API Q1 Risk Assessment Conformance _ Aston Technical Consulting Services LLC
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8/5/2015 API Q1 Risk Assessment Conformance | Aston Technical Consulting Services LLC https://astontechconsult.com/apiq1riskassessmentconformance/ 1/2 API Q1 Risk Assessment Conformance Posted on February 12, 2015 QUESTION: From: Fayyaz Ahmed Sent: Feb. 10, 2015 To: QBlog, Ask the Experts Subject: API Q1, clause 5.3, Risk Assessment and Management Fayyez Ahmed asks the following about API Q1: An organization started its transition from API Q1 8th to API Q1 9th edition during September 2013. They still had not performed risk assessment between June Nov 2013. This organization was audited by the API during Jan 2014. However, API Auditor did not issued an AAR. This organization is going to be audited during 2015, can API Auditor now issue an audit AAR because the organization did not conducted a risk assessment between June 2013 – Nov 2013? RESPONSE: From: ATCS QBlog Received: Feb. 12, 2015 Hello Fayyaz, I think I understand your point, but as you are aware is up to the assigned API Auditor to use his/her professional judgment to determine if the issuance of an AAR is justified. API Q1, 9th edition does require a documented procedure for risk management. However, unless the content of the organization’s procedure is known and we also know what was included in the Auditor’s observations, interviews and review of other audit evidence, it’s not possible to know why no AAR was issued. After observing recent API audits held at various client locations, I can say that these assigned Auditors did verify the existence of the required procedures. In addition, they did review supporting risk assessment records. My advice to any organization that is to be audited during 2015, is to ensure that their QMS meets all specified API Q1 requirements by conducting effective internal audits. This should minimize the probability of major nonconformances found by the Auditor. Other points to be kept in mind include, API Q1, API Q2 & ISO 9001 CERTIFICATION AND PRODUCT LICENSE SUPPORT INTERNAL & SUPPLIER QUALITY AUDITORS Primary: (281) 3592827 Toll Free: (888) 9689891
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Transcript of API Q1 Risk Assessment Conformance _ Aston Technical Consulting Services LLC
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
