精益产品设计-Lean Design for Product

DesignforLeanandSixSigmaEnterpriseExcellenceSeriesDisclaimerandApprovedUseDisclaimerThispresentationisintendedforuseintrainingindividualswithinanorganization.Thehandouts,tools,andpresentationsmaybecustomizedforeachapplication.THEFILESANDPRESENTATIONSAREDISTRIBUTEDONAN"ASIS"BASISWITHOUTWARRANTIESOFANYKIND,EITHEREXPRESSEDORIMPLIED.CopyrightThispresentationiscreatedandcopyrightedbyFactoryStrategiesGroupLLC.

ApprovedUseEachcopyofthispresentationcanbeusedthroughoutasingleCustomerlocation,suchasamanufacturingplant.Multiplecopiesmayresideoncomputerswithinthatlocation,orontheintranetforthatlocation.Contactusforauthorizationtousethispresentationatmultiplelocations.Thepresentationmaybecustomizedtosatisfythecustomer’sapplication.Thepresentation,orportionsormodificationsthereof,maynotbere-soldorre-distributedwithoutexpresswrittenpermission.Currentcontactinformationcanbefoundat:OutlineLeanDesignKeyPrinciplesofLeanDesignCharacteristicsoftheToyotaProductDevelopmentSystemTheImpactofVariationWasteinProductDevelopmentOptimalLeanDesignTeamCycleTimeIssuesProductCostIssuesQualityIssuesDesignforManufacturingDesignforSixSigmaGoalsToolsProcessDesignandISO9001:2000(Sectionbysectiondiscussion)Phase2ConceptPhase1Pre-conceptPhase3ProductDefinitionPhase4DetailedDesignPhase5Integration&TestValidationPhase6Production&OperationCUSTOMERCTQ’SBUSINESSCTQ’STECHNICALCTQ’STECHNICALREQUIREMENTSLISTManufacturingProcessControl

DesignforSixSigmaProductDevelopmentProcessLeanDesignSupplierRationalizationQualityImprovementCycleTimeandCostImprovementLean&SixSigmaDesignWhatisLeanDesign?AstructureddesignapproachthatEnablesLeanEnterpriseDeliverscustomersolutionsMinimizesvariationthatcauseswasteOptimizestotalprocessandproductcostLeandesigntechniquesoffer:FasterdevelopmentofnewproductsProductsthatcanberampedupquicklyProductsthatarereadyforproductionManufacturingcanimmediatelybuildthemefficientlySupplierscanfurnishmaterialquicklyandreliablyWhatisLeanDesign?AprocessthatgenerateslotsofideasfornewproductsAprocesstodecideonwhichideastodevelopAheavyweightprojectteamtodevelopandlaunchtheproductLeanDesignisn’t:ConfusionoverwhattodevelopSeniormanagementinterferencewiththedesignAprocessthatthrowsthedesignover“thewall”tomanufacturingEveryonepointingfingersKeyPrinciplesofLeanDesignWell-integratedbasicelementsofproductdevelopmentHighlyskilledandwellorganizedpeopleProcessesthatminimizewasteandmaximizethecapabilityofpeopleusingthemTechnologiesthatenhancetheperformanceofpeopleandprocessesCustomerfirstphilosophyUnderstandcustomerdefinedvaluesStrivetogivedefinedvaluestocustomerKeyPrinciplesofLeanDesignKnowledgebasedorganizationLearningandcontinuousimprovementaspartofjobStandardizationSkillsDesignstandardsProcesses/milestones/deliverablesReuseKnowledge/experienceDesign/designalternativesParts/configurationKeyLeanDesignConceptsDesigntoCostTheteamhasacosttargettomeetwiththedesignCosttargetsoftenassignedtosubassembliesandprocessesConstantmonitoringofproductcostbyPurchasingandManufacturingTradeoffdecisionsaremadeondesignvs.costonanongoingbasisDesigntoCostalsoused

