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 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.
To assure 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.
General
This 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
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 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.
Figure 1 — Relationship for 9103 among other IAQG standards
When a conflict between this document and the referenced standards exists, the requirements of this
document take precedence. Further bibliographical information supporting EN 9103 implementation
may be found in Annex A.
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 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.
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 9100, Quality Management Systems — Requirements for Aviation, Space, and Defence Organizations
1, 2
Quality Management Systems — Requirements for Conducting Audits of Aviation, Space and
EN 9101,
Defence Quality Management Systems
1, 2
EN 9102, Aerospace series — Quality systems — First article inspection requirements
EN 9110, Quality Management Systems — Requirements for Aviation Maintenance Organizations
EN 9138, Aerospace Series — Quality Management Systems — Statistical Product — Acceptance
Requirements
EN 9145, Aerospace Series — Requirements for Advanced Product Quality Planning and Production Part
Approval Process
ISO 3534-2, Statistics — Vocabulary and symbols — Part 2: Applied statistics
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 22514-7, Statistical methods in process management — Capability and performance — Part 7:
Capability of measurement processes
IAQG Supply Chain Management Handbook (SCMH) — (see IAQG website — https://iaqg.org/tools/scmh/)
SAE AS13006, Process Control Methods
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 as ASD-STAN Standard at the date of publication of this document by AeroSpace and Defence
industries Association of Europe — Standardization (ASD-STAN), https://www.asd-stan.org/.
Published by: ISO International Organization for Standardization http://www.iso.ch/.
Published by: SAE International (US) https://www.sae.org/.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, the IAQG International
5 6
Dictionary , EN 9100 , EN 9101 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
common cause
the 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 base.
EXAMPLE 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
Note 1 to entry: the intent of a CP is to control the product design characteristics and process variables to ensure
product quality.
3.3
design characteristics
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.
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.
Located on the IAQG website: https://iaqg.org/tools/dictionary/.
Particularly critical items (Cis) and special requirements.
3.4
design 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 information
Note 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, which includes:
— identification of potential failures and their effects;
— ranking of factors (e.g., severity, frequency of occurrence, detectability of the potential failures); and
— identification and results of actions taken to reduce or eliminate risk
Note 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 process drift.
Note 2 to entry: KC attributes can include:
— a characterization (e.g., nominal value with associated tolerances);
— a ranking of the effect of variation (e.g., significant severity of the effect of a potential
failure mode identified by design risk analysis); and
— the acceptable occurrence of non-detected nonconformities.
Note 3 to entry: validation of KCs includes in particular process dispositions and control/inspection operations.
Note 4 to entry: product KCs are those selected measurable geometrical, material properties, functional, and/or
cosmetic features of a product, whose variation control is necessary in meeting customer requirements, enhancing
customer satisfaction, or requires specific actions for the purpose of controlling variation.
Note 5 to entry: process KCs are those selected measurable characteristics of a manufacturing process whose
control is essential to manage variation of product KCs; for example, production variables (e.g., temperature, time,
pressure, voltage, operating amperage, vacuum degree).
Note 6 to entry: substitute KCs are “child” product KCs derived from the “parent” KC in order to guarantee the
“parent” needs (substitution characteristic), if the “parent” KC cannot be directly controlled or guaranteed by the
production process through process KCs. Substitute KCs are identified when a customer-defined KC is not readily
measurable within the manufacturing/maintenance setting and other characteristics are needed to be controlled
to ensure conformity.
Note 7 to entry: a KC is measurable if information on its condition can be detected. The variation in the
frequency of an attribute condition can be managed using this document.
[SOURCE: EN 9100:2018, 3.3, modified — All Notes to entry have been added.]
3.7
key characteristic owner
organization that defines the product and process KCs and recognizes the reasons for their selection
Note 1 to entry: typically, KC owner responsibilities are held by internal/external customer design, quality,
manufacturing, or maintenance engineering, and identified by a Multi-Functional Team (MFT) through risk
analyses.
Note 2 to entry: product KC owner is the design authority responsible for the product definition.
