Quality System Auditing质量体系审核

1 INTRODUCTIONTOQUALITYSYSTEMAUDITING 2 Outline BasicconceptionsofqualitysystemAuditingPreparationofauditingOn siteauditingAuditingreportandfollow upactions 3 Whatisqualityaudit Aqualityauditisasystematic independentanddocumentedprocessforobtainingauditevidenceandevaluatingitobjectivelytodeterminetheextenttowhichagreedcriteriaarefulfilled ISO9000 2005clause3 9 1 4 Auditcriteria Evidence Compare Auditfinding conclusion Howmany Yes No 5 ThreeKeyWords EvidenceCriteriaIndependent 6 Distinctionofsystemauditsbyparties 1stpartyaudits InternalAudits OrganizationauditsitsownQMSaccordingtoaqualitystandard2ndpartyaudits SupplierAudits Customerauditsthesupplier squalitysystem3rdpartyauditsExternalcertificationauditsbyanindependentinstitutioninordertocertifytheQMS 7 InternalAudit Anindependent objectiveassuranceandconsultingactivitydesignedtoaddvalueandapproveanorganization soperations Ithelpsanorganizationaccomplishitsobjectivesbybringingasystematic disciplinedapproachtoevaluateandimprovetheeffectivenessofriskmanagement control andgovernanceprocesses InstituteofInternalAuditors 8 Question Whatisthedifferencebetweenthirdpartauditandfirstpartaudit internalaudit 9 WhyAudit TodeterminewhetherthequalitysystemconformstospecifiedrequirementsTodeterminetheeffectivenessoftheimplementedsystemToinitiateimprovementsinthesystem 10 3typesofaudits ProcessauditsProductauditsSystemaudits 11 PROCESSAUDITS Evaluationofthecontentsandeffectivenessofspecificprocesses workactivities ToconfirmprocessparametersandimprovecapabilityoftheprocessToensuretherealizationtheprocessqualitycharacteristics Toensureimprovementofprocesscontrolduringserviceprovision 12 ProductAudits Investigationofproductconformancetospecifiedcharacteristics Toobtainadditionalneutralassessmentofproduct slevelofqualityToobtainadditionalassurancethatspecifiedqualityrequirementsaremet 13 Productaudits Toidentifyopportunitiesforimprovement ToestablishthequalitylevelofunitsafterfinalinspectionandtestingToestablishthecapabilityoftheinspectionfunctionTodeterminetheusefulnessofinspections tests 14 Systemaudits Evaluationofalltheelementsofthequalitysysteminorderto Verifyusefulness suitabilityandeffectivenessVerifyadequatedocumentationVerifycompliancewithrequirements Determineweakpoints 15 Whoisanauditor ApersonwhohasthequalificationtoperformqualityauditsCriteriaforqualityauditorsEducationTrainingExperiencePersonalAttributes 16 Attributesofanauditor A AnalyticalU Unassuming unbiasedD DiplomaticI Inquisitive independentT ThoroughO ObjectiveR Reliable 17 TheAuditProcess Planandpreparetheaudit50 Carryouttheaudit30 Reportingandfollow up20 18 OVERVIEWOFAUDITACTIVITES Planningandschedulingaudit Conductingdocumentreview Conductingaudit Prepareauditreport Conductingfollow up Preparingforon siteactivities 19 ForminganauditteamandassignrolesandresponsibilityandagreedonthescopeConductingdocumentreviewPreparingfortheon siteauditactivities Reviewdocuments SOPs auditfindings correctiveaction preventiveaction etc checktheintegrityofthequalitysystemandvariouscontrolsareeffective PreparingauditplanAssigningworktotheauditteamPreparingworkdocuments eg auditchecklists samplingplans formsforrecordinginformation questionnaires AUDITACTIVITIES 20 AUDITDOCUMENTATION Auditreportisanofficialdocumenttoreporttheauditfindings Auditplanshouldbesenttoauditeepriortoauditactivityfindingsfromthelastauditshouldbealsomentioned Auditnoteshouldincludeanauditquestionnaireallrecordsandcommentsduringtheaudit 21 AUDITPREPARATION EstablishaudittypeandscopeEstablishauditbasis itisthestandard manual proceduresorcombinationofthemEstablishauditpersonnel sizeisdependentonthetype purposeandscopeofaudit Auditteammayincludespecialists traineeauditors observersacceptabletoauditedandauditteam 22 AUDITPREPARATION ReadbasisdocumentationaswellaspreviousauditreportsanddeterminewhatrecordsshallbepulledinadvancePrepareprocessmodel identifyingtheexpectedresultsoftheprocesstobeauditedPrepareanauditplan orschedule 23 AUDITPREPARATION Notifytheauditeeinadvanceof time date thescope thebasis timetableoftheauditPreparechecklists useopenendedquestionswhat Why Who How Which 24 TheConsiderationoftheAuditingSchedule 1 AuditingScope2 Operationalperformance KPI 3 Customers feedbacks e gcomplains 4 NCRinlastauditing 5 Auditingresources 25 AnExampleofAuditingSchedule 26 AuditingPlan Basedonauditingschedule