ASTM D6299-07
(Practice)Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
SIGNIFICANCE AND USE
This practice can be used to continuously demonstrate the proficiency of analytical measurement systems that are used for establishing and ensuring the quality of petroleum and petroleum products.
Data accrued, using the techniques included in this practice, provide the ability to monitor analytical measurement system precision and bias.
These data are useful for updating test methods as well as for indicating areas of potential measurement system improvement.
SCOPE
1.1 This practice covers information for the design and operation of a program to monitor and control ongoing stability and precision and bias performance of selected analytical measurement systems using a collection of generally accepted statistical quality control (SQC) procedures and tools.
Note 1—A complete list of criteria for selecting measurement systems to which this practice should be applied and for determining the frequency at which it should be applied is beyond the scope of this practice. However, some factors to be considered include (1) frequency of use of the analytical measurement system, (2) criticality of the parameter being measured, (3) system stability and precision performance based on historical data, (4) business economics, and (5) regulatory, contractual, or test method requirements.
1.2 This practice is applicable to stable analytical measurement systems that produce results on a continuous numerical scale.
1.3 This practice is applicable to laboratory test methods.
1.4 This practice is applicable to validated process stream analyzers.
1.5 This practice is applicable to monitoring the differences between two analytical measurement systems that purport to measure the same property provided that both systems have been assessed in accordance with the statistical methodology in Practice D 6708 and the appropriate bias applied.
Note 2—For validation of univariate process stream analyzers, see also Practice D 3764.
Note 3—One or both of the analytical systems in 1.5 can be laboratory test methods or validated process stream analyzers.
1.6 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 4—For non-Gaussian processes, transformations of test results may permit proper application of these tools. Consult a statistician for further guidance and information.
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An American National Standard
Designation:D6299–07
Standard Practice for
Applying Statistical Quality Assurance and Control Charting
Techniques to Evaluate Analytical Measurement System
1
Performance
This standard is issued under the fixed designation D 6299; 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 2. Referenced Documents
2
1.1 This practice covers information for the design and 2.1 ASTM Standards:
operationofaprogramtomonitorandcontrolongoingstability D 3764 Practice for Validation of the Performance of Pro-
and precision and bias performance of selected analytical cess Stream Analyzer Systems
measurement systems using a collection of generally accepted D 5191 Test Method for Vapor Pressure of Petroleum Prod-
statistical quality control (SQC) procedures and tools. ucts (Mini Method)
D 6708 Practice for Statistical Assessment and Improve-
NOTE 1—Acomplete list of criteria for selecting measurement systems
ment of Expected Agreement Between Two Test Methods
towhichthispracticeshouldbeappliedandfordeterminingthefrequency
that Purport to Measure the Same Property of a Material
at which it should be applied is beyond the scope of this practice.
E 177 Practice for Use of the Terms Precision and Bias in
However, some factors to be considered include (1) frequency of use of
the analytical measurement system, (2) criticality of the parameter being
ASTM Test Methods
measured, (3) system stability and precision performance based on
E 178 Practice for Dealing With Outlying Observations
historical data, (4) business economics, and (5) regulatory, contractual, or
E 456 Terminology Relating to Quality and Statistics
test method requirements.
E 691 Practice for Conducting an Interlaboratory Study to
1.2 This practice is applicable to stable analytical measure-
Determine the Precision of a Test Method
ment systems that produce results on a continuous numerical
3. Terminology
scale.
1.3 This practice is applicable to laboratory test methods.
3.1 Definitions:
1.4 This practice is applicable to validated process stream
3.1.1 accepted reference value, n—a value that serves as an
analyzers.
agreed-uponreferenceforcomparisonandthatisderivedas(1)
1.5 This practice is applicable to monitoring the differences
atheoreticalorestablishedvalue,basedonscientificprinciples,
between two analytical measurement systems that purport to
(2) an assigned value, based on experimental work of some
measure the same property provided that both systems have
national or international organization, such as the U.S. Na-
beenassessedinaccordancewiththestatisticalmethodologyin
tional Institute of Standards and Technology (NIST), or (3)a
Practice D 6708 and the appropriate bias applied.
consensus value, based on collaborative experimental work
under the auspices of a scientific or engineering group.
NOTE 2—Forvalidationofunivariateprocessstreamanalyzers,seealso
E 177, E 456
Practice D 3764.
