ASTM D8146-22
(Guide)Standard Guide for Evaluating Test Method Capability and Fitness for Use
Standard Guide for Evaluating Test Method Capability and Fitness for Use
SIGNIFICANCE AND USE
4.1 This guide provides the developers of test methods with systematic approaches to evaluate the inherent adequacy (capability) of the precision and the adequacy of between-laboratory standardization as determined by interlaboratory testing in accordance with Practice D6300 for a new or modified test method.
4.1.1 The tools presented in this guide can be used to assess the adequacy of the repeatability and reproducibility determined for a given test method relative to their intended applications. For those test methods with less than optimal precision, the responsible subcommittees would have an opportunity to investigate, suggest improvements in the procedure, and design an interlaboratory study as necessary. It is important to note that non-optimal precision does not necessarily imply that the test method is invalid, but that the test method may be less capable for an intended application.
4.2 This guide is applicable to test method users to evaluate the relative performance of different test methods that purport to measure the same property as applied to a specific application of the test methods.
4.3 This guide can be used to evaluate the fitness for use of a test method reproducibility relative to its intended use in specifications.
4.3.1 When test method results are intended to be compared against specification limits, this guide provides the tools to assess whether the test method’s reproducibility is expected to be fit for use relative to the stated limits.
4.4 This guide is most effective when used in conjunction with sufficient knowledge of the chemistry, instrumental technology, metrology principles, sample characteristics, and a fundamental understanding of statistical meaning and implications associated with repeatability and reproducibility of the test method being evaluated.
4.5 This guide does not cover the qualitative and business factors that might also be considered in judging a test method’s capability or fitness for use versus...
SCOPE
1.1 This guide covers techniques for evaluating the statistical capability and fitness for use of standard test methods used for measuring properties of petroleum products, liquid fuels, and lubricants. Specifically, this guide provides strategies for evaluating the capability of a test method to provide a sufficiently precise estimate of the intended parameter versus a given level or value of that parameter and for assessing, with sufficient confidence, the fitness for use of a test method for determining the acceptability of products versus specification, regulatory, or manufacturing limits.
1.2 The assessment of capability in this guide is applicable to test methods that always yield non-negative numerical results and have a hard, fixed zero lower limit or fixed upper limit (for example, 100 %). Detailed knowledge of a test method and professional judgement may be required in determining the applicability of this guide to certain test methods.
1.3 In accordance with this guide, the assessment of fitness for use of a test method versus specification, regulatory, or manufacturing limits is generally applicable to test methods that provide numerical results and have applicable reproducibility precision values.
1.4 This guide is intended for use by test method developers, specification setters, and laboratories selecting test methods to evaluate products for specific purposes or versus specific limits.
1.5 This guide is not applicable to test methods that measure temperature to determine properties such as, but not limited to, freeze point, pour point, flash point, and distillations. This guide is not intended for use by laboratories for evaluating laboratory test method execution capability, nor is it intended to evaluate manufacturing process capability.
1.6 The expressions of capability and fitness for use derived from use of this guide should not be the only criteria for selection and use of a given tes...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8146 − 22 An American National Standard
Standard Guide for
1
Evaluating Test Method Capability and Fitness for Use
This standard is issued under the fixed designation D8146; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* to complete an analysis, typical product results relative to the
regulatory or manufacturing specification limit, closeness of
1.1 This guide covers techniques for evaluating the statisti-
the results to zero, and cost factors may contribute more
cal capability and fitness for use of standard test methods used
significantly to the decision to use a given test method for a
for measuring properties of petroleum products, liquid fuels,
specific application.
and lubricants. Specifically, this guide provides strategies for
evaluating the capability of a test method to provide a
1.7 This guide draws on statistical approaches covered in
sufficiently precise estimate of the intended parameter versus a
other standards supporting petroleum products, liquid fuels,
given level or value of that parameter and for assessing, with
and lubricants, including Practices D3244, D6259, D6299,
sufficient confidence, the fitness for use of a test method for
D6300, D6792 and ISO 4259.
determining the acceptability of products versus specification,
1.8 This standard does not purport to address all of the
regulatory, or manufacturing limits.
safety concerns, if any, associated with its use. It is the
1.2 The assessment of capability in this guide is applicable
responsibility of the user of this standard to establish appro-
to test methods that always yield non-negative numerical
priate safety, health, and environmental practices and deter-
results and have a hard, fixed zero lower limit or fixed upper
mine the applicability of regulatory limitations prior to use.
limit (for example, 100%). Detailed knowledge of a test
1.9 This international standard was developed in accor-
method and professional judgement may be required in deter-
dance with internationally recognized principles on standard-
mining the applicability of this guide to certain test methods.
ization established in the Decision on Principles for the
1.3 In accordance with this guide, the assessment of fitness
Development of International Standards, Guides and Recom-
for use of a test method versus specification, regulatory, or
mendations issued by the World Trade Organization Technical
manufacturing limits is generally applicable to test methods
Barriers to Trade (TBT) Committee.
that provide numerical results and have applicable reproduc-
ibility precision values.