Note 3 to entry: process KC owner is the producer. Producers may determine additional relevant process KCs to
establish variation control of customer-defined product KCs, based on the information and data collected during
the manufacturing or maintenance processes. They could also define a substitute KC to achieve variation
management of a not readily measurable customer-defined KC.
3.8
measurement system analysis
MSA
study of the effects of selected elements of a measurement process (i.e., people, machines, tools,
methods, materials, environment) on the accuracy, precision, and uncertainty of measurement
Note 1 to entry: MSA is the evaluation of variation of the measurement system in comparison to product
performance variation.
EXAMPLES Gage Repeatability and Reproducibility (Gage R&R), attribute agreement, bias assessment, stability
assessment, linearity assessment].
Note 2 to entry The purpose of an MSA study is to ensure the information collected is a true representation of
what is occurring in the activity/process being measured. Without an MSA, there is a risk of making decisions
based on an inaccurate ‘picture’ of product performance.
[SOURCE: EN 9145:2018, 3.14, modified — Note 1 to entry has been added.]
3.9
multi-functional team
MFT
team composed of representatives from the functions needed to perform the KC identification and
management process
EXAMPLES Design (product KC owner), dependability (reliability, availability, maintainability) and safety,
production (process KC owner).
Note 1 to entry: the multi-functional team is also commonly referred to as cross-functional team.
3.10
process capability
ability of a process or product to consistently meet specification or customer requirements
Note 1 to entry: the process capability is often expressed as a capability index (e.g., Cpk, Ppk).
Note 2 to entry: a detailed definition can be found in ISO 3534-2.
3.11
producer
organization that identifies process KCs and uses KC data to maintain, monitor, and improve the
manufacturing and maintenance processes
Note 1 to entry: the product KC owner may also identify and communicate process KCs.
Note 2 to entry: the producer can be an internal or external provider.
3.12
reaction plan
plan that will be applied or invoked when the manufacturing or maintenance process does not show to
be robust or healthy
Note 1 to entry: typically, the reaction plan documents, at a minimum, contain the following information:
— description of unstable or incapable process no matter whether the characteristic of the
affected part is within the tolerance or not;
— containment measures or immediate actions taken to stop the extension of the undesired
observations through the allocation of better resources to the affected process, including
100 % inspection to keep the process on-going without the risk of delivering
nonconforming product to customer;
— cause analysis, including tentative determination of the cause, supporting the identification
of the root cause;
— taking appropriate corrective actions;
— conducting the verification of the effectiveness of corrective actions taken; and
— returning to controlled production after closing the corrective action.
3.13
special cause
variation characterized by unanticipated emergent or previously neglected phenomena within the
system that is probabilistically unpredictable
EXAMPLES Machine start-up, faulty controllers, machine malfunction, computer crash, poor batch of raw
material, power surges, broken part, lack of awareness, operator absent.
Note 1 to entry: the special cause is also commonly referred to as the assignable cause.
4 General requirements
4.1 Flow down of product key characteristics
4.1.1 When determining product KC requirements, the producer shall communicate with the
customer to ensure that the customer product KCs are defined and understood.
NOTE By identifying the KCs of a product or process, work can focus on the characteristics where expected
variation most influences manufacturability and the cost of quality. Specific focus on product KC identification, as
early as possible during development, is important.
4.1.2 The producer shall ensure that product KCs are flowed down to applicable internal and external
providers by the use of appropriate design documentation.
4.1.3 The producer shall define substitute KCs necessary for production by appropriate tools
(e.g., through lessons learned, function analysis, design risk analysis or other risk assessments) in the
following cases:
a. the customer did not define the product KCs, but defined the product feature or attribute control
requirements for the producer (external provider or process KC owner); and
b. an external provider encounters variation effects that affect product quality.
NOTE There is a close link between the process risk analysis and design risk analysis. The design risk analysis
identifies potential failure modes, and the severity of the effects of the failure modes should be used as an input to
the process risk analysis. Updates to either may impact the other and should be taken into account.
4.2 Preparation of control plan inputs and outputs
4.2.1 The producer shall:
a. develop CPs to achieve customer satisfaction with the delivered product quality;
NOTE 1 The APQP product development planning process is defined in EN 9145.
