SIST EN 9131:2020
(Main)Aerospace series - Quality Management Systems - Nonconformance Data Definition and Documentation
Aerospace series - Quality Management Systems - Nonconformance Data Definition and Documentation
1.1 Application:
This document defines the common nonconformity data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision. The requirements are applicable, partly or totally, when reporting a product nonconformity to the owner or operator, as user of the end item (e.g. engine, aircraft, spacecraft, helicopter), if specified by contract.
Reporting of nonconformity data, either electronically or conventionally on paper, is subject to the terms and conditions of the contract. This also includes, where applicable, data access under export control regulations.
1.2 Purpose:
The process of exchanging, coordinating, and approving nonconformity data via waiver/concession or product quality escape varies with the multiple relationships and agreements among all parties concerned. The information provided by this document forms architecture for submitting and managing data that allows for concise and accurate communication using various methods. The main objective of this document is to provide the definition of a data set that can be integrated into any form of communication (e.g. electronic data interchange, submission of conventional paper forms).
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Nichtkonformitäts-Dokumentation
1.1 Anwendung
Dieses Dokument legt die allgemeine Definition von Nichtkonformitätsdaten und deren Dokumentation fest, die zwischen internen/externen Lieferanten oder Unterlieferanten und dem Kunden ausgetauscht werden müssen, wenn die Information über eine Nichtkonformität eine formelle Entscheidung erfordert. Sofern vertraglich festgelegt, gelten die Anforderungen – teilweise oder vollständig, – wenn dem Eigentümer oder dem Betreiber als Nutzer des Endprodukts (z. B. Triebwerk, Luftfahrzeug, Raumfahrzeug, Hubschrauber) eine Produkt Nichtkonformität angezeigt wird.
Die Mitteilung von Nichtkonformitätsdaten auf elektronischem oder konventionellem Weg mittels Papier unterliegt den Bestimmungen und Bedingungen des jeweiligen Vertrags. Dieses schließt auch, sofern zutreffend, den Datenzugriff unter Exportkontrollbestimmungen ein.
1.2 Zweck
Der Prozess des Austausches, der Koordination und der Genehmigung von Nichtkonformitätsdaten über Sonderfreigaben oder Produktqualitätsmängel variiert entsprechend den verschiedenen Beziehungen und getroffenen Vereinbarungen aller beteiligten Parteien. Die in diesem Dokument bereitgestellten Informationen bilden die Struktur zur Einreichung und Steuerung von Daten, die eine prägnante und genaue Kommunikation unter Verwendung verschiedener dokumentierter Verfahren ermöglicht. Das Hauptziel dieses Dokuments besteht darin, die Definition eines Datensatzes zu liefern, der in jede Kommunikations¬form integriert werden kann (z. B. elektronischer Datenaustausch, Vorlegen von konventionellen Papier¬formularen).
Série aérospatiale - Systèmes de management de la qualité - Documentation des non-conformités
1.1 Application
Le présent document définit les informations et la documentation des non-conformités communes que le fournisseur ou sous-traitant du fournisseur interne/externe est tenu de produire pour informer les clients de la non-conformité nécessitant une décision formelle. Les exigences sont applicables, partiellement ou en totalité, dans le cas de la notification d'une non-conformité au propriétaire ou à l'opérateur, en tant qu'utilisateur du produit final (par exemple, moteur, aéronef, engin spatial, hélicoptère), si spécifié dans le contrat.
La notification des informations de non-conformité, par mode électronique ou conventionnel sur papier, est sujette aux modalités des exigences contractuelles. Ceci inclut également l’accès aux informations soumises à la règlementation de contrôle des exportations, si applicable.
1.2 Objectif
Le processus d’échange, de coordination et d’approbation des informations de non-conformité par le biais de dérogation ou défaut de qualité du produit varie en fonction de la multiplicité des relations et des accords entre les parties concernées. Les informations fournies dans le présent document constituent une architecture pour la soumission et la gestion des informations qui permet de communiquer de manière concise et précise à l’aide de diverses méthodes documentées. Le principal objectif de ce document est de définir un ensemble d'informations susceptibles d'être intégrées dans n'importe quelle forme de communication (par exemple, échange de données électroniques, soumission de formulaires conventionnels sur papier).
