EN 9103:2023
(Main)Aerospace series - Quality management systems - Variation management of key characteristics
Aerospace series - Quality management systems - Variation management of key characteristics
1.1 General
This document is primarily intended to apply to new parts and products intended to be produced in an on-going production phase but can also be applied to parts currently in production (e.g., manufacturing, maintenance). This document is applicable to all production processes that influence the variation of KCs, as well as maintenance and service processes in which KCs are identified. It applies to organizations for assemblies and all levels of parts within an assembly, down to the basic materials including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product.
The variation control process begins with product definition, typically stated in the design documentation (e.g., digital model, engineering drawing, specification) which identifies KCs, and leads to a variation management process for those KCs. This process may also be used for producer-identified KCs (e.g., process KCs, additional/substitute product KCs).
Producers and their subcontractors are responsible for flow down of the standard requirements to those external providers, who produce design characteristics and provide production and service provisions, to ensure that KCs conform to the customer’s requirements.
1.2 Purpose
This document is designed to drive the improvement of manufacturing and maintenance processes through adequate planning and effective management of KC variation. This focus is intended to improve uniformity (less variation or minimum variation of product KCs) and acceptance probability of the end-product.
NOTE Control of a product or process KC per this document does not constitute, nor imply acceptance of the resulting product. If variation management, under this document, is to be part of an acceptance decision, the requirements need to be specified in the applicable product acceptance plan or contract.
1.3 Convention
The following conventions are used in this document:
- "shall" indicates a requirement;
- "should" indicates a recommendation;
- "may" indicates a permission; and
- "can" indicates a possibility or a capability.
Luft- und Raumfahrt - Qualitätsmanagementsystems - Management der Veränderung der Haupteigenschaften
Série aérospatiale - Systèmes de management de la qualité - Gestion des variations des caractéristiques clés
Aeronavtika - Sistemi vodenja kakovosti - Vodenje sprememb ključnih značilnosti
1.1 Splošno
Ta dokument je namenjen zlasti uporabi za nove dele in izdelke, ki so predvideni za trajno proizvodnjo, vendar ga je mogoče uporabiti tudi za dele, ki se trenutno proizvajajo (npr. proizvodnja, vzdrževanje). Ta dokument se uporablja za vse proizvodne postopke, ki vplivajo na spremembe ključnih značilnosti (KC), ter za vzdrževalne in servisne postopke, v katerih so opredeljene ključne značilnosti. Uporablja se za organizacije, ki izdelujejo sestave in vse ravni delov v sestavu, vse do osnovnih materialov, vključno z odlitki in izkovki, ter za organizacije, ki so odgovorne za proizvodnjo značilnosti zasnove izdelka.
Proces nadziranja sprememb se začne z definicijo izdelka, ki je običajno navedena v projektni dokumentaciji (npr. digitalni model, tehnična risba ali specifikacija), ki opredeljuje ključne značilnosti, in vodi v postopek vodenja sprememb za zadevne ključne značilnosti. Ta proces se lahko uporabi tudi za ključne značilnosti, ki jih opredeli proizvajalec (npr. ključne značilnosti procesov ali dodatnih/nadomestnih izdelkov).
Proizvajalci in njihovi podizvajalci so odgovorni za posredovanje standardnih zahtev zunanjim ponudnikom, ki proizvajajo značilnosti zasnove ter so odgovorni za proizvodnjo in izvedbo storitev, s čimer zagotovijo, da so ključne značilnosti v skladu z zahtevami strank.
1.2 Namen
Ta dokument je namenjen izboljšanju proizvodnje in proizvodnih postopkov z ustreznim načrtovanjem in učinkovitim vodenjem sprememb ključnih značilnosti. Poudarek je na večji enotnosti (manj sprememb ali minimalne spremembe ključnih značilnosti izdelkov) in verjetnosti sprejemljivosti končnega izdelka.
OPOMBA: Nadzor ključne značilnosti izdelka ali procesa v skladu s tem dokumentom ne pomeni ali nakazuje sprejemljivosti nastalega izdelka. Če naj bi bilo vodenje sprememb v skladu s tem dokumentom del odločitve o sprejemljivosti, je treba zahteve v zvezi s tem določiti v ustreznem načrtu ali pogodbi o sprejemljivosti izdelka.
