8/5/2015 APIQ1RiskAssessmentConformance|AstonTechnicalConsultingServicesLLChttps://astontechconsult.com/apiq1riskassessmentconformance/ 1/2APIQ1RiskAssessmentConformancePostedonFebruary12,2015QUESTION:From:FayyazAhmedSent:Feb.10,2015To:QBlog,AsktheExpertsSubject:APIQ1,clause5.3,RiskAssessmentandManagementFayyezAhmedasksthefollowingaboutAPIQ1:AnorganizationstarteditstransitionfromAPIQ18thtoAPIQ19theditionduringSeptember2013.TheystillhadnotperformedriskassessmentbetweenJuneNov2013.ThisorganizationwasauditedbytheAPIduringJan2014.However,APIAuditordidnotissuedanAAR.Thisorganizationisgoingtobeauditedduring2015,canAPIAuditornowissueanauditAARbecausetheorganizationdidnotconductedariskassessmentbetweenJune2013Nov2013?RESPONSE:From:ATCSQBlogReceived:Feb.12,2015HelloFayyaz,IthinkIunderstandyourpoint,butasyouareawareisuptotheassignedAPIAuditortousehis/herprofessionaljudgmenttodetermineiftheissuanceofanAARisjustified.APIQ1,9theditiondoesrequireadocumentedprocedureforriskmanagement.However,unlessthecontentoftheorganizationsprocedureisknownandwealsoknowwhatwasincludedintheAuditorsobservations,interviewsandreviewofotherauditevidence,itsnotpossibletoknowwhynoAARwasissued.AfterobservingrecentAPIauditsheldatvariousclientlocations,IcansaythattheseassignedAuditorsdidverifytheexistenceoftherequiredprocedures.Inaddition,theydidreviewsupportingriskassessmentrecords.Myadvicetoanyorganizationthatistobeauditedduring2015,istoensurethattheirQMSmeetsallspecifiedAPIQ1requirementsbyconductingeffectiveinternalaudits.ThisshouldminimizetheprobabilityofmajornonconformancesfoundbytheAuditor.Otherpointstobekeptinmindinclude,APIQ1,APIQ2&ISO9001CERTIFICATIONANDPRODUCTLICENSESUPPORT INTERNAL&SUPPLIERQUALITYAUDITORS Primary:(281)3592827TollFree:(888)96898918/5/2015 APIQ1RiskAssessmentConformance|AstonTechnicalConsultingServicesLLChttps://astontechconsult.com/apiq1riskassessmentconformance/ 2/2CopyProtectedbyChetan'sWPCopyprotect.AstonTechnicalConsultingServices,LLCisaproudAPIMemberCompany2015AstonTechnicalConsultingServices,LLC.Allrightsreserved1. EventhemostexperiencedAuditormaymisssomethingduringanaudit.2. Auditresultsonlyprovideasnapshotofthequalitymanagementsystemandnotacompletepicture.3. Riskassessmentsarenotstatic.Theymustbeperiodicallyreassessedtodeterminethepresentlevelofuncertainty,potentialofoccurrence,impactandneedforcontingencyplanning.Inmyopinion,anAuditorsreviewofrecordstoconfirmanorganizationsconformancetorequirementsisnotrestrictedtoanytimelimit.Soinreplytoyourquestion,yestheAuditorcouldgobackto2013ifhe/sheseesaneed.Butasalreadymentioned,thiswouldbeadecisionmadebytheAuditor.Ihopethishelps.BillAston,ManagingDirectorThisentrywaspostedin9thEdition,APIQ1,Auditing,QMSRequirementsandtaggedAPIQ1,QMSAudits,supplierqualityauditing.Bookmarkthepermalink.Resources