Space systems — Programme management — Non-conformance control system

ISO 23461:2010 specifies a control system for non-conformances related to any product for space systems, such as electrical, electronic, and electromechanical components and software, as well as operational non-conformances and anomalies. ISO 23461:2010 applies to all deliverable products and supplies, at all levels, which fail to conform to specification requirements and design baselines. ISO 23461:2010 is applicable throughout phases of: a) procurement, production, qualification, integration, and test; b) acceptance, delivery, and transportation; c) launch preparation and flight or launch readiness; d) operational validation or qualification; e) operation; f) refurbishment. ISO 23461:2010 also specifies requirements for the interfaces with company internal non-conformance reporting and processing. Engineering changes lie outside the scope of ISO 23461:2010.

Systèmes spatiaux — Management de programme — Système de maîtrise des non-conformités

General Information

Status
Published
Publication Date
18-May-2010
Current Stage
9093 - International Standard confirmed
Completion Date
20-Jul-2021
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INTERNATIONAL ISO
STANDARD 23461
First edition
2010-06-01

Space systems — Programme
management — Non-conformance control
system
Systèmes spatiaux — Management de programme — Système de
maîtrise des non-conformités




Reference number
ISO 23461:2010(E)
©
ISO 2010

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ISO 23461:2010(E)
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ISO 23461:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Abbreviated terms .2
5 Non-conformance control system — basic requirements .2
5.1 General principles .2
5.2 Non-conformance classes.2
5.3 Non-conformance review board .3
5.4 Non-conformance dispositions .4
5.5 Interfaces with internal non-conformance reporting and processing .5
6 Non-conformance processing requirements.5
6.1 General .5
6.2 Immediate actions .5
6.3 Report and recording.6
6.4 Processing by internal NRB .6
6.5 Processing by customer NRB.7
6.6 Corrective and preventive actions.8
6.7 Implementation of action and non-conformance close–out.8
7 Special non-conformance control requirements .9
7.1 Non-conformance of EEE components.9
7.2 Software non-conformances.10
7.3 Operation non-conformances and anomalies.10
8 Documentation requirements.12
8.1 Non-conformance report .12
8.2 Formats for non-conformance reporting .12
8.3 Non-conformance summary status report.12
9 Record requirements .13
9.1 Records associated with non-conformances.13
9.2 Non-conformance database .13
9.3 Analysis of records .13
Annex A (informative) Non-conformance processing flow chart.15
Annex B (informative) Non-conformance report (recommended format) .16

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ISO 23461:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 23461 was prepared by Technical Committee ISO/TC 20, Aircraft and space vehicles, Subcommittee
SC 14, Space systems and operations.
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ISO 23461:2010(E)
Introduction
This International Standard applies to non-conformance control in space programmes.
This International Standard applies to all deliverable products and supplies, at all levels, which fail to conform
to specification requirements and design baselines.
The objectives of the non-conformance control system are to:
a) identify and segregate the non-conforming items;
b) record, report and review effective communication between suppliers and customers;
c) take corrective action against root causes of failure to ensure conformance of the products.

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INTERNATIONAL STANDARD ISO 23461:2010(E)

