EN 16602-10-04-2014 en Space product assurance - Critical-item control《航空产品质量保证 关键项目控制》.pdf

1、BSI Standards PublicationBS EN 16602-10-04:2014Space product assurance Critical-item controlBS EN 16602-10-04:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN16602-10-04:2014.The UK participation in its preparation was entrusted to TechnicalCommittee ACE/68,

2、 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 its correctapplication. The British Standards Institution 2

3、014. Published by BSI StandardsLimited 2014ISBN 978 0 580 84097 5ICS 49.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2014.Amendments issued sinc

4、e publicationDate Text affectedBS EN 16602-10-04:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16602-10-04 September 2014 ICS 49.140 English version Space product assurance - Critical-item control Assurance produit des projets spatiaux - Contrle des lments critiques Raumfahrtproduktsicher

5、ung - Kontrolle von kritischen Teilen 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 stipulate the conditions for giving this European Standard the status of a national standard without any alter

6、ation. 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 member. This European Standard exists in three official versions (English, French, German). A version in any other l

7、anguage 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 versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of

8、 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, 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,

9、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 reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-10-04:2014 EBS EN 16602-10-

10、04:2014EN 16602-10-04:2014 (E) 2 Table of contents Foreword 4 Introduction 5 1 Scope . 6 2 Normative references . 7 3 Terms, definitions and abbreviated terms 8 3.1 Terms defined in other standards . 8 3.2 Abbreviated terms. 8 4 Overview of the critical-item control process 9 4.1 General . 9 4.2 Cri

11、tical-item control process 9 4.2.1 Critical items and critical-item control 9 4.2.2 Interfaces between critical-item control and risk management 9 4.2.3 Interfaces between critical-item control and product assurance. 10 4.2.4 Interfaces between critical-item control and product engineering 10 4.2.5

12、Integration of CI control activities 11 5 Requirements 12 5.1 Critical-item control process 12 5.1.1 General requirements . 12 5.2 Implementation requirements . 13 5.2.1 General . 13 5.2.2 Step 1: Define CI control requirement . 13 5.2.3 Step 2: Identify and classify the critical items 14 5.2.4 Step

13、 3: Decide and act 15 5.2.5 Step 4: Communicate and close-out . 16 5.3 Integration of CI control activities 16 5.3.1 Consolidation and gathering method . 16 BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 3 5.3.2 Preliminary design review (PDR) . 17 5.3.3 Critical design review (CDR) . 17 5.3.4 Accept

14、ance review (AR) 17 Annex A (normative) Critical-item list - DRD . 19 Annex B (informative) Critical-item control form 22 Annex C (informative) Check-list for potential critical items . 25 Annex D (informative) Examples of critical-item control measures . 27 Bibliography . 28 Figures Figure 4-1: Cri

15、tical-item control process, and its relation to the risk management process 10 Figure 5-1: Tasks associated with the 4-step approach of the CI control process . 13 Figure B- 1 Example of a criticalitem identification list (CIL form). 23 Figure B- 2 Example of a criticalitem control sheet 24 BS EN 16

16、602-10-04:2014EN 16602-10-04:2014 (E) 4 Foreword This document (EN 16602-10-04:2014) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-10-04:2014) originates from ECSS-Q-ST-10-04C. This European Standard shall be given the

17、 status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2015, 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 su

18、bject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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 specifica

19、lly space systems and has therefore precedence over any EN covering the same scope 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 Stan

20、dard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sp

21、ain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 5 Introduction Early identification of potential critical items provides valuable inputs to design engineering for their avoidance or elimination. Critical-item control provides management with acc

22、eptance rationale for those critical items that cannot be eliminated from the critical-item list, and identifies the means by which emanating risks can be controlled. This Standard provides the requirements for the implementation of the critical-item control process as described in ECSS-Q-ST-10. BS

23、EN 16602-10-04:2014EN 16602-10-04:2014 (E) 6 1 Scope This Standard defines the principles, process, implementation and requirements for critical-items control. Clause 4 is the informative part of this Standard whereas clause 5 and Annex A form the normative part. This standard may be tailored for th

24、e specific characteristics and constraints of a space project, in accordance with ECSS-S-ST-00. BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 7 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this ECSS Standa

25、rd. For dated references, subsequent amendments to, or revisions 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 most recent editions of the normative documents indicated below. For un

26、dated 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 BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 8 3 Terms, definitions and abbreviated terms 3.1 Terms defined in other standard

27、s For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply, in particular for the following terms: critical item 3.2 Abbreviated terms For the purpose of this Standard, the abbreviated terms from ECSS-S-ST-00-01 and the following apply: Abbreviation Meaning CI critical

28、item CIL critical-item list PMP parts, materials and processes SPF single-point failure BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 9 4 Overview of the critical-item control process 4.1 General The objectives of the critical-item control process are to prevent the occurrence of failures in or prob

29、lems with items through: provision of inputs to the risk management programme, identifying technical risks; identification of specific items likely to cause problems (critical items); identification of appropriate prevention and control measures; monitoring, implementation and verification of the co

