ASTM D6617-21
(Practice)Standard Practice for Laboratory Bias Detection Using Single Test Result from Standard Material
Standard Practice for Laboratory Bias Detection Using Single Test Result from Standard Material
SIGNIFICANCE AND USE
4.1 Laboratories performing petroleum test methods can use this practice to set an acceptable tolerance zone for infrequent testing of CS or CCS material, based on ε, and a desired Type I error, for the purpose of ascertaining if the test method is being performed without bias.
4.2 This practice can be used to estimate the power of correctly detecting bias of different magnitudes, given the acceptable tolerance zone set in 4.1, and hence, gain insight into the limitation of the true bias detection capability associated with this acceptable tolerance zone. With this insight, trade-offs can be made between desired Type I error versus desired bias detection capability to suit specific business needs.
4.3 The CS testing activities described in this practice are intended to augment and not replace the regular statistical monitoring of test method performance as described in Practice D6299.
SCOPE
1.1 This practice covers a methodology for establishing an acceptable tolerance zone for the difference between a single result obtained for a Check Standard (CS) from a single implementation of a test method using a single measurement system at a laboratory versus its Accepted Reference Value (ARV), based on user-specified Type I error, the user-established measurement system precision for the execution of the test method, the standard error of the ARV, and a presumed hypothesis that the measurement system as operated by the laboratory in the execution of the test method is not biased.
Note 1: Throughout this practice, the term “user” refers to the user of this practice, and the term “laboratory” (see 1.1) refers to the organization or entity that is performing the test method.
1.2 For the tolerance zone established in 1.1, a methodology is presented to estimate the probability that the single test result will fall outside the zone, in the event that the presumed hypothesis is not true and there is a bias (positive or negative) of a user-specified magnitude that is deemed to be of practical concern.
1.3 This practice is intended for ASTM Committee D02 test methods that produce results on a continuous numerical scale.
1.4 This practice assumes that the normal (Gaussian) model is adequate for the description and prediction of measurement system behavior when it is in a state of statistical control.
Note 2: While this practice does not cover scenarios in which multiple results are obtained on the same CS under site precision or repeatability conditions, the statistical concepts presented are applicable. Users wishing to apply these concepts for the scenarios described are advised to consult a statistician and to reference the CS methodology described in Practice D6299.
1.5 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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Standards Content (Sample)
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: D6617 − 21 An American National Standard
Standard Practice for
Laboratory Bias Detection Using Single Test Result from
1
Standard Material
This standard is issued under the fixed designation D6617; 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.
INTRODUCTION
Due to the inherent imprecision in all test methods, a laboratory cannot expect to obtain the
numerically exact accepted reference value (ARV) of a check standard (CS) material every time one
is tested. Results that are reasonably close to theARV should provide assurance that the laboratory is
performing the test method either without bias, or with a bias that is of no practical concern, hence
requiring no intervention. Results differing from the ARV by more than a certain amount, however,
should lead the laboratory to take corrective action.
results are obtained on the same CS under site precision or repeatability
1. Scope*
conditions,thestatisticalconceptspresentedareapplicable.Userswishing
1.1 This practice covers a methodology for establishing an
to apply these concepts for the scenarios described are advised to consult
acceptable tolerance zone for the difference between a single
a statistician and to reference the CS methodology described in Practice
D6299.
result obtained for a Check Standard (CS) from a single
implementation of a test method using a single measurement
1.5 This international standard was developed in accor-
system at a laboratory versus its Accepted Reference Value dance with internationally recognized principles on standard-
(ARV), based on user-specified Type I error, the user-
ization established in the Decision on Principles for the
established measurement system precision for the execution of Development of International Standards, Guides and Recom-
the test method, the standard error of theARV, and a presumed
mendations issued by the World Trade Organization Technical
hypothesis that the measurement system as operated by the Barriers to Trade (TBT) Committee.
laboratory in the execution of the test method is not biased.
2. Referenced Documents
NOTE 1—Throughout this practice, the term “user” refers to the user of
2
this practice, and the term “laboratory” (see 1.1) refers to the organization 2.1 ASTM Standards:
or entity that is performing the test method.