Aeronavtika - Sistemi vodenja kakovosti - Definicija podatkov o neskladnosti in dokumentacija
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9131:2020
01-oktober-2020
Nadomešča:
SIST EN 9131:2016
Aeronavtika - Sistemi vodenja kakovosti - Definicija podatkov o neskladnosti in
dokumentacija
Aerospace series - Quality Management Systems - Nonconformance Data Definition and
Documentation
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Nichtkonformitäts-Dokumentation
Série aérospatiale - Systèmes de management de la qualité - Documentation des non-
conformités
Ta slovenski standard je istoveten z: EN 9131:2020
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 9131:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9131:2020
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SIST EN 9131:2020
EN 9131
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2020
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9131:2016
English Version
Aerospace series - Quality Management Systems -
Nonconformance Data Definition and Documentation
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsysteme -
qualité - Documentation des non-conformités Nichtkonformitäts-Dokumentation
This European Standard was approved by CEN on 22 December 2019.
CEN 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
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 member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9131:2020 E
worldwide for CEN national Members.
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SIST EN 9131:2020
EN 9131:2020 (E)
Contents
Page
European foreword . 3
Rationale . 4
Foreword . 4
1 Scope . 5
1.1 Application . 5
1.2 Purpose . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Requirements . 7
5 Code catalog . 8
5.1 Nonconformity process codes . 8
5.2 Nonconformity cause codes . 8
5.3 Nonconformity Corrective Action Codes. 8
Annex A (informative) List of nonconformity documentation data (mandatory data fields
bolded with *) . 13
Annex B (informative) Nonconformity form (layout example) . 18
Bibliography . 19
2
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SIST EN 9131:2020
EN 9131:2020 (E)
European foreword
This document (EN 9131:2020) has been prepared by the Aerospace and Defence Industries
Association of Europe - Standardization (ASD-STAN).
After enquiries and votes carried out in accordance with the rules of this Association, this Standard has
received the approval of the National Associations and the Official Services of the member countries of
ASD-STAN, prior to its presentation to CEN.
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 January 2021, and conflicting national standards shall
be withdrawn at the latest by January 2021.
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 9131:2016.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
3
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SIST EN 9131:2020
EN 9131:2020 (E)
Rationale
This standard was created to provide for the uniform submittal of nonconformity information for
notification and/or approval when contractually invoked at any level or as guidance within the aviation,
space, and defense industry. This standard can be invoked as a stand-alone requirement or used in
conjunction with 9100-series standards (i.e., EN 9100, EN 9110, EN 9120).
Foreword
To assure customer satisfaction, aviation, space, and defense organizations must provide, and
continually improve, safe, reliable products and services that meet or exceed customer and applicable
statutory and regulatory requirements. The globalization of the industry, and the resulting diversity of
regional and national requirements and expectations, have complicated this objective. Organizations
have the challenge of purchasing products and services from external providers throughout the world
and at all levels of the supply chain. External providers have the challenge of delivering products and
services to multiple customers having varying quality requirements and expectations.
The aviation, space, and defense industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality and safety, and reductions in cost,
throughout the value stream. This organization includes representation from companies in the
Americas, Asia/Pacific, and Europe.
This document standardizes requirements for nonconformity data definition and documentation for the
industry. The establishment of common requirements, for use at all levels of the supply-chain by
organizations, should result in improved quality and safety, and decreased costs, due to the elimination
or reduction of organization-unique requirements and the resultant variation inherent in these multiple
expectations.
4
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SIST EN 9131:2020
EN 9131:2020 (E)
1 Scope
1.1 Application
This document defines the common nonconformity data definition and documentation that shall be
exchanged between an internal/external supplier or sub-tier supplier, and the customer when
informing about a nonconformity requiring formal decision. The requirements are applicable, partly or
totally, when reporting a product nonconformity to the owner or operator, as user of the end item (e.g.,
engine, aircraft, spacecraft, helicopter), if specified by contract.
Reporting of nonconformity data, either electronically or conventionally on paper, is subject to the
terms and conditions of the contract. This also includes, where applicable, data access under export
control regulations.
