oSIST prEN 9103:2022
(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;
- "can" indicates a possibility or a capability.
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Management der Veränderung der Haupteigenschaften
Série aérospatiale - Systèmes de management de la qualité - Management de la variation des caractéristiques clés
Aeronavtika - Sistemi vodenja kakovosti - Vodenje sprememb ključnih značilnosti
General Information
RELATIONS
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN 9103:2022
01-december-2022
Aeronavtika - Sistemi vodenja kakovosti - Vodenje sprememb ključnih značilnosti
Aerospace series - Quality management systems - Variation management of key
characteristics
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Management der Veränderung
der Haupteigenschaften
Série aérospatiale - Systèmes de management de la qualité - Management de la
variation des caractéristiques clés
Ta slovenski standard je istoveten z: prEN 9103
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 9103:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------oSIST prEN 9103:2022
---------------------- Page: 2 ----------------------
oSIST prEN 9103:2022
DRAFT
EUROPEAN STANDARD
prEN 9103
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2022
ICS 03.100.70; 03.120.10; 49.020 Will supersede 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 - Qualitätsmanagementsysteme -
qualité - Management de la variation des Management der Veränderung der Haupteigenschaften
caractéristiques clésThis 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, 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.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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 9103:2022 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
Contents Page
European foreword ...................................................................................................................................................... 4
Rationale .......................................................................................................................................................................... 5
Introduction .................................................................................................................................................................... 6
1 Scope .................................................................................................................................................................... 9
1.1 General................................................................................................................................................................ 9
1.2 Purpose ............................................................................................................................................................... 9
1.3 Convention ........................................................................................................................................................ 9
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 .................................................................... 14
4.4 Application of switching rules .................................................................................................................. 15
4.5 Restrictions of statistical process control ............................................................................................ 15
4.6 Personnel competence and training ...................................................................................................... 15
4.7 Key characteristic variation management and control documentation ................................... 16
5 Process model for variation management of key characteristics ............................................... 17
5.1 Stage 1: conduct product performance and key characteristics review ................................... 17
5.1.1 Reviewing customer provided design documentation to identify product keycharacteristics ................................................................................................................................................ 17
5.1.2 Determining process key characteristics............................................................................................. 17
5.1.3 Identifying substitute product key characteristics .......................................................................... 18
5.1.4 Releasing and maintaining identified key characteristics ............................................................ 18
5.1.5 Outputs of stage 1 ......................................................................................................................................... 19
5.2 Stage 2: define the plan to ensure a capable process ....................................................................... 19
5.2.1 Preparing the control plan ........................................................................................................................ 19
5.2.2 Developing the manufacturing or maintenance process flow diagram .................................... 19
5.2.3 Developing a manufacturing or maintenance process risk analysis ......................................... 19
5.2.4 Establishing the manufacturing or maintenance process.............................................................. 20
5.2.5 Updating the control plan .......................................................................................................................... 20
5.2.6 Outputs of stage 2 ......................................................................................................................................... 20
5.3 Stage 3: operate the process on trial basis to generate data ......................................................... 21
5.3.1 Developing the data collection plan ....................................................................................................... 21
5.3.2 Producing trial parts ................................................................................................................................... 21
5.3.3 Conducting a measurement system analysis study .......................................................................... 21
5.3.4 Collecting data to monitor process performance .............................................................................. 22
5.3.5 Plotting collected data or summary statistics on control chart ................................................... 22
5.3.6 Updating the control plan .......................................................................................................................... 23
5.3.7 Outputs of stage 3 ......................................................................................................................................... 23
5.4 Stage 4: analyse data for action ............................................................................................................... 23
5.4.1 Reviewing the control chart to monitor process performance .................................................... 23
5.4.2 Periodically analysing the data to ensure on-going process capability .................................... 24
5.4.3 Pursuing investigation into out-of-control conditions or sources of variation ..................... 24
---------------------- Page: 4 ----------------------oSIST prEN 9103:2022
prEN 9103:2022 (E)
5.4.4 Updating the control plan .......................................................................................................................... 24
5.4.5 Outputs of stage 4 ......................................................................................................................................... 24
5.5 Stage 5: take action from process performance study .................................................................... 25
5.5.1 Applying the control plan’s reaction plan to deal with an unstable process .......................... 25
5.5.2 Performing measurement system analysis to deal with incapable process ........................... 25
5.5.3 Implementing the plan to achieve containment ................................................................................ 25
5.5.4 Updating the control plan .......................................................................................................................... 26
5.5.5 Outputs of stage 5 ......................................................................................................................................... 26
5.6 Stage 6: continue to monitor the process............................................................................................. 26
5.6.1 Conducting verification of process performance on a regular basis ......................................... 26
5.6.2 Continually reviewing quality and/or workmanship indicators ................................................ 26
5.6.3 Outputs of stage 6 ......................................................................................................................................... 27
5.7 Stage 7: manage process change ............................................................................................................. 27
5.7.1 Documenting changes ................................................................................................................................. 27
5.7.2 Implementing changes, as required ...................................................................................................... 27
5.7.3 Outputs of stage 7 ......................................................................................................................................... 27
5.8 Maintaining documentation to demonstrate compliance ............................................................. 27
6 Control plan content requirements ....................................................................................................... 27
6.1 Purpose ............................................................................................................................................................ 27
6.2 General control plan principles and elements ................................................................................... 27
6.3 Variation management ............................................................................................................................... 29
Annex A (informative) Acronym log ..................................................................................................................... 30
Annex B (normative) Reaction plan guidance (use/application and content) ..................................... 31
Bibliography ................................................................................................................................................................. 32
FiguresFigure 1 — Relationship for 9103 among other IAQG standards ................................................................. 8
Figure 2 — Key characteristics variation management model .................................................................. 17
---------------------- Page: 5 ----------------------oSIST prEN 9103:2022
prEN 9103:2022 (E)
European foreword
This document (prEN 9103:2022) 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, prior to its presentation to CEN.This document is currently submitted to the CEN Enquiry.
