ASTM E1488-12(2018)
(Guide)Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods
ABSTRACT
This guide identifies statistical procedures for use in developing new test methods or revising or evaluating existing test methods, or both. It also cites statistical procedures especially useful in the application of test methods. This standard recommends what approaches may be taken and indicates which standards may be used to perform such assessments.
This standard introduces a series of phases which are recommended to be considered during the life cycle of a test method. These begin with a design phase where the standard is initially prepared. A development phase involves a variety of experiments that allow further refinement and understanding of how the test method performs within a laboratory. In an evaluation phase the test method is then examined by way of inter-laboratory studies resulting in precision and bias statistics which are published in the standard. Finally, the test method is subject to a monitoring phase.
SIGNIFICANCE AND USE
4.1 The creation of a standardized test method generally follows a series of steps from inception to approval and ongoing use. In all such stages there are questions of how well the test method performs.
4.1.1 Assessments of a new or existing test method generally involve statistical planning and analysis. This standard recommends what approaches may be taken and indicates which standards may be used to perform such assessments.
4.2 This standard introduces a series of phases which are recommended to be considered during the life cycle of a test method as depicted in Fig. 1. These begin with a design phase where the standard is initially prepared. A development phase involves a variety of experiments that allow further refinement and understanding of how the test method performs within a laboratory. In an evaluation phase the test method is then examined by way of interlaboratory studies resulting in precision and bias statistics which are published in the standard. Finally, the test method is subject to a monitoring phase.
FIG. 1 Sequence of Steps
4.3 All ASTM test methods are required to include statements on precision and bias.3
4.4 Since ASTM began to require all test methods to have precision and bias statements that are based on interlaboratory test methods, there has been increased concern regarding what statistical experiments and procedures to use during the development of the test methods. Although there exists a wide range of statistical procedures, there is a small group of generally accepted techniques that are beneficial to follow. This guide is designed to provide a brief overview of these procedures and to suggest an appropriate sequence of carrying out these procedures.
4.5 Statistical procedures often result in interpretations that are not absolutes. Sometimes the information obtained may be inadequate or incomplete, which may lead to additional questions and the need for further experimentation. Information outside the data is al...
SCOPE
1.1 This guide identifies statistical procedures for use in developing new test methods or revising or evaluating existing test methods, or both.
1.2 This guide also cites statistical procedures especially useful in the application of test methods.
1.3 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.
General Information
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Designation: E1488 − 12 (Reapproved 2018) An American National Standard
Standard Guide for
Statistical Procedures to Use in Developing and Applying
1
Test Methods
This standard is issued under the fixed designation E1488; 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 E2655 Guide for Reporting Uncertainty of Test Results and
Use of the Term Measurement Uncertainty in ASTM Test
1.1 This guide identifies statistical procedures for use in
Methods
developing new test methods or revising or evaluating existing
test methods, or both.
3. Terminology
1.2 This guide also cites statistical procedures especially
3.1 Definitions—For a more extensive list of terms in E11
useful in the application of test methods.
standards, see Terminology E456.
1.3 This international standard was developed in accor-
3.1.1 bias, n—the difference between the expectation of the
dance with internationally recognized principles on standard-
test results and an accepted reference value. E177
ization established in the Decision on Principles for the
3.1.1.1 Discussion—Statistical procedures include the sam-
Development of International Standards, Guides and Recom-
pling considerations or the experiment design for the collection
mendations issued by the World Trade Organization Technical
of data, or both, and the numerical and graphical approaches to
Barriers to Trade (TBT) Committee.
summarize and analyze the collected data.
2. Referenced Documents
3.1.2 coeffıcient of variation, CV, n—for a nonnegative
2
characteristic, the ratio of the standard deviation to the mean
2.1 ASTM Standards:
for a population or sample. E2586
E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
3.1.3 component of variance, n—a part of a total variance
E178 Practice for Dealing With Outlying Observations
identified with a specified source of variability.
