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

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1、QUALITYMANAGEMENTHANDBOOKQualitymanagementsystemTableofcontents4Qualitymanagementsystem24.1 Generalrequirements24.2 Documentationrequirements44.2.1 General44.2.2 Controlofdocuments44.2.3 Controlofqualityrecords74Qualitymanagementsystem4.1 GeneralrequirementsObjectiveThequalitymanagementsystemofCCIis

2、orientedaroundthefollowingprinciplesandrequirements:- StandardDINENISO-9001:2008Qualitymanagementsystems-Requirements*- (legal)guidelines- Product-relatedrequirementsfromcustomersPurposeofthequalitymanagementsystemOurqualitymanagementsystemisbasedonthefundamentalideaofpersonalresponsibilityofallCCI-

3、employees.Ifappliedcorrectly,itwillguaranteeasystematicinclusionoftheQuality*aspectinallphasesofproductdevelopmentandintheutilisationphase.Wethereforeensurethat- allfutureandexistingcustomershaveconfidenceinourqualitycapability,- arecustomersaresatisfiedwithourservices,- ourqualityorganisationiscond

4、uctedinaccordancewitheconomiccriteria.QualitypolicyDerivedfromthequalitypolicy,thefollowingqualityprinciplesapply:- Qualityisachievedattheworkplaceandisnottheresultofafinalinspection.- Everyemployeehasapersonalresponsibility.- Weconsiderthisqualitymanagementhandbookasatextbookfortheattainmentofourqu

5、alitytargets.ResponsibilitiesResponsibilityforqualitylieswiththecompanymanagement.Thequalityassurancedepartmentco-ordinatesandensuresthatallqualityassurancemeasuresareadheredto.Theymaintainandcontinuouslyoptimisethequalitymanagementsystem,andareauthorisedtorigourouslyenforceanyQAproceduralinstructio

6、nsrelevanttopositionswithinthecompanyandwhichinfluencethequalityofourproductsandservices.ScopeofthequalitymanagementsystemThequalitymanagementsystemencompassesallphasesoforganisationalstructuresandworkflowsforproductdevelopment.Thefollowingaretherebytakenintoconsideration:- QSinthemarketingphase- QS

7、inthequeryandofferphase- QSintheprocurementphase- QSintheproductionplanningandmanufacturingphase- QSintheassemblyphase- QSinthestart-upphase- QSintheutilisationphase(after-salesservices)ThequalitymanagementsystemisbindingforallpositionsandemployeesinvolvedwithproductproductionwithinCCI.4.24.2.1Docum

8、entationrequirementsGeneralStructureoftheQAdocumentsQAdocumentsarearrangedinaccordancewiththefollowingstructure,whereverappropriate:Section:Content:ObjectiveWhatistheobjectiveofthisdocument?ScopeofvalidityForwhichtasksand/orpositionsand/orproductsdoesthedocumentapply?QuotedstandardsTermsDefinitionof

9、thetermsusedinthesectionsProcedureBriefdescriptionoftasksandproceduresProceduraldescriptionRepresentationofprocedureintheformofaproceduretaskdiagramOtherapplicabledocumentationInformationregardingQAinstructionsandLN-worksstandards4.2.2ControlofdocumentsObjectiveWiththesedefinedtasksandresponsibiliti

10、esforthecompilation,verification,authorisation,distribution,recall,modificationandarchivingofquality-relateddocuments,wecanguaranteethatthecorrecteditionofdocumentisprovidedtoallthosepositionsinwhichtasksessentialforqualityassuranceareperformed,andthatobsoletedocumentscanbewithdrawnimmediatelyfromal

11、lpositions.ScopeofvalidityTheprocedureformonitoringofdocumentsappliesforalldocumentswhichareessentialforeffectivefunctioningofqualityassurance.DefinitionoftermsDocumentsfeaturedwithinthishandbookapplyasquality-relateddocumentationwhichservestoguaranteeallrequiredattributes.ProcedureStructureofdocume

12、ntation:QM-handbookQualityassurance-proceduralinstructions(QSA)SeeQSA000LN-worksstandardsseeLN1InstructionsforinspectionandoperationInspectioncharts:Inspectionchartsareindividualormodularinspectioninstructionsforwhichagoodsreceivedinspection,manufacturinginspectionandfinalinspectioniscarriedout.Draw

13、ingsThedrawingscompriseallspecifications,suchasdimensions,tolerances,surfacespecificationsandinformationregardinginspectionandmanufacturingguidelinesnecessaryforproductionorprocurementandinspectionofaproduct.Thedrawingsarecreatedcomputer-aidedwithCAD.ItemslistsItemslistsareavailableforallinhouse-man

