1、 ASD STANDARD NORME ASD ASD NORM ASD-STAN prEN 9145:2016 Edition 2016-11 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: Descriptors: Note Techn
2、ically equivalent writings published in all IAQG sectors ENGLISH VERSION Aerospace series Requirements for Advanced Product Quality Planning and Production Part Approval Process This “Aerospace Series” Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Indu
3、stries 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 the publication of this Prestandard, the technical content shall not be
4、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, the ASD-STAN prEN will be submitted as a draft European Standard (prEN) to CEN (European Committee
5、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 standards conflicting with the EN. ASD-STAN Technical Co
6、mmittee 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 infringement arising therefrom, is the sole responsibili
7、ty 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 arise. All rights reserved. No parts of this publication
8、 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. This document has been developed by IAQG to cover a wide domain of global applicability (Aerospac
9、e please be informed that some standards have been developed by CEN to cover specifically space systems (e.g. CEN/CENELEC TC5 EN 166XX series). For European space applications these standards may be taken into account. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edi
10、tion approved for publication Comments should be sent within six months after the date of publication to ASD-STAN Quality domain prEN 9145:2016 (E) 2 Contents Page Rationale . 3 Foreword 3 0 Introduction 4 0.1 General 4 0.2 Application 5 1 Scope 6 1.1 Purpose . 6 1.2 Convention . 6 2 References . 6
11、3 Terms and definitions . 7 4 Advanced product quality planning requirements . 12 4.1 General requirements 12 4.2 Advanced product quality planning project management 12 4.3 Phase 1 requirements planning . 13 4.4 Phase 2 requirements product design and development 14 4.5 Phase 3 requirements process
12、 design and development . 15 4.6 Phase 4 requirements product and process validation 17 4.7 Phase 5 requirements on-going production, use and post-delivery service . 20 5 Production part approval process requirements. 20 5.1 Process requirements for production part approval process . 20 5.2 Producti
13、on part approval process file and submission . 21 5.3 Production part approval process disposition 22 5.4 Production part approval process resubmission . 22 (informative) Acronym log . 23 Annex A(informative) Advanced product quality planning phase activities, deliverables Annex Band outputs . 25 (i
14、nformative) Control plan 30 Annex CC.1 Phases of the control plan . 30 C.2 Content of the control plan . 30 (informative) Production part approval process approval form . 31 Annex DFigures Figure 1 Product development process and advanced product quality planning (conceptual illustration) 5 Tables T
15、able 1 Acceptance criteria for process capability studies . 19 Table 2 Production part approval process file contents . 21 prEN 9145:2016 (E) 3 Rationale This standard was created to define the aviation, space and defence process requirements for Advanced Product Quality Planning (APQP) and Producti
16、on Part Approval Process (PPAP). The APQP aspects of this standard define a methodology for ensuring that the product development processes deployed throughout the aviation, space and defence industries are fully integrated phased processes that extend from concept and design through manufacturing p
17、rocess planning and execution and on into product use, service and customer feedback. The PPAP is an output of APQP confirming that the production process has demonstrated the potential to produce products that consistently fulfil all requirements at the customer demand rate. Foreword To assure cust
18、omer satisfaction, the aviation, space and defence industry organizations must produce and continually improve safe, reliable products that equal or exceed customer and regulatory authority requirements. The globalization of the industry and the resulting diversity of regional/national requirements
19、and expectations have complicated this objective. End-product organizations face the challenge of assuring the quality of and integration of product purchased from suppliers throughout the world and at all levels within the supply chain. Industry suppliers face the challenge of delivering product to
20、 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, delivery, safety and reductions in cost, throughout the v
21、alue stream. This organization includes representation from companies in the Americas, Asia/Pacific and Europe. This document standardizes the requirements for the Product Development Process (PDP) through the use of APQP and PPAP methodologies. The establishment of common requirements, for use at a
22、ll levels of the supply chain, should result in the elimination or reduction of organization unique requirements and the resulting variation inherent in the multiple expectations. prEN 9145:2016 (E) 4 0 Introduction 0.1 General This standard specifies requirements in a structured framework to plan a
23、nd complete actions of the product realization cycle which are necessary to ensure quality product(s) are delivered on time, while satisfying cost performance targets. APQP drives a quality focused approach to product development through the use of a phased planning process within which specific del
24、iverables are established, monitored and tracked to closure, while highlighting and mitigating risks as they are identified. PPAP is an output of APQP confirming that the production process has demonstrated the potential to produce products that consistently fulfil all requirements while operating a
25、t the customer demand rate. Successful implementation of APQP requires: management commitment and support from the beginning of the product development cycle and multidisciplinary project teams integrating all stakeholders and delivering a committed timeline for executing planned activities. APQP ha
26、s five phases (conceptually illustrated in Figure 1) starting with conceptual product needs and extending throughout the product life cycle. The actual duration of each phase will differ depending upon the scope and timing of the specific product and/or production development project. These phases a
