ASTM D6299-02

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An American National Standard
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. Scope D 3764 Practice for Validation of Process Stream Analyzer
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Systems
1.1 This practice provides information for the design and
D 5191 Test Method for Vapor Pressure of Petroleum Prod-
operationofaprogramtomonitorandcontrolongoingstability
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ucts (Mini Method)
and precision and bias performance of selected analytical
E 177 Practice for Use of the Terms Precision and Bias in
measurement systems using a collection of generally accepted
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ASTM Test Methods
statistical quality control (SQC) procedures and tools.
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E 178 Practice for Dealing with Outlying Observations
NOTE 1—Acomplete list of criteria for selecting measurement systems 3
E 456 Terminology Relating to Quality and Statistics
towhichthispracticeshouldbeappliedandfordeterminingthefrequency
E 691 Practice for Conducting an Interlaboratory Study to
at which it should be applied is beyond the scope of this practice.
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Determine the Precision of a Test Method
However, some factors to be considered include (1) frequency of use of
the analytical measurement system, (2) criticality of the parameter being
3. Terminology
measured, (3) system stability and precision performance based on
historical data, (4) business economics, and (5) regulatory, contractual, or 3.1 Definitions:
test method requirements.
3.1.1 accepted reference value, n—a value that serves as an
agreed-uponreferenceforcomparisonandthatisderivedas(1)
1.2 This practice is applicable to stable analytical measure-
atheoreticalorestablishedvalue,basedonscientificprinciples,
ment systems that produce results on a continuous numerical
(2) an assigned value, based on experimental work of some
scale.
national or international organization, such as the U.S. Na-
1.3 This practice is applicable to laboratory test methods.
tional Institute of Standards and Technology (NIST), or (3)a
1.4 This practice is applicable to validated process stream
consensus value, based on collaborative experimental work
analyzers.
under the auspices of a scientific or engineering group.
NOTE 2—Forvalidationofunivariateprocessstreamanalyzers,seealso
(E 456/E 177)
Practice D 3764.
3.1.2 accuracy, n—the closeness of agreement between an
1.5 This practice assumes that the normal (Gaussian) model
observed value and an accepted reference value. (E 456/
is adequate for the description and prediction of measurement
E 177)
system behavior when it is in a state of statistical control.
3.1.3 assignable cause, n—a factor that contributes to
variation and that is feasible to detect and identify. (E 456)
NOTE 3—For non-Gaussian processes, transformations of test results
3.1.4 bias, n—a systematic error that contributes to the
may permit proper application of these tools. Consult a statistician for
further guidance and information.
difference between a population mean of the measurements or
test results and an accepted reference or true value. (E 456/
1.6 This practice does not address statistical techniques for
E 177)
comparing two or more analytical measurement systems ap-
3.1.5 control limits, n—limits on a control chart that are
plying different analytical techniques or equipment compo-
used as criteria for signaling the need for action or for judging
nents that purport to measure the same property(s).
whether a set of data does or does not indicate a state of
2. Referenced Documents
statistical control. (E 456)
3.1.6 lot, n—a definite quantity of a product or material
2.1 ASTM Standards:
accumulated under conditions that are considered uniform for
sampling purposes. (E 456)
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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
Quality Assurance and Statistics.
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Current edition approved June 10, 2002. Published September 2002. Originally Annual Book of ASTM Standards, Vol 05.02.
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published as D 6299–98. Last previous edition D 6299–00. Annual Book of ASTM Standards, Vol 14.02.
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D6299–02
3.1.7 precision, n—the closeness of agreement between test 3.2.8.1 Discussion—ASTM Committee D02 conducts pro-
results obtained under prescribed conditions. (E 456) ficiency testing a
...