BS EN 9138:2019

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

Published By	Publication Date	Number of Pages
BSI	2019	114

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Category: BSI

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Description

This European standard 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.

PDF Catalog

PDF Pages	PDF Title
2	undefined
12	Rationale Foreword
13	Introduction 0.1 Paradigm of quality requirements and product acceptance plans 0.1.1 Engineering
14	0.1.2 Operations 0.2 Acceptance method considerations
17	1 Scope 1.1 Purpose 1.2 Application 2 Normative references 2.1 International Aerospace Quality Group publications
18	2.2 American National Standards Institute publications 2.3 International Organization for Standardization publications
19	2.4 Japanese standards 2.5 Published books and periodicals
20	2.6 SAE International publications 2.7 Standardization Administration of China publications 2.8 United States Military standards
21	3 Terms and definitions
32	4 General requirements 4.1 Introduction to general requirements 4.2 Trained personnel
33	4.3 Safety/critical characteristics 4.4 Quality requirements and parameters 4.4.1 Quality parameter 4.4.2 Quality parameter value
34	4.4.3 Alternative quality plans 4.4.4 Regulatory requirements 4.5 Selection of samples 4.6 Consideration of product and process characteristics 4.7 Evaluation systems
35	4.8 Non-conformances (within the sample) 4.9 Statistical product acceptance plans and records 4.10 Alternate statistical techniques for product acceptance 4.11 Auditing of statistical techniques for product acceptance
36	5 Required information to be documented 5.1 Documented procedure requirements 5.2 Initial Reliability Requirement or quality parameter values for product acceptance 5.3 Assigning responsibilities 5.4 Assigning where applied 5.5 Establishing a training program 5.6 Controlling non-conformances 5.7 Monitoring performance and effectiveness
37	5.8 Defining adjustments to inspection frequency 5.9 Customer approval of procedures and plans 6 Requirements for accepting product by individual lots 6.1 General requirements for individual lot sampling 6.2 Quality parameters for individual lot sampling 6.2.1 Delivered product conformance probability parameters 6.2.2 Probability of acceptance parameters 6.3 Sample sizes for individual lots 7 Requirements for accepting product under switching rules 7.1 General requirements for switching rules
38	7.2 Background information for switching rules 7.3 Quality parameter with switching rules 7.4 Requirements for accepting product with switching rules 7.4.1 Sampling documentation 7.4.2 General conditions
39	7.4.3 Sampling plan criteria 7.4.4 Qualification criteria for sampling 7.5 Requirements for accepting product by variables sampling plans using switching rules 7.5.1 Variable sampling application limits 7.5.2 Evaluating lot quality 7.5.3 Related requirements
40	8 Requirements for accepting product produced under process controls 8.1 General process control requirements 8.1.1 Data 8.1.2 Reducing inspection with process controls 8.1.3 Measurement systems 8.1.4 Training program
41	8.1.5 Process control points 8.1.6 Process control acceptance plans and records 8.1.7 Unbiased sampling 8.1.8 Time or production order sequence 8.1.9 Data retention plan 8.1.10 Periodic internal audits 8.1.11 Retrievability system 8.1.12 Limiting errors in measurement and recording 8.1.13 Evaluating effects of corrective actions 8.2 Statistical Process Control
42	8.2.1 Methods 8.2.2 Location and dispersion 8.2.3 Basis for control limits 8.2.4 Basis for stability
43	8.2.5 Investigation 8.2.6 Violation of stability 8.2.7 Re-evaluation of stability and capability 8.2.8 Capability and process control 8.2.8.1 Valid process capability measure 8.2.8.2 Adequate capability
44	8.2.8.3 Inadequate capability 8.2.8.4 Confidence limits on capability 8.2.9 Process monitoring frequency 8.3 Variation restrictions 8.4 Process parameter controls
45	9 Additional requirements for accepting products based on continuous sampling, skip-lot sampling, or methods for special cases 9.1 Continuous sampling 9.1.1 Quality parameters for continuous sampling 9.1.2 Inspection sequence 9.1.3 General conditions 9.1.4 Supply Chain Management Handbook continuous sampling tables
