INTRODUCTIONTO

QUALITYSYSTEM

AUDITING1OutlineBasicconceptionsofqualitysystemAuditingPreparationofauditingOn-siteauditingAuditingreportandfollow-upactions2Whatisqualityaudit?Aqualityauditisasystematic,independentanddocumentedprocessforobtainingaudit

evidenceandevaluatingitobjectivelytodeterminetheextenttowhichagreed

criteriaarefulfilled(ISO9000:2005clause3.9.1)3Auditcriteria

Evidence

CompareAuditfindingconclusionHowmany？Yes/No？4ThreeKeyWordsEvidenceCriteriaIndependent5Distinctionofsystemauditsbyparties1stpartyaudits (InternalAudits)–Organization auditsitsownQMSaccordingtoa qualitystandard2ndpartyaudits (SupplierAudits)–Customeraudits thesupplier’squalitysystem3rdpartyaudits Externalcertificationauditsbyan independentinstitutioninorderto certifytheQMS6InternalAuditAnindependent,objectiveassuranceandconsultingactivitydesignedtoaddvalueandapproveanorganization’soperations.Ithelpsanorganizationaccomplishitsobjectivesbybringingasystematic,disciplinedapproachtoevaluateandimprovetheeffectivenessofriskmanagement,control,andgovernanceprocesses.----InstituteofInternalAuditors7Question:Whatisthedifferencebetweenthirdpartauditandfirstpartaudit(internalaudit)8WhyAudit?TodeterminewhetherthequalitysystemconformstospecifiedrequirementsTodeterminetheeffectivenessoftheimplementedsystemToinitiateimprovementsinthesystem93typesofaudits

ProcessauditsProductauditsSystemaudits10PROCESSAUDITSEvaluationofthecontentsandeffectivenessofspecificprocesses&workactivities:ToconfirmprocessparametersandimprovecapabilityoftheprocessToensuretherealizationtheprocessqualitycharacteristics.Toensureimprovementofprocesscontrolduringserviceprovision11ProductAuditsInvestigationofproductconformancetospecifiedcharacteristics:Toobtainadditionalneutralassessmentofproduct’slevelofqualityToobtainadditionalassurancethatspecifiedqualityrequirementsaremet12Productaudits

Toidentifyopportunitiesforimprovement.ToestablishthequalitylevelofunitsafterfinalinspectionandtestingToestablishthecapabilityoftheinspectionfunctionTodeterminetheusefulnessofinspections&tests13SystemauditsEvaluationofalltheelementsofthequalitysysteminorderto:Verifyusefulness,suitabilityandeffectivenessVerifyadequatedocumentationVerifycompliancewithrequirements.Determineweakpoints14Whoisanauditor?

Apersonwhohasthequalificationtoperformqualityaudits

CriteriaforqualityauditorsEducationTrainingExperiencePersonalAttributes15Attributesofanauditor

A–Analytical U–Unassuming/unbiased D–Diplomatic I–Inquisitive/independent T–Thorough O–Objective R-Reliable16TheAuditProcessPlanandpreparetheaudit 50%Carryouttheaudit 30%Reportingandfollow-up 20%17OVERVIEWOFAUDITACTIVITESPlanningandschedulingauditConductingdocumentreviewConductingauditPrepareauditreportConductingfollow-upPreparingforon-siteactivities18ForminganauditteamandassignrolesandresponsibilityandagreedonthescopeConductingdocumentreviewPreparingfortheon-siteauditactivitiesReviewdocuments(SOPs,auditfindings,correctiveaction/preventiveaction,etc.),checktheintegrityofthequalitysystemandvariouscontrolsareeffectivePreparingauditplanAssigningworktotheauditteamPreparingworkdocuments (eg.auditchecklists,samplingplans,formsforrecordinginformation;questionnaires)AUDITACTIVITIES19AUDITDOCUMENTATION

Auditreportisanofficialdocumenttoreporttheauditfindings

Auditplanshouldbesenttoauditeepriortoauditactivityfindingsfromthelastauditshouldbealsomentioned

