{"id":420976,"date":"2024-10-20T06:33:48","date_gmt":"2024-10-20T06:33:48","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-91382019-2\/"},"modified":"2024-10-26T12:17:04","modified_gmt":"2024-10-26T12:17:04","slug":"bs-en-91382019-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-91382019-2\/","title":{"rendered":"BS EN 9138:2019"},"content":{"rendered":"

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\u2019s documented procedures that govern their application of statistical product acceptance methods.<\/p>\n

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
12<\/td>\nRationale
Foreword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction
0.1 Paradigm of quality requirements and product acceptance plans
0.1.1 Engineering <\/td>\n<\/tr>\n
14<\/td>\n0.1.2 Operations
0.2 Acceptance method considerations <\/td>\n<\/tr>\n
17<\/td>\n1 Scope
1.1 Purpose
1.2 Application
2 Normative references
2.1 International Aerospace Quality Group publications <\/td>\n<\/tr>\n
18<\/td>\n2.2 American National Standards Institute publications
2.3 International Organization for Standardization publications <\/td>\n<\/tr>\n
19<\/td>\n2.4 Japanese standards
2.5 Published books and periodicals <\/td>\n<\/tr>\n
20<\/td>\n2.6 SAE International publications
2.7 Standardization Administration of China publications
2.8 United States Military standards <\/td>\n<\/tr>\n
21<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
32<\/td>\n4 General requirements
4.1 Introduction to general requirements
4.2 Trained personnel <\/td>\n<\/tr>\n
33<\/td>\n4.3 Safety\/critical characteristics
4.4 Quality requirements and parameters
4.4.1 Quality parameter
4.4.2 Quality parameter value <\/td>\n<\/tr>\n
34<\/td>\n4.4.3 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 <\/td>\n<\/tr>\n
35<\/td>\n4.8 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 <\/td>\n<\/tr>\n
36<\/td>\n5 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 <\/td>\n<\/tr>\n
37<\/td>\n5.8 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 <\/td>\n<\/tr>\n
38<\/td>\n7.2 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 <\/td>\n<\/tr>\n
39<\/td>\n7.4.3 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 <\/td>\n<\/tr>\n
40<\/td>\n8 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 <\/td>\n<\/tr>\n
41<\/td>\n8.1.5 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 <\/td>\n<\/tr>\n
42<\/td>\n8.2.1 Methods
8.2.2 Location and dispersion
8.2.3 Basis for control limits
8.2.4 Basis for stability <\/td>\n<\/tr>\n
43<\/td>\n8.2.5 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 <\/td>\n<\/tr>\n
44<\/td>\n8.2.8.3 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 <\/td>\n<\/tr>\n
45<\/td>\n9 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 <\/td>\n<\/tr>\n
46<\/td>\n9.2 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 <\/td>\n<\/tr>\n
47<\/td>\n9.3.3 Predicting quality from correlated variables
9.3.4 Continuous manufacturing process \u2013 First and last unit for a lot produced
9.3.5 Sequential sampling
9.4 Other methods for special cases <\/td>\n<\/tr>\n
48<\/td>\nAnnex A (informative)Guidelines for assigning Initial Reliability Requirement quality levels
A.1 Introduction
A.2 Assigning quality levels
A.3 Initial Reliability Requirements <\/td>\n<\/tr>\n
51<\/td>\nAnnex B (informative)Acronym log <\/td>\n<\/tr>\n
54<\/td>\nAnnex C (informative)Mathematics for accepting product under lot-by-lot inspection
C.1 Yield estimation <\/td>\n<\/tr>\n
55<\/td>\nC.1.1 Yield estimates
C.1.2 Confidence limits on yield estimates
C.1.2.1 Mathematics of yield confidence limits <\/td>\n<\/tr>\n
56<\/td>\nC.1.2.2 Yield confidence limit from zero observed non-conformances
C.1.2.3 Yield confidence limit with observed non-conformances <\/td>\n<\/tr>\n
