EN 16602-10-09-2014 en Space product assurance - Nonconformance control system《航空产品质量保证 不一致性控制系统》.pdf

1、BSI Standards PublicationBS EN 16602-10-09:2014Space product assurance Nonconformance controlsystemBS EN 16602-10-09:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN16602-10-09:2014. It supersedes BS EN 14097:2001 which iswithdrawn.The UK participation in it

2、s preparation was entrusted to TechnicalCommittee ACE/68, Space systems and operations.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for it

3、s correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 84096 8ICS 49.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strat

4、egy Committee on 30 September 2014.Amendments issued since publicationDate Text affectedBS EN 16602-10-09:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-10-09 September 2014 ICS 49.140 Supersedes EN 14097:2001 English version Space product assurance - Nonconformance control system As

5、surance produit des projets spatiaux - Systme de contrle des non-conformits Raumfahrtproduktsicherung - Nichtkonformitts-/Abweichungs-Kontrollsystem This European Standard was approved by CEN on 1 March 2014. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which

6、 stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC membe

7、r. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official

8、versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, La

9、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN/CENELEC All rights of exploitation in any form and by any means res

10、erved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-10-09:2014 E BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 2 Table of contents Foreword 4 1 Scope . 5 2 Normative references . 6 3 Terms, definitions and abbreviated terms 7 3.1 Terms from other standards 7 3.2 Terms

11、 specific to the present standard . 7 3.3 Abbreviated terms. 8 4 Nonconformance control system principles 10 4.1 Process and objectives . 10 4.2 Detection and immediate actions 10 4.3 Nonconformance review board (NRB) 11 4.3.1 Internal NRB . 11 4.3.2 Customer NRB 12 4.4 Corrective and preventive act

12、ions . 12 4.5 Implementation of actions and nonconformance close-out 13 4.6 Documentation . 13 5 Nonconformance processing requirements 14 5.1 Detection and immediate actions 14 5.2 Nonconformance Review Board . 15 5.2.1 General . 15 5.2.2 Processing by internal NRB 15 5.2.3 Processing by customer N

13、RB . 17 5.3 Corrective and preventive actions . 18 5.4 Implementation of actions and nonconformance close-out 19 5.4.1 Implementation of actions . 19 5.4.2 Nonconformance close-out . 19 5.5 Documentation . 20 5.5.1 Formats for nonconformance reporting . 20 5.5.2 Nonconformance database . 20 BS EN 16

14、602-10-09:2014EN 16602-10-09:2014 (E) 3 5.5.3 Analysis of records 20 6 Special nonconformance control requirements 22 6.1 EEE components nonconformances . 22 6.1.1 Applicability . 22 6.1.2 Basic requirements . 22 6.1.3 Processing requirements. 22 6.2 Software nonconformances 23 6.2.1 Applicability .

15、 23 6.2.2 Basic requirements . 23 6.3 Operational nonconformances and anomalies 23 6.3.1 Applicability . 23 6.3.2 Basic requirements . 24 6.3.3 Processing requirements. 25 Annex A (normative) Nonconformance Report DRD . 26 Annex B (normative) NCR Status List - DRD . 31 Annex C (informative) Nonconfo

16、rmance report template 33 Bibliography . 38 Figures Figure 4-1: Nonconformance processing flow chart 11 Tables Table C-1 : Description of the NCR data requirements . 35 BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 4 Foreword This document (EN 16602-10-09:2014) has been prepared by Technical Committ

17、ee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-10-09:2014) originates from ECSS-Q-ST-10-09C. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2015,

18、and conflicting national standards shall be withdrawn at the latest by March 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. Thi

19、s document supersedes EN 14097:2001. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. This document has been developed to cover specifically space systems and has therefore precedence over any EN covering the same scope

20、but with a wider domain of applicability (e.g. : aerospace). According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia

21、, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16602-10-09:2014EN 1

22、6602-10-09:2014 (E) 5 1 Scope This Standard defines the requirements for the control of nonconformances. This Standard applies to all deliverable products and supplies, at all levels, which fail to conform to project requirements. This Standard is applicable throughout the whole project lifecycle as

23、 defined in ECSS-M-ST-10. This standard may be tailored for the specific characteristics and constrains of a space project in conformance with ECSS-S-ST-00. BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 6 2 Normative references The following normative documents contain provisions which, through refe

24、rence in this text, constitute provisions of this ECSS Standard. For dated references, subsequent amendments to, or revision of any of these publications do not apply, However, parties to agreements based on this ECSS Standard are encouraged to investigate the possibility of applying the more recent

25、 editions of the normative documents indicated below. For undated references, the latest edition of the publication referred to applies. EN reference Reference in text Title EN 16601-00-01 ECSS-S-ST-00-01 ECSS system Glossary of terms EN 16602-20 ECSS-Q-ST-20 Space product assurance Quality assuranc

26、e ESCC 22800 EEE Nonconformance control system BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 7 3 Terms, definitions and abbreviated terms 3.1 Terms from other standards For the purpose of this Standard, the terms and definitions from ECSS-ST-00-01 and ECSS-Q-ST-20 apply, in particular for the follow

27、ing terms: alert corrective action critical item customer deviation EEE component inspection item nonconformance preventive action repair requirement rework supplier technical expert verification waiver 3.2 Terms specific to the present standard 3.2.1 major nonconformances nonconformances which can