1.3 Konvencija
V tem dokumentu so uporabljene naslednje konvencije:
– »treba je« ali »mora« označuje zahtevo;
– »naj« označuje priporočilo;
– »sme« označuje dovoljenje;
– »lahko« označuje možnost ali sposobnost.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2024
Aeronavtika - Sistemi vodenja kakovosti - Vodenje sprememb ključnih značilnosti
Aerospace series - Quality management systems - Variation management of key
characteristics
Luft- und Raumfahrt - Qualitätsmanagementsystems - Management der Veränderung
der Haupteigenschaften
Série aérospatiale - Systèmes de management de la qualité - Management de la
variation des caractéristiques clefs
Ta slovenski standard je istoveten z: EN 9103:2023
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 9103
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9103:2014
English Version
Aerospace series - Quality management systems -
Variation management of key characteristics
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsystems -
qualité - Gestion des variations des caractéristiques Management der Veränderung der Haupteigenschaften
clés
This European Standard was approved by CEN on 7 August 2023.
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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9103:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 8
1.1 General. 8
1.2 Purpose . 8
1.3 Convention . 8
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 13
4.1 Flow down of product key characteristics . 13
4.2 Preparation of control plan inputs and outputs . 14
4.3 Conditions for performing statistical process control . 15
4.4 Application of switching rules . 15
4.5 Restrictions of statistical process control . 15
4.6 Personnel competence and training . 16
4.7 Key characteristic variation management and control documentation . 16
5 Process model for variation management of key characteristics . 17
5.1 General. 17
5.2 Stage 1: conduct product performance and key characteristics review . 19
5.2.1 Reviewing customer provided design documentation to identify product key
characteristics . 19
5.2.2 Determining process key characteristics. 19
5.2.3 Identifying substitute product key characteristics . 19
5.2.4 Releasing and maintaining identified key characteristics . 20
5.2.5 Outputs of stage 1 . 20
5.3 Stage 2: define the plan to ensure a capable process . 20
5.3.1 Preparing the control plan . 20
5.3.2 Developing the manufacturing or maintenance process flow diagram . 21
5.3.3 Developing a manufacturing or maintenance process risk analysis . 21
5.3.4 Establishing the manufacturing or maintenance process. 22
5.3.5 Updating the control plan . 22
5.3.6 Outputs of stage 2 . 22
5.4 Stage 3: operate the process on trial basis to generate data . 22
5.4.1 Developing the data collection plan . 22
5.4.2 Producing trial parts . 23
5.4.3 Conducting a measurement system analysis study . 23
5.4.4 Collecting data to monitor process performance . 24
5.4.5 Plotting collected data or summary statistics on control chart . 24
5.4.6 Updating the control plan . 25
5.4.7 Outputs of stage 3 . 25
5.5 Stage 4: analyse data for action . 25
5.5.1 Reviewing the control chart to monitor process performance . 25
5.5.2 Periodically analysing the data to ensure on-going process capability . 26
5.5.3 Pursuing investigation into out-of-control conditions or sources of variation . 26
5.5.4 Updating the control plan . 26
5.5.5 Outputs of stage 4 . 26
5.6 Stage 5: take action from process performance study . 26
5.6.1 Applying the control plan’s reaction plan to deal with an unstable process . 26
5.6.2 Performing measurement system analysis to deal with incapable process . 27
5.6.3 Implementing the plan to achieve containment . 27
5.6.4 Updating the control plan . 27
5.6.5 Outputs of stage 5 . 28
5.7 Stage 6: continue to monitor the process. 28
5.7.1 Conducting verification of process performance on a regular basis . 28
5.7.2 Continually reviewing quality and/or workmanship indicators . 28
5.7.3 Outputs of stage 6 . 28
5.8 Stage 7: manage process change . 29
5.8.1 Documenting changes . 29
5.8.2 Implementing changes, as required . 29
5.8.3 Outputs of stage 7 . 29
5.9 Maintaining documentation to demonstrate compliance . 29
6 Control plan content requirements . 29
6.1 Purpose . 29
6.2 General control plan principles and elements . 29
6.3 Variation management . 31
Annex A (informative) Acronym log . 32
Annex B (normative) Reaction plan guidance (use/application and content) . 33
Bibliography . 34
Figures
Figure 1 — Relationship for 9103 among other IAQG standards . 7
Figure 2 — Key characteristics variation management model . 18
European foreword
This document (EN 9103:2023) 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
document 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 document shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 9103:2014.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this document: 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,
Türkiye and the United Kingdom.
Introduction
This document was revised to align with the latest revisions of the International Aerospace Qu
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