Considerthespecificscopeandpurposes Considertheauditingresources Andailyworkassignment Workedoutbyleadingauditor 27 STC JZ02A4 1 28 CaseStudy 29 Checklist Coveralltherequirementsoftheauditingplan Workedoutbyeachauditor Roadmapofthecheckout Focusonthekeypoints 30 AuditApproach RouteApproach Basedondep BasedonprocessRoute Forwardtrace Backwardtrace 31 Auditingbasedondepartment Responsibilities 5 5 16 2 1 Resourses 6 26 36 4 Qualityobjectives 5 4 1 Communications 5 5 3 Processincharge Clause Dataanalysis 8 4 improvement 8 5 Process 32 EXAMPLEOFANAUDITCHECKLIST Generalformatforanauditchecklist 33 EXAMPLEOFANAUDITCHECKLIST 34 MONITORING 35 PERFORMINGTHEAUDIT Beforethestartofaudit Auditee smanagementinformspersonnelintheinvolveddepartmentsaboutexpectedauditLeadauditorandrestoftheteammustbeacceptabletoauditeemanagement 36 FOURPHASESOFANAUDIT OpeningmeetingExecutionofauditAuditors meetingClosingmeeting 37 AUDITINGACTIVITIES Conductingon siteauditactivities InterviewswithdifferentpersonnelCarryoutbothhorizontalandverticalaudits Focusonsafetyandqualityofproduct Use Trace back method ConductopeningmeetingGoodcommunicationduringtheauditRolesofescortandobserverStepsinconductingonsiteaudit 38 Typicalopeningmeetingagenda IntroductionofmembersandobserversandrecordingofthosepresentConfirmobjectives scope basis reasonsandbenefitsoftheauditReviewofauditplanExplanationoftheauditmethodanddocumentationtobeusedExplainthetasksoftheaccompanyingauditee srepresentatives i e guide 39 40 Executionofaudit THEAUDITLOZENGE Ask Record Check Observe 41 EXECUTIONOFAUDIT MustbedoneaccordingtotimetableOnlyaskopen factualquestionsVerifyanswerthroughobservationFollowanaudittrailDomorelisteningthantalking 2ear1mouth thereforelisten2 3ofthetime 42 Somerulesforauditors KeepcalmandrelaxedLookattheotherperson eyecontactKeepdiscussionfactualAskonequestionatatimeDonotlectureLettheotherpersonfinishtalking 43 Somerulesforaudit KeeptherightdistancefromthepersonBefriendlywithoutbeingtoofamiliarIfyourquestioncausesuneasinessoruncertainty formulateitdifferentlyInvolveallparticipantsUsetherightgestures expressionsKeeppersonalopinionstoyourself 44 AUDITORSINS AnauditorshouldneverComparetheauditeewithothersBesarcasticSwearCriticizeBesidetrackedArgueDiscusspersonalitiesDiscussreligionorpoliticsDiscusscompanypolicyDrinkbeerbeforeaninterviewBelate 45 Objectiveevidence Remember SHOWMECheckfordocuments records reports dataincomputersetcEnsureauditeesstatementsarecrosscheckedbysupportingevidencee g statementsbyotherpersonnelwithspecifiedauthority records documentaryevidencee g 46 CriticalPointsforchecking Documentsandrecords Machineryandequipments Measuringdevices Workersandtheiroperations Rawmaterialsandcomponents Logistics On sitescleaningandenvironments 47 48 49 50 AUDITORS MEETING Compilationoffindings observationsRecordingofnon conformitiesPreparationofsummaryreportFormationofopiniontobepresentedatclosingmeeting 51 GeneratingauditfindingsEitherconformityornon conformitySortoutisolatedorsystemicdeficiencies Isolateddeficiency Tendstohappenrandomly nomeaningfulpattern rarelyhappensSystemicdeficiency Couldbeconnectedtoaparticularprocess product material personororganisation showspattern happensmorethanonce AUDITINGACTIVITIES 52 ISOLATEDVERSUSSYSTEMICDEFICIENCY 53 Theauditfindingcanbeclassifiedinto2groups Compliance Satisfactory AdequateOutstandingNon compliance CriticaldeficiencyMajordeficiencyMinordeficiency AUDITMONITORING 54 ObjectivesAuditscopeIdentificationofauditteamleaderandmembersDateandplacewheretheon siteauditactivitieswereconductedAuditcriteriaandfindingsConclusions AUDITREPORT 55 Typicalclosingmeetingagenda IntroductionsandrecordingofattendanceThanktheauditeeMentiontheprinciplesofsamplingfollowedduringtheauditSummarizeauditobservations positive generalobservationsandnonconformities Givenon conformitiesindetails 56 TypicalClosingMeetingAgenda PresentoverallsummaryandconclusionsAllowfordiscussionRequestcorrectiveactionsandcorrectiveactiondatesAgreeonfollow updateClosemeeting 57 58 AUDITREPORT ANEXAMPLE 59 REPORTINGOFAUDITS Astandardformforthereportingofauditshouldbeused UsingthestandardauditreportsheetsprepareanarrativesummaryoftheauditEnsurethepositiveaswellasthenegativefindingsaresummarized 60 REPORTINGOFAUDITS Reportshouldcoverthefollowingheadings TitleScopeBasisAuditteamIntroduction openingmeeting FindingsDebriefing closingmeeting SummaryTheauditreportin