Auditnoteshouldincludeanauditquestionnaireallrecordsandcommentsduringtheaudit20AUDITPREPARATIONEstablishaudittypeandscopeEstablishauditbasis–itisthestandard,manual,proceduresorcombinationofthemEstablishauditpersonnel–sizeisdependentonthetype,purposeandscopeofaudit.Auditteammayincludespecialists,traineeauditors,observersacceptabletoauditedandauditteam21AUDITPREPARATIONReadbasisdocumentationaswellaspreviousauditreportsanddeterminewhatrecordsshallbepulledinadvancePrepareprocessmodel–identifyingtheexpectedresultsoftheprocesstobeauditedPrepareanauditplan(orschedule)22AUDITPREPARATIONNotifytheauditeeinadvanceof:time,date,thescope,thebasis,timetableoftheauditPreparechecklists–useopenendedquestionswhat?Why?Who?How?Which?23TheConsiderationoftheAuditingSchedule1.AuditingScope2.Operationalperformance(KPI)3.Customers’feedbacks(e.gcomplains);4.NCRinlastauditing;5.Auditingresources24AnExampleofAuditingSchedule

25AuditingPlanBasedonauditingschedule;Considerthespecificscopeandpurposes;Considertheauditingresources;Andailyworkassignment;Workedoutbyleadingauditor26STC/JZ02A4-127CaseStudy28ChecklistCoveralltherequirementsoftheauditingplan;Workedoutbyeachauditor;Roadmapofthecheckout;Focusonthekeypoints29AuditApproach&RouteApproach：

Basedondep.BasedonprocessRoute：

Forwardtrace

BackwardtraceBasedonDep.BasedonprocessforwardbackwardFlexiblecombination30AuditingbasedondepartmentResponsibilities5.5.16.2.1Resourses6.26.36.4Qualityobjectives5.4.1Communications5.5.3ProcessinchargeClauseDataanalysis8.4improvement8.5

Process31EXAMPLEOFANAUDITCHECKLISTGeneralformatforanauditchecklist32EXAMPLEOFANAUDITCHECKLIST33INTERNA:AUDITQUESTIONAIRESAreaaudited:______________________Date:__________________Question(QSR-GMPReference)Response1.Doesthecompanyhaveaworkinstructiontooperatethemachine?

2.Howisthemachinebeingcleanedandmaintained?

3.Arepersonneltrainedtousethemachine?

4.

Howoftenistheequipmentbeingcalibratedandcleaned?

5.

Whenisthelastbreakdownofthemachine?

Arethereanyproductbeingaffected?

MONITORING34PERFORMINGTHEAUDITBeforethestartofaudit:Auditee'smanagementinformspersonnelintheinvolveddepartmentsaboutexpectedauditLeadauditorandrestoftheteammustbeacceptabletoauditeemanagement35FOURPHASESOFANAUDITOpeningmeetingExecutionofauditAuditors’meetingClosingmeeting36AUDITINGACTIVITIESConductingon-siteauditactivitiesInterviewswithdifferentpersonnelCarryoutbothhorizontalandverticalaudits.Focusonsafetyandqualityofproduct.

Use“Trace-back”method

ConductopeningmeetingGoodcommunicationduringtheaudit

RolesofescortandobserverStepsinconductingonsiteaudit:37TypicalopeningmeetingagendaIntroductionofmembersandobserversandrecordingofthosepresentConfirmobjectives,scope,basis,reasonsandbenefitsoftheauditReviewofauditplanExplanationoftheauditmethodanddocumentationtobeusedExplainthetasksoftheaccompanyingauditee’srepresentatives(i.e.guide)3839ExecutionofauditTHEAUDITLOZENGE