Space systems — Programme management — Non-
conformance control system
1 Scope
This International Standard specifies a control system for non-conformances related to any product for space
systems, such as electrical, electronic, and electromechanical components and software, as well as
operational non-conformances and anomalies.
This International Standard applies to all deliverable products and supplies, at all levels, which fail to conform
to specification requirements and design baselines.
This International Standard is applicable throughout phases of:
a) procurement, production, qualification, integration, and test;
b) acceptance, delivery, and transportation;
c) launch preparation and flight or launch readiness;
d) operational validation or qualification;
e) operation;
f) refurbishment.
This International Standard also specifies requirements for the interfaces with company internal non-
conformance reporting and processing.
Engineering changes lie outside the scope of this International Standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 14300-1, Space systems — Programme management — Part 1: Structuring of a programme
ISO 14300-2, Space systems — Programme management — Part 2: Product assurance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14300-1 and ISO 14300-2 apply.
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ISO 23461:2010(E)
4 Abbreviated terms
CCN contract change notice
CIL critical item list
OTS off–the–shelf
DJF design justification file
EEE electrical, electronic, electromechanical
FMECA failure mode effect and criticality analysis
NCR non-conformance report
NRB non-conformance review board (formerly known as material review board or MRB)
QA quality assurance
PA product assurance
RFD request for deviation
RFW request for waiver
5 Non-conformance control system — basic requirements
5.1 General principles
The following general principles apply.
a) The system shall provide for a disciplined approach to the identification and segregation of non-
conforming items; the recording, reporting, review, disposition and analysis of non-conformances; and the
definition and implementation of corrective and preventive actions.
b) Special attention shall be paid to:
1) corrective actions against root causes, to avoid recurrence for other products;
2) prompt and effective communication between suppliers and customers;
3) the prevention of non-conformance occurrence, from the analysis of non-conformance records and
derived lessons learned.
c) The supplier shall document his implementation of the non-conformance control system.
5.2 Non-conformance classes
5.2.1 General
Non-conformances shall be classified as major or minor, based on the severity of their consequences, as
defined in 5.2.2 and 5.2.3. In case of doubt, non-conformances shall be classified as major.
Classification of non-conformances is not based on their consequences on cost and schedule.
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ISO 23461:2010(E)
5.2.2 Major
Major non-conformances shall be those which can have an impact on the customer's requirements in the
following areas:
a) safety of people or equipment;
b) operational, functional or any technical requirements imposed by the business agreement;
c) reliability, maintainability, availability;
d) lifetime;
e) functional or dimensional interchangeability;
f) interfaces with hardware or software regulated by different business agreements, and in the following
cases:
1) changes to or deviations from approved qualification or acceptance test procedures,
2) project specific items which are proposed to be scrapped,
3) for EEE components, in case of:
i) lot or batch rejection during manufacturing, screening or testing at the manufacturer's facilities, if
the purchaser proposes:
I) to use as–is the rejected lot or batch,
II) to continue processing, rework or testing, although the lot or batch does not conform to the
specified requirements;
ii) non-conformances detected after delivery from the manufacturer.
5.2.3 Minor
Minor non-conformances are those which by definition cannot be classified as major.
The following discrepancies relating to EEE components after delivery from the manufacturer may be
classified as minor:
a) random failures, where no risk for a lot–related reliability or quality problem exists;
b) if the form, fit or function are not affected;
c) minor inconsistencies in the accompanying documentation.
The consequences of several different minor non-conformances on the same item shall be evaluated for
proper classification.
5.3 Non-conformance review board
5.3.1 General
The non-conformance review board (NRB) shall:
a) be the sole technical authority for the treatment of non-conformances occurring in the frame of a business
agreement;
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ISO 23461:2010(E)
b) have all dispositions and decisions made by consensus by all core members;
c) involve higher management levels, in case of conflict;
d) maintain the independence of PA from the project management organization.
5.3.2 Internal NRB
The internal NRB shall:
a) have core members for the business agreement nominated and authorized by the supplier;
b) document the responsibilities and authorities of each member;
c) include core members from at least the following areas:
1) project PA (chair),
2) engineering;
d) have a chair who nominates additional members, or experts, depending on the subject of the non-
conformance report (NCR);
e) be responsible for the correct application of this International Standard and its proper interfacing with
internal non-conformance reporting and processing.
5.3.3 Customer NRB
For major non-conformances (see 5.2.2) the participation of the customer in the NRB is mandatory.
The customer NRB shall include representatives from at least the following areas:
a) project PA (chair);
b) engineering;
c) at least one customer's representative.
The customer's representative shall also nominate additional members or experts, depending on the NCR
subject. The customer's representative may, with the supplier's agreement, invite observers or consultants
from higher customer level, depending on the impacts of the non-conformance.
5.4 Non-conformance dispositions
5.4.1 General
