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1、JournalofPharmaceuticalandBiomedicalAnalysis54(2011)592–595ContentslistsavailableatScienceDirectJournalofPharmaceuticalandBiomedicalAnalysisjournalhomepage:www.elsevier.com/locate/jpbaShortcommunicationConsistencyofFMEAusedinthevalidationofanalyticalproceduresM.T.Oldenhofa,∗,J.F.van
2、Leeuwena,b,M.J.Nautaa,c,D.deKastea,Y.M.C.F.Odekerken-Romboutsa,M.J.Vredenbregta,M.Wedaa,D.M.BarendsaaNationalInstituteforPublicHealthandtheEnvironment(RIVM),Bilthoven,TheNetherlandsbMedicinesEvaluationBoard,TheHague,TheNetherlandscNationalFoodInstitute,DanishTechnicalUniversity(DTU)
3、,Søborg,DenmarkarticleinfoabstractArticlehistory:InordertoexploretheconsistencyoftheoutcomeofaFailureModeandEffectsAnalysis(FMEA)inReceived20May2010thevalidationofanalyticalprocedures,anFMEAwascarriedoutbytwodifferentteams.ThetwoteamsReceivedinrevisedformappliedtwoseparateFMEAstoaHi
4、ghPerformanceLiquidChromatography–DiodeArrayDetection–Mass13September2010Spectrometry(HPLC–DAD–MS)analyticalprocedureusedinthequalitycontrolofmedicines.EachteamAccepted17September2010wasfreetodefinetheirownrankingscalesfortheprobabilityofseverity(S),occurrence(O),anddetectionAvailabl
5、eonline20October2010(D)offailuremodes.WecalculatedRiskPriorityNumbers(RPNs)andweidentifiedthefailuremodesabovethe90thpercentileofRPNvaluesasfailuremodesneedingurgentcorrectiveaction;failuremodesKeywords:fallingbetweenthe75thand90thpercentileofRPNvalueswereidentifiedasfailuremodesneedi
6、ngAnalyticalvalidationFMEAnecessarycorrectiveaction,respectively.Team1andTeam2identifiedfiveandsixfailuremodesneedingReproducibilityurgentcorrectiveactionrespectively,withtwobeingcommonlyidentified.OfthefailuremodesneedingRiskanalysisnecessarycorrectiveactions,aboutathirdwerecommonlyid
7、entifiedbybothteams.TheseresultsshowinconsistencyintheoutcomeoftheFMEA.Toimproveconsistency,werecommendthatFMEAisalwayscarriedoutunderthesupervisionofanexperiencedFMEA-facilitatorandthattheFMEAteamhasatleasttwomemberswithcompetenceintheanalyticalmethodtobevalidated.However,theFMEAsof
8、bothteamscontainedv
