ASTM D6617-13
(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, using 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 the result obtained from a single implementation of a test method on a Check Standard (CS) and its ARV, based on user-specified Type I error, the user-established test method precision, the standard error of the ARV, and a presumed hypothesis that the laboratory is performing the test method without bias.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 there is a bias (positive or negative) of a user-specified magnitude that is deemed to be of practical concern (that is, the presumed hypothesis is not true).
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.
General Information
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Designation: D6617 − 13 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.
a statistician and to reference the CS methodology described in Practice
1. Scope*
D6299.
1.1 This practice covers a methodology for establishing an
acceptable tolerance zone for the difference between the result
2. Referenced Documents
obtained from a single implementation of a test method on a 2
2.1 ASTM Standards:
Check Standard (CS) and its ARV, based on user-specified
D2699Test Method for Research Octane Number of Spark-
Type I error, the user-established test method precision, the
Ignition Engine Fuel
standard error of theARV, and a presumed hypothesis that the
D6299Practice for Applying Statistical Quality Assurance
laboratory is performing the test method without bias.
and Control Charting Techniques to Evaluate Analytical
NOTE 1—Throughout this practice, the term user refers to the user of Measurement System Performance
thispractice;andthetermlaboratory(see1.1)referstotheorganizationor
E178Practice for Dealing With Outlying Observations
entity that is performing the test method.
3. Terminology
1.2 Forthetolerancezoneestablishedin1.1,amethodology
ispresentedtoestimatetheprobabilitythatthesingletestresult
3.1 Definitions for accepted reference value (ARV),
will fall outside the zone, in the event that there is a bias
accuracy, bias, check standard (CS), in statistical control, site
(positive or negative) of a user-specified magnitude that is
precision, site precision standard deviation (σ ), site preci-
SITE
deemed to be of practical concern (that is, the presumed
sion conditions, repeatability conditions, and reproducibility
hypothesis is not true).
conditions can be found in Practice D6299.
1.3 ThispracticeisintendedforASTMCommitteeD02test
3.2 Definitions of Terms Specific to This Standard:
methods that produce results on a continuous numerical scale.
3.2.1 acceptable tolerance zone, n—a numerical zone
bounded inclusively by zero 6 k ε (k is a value based on a
1.4 This practice assumes that the normal (Gaussian) model
user-specifiedTypeIerror;εisdefinedin3.2.7)suchthatifthe
is adequate for the description and prediction of measurement
differencebetweentheresultobtainedfromasingleimplemen-
system behavior when it is in a state of statistical control.
tation of a test method for a CS and its ARV falls inside this
NOTE2—Whilethispracticedoesnotcoverscenariosinwhichmultiple
zone, the presumed hypothesis that the laboratory or testing
results are obtained on the same CS under site precision or repeatability
organization is performing the test method without bias is
conditions,thestatisticalconceptspresentedareapplicable.Userswishing
accepted, and the difference is attributed to normal random
to apply these concepts for the scenarios described are advised to consult
variation of the test method. Conversely, if the difference falls
outside this zone, the presumed hypothesis is rejected.
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
Products and Lubricantsand is the direct responsibility of Subcommittee D02.94 on
2
Coordinating Subcommittee on Quality Assurance and Statistics. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved June 15, 2013. Published July 2013. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2008 as D6617–08. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D6617-13. 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, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
D6617 − 13
3.2.2 consensus check standard (CCS), n—aspecia
...
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 − 08 D6617 − 13 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 result
obtained from a single implementation of a test method on a CS Check Standard (CS) and its ARV, based on user-specified Type
I error, the user-established test method precision, the standard error of the ARV, and a presumed hypothesis that the laboratory
is performing the test method without bias.
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 there is a bias (positive or negative) of a user-specified magnitude that is deemed to
be of practical concern (that is, the presumed hypothesis is not true).
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.
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
E178 Practice for Dealing With Outlying Observations
3. Terminology
3.1 Definitions for accepted reference value (ARV), accuracy, bias, check standard (CS), in statistical control, site precision, site
precision standard deviation (σ ), site precision conditions, repeatability conditions, and reproducibility conditions can be found
SITE
in Practice D6299.
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products and Lubricantsand is the direct responsibility of Subcommittee D02.94 on
Coordinating Subcommittee on Quality Assurance and Statistics.
Current edition approved Dec. 1, 2008June 15, 2013. Published January 2009July 2013. Originally approved in 2000. Last previous edition approved in 20052008 as
D6617D6617 – 08.–05. DOI: 10.1520/D6617-08.10.1520/D6617-13.
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.
*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
---------------------- Page: 1 ----------------------
D6617 − 13
3.2 Definitions of Terms Specific to This Standard:
3.2.1 acceptable tolerance zone, n—a numerical zone bounded inclusively by zero 6 k ε (k is a value based on a user-specified
Type I error; ε is defined in 3.2.7) such that if the difference between the result obtained fro
...
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