3.1.2 accuracy, n—the closeness of agreement between an
NOTE 3—One or both of the analytical systems in 1.5 can be laboratory
test methods or validated process stream analyzers.
observed value and an accepted reference value. E 177,
E 456
1.6 This practice assumes that the normal (Gaussian) model
3.1.3 assignable cause, n—a factor that contributes to
is adequate for the description and prediction of measurement
variation and that is feasible to detect and identify. E 456
system behavior when it is in a state of statistical control.
3.1.4 bias, n—a systematic error that contributes to the
NOTE 4—For non-Gaussian processes, transformations of test results
difference between a population mean of the measurements or
may permit proper application of these tools. Consult a statistician for
test results and an accepted reference or true value. E 177,
further guidance and information.
E 456
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This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
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Products and Lubricants and is the direct responsibility of Subcommittee D02.94 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Coordinating Subcommittee on Quality Assurance and Statistics. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Nov. 1, 2007. Published February 2008. Originally Standards volume information, refer to the standard’s Document Summary page on
´1
approved in 1998. Last previous edition approved in 2002 as D 6299–02 . the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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This document is not anASTM standard and is intended only to provide the user of anASTM 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.
An American National Standard
e1
Designation:D6299–02 Designation:D6299–07
Standard Practice for
Applying Statistical Quality Assurance and Control Charting
Techniques to Evaluate Analytical Measurement System
1
Performance
This standard is issued under the fixed designation D 6299; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Equation references in A1.5.4.4 were corrected editorially in March 2006.
1. Scope
1.1 This practice providescovers information for the design and operation of a program to monitor and control ongoing stability
and precision and bias performance of selected analytical measurement systems using a collection of generally accepted statistical
quality control (SQC) procedures and tools.
NOTE 1—A complete list of criteria for selecting measurement systems to which this practice should be applied and for determining the frequency at
which it should be applied is beyond the scope of this practice. However, some factors to be considered include (1) frequency of use of the analytical
measurementsystem,(2)criticalityoftheparameterbeingmeasured,(3)systemstabilityandprecisionperformancebasedonhistoricaldata,(4)business
economics, and (5) regulatory, contractual, or test method requirements.
1.2 This practice is applicable to stable analytical measurement systems that produce results on a continuous numerical scale.
1.3 This practice is applicable to laboratory test methods.
1.4 This practice is applicable to validated process stream analyzers.
1.5 This practice is applicable to monitoring the differences between two analytical measurement systems that purport to
measure the same property provided that both systems have been assessed in accordance with the statistical methodology in
Practice D 6708 and the appropriate bias applied.
NOTE 2—For validation of univariate process stream analyzers, see also Practice D 3764.
1.5Thispracticeassumesthatthenormal(Gaussian)modelisadequateforthedescriptionandpredictionofmeasurementsystem
behavior when it is in a state of statistical control.
NOTE3—For non-Gaussian processes, transformations of test results may permit proper application of these tools. Consult a statistician for further
guidance and information.
1.6This practice does not address statistical techniques for comparing two or more analytical measurement systems applying
different analytical techniques or equipment components that purport to measure the same property(s). 3—One or both of the
analytical systems in 1.5 can be laboratory test methods or validated process stream analyzers.
1.6 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 4—For non-Gaussian processes, transformations of test results may permit proper application of these tools. Consult a statistician for further
guidance and information.
2. Referenced Documents
2
2.1 ASTM Standards:
D 3764 Practice for Validation of the Performance of Process Stream Analyzer Systems
D 5191 Test Method for Vapor Pressure of Petroleum Products (Mini Method)
E177Practice for Use of the Terms Precision and Bias in ASTM Test Methods
1
ThispracticeisunderthejurisdictionofASTMCommitteeD02onPetroleumProductsandLubricantsandisthedirectresponsibilityofSubcommitteeD02.94onQuality
Assurance and Statistics.
Current edition approved June 10, 2002. Published September 2002. Originally published as D6299–98. Last previous edition D6299–00.
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products and Lubricants and is the direct responsibility of Subcommittee D02.94 on
Coordinating Subcommittee on Quality Assurance and Statistics.
e1
Current edition approved Nov. 1, 2007. Published February 2008. Originally approved in 1998. Last previous edition approved in 2002 as D 6299–02 .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM 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
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D6299–07
D 6708 Practice
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