SAE ARP 9137-2010 Guidance for the Application of AQAP 2110 within a 9100 Quality Management System《9100质量管理体系内的AQAP 2110应用指南》.pdf

1、AEROSPACERECOMMENDEDPRACTICEARP9137 Issued 2010-05Guidance for the Application of AQAP 2110 within a9100 Quality Management System RATIONALEThis is the initial release of this standard. This standard is intended to provide guidance and assist an organization in the use and understanding of the relat

2、ionship between AQAP 2110 and 9100. FOREWORDIndustry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significant improvements in quality and reductions in cost througho

3、ut the value stream.This standard has been developed under the auspices of the IAQG Defense Relationship Growth Strategy Stream and in collaboration with the North Atlantic Treaty Organization (NATO) AC/327, Working Group 2 (WG2) to provide guidance on how the requirements of AQAP 2110 and 9100 can

4、be fulfilled by one common Quality Management System. This guidance document has been prepared jointly by the IAQG and NATO, and the content of this standard is identical to AQAP 2009 Annex F from this point onwards. TABLE OF CONTENTS 1. INTRODUCTION . 2 2. REFERENCES 23. GENERAL GUIDANCE . 24. DETA

5、ILED GUIDANCE 35. NOTES.11 TABLE 1 9100 AND AQAP 2110 TERMS EQUIVALENCE . 3TABLE 2 9100 AND AQAP 2110 DETAILED HARMONIZATION GUIDANCE . 4SAE Technical Standards Board Rules provide that: “This report is published by SAE to advance the state of technical and engineering sciences. The use of this repo

6、rt 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.” SAE reviews each technical report at least every five years at which time it may be reaffirmed, revised, or cancelled.

7、 SAE invites your written comments and suggestions. Copyright 2010 SAE International All rights reserved. No part 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 th

8、e prior written permission of SAE. TO PLACE A DOCUMENT ORDER: Tel: 877-606-7323 (inside USA and Canada) Tel: +1 724-776-4970 (outside USA) Fax: 724-776-0790 Email: CustomerServicesae.org SAE WEB ADDRESS: http:/www.sae.orgSAE values your input. To provide feedback on this Technical Report, please vis

9、it http:/www.sae.org/technical/standards/ARP9137ARP9137 - 2 -INTRODUCTION1.1 This document has been prepared and issued to provide information and guidance on the application of AQAP 2110 when the Supplier adheres to the provisions of 9100. This document is published as AQAP 2009 Annex F and 9137. I

10、t was jointly developed by NATO and industry representatives for use by NATO and industry to facilitate the use and understanding of the relationship between the AQAP 2110 and 9100. 1.2 It aims to contribute to commonality of interpretation of the AQAP 2110 requirements by the Acquirer and their 910

11、0 Supplier.1.3 Its content has no legal or contractual status nor does it supersede, add to, or cancel any of the AQAP 2110 or 9100 requirements.1.4 Because of the multiplicity of conditions that can exist (dependent on such factors as the type of work or process, the devices used, and the skill of

12、personnel involved), this guidance should not be considered as all-encompassing nor should it be considered as imposing specific means or methods for meeting contract requirements. Stakeholders should be aware that other means or methods could be used to meet these requirements. 1.5 Users of this gu

13、idance should keep in mind that the requirements of AQAP 2110 are mandatory, as cited in the contract, on Suppliers and Sub-suppliers. 2. REFERENCES The following documents are important references for the application guidance provided in this document. Only the edition cited applies for dated refer

14、ences. The latest edition of the referenced document (including any amendments) applies for undated references.AS/EN/JISQ 9100:2009 Quality Management Systems Requirements for Aviation, Space and Defense AQAP 2009 Edition 3 NATO Guidance on the Use of the AQAP 2000 Series AQAP 2070 Edition 2 NATO Mu

15、tual Government Quality Assurance (GQA) Process AQAP 2110 Edition 3 NATO Quality Assurance Requirements for Design, Development and Production AQAP 2120 Edition 3 NATO Quality Assurance Requirements for Production AQAP 2130 Edition 3 NATO Quality Assurance Requirements for Inspection and Test ISO 90

16、01:2008 Quality management systems Requirements ISO 10012:2003 Measurement management systems Requirements for measurement processes and measuring equipment 3. GENERAL GUIDANCE 3.1 In a 9100 certificated organization, the entire content of both standards is within the purview of Government Quality A

17、ssurance (GQA). 3.2 When reviewing the two documents (i.e. AQAP 2110, 9100) it is helpful to note the differences in wording used to describe the stakeholders. The following equivalence (see Table 1) is offered as a workable translation. The contract will normally define the points of contact, outli

