ASTM_D_8146_-_18.pdf

Designation:D814618An American National StandardStandard Guide forEvaluating Test Method Capability and Fitness for Use1This standard is issued under the fixed designation D8146;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.1.Scope1.1 This guide covers techniques for evaluating the statisti-cal capability and fitness for use of standard test methods usedfor measuring properties of petroleum products,liquid fuels,and lubricants.Specifically,this guide provides strategies forevaluating the capability of a test method to provide asufficiently precise estimate of the intended parameter versus agiven level or value of that parameter and for assessing,withsufficient confidence,the fitness for use of a test method fordetermining the acceptability of products versus specification,regulatory,or manufacturing limits.1.2 The assessment of capability in this guide is applicableto test methods that always yield non-negative numericalresults and have a hard,fixed zero lower limit or fixed upperlimit(for example,100%).Detailed knowledge of a testmethod and professional judgement may be required in deter-mining the applicability of this guide to certain test methods.1.3 In accordance with this guide,the assessment of fitnessfor use of a test method versus specification,regulatory,ormanufacturing limits is generally applicable to test methodsthat provide numerical results and have applicable reproduc-ibility precision values.1.4 This guide is intended for use by test methoddevelopers,specification setters,and laboratories selecting testmethods to evaluate products for specific purposes or versusspecific limits.1.5 This guide is not applicable to test methods that measuretemperature to determine properties such as,but not limited to,freeze point,pour point,flash point,and distillations.Thisguide is not intended for use by laboratories for evaluatinglaboratory test method execution capability,nor is it intendedto evaluate manufacturing process capability.1.6 The expressions of capability and fitness for use derivedfrom use of this guide should not be the only criteria forselection and use of a given test method.Other factors such asthe laboratorys experience with the test method,length of timeto complete an analysis,typical product results relative to theregulatory or manufacturing specification limit,closeness ofthe results to zero,and cost factors may contribute moresignificantly to the decision to use a given test method for aspecific application.1.7 This guide draws on statistical approaches covered inother standards supporting petroleum products,liquid fuels,and lubricants,including Practices D3244,D6259,D6299,D6300,D6792 and ISO 4259.1.8 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.9 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:2D3244 Practice for Utilization of Test Data to DetermineConformance with SpecificationsD6259 Practice for Determination of a Pooled Limit ofQuantitation for a Test MethodD6299 Practice for Applying Statistical Quality Assuranceand Control Charting Techniques to Evaluate AnalyticalMeasurement System PerformanceD6300 Practice for Determination of Precision and BiasData for Use in Test Methods for Petroleum Products andLubricantsD6792 Practice for Quality Management Systems in Petro-leum Products,Liquid Fuels,and Lubricants TestingLaboratories1This guide is under the jurisdiction of ASTM Committee D02 on PetroleumProducts,Liquid Fuels,and Lubricants and is the direct responsibility of Subcom-mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics.Current edition approved Oct.1,2018.Published November 2018.DOI:10.1520/D8146-18.2For 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.Copyright 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 Recommend