1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9116 Edition P 1 October 2014 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.org ICS: Descriptors: Note Technically
2、equivalent writings published in all IAQG sectors ENGLISH VERSION Aerospace series Notice of Change (NOC) Requirements Srie arospatiale Avis de modification Luft- und Raumfahrt Anforderungen an eine nderungsmitteilung This “Aerospace Series“ Prestandard has been drawn up under the responsibility of
3、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 the publication of this Prestand
4、ard, 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 draft European Standard (prEN) to
5、 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 standards conflicting with the
6、EN. Edition approved for publication 1st October 2014 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2014 by ASD-STAN prEN 9116:2014 (E) 2 RATIONALE This standard was created to define the process requirements and data expectations for th
7、e submission of proposed changes in design information that requires concurrent approval of the design authority, when the design authority is different from the design activity. This standard provides for the organizational requirements, definitions, and data submission, including suggested data de
8、scriptions and format (paper or electronic submission). This standard was created to provide for the uniform submittal of change notifications and/or approval when contractually invoked at any level or as guidance within the aviation, space, and defence industries. This standard can be invoked as a
9、stand-alone requirement or used in conjunction with 9100-series standards (i.e., 9100, 9110, 9120). FOREWORD To assure customer satisfaction, aviation, space, and defence industry organizations must produce and continually improve safe, reliable products that meet or exceed customer and regulatory a
10、uthority requirements. The globalization of the industry and the resulting diversity of regional/national requirements and expectations have complicated this objective. End-product organizations face the challenge of assuring the quality and integration of product purchased from suppliers throughout
11、 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 International Aerospace Quality Group
12、 (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 international standard has been prepared by the IAQG. A ch
13、ange process consists of design change management and/or manufacturing process change to a previously approved design (baseline configuration) of the product. This document standardizes requirements for Notice of Change (NOC) data definition and documentation for the aviation, space, and defence ind
14、ustries. The establishment of common requirements for use at all levels of the supply-chain is intended to improve quality, safety, and decrease costs by the elimination or reduction of organization-unique requirements and the resultant variation inherent in these multiple expectations. prEN 9116:20
15、14 (E) 3 Contents Page RATIONALE . 2 FOREWORD 2 Foreword . 4 1 Scope 5 1.1 General . 5 1.2 Application . 5 2 Normative references 6 3 Terms and definitions . 6 4 Configuration change definitions 8 4.1 Changes to baseline configuration . 8 4.2 Change types . 11 4.2.1 Changes that require customer acc
16、eptance prior to implementation . 11 4.2.2 Changes that may require customer acceptance prior to implementation . 11 4.2.3 Changes implemented concurrent with notification for customer acceptance . 12 4.2.4 Changes non-configuration 12 4.3 Change impact analysis tool 13 5 Requirements for organizati
17、ons to obtain authorization to analyze changes on behalf of customer 13 5.1 Quality management system requirements 14 5.2 Customer agreements. 14 5.3 Approval of design activity to perform change impact assessments . 14 5.3.1 Prerequisites for design activities to perform change impact assessments 1
18、4 5.3.2 Requesting and maintaining design change impact assessment approval . 15 5.3.3 Design change impact assessment processes and procedures . 15 5.4 Requirements for data submission of notice of change . 16 5.5 Record retention 17 6 NOTES 17 Appendices Appendix A (informative) Acronym log . 18 A
19、ppendix B (informative) Supplier Notification of Change (NOC) Change Impact Analysis (CIA) logic tree . 19 Appendix C (informative) LIST OF NOTICE OF CHANGE (NOC) DATA . 24 Appendix D (informative) Sample Notice of Change (NOC) form 30 Figures Figure 1 Typical design requirements and change notifica
20、tion flow . 5 Figure 2 Flow chart for Notice of Change (NOC) submittal (Design Activity is NOT Authorized to Analyze Changes on Behalf of Customer) . 9 Figure 3 Flow chart for Notice of Change (NOC) submittal (Design Activity is Authorized to Analyze Changes on Behalf of Customer) 10 prEN 9116:2014
21、(E) 4 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 9116:2014 (
22、E) 5 1 Scope 1.1 General The aviation, space, and defence industries rely on the development and manufacture of complex products comprised of multiple systems, subsystems, and components each designed by individual designers (design activities) at various levels within the supply chain. Each design
23、activity controls various aspects of the configuration and specifications related to the product. When a change to design information is requested or required, the change has to be evaluated against the impacts to the higher-level system. Proposed changes to design information that the design activi
24、ty identifies to be minor and have no effect on their product requirements or specifications have the potential to be concurrently implemented and approved, where authorized to do so. Changes that affect customer mandated requirements or specifications shall be approved prior to implementation. In m
25、any cases, the design activity is not the design approver or authority; ultimate approval may be several layers above the design activity. The typical flow of design requirements to the supplier, from the design authority, and the change notification flow is presented in Figure 1. REQUIREMENTS Suppl
26、ier Integrator Design Holder Design Authority SUPPLIER CHANGE NOTIFICATION Design Activity Change Evaluator (Customer) Design Authority Figure 1 Typical design requirements and change notification flow Submitting NOC data either electronically or conventionally on paper is subject to the terms and c