27、re described as follows: Phase 1 Planning: The goal of this phase is to capture customer inputs, benchmark data, lessons learned, regulatory requirements, technical specifications, company know-how and strategy into a product concept and realization plan. This includes identification of the high-lev
28、el technical, quality and cost targets. Phase 2 Product Design and Development: The goal of this phase is to translate the technical, quality and cost requirements into a controlled, verified and validated product design. Design validation is achieved using prototype, development, or production part
29、s in test environments that can represent the customers installation and subject the product to extreme conditions required by contract or regulation. Phase 3 Process Design and Development: The goal of this phase is to design and develop the production processes needed to produce product that consi
30、stently fulfil technical, quality and cost requirements while operating at the customer demand rate. Phase 4 Product and Process Validation: The goal of this phase is to validate that product fulfils the design requirements and the production processes have demonstrated the capability to consistentl
31、y produce conforming product at the customer demand rate. Product validation is achieved using product produced from the defined production processes. Phase 5 On-going Production, Use and Post-delivery Service: The goal of this phase is to ensure customer requirements are continually fulfilled throu
32、gh the use of process control, lessons learned and continuous improvement. prEN 9145:2016 (E) 5 Figure 1 Product development process and advanced product quality planning (conceptual illustration) 0.2 Application This standard applies to new product development efforts, but can also be applied to pr
33、oducts currently in production where changes are planned. It can be applied to the final product or selected levels of parts (i. e. parts within an assembly as defined by the organization or customer). When this standard is flowed down as a general contractual requirement (i. e. not for a specific p
34、rogram or project), the scope of applicability is established between the organization and the customer. This standard is generally not applied to standard parts or Commercial-off-the-Shelf (COTS) items. Producers and their suppliers are responsible for flow down of the requirements of this standard
35、, as appropriate, to suppliers who design and/or produce product. When this standard is invoked, APQP and PPAP shall continue to apply when previously approved products and processes undergo change (e. g. introduction of a new production process, change to existing production process, change of prod
36、uction source, addition to the existing production sources). prEN 9145:2016 (E) 6 1 Scope This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins with conceptual product needs and extends through product definition, production planning, product and process va
37、lidation (i. e. PPAP), product use, and post-delivery service. This standard integrates and collaborates with the requirements of the EN 9100, EN 9102, EN 9103 and EN 9110 standards. The requirements specified in this standard are complementary (not alternative) to contractual and applicable statuto
38、ry and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence. 1.1 Purpose The purpose of this standard is to establish a uniform approach to product realization across the av
39、iation, space and defence industry ensuring that quality products are delivered on time, while satisfying cost performance targets. 1.2 Convention The following conventions are used in this standard: the word “shall” indicates a requirement; the word “should” indicates a recommended action (content
40、or path), but not mandatory application; words “typical”, “example”, “for reference” or “e. g.” indicate suggestions given for guidance only; “NOTES” are used for additional clarification; words or phrases with specific meaning pertaining to this document are defined in 3 (Terms and definitions). 2
41、References The following referenced documents are indispensable for the application of this standard. 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 Re
42、quirements for Aviation, Space and Defence Organizations EN 9102, Aerospace First Article Inspection Requirement EN 9103, Aerospace series Quality management systems Variation management of key characteristics EN 9110, Quality Management Systems Requirements for Aviation Maintenance Organizations EN
43、 ISO 9000:2015, Quality management systems Fundamentals and vocabulary NOTE Equivalent versions (e. g. AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published internationally in each sector. prEN 9145:2016 (E) 7 IAQG Supply Chain Management Handbook (SCMH) http:/www.sae.org/iaqg/:
44、Advanced Product Quality Planning (APQP); Aerospace Advanced Product Quality Planning (APQP) Manual. Advanced Product Quality Planning and Control Plan; APQP Second Edition; Automotive Industry Action Group (AIAG); www.aiag.org. ASTM E 2782, Standard Guide for Measurement Systems Analysis (MSA) IEEE
45、 1490:2011, Guide Adoption of the Project Management Institute (PMI) Standard; “A Guide to the Project Management Body of Knowledge (PMBOK Guide)” Fourth Edition; www.ieee.org SAE J1739, Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis
46、in Manufacturing and Assembly Processes (Process FMEA) 3 Terms and definitions Definitions for general terms can be found in EN ISO 9000 and the IAQG International Dictionary (located on the IAQG website). An acronym log for this document is presented in Annex A. For the purpose of this standard, th
47、e following definitions apply: 3.1 Bill of Material BOM list of components and materials contained in the design record(s) of a product 3.2 Commercial off-the-Shelf COTS commercially available products, defined by industry recognized specifications and standards, sold through public catalogue listin
48、gs 3.3 control plan a documented description linking manufacturing process steps to key inspection and control activities. The intent of a control plan is to control the design characteristics and the process variables to ensure product quality 3.4 Critical Item CI those items (e. g. functions, part
49、s, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples include: safety CIs, fracture CIs, mission CIs, Key Characteristics (KCs) and maintenance tasks critical for safety (reference EN 9103 standard) 3.5 customer organization, legal entity, or person that receives a product or service (e. g. consu