A basic disposition for a non-conforming item can be one of 5.4.2 to 5.4.6.
5.4.2 Return to supplier
This disposition only applies to non-conforming procured items.
5.4.3 Use “as–is”
The item is found to be usable without eliminating the non-conformance.
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ISO 23461:2010(E)
5.4.4 Rework
The item is recoverable to conform completely to all specified requirements. By definition, rework is the re–
application of the process as originally planned.
Additional work shall be performed to prepare the item for the rework (e.g. removal of faulty work and
cleaning). In no case shall the result of earlier applied processes or the precondition for other processes to be
applied later on, be affected.
5.4.5 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 shall be one of the following:
a) qualified or standard — approved by the customer in advance for defined applications;
b) specific — drawn up for the specific non-conformance and approved by the NRB.
Any repair procedure shall include the verifications needed to check the repair result.
5.4.6 Scrap
The item is not recoverable by rework or repair, for technical or economic reasons.
5.5 Interfaces with internal non-conformance reporting and processing
The supplier's internal reporting and processing of non-conformances shall:
a) not conflict with this International Standard;
b) be open and visible to customer reviews;
c) not delay the processing of the non-conformance in accordance with this International Standard.
6 Non-conformance processing requirements
6.1 General
A non-conformance processing flow chart appears in Figure A.1.
6.2 Immediate actions
The immediate actions in response to detection of non-conformance shall be:
a) performance of an immediate preliminary assessment by the project PA member to establish its extent
and cause;
b) follow-up, without delay, of the assessment, consisting of:
1) provision for the safety of personnel and equipment,
2) prevention of unauthorized use of the non-conforming items, by marking and, unless otherwise
determined by the PA representative, segregation until their disposition,
3) prevention of the recurrence of the non-conformance on similar or identical items under processing
or testing at that time, which can require suspension of manufacturing or testing;
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ISO 23461:2010(E)
c) segregation of non-conforming articles, including:
1) establishment by the supplier of a clearly marked holding area for non-conforming items pending
NRB disposition,
2) limitation of access to this area to PA members or personnel authorized by the NRB,
3) provisions against unauthorized removal of any item,
4) prominent identification of items whose segregation in the holding area is not practicable.
6.3 Report and recording
Non-conformance shall be reported and recorded by:
a) submission, after verification that non-conformance exists, of a completed NCR, prepared by any project
team member, to the internal NRB;
b) provision of a clear, unambiguous, and sufficiently detailed description of the non-conformance, so that it
can be understood by personnel not involved in its detection;
c) entry of the NCR reference on to relevant quality and manufacturing records related to the non-
conforming item;
d) entry of the NCR reference, together with key data, on to non-conformance records (see Clause 9).
6.4 Processing by internal NRB
6.4.1 NRB initiation
Immediately after the reporting of non-conformance, its processing by the internal NRB shall be initiated.
Each NRB performed and it participants shall be recorded on the NCR in order to provide traceability of the
dispositions and to determine corrective actions derived from it.
Each NRB requires an update of the NCR with higher issue and actual date.
6.4.2 Classification
After verification that the non-conformance has been fully described and that the NCR is correctly completed,
the internal NRB shall classify the non-conformance in accordance with the criteria defined in 5.2.
6.4.3 Analysis of cause and consequence
Analysis of cause and consequence shall be implemented as follows:
a) investigation, by the internal NRB or, if necessary, of a separate group of experts engaged for the
purpose, of the root cause(s) of the non-conformance;
b) performance of no irreversible physical operation on the non-conforming item without prior approval by
the customer — non–destructive testing may be used, if the techniques involved have previously been
approved by the customer;
c) analysis by the internal NRB of whether human error or poor workmanship are the primary or secondary
cause for the non-conformance — in which cases, related documents and the competence level of
personnel shall be reviewed in order to prevent recurrence;
d) support of the investigation of the consequences of the non-conformance, where appropriate, by
dependability experts or by documentation such as FMECA, CIL or DJF.
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ISO 23461:2010(E)
6.4.4 Disposition of minor non-conformances
Minor non-conformances shall be disposed as follows:
a) by the internal NRB in accordance with 5.4 — unless otherwise stated in the business agreement, minor
non-conformances need not be notified to the customer;
b) inclusion in the summary status report (see 8.3) which is made available to the customer, upon request,
for the review of the correct application of classification criteria and appropriate processing.
6.4.5 Processing of major non-conformances
Major non-conformances shall be processed as follows:
a) subjection to customer NRB processing;
b) submission by the supplier of a report to the customer within 5 working days of detection, e.g. 2 days,
unless otherwise specified in the business agreement;
c) provision of all information defined as mandatory in the recommended NCR format in Annex B, including
a proposed disposition.
6.5 Processing by customer NRB
6.5.1 Assessment of higher level impacts
The customer shall assess whether the requirements of the higher level customer are impacted. In case of
actual or suspected impacts, the customer shall notify his customer and involve him in the ensuing NRB.
6.5.2
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