Risk Analysis and Mitigation Matrix (RAMM) – A Risk Tool for Quality Management

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1、ReprintedfromPHARMACEUTICALENGINEERING®TheOfficialMagazineofISPEJanuary/February2012,Vol.32No.1QualityriskManagementwww.PharmaceuticalEngineering.org©CopyrightISPE2012ThisarticleRiskAnalysisandMitigationMatrixpresentsanewtypeofrisktool.(RAMM)–ARiskToolforQualityRiskAnalysisandMitigationMatrix

2、Management(RAMM)wasdevelopedtobeincorporatedintobyAlexBrindle,SteveDavy,DavidTiffanyandamodernriskChrisWattsmanagementsystemandalignwithlatestFDAguidances.iskanalysisandmanagementisthecor-provideapracticalexampleasappliedtoanerstoneofanyscience-andrisk-basedmonoclonalantibody(Mab)process,ands

3、howapproach1formoderndrugdevelopmenthowtoincorporatethetoolintoaqualityman-Randmanufacturing.2Inordertounder-agementsystem.standanddocumentprocessesandproducts,standardriskanalysistoolshavebeenadaptedUseofRiskforDevelopmentfromotherindustriesandacademia.ThesetoolsandManufacturingincludeIshika

4、waDiagrams,3P-Diagrams,Pre-WhendevelopinganewprocessandproductorliminaryHazardAnalysis(PHA),FailureModesattemptingtounderstandanexistingprocessandEffectAnalysis(FMEA4),FailureModesandandproduct,knowinghowmaterials,processes,EffectCriticalityAnalysis(FMECA5),Hazardandcontrolsaffectthefinalprod

5、uctisessential.AnalysisofCriticalControlPoints(HACCP6),Ifonecanidentifythecriticalprocessinputandseveralmore.factors,thevariationintheprocessresponsesTheRiskAnalysisandMitigationMatrixshouldbeabletobeunderstoodandcontrolled.(RAMM)wascreatedtoprovideapragmaticWithoutthisknowledge,thedevelopero

6、rmanu-compromisewhereotherrisktoolssuchasfacturerissimplyguessinghowgoodproductsPreliminaryHazardAnalysis(PHA)orFailurearemadeandmostlikelyrelyingheavilyonaModeEffectsandCriticalityAnalysis(FMECA)qualitycontrolunittorejectanybadproductsaremaybeeithertoosimpleandlackinginde-manufactured.tail,o

7、rtheyaremaybetoocomplicated,makingFromadevelopmentormanufacturingitdifficulttoworkconsistentlywithlimitedperspective,oneofthekeypartsofthispath-resourceacrossallproducts.wayisunderstandingwhichrawmaterialsThegoaloftheRAMMwasalsotoalignwithand