ASTM D6299-23a
(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
5.1 This practice may 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.
5.2 Data accrued, using the techniques included in this practice, provide the ability to monitor analytical measurement system precision and bias.
5.3 These data are useful for updating test methods as well as for indicating areas of potential measurement system improvement.
5.4 Control chart statistics can be used to compute limits that the signed difference (Δ) between two single results for the same sample obtained under site precision conditions is expected to fall outside of about 5 % of the time, when each result is obtained using a different measurement system in the same laboratory executing the same test method, and both systems are in a state of statistical control.
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 may 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.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D6299 − 23a An American 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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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.
operation of a program to monitor and control ongoing stability
1.7 This international standard was developed in accor-
and precision and bias performance of selected analytical
dance with internationally recognized principles on standard-
measurement systems using a collection of generally accepted
ization established in the Decision on Principles for the
statistical quality control (SQC) procedures and tools.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
NOTE 1—A complete list of criteria for selecting measurement systems
to which this practice should be applied and for determining the frequency
Barriers to Trade (TBT) Committee.
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
2. Referenced Documents
the analytical measurement system, (2) criticality of the parameter being
2
2.1 ASTM Standards:
measured, (3) system stability and precision performance based on
historical data, (4) business economics, and (5) regulatory, contractual, or
D3764 Practice for Validation of the Performance of Process
test method requirements.
Stream Analyzer Systems
1.2 This practice is applicable to stable analytical measure- D4175 Terminology Relating to Petroleum Products, Liquid
ment systems that produce results on a continuous numerical Fuels, and Lubricants
D5191 Test Method for Vapor Pressure of Petroleum Prod-
scale.
ucts and Liquid Fuels (Mini Method)
1.3 This practice is applicable to laboratory test methods.
D6300 Practice for Determination of Precision and Bias
1.4 This practice is applicable to validated process stream
Data for Use in Test Methods for Petroleum Products,
analyzers.
Liquid Fuels, and Lubricants
1.5 This practice is applicable to monitoring the differences D6617 Practice for Laboratory Bias Detection Using Single
Test Result from Standard Material
between two analytical measurement systems that purport to
measure the same property provided that both systems have D6708 Practice for Statistical Assessment and Improvement
of Expected Agreement Between Two Test Methods that
been assessed in accordance with the statistical methodology in
Practice D6708 and the appropriate bias applied. Purport to Measure the Same Property of a Material
NOTE 2—For validation of univariate process stream analyzers, see also D6792 Practice for Quality Management Systems in Petro-
Practice D3764.
leum Products, Liquid Fuels, and Lubricants Testing
NOTE 3—One or both of the analytical systems in 1.5 may be laboratory
Laboratories
test methods or validated process stream analyzers.
D7372 Guide for Analysis and Interpretation of Proficiency
1.6 This practice assumes that the normal (Gaussian) model
Test Program Results
is adequate for the description and prediction of measurement
D7915 Practice for Application of Generalized Extreme
system behavior when it is in a state of statistical control.
Studentized Deviate (GESD) Technique to Simultane-
ously Identify Multiple Outliers in a Data Set
E177 Practice for Use of the Terms Precision and Bias in
ASTM Test Methods
E178 Practice for Dealing With Outlying Observations
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum
Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom-
2
mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2023. Published December 2023. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ɛ1
approved in 1998. Last previous edition approved in 2023 as D6299 – 23 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D6299-23A. the ASTM website.
*A S
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
´1
Designation: D6299 − 23 D6299 − 23a An American 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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Editorially corrected an equation in A1.11.2 in September 2023.
1. 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 may 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.
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcommittee
D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.
Current edition approved July 1, 2023Dec. 1, 2023. Published September 2023December 2023. Originally approved in 1998. Last previous edition approved in 20222023
ɛ1
as D6299 – 22D6299 – 23 . DOI: 10.1520/D6299-23E01.10.1520/D6299-23A.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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D6299 − 23a
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.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D3764 Practice for Validation of the Performance of Process Stream Analyzer Systems
D4175 Terminology Relating to Petroleum Products, Liquid Fuels, and Lubricants
D5191 Test Method for Vapor Pressure of Petroleum Products and Liquid Fuels (Mini Method)
D6300 Practice for Determination of Precision and Bias Data for Use in Test Methods for Petroleum Products, Liquid Fuels, and
Lubricants
D6617 Practice for Laboratory Bias Detection Using Single Test Result from Standard Material
D6708 Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purport
to Measure the Same Property of a Material
D6792 Practice for Quality Management Systems in Petroleum Products, Liquid Fuels, and Lubricants Testing Laboratories
D7372 Guide for Analysis and Interpretation of Proficiency Test Program Results
D7915 Practice for Ap
...
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