Aerospace Series - Quality Management Systems - Statistical Product - Acceptance Requirements

This document establishes requirements when implementing statistical product acceptance methods to meet defined risk requirements. This standard also establishes the minimum content required to be covered in an organization’s documented procedures that govern their application of statistical product acceptance methods. These general requirements and documented procedures apply the requirements of the EN 9100/EN 9110/EN 9120 quality management system standards, in addition to establishing requirements for retrievability, safety/critical characteristics, and quality parameters that protect the customer. Application This standard is applicable when invoked in a purchasing contract or specification, contractual document, customer agreement, or adopted by the organization. The purchase contract/agreement may or may not identify the appropriate EN 9138 clause(s) to be applied by the organization. All statistical methods of product acceptance require the use of Clause 4 and Clause 5. To accept product produced: - by individual lots, see Clause 6; - under switching rules, see Clause 7; - under process controls, see Clause 8; and - by continuous sampling or special case methods, see Clause 9.

Luft- und Raumfahrt - Qualitätsmanagementsysteme - Statistische Produktannahmeanforderungen

1.1 Zweck
Diese Europäische Norm legt die Anforderungen für die Einführung statistischer Verfahren für die Pro-duktannahme zur Erfüllung festgelegter Risikoanforderungen fest. Diese Norm legt auch den erforderlichen Mindestinhalt fest, der in den dokumentierten Verfahren einer Organisation zu behandeln ist, die die Anwendung von statistischen Verfahren für die Produktannahme regeln.
Diese allgemeinen Anforderungen und dokumentierten Verfahren wenden die Anforderungen nach den Qualitätsmanagementsystemnormen EN 9100/EN 9110/EN 9120 an, zusätzlich zur Festlegung von Anfor-derungen an die Rückholbarkeit, Sicherheitsmerkmale/kritische Merkmale und Qualitätsparameter, die den Kunden schützen.
1.2 Anwendung
Diese Norm gilt, wenn sich ein Kaufvertrag oder eine Spezifikation, Vertragsdokument, Kundenvereinbarung darauf berufen oder sie von der Organisation übernommen wird. Der/Die Kaufvertrag/-vereinbarung darf den/die entsprechenden Abschnitt/Abschnitte nach EN 9138 benennen, der/die von der Organisation anzu¬wenden ist/sind oder dies unterlassen. Alle statistischen Verfahren für die Produktannahme erfordern die Anwendung von Abschnitt 4 und Abschnitt 5.
Um Produkte anzunehmen, die hergestellt wurden
- durch Einzellose, siehe Abschnitt 6,
- unter Variierung des Prüfumfangs, siehe Abschnitt 7,
- mit Prozessüberwachungen, siehe Abschnitt 8 und
- durch kontinuierliche Stichprobenahme oder Verfahren für Sonderfälle, siehe Abschnitt 9.

Série Aérospatiale - Système de management de la qualité - Exigences d'acceptation statistique des produits

La présente norme s’applique lorsqu’elle est invoquée dans un contrat d’achat ou une spécification, un document contractuel, un contrat client ou qu’elle est adoptée par l’organisme. L’accord/contrat d’achat peut identifier ou non le(s) article(s) approprié(s) de l’EN 9138 à appliquer par l’organisme. Toutes les méthodes statistiques d’acceptation des produits exigent d’utiliser les Articles 4 et 5.
Pour accepter le produit fabriqué :
- en lots individuels, voir l’Article 6 ;
- conformément aux règles de modification du contrôle, voir l’Article 7 ;
- conformément aux maîtrises du processus, voir l’Article 8 ; et
- par échantillonnage continu ou à l’aide de méthodes pour cas particuliers, voir l’Article 9.

Aeronavtika - Sistemi vodenja kakovosti - Statistični proizvod - Zahteve za sprejem

Ta dokument določa zahteve pri izvajanju metod sprejemanja statističnega proizvoda za izpolnjevanje določenih zahtev glede tveganja. Standard prav tako določa minimalno vsebino, ki mora biti zajeta v dokumentiranih postopkih organizacije, ki ureja uporabo metod sprejemanja statističnega proizvoda. Te splošne zahteve in dokumentirani postopki upoštevajo zahteve iz standardov za sisteme vodenja kakovosti EN 9100/EN 9110/EN 9120, poleg tega pa določajo zahteve za dostopnost, varnostne/kritične značilnosti in parametre za kakovost, ki varujejo potrošnika. Uporaba: Ta standard se uporablja ob sklicevanju nanj v prodajni pogodbi ali specifikaciji, pogodbenem dokumentu, pogodbi z uporabnikom, ali če ga sprejme organizacija. V prodajni pogodbi/dogovoru bodo morda upoštevane ustrezne točke standarda EN 9138, ki jih mora organizacija uveljaviti. Vse statistične metode za sprejem proizvoda zahtevajo uporabo točk 4 in 5. Za sprejem izdelanega proizvoda: – po posameznih serijah, glej točko 6; – pod pravili za zamenjavo, glej točko 7; – pod nadzori procesov, glej točko 8; in – z neprekinjenim vzorčenjem ali po metodah posebnih primerov, glej točko 9.

