ASTM D6299-2018 red 1875 Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance《应用统计质量保证.pdf

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1、Designation: D6299 17bD6299 18 An American National StandardStandard Practice forApplying Statistical Quality Assurance and Control ChartingTechniques to Evaluate Analytical Measurement SystemPerformance1This standard is issued under the fixed designation D6299; the number immediately following the

2、designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This practice covers info

3、rmation for the design and operation of a program to monitor and control ongoing stability andprecision and bias performance of selected analytical measurement systems using a collection of generally accepted statisticalquality control (SQC) procedures and tools.NOTE 1A complete list of criteria for

4、 selecting measurement systems to which this practice should be applied and for determining the frequency atwhich it should be applied is beyond the scope of this practice. However, some factors to be considered include (1) frequency of use of the analyticalmeasurement system, (2) criticality of the

5、 parameter being measured, (3) system stability and precision performance based on historical data, (4) businesseconomics, 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 numeri

6、cal 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 tomeasure the same property provided that b

7、oth systems have been assessed in accordance with the statistical methodology inPractice D6708 and the appropriate bias applied.NOTE 2For validation of univariate process stream analyzers, see also Practice D3764.NOTE 3One or both of the analytical systems in 1.5 can be laboratory test methods or va

8、lidated process stream analyzers.1.6 This practice assumes that the normal (Gaussian) model is adequate for the description and prediction of measurementsystem behavior when it is in a state of statistical control.1 This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products,

9、 Liquid Fuels, and Lubricants and is the direct responsibility of SubcommitteeD02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.Current edition approved Dec. 15, 2017April 1, 2018. Published March 2018May 2018. Originally approved in 1998. Last previous edition approved in 2017

10、 asD6299 17a.D6299 17b. DOI: 10.1520/D6299-17B.10.1520/D6299-18.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. Becauseit may not be technically possible to adequately depict all

11、changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100

12、 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1NOTE 4For non-Gaussian processes, transformations of test results may permit proper application of these tools. Consult a statistician for furtherguidance and information.1.7 This international standard was developed in

13、 accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 A

14、STM Standards:2D3764 Practice for Validation of the Performance of Process Stream Analyzer SystemsD4175 Terminology Relating to Petroleum Products, Liquid Fuels, and LubricantsD5191 Test Method for Vapor Pressure of Petroleum Products (Mini Method)D6300 Practice for Determination of Precision and Bi

15、as Data for Use in Test Methods for Petroleum Products and LubricantsD6708 Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purportto Measure the Same Property of a MaterialD6792 Practice for Quality Management Systems in Petroleum Products, Liq

16、uid Fuels, and Lubricants Testing LaboratoriesD7372 Guide for Analysis and Interpretation of Proficiency Test Program ResultsE177 Practice for Use of the Terms Precision and Bias in ASTM Test MethodsE178 Practice for Dealing With Outlying ObservationsE456 Terminology Relating to Quality and Statisti

17、csE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method3. Terminology3.1 Definitions:3.1.1 accepted reference value, na value that serves as an agreed-upon reference for comparison and that is derived as (1) atheoretical or established value, based on scie

18、ntific principles, (2) an assigned value, based on experimental work of some nationalor international organization, such as the U.S. National Institute of Standards and Technology (NIST), or (3) a consensus value,based on collaborative experimental work under the auspices of a scientific or engineer

19、ing group. E177, E4563.1.1 More extensive lists of terms related to quality and statistics are found in Terminology D4175, Practice D6300, andTerminology E456.3.1.2 accuracy, nthe closeness of agreement between an observed value and an accepted reference value. E177, E4563.1.3 assignable cause, na f

20、actor that contributes to variation and that is feasible to detect and identify. E4563.1.4 bias, na systematic error that contributes to the difference between a population mean of the measurements or test resultsand an accepted reference or true value. E177, E4563.1.5 control limits, nlimits on a c

21、ontrol chart that are used as criteria for signaling the need for action or for judging whethera set of data does or does not indicate a state of statistical control. E4563.1.6 lot, na definite quantity of a product or material accumulated under conditions that are considered uniform for samplingpur

22、poses. E4563.1.7 precision, nthe closeness of agreement between test results obtained under prescribed conditions. E4563.1.2 repeatability conditions, nconditions where mutually independent test results are obtained with the same testmethodmethod on identical test items in the same laboratory by the

23、 same operator withusing the same equipment within shortintervals of time, using test specimens taken at random from a single sample of material.time. D63003.1.3 reproducibility (R), na quantitative expression for the random error associated with the difference between twoindependent results obtaine

24、d under reproducibility conditions that would be exceeded with an approximate probability of 5 % (onecase in 20 in the long run) in the normal and correct operation of the test method. D63003.1.4 reproducibility conditions, nconditions under whichwhere independent test results are obtained with the

25、same methodon identical test items in different laboratories with the same test method, using test specimens taken at random from the samesample of material. different operators using different equipment.3.1.4.1 DiscussionDifferent laboratory by necessity means a different operator, different equipm

26、ent, and different location and under differentsupervisory control. D63002 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the A

27、STM website.D6299 1823.2 Definitions of Terms Specific to This Standard:3.2.1 More extensive lists of terms related to quality and statistics are found in Terminology D4175, Practice D6300, andTerminology E456.3.2.2 accepted reference value, na value that serves as an agreed-upon reference for compa

