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1、QUALITYMANAGEMENT-HANDBOOK5990256678000001111111112222222ProductRealisationTableofContents7.1 Productrealisationplanning7.2 Customer-relatedprocesses7.2.1 Determiningtherequirementsinrelationtotheproduct7.2.2 Evaluatingtherequirementsinrelationtotheproduct7.2.3 Communicationwiththecustomer7.3 Develo
2、pment7.4 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.
3、7.1 Implementationofproductsafetyfeatures7.7.2 Warninginformation7.7.3 Documentation7.7.4 Recallingproducts7.7.5 Rulingonrecalls7.7.6 Implementingrecalls7.7.7 Otherapplicabledocumentation7.8 Otherapplicableproceduralinstructions7.1 ProductrealisationplanningTheprocessmanagementhasadutytoarrangeallpr
4、ocessesrelatedtorealisationoftheproductwithinthecompany.Tothisend,itisimperativethatthefollowingpointsarenoted: Qualitytargetsandrequirementsfortheproduct Demandforimplementationofprocesses,creationofdocumentsandpreparationofresourceswhichrelatedirectlytotheproduct Essentialverification,validation,m
5、onitoringandinspectiontasks,aswellasproductacceptancecriteria Generationofessentialrecordsprovingthattheprocesses,andthereforetheproductssubsequentlyresulted,complywiththerequirements Considerationofenvironmentalprotectionandoperationalsafety,aswellashealth-relatedissues.Wecanconcludethen,thatthepla
6、nninganddefinitionofprocessesintheproceduralandworkinginstructions,suchasdocumentationrelatingtoorders,productsandprojectsshouldensurethatallundertakingsandresultswithinthecompanycorrespondwiththerequirementsofthecustomerandthetargetsofthecompany.Theseundertakingsinvolveinspectionswhichshoulddemonst
7、ratethatallundertakingsandresultscorrelatewiththeproductrequirements.Traceabilityrequiresthegenerationofrecordscoveringallundertakingsandresults.7.2 Customer-relatedprocesses7.2.1 DeterminingtherequirementsinrelationtotheproductAllcustomerrequirementsaredeterminedwithintheframeworkofmarketanalysisan
8、dmarketcultivation,aswellasdirectcustomersupportregardingtheprocessingofqueries,offersandorders(seeQSA207-1,Processingqueries,offersandorders*).Thefollowingpointsarethereforetobeconsidered: Requirementsstipulatedbythecustomerfortheproduct,includingspecificationsregardingdeliveryandservicesfollowingd
9、elivery Requirementswhichwerenotexplicitlystipulatedbythecustomer,however,areessentialforfulfilmentoftherespectivepurposeOtherrequirementsrelatedtotheproduct,includingadministrativeandstatutorystipulations(environmentalprotectionandoperationalsafety,aswellashealth-relatedissues.)7.2.2 Evaluatingther
10、equirementsinrelationtotheproductAthoroughevaluationofproductrequirementsisundertakenforallqueriesreceived(bothwrittenandoralqueries).Thisevaluationincludesanyrequirementswhichhavebeenspecifiedinadditiontothecustomerrequirementsandmustbecompletedbeforeanydeliveryobligationwiththecustomerhasbeenconcl
11、uded(e.g.submissionofabindingoffer,acceptanceofanorderorenteringintoacontract).Theevaluationmustensurethat: Productrequirementsareadequatelydetermined Anyinconsistenciesbetweentheorderorcontractandthepredeterminedstipulationsmustbeironedout(e.g.offerorcontract) Therequirementsdeterminedfortheproduct
12、canbefulfilled(ifnecessarybycarryingouttheevaluationwiththevariouspositionsinvolved,e.g.manufacturing,assembly,therespectivesuppliersetc.)Thisnecessitatesthefollowingmeasures: Offersareonlyauthorisedoncetheevaluationhasbeenconcluded. Allcustomerordersarecheckedtoensurethatthespecificationsstipulated
