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 D6708 and the appropriate bias applied.
Note 2—For validation of univariate process stream analyzers, see also Practice D3764.
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.

General Information

Status
Historical
Publication Date
28-Feb-2010
Current Stage
Ref Project

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ASTM D6299-10e1 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
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An American National Standard
´1
Designation:D6299–10
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 D6299; 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
´ NOTE—Corrected definition references and figure numbering editorially in March 2011.
may permit proper application of these tools. Consult a statistician for
1. Scope
further guidance and information.
1.1 This practice covers information for the design and
operationofaprogramtomonitorandcontrolongoingstability
2. Referenced Documents
and precision and bias performance of selected analytical
2
2.1 ASTM Standards:
measurement systems using a collection of generally accepted
D3764 Practice for Validation of the Performance of Pro-
statistical quality control (SQC) procedures and tools.
cess Stream Analyzer Systems
NOTE 1—Acomplete list of criteria for selecting measurement systems D5191 Test Method for Vapor Pressure of Petroleum Prod-
towhichthispracticeshouldbeappliedandfordeterminingthefrequency
ucts (Mini Method)
at which it should be applied is beyond the scope of this practice.
D6708 PracticeforStatisticalAssessmentandImprovement
However, some factors to be considered include (1) frequency of use of
of Expected Agreement Between Two Test Methods that
the analytical measurement system, (2) criticality of the parameter being
Purport to Measure the Same Property of a Material
measured, (3) system stability and precision performance based on
D6792 Practice for Quality System in Petroleum Products
historical data, (4) business economics, and (5) regulatory, contractual, or
and Lubricants Testing Laboratories
test method requirements.
D7372 Guide forAnalysis and Interpretation of Proficiency
1.2 This practice is applicable to stable analytical measure-
Test Program Results
ment systems that produce results on a continuous numerical
E177 Practice for Use of the Terms Precision and Bias in
scale.
ASTM Test Methods
1.3 This practice is applicable to laboratory test methods.
E178 Practice for Dealing With Outlying Observations
1.4 This practice is applicable to validated process stream
E456 Terminology Relating to Quality and Statistics
analyzers.
E691 Practice for Conducting an Interlaboratory Study to
1.5 This practice is applicable to monitoring the differences
Determine the Precision of a Test Method
between two analytical measurement systems that purport to
measure the same property provided that both systems have
3. Terminology
beenassessedinaccordancewiththestatisticalmethodologyin
3.1 Definitions:
Practice D6708 and the appropriate bias applied.
3.1.1 accepted reference value, n—a value that serves as an
NOTE 2—Forvalidationofunivariateprocessstreamanalyzers,seealso
agreed-uponreferenceforcomparisonandthatisderivedas(1)
Practice D3764.
atheoreticalorestablishedvalue,basedonscientificprinciples,
NOTE 3—One or both of the analytical systems in 1.5 can be laboratory
(2) an assigned value, based on experimental work of some
test methods or validated process stream analyzers.
national or international organization, such as the U.S. Na-
1.6 This practice assumes that the normal (Gaussian) model
tional Institute of Standards and Technology (NIST), or (3)a
is adequate for the description and prediction of measurement
consensus value, based on collaborative experimental work
system behavior when it is in a state of statistical control.
under the auspices of a scientific or engineering group.
E177, E456
NOTE 4—For non-Gaussian processes, transformations of test results
3.1.2 accuracy, n—the closeness of agreement between an
observed value and an accepted reference value. E177, E456
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
Products and Lubricants and 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 March 1, 2010. Published June 2010. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1998. Last previous edition approved in 2009 as D6299–09. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D6299-10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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D6299–10
3.1.3 assignable
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