46	9.2 Skip-lot sampling 9.2.1 General conditions for skip-lot sampling 9.2.2 Quality protection equivalency 9.2.3 Considerations for subsequent lots 9.3 Sampling strategies for special cases 9.3.1 Special sampling customer approvals 9.3.2 Special case statistical validity
47	9.3.3 Predicting quality from correlated variables 9.3.4 Continuous manufacturing process – First and last unit for a lot produced 9.3.5 Sequential sampling 9.4 Other methods for special cases
48	Annex A (informative)Guidelines for assigning Initial Reliability Requirement quality levels A.1 Introduction A.2 Assigning quality levels A.3 Initial Reliability Requirements
51	Annex B (informative)Acronym log
54	Annex C (informative)Mathematics for accepting product under lot-by-lot inspection C.1 Yield estimation
55	C.1.1 Yield estimates C.1.2 Confidence limits on yield estimates C.1.2.1 Mathematics of yield confidence limits
56	C.1.2.2 Yield confidence limit from zero observed non-conformances C.1.2.3 Yield confidence limit with observed non-conformances
57	C.2 Probability of acceptance mathematics C.2.1 Hypergeometric probability of acceptance
58	C.2.2 Legacy Pa lot acceptance mathematics
59	C.2.3 Yield rates, discrete units, and conformance probabilities
60	C.2.4 Impact lot sampling methods on delivered yield
62	C.3 Controlling the probability of conformance for delivered product C.3.1 Average Outgoing Quality Limits
63	C.3.2 Average Outgoing Quality Limit sample sizes C.3.2.1 Sample sizes for screened and rectified lot sampling
64	C.3.2.2 Sample sizes for screened and lot sampling with scrapping C.3.3 Outgoing Quality Confidence Limit sample sizes
65	C.3.4 Lot sampling with deliveries from the sample of failed lots
66	C.3.5 Probability of acceptance sample sizes C.3.6 Lot sampling with destructive tests
67	C.4 Mathematics to control clustering C.4.1 Formulation for cluster control
68	C.4.2 Fixed number of maximum escapements C.4.3 Controlling clusters in increasing lot sizes
69	Annex D (informative)Guidelines and recommendations for successful implementation of statistical product acceptance methods D.1 Guidelines for 4.2 — Trained personnel D.1.1 General training D.1.1.1 Training on alternatives for selecting representative samples D.1.1.2 Training plan D.1.1.3 Auditor training D.1.2 Training for lot sampling
70	D.1.3 Training for product acceptance based on process controls D.1.4 Training for continuous sampling, lot sampling with switching rules, skip-lot sampling, or process control methods D.1.5 Non-published statistical methods D.2 Guidelines for 4.3 — Safety/critical characteristics
71	D.3 Guidelines for 4.4 — Quality requirements and parameters D.3.1 Guidelines for Initial Reliability Requirement assignment D.3.2 Guidelines for quality parameter measures D.4 Guidelines for 4.5 — Selection of samples D.4.1 Sampling recommendations
72	D.4.2 Simple random sampling D.4.3 Stratification sampling D.4.4 Systematic sampling D.4.5 Cluster sampling D.4.6 Representative sampling without randomization
73	D.5 Guidelines for 4.6 — Identification of product characteristics D.6 Guidelines for 4.7 — Evaluation systems D.6.1 Measurement devices D.6.2 Non-Destructive Testing
74	D.6.3 Destructive testing D.7 Guidelines for 4.8 — Non-conformances (within the sample) D.7.1 Non-conformance risks D.7.2 C = 0 sampling
75	D.7.3 Retrievability in reduced, continuous, or skip-lot sampling D.8 Guidelines for 4.9 — Statistical product acceptance plans and records D.8.1 Statistical product acceptance plans D.8.2 Acceptance records
76	D.8.3 Training records D.9 Guidelines for 4.10 — Alternate statistical techniques for product acceptance D.10 Guidelines for 4.11 — Auditing of statistical techniques for product acceptance
77	D.11 Guidelines for 5.3 — Assigning responsibilities D.12 Guidelines for 5.4 — Assigning where applied
78	D.13 Guidelines for 5.5 — Establishing a training program D.14 Guidelines for 5.6 — Controlling non-conformances D.15 Guidelines for 5.7 — Monitoring performance and effectiveness
79	Annex E (informative)Discussion on the technical rationale and history of the relationship of quality parameters to reliability E.1 Technical rationale for quality — Reliability relationship in quality parameters
80	E.1.1 Minimum probability of conformance E.1.2 Probability of non-conformance E.1.3 Reliability E.2 History of quality — Reliability relationship in quality parameters
81	E.2.1 Acceptable Quality Level E.2.2 Average Outgoing Quality Limit
82	E.2.3 Short run sampling E.3 Recommended quality parameter choices