13、withincomplyonehundredpercentwiththespecificationsintheoffer.Ifnot,theproductrequirementsarere-evaluated(albeitbasedonlyonthedeviationsbetweenofferandcustomerorder). Ordersforwhichtherewasnoprecedingofferareevaluatedpriortoacceptance. Productrequirementsarealsoevaluatedintheeventofmodificationsbeing
14、madeintheorder.Modificationsmustbedocumentedandallpositionsinvolved(bothinternalandexternal)mustbenotifiedassoonaspossible.Therequisitemodificationsmustbecarriedoutinthedocuments.Theresultsoftheevaluation,andwherenecessarytherequisitemeasures,mustberecorded.Adherencetoroadtrafficlawrequirementsisals
15、oanessentialfactorinthecertificationrelatingtosubmissionofanofferoranorder,orsubmissionofanorderfortraceability.Ifneeded,theexistingpermitscanberevisedorupgraded,ornewonescanbeappliedfor.Forcommercialandtechnicalmodifications,completeorderconfirmationswithsequentialnumberingarecompiledanew.Processin
16、giscarriedoutinthesamewayasiftheywereneworders.Intheeventofpotentialbottlenecks,forexampleifacustomerrequiresashortdeliverytime,thiscanbediscussedintheweeklyconveningcoordinatingcommitteeandspecialmeasurescanbeimplementedasnecessary.Thecoordinatingcommitteeismadeupofrepresentativesfromdepartmentsfor
17、sales,purchasingAND;productionplanning.7.2.3 CommunicationwiththecustomerAllpositionswhichmaintaindirectcontactwiththecustomerareresponsibleforensuringaneffectivecollaborationwiththosecustomers.Thesalesdepartmentaretheprinciplecontactpartners.Salesandmarketingareresponsibleforprovidinginformationreg
18、ardingthemarket,aswellprovidingthecustomerwithinformationregardingproducts.Customercomplaintsandotherreportsregardingnon-complianceofrequirements(customerdissatisfaction)arehandledbythewarrantydepartment.Customerresponsestothefulfilmentofproductrequirements(customersatisfaction)arerecordedbythesales
19、,marketingandafter-salesservicesdepartmentsandevaluatedbythemarketingsection.7.3 DevelopmentNoneoftheproductsproducedbyCCIunderwentdevelopmentbyCCI.Furthermore,thedesignauthoritywillberetainedbytheindividualcompanies(LMTundLBC)inthefuture,thusCCIproductswillnotbedevelopedbyCCIthemselves.7.4 Purchasi
20、ngPurpose:Withthisdocumentedanddefinedprocess,wecanguaranteethatallexternally-manufacturedpartsandproductionpartsmeetthedesignatedrequirements(clear,completeandrevisedacquisitiondocumentation),andthatanacceptablesupplier,regardingqualityonthebasisofsupplierassessmentandsupplierevaluationisselectedpr
21、iortoawardingthecontract.Scopeofvalidity:Thisdescriptionappliesforallpurchasingproceduresintheacquisitionofexternally-manufacturedproductswhichare,oraretobecome,anintegralpartofourdeliveryscope.Procedure:Itistheresponsibilityofthepurchasingdepartmenttoensurethatalldocumentationnecessaryfortheacquisi
22、tionofexternally-manufacturedproductsismadeavailableandincludedinthepurchaseorder.Theheadofthepurchasingdepartmentisresponsibleforinspectionandapprovaloforders.Processdescription:AcquisitiondocumentationTheacquisitiondocumentationcomprisesof- theorderformwhichcontainsaclearanddistinctivedescriptiono
23、fthegoodsbeingpurchasedandwherevernecessary,technicaldocumentationsuchas- drawings- worksstandards,aswellasnationalandinternationalstandardsandguidelines- specifications- manufacturing,inspection,packagingandshipmentdirectives- suppliersspecifications- testplans/testprotocolsThetechnicaldocumentatio
24、nisgenerallycreatedorcompiledbythepositionresponsiblefordesign,beforebeingrevisedforentiretyandvalidityandintegratedinthepurchaseorderbythepurchasingdepartment.Thecontractor(supplier)mustcheckandapprovetheacquisitiondocumentationregardingappropriatenessoftheprescribedrequirements(orderconfirmation).