30、ntrol measures. 4.2 Critical-item control process 4.2.1 Critical items and critical-item control Critical items are potential threats to the performance, quality, dependability and safety of a system that are controlled by a specific action plan in order to mitigate emanating risks and to prevent un

31、desirable consequences. 4.2.2 Interfaces between critical-item control and risk management By their nature critical items have the potential to introduce risks into a project. The potential threats to safety, dependability, performance and quality can be triggered within risk scenarios, which are de

32、alt with by risk management. While critical items are controlled through the CI control process, the associated risks are managed through the risk management process. The interfaces between the risk management and critical-item control processes include (refer to Figure 4-1): critical item inputs to

33、 the risk identification activity, risk classifications used to prioritise critical items, references between risk reduction and critical-item control measures, status of critical-item control implementation. BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 10 Figure 4-1: Critical-item control process,

34、 and its relation to the risk management process 4.2.3 Interfaces between critical-item control and product assurance Critical-item control is part of the product assurance programme of a project. Results from various PA analyses provide considerable inputs for critical item identification (e.g. RAM

35、S: FMECA results, hazard analysis results; PMP: non-qualified parts materials and processes; EEE: non-qualified parts or new technology; lessons learned from previous programmes). 4.2.4 Interfaces between critical-item control and product engineering Critical-item control requirements affect both th

36、e specification of a product and the realisation of the product. Therefore, the inputs and the outputs of the engineering process (e.g. technical specifications, and design documents) are reviewed for the identification and classification of critical items (taking into account the lessons learned fr

37、om previous programmes). Critical-item control measures can establish constraints on the design and development process and are agreed with engineering. Step 1 Define CI control requirement Step 2 Identify and classify the critical items Step 3 Decide and act Step 4 Communicate and close-out Critica

38、l-item (CI) control process Step 1 Define risk management implementation requirements Step 2 Identify and assess the risks Step 3 Decide and act Risk management process ECSS-M-ST-80 Step 4 Monitor, communicate and accept BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 11 4.2.5 Integration of CI contro

39、l activities CI control activities are performed at different levels of the customer-supplier chain. The lower level activities are integrated into the system level activities. The CIL evolves throughout the project life cycle starting with a preliminary CIL at PDR. BS EN 16602-10-04:2014EN 16602-10

40、-04:2014 (E) 12 5 Requirements 5.1 Critical-item control process 5.1.1 General requirements a. The supplier shall uniquely identify critical items. b. The supplier shall classify critical items according to the nature of their criticality. c. The supplier shall establish and maintain the critical-it

41、em list (CIL) for the project throughout all the project phases to allow the tracking and monitoring of all the critical items identified, in conformance with Annex A. d. The supplier shall define specific control measures for the critical items. e. The supplier shall define evaluation points for as

42、sessing the implementation of critical-item control measures. f. At each evaluation point, the supplier shall evaluate the need to retain each item in the critical-item list. g. The supplier shall report the status of the critical items and of the related control measures as part of the project prog

43、ress reporting and at milestone reviews. h. The supplier shall reduce the criticality of an item either by design or by procedural means. NOTE A critical item for which the associated risk is controlled by means of procedures receives particular attention in the further processing of the item. i. Th

44、e supplier shall list all design, manufacturing, and test documentation related to critical items in the CIL. NOTE Document traceability is maintained by document number and issue. j. The supplier shall monitor manufacturing, assembly, integration, testing, maintenance and operation involving a crit

45、ical item for problems that can affect the performance of the item during the operational phase. BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 13 5.2 Implementation requirements 5.2.1 General a. The supplier shall implement the critical-item control process as shown in Figure 5-1. Task 6: Prioritize

46、 critical items Task 7: Propose CI control measures Task 8: Decide on the CI control measures Task 9: Implement agreed CI control measures Step 4 Communicate and closeout Step 3 Decide and act Step 2 Identify and classify the critical items Step 1 Define CI implementation requirements Task 1: Establ

47、ish the CI definition for the project Task 2: Define the CI control process scope and objectives Task 3: Plan the implementation of the CI control process for the project Task 4: Identify critical items Task 5: Classify critical items Criticalitem control cycle Task 10: Monitor and communicate the r

48、esults of the CI control process Task 11: Closeout the CI control process for the project Figure 5-1: Tasks associated with the 4-step approach of the CI control process 5.2.2 Step 1: Define CI control requirement 5.2.2.1 Task 1: Establish the CI definition for the project a. The supplier shall iden

49、tify the applicable requirements for CI control and document the implementation approach chosen in the projects Product Assurance Plan b. The supplier shall establish the CI classification criteria. c. The supplier shall establish scoring schemes for the ranking of critical items commensurate with the applicable project risk management policy as defined in the project risk management plan. NOTE Risk ranking is provided in ECSS-M-ST-80. BS EN 16602-10-04:2014EN 16602-10-04:2014 (E) 14 5.2.2.2 Task 2: Define the CI control process scope and objectives a. The su