, space, and defence industry, this standard can also be used in other industry sectors where a DPRV process may be of benefit. BS EN 9117:2017EN 9117:2017 (E) 5 1 Scope 1.1 Gen

29、eral 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 their supplier (reference EN 910

30、0 and EN 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 Application This standard is inte

31、nded 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 alternative, to contractual a

32、nd 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 whole or in part, are norm

33、atively 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. EN 9100, Quality Management Systems Requirement for Aviation,

34、 Space and Defence Organization EN 9102, Quality Management Systems Aerospace First Article Inspection Requirement EN 9107, Quality Systems Direct Delivery Authorization Guidance for Aerospace Companies1)EN 9110, Quality Management Systems Requirements for Aviation Maintenance Organizations EN 9114,

35、 Quality Systems Direct Ship Guidance for Aerospace Companies1)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 Vocabulary2)1) Published as ASD-STAN Pre

36、standard at the date of publication of this standard. http:/www.asd-stan.org/ 2) Published by: ISO International Organization for Standardization. http:/www.iso.ch/ BS EN 9117:2017EN 9117:2017 (E) 6 3 Terms and definitions For the purposes of this standard, the following terms and definitions apply.

37、 3.1 Delegate Product Release Verification (DPRV) process whereby a supplier is delegated the authority to act on behalf of the delegating organization to verify and release products / services 3.2 final inspection verification of product features and documentation to validate that the completed pro

38、duct conforms to all customer requirements 3.3 organization group of people and facilities with an arrangement of responsibilities, authorities, and relationships SOURCE: ISO 9000:2000, 3.1.1 3.4 supplier organization or person that provides a product or service SOURCE: ISO 9000:2015, 3.2.5, modifie

39、d 4 Requirements 4.1 System requirements for delegating organization 4.1.1 The delegating organization shall have a documented process defining their delegation requirements, including the organizations responsibilities and authority for selection, qualification, maintenance, removal, suspension, an

40、d limitation of the delegation. 4.1.2 DPRV supplier selection criteria shall include 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

41、program. c) During selection of suppliers for DPRV, the delegating organization shall 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

42、 responsiveness to corrective action requests. d) The delegating organization shall verify that the supplier is knowledgeable of its requirements and expectations associated to product quality. BS EN 9117:2017EN 9117:2017 (E) 7 4.1.3 The delegating organization shall define and document the scope an

43、d limitations of the delegation. Documentation stating the scope and limitations of delegation shall be provided to and 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

44、requiring notification and process for communicating these changes. 4.1.5 The delegating 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 perio

45、dic review of the suppliers DPRV process. d) Actions to address poor supplier performance. 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

46、 have a documented process detailing the requirements for the DPRV, including the 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 responsib

47、le for assuring that the authorized DPRV personnel have prerequisites, including 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)

48、 Sufficient time allotted to adequately perform the associated product verification 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 appr

49、opriate product knowledge. BS EN 9117:2017EN 9117:2017 (E) 8 4.2.5 The supplier shall provide the delegating organization notification of changes affecting the DPRV process (see 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 requirements. 4.2.7 The supplier shall monitor DPRV personnel performance and have defined criteria to disqualify / suspend the