toselectandmanage

suppliersSuppliersareexpected

tomeetcostgoals,but

arealsoexpectedto

makeaprofitKeyLeanDesignConceptsEngineeringEngineeringandProductionarenotconsideredopposingforcesExample:HondadesignengineersmustworkonthefactoryfloorforaperiodoftimePurchasingSuppliersaretruepartnersKeysuppliersareselectedtobepartofthecoreteamfromdayoneOnmajorprojectsrepresentativesfromthesuppliersareco-locatedwiththedesignteamSuppliersanddesignteamareusingthesamesoftwareanddesigntoolsAbsolutetrustmustexistbetweentheteamandsuppliersKeyLeanDesignConceptsManufacturingSelectedplantpersonnel-supervisors,leads,senioroperatorsetcmustbepartofthedesignteamandco-locatedTheremustbearegularroutineoftakingdesigninformationtoplantproductionpersonnelfortheirreviewandinputObjectiveistohaveaproductthatcanhaveahighqualityproducteasilyproducedintheplantAsecondobjectiveisfortheplanttoquicklyrampuptofullproductionwiththenewproductKeyLeanDesignConceptsKnowledgeTransferLeanDesigncompaniesandteamsmakespecialeffortstosharedata-whathasworked,mistakesmade,whereimprovementscanbemade-onaroutinebasisDonebyoftechnology-teamrooms,websites,etc…Donebyhumans-designconferencesandmeetingswhereteamspresenttheirfindings,lessonslearnedetctotheirpeersThiscross-pollinationofexpertisebetweenteamstakestime,effortandmoneybuthashugebenefitswhendonerightCommonparts,sub-assemblies,platformsKeyLeanDesignConceptsGlobalOperationsAfactoflifetodayisthatagreatmajorityofdesigneffortsarenowglobalProductwillbedesignedfortheglobalmarketplaceDesigneffortscanbeglobalSupplierswillbeglobalPlantswillbeglobalAlloftheissues,problemstalkedaboutwillbelargerandmorecomplexMoretimeandenergywillbeneededtomakethetimeproductiveInformationsystemswillbemoreimportantThehumanelement-bringingtheteamtogether-willbecomeahugeeffortoftheleadershipteamTryschedulingamanagementmeetingwithleadersinGermany,UK,USandChinaTrydealingwithconflictwhenyourteamisinGermany,UK,USandChinaandIndiaToyotaProductDevelopmentSystemFocusonbusinessperformanceValuecustomers’opinionStandardizeddevelopmentmilestonesPrioritizeandReuseFunctionalteamsSet-basedconcurrentengineeringSupplierinvolvementChiefengineersystemToyotaProductDevelopmentSystemFocusonbusinessperformanceApplytechnologiesthatsellcarsGatherandincorporatecustomers’opinionalongdesignprocessMultiplechoicesystem(design/costtrade-offs)StandarddevelopmentmilestonesSimilarprogramstructureacrossallvehicleprogramsSchedulecustomizebychiefengineerNostandarddevelopmentprocessToyotaProductDevelopmentSystemPrioritizeandReuse12%parts=80%costand60%weightHighcostpartswithlowcustomervisibility/value60-70%ofvehiclepartsare“common”ToyotaProductionSystemprinciplesJIT(Just-in-time)Kaizen(Continuousincrementalimprovement)Pullsystem(Tasksbasedondownstreampull)ToyotaProductDevelopmentSystemFunctionalteamsEvaluatedonsupportforproductdevelopmentBroadEngineersHighlyskilled/coreknowledgeLimitedrotationbefore5yearsValuelearning/knowledgegatheringMentorship/apprenticessystemManager’sresponsibility/jobfunctionMaintainownlessons-learnedbooksCurrentcompanycapability(feasibilityranges)ExtensivechecklistToyotaProductDevelopmentSystemSet-basedconcurrentengineeringParallelevaluationofmultiplealternativesImposeminimalconstraintsondesignrequirementEfficientdocumentationSmallsize(equiv.To8.5”x11”)SameformatFocuseddiscussionmeetingsDifferentmeetingsfordifferentissues/concernsWell-informedandpreparedwithsolutionsHighnumberofprototypesAllowminutedesignadjustmentforassemblypurposesToyotaProductDevelopmentSystemSupplierinvolvementindesignprocessLong-termrelationshipsBestonesuseset-basedengineeringMinimaldesignreviewoncespecsaregivenResponsiblefordesignandperformancerequirementToyotakeepscurrentonsupplier’scapabilitiesDesignandmfgcapabilitiesNewtechnologyandinnovationWorkwithsupplierstoimprovesuppliers’capabilitiesifneededToyotaProductDevelopmentSystemChiefengineersystemPersonallyresponsibleforsuccess/failureofprogramSellsnewvehicleconcepttoboardofdirectorsReportsbackafterlaunchwithresultsandlessonslearnedEquivalenttoGeneralManagerDesignandorchestrateallaspectsofvehicledevelopmentHighly-skilledinone(ormore)functionalareas20+yearsofexperienceRespectedforexpertiseSmallsupport/staffteam(5-15people)NodirectauthorityoverfunctionalteamsTheImpactofVariationVariationcanbegoodProvidesCompetitiveAdvantageUtilizesIntellectualPropertyDifferentiatesOurProductSatisfiesCustomerNeedsButvariationisusuallybadMisinterpretCustomerNeedsDesignedinIsolationAddsHiddenCostAddsUnnecessaryTimeIntroducedEarlyintheProcessDonetoShortenDesignProcessDonetoResolvePartIssueWasteinProductDevelopmentWhyIsWasteHardtoSeeinProductDevelopment?Onamanufacturingfloor,wasteiseasytoseeonceyouknowwhatyou’relookingfor:excessinventory,extrasteps,extratransportation,waiting,defects,excessmotionandoverproduction.Findingwasteinproductdevelopmentismuchmorechallengingbecausethe“product”ofnewproductdevelopmentisknowledge:knowledgeaboutcustomers,knowledgeabouttechnologiesandprocesscapabilitiesintegratedintospecificknowledgeabouthowtomakeaproduct-theproductdesign.Allthisknowledgeishardtosee.Sometimestherearephysicalmanifestations:drawings,reports,slidesetsorprototypes.Butmuchoftheknowledge,andoftenthemostimportantknowledgeforvaluecreation,residesinthemindsoftheindividualsengagedintheprocess.WasteinProductDevelopmentCommonWasteinProductDevelopmentReinventionLeanproductdevelopmentteamsappreciatethevalueofknowledge,andensurethatknowledgeiseasytocapture,easytoreuseandalwaysusedtomakedecisions.ExcessRequirementsLeanproductdevelopmentteamsrecognizethateveryextrafeatureorperformanceenhancementmustbedesigned,produced,maintainedandsupported–andcustomerspaythepriceingreatercomplexityandgreaterriskoffailure.OverloadedResourcesLeanproductdevelopmentteamsknowthatoverloadingresourcesmakesthemslowerandlessflexible,andthattask-switchingcostsengineersvaluabletime.UnintegratedDesignLeanproductdevelopmentteamsstrivetounderstandandthenmanagetheirdesignsasanintegratedsystem,sothattheycanfocusinnovationonareasthatimprovethemarketperformanceoftheirentireportfolioofproducts.WasteinProductDevelopmentCommonWasteinProductDevelopment,continuedIneffectiveRiskManagementLeanproductdevelopmentteamsacknowledgetheuncertaintyinproductdevelopment,anddevelopplanstomitigateitsimpactonthesystem.WaterfallDevelopmentinDepartmentalSilosLeanproductdevelopmentteamsdoworkwhenandwhereitmakesthemostsensetodoit,ratherthanallowingrigidprocessesororganizationalboundariestodictateworkflow.UnproductiveMeetingsLeanproductdevelopmentteamsvaluetheirtime,andusegoodmeetingmanagementtospendthetimetheyhavetogetherforsolvingproblemsormakingdecisionsratherthansimplypassingoninformationthatcouldhavebeenemailed.WasteinProductDevelopmentWasteCategoryExampleImplicationDefectiveProductsExcessiveInventoriesExcessiveMotionExcessiveProcessingTransportationWaitingOverProductionexcessiveengineeringchangesrequirementschangeimpactdesignmovinginfofromoneperson/grouptoanotherprojectsdesiredfuturebusinesswork-in-processexceedscapacitypartiallydoneworkworkingw/incompleterequirementsnotusingstandardpartsandsubsextrasoftwarefeaturesdrawingorcodeerrorsworkdoesnotmatchcustomerneedsunnecessaryitemsspecifiedtoomanyapprovalsrequiredtoomuch“paperwork”excessiveapprovalsandcontrolsprocessmonumentstaskswitchingonmultipleprojectsworkloadcapacityexcessivemulti-taskingdelaysduetoreviews/approvals/testing

