1、BS ISO23461:2010ICS 49.140NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSpace systems Programmemanagement Non-conformance controlsystemThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISB
2、N 978 0 580 57014 8Amendments/corrigenda issued since publicationDate CommentsBS ISO 23461:2010National forewordThis British Standard is the UK implementation of ISO 23461:2010.The UK participation in its preparation was entrusted to TechnicalCommittee ACE/68/-/5, Space systems and operations - Prog
3、rammemanagement.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer
4、immunityfrom legal obligations.BS ISO 23461:2010Reference numberISO 23461:2010(E)ISO 2010INTERNATIONAL STANDARD ISO23461First edition2010-06-01Space systems Programme management Non-conformance control system Systmes spatiaux Management de programme Systme de matrise des non-conformits BS ISO 23461:
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9、at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 23461:2010ISO 23461:201
10、0(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Abbreviated terms .2 5 Non-conformance control system basic requirements 2 5.1 General principles .2 5.2 Non-conformance classes2 5.3 Non-conformance review boa
11、rd 3 5.4 Non-conformance dispositions .4 5.5 Interfaces with internal non-conformance reporting and processing .5 6 Non-conformance processing requirements5 6.1 General .5 6.2 Immediate actions .5 6.3 Report and recording6 6.4 Processing by internal NRB .6 6.5 Processing by customer NRB7 6.6 Correct
12、ive and preventive actions.8 6.7 Implementation of action and non-conformance closeout.8 7 Special non-conformance control requirements .9 7.1 Non-conformance of EEE components.9 7.2 Software non-conformances10 7.3 Operation non-conformances and anomalies10 8 Documentation requirements.12 8.1 Non-co
13、nformance report 12 8.2 Formats for non-conformance reporting 12 8.3 Non-conformance summary status report12 9 Record requirements 13 9.1 Records associated with non-conformances.13 9.2 Non-conformance database .13 9.3 Analysis of records .13 Annex A (informative) Non-conformance processing flow cha
14、rt.15 Annex B (informative) Non-conformance report (recommended format) .16 BS ISO 23461:2010ISO 23461:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep
15、aring International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in
16、liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task
17、of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention
18、is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 23461 was prepared by Technical Committee ISO/TC 20, Aircraft and space vehicles, Subcommittee SC 14, Space
19、 systems and operations. BS ISO 23461:2010ISO 23461:2010(E) ISO 2010 All rights reserved vIntroduction This International Standard applies to non-conformance control in space programmes. This International Standard applies to all deliverable products and supplies, at all levels, which fail to confor
20、m to specification requirements and design baselines. The objectives of the non-conformance control system are to: a) identify and segregate the non-conforming items; b) record, report and review effective communication between suppliers and customers; c) take corrective action against root causes o
21、f failure to ensure conformance of the products. BS ISO 23461:2010BS ISO 23461:2010INTERNATIONAL STANDARD ISO 23461:2010(E) ISO 2010 All rights reserved 1Space systems Programme management Non-conformance control system 1 Scope This International Standard specifies a control system for non-conforman
22、ces related to any product for space systems, such as electrical, electronic, and electromechanical components and software, as well as operational non-conformances and anomalies. This International Standard applies to all deliverable products and supplies, at all levels, which fail to conform to sp
23、ecification requirements and design baselines. This International Standard is applicable throughout phases of: a) procurement, production, qualification, integration, and test; b) acceptance, delivery, and transportation; c) launch preparation and flight or launch readiness; d) operational validatio
24、n or qualification; e) operation; f) refurbishment. This International Standard also specifies requirements for the interfaces with company internal non-conformance reporting and processing. Engineering changes lie outside the scope of this International Standard. 2 Normative references The followin
25、g 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. ISO 14300-1, Space systems Programme management Part 1: Struc
26、turing of a programme ISO 14300-2, Space systems Programme management Part 2: Product assurance 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14300-1 and ISO 14300-2 apply. BS ISO 23461:2010ISO 23461:2010(E) 2 ISO 2010 All rights reserved4 Abbrevia
27、ted terms CCN contract change notice CIL critical item list OTS offtheshelf DJF design justification file EEE electrical, electronic, electromechanical FMECA failure mode effect and criticality analysis NCR non-conformance report NRB non-conformance review board (formerly known as material review bo
28、ard or MRB) QA quality assurance PA product assurance RFD request for deviation RFW request for waiver 5 Non-conformance control system basic requirements 5.1 General principles The following general principles apply. a) The system shall provide for a disciplined approach to the identification and s
29、egregation of non-conforming items; the recording, reporting, review, disposition and analysis of non-conformances; and the definition and implementation of corrective and preventive actions. b) Special attention shall be paid to: 1) corrective actions against root causes, to avoid recurrence for ot
30、her products; 2) prompt and effective communication between suppliers and customers; 3) the prevention of non-conformance occurrence, from the analysis of non-conformance records and derived lessons learned. c) The supplier shall document his implementation of the non-conformance control system. 5.2
