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APIQ1RiskAssessmentConformance|AstonTechnicalConsultingServicesLLC

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INTERNAL&SUPPLIERQUALITYAUDITORS
APIQ1RiskAssessmentConformance
PostedonFebruary12,2015

QUESTION:
From:FayyazAhmed
Sent:Feb.10,2015
To:QBlog,AsktheExperts
Subject:APIQ1,clause5.3,RiskAssessmentandManagement
FayyezAhmedasksthefollowingaboutAPIQ1:
AnorganizationstarteditstransitionfromAPIQ18thtoAPIQ19theditionduringSeptember2013.Theystillhad
notperformedriskassessmentbetweenJuneNov2013.ThisorganizationwasauditedbytheAPIduringJan
2014.However,APIAuditordidnotissuedanAAR.
Thisorganizationisgoingtobeauditedduring2015,canAPIAuditornowissueanauditAARbecausethe
organizationdidnotconductedariskassessmentbetweenJune2013Nov2013?
RESPONSE:
From:ATCSQBlog
Received:Feb.12,2015
HelloFayyaz,
IthinkIunderstandyourpoint,butasyouareawareisuptotheassignedAPIAuditortousehis/herprofessional
judgmenttodetermineiftheissuanceofanAARisjustified.APIQ1,9theditiondoesrequireadocumented
procedureforriskmanagement.However,unlessthecontentoftheorganizationsprocedureisknownandwealso
knowwhatwasincludedintheAuditorsobservations,interviewsandreviewofotherauditevidence,itsnot
possibletoknowwhynoAARwasissued.
AfterobservingrecentAPIauditsheldatvariousclientlocations,IcansaythattheseassignedAuditorsdidverify
theexistenceoftherequiredprocedures.Inaddition,theydidreviewsupportingriskassessmentrecords.
Myadvicetoanyorganizationthatistobeauditedduring2015,istoensurethattheirQMSmeetsallspecifiedAPI
Q1requirementsbyconductingeffectiveinternalaudits.Thisshouldminimizetheprobabilityofmajor
nonconformancesfoundbytheAuditor.Otherpointstobekeptinmindinclude,
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APIQ1RiskAssessmentConformance|AstonTechnicalConsultingServicesLLC

1. EventhemostexperiencedAuditormaymisssomethingduringanaudit.
2. Auditresultsonlyprovideasnapshotofthequalitymanagementsystemandnotacompletepicture.
3. Riskassessmentsarenotstatic.Theymustbeperiodicallyreassessedtodeterminethepresentlevelof
uncertainty,potentialofoccurrence,impactandneedforcontingencyplanning.
Inmyopinion,anAuditorsreviewofrecordstoconfirmanorganizationsconformancetorequirementsisnot
restrictedtoanytimelimit.Soinreplytoyourquestion,yestheAuditorcouldgobackto2013ifhe/sheseesaneed.
Butasalreadymentioned,thiswouldbeadecisionmadebytheAuditor.
Ihopethishelps.
BillAston,ManagingDirector
Thisentrywaspostedin9thEdition,APIQ1,Auditing,QMSRequirementsandtaggedAPIQ1,QMSAudits,supplierqualityauditing.Bookmarkthepermalink.

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