1.2 Purpose
The process of exchanging, coordinating, and approving nonconformity data via concession or product
quality escape varies with the multiple relationships and agreements among all parties concerned. The
information provided by this document forms architecture for submitting and managing data that
allows for concise and accurate communication using various documented methods. The main objective
of this document is to provide the definition of a data set that can be integrated into any form of
communication (e.g., electronic data interchange, submission of conventional paper forms).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
EN ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
1
EN 9100, Quality Management Systems — Requirements for Aviation, Space and Defence Organizations
1
EN 9110, Quality Management Systems — Requirements for Aviation Maintenance Organizations
1
EN 9120, Quality Management Systems — Requirements for Aviation, Space and Defence Distributors
IAQG Supply Chain Management Handbook (SCMH) — http://www.sae.org/iaqg/
1 As developed under the auspice of the IAQG and published by various standards bodies [e.g., AeroSpace and
Defense Industries Association – Standardization (ASD-STAN), SAE International, European Committee for
Standardization (CEN), Japanese Standards Association (JSA)/Society of Japanese Aerospace Companies (SJAC),
Brazilian Association for Technical Norms (ABNT)].
5
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SIST EN 9131:2020
EN 9131:2020 (E)
3 Terms and definitions
Definitions for general terms can be found in EN ISO 9000 and the IAQG International Dictionary
(located on the IAQG website).
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
ISO Online browsing platform: available at http://www.iso.org/obp
IEC Electropedia: available at http://www.electropedia.org/
3.1
customer
recipient of a product provided by an internal/external supplier or sub-tier supplier
3.2
mandatory data
common and transferable data systematically filled in and provided; if printed, this field shall be
included on the printed form
3.3
optional data
all data fields that are not defined as mandatory by this standard; these fields may be requested by a
customer or needed by the originator for their own purposes
3.4
product
output of an organization that can be produced without any transaction taking place between the
organization and the customer
Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between
provider and customer, but can often involve this service element upon its delivery to the customer.
Note 2 to entry: The dominant element of a product is that it is generally tangible.
Note 3 to entry: Hardware is tangible and its amount is a countable characteristic (e.g. tyres). Processed
materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and
processed materials are often referred to as goods. Software consists of information regardless of delivery
medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical
composition copyright, driver's license).
EXAMPLE vehicle, engine, equipment, component, deliverable software, or parts and materials thereof
[SOURCE: EN ISO 9000:2015, 3.7.6 – modified: numbering in brackets removed, example added]
3.5
product quality escape
any product released by an internal/external supplier or sub-tier supplier, that is subsequently
determined to have one or more nonconformities to contract and/or product specification require-
ments, that have not been positively dispositioned prior to delivery
6
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SIST EN 9131:2020
EN 9131:2020 (E)
3.6
concession
documented authorization from the customer to the internal/external supplier to use or release a
product which does not conform to the specified requirements
Note 1 to entry: Concession and product quality escape differ with respect to the point in time when a
nonconformity is detected during the product life cycle. Concession is evident before delivery to the customer,
while a product quality escape is identified after delivery to the customer.
4 Requirements
4.1 Data related to the description of a nonconformity (i.e., content, format, size) shall be in
accordance with the complete set defined in Annex A and the contractual requirements.
a) Mandatory data fields, identified in bold text and marked with an asterisk (*) shall be
systematically recorded and reported to the customer.
b) Optional data fields shall be recorded, when required, provided that it is not in contradiction with
contractual requirements.
NOTE 1 Any data field, whether mandatory or optional data, recorded and reported to the customer that is not
applicable shall have N/A entered in the field, prior to final approval/signature.
NOTE 2 Customers may require different optional data fields be recorded and reported. It is therefore
recommended that the Information Technology System be capable of defining optional data fields and/or
inactivating data fields based on each customer’s recording/reporting requirements. This includes the capability
of the Information Technology System to process with data types and data sizes specified in this standard.
NOTE 3 While this standard provides requirements that cover the development of forms or electronic systems,
exceptions for use of the form or system are allowed as permitted by the customer. For example, where a process
batch containing multiple part numbers is to be dispositioned together, the first part number and associated fields
would be on the form and additional part numbers and those fields could be on an attachment (see 4.3).