This document will supersede EN 9103:2014.
---------------------- Page: 6 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
Rationale
This document was revised to align with the latest revisions of the International Aerospace Quality
Group (IAQG) standards (i.e. EN 9100, EN 9110, EN 9102, EN 9138, EN 9145) and to incorporate
industry feedback. Other changes made to standard requirements presented herein were editorial in
nature for increased clarity, including additional terms and definitions, and references to other relevant
external standards.---------------------- Page: 7 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
Introduction
To ensure customer satisfaction, aviation, space, and defence industry organizations must 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 external providers
throughout the world and at all levels within the supply chain. Industry producers, including external
providers, face the challenge of delivering product to multiple customers having varying quality
expectations and requirements.The aviation, space, and defence industry established the 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 the variation management of key characteristics (KCs).
The establishment of common requirements, for use at all levels of the supply chain, 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.
GeneralThis document establishes variation management requirements for KCs and provides a process to
achieve those requirements.The document requires a thorough assessment of the applicable manufacturing and maintenance
processes with the primary goals being to control and minimize variation in characteristics generated
by these processes. Specifically, the standard requires:— understanding process elements that affect KCs;
— disciplined determination of process KCs using appropriate analysis tools for variation control and
reduction to satisfy customer requirements;— control and capability assessment to ensure variation is well understood;
— control plan (CP) that defines specific control of KCs, and manufacturing or maintenance process
parameters.Product acceptance and release are carried out according to customer requirements; this document
cannot be used as the basis for product acceptance and release. This document does not:
— require rejection of any part that conforms to engineering specifications;— inhibit shipment or use of product during production process capability assessment.
For the purpose of this document, the variation control process does not apply to lab-scale, pilot, or pre-
production processes; however, particular management of some KCs might be required using methods
other than those described in this document, during the various phases of a program, when required by
the customer or deemed appropriate by the organization (e.g. engineering, manufacturing).
Although this document is focused on variation control of KCs for manufacturing and maintenance
activities, this document can also be used as a model for other characteristics, such as those that are
related to customer satisfaction (e.g. cost, on-time-delivery).Application
---------------------- Page: 8 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
This document was created to provide requirements for the variation management of KCs when
contractually invoked at any level of the supply chain. This document can also be used as guidance
within the aviation, space, and defence industry in the control of KCs. This document can be invoked as
a stand-alone requirement or used in conjunction with other IAQG standards (e.g. EN 9100, EN 9110,
EN 9102, EN 9138, EN 9145).For any design characteristic required by the customer (design authority or KC owner), there is a
minimum probability of conformity that is needed for the product to perform its design function.
Continuing to improve the process beyond that point is desirable whenever global cost-effective
methods are available.— This document provides requirements on performing that ongoing improvement.
— EN 9145 provides a structured framework for the product development process through the use of
Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP)
methodologies to ensure quality product(s) are delivered on time, while satisfying cost
performance targets.— EN 9138 provides methods to ensure the minimum probability of conformity is achieved for each
characteristic for which information is collected.— EN 9102 provides the method to validate with objective evidence that product realization
processes are capable of producing parts and assemblies that meet engineering and design
requirements.The relationship between these standards is conceptually illustrated in Figure 1, making the link with
the development milestones and EN 9145 process phases, starting with conceptual product needs and
extending throughout the product life cycle.— The sooner KCs are identified and put under production control, the sooner the organization can
start the capitalization and optimization of the processes.— Prior to the end of EN 9145 Phase 4 (Product and Process Validation), EN 9103 methods are used
to verify the capability of the production processes prior to on-going production.