D2699Test Method for Research Octane Number of Spark-
Ignition Engine Fuel
1.2 Forthetolerancezoneestablishedin1.1,amethodology
D6299Practice for Applying Statistical Quality Assurance
ispresentedtoestimatetheprobabilitythatthesingletestresult
and Control Charting Techniques to Evaluate Analytical
will fall outside the zone, in the event that the presumed
Measurement System Performance
hypothesis is not true and there is a bias (positive or negative)
D7915Practice for Application of Generalized Extreme
of a user-specified magnitude that is deemed to be of practical
Studentized Deviate (GESD) Technique to Simultane-
concern.
ously Identify Multiple Outliers in a Data Set
1.3 ThispracticeisintendedforASTMCommitteeD02test
methods that produce results on a continuous numerical scale.
3. Terminology
1.4 This practice assumes that the normal (Gaussian) model
3.1 Definitions for accepted reference value (ARV),
is adequate for the description and prediction of measurement
accuracy, bias, check standard (CS), in statistical control, site
system behavior when it is in a state of statistical control.
precision, site precision standard deviation (σ ), site preci-
SITE
NOTE2—Whilethispracticedoesnotcoverscenariosinwhichmultiple
sion conditions, repeatability conditions, and reproducibility
conditions can be found in Practice D6299.
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
Products, Liquid Fuels, and Lubricantsand 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 May 1, 2021. Published May 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2017 as D6617–17. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D6617-21. the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken,
...
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: D6617 − 17 D6617 − 21 An American National Standard
Standard Practice for
Laboratory Bias Detection Using Single Test Result from
1
Standard Material
This standard is issued under the fixed designation D6617; 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.
INTRODUCTION
Due to the inherent imprecision in all test methods, a laboratory cannot expect to obtain the
numerically exact accepted reference value (ARV) of a check standard (CS) material every time one
is tested. Results that are reasonably close to the ARV should provide assurance that the laboratory is
performing the test method either without bias, or with a bias that is of no practical concern, hence
requiring no intervention. Results differing from the ARV by more than a certain amount, however,
should lead the laboratory to take corrective action.
1. Scope*
1.1 This practice covers a methodology for establishing an acceptable tolerance zone for the difference between the a single result
obtained for a Check Standard (CS) from a single implementation of a test method on a Check Standard (CS) and its ARV, using
a single measurement system at a laboratory versus its Accepted Reference Value (ARV), based on user-specified Type I error, the
user-established test method precision, measurement system precision for the execution of the test method, the standard error of
the ARV, and a presumed hypothesis that the laboratory is performing the test method without bias.measurement system as
operated by the laboratory in the execution of the test method is not biased.
NOTE 1—Throughout this practice, the term “user” refers to the user of this practice, and the term “laboratory” (see 1.1) refers to the organization or entity
that is performing the test method.
1.2 For the tolerance zone established in 1.1, a methodology is presented to estimate the probability that the single test result will
fall outside the zone, in the event that the presumed hypothesis is not true and there is a bias (positive or negative) of a
user-specified magnitude that is deemed to be of practical concern.
1.3 This practice is intended for ASTM Committee D02 test methods that produce results on a continuous numerical scale.
1.4 This practice assumes that the normal (Gaussian) model is adequate for the description and prediction of measurement system
behavior when it is in a state of statistical control.
NOTE 2—While this practice does not cover scenarios in which multiple results are obtained on the same CS under site precision or repeatability
conditions, the statistical concepts presented are applicable. Users wishing to apply these concepts for the scenarios described are advised to consult a
statistician and to reference the CS methodology described in Practice D6299.
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products, Liquid Fuels, and Lubricantsand is the direct responsibility of Subcommittee
D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.
Current edition approved May 1, 2017May 1, 2021. Published May 2017May 2021. Originally approved in 2000. Last previous edition approved in 20132017 as
D6617 – 13.D6617 – 17. DOI: 10.1520/D6617-17.10.1520/D6617-21.
*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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D6617 − 21
1.5 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:
D2699 Test Method for Research Octane Number of Spark-Ignition Engine Fuel
D6299 Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measure-
ment System Performance
D7915 Practice for Application of Generalized Extreme Studentized Deviate (GESD) Technique to Simultaneously Identify
Multiple Outliers in a Data Set
3. Terminology
3.1 Definitions for accepted reference value (ARV), accuracy, bias, check standard (CS),
...
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