General Information

Status
Published
Publication Date
24-Nov-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
20-Nov-2019
Due Date
25-Jan-2020
Completion Date
25-Nov-2019

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SLOVENSKI STANDARD
SIST EN 9138:2020
01-januar-2020

Aeronavtika - Sistemi vodenja kakovosti - Statistični proizvod - Zahteve za sprejem

Aerospace Series - Quality Management Systems - Statistical Product - Acceptance
Requirements
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Statistische
Produktannahmeanforderungen

Série Aérospatiale - Système de management de la qualité - Exigences d'acceptation

statistique des produits
Ta slovenski standard je istoveten z: EN 9138:2019
ICS:
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 9138:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 9138:2020
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SIST EN 9138:2020
EN 9138
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 03.120.10; 49.020
English Version
Aerospace Series - Quality Management Systems -
Statistical Product - Acceptance Requirements

Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsysteme -

qualité - Exigences d'acceptation statistique des Statistische Produktannahmeanforderungen

produits
This European Standard was approved by CEN on 10 December 2018.

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

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9138:2019 E

worldwide for CEN national Members.
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SIST EN 9138:2020
EN 9138:2019 (E)
Contents
Page

0.1 Paradigm of quality requirements and product acceptance plans ............................................ 11

0.1.1 Engineering .................................................................................................................................................... 11

0.1.2 Operations ...................................................................................................................................................... 12

0.2 Acceptance method considerations ...................................................................................................... 12

1 Scope ................................................................................................................................................................. 15

1.1 Purpose ............................................................................................................................................................ 15

1.2 Application ..................................................................................................................................................... 15

2 Normative references ................................................................................................................................. 15

2.1 International Aerospace Quality Group publications ..................................................................... 15

2.2 American National Standards Institute publications ...................................................................... 16

2.3 International Organization for Standardization publications ..................................................... 16

2.4 Japanese standards ..................................................................................................................................... 17

2.5 Published books and periodicals ........................................................................................................... 17

2.6 SAE International publications ............................................................................................................... 18

2.7 Standardization Administration of China publications ................................................................. 18

2.8 United States Military standards ............................................................................................................ 18

3 Terms and definitions ................................................................................................................................ 19

4 General requirements ................................................................................................................................ 30

4.1 Introduction to general requirements ................................................................................................. 30

4.2 Trained personnel ....................................................................................................................................... 30

4.3 Safety/critical characteristics ................................................................................................................. 31

4.4 Quality requirements and parameters ................................................................................................ 31

4.4.1 Quality parameter ........................................................................................................................................ 31

4.4.2 Quality parameter value ............................................................................................................................ 31

4.4.3 Alternative quality plans ........................................................................................................................... 32

4.4.4 Regulatory requirements .......................................................................................................................... 32

4.5 Selection of samples .................................................................................................................................... 32

4.6 Consideration of product and process characteristics ................................................................... 32

4.7 Evaluation systems ...................................................................................................................................... 32

4.8 Non-conformances (within the sample) .............................................................................................. 33

4.9 Statistical product acceptance plans and records ............................................................................ 33

4.10 Alternate statistical techniques for product acceptance ............................................................... 33

4.11 Auditing of statistical techniques for product acceptance ............................................................ 33

5 Required information to be documented ............................................................................................ 34

5.1 Documented procedure requirements ................................................................................................ 34

5.2 Initial Reliability Requirement or quality parameter values for product acceptance ....... 34

5.3 Assigning responsibilities ......................................................................................................................... 34

5.4 Assigning where applied ........................................................................................................................... 34

5.5 Establishing a training program ............................................................................................................. 34

5.6 Controlling non-conformances ............................................................................................................... 34

5.7 Monitoring performance and effectiveness ....................................................................................... 34

5.8 Defining adjustments to inspection frequency ................................................................................. 35

5.9 Customer approval of procedures and plans ..................................................................................... 35

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EN 9138:2019 (E)

6 Requirements for accepting product by individual lots ................................................................. 35

6.1 General requirements for individual lot sampling .......................................................................... 35

6.2 Quality parameters for individual lot sampling ................................................................................ 35

6.2.1 Delivered product conformance probability parameters ............................................................. 35

6.2.2 Probability of acceptance parameters .................................................................................................. 35

6.3 Sample sizes for individual lots ............................................................................................................... 35

7 Requirements for accepting product under switching rules ........................................................ 35

7.1 General requirements for switching rules .......................................................................................... 35

