ORA-LAB.4.11 Corrective Action (v02).pdfVIP专享VIP免费原创优质

FOODANDDRUGADMINISTRATIONOFFICEOFREGULATORYAFFAIRSORALaboratoryManualVolumeIIDocumentNumber:ORA-LAB.4.11Revision#:02Revised:05/15/2019Title:CorrectiveActionPage1of8Forthemostcurrentandofficialcopy,checkQMiS.SectionsinThisDocument1.Purpose....................................................................................................................................12.Scope.......................................................................................................................................13.Responsibility............................................................................................................................24.Background...............................................................................................................................25.References...............................................................................................................................36.Procedure.................................................................................................................................36.1.ReviewofNonconformity...............................................................................................36.2.Correction.......................................................................................................................36.3.RootCause&CorrectiveAction....................................................................................46.4.MonitoringforEffectiveness...........................................................................................46.5.RecordingCorrection(s)andCorrectiveAction(s).........................................................51.1ProcessMap..................................................................................................................67.Glossary/Definitions..................................................................................................................78.Records....................................................................................................................................79.SupportingDocuments.............................................................................................................710.DocumentHistory.....................................................................................................................811.ChangeHistory.........................................................................................................................812.Attachments..............................................................................................................................81.PurposeToprovideguidanceintheprocessofidentifying,evaluating,recording,investigating,correctingthecausesof,anddeterminingthedispositionofnonconformingprocesses,services,andworkproducts(hereafterreferredtoasnonconformances).Thecornerstoneofcorrectiveactionsiswrittenandretrievablerecordsofactionstakenandfollow-upmonitoringtodeterminethatcorrectiveactionshavebeenperformed,documented,andfoundtobeeffective.2.ScopeThisprocedureappliestotheOfficeofRegulatoryScience(ORS)laboratoriesandlaboratoryworkproductsandprocesses.Thisproceduredirectlyconcernsthelaboratory’squalityassuranceprogram.FOODANDDRUGADMINISTRATIONOFFICEOFREGULATORYAFFAIRSORALaboratoryManualVolumeIIDocumentNumber:ORA-LAB.4.11Revision#:0...