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DellComputerCorporationIPOOnBoardTraining,SupplierQualityStandardPreparedby:EricHoh,Content,QualitySystemRequirementsContractReviewDesignControlDocumentControlSupplierQualityControlProductIdentificationandLotTraceabilityProcessControlInspectionandTestingCalibrationInspectionandTestStatusControlofNonconformingProductHandling,Storage,Packaging,andDeliveryQualityRecordsDeliverables,SupplierQualityStandard,AhighlevelstandardtooutlinethequalityprogramrequirementsforDellSupplierRFQ/ContractshalltakeprecedentifconflictwiththeSQSrequirementsExceptionstoSQSrequirementsmustbeapprovedbyGSQE,QualitySystemRequirements,QualityProgramConsistentwithISO9001and9002requirementsManagementResponsibilityDevelopcompany-widequalitypolicyEnsurethecontinuingsuitabilityandeffectivenessofthequalitysystemMonitorcompliancetothesystem,andtoensurecorrective/preventivemeasuresareimplemented,QualitySystemRequirements-Continued,OrganizationSupports,implementsandmaintainsthequalitysystematalllevels.QualityPolicies,Procedures,andWorkInstructionsDocumentedqualityprogramtoensureproductand/orservicescomplywiththerequirementsQualityManagementPlanQualityprogramusedforthedesign,manufacture,test,andinspectionofproductdeliveredtoDell,QualitySystemRequirements-Continued,InternalAuditProgramGapAnalysis(Audit)SystemAuditsProcess/ProductAuditsDellAuditsPeriodicbasis,includingsub-contractorfacilitiesTrainingIdentifytrainingrequirementsQualificationbasedoneducation,trainingand/orexperienceQualification,re-qualification,anddisqualification,ContractReview,SupplierShouldAssure:DellrequirementsareunderstoodConflictsbetweenspecifications,drawings,andcontractrequirementsareresolvedAssurethatanyrequirementsdifferingfromthoseinthetenderareresolvedTheSupplierhasthecapabilitytomeetcontractualrequirements.,DesignControl,DesignDevelopmentandPlanningOutlinesactivitiesanddefineresponsibilityforimplementationDesignInputEnsurecustomerrequirements,statutoryandregulatoryareclearlyidentified,documented,andreviewedDesignOutputMeetsalldesigninputrequirements.Containsacceptancecriteriaperspecifications.Identifysafetyandfunctionalcharacteristics,DesignControl-Continued,DesignReviewReviewatappropriatelevels/keymilestonesDesignVerificationDesignmeetsdefinedrequirementsatdifferentdesignstages(i.e.EVT,DVT,PVT)DesignValidationDesignconformstodefinedrequirementsDesignChangesIdentified,documented,researchedandapprovedbyauthorizedpersonnelattheSupplier.FinalapprovalbyDellGSQEpriortoimplementation,DocumentControl,RevisioncontrolledandavailabletoallnecessarypersonnelUpdate/removeobsoletedocumentationRedLinedocumentationcanbeacceptedonlyif:HavebeenclearlymarkedReviewedandapprovedbyappropriateauthorizedpersonnelwithoriginalsignaturesoneverycopyDateofissueandexpirationdatesarespecifiedAllRedLineddocumentationmustbereplacedbyformal/controlledrevisionwithin30days,SupplierQualityControl,Theplanshouldcovers:QualitygoalsSurveys/auditsQualityprogramrequirementsChangecontrolrequirementsTestandinspectionsFirstarticleinspectionsQualitydata/information,ProductIdentificationandLotTraceability,Traceabilitythroughthefinishedproductserialnumberduringthebelowstages:,IncomingStorageMaterialIssuingProductionDeliveryInstallation,ProcessControlControlledConditions,DocumentedworkinstructionsIdentificationofcriticalparameters,implementationofstatisticalprocesscontrols,andinitiationofcorrectiveactionProofingoutthemanufacturing,inspectionandtestprocessespriortomassproductionManufacturingequipmentvalidationWorkmanshipcriterionPreventivemaintenanceprogram,ProcessControlProcessQualification,AllprocessesshallbequalifiedbyDellChangetoqualifiedmanufacturingprocessormaterialmustobtainwrittenapprovalfromDell.ProcessqualificationshallincludeSupplier-generatedprocesscapabilityassessmentsProcessstabilitytobedemonstratedandmaintainedviastatisticalmethods,ProcessControlQualityMetrics,IncomingQualityAssurance(IQA)resultsManufacturingYieldsTestStationYieldsInspectionYieldsMeanTimeBetweenFailures(MTBF)demonstrationdataOutofBoxAudits(OBA)AnnualizedFailureRate(AFR)/AnnualizedReturnRate(ARR)performanceReliabilitytestresultsDellInitialFieldIncidentRate(IFIR)andLineRejectRate(LRR),ProcessControlContinuousImprovementProcess(CIP),Adocumented,systematicapproachforidentifyingCIPfocusareasDesignforqualityinitiative(i.e.,HALT,FMEA,MarginAnalysis,ToleranceStack-upAnalysis)SuppliermanagementstrategyManufacturingprocesscontrolsLRRandIFIRreductionplanstoachieveDellgoals,InspectionandTesting,Source/ReceivingInspectionandTestsWorkinstructionsSamplingplanIn-ProcessInspectionsandTestingProcesses,andinstructionsWorkmanshipandfunctionalityFinalInspectionandTestingDellspecificrequirementsWorkmanship,assemblyverification,andfunctionality,InspectionandTesting-continued,ShippingInspection(OBATesting/Inspection)Functionality,Appearance,Accessories,labeling,packaging,.ReliabilityTestingFailurestobecontainedControlsforidentificationandrecallifrequiredMaintainInspectionandTestRecordsEvidenceforacceptance,Calibration,CalibrationProceduresMeasurements,Accuracy,Equipment,EnvironmentalconditionsRecallList(CalibrationSchedule)CalibrationnotificationCalibrationRecordsCalibrationprocedureapplied,inspector,status/result,StandardtraceabilityOutofTolerance(Calibration)NoticesTraceabilityforproductproducedandacceptedbythedefectiveinstrument,InspectionandTestStatus,IdentificationoftheinspectionandteststatusTracktheacceptancestatusSegregationofnon-conformingproduct,ControlofNonconformingProductReviewandDispositionofNonconformingProducts,MaterialReviewBoard(MRB)DesignEngineering,ManufacturingEngineering,Procurement,andQualityEngineeringDispositionRework,UseasIs,Repaired,Scrap,ScreenNote:“UseasIs”requiresfinalapprovalfromDellSQE,ControlofNonconformingProductCorrectiveActionProcess,Use8-DprinciplestotrackandclosetheCAInvestigaterootcauses,andidentifycorrectiveactionEliminatepotentialcausesofnonconformingEnsurecorrectiveactionsareeffectiveImplementandrecordchangeinprocedure8-D:Specificdefect,Technicalinvestigation/analysis,Rootcause,Containmentfordefect,Correctiveactionplan,Preventiveactionstoprecludearecurrence,VerificationofeffectivenessofactionsCorrectiveactionsshallbeclosedwithin30daysunlessotherwisedirectedbyDellSQE,ControlofNonconformingProductPrincipleforCorrectiveAction,SMART,PECIFIC,EASURABLE,CHIEVABLE,ELEVANT,IMEBOUND,Handling,Storage,Packaging,a
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