7.2 Background information for switching rules ..................................................................................... 36

7.3 Quality parameter with switching rules ............................................................................................... 36

7.4 Requirements for accepting product with switching rules ........................................................... 36

7.4.1 Sampling documentation ........................................................................................................................... 36

7.4.2 General conditions ....................................................................................................................................... 36

7.4.3 Sampling plan criteria................................................................................................................................. 37

7.4.4 Qualification criteria for sampling ......................................................................................................... 37

7.5 Requirements for accepting product by variables sampling plans using switching

rules ................................................................................................................................................................... 37

7.5.1 Variable sampling application limits .................................................................................................... 37

7.5.2 Evaluating lot quality .................................................................................................................................. 37

7.5.3 Related requirements ................................................................................................................................. 37

8 Requirements for accepting product produced under process controls ................................. 38

8.1 General process control requirements ................................................................................................. 38

8.1.1 Data .................................................................................................................................................................... 38

8.1.2 Reducing inspection with process controls ........................................................................................ 38

8.1.3 Measurement systems ................................................................................................................................ 38

8.1.4 Training program ......................................................................................................................................... 38

8.1.5 Process control points ................................................................................................................................ 39

8.1.6 Process control acceptance plans and records .................................................................................. 39

8.1.7 Unbiased sampling ....................................................................................................................................... 39

8.1.8 Time or production order sequence ...................................................................................................... 39

8.1.9 Data retention plan ...................................................................................................................................... 39

8.1.10 Periodic internal audits .............................................................................................................................. 39

8.1.11 Retrievability system .................................................................................................................................. 39

8.1.12 Limiting errors in measurement and recording ............................................................................... 39

8.1.13 Evaluating effects of corrective actions ................................................................................................ 39

8.2 Statistical Process Control ......................................................................................................................... 39

8.2.1 Methods ............................................................................................................................................................ 40

8.2.2 Location and dispersion ............................................................................................................................. 40

8.2.3 Basis for control limits ................................................................................................................................ 40

8.2.4 Basis for stability .......................................................................................................................................... 40

8.2.5 Investigation ................................................................................................................................................... 41

8.2.6 Violation of stability .................................................................................................................................... 41

8.2.7 Re-evaluation of stability and capability ............................................................................................. 41

8.2.8 Capability and process control ................................................................................................................ 41

8.2.9 Process monitoring frequency ................................................................................................................. 42

8.3 Variation restrictions .................................................................................................................................. 42

8.4 Process parameter controls ...................................................................................................................... 42

9 Additional requirements for accepting products based on continuous sampling,

skip-lot sampling, or methods for special cases ................................................................................ 43

9.1 Continuous sampling ................................................................................................................................... 43

9.1.1 Quality parameters for continuous sampling .................................................................................... 43

9.1.2 Inspection sequence .................................................................................................................................... 43

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EN 9138:2019 (E)

9.1.3 General conditions ....................................................................................................................................... 43

9.1.4 Supply Chain Management Handbook continuous sampling tables .......................................... 43

9.2 Skip-lot sampling.......................................................................................................................................... 44

9.2.1 General conditions for skip-lot sampling ............................................................................................ 44

9.2.2 Quality protection equivalency ............................................................................................................... 44

9.2.3 Considerations for subsequent lots ....................................................................................................... 44

9.3 Sampling strategies for special cases .................................................................................................... 44

9.3.1 Special sampling customer approvals .................................................................................................. 44

9.3.2 Special case statistical validity ................................................................................................................ 44

9.3.3 Predicting quality from correlated variables .................................................................................... 45

9.3.4 Continuous manufacturing process – First and last unit for a lot produced .......................... 45

9.3.5 Sequential sampling .................................................................................................................................... 45

9.4 Other methods for special cases ............................................................................................................. 45

Annex A (informative) Guidelines for assigning Initial Reliability Requirement quality

levels ................................................................................................................................................................. 46

A.1 Introduction ................................................................................................................................................... 46

A.2 Assigning quality levels ............................................................................................................................. 46

A.3 Initial Reliability Requirements ............................................................................................................. 46

Annex B (informative) Acronym log ................................................................................................................... 49

Annex C (informative) Mathematics for accepting product under lot-by-lot inspection ................ 52

C.1 Yield estimation ............................................................................................................................................ 52

C.1.1 Yield estimates .............................................................................................................................................. 53

C.1.2 Confidence limits on yield estimates .................................................................................................... 53

C.2 Probability of acceptance mathematics ............................................................................................... 55

C.2.1 Hypergeometric probability of acceptance ........................................................................................ 55

C.2.2 Legacy Pa lot acceptance mathematics ................................................................................................ 56

C.2.3 Yield rates, discrete units, and conformance probabilities .......................................................... 57