27、onditions of the customers contract. This also includes, where applicable, data access under the regulations of export control. The process of exchanging, coordinating, and approving NOC data varies with the multiple relationships and agreements among all organizations concerned. The information pro
28、vided by this standard forms the architecture for submitting and managing data that allows for concise and accurate communication using various methods. One objective of this standard is to provide the definition of a data set that can be integrated into any form of communication (e.g., electronic d
29、ata interchange, submission of conventional paper forms). If all or part of this standard is invoked in the contract, design activities and design holders (i.e., the organization responsible for the design) that have responsibility for change management of products used on other higher-level designs
30、 shall use the information and processes defined in this standard, and in accordance with the contract, for submitting change notifications to customers. 1.2 Application This standard defines the common NOC requirements for aviation, space, and defence organizations. Included are the requirements th
31、at an internal/external supplier or subcontractor shall use when submitting a NOC to the customer for either change authorization or notification. A NOC informs the customer of physical or functional (including software) changes to an established baseline configuration. Retention of the NOC establis
32、hes a means of configuration control and captures the evolution of the part. This requirement is of utmost importance in commercial/civil aviation products where changes to type certificated products are mandated by regulations. However, these same concepts are also required to some degree in defenc
33、e and space applications per contractual requirements. prEN 9116:2014 (E) 6 This standard is not applicable to products that are manufactured by a supplier to their customers designs and processing requirements (also known as build-to-print). Change requests to this type of product shall be formally
34、 submitted to the customer and approved via the customers change request process. Additionally, this standard is not applicable to commercial parts (off-the-shelf items not specifically designed for aviation, space, or defence products) for which changes in product definition is not affected or know
35、n, but change to commercial parts that are known (i.e., change in definition from one commercial part number to a different commercial part number) shall be processed in accordance with this standard. When this standard is applied to an organization that distributes product, then this standard shall
36、 be a requirement from the distribution organization to the organization from which the product is procured. The distribution organization may act as a conduit for the NOC or the design activity (supplier) may work directly with the design authority (customer). The distributor should be compliant wi
37、th the 9120 standard, as defined by customer requirements. Application or implementation of this standard in any form, either expressed or implied, is not allowed for product which has escaped the suppliers quality system. 2 Normative references The following documents, in whole or in part, are norm
38、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. When a conflict in requirements between this document and ref
39、erenced standards exists, the requirements of this document shall take precedence. Nothing in this document, however, supersedes applicable laws and regulations, unless a specific exemption has been obtained. EN 9100, Quality Management Systems Requirements for Aviation, Space and Defence Organizati
40、ons EN 9110, Quality Management Systems Requirements for Aviation Maintenance Organizations EN 9120, Quality Management Systems Requirements for Aviation, Space, and Defence Distributors NOTE Equivalent versions (e.g., AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published interna
41、tionally in each sector. ANSI/ASME Y14.24, Types and Applications of Engineering Drawings document available from American National Standards Institute (ANSI); www.ansi.org ARP9034, A Process Standard for the Storage, Retrieval and Use of Three-Dimensional Type Design Data EIA 649, National Consensu
42、s Standard for Configuration Management document available from Electronic Industries Alliance (EIA) Publications; www.eia.org ISO 9000:2005, Quality management systems Fundamentals and vocabulary RTCA/DO-254 (EUROCAE ED-80), Design Assurance Guide for Airborne Electronic Hardware document available
43、 from Radio Technical Commission for Aeronautics Inc.; www.rtca.org 3 Terms and definitions Definitions for general terms can be found in ISO 9000 and the IAQG Dictionary, which is located on the IAQG website. An acronym log for this standard is presented in Appendix A. For the purpose of this stand
44、ard, the following shall apply: 3.1 baseline configuration the design definition for the physical product and its performance requirements from which design change control can then take place. This is determined jointly by the customer and the design activity prEN 9116:2014 (E) 7 3.2 change evaluato
45、r the person authorized on behalf of the design authority to assess the potential impact of the change(s), evaluates changes for the potential impact on the fit, form, or functionality of the part, system, or assembly and failure to meet the customer requirements. The change evaluator could also be
46、the customer or the producer of the end item and/or the design authority. 3.3 critical items those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, pro
47、ducibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. 3.4 deliverable any design data provided to the customer which rep
48、resents the product provided 3.5 design activities the supplier design activity or subcontractor that owns the design and provides a deliverable to the customer 3.6 design authority an organization with formal authority for the design, validation, and service support of a product Note 1 to entry: In
49、 civil aviation, this is the organization responsible for the design of articles or for changes thereto that is the holder of a design approval granted by a regulatory authority i.e., Type Certificate (TC); Supplemental Type Certificate (STC); Parts Manufacturer Approval (PMA); Technical Standard Order (TSO)/European Technical Standard Order (ETSO); European Part Approval (EPA); European Aviation Safety Agency (EASA) Part 21 - “Design Organization Approval Holder”, or eq