31、 Non-conformance classes 5.2.1 General Non-conformances shall be classified as major or minor, based on the severity of their consequences, as defined in 5.2.2 and 5.2.3. In case of doubt, non-conformances shall be classified as major. Classification of non-conformances is not based on their consequ
32、ences on cost and schedule. BS ISO 23461:2010ISO 23461:2010(E) ISO 2010 All rights reserved 35.2.2 Major Major non-conformances shall be those which can have an impact on the customers requirements in the following areas: a) safety of people or equipment; b) operational, functional or any technical
33、requirements imposed by the business agreement; c) reliability, maintainability, availability; d) lifetime; e) functional or dimensional interchangeability; f) interfaces with hardware or software regulated by different business agreements, and in the following cases: 1) changes to or deviations fro
34、m approved qualification or acceptance test procedures, 2) project specific items which are proposed to be scrapped, 3) for EEE components, in case of: i) lot or batch rejection during manufacturing, screening or testing at the manufacturers facilities, if the purchaser proposes: I) to use asis the
35、rejected lot or batch, II) to continue processing, rework or testing, although the lot or batch does not conform to the specified requirements; ii) non-conformances detected after delivery from the manufacturer. 5.2.3 Minor Minor non-conformances are those which by definition cannot be classified as
36、 major. The following discrepancies relating to EEE components after delivery from the manufacturer may be classified as minor: a) random failures, where no risk for a lotrelated reliability or quality problem exists; b) if the form, fit or function are not affected; c) minor inconsistencies in the
37、accompanying documentation. The consequences of several different minor non-conformances on the same item shall be evaluated for proper classification. 5.3 Non-conformance review board 5.3.1 General The non-conformance review board (NRB) shall: a) be the sole technical authority for the treatment of
38、 non-conformances occurring in the frame of a business agreement; BS ISO 23461:2010ISO 23461:2010(E) 4 ISO 2010 All rights reservedb) have all dispositions and decisions made by consensus by all core members; c) involve higher management levels, in case of conflict; d) maintain the independence of P
39、A from the project management organization. 5.3.2 Internal NRB The internal NRB shall: a) have core members for the business agreement nominated and authorized by the supplier; b) document the responsibilities and authorities of each member; c) include core members from at least the following areas:
40、 1) project PA (chair), 2) engineering; d) have a chair who nominates additional members, or experts, depending on the subject of the non-conformance report (NCR); e) be responsible for the correct application of this International Standard and its proper interfacing with internal non-conformance re
41、porting and processing. 5.3.3 Customer NRB For major non-conformances (see 5.2.2) the participation of the customer in the NRB is mandatory. The customer NRB shall include representatives from at least the following areas: a) project PA (chair); b) engineering; c) at least one customers representati
42、ve. The customers representative shall also nominate additional members or experts, depending on the NCR subject. The customers representative may, with the suppliers agreement, invite observers or consultants from higher customer level, depending on the impacts of the non-conformance. 5.4 Non-confo
43、rmance dispositions 5.4.1 General A basic disposition for a non-conforming item can be one of 5.4.2 to 5.4.6. 5.4.2 Return to supplier This disposition only applies to non-conforming procured items. 5.4.3 Use “asis” The item is found to be usable without eliminating the non-conformance. BS ISO 23461
44、:2010ISO 23461:2010(E) ISO 2010 All rights reserved 55.4.4 Rework The item is recoverable to conform completely to all specified requirements. By definition, rework is the reapplication of the process as originally planned. Additional work shall be performed to prepare the item for the rework (e.g.
45、removal of faulty work and cleaning). In no case shall the result of earlier applied processes or the precondition for other processes to be applied later on, be affected. 5.4.5 Repair The item is recoverable such that it fulfils the intended usage requirements although it does not conform to the or
46、iginally specified requirements. The repair procedure shall be one of the following: a) qualified or standard approved by the customer in advance for defined applications; b) specific drawn up for the specific non-conformance and approved by the NRB. Any repair procedure shall include the verificati
47、ons needed to check the repair result. 5.4.6 Scrap The item is not recoverable by rework or repair, for technical or economic reasons. 5.5 Interfaces with internal non-conformance reporting and processing The suppliers internal reporting and processing of non-conformances shall: a) not conflict with
48、 this International Standard; b) be open and visible to customer reviews; c) not delay the processing of the non-conformance in accordance with this International Standard. 6 Non-conformance processing requirements 6.1 General A non-conformance processing flow chart appears in Figure A.1. 6.2 Immedi
49、ate actions The immediate actions in response to detection of non-conformance shall be: a) performance of an immediate preliminary assessment by the project PA member to establish its extent and cause; b) follow-up, without delay, of the assessment, consisting of: 1) provision for the safety of personnel and equipment, 2) prevention of unauthorized use of the non-conforming items, by marking and, unless otherwise determined by the PA representative, segregation until their disposition, 3) prevention
