DIN EN 16602-10-09-2014 Space product assurance - Nonconformance control system English version EN 16602-10-09 2014《航天产品保证 不合格控制系统 英文版本EN 16602-10-09-2014》.pdf

1、Dezember 2014DEUTSCHE NORM DIN-Normenausschuss Luft- und Raumfahrt (NL)Preisgruppe 17DIN Deutsches Institut fr Normung e. V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e. V., Berlin, gestattet.ICS 49.140!%;se“2248066www.din.deDDIN EN 16

2、602-10-09Raumfahrtproduktsicherung Nichtkonformitts-/Abweichungs-Kontrollsystem;Englische Fassung EN 16602-10-09:2014Space product assurance Nonconformance control system;English version EN 16602-10-09:2014Assurance produit des projets spatiaux Systme de contrle des non-conformits;Version anglaise E

3、N 16602-10-09:2014Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 BerlinErsatz frDIN EN 14097:2002-10www.beuth.deGesamtumfang 42 SeitenDIN EN 16602-10-09:2014-12 2 Nationales Vorwort Dieses Dokument (EN 16602-10-09:2014) wurde vom Technischen Komitee CEN/CLC/TC 5 Raumfahrt“ erarbeitet, desse

4、n Sekretariat vom DIN (Deutschland) gehalten wird. Das zustndige deutsche Normungsgremium ist der Arbeitsausschuss NA 131-10-01 AA Interoperabilitt von Informations-, Kommunikations- und Navigationssystemen“ im DIN-Normenausschuss Luft- und Raumfahrt (NL). Dieses Dokument ersetzt DIN EN 14097:2002-1

5、0. Dieses Dokument (EN 16602-10-09:2014) basiert auf ECSS-Q-ST-10-09C. Dieses Dokument enthlt unter Bercksichtigung des DIN-Prsidialbeschlusses 1/2004 nur die englische Originalfassung von EN 16602-10-09:2014. Dieses Dokument wurde speziell zur Behandlung von Raumfahrtsystemen erarbeitet und hat dah

6、er Vorrang vor jeglicher Europischer Norm, da es denselben Anwendungsbereich hat, jedoch ber einen greren Geltungsbereich (z. B. Luft- und Raumfahrt) verfgt. nderungen Gegenber DIN EN 14097:2002-10 wurden folgende nderungen vorgenommen: a) Norm-Nummer gendert; b) keinerlei nderungen des Textes. Frhe

7、re Ausgaben DIN EN 14097: 2002-10 DIN EN 16602-10-09:2014-12 3 Nationaler Anhang NA (informativ) 3 Begriffe und Abkrzungen 3.1 Benennungen, die in anderen Normen festgelegt sind Fr die Anwendung dieses Dokuments gelten die Begriffe nach ECSS-ST-00-01 und ECSS-Q-ST-20 und die folgenden Benennungen: W

8、arnmeldung Korrekturmanahme kritische Einheit Kunde Sonderfreigabe (vor Realisierung) EEE-Bauteil Prfung Einheit Nichtkonformitt Vorbeugungsmanahme Reparatur Anforderung Nacharbeit Lieferant Technischer Sachverstndiger Verifizierung Sonderfreigabe (nach Realisierung) 3.2 Benennungen, die fr die vorl

9、iegende Norm spezifisch sind 3.2.1 wesentliche Nichtbereinstimmungen Nichtbereinstimmungen, die einen Einfluss auf die Anforderungen des Kunden in den folgenden Bereichen und Fllen haben knnen: Sicherheit des Personals oder des Gerts; betriebliche, funktionelle oder alle technischen Anforderungen, d

10、ie durch die Geschftsvereinbarung angeordnet werden; Funktionsfhigkeit, Instandhaltbarkeit, Verfgbarkeit; Lebensdauer; funktionelle und maliche Austauschbarkeit; DIN EN 16602-10-09:2014-12 4 Schnittstellen zur Hard- oder Software, die durch unterschiedliche Geschftsvereinbarungen geregelt werden; nd

11、erungen von Sonderfreigaben (vor Realisierung) oder nderungen der Sonderfreigaben (vor Realisierung) gegenber den zugelassenen Qualifizierungs- oder Abnahmeprfverfahren; projektspezifische Einheiten, deren Aussortierung vorgeschlagen wird. 3.2.2 unwesentliche Nichtbereinstimmungen Nichtbereinstimmun

12、gen, die definitionsgem nicht als wesentliche Nichtbereinstimmungen klassifiziert werden knnen ANMERKUNG Beispielsweise knnen folgende EEE-Unstimmigkeiten vom Hersteller nach der Lieferung als unwesentlich klassifiziert werden: zufllige Ausflle, sofern kein Risiko fr die Funktionsfhigkeit oder ein Q

13、ualittsproblem fr das gesamte Los existiert; wenn Form, Passung oder Funktion nicht beeinflusst werden; geringfgige Widersprche in den Begleitpapieren. 3.3 Abkrzungen Fr die Anwendung dieses Dokuments gelten die Abkrzungen nach ECSS-S-ST-00-01 und die folgenden Abkrzungen: Abkrzung Bedeutung CIDL Li

14、ste fr Konfigurationsdaten (en: configuration item data list) CIL Liste fr kritische Einheiten (en: critical-item list) COTS kommerzielle Produkte aus dem Regal (en: commercial off-the-shelf) DJF Designbegrndungsakte (en: design justification file) ECSS European Cooperation for Space Standardization