deployment/staffing/workloadprojectsitsfornext‘event’notcosteffectiveinefficienciesbuilt-inqueuetime,work-aroundsbatchprocessing,noflowineffectiveuseofskillsnodecisionrulesdrivesreworkandinflexibilitybarrierstoaddingvaluecapacityconsumedbyreworklonglead-time,reworkinvestmentnotrealizedqueuetimedriveslead-timenore-useofknowledgedrivessupplychainvariationexcessivechanges,scraprework,scrap,warrantyOptimalLeanDesignTeamTeammembersarefull-timeCo-locatedMembersrepresentallgroupsMarketingSalesEngineeringManufacturingToolingPurchasingSuppliersQualityCustomerOptimalLeanDesignTeamTheprojectmanageriscriticalToyotausesthe“ChiefEngineer”conceptNotdepartmentmanagersThePMistotallyresponsiblefortheprojectThePMhastheresponsibilityandauthoritytomakedesigndecisionsThePMishands-on,involved,andmakesdecisionsThePMisnotoffice-boundExcessiveProductDevelopmentCycleTime11MonthsonAverageWhy?ReworkLoopsFromDetailedDesignStartingBeforeProductReqs.AreDefinedDetailedDesignTakesTooLongRequirementsCapture&LockdownTakesTooLong

Why?

Why?NoProcessforRequirementsCaptureLackReqs.LockdownDisciplineLackSimilartoProductCapabilitiesCapableResourcesnotAvailableRedesignRatherthanReuseCapableProductsSupplierSelectionTimeDelay(6weeks)LongLeadTimePartsProcurementDelay(12weeks)

Why?

Why?CycleTimeIssuesExcessiveProductCost2XimprovementRequiredWhy?LowProductionVolumesDriveHigherCostsPayTooMuchforPartsUnnecessaryorDifficultDesignFeaturesDriveHigherCosts

Why?NoDesignForManufacturingProcessDon’tKnowExistingProductCapabilitiesRedesignRatherthanReuseCapableProductsDon’tKnowWhatPartsShouldCostShortageofQualifiedSuppliers

Why?

Why?Don’tKnowSupplierCapabilitiesTooManySuppliersforSamePartTypesWhy?ProductCostIssuesQualityIssuesProductEntryintoServiceProblemsWhy?MechanicalFailureofCriticalComponent&EarlyWear-OutofLifeLimitedComponentsFailuretoOperateinSevereEnvironments

Why?OperatingEnvironmentExceededSpecLevelsProductDesigned&TestedtoMeetOnlySpecLimitsLackProcessforRiskAssessment&ManagementReuseofUncharacterizedComponentsLackSimilartoProductCapabilities

