质量管理手册 4 QUALITY MANAGEMENT HANDBOOK_Product Realisation.docx

QUALITYMANAGEMENT-HANDBOOK5990256678000001111111112222222ProductRealisationTableofContents7.1 Productrealisationplanning7.2 Customer-relatedprocesses7.2.1 Determiningtherequirementsinrelationtotheproduct7.2.2 Evaluatingtherequirementsinrelationtotheproduct7.2.3 Communicationwiththecustomer7.3 Development7.4 Purchasing7.5 Production7.5.1 Workinginstructionsforproductionandassembly7.5.2 Qualitycontrol7.5.3 Labellingandtraceability7.5.4 Propertyofthecustomer7.5.5 Productpreservation7.5.5.1 Storageandshipment7.5.5.2 After-salesservices7.6 Controlofmonitoringandmeasuringequipment7.7 Productsafety7.7.1 Implementationofproductsafetyfeatures7.7.2 Warninginformation7.7.3 Documentation7.7.4 Recallingproducts7.7.5 Rulingonrecalls7.7.6 Implementingrecalls7.7.7 Otherapplicabledocumentation7.8 Otherapplicableproceduralinstructions7.1 ProductrealisationplanningTheprocessmanagementhasadutytoarrangeallprocessesrelatedtorealisationoftheproductwithinthecompany.Tothisend,itisimperativethatthefollowingpointsarenoted: Qualitytargetsandrequirementsfortheproduct Demandforimplementationofprocesses,creationofdocumentsandpreparationofresourceswhichrelatedirectlytotheproduct Essentialverification,validation,monitoringandinspectiontasks,aswellasproductacceptancecriteria Generationofessentialrecordsprovingthattheprocesses,andthereforetheproductssubsequentlyresulted,complywiththerequirements Considerationofenvironmentalprotectionandoperationalsafety,aswellashealth-relatedissues.Wecanconcludethen,thattheplanninganddefinitionofprocessesintheproceduralandworkinginstructions,suchasdocumentationrelatingtoorders,productsandprojectsshouldensurethatallundertakingsandresultswithinthecompanycorrespondwiththerequirementsofthecustomerandthetargetsofthecompany.Theseundertakingsinvolveinspectionswhichshoulddemonstratethatallundertakingsandresultscorrelatewiththeproductrequirements.Traceabilityrequiresthegenerationofrecordscoveringallundertakingsandresults.7.2 Customer-relatedprocesses7.2.1 DeterminingtherequirementsinrelationtotheproductAllcustomerrequirementsaredeterminedwithintheframeworkofmarketanalysisandmarketcultivation,aswellasdirectcustomersupportregardingtheprocessingofqueries,offersandorders(seeQSA207-1,Processingqueries,offersandorders*).Thefollowingpointsarethereforetobeconsidered: Requirementsstipulatedbythecustomerfortheproduct,includingspecificationsregardingdeliveryandservicesfollowingdelivery Requirementswhichwerenotexplicitlystipulatedbythecustomer,however,areessentialforfulfilmentoftherespectivepurposeOtherrequirementsrelatedtotheproduct,includingadministrativeandstatutorystipulations(environmentalprotectionandoperationalsafety,aswellashealth-relatedissues.)7.2.2 EvaluatingtherequirementsinrelationtotheproductAthoroughevaluationofproductrequirementsisundertakenforallqueriesreceived(bothwrittenandoralqueries).Thisevaluationincludesanyrequirementswhichhavebeenspecifiedinadditiontothecustomerrequirementsandmustbecompletedbeforeanydeliveryobligationwiththecustomerhasbeenconcluded(e.g.submissionofabindingoffer,acceptanceofanorderorenteringintoacontract).Theevaluationmustensurethat: Productrequirementsareadequatelydetermined Anyinconsistenciesbetweentheorderorcontractandthepredeterminedstipulationsmustbeironedout(e.g.offerorcontract) Therequirementsdeterminedfortheproductcanbefulfilled(ifnecessarybycarryingouttheevaluationwiththevariouspositionsinvolved,e.g.manufacturing,assembly,therespectivesuppliersetc.)Thisnecessitatesthefollowingmeasures: