EN 16602-10-09:2014
(Main)Space product assurance - Nonconformance control system
Space product assurance - Nonconformance control system
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 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.
Raumfahrtproduktsicherung - Nichtkonformitäts-/Abweichungs-Kontrollsystem
Assurance produit des projets spatiaux - Instruction et traitement des anomalies
La présente norme définit les exigences relatives au contrôle des anomalies.
La présente norme s'applique à tous les produits et fournitures livrables non conformes aux exigences du projet, quel que soit leur niveau.
La présente norme s’applique tout au long du cycle de vie du projet, comme défini dans le standard ECSS-M-ST-10.
La présente norme peut être adaptée aux caractéristiques et contraintes spécifiques à un projet spatial, selon le standard ECSS-S-ST-00.
Zagotavljanje varnih proizvodov v vesoljski tehniki - Sistem kontrole neskladnosti
Standard EN 16602-10-09 določa zahteve za kontrolo neskladnosti. Ta standard velja za vse dobavljive izdelke in materiale na vseh ravneh, ki niso v skladu s projektnimi zahtevami. Ta standard se uporablja za celoten življenjski cikel projekta, kot je opredeljeno v ECSS-M-ST-10. Ta standard se lahko prilagodi posameznim lastnostim in omejitvam vesoljskega projekta v skladu s standardom ECSS-S-ST-00.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2014
1DGRPHãþD
SIST EN 14097:2004
Zagotavljanje varnih proizvodov v vesoljski tehniki - Sistem kontrole neskladnosti
Space product assurance - Nonconformance control system
Raumfahrtproduktsicherung - Nichtkonformitäts-/Abweichungs-Kontrollsystem
Assurance produit des projets spatiaux - Système de contrôle des non-conformités
Ta slovenski standard je istoveten z: EN 16602-10-09:2014
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
49.140 Vesoljski sistemi in operacije Space systems and
operations
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 16602-10-09
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2014
ICS 49.140 Supersedes EN 14097:2001
English version
Space product assurance - Nonconformance control system
Assurance produit des projets spatiaux - Système de Raumfahrtproduktsicherung - Nichtkonformitäts-
contrôle des non-conformités /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 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
member.
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 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, Latvia, 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 reserved Ref. No. EN 16602-10-09:2014 E
worldwide for CEN national Members and for CENELEC
Members.
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 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 actions . 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 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
5.4.2 Nonconformance close-out . 19
5.5 Documentation . 20
5.5.1 Formats for nonconformance reporting . 20
5.5.2 Nonconformance database . 20
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 . 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) Nonconformance 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
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 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, 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.
This 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 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, 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.
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 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.
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 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 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 assurance
ESCC 22800 EEE Nonconformance control system
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 following 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 have an impact on the customer’s requirements in
the following areas and cases:
• safety of people or equipment,
• 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
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
nonconformances 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 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
configuration item data list
CIDL
critical-item list
CIL
commercial off-the-shelf
COTS
design justification file
DJF
European Cooperation for Space Standardization
ECSS
electrical, electronic, electromechanical
EEE
failure mode effect and criticality analysis
FMECA
nonconformance report
NCR
nonconformance review board
NRB
NOTE: Formerly known as MRB (material review
board).
product assurance
PA
quality assurance
QA
reliability, availability, maintainability, safety
RAMS
request for deviation
RFD
request for waiver
RFW
space component coordination
SCC
Nonconformance control system
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 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 its extent and cause. In addition he takes immediate actions
...
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