25、Selectingthecontractor/supplierOrdersareessentiallyonlygrantedtothosecontractorswhich- fulfilallprerequisitesoftheoperationalandorganisationalstructureforflawlessorderprocessing,- areinpossessionofthenecessarytechnicalequipmentandsystemsformanufactureandinspectionoftheproductsbeingpurchased,- areinp
26、ossessionoftherequisitecertification,whereverpartsandcomponentswhicharesubjecttogeneraltechnicalmonitoringarebeingmanufactured(e.g.,weldingsuitabilitycertificate).Thepurchasingdepartment,incollaborationwiththespecialistdepartmentsifnecessary,determinesthepotentialsuppliersbywayof- evaluationofsample
27、s,- practicalexperiencewithproductsofpreviousdeliveries,- othermeansoffamiliarisationwiththeproductsofthesupplier.AssessmentandapprovalofthesupplierIfanewsupplierbecomesinvolved,hewillprincipallybeassessed,bythepurchasingdepartmentincollaborationwithqualityassuranceandifnecessarywiththespecialistdep
28、artments,onthebasisofhisproductslendingqualitytoourproducts,andthenapprovedfortheproductbeingpurchasedonthestrengthofhisqualificationsandcapabilities.Assessmentandapprovalofthesupplierisresulted- withdrawing-basedweldedsteelstructuresinaccordancewithQSA206ff,-withstructuralsteelsforsteelconstruction
29、viaevaluationofthesubmittedmaterialcertificatesandtheirownrandomtesting.Onlymaterialsapprovedbytheconstructionauthoritiesareprocessed,- withcastpartsandforgespartsviaevaluationofinitialsampletestreportsandmaterialcertificates,aswellastheirowntesting,- withweldingfillermaterialsviaevaluationofcertifi
30、catesforapprovedandtestedmaterials,- withqualitysteelsviaevaluationofmaterialcertificatesandtheirowntesting,- withelectricalswitchgearunitsandmotorssampletestinginthetestfieldoraprototypetesting,ifthepartsareinstalledincomplexsystems,- forstandardpartsviatheinspectionofcertificatesandtheirowninspect
31、ionsastowhetherthestandardshavebeenadheredto.Anauthorisationisgrantediftheinspectionshavebeenassessedaspositive.ThesuppliersareincorporatedintheOrder-EDPSupplierfile,.Deficienciesinqualityarerecordedandthecorrespondingcontrolreportsgenerated.Forseriousorcontinuingqualityproblems,thesupplierofthereje
32、ctedpartissuspendedfollowingconsultationbetweenQAandisremovedfromthesupplierfilebythepurchasingdepartment.Nomoreordersarenowpossible.Objectivecriteriafortheassessmentofsuppliersinclude- qualitydeficiency,- incorrectdeliveries,- deviationsindeadlines,- remindernotices,- differencesinquantities,- pric
33、edifferences.Subjectivecriteriafortheassessmentinclude- communication,- reliability,- processingofcomplaints,- flexibility.QA-compliancetestsandqualityinspectionsbythesupplierThecontractstipulateswhetherfurtheractionsshouldbecarriedoutattheinstigationof,andundertheresponsibilityofCCsqualityassurance
34、,aswellasthequalityassuranceofthecontractorinhiscompany.Thisconcernsessentially- qualitycontrolduringproductionor- acceptanceinspectionoftheproductsbyqualitycontrolrepresentativesfromourcompany.- Theorderalsorequests,whereapplicable,thetemplateofresultsforstipulatedinspections,suchas- initialsamplet
35、estreports,(basedonVDA2)- materialcertificatesinaccordancewithEN10204- inspectionprotocolsinaccordancewithinternalLN-standards,- otherinspectionprotocols.ReceivinginspectionforCCI:Receivinginspectionsareconductedusingapredeterminedmethodandwithregardtotestlevelandinspectionscopeareessentiallybasedon
36、- thesignificanceofthepurchasepartforthequalityofourproducts- theperceiveddiligenceofthesupplier;- theresultsfrompreviousreceivinginspections,aswellas- inspectionsalreadycarriedoutbyourqualityassuranceatthesupplierscompany.Asarule,thereceivinginspectioniscarriedoutasasamplinginspectionForotherapplic