4.2 The entities responsible for entering and approving/acknowledging nonconformity data (in
particular disposition, category/classification of the nonconformity, and associated limitations) shall
respond in accordance with the terms and conditions of the contractual or regulatory requirements.
4.3 Attached files should be in a protected format (e.g., pdf, tif, jpg), whenever possible. Where this is
not practical, appropriate precautions shall be taken to prevent inadvertent changes to the attachments.
4.4 Where file sizes are constrained, a file size optimization tool should be used. If file compression is
not capable of meeting file size constraints, the data exchange shall be agreed upon between both
parties (e.g., via compact disk, USB flash drive, e-mail correspondence, direct access to data system).
4.5 When the description of a nonconformity is not required in an electronic format and/or is
required as a printout, it shall be in a format similar to the example depicted in Annex B; however, the
size and order of the fields may be changed to suit the individual application provided that
a) the contents of the boxes specified in this standard are maintained; alternatively a cross reference
can be used,
b) the form is identified as a nonconformity record and
c) it complies with contractual/regulatory requirements.
7
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SIST EN 9131:2020
EN 9131:2020 (E)
4.6 When required, continuation/additional sheets and attachments shall include the same reference
number as the original document.
NOTE Reference Annex A, the data fields ‘Nonconformity Description’ (see No. 19) and ‘Disposition’
(see No. 25) may be presented either as a summary or in a clearly defined sub-structure (see No. 19 a-i and
No. 25 a-e).
4.7 The forms may be pre-printed, computer generated, or accessed via a net-based system
(intranet/internet), but in all cases, the printing of lines and characters shall be clear and legible. The
details entered on the forms shall preferably be machine/computer printed, but may be handwritten as
long as upper case letters are used and the document remains legible.
NOTE The use of abbreviations should be kept at a minimum.
4.8 The information shall be in English, but other languages may be acceptable (e.g., bilingual: English
and native) when specified in the contract.
NOTE The use of abbreviations should be kept to a minimum.
5 Code catalog
The following codes are recommended for codifying affected processes, causes of process deviations,
and corrections made to remedy the nonconformity. If codes are defined by a contract and/or the
originators already have codes defined that satisfy their needs, these codes shall take precedence over
those proposed in the following sections.
NOTE The following codes represent a minimum selection of possible v
...
SLOVENSKI STANDARD
oSIST prEN 9131:2018
01-september-2018
Aeronavtika - Sistemi vodenja kakovosti - Definicija podatkov o neskladnosti in
dokumentacija
Aerospace series - Quality Management Systems - Nonconformance Data Definition and
Documentation
Ta slovenski standard je istoveten z: prEN 9131
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
oSIST prEN 9131:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 9131:2018
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oSIST prEN 9131:2018
DRAFT
EUROPEAN STANDARD
prEN 9131
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2018
ICS 03.120.10; 03.100.70; 49.020 Will supersede EN 9131:2016
English Version
Aerospace series - Quality Management Systems -
Nonconformance Data Definition and Documentation
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee ASD-
STAN.
If this draft becomes a European Standard, CEN 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.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9131:2018 E
worldwide for CEN national Members.
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oSIST prEN 9131:2018
prEN 9131:2018 (E)
Contents Page
European foreword . 3
0 Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements . 6
5 Code catalogue . 7
Annex A (informative) List of nonvonformity documentation data (mandatory data fields
bolded with *) . 13
Annex B (informative) Nonconformity form (layout example) . 18
Bibliography . 19
Tables
Table 1 — Nonconformity process codes. 8
Table 2 — Nonconformity cause codes . 10
Table 3 — Nonconformity Corrective action codes . 12
2
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oSIST prEN 9131:2018
prEN 9131:2018 (E)
European foreword
This document (prEN 9131:2018) has been prepared by the Aerospace and Defence Industries
Association of Europe - Standardization (ASD-STAN).
After enquiries and votes carried out in accordance with the rules of this Association, this Standard has
received the approval of the National Associations and the Official Services of the member countries of
ASD, prior to its presentation to CEN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 9131:2016.
3
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oSIST prEN 9131:2018
prEN 9131:2018 (E)
0 Introduction
0.1 Rationale
This document has been significantly revised further defining process requirements and data
expectations; restructuring the nonconformity documentation data and providing further definition of
data descriptions; and providing process defect, cause, and corrective action codes.
