ASTM_D_6617_-_21.pdf

Designation:D661721An American National StandardStandard Practice forLaboratory Bias Detection Using Single Test Result fromStandard Material1This standard is issued under the fixed designation D6617;the number immediately following the 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.INTRODUCTIONDue to the inherent imprecision in all test methods,a laboratory cannot expect to obtain thenumerically exact accepted reference value(ARV)of a check standard(CS)material every time oneis tested.Results that are reasonably close to the ARV should provide assurance that the laboratory isperforming the test method either without bias,or with a bias that is of no practical concern,hencerequiring no intervention.Results differing from the ARV by more than a certain amount,however,should lead the laboratory to take corrective action.1.Scope*1.1 This practice covers a methodology for establishing anacceptable tolerance zone for the difference between a singleresult obtained for a Check Standard(CS)from a singleimplementation of a test method using a single measurementsystem at a laboratory versus its Accepted Reference Value(ARV),based on user-specified Type I error,the user-established measurement system precision for the execution ofthe test method,the standard error of the ARV,and a presumedhypothesis that the measurement system as operated by thelaboratory in the execution of the test method is not biased.NOTE1Throughout this practice,the term“user”refers to the user ofthis practice,and the term“laboratory”(see 1.1)refers to the organizationor entity that is performing the test method.1.2 For the tolerance zone established in 1.1,a methodologyis presented to estimate the probability that the single test resultwill fall outside the zone,in the event that the presumedhypothesis is not true and there is a bias(positive or negative)of a user-specified magnitude that is deemed to be of practicalconcern.1.3 This practice is intended forASTM Committee D02 testmethods that produce results on a continuous numerical scale.1.4 This practice assumes that the normal(Gaussian)modelis adequate for the description and prediction of measurementsystem behavior when it is in a state of statistical control.NOTE2While this practice does not cover scenarios in which multipleresults are obtained on the same CS under site precision or repeatabilityconditions,the statistical concepts presented are applicable.Users wishingto apply these concepts for the scenarios described are advised to consulta statistician and to reference the CS methodology described in PracticeD6299.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D2699 Test Method for Research Octane Number of Spark-Ignition Engine FuelD6299 Practice for Applying Statistical Quality Assuranceand Control Charting Techniques to Evaluate AnalyticalMeasurement System PerformanceD7915 Practice for Application of Generalized ExtremeStudentized Deviate(GESD)Technique to Simultane-ously Identify Multiple Outliers in a Data Set3.Terminology3.1 Definitions for accepted reference value(ARV),accuracy,bias,check standard(CS),in statistical control,siteprecision,site precision standard deviation(SITE),site preci-sion conditions,repeatability conditions,and reproducibilityconditions can be found in Practice D6299.1This practice is under the jurisdiction of ASTM Committee D02 on PetroleumProducts,Liquid Fuels,and Lubricantsand is the direct responsibility of Subcom-mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.Current edition approved May 1,2021.Published May 2021.Originallyapproved in 2000.Last previous edition approved in 2017 as D6617 17.DOI:10.1520/D6617-21.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.13.2 Definitions of Terms Specific to This Standard:3.2.1 acceptable tolerance zone,na numeri