Designation:D6122−13StandardPracticeforValidationofthePerformanceofMultivariateOnline,At-Line,andLaboratoryInfraredSpectrophotometerBasedAnalyzerSystems1ThisstandardisissuedunderthefixeddesignationD6122;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONOperationofalaboratoryorprocessstreamanalyzersystemtypicallyinvolvesfoursequentialactivities.(1)AnalyzerCalibration—Whenananalyzerisinitiallyinstalled,oraftermajormaintenancehasbeenperformed,diagnostictestingisperformedtodemonstratethattheanalyzermeetsthemanufacturer’sspecificationsandhistoricalperformancestandards.Thesediagnostictestsmayrequirethattheanalyzerbeadjustedsoastoprovidepredeterminedoutputlevelsforcertainreferencematerials.(2)Correlation—Oncethediagnostictestingiscompleted,processstreamsamplesareanalyzedusingboththeanalyzersystemandthecorrespondingprimarytestmethod(PTM).Amathematicalfunctionisderivedthatrelatestheanalyzeroutputtotheprimarytestmethod(PTM).Theapplicationofthismathematicalfunctiontoananalyzeroutputproducesapredictedprimarytestmethodresult(PPTMR).(3)ProbationaryValidation—OncetherelationshipbetweentheanalyzeroutputandPTMRshasbeenestablished,aprobationaryvalidationisperformedusinganindependentbutlimitedsetofmaterialsthatwerenotpartofthecorrelationactivity.ThisprobationaryvalidationisintendedtodemonstratethatthePPTMRsagreewiththePTMRstowithinuser-specifiedrequirementsfortheanalyzersystemapplication.(4)GeneralandContinualValidation—AfteranadequatenumberofPPTMRsandPTMRshavebeenaccruedonmaterialsthatwerenotpartofthecorrelationactivity,acomprehensivestatisticalassessmentisperformedtodemonstratethatthePPTMRsagreewiththePTMRstowithinuser-specifiedrequirements.Subsequenttoasuccessfulgeneralvalidation,qualityassurancecontrolchartmonitoringofthedifferencesbetweenPPTMRandPTMRiscond...