18、ning their role and authority. ARP9137 - 3 -TABLE 1 AQAP 2110 AND 9100 STAKEHOLDER TERMS AQAP 2110 9100Acquirer Customer, only if it is the Acquiring government.Government Quality Assurance Representative (GQAR)A Customers Quality Representative.Supplier Organization with a direct contract with the

19、government.Sub-supplier Supplier or Organization without a direct contract with the government.3.3 9100 is complementary (not alternative) to contractual and applicable law and regulatory requirements. It includes ISO 9001:2008 Quality Management System (QMS) requirements and specifies additional re

20、quirements for a quality management system for the aviation, space and defense industries. 3.4 The common ISO 9001:2008 baseline inherently makes 9100 and AQAP 2110 appear almost identical. However, four features differentiate the two documents: a) AQAP 2110 defines contractual requirements; while 9

21、100 defines organizational provisions to be addressed within the scope of certification;b) AQAP 2110 reflects the agreement between NATO members to contract using the mandatory QMS clauses that enables reciprocal GQA; while industry conformance to 9100 is voluntary; c) The additions to ISO 9001:2008

22、 of both documents add higher level quality management functions. AQAP 2110 also includes additional requirements related to communication and GQAR access to contract pertinent facilities, information and processes; d) 9100 can be tailored by exclusions, according to the scope of the QMS; whereas AQ

23、AP 2110 is pre-tailored into AQAP 2120 and AQAP 2130. 3.5 It is acceptable for a Supplier to offer a QMS that complies with the provisions of 9100 as a satisfactory response to the QMS requirements of AQAP 2110, under two conditions: a) The Supplier formally states that, “All 9100 requirements appli

24、cable to the organization are applicable to this contract”;b) The Supplier formally states that, “No exclusions to 9100 taken by the organization shall in any way diminish, alter, or relieve the AQAP 2110 requirements of this contract”. These formal statements could be made in tender documentation,

25、the contract, or the Quality Plan (QP) and should always be brought to the attention of the GQAR. 4. DETAILED GUIDANCE Detailed guidance is provided only where there is either the need for clarification or the potential for conflict or misunderstanding exists. Each paragraph and sub-paragraph of the

26、 standards (i.e., 9100, AQAP 2110) are listed below in Table 2 9100 AND AQAP 2110 DETAILED HARMONIZATION GUIDANCE. Where either standard contains additional requirements or notes to the base standard (i.e. ISO 9001:2008), the clause heading text is bolded. ARP9137 - 4 -TABLE 2 9100 AND AQAP 2110 DET

27、AILED HARMONIZATION GUIDANCE 9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 4. QUALITY MANAGEMENT SYSTEM 4.0 Quality management system 4.1 General Requirements4.1 General requirementsThe Acquirer has chosen the Supplier based in part, on their 9100 QMS.With respect to the NATO specific

28、 requirements:9100 highlights the need to include customer and applicable statutory and regulatory requirements in the scope of the QMS in addition to the 9001 provisions relating to the product (see clause7.2.1).The Acquirer and/or GQAR have the right to review and verify that the QMS meets the cer

29、tification and contractual requirements. Where objective evidence of non-compliance is presented, the Supplier is obliged to take corrective action. If corrective action is not taken or is shown to be persistently ineffective then ultimately the QMS might be rejected, but this is neither a desired o

30、r common outcome.Sharing details of 9100 certification results from the Online Aerospace Supplier Information System (OASIS) and audit reports provides ongoing evidence of how the system is meeting the certification requirements and may reduce the need for the Acquirer/GQAR to conduct additional aud

31、its. 4.2 Documentation Requirements4.2 Documentation requirements4.2.1 General 4.2.1 General4.2.2 Quality Manual 4.2.2 Quality manual In 9100 exclusions can be made based on the processes within the organization. Such exclusions are permissible as long as they match the tailoring criteria of the AQA

32、P series as shown in AQAP 2009 Figure 2.With reference to AQAP 2110 clause 5.4 it is permissible to detail any interpretational clarifications or specific application of AQAP requirements in the QP.4.2.3 Control of Documents 4.2.3 Control of documentsARP9137 - 5 -9100 CLAUSE AQAP 2110 CLAUSE DETAILE

33、D HARMONIZATION GUIDANCE 4.2.4 Control of Records 4.2.4 Control of records 5. MANAGEMENT RESPONSIBILITY5.0 Management responsibility5.1 Management Commitment5.1 Management commitment5.2 Customer Focus 5.2 Customer focus 5.3 Quality Policy 5.3 Quality policy 5.4 Planning 5.4 Planning Both 9100 and AQ