57<\/td>\nC.2 Probability of acceptance mathematics
C.2.1 Hypergeometric probability of acceptance <\/td>\n<\/tr>\n
58<\/td>\nC.2.2 Legacy Pa lot acceptance mathematics <\/td>\n<\/tr>\n
59<\/td>\nC.2.3 Yield rates, discrete units, and conformance probabilities <\/td>\n<\/tr>\n
60<\/td>\nC.2.4 Impact lot sampling methods on delivered yield <\/td>\n<\/tr>\n
62<\/td>\nC.3 Controlling the probability of conformance for delivered product
C.3.1 Average Outgoing Quality Limits <\/td>\n<\/tr>\n
63<\/td>\nC.3.2 Average Outgoing Quality Limit sample sizes
C.3.2.1 Sample sizes for screened and rectified lot sampling <\/td>\n<\/tr>\n
64<\/td>\nC.3.2.2 Sample sizes for screened and lot sampling with scrapping
C.3.3 Outgoing Quality Confidence Limit sample sizes <\/td>\n<\/tr>\n
65<\/td>\nC.3.4 Lot sampling with deliveries from the sample of failed lots <\/td>\n<\/tr>\n
66<\/td>\nC.3.5 Probability of acceptance sample sizes
C.3.6 Lot sampling with destructive tests <\/td>\n<\/tr>\n
67<\/td>\nC.4 Mathematics to control clustering
C.4.1 Formulation for cluster control <\/td>\n<\/tr>\n
68<\/td>\nC.4.2 Fixed number of maximum escapements
C.4.3 Controlling clusters in increasing lot sizes <\/td>\n<\/tr>\n
69<\/td>\nAnnex D (informative)Guidelines and recommendations for successful implementation of statistical product acceptance methods
D.1 Guidelines for 4.2 \u2014 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 <\/td>\n<\/tr>\n
70<\/td>\nD.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 \u2014 Safety\/critical characteristics <\/td>\n<\/tr>\n
71<\/td>\nD.3 Guidelines for 4.4 \u2014 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 \u2014 Selection of samples
D.4.1 Sampling recommendations <\/td>\n<\/tr>\n
72<\/td>\nD.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 <\/td>\n<\/tr>\n
73<\/td>\nD.5 Guidelines for 4.6 \u2014 Identification of product characteristics
D.6 Guidelines for 4.7 \u2014 Evaluation systems
D.6.1 Measurement devices
D.6.2 Non-Destructive Testing <\/td>\n<\/tr>\n
74<\/td>\nD.6.3 Destructive testing
D.7 Guidelines for 4.8 \u2014 Non-conformances (within the sample)
D.7.1 Non-conformance risks
D.7.2 C = 0 sampling <\/td>\n<\/tr>\n
75<\/td>\nD.7.3 Retrievability in reduced, continuous, or skip-lot sampling
D.8 Guidelines for 4.9 \u2014 Statistical product acceptance plans and records
D.8.1 Statistical product acceptance plans
D.8.2 Acceptance records <\/td>\n<\/tr>\n
76<\/td>\nD.8.3 Training records
D.9 Guidelines for 4.10 \u2014 Alternate statistical techniques for product acceptance
D.10 Guidelines for 4.11 \u2014 Auditing of statistical techniques for product acceptance <\/td>\n<\/tr>\n
77<\/td>\nD.11 Guidelines for 5.3 \u2014 Assigning responsibilities
D.12 Guidelines for 5.4 \u2014 Assigning where applied <\/td>\n<\/tr>\n
78<\/td>\nD.13 Guidelines for 5.5 \u2014 Establishing a training program
D.14 Guidelines for 5.6 \u2014 Controlling non-conformances
D.15 Guidelines for 5.7 \u2014 Monitoring performance and effectiveness <\/td>\n<\/tr>\n
79<\/td>\nAnnex E (informative)Discussion on the technical rationale and history of the relationship of quality parameters to reliability
E.1 Technical rationale for quality \u2014 Reliability relationship in quality parameters <\/td>\n<\/tr>\n
80<\/td>\nE.1.1 Minimum probability of conformance
E.1.2 Probability of non-conformance
E.1.3 Reliability
E.2 History of quality \u2014 Reliability relationship in quality parameters <\/td>\n<\/tr>\n
81<\/td>\nE.2.1 Acceptable Quality Level
E.2.2 Average Outgoing Quality Limit <\/td>\n<\/tr>\n
82<\/td>\nE.2.3 Short run sampling
E.3 Recommended quality parameter choices <\/td>\n<\/tr>\n
83<\/td>\nE.4 Consideration of cluster effects <\/td>\n<\/tr>\n