37、abledocumentation,seetheSharepointForexample:QSA206-1Supplierselection,assessmentandsuspensionfordrawingbasedpurchaseparts(weldedstructure)QSA206-3AcquisitionprocessforpurchasepartsandinitialsamplingQSA241-2Selectionmatrixforunmachinedparts,Appendix1QSA241-3Selectionmatrixforunmachinedparts,Appendix
38、17.5ProductionThecontrolofprocessesincludesthefollowingpointsasdescribed: Ensurethatallspecificationswhichdefinetheproductfeaturesareavailable Drawingupofworkinginstructions,wherevertheyarenecessaryorhelpful Drawingupoftestschedules,wherevertheyarenecessaryorrequired Determinationandapplicationofsui
39、tableequipmentfortheproductionorprovisionofservices Maintenanceoftheequipment Availabilityandutilisationoftestequipment Monitoringofproductiontasks After-salesservicesinaccordancewiththedefinitionsinQSA207-3,Aftersalesservices7.5.1 Workinginstructions,inspectionplanningforproductionandassembly(produ
40、ctionplanning)Workinginstructionsandinspectionplanningdefiningmethodsandproceduresareavailablefortherelevanttasksinproductionandassembly.Thesearedocumentedintheformofworkschedulesandinspectionplans.Furthermore,theworkschedulesspecifywhichassemblyandmanufacturingequipmentistobeusedforeachrespectiveop
41、erationalprocedure,oratwhichworkstationthetaskshouldbecarriedout.Accompanyingchartsrespectivetomaterialsandmanufacturingaresuppliedthroughouttheproductionprocess.Theindividualproduction,operationandassemblystagescanbetracedinrelationtomachine/workstation,aswellaschronologically,andcanberetracedinthe
42、operationaldatarecordingsystem.Processingoftheproductionordersisgenerallycarriedoutintheoperationaldatarecordingsystem.TheoperatorregistershimselfattheBDEterminalfortherespectiveproductionorder.Followingcompletionofthetask,thequantityisenteredandtherespectiveoperatingsequenceisrecordedascomplete.For
43、selectedproductionareas,theoperatorisissuedawageslipfeaturingaCompletionnotificationstubpriortocommencinghisshift.ConclusionoftheworkisindicatedbytheproductioncontrolviatheCompletionnotificationstub.Theoperatorentershisnameandhispersonalnumberontothewageslip.Ifinspectionsareprescribedinthedrawings,t
44、heseinspectionstagesaregenerallyintegratedintheinspectionplansorintheworkschedules.Settinginstructionsareprovidedviaitemslists(=itemslistposition.Aqualitycontrol(SPC)isundertakenduringproductionandassemblyusingthedefinedprocessandproductionfeatures.Thesearepreventative,supervisoryandcorrectivetaskst
45、obecarriedoutinaccordancewithresultsofthequalityinspectionsand/orotherqualitydata.Thereisadifferencebetween- directqualitycontroland- indirectqualitycontrolDirectqualitycontrolDirectqualitycontrolisqualitycontrolduringthemanufactureorassemblyofapart,anassemblyoraproduct.Thisconcernscorrectivemeasure
46、scarriedoutinaccordancewiththeresults,immediatelybeforethequalityinspectionsundertakenduringtheongoingprocess.Qualityinspectionsduringtheongoingprocessinclude- self-inspectionsbytheemployeecarryingouttheworkingstageand/or- samplinginspectionsbyqualityassurance.Theexecutionofdirectqualitycontrolisinc
47、umbentuponqualityassurancetogetherwiththeemployeefromtheproductiondepartmentcarryingouttherespectivetask.IndirectqualitycontrolThesearemeasureswhichrelatetopersonnel,procedures,equipmentandproductsfortheattainment,retentionorimprovementofthequalityefficiencynecessaryforthemanufactureofaproductbywayo
48、fcorrectivemeasuresandqualitypromotionmeasures.Examplesofthisinclude:- Maintenanceofmachines,equipmentetc.- Subsequentdevelopmentofmanufacturingprocedures- ProductmodificationsduetoproblemswithqualityThepersonsresponsiblefortherespectiveprocessesarealsoresponsibleforindirectqualitycontrol.AuthorisationofprocessesandequipmentAuthorisationofnewmanufacturingproceduresandequipmentNewmanufacturingproceduresandequipmentwhichhaveaconsiderableinfluenceonthequalityofourproductsrequi