34、AP 2110 require planning for quality to be undertaken and recorded, describing how the product will be realized (reference clause 7.1). AQAP 2110 requires a contract specific QP be documented and provided to the Acquirer so that it may be reviewed against the contractual requirements.The QP describe

35、s the application of the QMS to fulfill the contract requirements; describing what the Supplier will actually do (e.g. what requirements apply or how they are interpreted). To be compliant, QPs should address clause 5.4 of AQAP 2110 and clause 7.1 of both standards. QPs should be developed in conjun

36、ction with other project related planning (reference to 9100 clause 7.1.1).5.4.1 Quality Objectives 5.4.1 Quality objectives 5.4.2 Quality Management System Planning 5.4.2 Quality Management system planning 5.5 Responsibility, Authority and Communication5.5 Responsibility, authority and communicatio

37、n5.5.1 Responsibility and Authority5.5.1 Responsibility and authorityARP9137 - 6 -9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 5.5.2 Management Representative 5.5.2 Management representative AQAP 2110 requires that the management representative reports directly to top management.9100

38、 requires that the management representative has unrestricted access to top management.The key aspect is that AQAP 2110 requires the management representative to have the necessary organizational authority and freedom to resolve matters pertaining to the QMS and product quality.In that respect, the

39、standards are considered to be in harmony. 5.5.3 Internal Communication5.5.3 Internal communicationThe NATO Specific requirement for communication with the GQAR should be considered as part of 9100 clause 7.2.3 customer communication.5.6 Management Review 5.6 Management review 5.6.1 General 5.6.1 Ge

40、neral 5.6.2 Review Input 5.6.2 Review input 5.6.3 Review Output5.6.3 Review output 6. RESOURCE MANAGEMENT6.0 Resource management6.1 Provision of Resources6.1 Provision of resources 6.2 Human Resources 6.2 Human resources 6.2.1 General6.2.1 General 6.2.2 Competence, Awareness and Training6.2.2 Compet

41、ence, awareness and training 6.3 Infrastructure 6.3 Infrastructure 6.4 Work Environment 6.4 Work environment ARP9137 - 7 -9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 7. PRODUCT REALIZATION7.0 Product realisation 7.1 Planning of Product Realization7.1 Planning of product realisation7

42、.1.1 Project Management7.1.2 Risk Management7.1.3 Configuration ManagementThe 9100 additional requirement should be viewed in conjunction with AQAP 2110 clause 7.7.7.1.4 Control of Work TransfersWith respect to the 9100 additional requirement, work transfers include transfers within and outside of t

43、he organization.7.2 Customer-Related Processes 7.2 Customer-related processes7.2.1 Determination of Requirements Related to the Product 7.2.1 Determination of requirements related to the product 7.2.2 Review of Requirements Related to the Product 7.2.2 Review of requirements related to the product 7

44、.2.3 Customer Communication7.2.3 Customer communicationThe NATO Specific requirement for communication with the GQAR includes the NATO specific requirement in AQAP 2110 clause 5.5.3 Internal communication.7.3 Design and Development7.3 Design and development7.3.1 Design and Development Planning 7.3.1

45、 Design and development planning 7.3.2 Design and Development Inputs 7.3.2 Design and development inputs 7.3.3 Design and Development Outputs 7.3.3 Design and development outputs 7.3.4 Design and Development Review 7.3.4 Design and development review The authorization referred to in 9100 for progres

46、sing to the next stage in design and ARP9137 - 8 -9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE development is the Suppliers process and should not be confused with Acquirer intermediate or final acceptance of product.7.3.5 Design and Development Verification7.3.5 Design and developme

47、nt verification 7.3.6 Design and Development Validation7.3.6 Design and development validation 7.3.6.1 Design and/or development verification and validation testing Within 9100 prove means to demonstrate or to provide evidence. The intent is that the act of planning, controlling, reviewing and docum

48、enting verification and validation testing will collectively ensure that the requirements contained in a) and b) are fulfilled and that c), d) and e) are proved. 7.3.6.2 Design and/or development verification and validation documentation7.3.7 Control of Design and Development Changes7.3.7 Control of

49、 design and development changes7.4 Purchasing 7.4 Purchasing 7.4.1 Purchasing Process7.4.1 Purchasing processWith respect to the NATO specific requirement to provide copies of subcontracts or orders for products, those documents may obscure or exclude pricing information.With respect to the NATO Specific requirement f