Why?CapableResourcesnotAvailableDesignCompromisedtoMeetSchedule&BudgetLimitedDevelopmentTesting(TestingforSuccess)DesignForManufacturing(DFM)Designingproductsforeasy&economicalproductionUserecommendedpartsandstrategicsuppliersProductsaredesignedtobeconsistentwithinternalandexternalprocesscapabilitiesModulardesigns/easeofconfigurabilityConcurrentProductandProcessDesignDFMkeepsanoperationmanageableFocusedsetofsuppliersandleveragingtheircapabilitiesControllingthenumberofpartsMinimumnumberofprocessesSimplify—Simplify--SimplifyDesignforSixSigmaWhatisDesignforSixSigma?Adesignphilosophyofsystematicmethodology,tools,andtechniqueswhichenableustodesignproductsandprocessesthatmeetcustomerexpectationsandcanbeproducedatthe6sigmalevel.DFSSincorporatestheValueMethodologywiththeDMAICmethodologyinaLeanCultureDesignforSixSigma-GoalsResourceEfficient–LEANCapableofveryhighyieldsregardlessofvolumeNotaffectedbyprocessvariation;RobustLeadtoa“flawlesslaunch”MeetsPerformanceTargets(Quality)MeetsDeliveryTargets(OnTime)MeetsFinancialTargets(TargetCost)DesignforSixSigma-ToolsDesignforSixSigma-ToolsDesignforSixSigma-ProcessIdentifyCustomerrequirementsVE,QFD,CTQEstimateBaselineBenchmark,Patentsearch,ProductScorecard,ProcessMap,ValueStreamMapDetermineFunctionalRequirementsVE,DFMEAGenerate,Evaluate,SelectDesign&ProcessConcept(s)VE,3P,TRIZ,BrainstormOptimizeDesignandProcessConceptsDOE,CAE,FEA,Simulation,AnalyticalmodelsVerifyDesignandProcessPFMEA,DVP&R,PPAPMaintaintheGainsControlPlan,SPC,KaizenDesignforSixSigma-ProcessIdentifyCustomerRequirementsCustomerneedsmustbeaddressedinalldesigns(product&process).Needsmustbetranslatedintotechnical,measurabletermstotrackimprovement/success.CTMatrixprovidescomparableresultsasQFD.DesignforSixSigma-ProcessEstimateBaselineProcessMapOpportunityCountWorksheetProductScorecardDFSSWorksheetValueStreamMapDesignforSixSigma-ProcessDetermineFunctionalRequirementsValueEngineering–FunctionAnalysisDesignFMEAThisistherootcausedeterminationstepoftheproblemoropportunity….(HighValue6-SigmaDesign)DesignforSixSigma-ProcessGenerateandSelectConceptsValueEngineering–VEProductionPreparationProcessKaizen–3PDesignforManufacturing/Assembly-DFM/ABrainstormingOrasetasuchTechniquesDesignforSixSigma-ProcessOptimizeConceptsRobustDesignorParameterDesignMeasureEnergyTransformationOptimizeFunctionforEnergyTransformationOther6-SigmaTools(ImprovePhase)DOE,HypothesisTesting,RegressionAnalysis,DesignforSixSigma-ProcessVerifyDesignandProcessDesignVerification–DVProcessVerification–PVDVP&RPPAPDesignforSixSigma-ProcessMaintaintheGainsEstimateBenefits–$$SavingsorAvoidanceBookshelfSolutions&PotentialSolutionsCompleteControlPhasePFMEA,ControlPlan,SPC,etc.NextProjectDesignforSixSigma-PerspectiveDesignandISO9001:2000ISO9001:2000StandardSections7.1–7.3.7Thispresentationwillcovertheintentofthestandard.Alltextinpurpleisfromthestandard,thewhiteisfromsupportingdocumentation.ISO9001:2000RelevantSections7ProductRealization7.1Planningofproductrealization7.2Customer-relatedprocesses7.2.1Determinationofrequirementsrelatedtotheproduct7.2.2Reviewofrequirementsrelatedtothe product7.2.3Customercommunication7.3Planningofproductrealization7.3.1Designanddevelopmentplanning7.3.2Designanddevelopmentinputs7.3.3Designanddevelopmentoutputs7.3.4Designanddevelopmentreview7.3.5Designanddevelopmentverification7.3.6Designanddevelopmentvalidation7.3.7ControlofdesignanddevelopmentchangesVocabularyQualityPlan–documentspecifyingwhichproceduresandassociatedresourcesshallbeappliedbywhomandwhentoaspecificproject,product,processorcontract.QMS–QualityManagementSystemProductRealization–includesNPIprocess(NewProductIntroduction)andexistingproductasappropriate.ObjectiveEvidence–datasupportingtheexistenceorverifyofsomethingVocabulary(Cont’d)Verification–confirmation,throughtheprovisionofobjectiveevidence,thatspecifiedrequirementshavebeenfulfilled.Validation–confirmation,throughtheprovisionofobjectiveevidence,thattherequirementsforaspecificintendeduseorapplicationhavebeenfulfilled.ProductRealization