15、 EEE Elektronisch, elektrisch, elektromechanisch (en: electrical, electronic, electromechanical) FMECA Fehlerart-, -auswirkungs- und -kritizittsanalyse (en: failure mode effect and criticality analysis) NCR Nichtkonformitten-/Fehler-Bericht (en: non-conformance report) NRB Nichtkonformitts-Untersuch

16、ungsausschuss (en: non-conformance review board) ANMERKUNG Frher bekannt als Material-Untersuchungsausschuss (MRB) (en: material review board). PA Produktsicherung (en: product assurance) QA Qualittssicherung (en: quality assurance) RAMS Funktionsfhigkeit, Verfgbarkeit, Instandhaltbarkeit, Sicherhei

17、t (en: reliability, availability, maintainability, safety) RFD Antrag auf Sonderfreigabe (vor Realisierung) (en: request for deviation) RFW Antrag auf Sonderfreigabe (nach Realisierung) (en: request for waiver) SCC Koordinierung von Raumfahrtteilen (en: space component coordination) EUROPEAN STANDAR

18、D NORME EUROPENNE EUROPISCHE NORM EN 16602-10-09 October 2014 ICS 49.140 Supersedes EN 14097:2001 English version Space product assurance - Nonconformance control system Assurance produit des projets spatiaux - Systme de contrle des non-conformits Raumfahrtproduktsicherung - Nichtkonformitts-/Abweic

19、hungs-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 stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date

20、 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 language made by t

21、ranslation 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 Austria, Belgium

22、, 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, Sweden, Switzerla

23、nd, 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 16602-10-09:2014 EEN 16602-10-09:2014 (E) 2 Table

24、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 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 Detect

25、ion 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 actions . 12 4.5 Implementation of actions and nonconformance close-out 13 4.6 Documentation . 13 5 Nonconformance processing requirements 14 5.1 Detectio

26、n 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 NRB . 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

27、.4.2 Nonconformance close-out . 19 5.5 Documentation . 20 5.5.1 Formats for nonconformance reporting . 20 5.5.2 Nonconformance database . 20 DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 3 5.5.3 Analysis of records 20 6 Special nonconformance control requirements 22 6.1 EEE components nonconfor

28、mances . 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 . 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 Pr

29、ocessing requirements. 25 Annex A (normative) Nonconformance Report DRD . 26 Annex B (normative) NCR Status List - DRD . 31 Annex C (informative) Nonconformance report template 33 Bibliography . 38 Figures Figure 4-1: Nonconformance processing flow chart 11 Tables Table C-1 : Description of the NCR

30、data requirements . 35 DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 4 Foreword This document (EN 16602-10-09:2014) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-10-09:2014) originates from ECSS-Q-ST-10-09C. This

31、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 April 2015, and conflicting national standards shall be withdrawn at the latest by April 2015. Attention is drawn to the possibility that some of the ele

32、ments 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. This document supersedes EN 14097:2001. This document has been prepared under a mandate given to CEN by the European Commission and the European

33、 Free Trade Association. This document has been developed to cover specifically 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 organi

34、zations of the following countries are bound to implement this European Standard: 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, M

35、alta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 5 1 Scope This Standard defines the requirements for the control of nonconformances. This Standard applies to all de

36、liverable products and supplies, at all levels, which fail to conform to project requirements. This Standard is applicable throughout the whole project lifecycle as defined in ECSS-M-ST-10. This standard may be tailored for the specific characteristics and constrains of a space project in conformanc

37、e with ECSS-S-ST-00. DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 6 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this ECSS Standard. For dated references, subsequent amendments to, or revision of any

38、 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 editions of the normative documents indicated below. For undated references, the latest edition of the publication referred to app

39、lies. 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 assurance ESCC 22800 EEE Nonconformance control system DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 7 3 Terms, definitions and abbrev

40、iated 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 following terms: alert corrective action critical item customer deviation EEE component inspection item nonconformance preventive ac

41、tion repair requirement rework supplier technical expert verification waiver 3.2 Terms specific to the present standard 3.2.1 major nonconformances nonconformances which can have an impact on the customers requirements in the following areas and cases: safety of people or equipment, DIN EN 16602-10-

42、09:2014-12 EN 16602-10-09:2014 (E) 8 operational, functional or any technical requirements imposed by the business agreement, reliability, maintainability, availability, lifetime, functional or dimensional interchangeability, interfaces with hardware or software regulated by different business agree

43、ments, 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 nonconformances which by definition cannot be classified as major NOTE For example, the following EEE discrepancies after d

44、elivery 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 not affected; minor inconsistencies in the accompanying documentation. 3.3 Abbreviated terms For the purpose of this Stan

45、dard, 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-shelf DJF design justification file ECSS European Cooperation for Space Standardization EEE electrical, electronic, electrom

46、echanical FMECA failure mode effect and criticality analysis NCR nonconformance report NRB nonconformance review board NOTE: Formerly known as MRB (material review board). PA product assurance QA quality assurance DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 9 RAMS reliability, availability, m

47、aintainability, safety RFD request for deviation RFW request for waiver SCC space component coordination DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 10 4 Nonconformance control system principles 4.1 Process and objectives The Figure 4-1 describes the approach to the identification and process

48、ing 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 effective communication between suppliers and customers; the prevention of nonconformance occurrence, from the

49、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 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. DIN EN 16602-10-09:2014-12 EN 16602-10-09:2014 (E) 11 N