28、rison and that is derived as (1) atheoretical or established value, based on scientific principles, (2) an assigned value, based on experimental work of some nationalor international organization, such as the U.S. National Institute of Standards and Technology (NIST), or (3) a consensus value,based

29、on collaborative experimental work under the auspices of a scientific or engineering group.3.2.3 accuracy, nthe closeness of agreement between an observed value and an accepted reference value.3.2.4 analytical measurement system, na collection of one or more components or subsystems, such as sampler

30、s, testequipment, instrumentation, display devices, data handlers, printouts or output transmitters, that is used to determine a quantitativevalue of a specific property for an unknown sample in accordance with a test method.3.2.4.1 DiscussionA standard test method (for example, ASTM, ISO) is an exa

31、mple of an analytical measurement system.3.2.4.2 DiscussionAn analytical measurement system may comprise multiple instruments being used for the same test method provided there is nostatistically observable bias and precision differences between the multiple instruments.3.2.5 assignable cause, na fa

32、ctor that contributes to variation and that is feasible to detect and identify.3.2.6 bias, na systematic error that contributes to the difference between a population mean of the measurements or test resultsand an accepted reference or true value.3.2.7 blind submission, nsubmission of a check standa

33、rd or quality control (QC) sample for analysis without revealing theexpected value to the person performing the analysis.3.2.8 check standard, nin QC testing, a material having an accepted reference value used to determine the accuracy of ameasurement system.3.2.8.1 DiscussionA check standard is pre

34、ferably a material that is either a certified reference material with traceability to a nationally recognizedbody or a material that has an accepted reference value established through interlaboratory testing. For some measurement systems,a pure, single component material having known value or a sim

35、ple gravimetric or volumetric mixture of pure components havingcalculable value may serve as a check standard. Users should be aware that for measurement systems that show matrixdependencies, accuracy determined from pure compounds or simple mixtures may not be representative of that achieved on act

36、ualsamples.3.2.9 common (chance, random) cause, nfor quality assurance programs, one of generally numerous factors, individually ofrelatively small importance, that contributes to variation, and that is not feasible to detect and identify.3.2.10 control limits, nlimits on a control chart that are us

37、ed as criteria for signaling the need for action or for judging whethera set of data does or does not indicate a state of statistical control.3.2.11 double blind submission, nsubmission of a check standard or QC sample for analysis without revealing the checkstandard or QC sample status and expected

38、 value to the person performing the analysis.3.2.12 in-statistical-control, adja process, analytical measurement system, or function that exhibits variations that can onlybe attributable to common cause.3.2.13 lot, na definite quantity of a product or material accumulated under conditions that are c

39、onsidered uniform for samplingpurposes.3.2.14 out-of-statistical-control, adja process, analytical measurement system, or function that exhibits variations in additionto those that can be attributable to common cause and the magnitude of these additional variations exceed specified limits.3.2.14.1 D

40、iscussionFor clarification, a transition from an in-statistical-control system to an out-of-statistical-control system does not automaticallyimply that there is a change in the fit for use status of the system in terms of meeting the requirements for the intended application.3.2.15 precision, nthe c

41、loseness of agreement between test results obtained under prescribed conditions.D6299 1833.2.16 proficiency testing, ndetermination of a laboratorys testing capability by participation in an interlaboratory crosscheckprogram.3.2.16.1 DiscussionASTM Committee D02 conducts proficiency testing among hu

42、ndreds of laboratories, using a wide variety of petroleum productsand lubricants.3.2.17 quality control (QC) sample, nfor use in quality assurance programs to determine and monitor the precision andstability of a measurement system, a stable and homogeneous material having physical or chemical prope

43、rties, or both, similar tothose of typical samples tested by the analytical measurement system. The material is properly stored to ensure sample integrity,and is available in sufficient quantity for repeated, long term testing.3.2.18 site expected value (SEV), nfor a QC sample this is an estimate of

44、 the theoretical limiting value towards which theaverage of results collected from a single in-statistical-control measurement system under site precision conditions tends as thenumber of results approaches infinity.3.2.18.1 DiscussionThe SEV is associated with a single measurement system; for contr

45、ol charts that are plotted in actual measured units, the SEV isrequired, since it is used as a reference value from which upper and lower control limits for the control chart specific to a batchof QC material are constructed.3.2.19 site precision (R), nthe value below which the absolute difference b

46、etween two individual test results obtained undersite precision conditions may be expected to occur with a probability of approximately 0.95 (95 %). It is defined as 2.77 times R,the standard deviation of results obtained under site precision conditions.3.2.20 site precision conditions, nconditions

47、under which test results are obtained by one or more operators in a single sitelocation practicing the same test method on a single measurement system which may comprise multiple instruments, using testspecimens taken at random from the same sample of material, over an extended period of time spanni

48、ng at least a 15 day interval.3.2.20.1 DiscussionSite precision conditions should include all sources of variation that are typically encountered during normal, long term operationof the measurement system. Thus, all operators who are involved in the routine use of the measurement system should cont

49、ributeresults to the site precision determination. In situations of high usage of a test method where multiple QC results are obtainedwithin a 24 h period, then only results separated by at least 4 h to 8 h, depending on the absence of auto-correlation in the data,the nature of the test method/instrument, site requirements, or regulations, should be used in site precision calculations to reflectthe longer term variation in the system.3.2.21 site precision standard deviation, nthe standard deviation of results obtained under site p