E456 Terminology Relating to Quality and Statistics
3.1.4 control chart, n—chart on which are plotted a statis-
E691 Practice for Conducting an Interlaboratory Study to
tical measure of a subgroup versus time of sampling along with
Determine the Precision of a Test Method
limits based on the statistical distribution of that measure so as
E1169 Practice for Conducting Ruggedness Tests
to indicate how much common, or chance, cause variation is
E1402 Guide for Sampling Design
inherent in the process or product. E2587
E2282 Guide for Defining the Test Result of a Test Method
E2489 Practice for Statistical Analysis of One-Sample and 3.1.5 observation, n—the process of obtaining information
regarding the presence or absence of an attribute of a test
Two-Sample Interlaboratory Proficiency Testing Programs
E2554 Practice for Estimating and Monitoring the Uncer- specimen, or of making a reading on a characteristic or
dimension of a test specimen. E2282
tainty of Test Results of a Test Method Using Control
Chart Techniques
3.1.6 observed value, n—the value obtained by making an
E2586 Practice for Calculating and Using Basic Statistics
observation. E2282
E2587 Practice for Use of Control Charts in Statistical
3.1.7 precision, n—the closeness of agreement between
Process Control
independent test results obtained under stipulated conditions.
E177
1
This guide is under the jurisdiction of ASTM Committee E11 on Quality and
3.1.8 proficiency testing, n—determination of laboratory
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
testing performance by means of interlaboratory comparisons.
Evaluation and Quality Control.
E2489
Current edition approved April 1, 2018. Published May 2018. Originally
ɛ1
approved in 1992. Last previous edition approved in 2012 as E1488 – 12 . DOI:
3.1.9 repeatability, n—precision under repeatability condi-
10.1520/E1488-12R18.
2
tions. E177
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3.1.10 repeatability conditions, n—conditions where inde-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. pendent test results are obtained with the same method on
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1488 − 12 (2018)
identical test items in the same laboratory by the same operator 4.1.1 Assessments of a new or existing test method gener-
using the same equipment within short intervals of time. E177 ally involve statistical planning and analysis. This standard
reco
...
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.
´1
Designation: E1488 − 12 E1488 − 12 (Reapproved 2018) An American National Standard
Standard Guide for
Statistical Procedures to Use in Developing and Applying
1
Test Methods
This standard is issued under the fixed designation E1488; 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
ε NOTE—Editorial corrections were made to 3.1.25 in April 2013.
1. Scope
1.1 This guide identifies statistical procedures for use in developing new test methods or revising or evaluating existing test
methods, or both.
1.2 This guide also cites statistical procedures especially useful in the application of test methods.
1.3 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:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E178 Practice for Dealing With Outlying Observations
E456 Terminology Relating to Quality and Statistics
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E1169 Practice for Conducting Ruggedness Tests
E1402 Guide for Sampling Design
E2282 Guide for Defining the Test Result of a Test Method
E2489 Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs
E2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques
E2586 Practice for Calculating and Using Basic Statistics
E2587 Practice for Use of Control Charts in Statistical Process Control
E2655 Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods
3. Terminology
3.1 Definitions—For a more extensive list of terms in E11 standards, see Terminology E456.
3.1.1 bias, n—the difference between the expectation of the test results and an accepted reference value. E177
3.1.1.1 Discussion—
Statistical procedures include the sampling considerations or the experiment design for the collection of data, or both, and the
numerical and graphical approaches to summarize and analyze the collected data.
3.1.2 coeffıcient of variation, CV, n—for a nonnegative characteristic, the ratio of the standard deviation to the mean for a
population or sample. E2586
3.1.3 component of variance, n—a part of a total variance identified with a specified source of variability.
1
This guide is under the jurisdiction of ASTM Committee E11 on Quality and Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method Evaluation
and Quality Control.
Current edition approved Aug. 1, 2012April 1, 2018. Published September 2012 May 2018. Originally approved in 1992. Last previous edition approved in 20092012 as
ɛ1
E1488 – 09.E1488 – 12 . DOI: 10.1520/E1488-12E01.10.1520/E1488-12R18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1488 − 12 (2018)
3.1.4 control chart, n—chart on which are plotted a statistical measure of a subgroup versus time of sampling along with limits
based on the statistical distribution of that measure so as to indicate how much common, or chance, cause variation is inherent in
the process or product. E2587
3.1.5 observation, n—the process of obtaining information regarding the presence or absence of an attribute of a test specimen,
or of making a reading on a characteristic or dimension of a test specimen. E2282
3.1.6 observed value, n—the value obtained by making an observation. E2282
3.1.7 precision, n—the closeness of agreement between independent test results obtained under stipulated conditions. E177
3.1.8 proficiency testing, n—determination of laboratory testing performance by means of interlaboratory comparisons. E2489
3.1.9 repeatability, n—precision unde
...
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