Offersareonlyauthorisedoncetheevaluationhasbeenconcluded. Allcustomerordersarecheckedtoensurethatthespecificationsstipulatedwithincomplyonehundredpercentwiththespecificationsintheoffer.Ifnot,theproductrequirementsarere-evaluated(albeitbasedonlyonthedeviationsbetweenofferandcustomerorder). Ordersforwhichtherewasnoprecedingofferareevaluatedpriortoacceptance. Productrequirementsarealsoevaluatedintheeventofmodificationsbeingmadeintheorder.Modificationsmustbedocumentedandallpositionsinvolved(bothinternalandexternal)mustbenotifiedassoonaspossible.Therequisitemodificationsmustbecarriedoutinthedocuments.Theresultsoftheevaluation,andwherenecessarytherequisitemeasures,mustberecorded.Adherencetoroadtrafficlawrequirementsisalsoanessentialfactorinthecertificationrelatingtosubmissionofanofferoranorder,orsubmissionofanorderfortraceability.Ifneeded,theexistingpermitscanberevisedorupgraded,ornewonescanbeappliedfor.Forcommercialandtechnicalmodifications,completeorderconfirmationswithsequentialnumberingarecompiledanew.Processingiscarriedoutinthesamewayasiftheywereneworders.Intheeventofpotentialbottlenecks,forexampleifacustomerrequiresashortdeliverytime,thiscanbediscussedintheweeklyconveningcoordinatingcommitteeandspecialmeasurescanbeimplementedasnecessary.Thecoordinatingcommitteeismadeupofrepresentativesfromdepartmentsforsales,purchasingAND;productionplanning.7.2.3 CommunicationwiththecustomerAllpositionswhichmaintaindirectcontactwiththecustomerareresponsibleforensuringaneffectivecollaborationwiththosecustomers.Thesalesdepartmentaretheprinciplecontactpartners.Salesandmarketingareresponsibleforprovidinginformationregardingthemarket,aswellprovidingthecustomerwithinformationregardingproducts.Customercomplaintsandotherreportsregardingnon-complianceofrequirements(customerdissatisfaction)arehandledbythewarrantydepartment.Customerresponsestothefulfilmentofproductrequirements(customersatisfaction)arerecordedbythesales,marketingandafter-salesservicesdepartmentsandevaluatedbythemarketingsection.7.3 DevelopmentNoneoftheproductsproducedbyCCIunderwentdevelopmentbyCCI.Furthermore,thedesignauthoritywillberetainedbytheindividualcompanies(LMTundLBC)inthefuture,thusCCIproductswillnotbedevelopedbyCCIthemselves.7.4 PurchasingPurpose:Withthisdocumentedanddefinedprocess,wecanguaranteethatallexternally-manufacturedpartsandproductionpartsmeetthedesignatedrequirements(clear,completeandrevisedacquisitiondocumentation),andthatanacceptablesupplier,regardingqualityonthebasisofsupplierassessmentandsupplierevaluationisselectedpriortoawardingthecontract.Scopeofvalidity:Thisdescriptionappliesforallpurchasingproceduresintheacquisitionofexternally-manufacturedproductswhichare,oraretobecome,anintegralpartofourdeliveryscope.Procedure:Itistheresponsibilityofthepurchasingdepartmenttoensurethatalldocumentationnecessaryfortheacquisitionofexternally-manufacturedproductsismadeavailableandincludedinthepurchaseorder.Theheadofthepurchasingdepartmentisresponsibleforinspectionandapprovaloforders.Processdescription:AcquisitiondocumentationTheacquisitiondocumentationcomprisesof- theorderformwhichcontainsaclearanddistinctivedescriptionofthegoodsbeingpurchasedandwherevernecessary,technicaldocumentationsuchas- drawings- worksstandards,aswellasnationalandinternationalstandardsandguidelines- specifications- manufacturing,inspection,packagingandshipmentdirectives- supplier'sspecifications- testplans/testprotocolsThetechnicaldocumentationisgenerallycreatedorcompiledbythepositionresponsiblefordesign,beforebeingrevisedforentiretyandvalidityandintegratedinthepurchaseorderbythepurchasingdepartment.Thecontractor(supplier)mustcheckandapprovetheacquisitiondocumentationregardingappropriatenessoftheprescribedrequirements(orderconfirmation).Selectingthecontractor/supplierOrdersareessentiallyonlygrantedtothosecontractorswhich- fulfilallprerequisitesoftheoperationalandorganisationalstructureforflawlessorderprocessing,- areinpossessionofthenecessarytechnicalequipmentandsystemsformanufactureandinspectionoftheproductsbeingpurchased,- areinpossessionoftherequisitecertification,whereverpartsandcomponentswhicharesubjecttogeneraltechnicalmonitoringarebeingmanufactured(e.g.',weldingsuitabilitycertificate").Thepurchasingdepartment,incollaborationwiththespecialistdepartmentsifnecessary,determinesthepotentialsuppliersbywayof- evaluationofsamples,- practicalexperiencewithproductsofpreviousdeliveries,- othermeansoffamiliarisationwiththeproductsofthesupplier.AssessmentandapprovalofthesupplierIfanewsupplierbecomesinvolved,hewillprincipallybeassessed,bythepurchasingdepartmentincollaborationwithqualityassuranceandifnecessarywiththespecialistdepartments,onthebasisofhisproductslendingqualitytoourproducts,andthenapprovedfortheproductbeingpurchasedonthestrengthofhisqualificationsandcapabilities.Assessmentandapprovalofthesupplierisresulted- withdrawing-basedweldedsteelstructuresinaccordancewithQSA206ff,-withstructuralsteelsforsteelconstructionviaevaluationofthesubmittedmaterialcertificatesandtheirownrandomtesting.Onlymaterialsapprovedbytheconstructionauthoritiesareprocessed,- withcastpartsandforgespartsviaevaluationofinitialsampletestreportsandmaterialcertificates,aswellastheirowntesting,- withweldingfillermaterialsviaevaluationofcertificatesforapprovedandtestedmaterials,- withqualitysteelsviaevaluationofmaterialcertificatesandtheirowntesting,- withelectricalswitchgearunitsandmotorssampletestinginthetestfieldoraprototypetesting,ifthepartsareinstalledincomplexsystems,- forstandardpartsviatheinspectionofcertificatesandtheirowninspectionsastowhetherthestandardshavebeenadheredto.Anauthorisationisgrantediftheinspectionshavebeenassessedaspositive.ThesuppliersareincorporatedintheOrder-EDP"Supplierfile',.Deficienciesinqualityarerecordedandthecorrespondingcontrolreportsgenerated.Forseriousorcontinuingqualityproblems,thesupplieroftherejectedpartissuspendedfollowingconsultationbetweenQAandisremovedfromthesupplierfilebythepurchasingdepartment.Nomoreordersarenowpossible.Objectivecriteriafortheassessmentofsuppliersinclude- qualitydeficiency,- incorrectdeliveries,- deviationsindeadlines,- remindernotices,- differencesinquantities,- pricedifferences.Subjectivecriteriafortheassessmentinclude- communication,- reliability,- processingofcomplaints,- flexibility.QA-compliancetestsandqualityinspectionsbythesupplierThecontractstipulateswhetherfurtheractionsshouldbecarriedoutattheinstigationof,andundertheresponsibilityofCCsqualityassurance,aswellasthequalityassuranceofthecontractorinhiscompany.Thisconcernsessentially- qualitycontrolduringproductionor- acceptanceinspectionoftheproductsbyqualitycontrolrepresentativesfromourcompany.- Theorderalsorequests,whereapplicable,thetemplateofresultsforstipulatedinspections,suchas- initialsampletestreports,(basedonVDA2)- materialcertificatesinaccordancewithEN10204- inspectionprotocolsinaccordancewithinternalLN-standards,- otherinspectionprotocols.ReceivinginspectionforCCI:Receivinginspectionsareconductedusingapredeterminedmethodandwithregardtotestlevelandinspectionscopeareessentiallybasedon- thesignificanceofthepurchasepartforthequalityofourproducts- theperceiveddiligenceofthesupplier;- theresultsfrompreviousreceivinginspections,aswellas- inspectionsalreadycarriedoutbyourqualityassuranceatthesupplier'scompany.Asarule,thereceivinginspectioniscarriedoutasasamplinginspectionForotherapplicabledocumentation,seetheSharepointForexample:QSA206-1"Supplierselection,assessmentandsuspensionfordrawingbasedpurchaseparts(weldedstructure)"QSA206-3'Acquisitionprocessforpurchasepartsandinitialsampling"QSA241-2Selectionmatrixforunmachinedparts,Appendix1"QSA241-3"Selectionmatrixforunmachinedparts,Appendix1"7.5ProductionThecontrolofprocessesincludesthefollowingpointsasdescribed: Ensurethatallspecificationswhichdefinetheproductfeaturesareavailable Drawingupofworkinginstructions,wherevertheyarenecessaryorhelpful Drawingupoftestschedules,wherevertheyarenecessaryorrequired Determinationandapplicationofsuitableequipmentfortheproductionorprovisionofservices Maintenanceoftheequipment Availabilityandutilisationoftestequipment Monitoringofproductiontasks After-salesservicesinaccordancewiththedefinitionsinQSA207-3,Aftersalesservices"7.5.1 Workinginstructions,inspectionplanningforproductionandassembly(productionplanning)Workinginstructionsandinspectionplanningdefiningmethodsandproceduresareavailablefortherelevanttasksinproductionandassembly.Thesearedocumentedintheformofworkschedulesandinspectionplans.Furthermore,theworkschedulesspecifywhichassemblyandmanufacturingequipmentistobeusedforeachrespectiveoperationalprocedure,oratwhichworkstationthetaskshouldbecarriedout.Accompanyingchartsrespectivetomaterialsandmanufacturingaresuppliedthroughouttheproductionprocess.Theindividualproduction,operationandassemblystagescanbetracedinrelationtomachine/workstation,aswellaschronologically,andcanberetracedintheoperationaldatarecordingsystem.Processingoftheproductionordersisgenerallycarriedoutintheoperationaldatarecordingsystem.TheoperatorregistershimselfattheBDEterminalfortherespectiveproductionorder.Followingcompletionofthetask,thequantityisenteredandtherespectiveoperatingsequenceisrecordedascomplete.Forselectedproductionareas,theoperatorisissuedawageslipfeaturinga"Completionnotification"stubpriortocommencinghisshift.Conclusionoftheworkisindicatedbytheproductioncontrolviathe"Completionnotification"stub.Theoperatorentershisnameandhispersonalnumberontothewageslip.Ifinspectionsareprescribedinthedrawings,theseinspectionstagesaregenerallyintegratedintheinspectionplansorintheworkschedules.Settinginstructionsareprovidedviaitemslists(=itemslistposition.Aqualitycontrol(SPC)isundertakenduringproductionandassemblyusingthedefinedprocessandproductionfeatures.Thesearepreventative,supervisoryandcorrectivetaskstobecarriedoutinaccordancewithresultsofthequalityinspectionsand/orotherqualitydata.Thereisadifferencebetween- directqualitycontroland- indirectqualitycontrolDirectqualitycontrolDirectqualitycontrolisqualitycontrolduringthemanufactureorassemblyofapart,anassemblyoraproduct.Thisconcernscorrectivemeasurescarriedoutinaccordancewiththeresults,immediatelybeforethequalityinspectionsundertakenduringtheongoingprocess.Qualityinspectionsduringtheongoingprocessinclude- self-inspectionsbytheemployeecarryingouttheworkingstageand/or- samplinginspectionsbyqualityassurance.Theexecutionofdirectqualitycontrolisincumbentuponqualityassurancetogetherwiththeemployeefromtheproductiondepartmentcarryingouttherespectivetask.IndirectqualitycontrolThesearemeasureswhichrelatetopersonnel,procedures,equipmentandproductsfortheattainment,retentionorimprovementofthequalityefficiencynecessaryforthemanufactureofaproductbywayofcorrectivemeasuresandqualitypromotionmeasures.Examplesofthisinclude:- Maintenanceofmachines,equipmentetc.- Subsequentdevelopmentofmanufacturingprocedures- ProductmodificationsduetoproblemswithqualityThepersonsresponsiblefortherespectiveprocessesarealsoresponsibleforindirectqualitycontrol.AuthorisationofprocessesandequipmentAuthorisationofnewmanufacturingproceduresandequipmentNewmanufacturingproceduresandequipmentwhichhaveaconsiderableinfluenceonthequalityofourproductsrequi