Handling of out of specification results.ppt

        Purpose:                Objective:     Toprovideadocumentedprocedureforhandlingofoutofspecificationresults.        Scope:                   Responsibility:Primary:Officer–QCSecondary:Officer-QA/Officer-      ProcedureInitiationofOOS(PhaseI):QCchemistshallreporttoQCIn-charge,--chargeforthefollowingtypesoftheOOSfailure:      Procedure:Materialfailure:,:Changeinreactiontime/ponents/Functioningoftheequipment/reviewofBMR(BatchManufacturingRecord).IfOOSisidentifiedrejecttheproductofthereprocessIfOOSdoesnotidentified,: Inlaboratory,therearefourpossibilitiesforerror:      Procedure:Clericalerror:ordingtoclericalerror,:Powerfailure/calibrationfailurecheck/anyspillageorcontaminationinstandardandsample/unsuitableinstrumentisused/:Errorsindilution/Usageofappropriateandvalidstandard/methodfollowed/samplestoredappropriately/statusofbalance/Homogeneityofthesamplingprocedure/:Samplepreparationmethodfollowed/sampletakenisrepresentative/samplingplanfollowed/      Procedure:Ifnotfoundfromalltheabove-mentionedfailures,-chargewillf