7.1PlanningofProductRealizationTheorganizationshallplan&developprocessesneededforproductrealizationandshouldbeconsistentwiththerequirementsoftheotherprocessesoftheQMS.ProductRealization

7.1PlanningofProductRealizationInplanningproductrealization,determinethefollowingasappropriate:QualityobjectivesandrequirementsfortheproductTheneedtoestablishprocesses,documentsandprovideresourcesRequiredverification,validation,monitoring,inspectionandtestactivitiesandthecriteriaforproductacceptance.Recordstoprovideproofthetheprocessandproductmeetrequirements(4.2.4)Outputofthisplanningshallbeinasuitableformfortheorganization’smethodofoperation.Note1:Aqualityplanincludesproductrealizationprocesses.Note2:Theorganizationcanalsoapply7.3(Design&development)tothedevelopmentofproductrealizationprocesses.7.1PlanningofProductRealization

(Cont’d)Resultsfromverification&validationofprocesses&outputsshouldalsobeconsideredasinputstoaprocess,toachievecontinualimprovement.ContinualimprovementofprocesseswillimprovetheeffectivenessandefficiencyoftheQMS.Documentationrelatedtoprocessesshouldsupport:Identifying&communicatingsignificantfeaturesoftheprocessesSharingknowledgeandexperienceinteamsMeasurement&auditofprocessesAnalysis,review&improvement7.1PlanningofProductRealization

(Cont’d)Roleofpeoplewithintheprocessesshouldbeevaluatedto:Ensurehealth&safetyNecessaryskillsexistSupportcoordinationofprocessesInputfrompeopleinprocessanalysisPromoteinnovationOperatingplanshouldbedefinedtomanageprocesses,including:Input&outputrequirementsActivitiesVerification&validationAnalysisofprocessincludingdependabilityIdentification,assessment&mitigationofriskCAPAProcessimprovementControlofchanges7.1PlanningofProductRealization

(Cont’d)Theprocessapproachensuresthatprocessinputsaredefinedandrecordedinordertoprovideabasisforformulationofrequirementstobeusedforverification&validationofoutputs.Inputissuestoconsider:CompetenceofpeopleDocumentationEquipmentcapability&monitoringHealth,safetyandworkenvironmentProcessoutputsthathavebeenverifiedagainstprocessinputrequirements,includeAcceptancecriteriaNeeds&expectationsofinterestedpartiesRecorded&evaluatedagainstinputrequirementsIdentifyCAPA7.1PlanningofProductRealization

(Cont’d)ManagementreviewsshouldincludeReliability&repeatabilityoftheprocessIdentification&preventionofpotentialnonconformitiesAdequacy&consistencyofdesign&developmentinputs&outputsPotentialforimprovementsUnresolvedissues7.2Customer-relatedProcesses

7.2.1DeterminationofRequirements

RelatedtotheProductTheorganizationshalldetermine:Requirementsspecifiedbythecustomer,includingdelivery&post-deliveryactivitiesRequirementsnotstatedbycustomer,butnecessaryforspecifiedorintendeduse,whereknownStatutory®ulatoryrequirementsrelatedtotheproductAnyadditionalrequirementsdeterminedbytheorganization7.2.1DeterminationofRequirements