NOTE 2 Statistical product control methods related to product KCs are described in EN 9138.
b. determine a process for reviewing and updating the CP when changes occur (e.g., affecting product,
production process, measurement, logistics, supply sources, process risk analyses). This includes
seeking customer approval, when required.
Reviews and updates of process flow diagrams (PFDs), PFMEAs, and CPs should also capture process
and inspection changes, and new knowledge gained during production (e.g., lessons learned from
production stops or delays, nonconformity, product quality escapes, inspection data, root cause
corrective action investigations on current or similar products, scrap data).
4.2.2 To obtain the information needed for the development of a CP, the producer shall:
a. establish a process flow and conduct the process risk analysis (e.g., PFMEA or equivalent causal
analysis) representing the corresponding manufacturing or maintenance activities;
b. identify the design documentation requirements and associated process flow, as well as the design
and process risk analyses outputs;
c. document the engineering specifications, product KCs, process KCs, and control methods in the CP
where each KC is controlled or measured;
d. trace the process step in the manufacturing or maintenance plan where each KC is controlled or
measured (e.g., with an appropriate visibility symbol);
e. choose the proper process monitoring or control methods to control the KCs.
Evidence of sufficient process control may include, but is not limited to procedures and records of
configuration control of process inputs, elements, or characteristics that affect conformity of products
to specifications or Statistical Process Control (SPC) methods with a CP, and audit records showing that
the process is consistently practiced (as defined).
4.3 Conditions for performing statistical process control
4.3.1 Where non-SPC control methods (e.g., tooling, error-proofing) are used to ensure process
control and capability, measurable evidence shall demonstrate that the controls are effective.
4.3.2 Where SPC is chosen as the method for the control of KCs, the following requirements shall be met:
a. the process shall be statistically stable and capable (i.e., with Cpk > 1,33) or as defined by or agreed
with the customer;
Process capability indexes only refer to processes in statistical control and cannot be used to
describe the output of a process which is not stable. A low Cp indicates a dispersed production.
A process is considered capable, if its Cpk meets or exceeds the target of 1,33 or the targeted value
as defined by or agreed with the customer. Other comparable measures of process capability may
be used (e.g., process performance index Ppk).
b. the process capability index (e.g., Cp, Cpk) shall only be calculated and established when the
process is shown to be stable and in statistical control through use of appropriate statistical
methods and/or control charts.
NOTE Information on process stability and capability can be found in EN 9138. Further information for the
calculation of process capability indices and the calculation of measurement uncertainty can be found in ISO 3534-2
and ISO 22514-7.
4.4 Application of switching rules
4.4.1 If the process performance deteriorates such that it is no longer meeting minimum capability
requirements, the producer or process KC owner shall implement the customer approved acceptance
sampling plan or 100 % inspection of the product until the cause has been identified, corrected, and
process capability and control have been re-established and revalidated.
For cases with evaluation uncertainty, further or repeated inspection may be necessary.
4.4.2 When process capability is used to justify reduced frequency of inspection, the probability of
nonconformity shall be determined using industry recognized statistical methods.
4.5 Restrictions of statistical process control
4.5.1 When KCs related to safety aspects are identified in the design documentation, the customer-
identified product KCs shall not be accepted using sampling or other statistical product acceptance
methods, unless specific justification by the product KC owner is granted from the customer
(e.g., customer approved procedure, method for acceptance is defined in the design documentation).
4.5.2 Where it is impossible or prohibitively expensive to satisfy the stability and capability
requirements for a process, the exceptions shall be documented by the producer and the customer
informed.
4.5.3 The producer shall establish an internal assessment process of product and process KCs to
verify on-going variation reduction and evaluate related continual improvement efforts.
4.6 Personnel competence and training
4.6.1 To ensure effective KC variation management and control methods, the producer shall be
capable in using the tools and methodologies defined within this document.
4.6.2 The producer shall ensure that personnel involved in the identification, control, documentation,
and approval of KCs meet the training requirements of the Aerospace Quality Management system
(AQMS), and have a good knowledge of the customer’s requirements for the application of process
cont
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...