1、 ASD STANDARD NORME ASD ASD NORM prEN 9103:2012 Edition P 2 2012-08 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION 270 Avenue de Tervuren, B-1150 Brussels - Tel +32 2 775 8126 - Fax +32 2 775 8131 - www.asd-stan.org ICS: Supersedes Edition P 1 of July 2001
2、and will supersede EN 9103:2005 Note: Technically equivalent writings published in all IAQG sectors Descriptors: ENGLISH VERSION Aerospace series Quality management systems Variation management of key characteristics Luft- und Raumfahrt Qualittsmanagementsystems Management der Vernderung der Hauptei
3、genshaften Srie arospatiale Systmes de management de la qualit Management de la variation des caractristiques clefs 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 publishe
4、d on green paper for the needs of the European Aerospace and Defence 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 changed to an extent that interchang
5、eability 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 draft European Standard to CEN (European Committee for Standardization) for formal vote. Edition approved for
6、publication Comments should be sent within six months after the date of publication to ASD-STAN prEN 9103:2012 (E) 2 Contents Page Error! No table of contents entries found. Appendix Page Appendix A (Normative) Guidelines to meeting requirements for variation management of key characteristics9 Appen
7、dix B (Normative) Process control document example. 13 Figures Page Figure 1 Preferred model for key characteristic variation management8 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
8、ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. prEN 9103:2012 (E) 3 Rationale This standard was revised to coincide with the updated information presented in the International Aerospace Quality Group (IAQG) 9100-series standards (i.e., 9100
9、:2009, 9110:2009). All other changes made to standard requirements or methods presented herein were editorial in nature. Foreword To assure customer satisfaction, the aviation, space, and defence industry organizations must produce and continually improve safe, reliable products that meet or exceed
10、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 integrating, product purchas
11、ed 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 requirements. The aviation, space, and defence industry established the Internati
12、onal 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/Pacific, and Europe. This document standardizes require
13、ments for “Key Characteristic” (KC) identification, control, documentation, and approval for the industry. The establishment of common requirements, for use at all levels of the supply-chain by organizations, should result in improved quality and safety, and decreased costs, due to the elimination o
14、r reduction of organization-unique requirements and the resultant variation inherent in these multiple expectations. 0. Introduction 0.1 General This standard establishes variation management requirements for KCs. The standard also specifies general requirements and provides a process to achieve tho
15、se requirements. The standard requires a thorough assessment of the applicable production/maintenance process with the primary goals being to control and minimize variation in characteristics generated by the process. Specifically, the standard requires: Understanding process elements that affect KC
16、s. Disciplined determination of process KCs using appropriate analysis tools for variation control and reduction to satisfy customer requirements. Control and capability assessment to ensure variation is well understood. Process Control Documents (PCDs) or equivalent documentation that defines speci
17、fic control of KCs and manufacturing/maintenance process parameters. This standard does not: Require rejection of any part that conforms to engineering specification. Inhibit shipment or use of product during production process capability assessment. Although the 9103 standard is focused on variatio
18、n control of KCs for production and maintenance activities, this process can also be used as a model for other characteristics, such as those that affect cost and delivery. prEN 9103:2012 (E) 4 0.2 Application This standard was created to provide for a uniform process for the identification, control
19、, documentation, and approval of KCs when contractually invoked at any level or as guidance within the aviation, space, and defence industry in the control of Critical Items (CIs). This standard can be invoked as a stand-alone requirement or used in conjunction with 9100-series standards (i.e., 9100
20、, 9110). 1 Scope This standard is primarily intended to apply to new parts and products, but can also be applied to parts currently in production. The standard shall be applicable to all production processes that influence the variation of KCs, as well as maintenance processes in which KCs are ident
21、ified. It applies to assemblies and all levels of parts within an assembly, down to the basic materials including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product. It does not apply to lab-scale, pilot, or pre-production process
22、es. However, particular management of some KCs might be required using other methods than those described in the standard, during these phases of a programme, when required by the customer or deemed appropriate by the organization (e.g., Engineering department requirement). The variation control pro
23、cess begins with product definition, typically an engineering drawing or specification which identifies KCs, and leads to a variation management program for those KCs. This process may also be used for producer-identified KCs. Producers and their subcontractors shall be responsible for flow down of
24、the requirements of the applicable revision of this standard to subcontractors, who produce design characteristics, and for ensuring that KCs conform to customer requirements. 1.1 Purpose This standard is designed to drive the improvement of manufacturing and maintenance processes through adequate p
25、lanning and effective management of KC variation. The KC focus is intended to improve confidence for part features whose variation has a significant influence on to end-product form, fit, performance, service life, and producibility. NOTE Control of a product or process KC per this standard does not
26、 constitute, nor imply, acceptance of the resulting product. If variation management, under this standard, is to be part of an acceptance decision, the requirements must be specified in the applicable product acceptance plan or contract. 1.2 Convention The following conventions are used in this stan