83	E.4 Consideration of cluster effects
84	Annex F (informative)Guidelines for choosing a statistical product acceptance technique and quality parameter F.1 Guidance for choosing a method of statistical product acceptance F.1.1 General guidance
85	F.1.2 Clause-specific guidance
86	F.2 Directions to match a quality parameter to a statistical acceptance technique F.2.1 Guidelines for applying quality parameters F.2.2 Overview of quality parameter relationships to Initial Reliability Requirement F.2.3 Quality parameters for individual lot sampling F.2.4 Quality parameters for lot sampling with switching rules
87	F.2.5 Quality parameters for product acceptance using process controls F.2.6 Quality parameters for continuous sampling and special methods F.3 Assigned by feature and tolerance
88	Annex G (informative)Guidelines and recommendations for accepting product by individual lots G.1 Introduction G.1.1 Process steps for evaluating individual or isolated lots
89	G.1.2 Selecting an appropriate sampling model
90	G.1.3 Screening lots
91	G.2 Guidelines for 6.1.2 — Delivered product conformance probability parameters G.3 Guidelines for 6.2.2 — Probability of acceptance parameters
92	G.4 Guidelines for relating AQL to a quality parameter G.5 Guidelines for 6.3 — Sample sizes for individual lots
93	Annex H (informative)Guidelines for some special acceptance methods H.1 Continuous sampling extensions H.1.1 Guidelines for skip-lot sampling plans H.1.2 Guidelines for variables continuous sampling
94	H.1.3 Poisson continuous sampling
95	H.2 Process characterization H.2.1 Guidelines for 9.3.3 — Predicting quality from correlated variables
96	H.2.2 Guidelines for 9.3.4 — Lot acceptance by first and last unit inspections
97	H.2.3 Guidelines for Expected Outgoing Quality H.2.3.1 Condition for Expected Outgoing Quality sampling H.2.3.2 Steps to create a lot sampling plan with Expected Outgoing Quality protection
98	H.2.3.3 Example for Expected Outgoing Quality computations
99	H.3 Probability Outgoing Quality Limit H.4 Validation of special acceptance methods — Simulation H.5 Guidance for small production volumes
100	Annex I (informative)Guidelines and recommendations for accepting product produced under switching rules I.1 Guidelines for Clause 7 — Requirements for accepting product produced under switching rules I.2 Guidelines for 7.4 — Requirements for accepting product produced in repetitive lots by attribute sampling plans
101	I.3 Guidelines for 7.5 — Requirements for accepting product produced in repetitive lots by variables sampling plans
102	Annex J (informative)Guidelines and recommendations for accepting product produced under process controls J.1 Guidelines for 8.1 — General process control requirements J.1.1 Guidelines for 8.1.12 — Limiting errors in measurement and recording J.2 Guidelines for 8.2 — Statistical Process Control J.2.1 Guidelines for 8.2.1 — Methods
103	J.2.2 Guidelines for 8.2.3 — Basis for control limits J.2.2.1 Adequate samples J.2.2.2 Guidelines for using warning limits on control charts J.2.3 Guidelines for 8.2.5 — Investigation
104	J.2.4 Guidelines for 8.2.6 — Violation of stability J.3 Guidelines for 8.3 — Variation restrictions J.4 Guidelines for 8.4 — Process parameter controls
105	J.5 Step-by-step summary
106	Annex K (informative)Guidelines and recommendations for accepting product based on continuous sampling K.1 Applicability of continuous sampling K.1.1 Conditions necessary for continuous sampling plans
107	K.1.2 Conditions when continuous sampling inspection might be desirable K.1.3 Conditions when sampling plans require approval K.2 Types of continuous sampling plans
108	K.3 Implementing continuous sampling K.3.1 Guidelines for 9.1.1 — Quality parameters K.3.2 Guidelines for 9.1.2 — Inspection sequence K.3.3 Submission of product K.3.4 Sample selection K.3.5 Corrective action indications K.3.6 Example continuous sampling plan

Additional information

Status	Definitive
Pages	114
Publication Date	2019-11-15
ISBN	978 0 580 91710 3
Standard Number	BS EN 9138:2019
Title	Aerospace Series. Quality Management Systems. Statistical Product. Acceptance Requirements
Identical National Standard Of	EN 9138
Descriptors	Management, Quality, Quality management, Acceptance (approval), Air transport engineering, Products
Publisher	BSI
Committee	ACE/1
ICS Codes	49.020 - Aircraft and space vehicles in general

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