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 D6299-10e2 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
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Contact ASTM International (www.astm.org) for the latest information
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Designation: D6299 − 10 AnAmerican National Standard
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.Anumber 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.
2
´ NOTE—Corrected Table A1.8 footnote editorially in March 2012.
NOTE 4—For non-Gaussian processes, transformations of test results
1. Scope
may permit proper application of these tools. Consult a statistician for
1.1 This practice covers information for the design and
further guidance and information.
operationofaprogramtomonitorandcontrolongoingstability
2. Referenced Documents
and precision and bias performance of selected analytical
2
measurement systems using a collection of generally accepted
2.1 ASTM Standards:
statistical quality control (SQC) procedures and tools.
D3764PracticeforValidationofthePerformanceofProcess
Stream Analyzer Systems
NOTE 1—Acomplete list of criteria for selecting measurement systems
D5191Test Method for Vapor Pressure of Petroleum Prod-
towhichthispracticeshouldbeappliedandfordeterminingthefrequency
at which it should be applied is beyond the scope of this practice. ucts (Mini Method)
However, some factors to be considered include (1) frequency of use of
D6708Practice for StatisticalAssessment and Improvement
the analytical measurement system, (2) criticality of the parameter being
of Expected Agreement Between Two Test Methods that
measured, (3) system stability and precision performance based on
Purport to Measure the Same Property of a Material
historical data, (4) business economics, and (5) regulatory, contractual, or
D6792Practice for Quality System in Petroleum Products
test method requirements.
and Lubricants Testing Laboratories
1.2 This practice is applicable to stable analytical measure-
D7372Guide for Analysis and Interpretation of Proficiency
ment systems that produce results on a continuous numerical
Test Program Results
scale.
E177Practice for Use of the Terms Precision and Bias in
1.3 This practice is applicable to laboratory test methods.
ASTM Test Methods
1.4 This practice is applicable to validated process stream E178Practice for Dealing With Outlying Observations
analyzers. E456Terminology Relating to Quality and Statistics
E691Practice 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
NOTE2—Forvalidationofunivariateprocessstreamanalyzers,seealso
agreed-uponreferenceforcomparisonandthatisderivedas(1)
Practice D3764.
NOTE 3—One or both of the analytical systems in 1.5 can be laboratory atheoreticalorestablishedvalue,basedonscientificprinciples,
test methods or validated process stream analyzers.
(2) an assigned value, based on experimental work of some
national or international organization, such as the U.S. Na-
1.6 This practice assumes that the normal (Gaussian) model
is adequate for the description and prediction of measurement tional Institute of Standards and Technology (NIST), or (3)a
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
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
ProductsandLubricantsandisthedirectresponsibilityofSubcommitteeD02.94on
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
3.1.2 accuracy, n—the closeness of agreement between an 3.2.4 common (chance, random) cause
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