SIST EN 16602-10-09:2014
(Main)Space product assurance - Nonconformance control system
Space product assurance - Nonconformance control system
EN 16602-10-09 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 - Système de contrôle des non-conformités
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
SIST EN 16602-10-09:2014
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
SIST EN 16602-10-09:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 16602-10-09:2014
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SIST EN 16602-10-09:2014
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.
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EN 16602-10-09:2014 (E)
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
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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
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EN 16602-10-09:2014 (E)
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.
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EN 16602-10-09:2014 (E)
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 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.
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EN 16602-10-09:2014 (E)
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 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
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EN 16602-10-09:2014 (E)
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 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,
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• 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
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EN 16602-10-09:2014 (E)
reliability, availability, maintainability, safety
RAMS
request for deviation
RFD
request for waiver
RFW
space component coordination
SCC
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EN 16602-10-09:2014 (E)
4
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 to prevent
unauthorized use of the nonconforming item. The nonconformance is
documented on the NCR form and submitted to the internal NRB.
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Higher level
Supplier Customer
customer(s)
NC detection
1. immediat actions
2. (Internal) NCR
3. Recording
Internal NRB
Analyse causes and
consequences
Propose dispostion
NCR classification
Major
Notification and
customer NRB
convening
NCR classification
Minor
Yes and major impacts
Arrange NRB
No or minor
Inputs or participation
participation of higher
impact
to NRB, if any
level customer(s)
Internal NRB Customer NRB
Disposition Disposition
corrective and corrective and
preventive actions preventive actions
Actionee(s)
Corrective and No
RFW (if any
Yes
preventive actions
(or no RFW
accepted?
implementaion
PA function
Verification and
close-out
Figure 4-1: Nonconformance processing 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.
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Furthermore, minor nonconformances are 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 performed 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
economic 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 approved 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 are 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 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 nonconformances. Preventive actions are identified
to avoid the occurrence of the nonconformance on similar items.
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4.5 Implementation of actions and nonconformance
close-out
The supplier implements the corrective and/or preventive actions as defined by
the NRB.
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 supplier’s internal reporting and processing of nonconformances 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. electronically process the nonconformance.
The amount of information stored should be sufficient to allow statistical and
trend analysis.
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5
Nonconformance processing requirements
5.1 Detection and immediate actions
a. The supplier’s 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 supplier’s project PA
representative shall take the following actions without delay:
1. Provisions for the safety of the personnel and of the equipment.
2. Prevention of unauthorized use of the nonconforming items, by
marking and, unless otherwise determined by the PA
representative, segregation until their disposition.
3. Prevention of the recurrence of the nonconformances on similar or
identical items under processing or testing at that time.
NOTE This can lead to the suspension of manufacturing
or testing.
c. The supplier shall apply the following actions to the segregation of
nonconforming articles:
1. Establish a clearly marked holding area for nonconforming items
pending NRB disposition.
2. Limit the access to this area to NRB members or personnel
authorized by the NRB.
3. Make provisions to prevent unauthorized removal of any item.
d. For items whose segregation in the holding area is not practicable the
supplier shall perform the following actions:
1. Mark the item as “not to be used”.
2. Make sure that the item can not be used by unauthorized
personnel.
e. The supplier shall complete the nonconformance report in conformance
with Annex A, and submit it to the internal NRB.
f. The supplier shall describe the nonconformance clear, unambiguous and
sufficiently detailed that it can be understood by personnel not involved
in its detection.
g. The supplier shall ensure traceability between the NCR and the quality
and manufacturing records related to the nonconforming item.
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5.2 Nonconformance Review Board
5.2.1 General
a. The NRB shall be the sole technical authority for the treatment of
nonconformances occurring in the frame of a business agreement.
b. All NRB members shall make dispositions and decisions by consensus.
c. The NRB chairman shall involve higher management levels in case of
conflict.
5.2.2 Processing by internal NRB
5.2.2.1 NRB meeting
a. The supplier shall nominate and authorize the internal NRBs core
members for the business agreement.
b. The responsibilities and authorities of each member shall be assigned.
c. The internal NRB shall include, at least, core members from the following
areas:
1. Project PA (chairman),
2. Engineering.
NOTE Additional members, or experts, depending on the
NCR subject can be nominated by the chairman.
d. Immediately after the reporting of a nonconformance, the chairman shall
convene an internal NRB.
5.2.2.2 Classification
a. The internal NRB shall classify nonconformances as major or minor,
based on the severity of their consequences.
NOTE Classification of nonconformances is not based on
their consequences on cost and schedule.
b. In case of several different minor nonconformances on the same item, the
internal NRB shall evaluate whether the nonconformances remain minor
or reclassified as “major”.
c. In case of doubt, the internal NRB shall classify nonconformances as
major.
5.2.2.3 Analysis of causes and consequences
a. The internal NRB shall investigate the cause(s) of the nonconformance.
NOTE If necessary, a separate group of experts can be
assigned for the investigation.
b. The supplier shall carry out physical operation of an irreversible nature
on the nonconforming item only with prior approval by the customer.