2. Referenced Documents
1.4 This guide is intended for use by test method
2
2.1 ASTM Standards:
developers, specification setters, and laboratories selecting test
D3244Practice for Utilization of Test Data to Determine
methods to evaluate products for specific purposes or versus
Conformance with Specifications
specific limits.
D6259Practice for Determination of a Pooled Limit of
1.5 Thisguideisnotapplicabletotestmethodsthatmeasure
Quantitation for a Test Method
temperaturetodeterminepropertiessuchas,butnotlimitedto,
D6299Practice for Applying Statistical Quality Assurance
freeze point, pour point, flash point, and distillations. This
and Control Charting Techniques to Evaluate Analytical
guide is not intended for use by laboratories for evaluating
Measurement System Performance
laboratory test method execution capability, nor is it intended
D6300Practice for Determination of Precision and Bias
to evaluate manufacturing process capability.
Data for Use in Test Methods for Petroleum Products,
1.6 Theexpressionsofcapabilityandfitnessforusederived
Liquid Fuels, and Lubricants
from use of this guide should not be the only criteria for
D6792Practice for Quality Management Systems in Petro-
selection and use of a given test method. Other factors such as
leum Products, Liquid Fuels, and Lubricants Testing
thelaboratory’sexperiencewiththetestmethod,lengthoftime
Laboratories
1
This guide is under the jurisdiction of ASTM Committee D02 on Petroleum
Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom-
2
mittee D02.94 on Coordinating Subcommittee on QualityAssurance and Statistics. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 1, 2022. Published November 2022. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved i
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: D8146 − 18 D8146 − 22 An American National Standard
Standard Guide for
1
Evaluating Test Method Capability and Fitness for Use
This standard is issued under the fixed designation D8146; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Scope*
1.1 This guide covers techniques for evaluating the statistical capability and fitness for use of standard test methods used for
measuring properties of petroleum products, liquid fuels, and lubricants. Specifically, this guide provides strategies for evaluating
the capability of a test method to provide a sufficiently precise estimate of the intended parameter versus a given level or value
of that parameter and for assessing, with sufficient confidence, the fitness for use of a test method for determining the acceptability
of products versus specification, regulatory, or manufacturing limits.
1.2 The assessment of capability in this guide is applicable to test methods that always yield non-negative numerical results and
have a hard, fixed zero lower limit or fixed upper limit (for example, 100 %). Detailed knowledge of a test method and professional
judgement may be required in determining the applicability of this guide to certain test methods.
1.3 In accordance with this guide, the assessment of fitness for use of a test method versus specification, regulatory, or
manufacturing limits is generally applicable to test methods that provide numerical results and have applicable reproducibility
precision values.
1.4 This guide is intended for use by test method developers, specification setters, and laboratories selecting test methods to
evaluate products for specific purposes or versus specific limits.
1.5 This guide is not applicable to test methods that measure temperature to determine properties such as, but not limited to, freeze
point, pour point, flash point, and distillations. This guide is not intended for use by laboratories for evaluating laboratory test
method execution capability, nor is it intended to evaluate manufacturing process capability.
1.6 The expressions of capability and fitness for use derived from use of this guide should not be the only criteria for selection
and use of a given test method. Other factors such as the laboratory’s experience with the test method, length of time to complete
an analysis, typical product results relative to the regulatory or manufacturing specification limit, closeness of the results to zero,
and cost factors may contribute more significantly to the decision to use a given test method for a specific application.
1.7 This guide draws on statistical approaches covered in other standards supporting petroleum products, liquid fuels, and
lubricants, including Practices D3244, D6259, D6299, D6300, D6792 and ISO 4259.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1
This guide is under the jurisdiction of ASTM Committee D02 on Petroleum Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcommittee
D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.
Current edition approved Oct. 1, 2018Nov. 1, 2022. Published November 2018November 2022. Originally approved in 2018. Last previous edition approved in 2018 as
D8146 – 18. DOI: 10.1520/D8146-18.10.1520/D8146-22.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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D8146 − 22
1.9 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D3244 Practice for Utilization of Test Data to Determine Conformance with Specifications
D6259 Practice for Determination of a Pooled Limit of Quantitation for a Test Method
D6299
...
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