28、have an impact on the customers requirements in the following areas and cases: safety of people or equipment, BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 8 operational, functional or any technical requirements imposed by the business agreement, reliability, maintainability, availability, lifetime,

29、 functional or dimensional interchangeability, interfaces with hardware or software regulated by different business agreements, changes to or deviations from approved qualification or acceptance test procedures, project specific items which are proposed to be scrapped. 3.2.2 minor nonconformances no

30、nconformances which by definition cannot be classified as major NOTE For example, the following EEE discrepancies after delivery from the manufacturer can be classified as minor: random failures, where no risk for a lot-related reliability or quality problem exists; if the form, fit or function are

31、not affected; minor inconsistencies in the accompanying documentation. 3.3 Abbreviated terms For the purpose of this Standard, the abbreviated terms from ECSS-S-ST-00-01 and the following apply: Abbreviation Meaning CIDL configuration item data list CIL critical-item list COTS commercial off-the-she

32、lf DJF design justification file ECSS European Cooperation for Space Standardization EEE electrical, electronic, electromechanical FMECA failure mode effect and criticality analysis NCR nonconformance report NRB nonconformance review board NOTE: Formerly known as MRB (material review board). PA prod

33、uct assurance QA quality assurance BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 9 RAMS reliability, availability, maintainability, safety RFD request for deviation RFW request for waiver SCC space component coordination BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 10 4 Nonconformance control syste

34、m principles 4.1 Process and objectives The Figure 4-1 describes the approach to the identification and processing of nonconforming items, which can be performed at each customer/supplier level This includes: corrective actions against root causes, to avoid recurrence for other products; prompt and

35、effective communication between suppliers and customers; the prevention of nonconformance occurrence, from the analysis of nonconformance records and derived lessons learned. 4.2 Detection and immediate actions When a nonconformance is detected, the project PA representative analyses it to identify

36、its extent and cause. In addition he takes immediate actions to prevent unauthorized use of the nonconforming item. The nonconformance is documented on the NCR form and submitted to the internal NRB. BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 11 NC detectionSupplier CustomerHigher level customer(

37、s)1. immediat actions2. (Internal) NCR3. RecordingInternal NRBAnalyse causes and consequencesPropose dispostionNotification and customer NRB conveningNCR classificationMajorNCR classificationArrange NRB participation of higher level customer(s)Yes and major impactsCustomer NRBDispositioncorrective a

38、nd preventive actionsNo or minorimpactInputs or participation to NRB, if anyInternal NRBDispositioncorrective and preventive actionsMinorActionee(s)Corrective and preventive actions implementaionPA functionVerification andclose-outRFW (if any accepted?Yes(or no RFWNoFigure 4-1: Nonconformance proces

39、sing flow chart 4.3 Nonconformance review board (NRB) 4.3.1 Internal NRB The internal NRB investigates the causes and consequences of the nonconformance and classifies the nonconformance either as minor or major. BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 12 Furthermore, minor nonconformances are

40、 then disposed as follows: Return to supplier: This disposition only applies to nonconforming procured items. Use “as-is”: The item is found to be usable without eliminating the nonconformance. Rework: The item is recoverable to conform completely to all specified requirements. Additional work is pe

41、rformed to prepare the item for the rework (e.g. removal of faulty work and cleaning). In no case should the result of earlier applied processes or the precondition for other processes to be applied later on, be affected. Scrap: The item is not recoverable by rework or repair, for technical or econo

42、mic reasons. Repair: The item is recoverable such that it fulfils the intended usage requirements although it does not conform to the originally specified requirements. The repair procedure is one of the following: a. Qualified or standard repair procedure: Those repair procedures which have been ap

43、proved by the customer in advance for defined applications. b. Specific repair procedure: Those repair procedures which are prepared for the specific nonconformance and are approved by the NRB. Any repair procedure includes the verifications needed to check the repair result. Major nonconformances a

44、re submitted to the customer NRB. 4.3.2 Customer NRB In principle the customer NRB follows the same process as the internal NRB. In addition, an assessment whether requirements of higher level customers are impacted is performed. If so, these higher level customers are involved in ensuing NRBs. The

45、need for a waiver is also identified and recommended by this NRB. NOTE Multiple internal or customer NRBs can be held before the NCR is closed out. 4.4 Corrective and preventive actions During internal as well as customer NRB, corrective actions are determined to eliminate the causes of the nonconfo

46、rmances. Preventive actions are identified to avoid the occurrence of the nonconformance on similar items. BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 13 4.5 Implementation of actions and nonconformance close-out The supplier implements the corrective and/or preventive actions as defined by the NR

47、B. As soon as all actions are performed and verified, the supplier PA representative closes-out the nonconformance and informs the customer. 4.6 Documentation The supplier documents his implementation of the nonconformance control system. The suppliers internal reporting and processing of nonconform

48、ances is open and visible to customer reviews and do not delay the processing of the nonconformance in accordance with this Standard. The supplier may maintain a database of minor and major nonconformances to a. follow-up the NCR, b. generate a nonconformance status list (see Annex B), c. electronic

49、ally process the nonconformance. The amount of information stored should be sufficient to allow statistical and trend analysis. BS EN 16602-10-09:2014EN 16602-10-09:2014 (E) 14 5 Nonconformance processing requirements 5.1 Detection and immediate actions a. The suppliers project PA representative shall perform an immediate preliminary assessment of the nonconformance to establish its extent and cause when it is detected. b. Based on the preliminary assessment the suppliers project PA representative shall take the following actions with