RelatedtotheProduct(Cont’d)Managementshouldensurethatvalidationofproductsmeettheneeds&expectationsofinterestedparties.Validationincludesmodeling,simulation&trials,andreviewsinvolvingcustomers.Issuestoconsider:Qualitypolicy&objectivesCapabilityorqualificationofequipmentOperatingconditions,useorapplicationanddisposaloftheproductProductlifecycleEnvironmentalimpactanduseofnaturalresourcesProcessvalidationshouldbedoneatappropriateintervalstoensuretimelyreactiontochangesimpactingtheprocess.7.2.1DeterminationofRequirements

RelatedtotheProduct(Cont’d)Riskassessmentshouldbedonetoassesspotentialfor,andtheeffectof,possiblefailuresorfaultsinprocesses.Examples:Faultmodes&effectsanalysisFaulttreeanalysisRelationshipdiagramsSimulationtechniquesReliabilityprediction7.2.1DeterminationofRequirements

RelatedtotheProduct(Cont’d)Managementshouldensurethattheorganizationhasdefinedmutuallyacceptableprocessesforcommunicatingeffectively&efficientlywithitscustomers&otherinterestedparties.Theseprocessesshouldincludeidentification&reviewofrelevantinformationandshouldinvolveinterestedparties.Examplesofrelevantprocessinformation:RequirementsofinterestedpartiesMarketresearchContractrequirementsCompetitoranalysisBenchmarkingProcessesduetostatutoryorregulatoryrequirements7.2.2ReviewofRequirements

RelatedtotheProductTheorganizationshallreviewrequirementsrelatedtotheproductPriortocommitmenttosupplyproducttothecustomerandshallensurethatProductrequirementsaredefinedContractororderrequirementsdifferingfromthosepreviouslyexpressedareresolvedOrganizationhasabilitytomeetdefinedrequirementsResults&actionsofthereviewwillberecorded.Ifcustomerdoesn’tprovidedocumentedstatementofrequirements,thecustomerrequirementsshallbeconfirmedbytheorganizationbeforeacceptance.Whereproductrequirementschange,relevantdocumentationwillbeupdatedandappropriatepersonnelinformed.7.2.3CustomerCommunicationTheorganizationshalldetermine&implementeffectivearrangementsforcommunicatingwithcustomersinrelationto:ProductinformationEnquiries,contractsororderhandling,includingamendmentsCustomerfeedback,includingcustomercomplaints7.3DesignandDevelopment

7.3.1DesignandDevelopmentPlanningTheorganizationshallplan&controldesign&developmentofproductDuringthisphase,theorganizationshalldetermine:Design&developmentstagesReview,verification&validationthatareappropriatetoeachdesign&developmentstageResponsibilities&authoritiesManageinterfacesbetweengroupsinvolvedindesign&developmenttoensurecommunication&clearassignmentofresponsibility.Planningoutputshallbeupdated,asappropriate,asthedesign&developmentprogresses.7.3.1DesignandDevelopmentPlanning(Cont’d)Managementshouldconsiderallfactorsthatcontributetomeetingtheproduct&processperformanceexpectedbycustomersandinterestedparties,suchas:LifecycleSafety&healthTestabilityandusabilityUser-friendlinessDependability,durabilityErgonomicsEnvironment,productdisposal7.3.2DesignandDevelopmentInputsInputsrelatingtoproductrequirementsshallbedetermined&recordsmaintained.Inputswillinclude:Functional&performancerequirementsApplicablestatutory®ulatorystandardsWhereapplicable,informationderivedfromprevioussimilardesignsOtherrequirementsessentialfordesign&developmentTheseinputsshallbereviewedforadequacy.Requirementsshallbecomplete&unambiguousandnotinconflictwitheachother.7.3.2DesignandDevelopmentInputs(Cont’d)Theorganizationshouldidentifyprocessinputsthataffectdesign&developmentofproductsthatfacilitateeffective&efficientprocessperformancetosatisfyinterestedparties.Theexternal&internalneedsshouldtranslateintoinputrequirements.Externalinputs(examples)Customerormarketplaceneeds&expectationsSupplier’scontributionsUserinputtoachieverobustdesignChangesinstatutory®ulatorystandardsIndustrycodesofpract