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NOTE Non-destructive testing can be used, if the
techniques involved have previously been
approved by the customer.
c. The internal NRB shall analyse whether human error or poor
workmanship are the primary or secondary cause for the
nonconformance.
d. In case that human error or poor workmanship are the primary or
secondary cause for the nonconformance, the supplier shall review all
related documents and the competence level of personnel in order to
prevent recurrence.
e. The internal NRB shall investigate the consequences of the
nonconformance.
NOTE This can be supported, where appropriate, by
dependability experts or by documentation such as
FMECA, CIL, or DJF.
f. The internal NRB shall document the results of the investigation in the
nonconformance report.
5.2.2.4 Disposition of minor nonconformances
a. The internal NRB shall dispose minor nonconformances according to the
following criteria:
1. Return to supplier
2. Use “as-is”
3. Rework
4. Repair
5. Scrap
b. The supplier shall include minor nonconformances in the
nonconformance status list.
NOTE Unless otherwise stated in the business agreement,
minor nonconformances need not be notified to the
customer.
c. The supplier shall provide the nonconformance status list to the
customer, upon request, for the review of the correct application of
classification criteria and appropriate processing.
5.2.2.5 Processing of major nonconformances
a. The supplier shall notify the customer each time a nonconformance is
classified as “major” within five working days of their detection.
b. The internal NRB shall submit major nonconformances reports to the
customer NRB.
c. The supplier shall provide a nonconformance report in conformance to
Annex A, including a proposed disposition.
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5.2.3 Processing by customer NRB
5.2.3.1 NRB meeting
a. For major nonconformances the supplier shall include, at least:
1. customer’s PA representative (chairman), and
2. customer’s engineering representative.
b. The chairman shall nominate additional members, or experts, depending
on the NCR subject.
NOTE The customer’s representatives may invite
observers or consultants from higher customer
level, depending on the impacts of the
nonconformance.
5.2.3.2 Assessment of higher level impacts
a. The customer shall assess whether the requirements of the higher level
customer are impacted.
b. In case of actual or suspected impacts, the customer shall notify his
customer and involve him in the ensuing NRB.
5.2.3.3 Confirmation of causes and consequences
a. Based on the results of the internal NRB’s investigations, the customer
NRB shall decide on the need to perform complementary investigations
of causes and consequences.
b. The customer NRB shall decide if additional analyses are needed from
the supplier to assess the cause and consequences of a nonconformance
and to support its disposition.
c. On request of the customer’s NRB, the supplier shall submit the
additional analyses to the customer NRB for approval.
d. The customer NRB shall addresses the following points during the
meeting:
1. the detailed circumstances of the nonconformance;
2. the different analyses, tests or simulations performed to
understand the cause of the nonconformance;
3. the consequences of the nonconformance.
e. The customer NRB shall determine the consequences of the
nonconformance.
5.2.3.4 Disposition of major nonconformances
a. The customer NRB shall dispose major nonconformances according to
the following criteria:
1. Return to supplier
2. Use “as-is”
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3. Rework
4. Repair
5. Scrap
b. When determining a disposition, the NRB shall perform the following
tasks:
1. Analyse NCRs and provided analyses
2. Review records of any previous similar or identical
nonconformances.
3. Assess the feasibility of the intended dispositions.
4. Assess the applicability of dispositions and corrective actions to
existing and in-process items
NOTE This also includes re-inspection and retest.
5. Assess the effect of the nonconformance on the requirements of the
business agreement
6. Assess the effect of the nonconformance on the intended use of the
item
7. Assess whether the item is identified as critical
8. Assess the need for raising an alert to other users of similar
nonconforming items, and activate the related procedures
established in the business agreement.
5.2.3.5 Request for waiver or deviation
a. The responsible NRB shall identify and recommend the need for a waiver
or deviation.
b. Upon request of the NRB, the supplier shall submit a “request for
waiver” for major nonconformances with the “use as-is” or “repair”
disposition for customer approval.
c. Upon request of the NRB, the supplier shall submit a “request for
deviation” or a “contract change notice, for follow-on production of the
unit.
5.3 Corrective and preventive actions
a. The NRBs shall determine corrective actions to eliminate the cause(s) of
the nonconformance and prevent any recurrence.
NOTE Typical corrective actions consist of, for instance,
changes to tools, equipment, facilities, processes,
materials, drawings, specifications, and
procedures.
b. The NRB shall determine also preventive actions to avoid the occurrence
of the nonconformance on similar items.
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c. A NRB dispositioned “use as-is” need not any physical action on the
nonconforming item to make it usable, however corrective and
preventive actions shall be performed.
5.4 Implementation of actions and nonconformance
close-out
5.4.1 Implementation of actions
a. The supplier shall implement disposition by performing actions defined
by the NRB and approved RFWs and RFDs.
b. The supplier shall re-submit reworked and repaired items to all planned
inspections and tests.
NOTE Repair can invoke additional inspection and tests,
as defined in the applicable repair procedure.
c. The supplier shall identify and segregate items with “scrap” disposition
from all other material within a bonded area under QA supervision.
d. The supplier shall maintain a list of scrapped items which are finally
disposed.
e. The supplier shall establish the traceability to and from the associated
NCR of the performance and results of all actions related to a
nonconformance.
5.4.2 Nonconformance close-out
a. The supplier shall close-out an NCR only after the following action have
been performed:
1. All related act
...
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