84<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
85<\/td>\nF.1.2 Clause-specific guidance <\/td>\n<\/tr>\n
86<\/td>\nF.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 <\/td>\n<\/tr>\n
87<\/td>\nF.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 <\/td>\n<\/tr>\n
88<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
89<\/td>\nG.1.2 Selecting an appropriate sampling model <\/td>\n<\/tr>\n
90<\/td>\nG.1.3 Screening lots <\/td>\n<\/tr>\n
91<\/td>\nG.2 Guidelines for 6.1.2 \u2014 Delivered product conformance probability parameters
G.3 Guidelines for 6.2.2 \u2014 Probability of acceptance parameters <\/td>\n<\/tr>\n
92<\/td>\nG.4 Guidelines for relating AQL to a quality parameter
G.5 Guidelines for 6.3 \u2014 Sample sizes for individual lots <\/td>\n<\/tr>\n
93<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
94<\/td>\nH.1.3 Poisson continuous sampling <\/td>\n<\/tr>\n
95<\/td>\nH.2 Process characterization
H.2.1 Guidelines for 9.3.3 \u2014 Predicting quality from correlated variables <\/td>\n<\/tr>\n
96<\/td>\nH.2.2 Guidelines for 9.3.4 \u2014 Lot acceptance by first and last unit inspections <\/td>\n<\/tr>\n
97<\/td>\nH.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 <\/td>\n<\/tr>\n
98<\/td>\nH.2.3.3 Example for Expected Outgoing Quality computations <\/td>\n<\/tr>\n
99<\/td>\nH.3 Probability Outgoing Quality Limit
H.4 Validation of special acceptance methods \u2014 Simulation
H.5 Guidance for small production volumes <\/td>\n<\/tr>\n
100<\/td>\nAnnex I (informative)Guidelines and recommendations for accepting product produced under switching rules
I.1 Guidelines for Clause 7 \u2014 Requirements for accepting product produced under switching rules
I.2 Guidelines for 7.4 \u2014 Requirements for accepting product produced in repetitive lots by attribute sampling plans <\/td>\n<\/tr>\n
101<\/td>\nI.3 Guidelines for 7.5 \u2014 Requirements for accepting product produced in repetitive lots by variables sampling plans <\/td>\n<\/tr>\n
102<\/td>\nAnnex J (informative)Guidelines and recommendations for accepting product produced under process controls
J.1 Guidelines for 8.1 \u2014 General process control requirements
J.1.1 Guidelines for 8.1.12 \u2014 Limiting errors in measurement and recording
J.2 Guidelines for 8.2 \u2014 Statistical Process Control
J.2.1 Guidelines for 8.2.1 \u2014 Methods <\/td>\n<\/tr>\n
103<\/td>\nJ.2.2 Guidelines for 8.2.3 \u2014 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 \u2014 Investigation <\/td>\n<\/tr>\n
104<\/td>\nJ.2.4 Guidelines for 8.2.6 \u2014 Violation of stability
J.3 Guidelines for 8.3 \u2014 Variation restrictions
J.4 Guidelines for 8.4 \u2014 Process parameter controls <\/td>\n<\/tr>\n
105<\/td>\nJ.5 Step-by-step summary <\/td>\n<\/tr>\n
106<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
107<\/td>\nK.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 <\/td>\n<\/tr>\n
108<\/td>\nK.3 Implementing continuous sampling
K.3.1 Guidelines for 9.1.1 \u2014 Quality parameters
K.3.2 Guidelines for 9.1.2 \u2014 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 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Aerospace Series. Quality Management Systems. Statistical Product. Acceptance Requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n114<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":420981,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-420976","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/420976","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/420981"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=420976"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=420976"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=420976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}