This document was created to provide for the uniform submittal of nonconformity information for
notification and/or approval when contractually invoked at any level or as guidance within the aviation,
space, and defence industry. This document can be invoked as a stand-alone requirement or used in
conjunction with the EN 9100 series standards (i.e. EN 9100, EN 9110, EN 9120).
0.2 Foreword
To ensure customer satisfaction, aviation, space, and defence industry organizations will produce, and
continually improve, safe, reliable products that meet or exceed customer and regulatory authority
requirements. The globalization of the industry, and the resulting diversity of regional/national
requirements and expectations, has complicated this objective. End product organizations face the
challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the
world and at all levels within the supply chain. Industry suppliers and processors face the challenge of
delivering product to multiple customers having varying quality expectations and requirements.
The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality and safety, and reductions in cost,
throughout the value stream. This organization includes representation from companies in the
Americas, Asia/Pacific, and Europe.
This document standardizes requirements for nonconformity data definition and documentation for the
industry. The establishment of common requirements, for use at all levels of the supply-chain by
organizations, should result in improved quality and safety, and decreased costs, due to the elimination
or reduction of organization-unique requirements and the resultant variation inherent in these multiple
expectations.
4
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oSIST prEN 9131:2018
prEN 9131:2018 (E)
1 Scope
1.1 Application:
This document defines the common nonconformity data definition and documentation that shall be
exchanged between an internal/external supplier or sub-tier supplier, and the customer when
informing about a nonconformity requiring formal decision. The requirements are applicable, partly or
totally, when reporting a product nonconformity to the owner or operator, as user of the end item
(e.g. engine, aircraft, spacecraft, helicopter), if specified by contract.
Reporting of nonconformity data, either electronically or conventionally on paper, is subject to the
terms and conditions of the contract. This also includes, where applicable, data access under export
control regulations.
1.2 Purpose:
The process of exchanging, coordinating, and approving nonconformity data via waiver/concession or
product quality escape varies with the multiple relationships and agreements among all parties
concerned. The information provided by this document forms architecture for submitting and managing
data that allows for concise and accurate communication using various methods. The main objective of
this document is to provide the definition of a data set that can be integrated into any form of
communication (e.g. electronic data interchange, submission of conventional paper forms).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
EN ISO 9000:2015, Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 9000:2015 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
customer
recipient of a product provided by an internal/external supplier or sub-tier supplier
3.2
mandatory data
common and transferable data systematically filled in and provided
Note 1 to entry: The data field shall be printed out on the paper form.
5
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oSIST prEN 9131:2018
prEN 9131:2018 (E)
3.3
optional data
all data fields that are not defined as mandatory by this document
Note 1 to entry: These fields may be requested by a customer or needed by the originator for their own
purposes.
3.4
product
product of which examples include a vehicle, engine, equipment, component, deliverable software, or
parts and materials thereof
Note 1 to entry: The definition of EN ISO 9000:2015, 3.7.6 applies.
3.5
product quality escape
product released by an internal/external supplier or sub-tier supplier, that is subsequently determined
to have one or more nonconformities to contract and/or product specification requirements, that have
not been positively dispositioned prior to delivery
3.6
waiver/concession
written authorization from the customer to the internal/external supplier to use or release a product
which does not conform to the specified requirements
Note 1 to entry: Waiver/concession and product quality escape differ with respect to the point in time when a
nonconformity is detected during the product life cycle. Waiver/concession is evident before delivery to the
customer, while a product quality escape is identified after delivery to the customer.
4 Requirements
4.1 Data related to the description of a nonconformity (i.e. content, format, size) shall be in
accordance with the complete set defined in Annex A and the contractual requirements.
a) Mandatory data fields, identified in bold text and marked with an asterisk (*) shall be
systematically recorded and reported to the customer.
b) Optional data fields shall be recorded, when required, provided that it is not in contradiction with
contractual requirements.
For any data field, whether mandatory or optional data, recorded and reported to the customer that
is not applicable shall have N/A entered in the field, prior to final approval/signature.
Customers may require different optional data fields be recorded and reported. It is therefore
recommended that the information technology system be capable of defining optional data fields
and/or inactivating data fields based on each customer’s recording/reporting requirements. This
includes the capability of the information technology system to process with data types and data
sizes specified in this document.
