Standard Practice for Applying Statistical Quality Assurance 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 provides 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.
Note 2—For validation of univariate process stream analyzers, see also Practice D 3764.
1.5 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 3—For non-Gaussian processes, transformations of test results may permit proper application of these tools. Consult a statistician for further guidance and information.
1.6 This 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).

General Information

Status
Historical
Publication Date
09-Jun-2002
Current Stage
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ASTM D6299-02e1 - Standard Practice for Applying Statistical Quality Assurance Techniques to Evaluate Analytical Measurement System Performance
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
An American National Standard
e1
Designation:D6299–02
Standard Practice for
Applying Statistical Quality Assurance Techniques to
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Evaluate Analytical Measurement System 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 2. Referenced Documents
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1.1 This practice provides information for the design and 2.1 ASTM Standards:
operationofaprogramtomonitorandcontrolongoingstability D 3764 Practice for Validation of Process Stream Analyzer
and precision and bias performance of selected analytical 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)
E 177 Practice for Use of the Terms Precision and Bias in
NOTE 1—Acomplete list of criteria for selecting measurement systems
ASTM Test Methods
towhichthispracticeshouldbeappliedandfordeterminingthefrequency
E 178 Practice for Dealing With Outlying Observations
at which it should be applied is beyond the scope of this practice.
E 456 Terminology Relating to Quality and Statistics
However, some factors to be considered include (1) frequency of use of
the analytical measurement system, (2) criticality of the parameter being
E 691 Practice for Conducting an Interlaboratory Study to
measured, (3) system stability and precision performance based on
Determine the Precision of a Test Method
historical data, (4) business economics, and (5) regulatory, contractual, or
test method requirements.
3. Terminology
1.2 This practice is applicable to stable analytical measure-
3.1 Definitions:
ment systems that produce results on a continuous numerical
3.1.1 accepted reference value, n—a value that serves as an
scale.
agreed-uponreferenceforcomparisonandthatisderivedas(1)
1.3 This practice is applicable to laboratory test methods.
atheoreticalorestablishedvalue,basedonscientificprinciples,
1.4 This practice is applicable to validated process stream
(2) an assigned value, based on experimental work of some
analyzers.
national or international organization, such as the U.S. Na-
tional Institute of Standards and Technology (NIST), or (3)a
NOTE 2—Forvalidationofunivariateprocessstreamanalyzers,seealso
consensus value, based on collaborative experimental work
Practice D 3764.
under the auspices of a scientific or engineering group.
1.5 This practice assumes that the normal (Gaussian) model
(E 456/E 177)
is adequate for the description and prediction of measurement
3.1.2 accuracy, n—the closeness of agreement between an
system behavior when it is in a state of statistical control.
observed value and an accepted reference value. (E 456/
NOTE 3—For non-Gaussian processes, transformations of test results
E 177)
may permit proper application of these tools. Consult a statistician for
3.1.3 assignable cause, n—a factor that contributes to
further guidance and information.
variation and that is feasible to detect and identify. (E 456)
1.6 This practice does not address statistical techniques for 3.1.4 bias, n—a systematic error that contributes to the
comparing two or more analytical measurement systems ap-
difference between a population mean of the measurements or
plying different analytical techniques or equipment compo- test results and an accepted reference or true value. (E 456/
nents that purport to measure the same property(s).
E 177)
3.1.5 control limits, n—limits on a control chart that are
used as criteria for signaling the need for action or for judging
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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
Quality Assurance and Statistics. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved June 10, 2002. Published September 2002. Originally Standards volume information, refer to the standard’s Document Summary page on
published as D 6299–98. Last previous edition D 6299–00. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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D6299–02
whether a set of data does or does not indicate a state of 3.2.7 in-statistical-control, adj—a process, analytical mea-
statistical control. (E 456) surement system, or function t
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