14、ufacturedpartsandforpurchaseparts.Theycomprisealistofallparts,materialsandassembliesrequiredforproductionofapartoranassembly.Anitemcodeisprovidedforeverypartandeveryassembly.Operationalprocedures,wageslips,materialdispatchcardsAlloperationalproceduresnecessaryforthemanufactureofapartoranassemblyared

15、escribedindetailintheworkschedules.Thefollowingisspecifiedindependentlyofapplicationofthesoftwaresystem- Partialoperationalstages- Responsiblecostcentres- Necessaryproductionequipment(workstation,machine,appliance,- Targettimeswherevernecessary,informationregardingguidelines(e.g.manufacturingandinsp

16、ectionguidelines)Workschedulesarecreatedormodifiedbyproductionplanning.OperatinginstructionsOperatinginstructionscompriseallinformationregardingerection(assembly),dismantling(disassembly),operation(notesonoperationandsafety,aswellaswarninginformation,repairandmaintenance).Theyalsoincludeelectricalci

17、rcuitdiagramsandspare-partslists.ThebasicsafetyrequirementsoftheEC-MachineDirectivearetakenfreelyintoconsideration.Technicalinformation(Tl)Technicalinformationiscompiledif- particularpotentialhazardsnotincludedintheoperatinginstructionsaretobereferredto.- Supplementsoramendmentsaretobeincludedorrepl

18、acedintheoperatinginstructionsoftheoperatinginstructionshandbook.- Safetyrequirementsaretobe,orhavebeenchanged,whichwillrequisiteconversionoftheproductetc.Inspecialcases,theTsalsoincludeallofourproductusers.MaterialcertificateMaterialcertificatesforprofilesandsemifinishedproductsareverifiedandfiledb

19、ythequalityassurancedepartment.OrdersOrderscompriseacompletedescriptionofproperties,procurementstatusesandrequirementsoftheorderedgoods.Customerorders(orderconfirmations)Ordersfromcustomersarecheckedforentiretyinthesalesdepartmentandareconvertedintoorderconfirmationsandimplementationlists.PricelistP

20、ricelists,togetherwithdimensionsheets,provideacompositionofaproduct(modulardesignsystem).ResponsibilitiesImportantdocumentsandresponsibilities-compilation,verificationandauthorisation,issueandexchange,filing-arelistedbelow:DocumentCompilationormodificationResponsibilitiesInspectionandcertificationIs

21、sueorreplacementSDurationYearsmin.torageLocationQAhandbookQAQSL5GFQA13QAorEDPQA-proceduralinstructionsQSASpecialistdepartmentswithQAHeadofdepartmentGFQA13QAorEDPInspectionandoperationalinstructionsAllResponsibledivisionalmanagerQA13QAWorkschedulesAVAVViaEDP-一Technicalinformation(Tl)TBGFtechnology,GF

22、salesSalespromotion30ArchiveTB-secretaryMaterialcertificateSupplierQA13QAOrdersEKEKViaEDP13EDPOrders,orderconfirmationsVKVKLVK13EDPPricelistsVKGFsalesVK13EDP4.2.3ControlofqualityrecordsObjectiveTheserecordsserveasproofthatallrequirementshavebeenfulfilledandthattheQMsystemisfunctioningeffectively.Sco

23、peofvalidityThisextendstoallcompanydivisionsandisappliedinrelationtoproducts,qualitymanagementsystem,suppliersandcustomers.DescriptionThefollowingtablegivesasummaryofthequalityrecordswhichnecessitatemonitoring.Thedesignatedtimescale,theidentificationandthefilinglocationarealsolisted.Records,reportsv

24、iaFilesystemStoragYearsmin.eLocationQM-systemevaluationsbythemanagementDate13GFAuditreportsM-ReviewDate13GFandQACustomersatisfactionresultsDate13VKProductmeetingprotocolDate13VKInspectionuponreceiptItemcode13QAIntermediateinspectionsItemcode13QAFinalinspectionItemcodeorworksnumber13QACranetestbookWo

25、rksno.withoutrestrictionCranerecordCrane:TypeapprovaltestCranetypewithoutrestrictionArchiveTB-KTMicroprocessorsystems(DINEN45501)TypewithoutrestrictionArchiveTB-STCustomerclaimsandwarrantystatisticWorksno.EDP-supported13CranerecordProofofrepairWorksno.13CranerecordFindingsreportDate13QAProofoftrainingPersonnelno.13PAProofoftrainingPersonnelno.13PAComponenttests(e.g.MPAStuttgart)Date13ArchiveTB-KTAuthorisedsuppliersEDP,non-authorisedsuppliersaredeletedfromtheEDPsystem