Designation:D7235−21aStandardGuideforEstablishingaLinearCorrelationRelationshipBetweenAnalyzerandPrimaryTestMethodResultsUsingRelevantASTMStandardPractices1ThisstandardisissuedunderthefixeddesignationD7235;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONOperationofaprocessstreamanalyzersystemtypicallyinvolvesfoursequentialactivities:(1)AnalyzerCalibration—Whenananalyzerisinitiallyinstalled,oraftermajormaintenancehasbeenperformed,diagnostictestingwilltypicallybeperformedtodemonstratethattheanalyzermeetsmanufacturer’sspecificationsandhistoricalperformancestandards.Thesediagnostictestsmayrequirethattheanalyzerbeadjustedsoastoprovidepredeterminedoutputlevelsforcertainreferencematerials.(2)CorrelationtoPrimaryTestMethod—ForprocessstreamanalyzersystemswheretheapplicationobjectiveistoprovidepredictionofresultsfromaPrimaryTestmethod,oncethediagnostictestingiscompleted,processstreamsampleswilltypicallybeanalyzedusingboththeanalyzersystemandthecorrespondingprimarytestmethod.Amathematicalfunctionwillbederivedthatrelatestheanalyzeroutputtotheprimarytestmethod(PTM).TheapplicationofthismathematicalfunctiontoananalyzeroutputproducesapredictedPTMresult.(3)InitialValidation—Oncetherelationshipbetweentheanalyzeroutputandprimarytestmethodresultshasbeenestablished,aninitialvalidationisperformedusinganindependentdatasettodemonstratethatthepredictedPTMresultsagreewiththosefromtheprimarytestmethodwithinthetolerancesestablishedfromtheCorrelationactivitiesandwithnostatisticallyobservablesystemicbias.(4)ContinualValidation—Duringnormaloperationoftheprocessanalyzersystem,qualityassurancetestingisconductedtodemonstratethattheagreementbetweenanalyzerandprimarytestmethodresultsduringtheInitialValidationismaintained.Thisdocumentprovidesguidanceforitem(2)above.1.Scope*1.1...
