质量管理手册 4 QUALITY MANAGEMENT HANDBOOK_Quality management system.docx

QUALITYMANAGEMENTHANDBOOKQualitymanagementsystemTableofcontents4Qualitymanagementsystem24.1 Generalrequirements24.2 Documentationrequirements44.2.1 General44.2.2 Controlofdocuments44.2.3 Controlofqualityrecords74Qualitymanagementsystem4.1 GeneralrequirementsObjectiveThequalitymanagementsystemofCCIisorientedaroundthefollowingprinciplesandrequirements:- StandardDINENISO-9001:2008"Qualitymanagementsystems-Requirements*- (legal)guidelines- Product-relatedrequirementsfromcustomersPurposeofthequalitymanagementsystemOurqualitymanagementsystemisbasedonthefundamentalideaofpersonalresponsibilityofallCCI-employees.Ifappliedcorrectly,itwillguaranteeasystematicinclusionofthe"Quality*aspectinallphasesofproductdevelopmentandintheutilisationphase.Wethereforeensurethat- allfutureandexistingcustomershaveconfidenceinourqualitycapability,- arecustomersaresatisfiedwithourservices,- ourqualityorganisationisconductedinaccordancewitheconomiccriteria.QualitypolicyDerivedfromthequalitypolicy,thefollowingqualityprinciplesapply:- Qualityisachievedattheworkplaceandisnottheresultofafinalinspection.- Everyemployeehasapersonalresponsibility.- Weconsiderthisqualitymanagementhandbookasatextbookfortheattainmentofourqualitytargets.ResponsibilitiesResponsibilityforqualitylieswiththecompanymanagement.Thequalityassurancedepartmentco-ordinatesandensuresthatallqualityassurancemeasuresareadheredto.Theymaintainandcontinuouslyoptimisethequalitymanagementsystem,andareauthorisedtorigourouslyenforceanyQAproceduralinstructionsrelevanttopositionswithinthecompanyandwhichinfluencethequalityofourproductsandservices.ScopeofthequalitymanagementsystemThequalitymanagementsystemencompassesallphasesoforganisationalstructuresandworkflowsforproductdevelopment.Thefollowingaretherebytakenintoconsideration:- QSinthemarketingphase- QSinthequeryandofferphase- QSintheprocurementphase- QSintheproductionplanningandmanufacturingphase- QSintheassemblyphase- QSinthestart-upphase- QSintheutilisationphase(after-salesservices)ThequalitymanagementsystemisbindingforallpositionsandemployeesinvolvedwithproductproductionwithinCCI.4.24.2.1DocumentationrequirementsGeneralStructureoftheQAdocumentsQAdocumentsarearrangedinaccordancewiththefollowingstructure,whereverappropriate:Section:Content:ObjectiveWhatistheobjectiveofthisdocument?ScopeofvalidityForwhichtasksand/orpositionsand/orproductsdoesthedocumentapply?QuotedstandardsTermsDefinitionofthetermsusedinthesectionsProcedureBriefdescriptionoftasksandproceduresProceduraldescriptionRepresentationofprocedureintheformofaproceduretaskdiagramOtherapplicabledocumentationInformationregardingQAinstructionsandLN-worksstandards4.2.2ControlofdocumentsObjectiveWiththesedefinedtasksandresponsibilitiesforthecompilation,verification,authorisation,distribution,recall,modificationandarchivingofquality-relateddocuments,wecanguaranteethatthecorrecteditionofdocumentisprovidedtoallthosepositionsinwhichtasksessentialforqualityassuranceareperformed,andthatobsoletedocumentscanbewithdrawnimmediatelyfromallpositions.ScopeofvalidityTheprocedureformonitoringofdocumentsappliesforalldocumentswhichareessentialforeffectivefunctioningofqualityassurance.DefinitionoftermsDocumentsfeaturedwithinthishandbookapplyasquality-relateddocumentationwhichservestoguaranteeallrequiredattributes.ProcedureStructureofdocumentation:QM-handbookQualityassurance-proceduralinstructions(QSA)SeeQSA000LN-worksstandardsseeLN1InstructionsforinspectionandoperationInspectioncharts:Inspectionchartsareindividualormodularinspectioninstructionsforwhichagoodsreceivedinspection,manufacturinginspectionandfinalinspectioniscarriedout.DrawingsThedrawingscompriseallspecifications,suchasdimensions,tolerances,surfacespecificationsandinformationregardinginspectionandmanufacturingguidelinesnecessaryforproductionorprocurementandinspectionofaproduct.Thedrawingsarecreatedcomputer-aidedwithCAD.ItemslistsItemslistsareavailableforallinhouse-manufacturedpartsandforpurchaseparts.Theycomprisealistofallparts,materialsandassembliesrequiredforproductionofapartoranassembly.Anitemcodeisprovidedforeverypartandeveryassembly.Operationalprocedures,wageslips,materialdispatchcardsAlloperationalproceduresnecessaryforthemanufactureofapartoranassemblyaredescribedindetailintheworkschedules.Thefollowingisspecifiedindependentlyofapplicationofthesoftwaresystem- Partialoperationalstages- Responsiblecostcentres- Necessaryproductionequipment(workstation,machine,appliance,- Targettimeswherevernecessary,informationregardingguidelines(e.g.manufacturingandinspectionguidelines)Workschedulesarecreatedormodifiedbyproductionplanning.OperatinginstructionsOperatinginstructionscompriseallinformationregardingerection(assembly),dismantling(disassembly),operation(notesonoperationandsafety,aswellaswarninginformation,repairandmaintenance).Theyalsoincludeelectricalcircuitdiagramsandspare-partslists.ThebasicsafetyrequirementsoftheEC-MachineDirectivearetakenfreelyintoconsideration.Technicalinformation(Tl)Technicalinformationiscompiledif- particularpotentialhazardsnotincludedintheoperatinginstructionsaretobereferredto.- Supplementsoramendmentsaretobeincludedorreplacedintheoperatinginstructionsoftheoperatinginstructionshandbook.- Safetyrequirementsaretobe,orhavebeenchanged,whichwillrequisiteconversionoftheproductetc.Inspecialcases,theTsalsoincludeallofourproductusers.MaterialcertificateMaterialcertificatesforprofilesandsemifinishedproductsareverifiedandfiledbythequalityassurancedepartment.OrdersOrderscompriseacompletedescriptionofproperties,procurementstatusesandrequirementsoftheorderedgoods.Customerorders(orderconfirmations)Ordersfromcustomersarecheckedforentiretyinthesalesdepartmentandareconvertedintoorderconfirmationsandimplementationlists.PricelistPricelists,togetherwithdimensionsheets,provideacompositionofaproduct(modulardesignsystem).ResponsibilitiesImportantdocumentsandresponsibilities-compilation,verificationandauthorisation,issueandexchange,filing-arelistedbelow:DocumentCompilationormodificationResponsibilitiesInspectionandcertificationIssueorreplacementSDurationYearsmin.torageLocationQAhandbookQAQSL5GFQA13QAorEDPQA-proceduralinstructionsQSASpecialistdepartmentswithQAHeadofdepartmentGFQA13QAorEDPInspectionandoperationalinstructionsAllResponsibledivisionalmanagerQA13QAWorkschedulesAVAVViaEDP-一Technicalinformation(Tl)TBGFtechnology,GFsalesSalespromotion30ArchiveTB-secretaryMaterialcertificateSupplierQA13QAOrdersEKEKViaEDP13EDPOrders,orderconfirmationsVKVKLVK13EDPPricelistsVKGFsalesVK13EDP4.2.3ControlofqualityrecordsObjectiveTheserecordsserveasproofthatallrequirementshavebeenfulfilledandthattheQMsystemisfunctioningeffectively.ScopeofvalidityThisextendstoallcompanydivisionsandisappliedinrelationtoproducts,qualitymanagementsystem,suppliersandcustomers.DescriptionThefollowingtablegivesasummaryofthequalityrecordswhichnecessitatemonitoring.Thedesignatedtimescale,theidentificationandthefilinglocationarealsolisted.Records,reportsviaFilesystemStoragYearsmin.eLocationQM-systemevaluationsbythemanagementDate13GFAuditreportsM-ReviewDate13GFandQACustomersatisfactionresultsDate13VKProductmeetingprotocolDate13VKInspectionuponreceiptItemcode13QAIntermediateinspectionsItemcode13QAFinalinspectionItemcodeorworksnumber13QACranetestbookWorksno.withoutrestrictionCranerecordCrane:TypeapprovaltestCranetypewithoutrestrictionArchiveTB-KTMicroprocessorsystems(DINEN45501)TypewithoutrestrictionArchiveTB-STCustomerclaimsandwarrantystatisticWorksno.EDP-supported13CranerecordProofofrepairWorksno.13CranerecordFindingsreportDate13QAProofoftrainingPersonnelno.13PAProofoftrainingPersonnelno.13PAComponenttests(e.g.MPAStuttgart)Date13ArchiveTB-KTAuthorisedsuppliersEDP,non-authorisedsuppliersaredeletedfromtheEDPsystem