AskRecordCheckObserve40EXECUTIONOFAUDITMustbedoneaccordingtotimetableOnlyaskopen,factualquestionsVerifyanswerthroughobservationFollowanaudittrailDomorelisteningthantalking,2ear1mouth;thereforelisten2/3ofthetime41SomerulesforauditorsKeepcalmandrelaxedLookattheotherperson-eyecontactKeepdiscussionfactualAskonequestionatatimeDonotlectureLettheotherpersonfinishtalking42SomerulesforauditKeeptherightdistancefromthepersonBefriendlywithoutbeingtoofamiliarIfyourquestioncausesuneasinessoruncertainty,formulateitdifferentlyInvolveallparticipantsUsetherightgestures/expressionsKeeppersonalopinionstoyourself43AUDITORSINSAnauditorshouldneverComparetheauditeewithothersBesarcasticSwearCriticizeBesidetrackedArgueDiscusspersonalitiesDiscussreligionorpoliticsDiscusscompanypolicyDrinkbeerbeforeaninterviewBelate44ObjectiveevidenceRemember----SHOWMECheckfordocuments,records,reports,dataincomputersetcEnsureauditeesstatementsarecrosscheckedbysupportingevidencee.g.statementsbyotherpersonnelwithspecifiedauthority,records,documentaryevidencee.g..45CriticalPointsforcheckingDocumentsandrecords;Machineryandequipments;Measuringdevices;Workersandtheiroperations;Rawmaterialsandcomponents;Logistics;On-sitescleaningandenvironments46474849AUDITORS’MEETINGCompilationoffindings/observationsRecordingofnon-conformitiesPreparationofsummaryreportFormationofopiniontobepresentedatclosingmeeting50GeneratingauditfindingsEitherconformityornon-conformitySortoutisolatedorsystemicdeficienciesIsolateddeficiency:

Tendstohappenrandomly;nomeaningfulpattern;rarelyhappensSystemicdeficiency:Couldbeconnectedtoaparticularprocess,product,material,personororganisation;showspattern;happensmorethanonceAUDITINGACTIVITIES51ISOLATEDVERSUSSYSTEMICDEFICIENCY

NONCONFORMANCEDEFICIENCIES

ISOLATEDSYSTEMICLatexglovesripSOPcontainserrorsWrongexpirationdatewrittenonareagentbottleBatchrecordispoorlywrittensoinstructioncanbeconfusingOperatororlabtechnicianspillsasampleAreamanagementdoesnotreinforcerequirementtocontinuallyrecordinformationproperlyPressingmachineofeyeshadowburnsoutPreventivemaintenanceprogramdoesnotincludeliquidfillingmachinemotor52Theauditfindingcanbeclassifiedinto2groups:Compliance:Satisfactory

/AdequateOutstandingNon-compliance:CriticaldeficiencyMajordeficiencyMinordeficiencyAUDITMONITORING53ObjectivesAuditscopeIdentificationofauditteamleaderandmembersDateandplacewheretheon-siteauditactivitieswereconductedAuditcriteriaandfindingsConclusions

AUDITREPORT54TypicalclosingmeetingagendaIntroductionsandrecordingofattendanceThanktheauditeeMentiontheprinciplesofsamplingfollowedduringtheauditSummarizeauditobservations(positive,generalobservationsandnonconformities)Givenon–conformitiesindetails55TypicalClosingMeetingAgendaPresentoverallsummaryandconclusionsAllowfordiscussionRequestcorrectiveactionsandcorrectiveactiondatesAgreeonfollow-updateClosemeeting5657NoclauseFindingsGradingLocationAuditeeAuditor1.2.1.1ProductionandQCdepartmentsareheadedbythesamepersonCriticalHumanResourcesAbasBudi2.4.3MonitoringoftemperatureinawarehouseMajororMinorWarehouseTutiMayLin311.1Inadequatecontroloversub-contractorMajororMinorProductionHermanIdaAUDITREPORT:ANEXAMPLE

58REPORTINGOFAUDITSAstandardformforthereportingofauditshouldbeused.UsingthestandardauditreportsheetsprepareanarrativesummaryoftheauditEnsurethepositiveaswellasthenegativefindingsaresummarized59REPORTINGOFAUDITSReportshouldcoverthefollowing