4.2 The entities responsible for entering and approving/acknowledging nonconformity data (in
particular disposition, category/classification of the nonconformity, and associated limitations) shall
respond in accordance with the terms and conditions of the contractual or regulatory requirements.
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4.3 Attached files should be in a protected format (e.g. pdf, tif, jpg), whenever possible. Where this is
not practical, appropriate precautions shall be taken to prevent inadvertent changes to the attachments.
4.4 Where file sizes are constrained, file size optimization tool should be used. If a file compression is
not capable of meeting file size constraints, the data exchange shall be agreed upon between both
parties [e.g. via compact disk, USB flash drive, e-mail correspondence, direct access to data system].
4.5 When the description of a nonconformity is not required in an electronic format and/or is
required as a printout, it shall be in a format similar to the example depicted in Annex B; however, the
size and order of the fields may be changed to suit the individual application provided that:
a) the contents of the boxes specified in this document are maintained; alternatively a cross reference
can be used.
b) the form is identified as a nonconformity record.
c) complies with contractual/regulatory requirements.
4.6 When required, continuation/additional sheets and attachments shall include the same reference
number as the original document.
Reference Annex A, the data fields “Nonconformity Description” (see No. 19) and “Disposition”
(see No. 25) may be presented either as a summary or in a clearly defined sub-structure (see No. 19 a-i
and No. 25 a-e).
4.7 The forms may be pre-printed, computer generated, or accessed via a net-based system
(intranet/internet), but in all cases, the printing of lines and characters shall be clear and legible. The
details entered on the forms shall preferably be machine/computer printed, but may be handwritten as
long as upper case letters are used and the document remains legible.
The use of abbreviations should be kept at a minimum.
4.8 The information shall be in English, but other languages may be acceptable (e.g. bilingual: English
and native) when specified in the contract.
The use of abbreviations should be kept to a minimum.
5 Code catalogue
5.1 General
The following codes are recommended for codifying affected processes, causes of process deviations,
and corrections made to remedy the nonconformity. If codes are defined by a contract and/or the
originators already have codes defined that satisfy their needs, these codes shall take precedence over
those proposed in the following sections.
NOTE The following codes represent a minimum selection of possible variances. In case of needing additional
code definitions (e.g. software, electronic, composites, structures), the tables can be enhanced by using the
existing structure.
5.2 Nonconformity Process Codes
A product nonconformity is typically associated with a process deviation. See Table 1 for a list of codes.
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5.3 Nonconformity Cause Codes
The causes of process deviations are defined in Table 2. The categorization of the list is set up to
facilitate the use of process improvement tools (e.g. cause and effect diagram). The “Main Term” code
can be used as the cause code, if appropriate, or further definition may be provided.
One or more cause codes may be used to define the cause(s) for a product nonconformity.
NOTE The allocation of a cause code could be either apparent (preliminary/initial) or final, depending on the
status of root cause analysis. For further support, see EN 9136 and the SCMH (“Root Cause Analysis and Problem
Solving” chapter).
5.4 Nonconformity Corrective Action Codes
Common corrective action codes are defined in Table 3; intended to correspond directly to the cause
codes identified in Table 2, as appropriate.
One or more corrective action codes may be used to define the corrective action(s) taken for a product
nonconformity/cause code.
Table 1 — Nonconformity process codes
Main Term Process code Definition/Description
P1 – Shipping and Transportation P11 Shipping
P12 Transportation
P13 Order Preparation
P14 Preparation of Packaging
P15 Packaging
P2 – Manufacturing P201 Assembly
P202 Test
P203 Balancing
P204 Benching
P205 Blasting
P206 Bonding
P207 Brazing
P208 Broaching
P209 Casting
P210 Cleaning
P211 Coating
P212 Composite Manufacturing
P213 Crimping
P214 Deburring
P215 Drilling
P216 Electrochemical Processing
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Main Term Process code Definition/Description
P217 Etching
P218 Forging
P219 Forming
P220 Grinding
P221 Heat Treatment
P222 Precision Hole Making
P223 Honing and Lapping
P224 Hot Isostatic Pressing
P
...
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