— By the end of EN 9145 Phase 4, the design authority has concluded that all applicable customer
commitments have been satisfied in the design of the product and that the production processes
“consistently” produce conforming product. This “consistent” production can be represented by a
probability of conformity value in delivered product above the minimum that is acceptable to the
design authority. Where EN 9138 applies, that minimum value is designated the Initial Reliability
Requirement (IRR).— During EN 9145 Phase 5 (On-Going Production, Use, and Post-Delivery Service), the focus of EN
9103 is to further improve the manufacturing or maintenance process maturity, reduce the cost of
variation to the producer, and increase the probability of conformity rate in delivered product
while remaining under the global cost-effectiveness limit (the point at which further improvement
opportunities cost more than the improvement returns). This limit may evolve as more cost-
effective improvements are discovered.NOTE The actual duration of each phase will differ depending upon the scope and timing of the specific
product and/or product development project.---------------------- Page: 9 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
Figure 1 — Relationship for 9103 among other IAQG standards
---------------------- Page: 10 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
1 Scope
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 ConventionThe following conventions are used in this document:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
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.
When a conflict between this document and the referenced standards exists, the requirements of this
document shall take precedence. Further bibliographical information supporting EN 9103
implementation may be found in Annex A.---------------------- Page: 11 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
EN 9100, Quality Management Systems — Requirements for Aviation, Space, and Defence Organizations
EN 9101, Quality Management Systems — Audit Requirements for Aviation, Space, and Defence
OrganisationsISO 3534-2, Statistics — Vocabulary and symbols — Part 2: Applied statistics
ISO 9000, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, the IAQG International
3) 4)Dictionary , EN 9100 , EN 9101 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• ISO Online browsing platform: available at https://www.iso.org/obp/ui• IEC Electropedia: available at https://www.electropedia.org/
3.1
common cause
usual, historical, quantifiable variation in a process characterized by phenomena constantly active in
the process, probabilistically predictable, and lacking significant high or low values
Note 1 to entry: Common cause may also include irregular, but predictable variation within a historical
experience baseEXAMPLE The variation caused by inappropriate/insufficient procedures, designs, and facilities, which may
result from current limited know-how, technical conditions and technologies, awareness, etc. (e.g. poor design,
poor maintenance of machines, lack of clearly defined standard operating procedures, poor working conditions,
dirt, temperature, machines not suited to the job, substandard raw materials, measurement error, vibration in
industrial processes, insufficient training).3.2
control plan
(CP)
documented description linking manufacturing or maintenance process steps to key inspection and
control activities. The intent of a CP is to control the product design characteristics and process
variables to ensure product quality3.3
design characteristics
those dimensional, visual, functional, mechanical, cosmetic, and material features or properties, which
describe and constitute the design of the article, as specified by design definition file requirements
Note 1 to entry: Design characteristics can be measured, inspected, tested, or verified to determine conformity
to the design requirements.As developed under the auspice of the IAQG and published by various standards bodies [e.g., 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)].
Published by: ISO International Organization for Standardization http://www.iso.ch/.
Located on the IAQG website: https://iaqg.org/tools/dictionary/.Particularly critical items (CIs) and special requirements.
---------------------- Page: 12 ----------------------
oSIST prEN 9103:2022
prEN 9103:2022 (E)
Note 2 to entry: Dimensional features include in-process locating features (e.g. target-machined or forged/cast
dimensions on forgings and castings, weld/braze joint preparation necessary for acceptance of finished joint).
Material features or properties may include processing variables and sequences, which are specified by the design
definition file (e.g. heat treat temperature, fluorescent penetrant class, ultrasonic scans, sequence of welding and
heat treat). These provide assurance of intended characteristics that could not be otherwise inspected.
3.4design documentation
documentation supporting engineering definition/specification, which fully define the product,
including physical or electronic/digital drawings, electronic/digital models, firmware/software, or
other associated informationNote 1 to entry: This includes records of authorized engineering changes not yet incorporated into the released
engineering definition/specification.3.5
failure mode and effects analysis
(FMEA)
structured method for analysing risk by ranking and documenting potential failure mode(s) in a system,
design, or process. The analysis includes:— identification of potential failures and their effects;
— ranking of factors (e.g., severity, frequency of occurrence, detectability of the potential failures);
— identification and results of actions taken to reduce or eliminate riskNote 1 to entry: The FMEA assists in the identification of CIs as well as key product and process characteristics,
helps prioritize action plans for mitigating risk, and serves as a repository for lessons learned. FMEA examples
include: system FMEA, interface FMEA, design failure mode and effects analysis (DFMEA), and process failure
mode and effects analysis (PFMEA).Note 2 to entry: PFMEA is a means of analysis using the FMEA methodology and DFMEA results, when available,
to identify and analyse potential failures and their effects during manufacturing or maintenance processes, and to
take preventive actions and controls to reduce or eliminate risks.3.6
key characteristic
(KC)
attribute or feature whose variation has a significant effect on product fit, form, function, performance,
service life, or producibility that requires specific actions for the purpose of controlling variation
Note 1 to entry: Other identified characteristics may be included in order to master interfaces, functional
characteristics, and the process capability and potential proces...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.