27、dard: The words “shall“, “will“, or “must“ indicate mandatory requirements. The word “should“ indicates a requirement with some flexibility allowed in compliance methodology. Producers choosing other methods to satisfy a “should“ shall be able to show that their approach meets the intent of the requ
28、irements of this standard. Words “typical“, “example“, “for reference“, “may“, 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 Clause 3, Terms and Definitions. prE
29、N 9103:2012 (E) 5 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 9100,
30、 Quality management systems Requirements for aviation, space and defence organization EN 9102, Aerospace first article inspection requirement EN 9110, Quality management systems Requirements for aviation maintenance organization ISO 9000:2005, Quality management systems Fundamentals and vocabulary 2
31、.1 Related publications The following publications are provided for information purposes only and are not a required part of this SAE Aerospace Technical Report. ISO 9001:2008, Quality management systems Requirements ISO 9004:2009, Managing for the sustained success of an organization A quality mana
32、gement approach 3 Terms and Definitions For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. 3.1 Critical Item (CI) Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and u
33、se 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, KCs, and maintenance tasks critical for safety. 3.2 Customer The orga
34、nization which identifies CIs and/or provides part or system KCs via engineering drawings, specifications, or purchase order/contract requirements. For example, a customer may be an internal engineering department for a company which has design authority, in addition to the external customer who spe
35、cifies system KCs. 3.3 Key Characteristic (KC) An attribute or feature whose variation has a significant influence on product fit, performance, service life, or producibility; that requires specific action for the purpose of controlling variation (reference 9100 and 9110). This definition is further
36、 explained as follows: KCs for a part, subassembly, or system are those selected geometrical, material properties, functional, and/or cosmetic features; which are measurable, whose variation control is necessary in meeting customer requirements and enhancing customer satisfaction. Process KCs are th
37、ose selected measurable characteristics of a process whose control is essential to manage variation of part or system KCs. Substitute KCs may be identified when a customer-defined KC is not readily measurable within the production/maintenance setting and other characteristics may need to be controll
38、ed to ensure conformance. prEN 9103:2012 (E) 6 NOTE Design output can include identification of critical items that require specific actions to ensure they are adequately managed. Some CIs shall be further classified as KCs because their variation needs to be controlled. 3.4 Key Characteristic (KC)
39、Owner The person or function that defines the KCs and recognizes the reasons for the selection of the KCs. Typically, these responsibilities are held by internal/external customer design, quality, manufacturing, or maintenance engineering and are identified by a cross-functional team. 3.5 Key Charac
40、teristic (KC) Process Owner The person or function that uses KC data to maintain and improve the process. 3.6 Process Control Document (PCD) a written description of manufacturing/maintenance plan developed to control variation in KCs. It is a living document and is updated to reflect the addition/d
41、eletion of KCs. 3.7 Producer An organization that performs any process affecting the manufacture or maintenance of the part/product. 3.8 Special cause Variation caused by a source that is not part of the constant system or process. NOTE Also commonly referred to as assignable cause. 4 General requir
42、ements 4.1 This clause defines general requirements which shall be met regardless of the variation management methodology applied. NOTE Further detailed guidelines are provided in Appendix A. 4.2 Variation management activities shall be performed on identified KCs and processes until they are in con
43、trol and the required process capability has been established. Appropriate monitoring methodology should then be implemented to ensure continued performance. 4.3 The producer shall maintain appropriate documentation of KCs and manufacturing or maintenance process elements that influence variation in
44、 KCs as well as their control techniques and measurement methods. This documentation shall be developed when any of the following occurs: a. Customer defines a CI or product/process KC. b. Lower level or substitute KCs are required to control variation of higher level KCs. c. Analysis performed as p
45、art of a process improvement activity to meet quality objectives required by 9100/9110 standard results in the identification of a KC or process. NOTE PCD shown in Appendix B in one acceptable method of documentation. 4.4 If Statistical Process Control (SPC) is chosen as the method of control for th
46、e KC, the following requirements shall be met: prEN 9103:2012 (E) 7 a. Process capability shall be established for KCs. The process capability index (e.g., Cp and Cpk) shall be calculated only when the process is shown to be stable and in statistical control, using appropriate statistical methods an
47、d/or appropriate control charts. b. The process shall be capable (i.e., with Cpk 1.33) or as specified by the customer. NOTE A KC is considered capable, if its Cpk meets or exceeds 1.33. Other comparable measures of process capability may be used. If the process does not meet capability requirements
48、, the producer may have several options as described in this sub-clause. c. When similar KCs from different products are combined on the same control chart (e.g., a part, product family, or process output control approach), the characteristics shall have similar variability and be traceable to the s
49、pecific part or product. d. When process capability is used to justify reduced frequency of inspection, the process capability (probability of nonconformance) shall be determined using recognized industry statistical methods. NOTE Evidence of sufficient process control may include, but not be limited to procedures and records of configuration control of process inputs, elements or characteristics that affect conformance of products to specifications, or SPC methods with a process control plan; and audit records showing that the process
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