C.2.4 Impact lot sampling methods on delivered yield ............................................................................. 58

C.3 Controlling the probability of conformance for delivered product ........................................... 60

C.3.1 Average Outgoing Quality Limits ............................................................................................................ 60

C.3.2 Average Outgoing Quality Limit sample sizes .................................................................................... 61

C.3.3 Outgoing Quality Confidence Limit sample sizes .............................................................................. 62

C.3.4 Lot sampling with deliveries from the sample of failed lots ........................................................ 63

C.3.5 Probability of acceptance sample sizes ................................................................................................ 64

C.3.6 Lot sampling with destructive tests ...................................................................................................... 64

C.4 Mathematics to control clustering ......................................................................................................... 65

C.4.1 Formulation for cluster control .............................................................................................................. 65

C.4.2 Fixed number of maximum escapements ........................................................................................... 66

C.4.3 Controlling clusters in increasing lot sizes ......................................................................................... 66

Annex D (informative) Guidelines and recommendations for successful implementation of

statistical product acceptance methods .............................................................................................. 67

D.1 Guidelines for 4.2 — Trained personnel.............................................................................................. 67

D.1.1 General training ............................................................................................................................................ 67

D.1.2 Training for lot sampling .......................................................................................................................... 67

D.1.3 Training for product acceptance based on process controls ....................................................... 68

D.1.4 Training for continuous sampling, lot sampling with switching rules, skip-lot

sampling, or process control methods ................................................................................................. 68

D.1.5 Non-published statistical methods ........................................................................................................ 68

D.2 Guidelines for 4.3 — Safety/critical characteristics ........................................................................ 68

D.3 Guidelines for 4.4 — Quality requirements and parameters ....................................................... 69

D.3.1 Guidelines for Initial Reliability Requirement assignment .......................................................... 69

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EN 9138:2019 (E)

D.3.2 Guidelines for quality parameter measures ....................................................................................... 69

D.4 Guidelines for 4.5 — Selection of samples ........................................................................................... 69

D.4.1 Sampling recommendations ..................................................................................................................... 69

D.4.2 Simple random sampling ........................................................................................................................... 70

D.4.3 Stratification sampling ............................................................................................................................... 70

D.4.4 Systematic sampling .................................................................................................................................... 70

D.4.5 Cluster sampling ........................................................................................................................................... 70

D.4.6 Representative sampling without randomization ............................................................................ 70

D.5 Guidelines for 4.6 — Identification of product characteristics .................................................... 71

D.6 Guidelines for 4.7 — Evaluation systems ............................................................................................. 71

D.6.1 Measurement devices ................................................................................................................................. 71

D.6.2 Non-Destructive Testing ............................................................................................................................ 71

D.6.3 Destructive testing ....................................................................................................................................... 72

D.7 Guidelines for 4.8 — Non-conformances (within the sample) ..................................................... 72

D.7.1 Non-conformance risks .............................................................................................................................. 72

D.7.2 C = 0 sampling ................................................................................................................................................ 72

D.7.3 Retrievability in reduced, continuous, or skip-lot sampling ........................................................ 73

D.8 Guidelines for 4.9 — Statistical product acceptance plans and records ................................... 73

D.8.1 Statistical product acceptance plans ..................................................................................................... 73

D.8.2 Acceptance records ...................................................................................................................................... 73

D.8.3 Training records ........................................................................................................................................... 74

D.9 Guidelines for 4.10 — Alternate statistical techniques for product acceptance ................... 74

D.10 Guidelines for 4.11 — Auditing of statistical techniques for product acceptance ................ 74

D.11 Guidelines for 5.3 — Assigning responsibilities ................................................................................ 75

D.12 Guidelines for 5.4 — Assigning where applied .................................................................................. 75

D.13 Guidelines for 5.5 — Establishing a training program .................................................................... 76

D.14 Guidelines for 5.6 — Controlling non-conformances ...................................................................... 76

D.15 Guidelines for 5.7 — Monitoring performance and effectiveness .............................................. 76

Annex E (informative) Discussion on the technical rationale and history of the relationship

of quality parameters to reliability ........................................................................................................ 77

E.1 Technical rationale for quality — Reliability relationship in quality parameters ............... 77

E.1.1 Minimum probability of conformance .................................................................................................. 78

E.1.2 Probability of non-conformance ............................................................................................................. 78

E.1.3 Reliability ........................................................................................................................................................ 78

E.2 History of quality — Reliability relationship in quality parameters ......................................... 78

E.2.1 Acceptable Quality Level ............................................................................................................................ 79

E.2.2 Average Outgoing Quality Limit .............................................................................................................. 79

E.2.3 Short run sampling ....................................................................................................................................... 80

E.3 Recommended quality parameter choices ........................
...

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