形态控制-批量生产

1ConfigurationManagement2OverviewofCMRequirement&DefinitionIntroductiontoCMmainframeCMPlanningCI,CC,CSA&CABusinessopportunity3LearningObjectivesAftercompletingthisstudy,youshouldbeableto:DefineConfigurationManagementDefineCMProcessExplainCI,CC,CSA,&CAExplainthestructureofCMDescribeproceduresforCI,CC,CSA&CA4RequirementsISO-9001:2008Clause7.5.3:IdentificationandTraceabilityNote:Insomeindustrysectors,configurationmanagementisameansbywhichidentificationandtraceabilityaremaintained5RequirementsTL-9000,7.1.HS.1:ConfigurationManagementPlan:ThesuppliershallestablishandmaintainaCMPwhichinclude:a)IDandscopeofCMactivities;b)Scheduleforperformingtheseactivitiesc)CMtools6Requirements•d)CMmethodsanddocumentedprocedure(s);•e)Organizationsandresponsibilitiesassignedtothem;•f)Levelofrequiredcontrolforeachconfigurationitem;and•g)Pointsatwhichitemsarebroughtunderconfigurationmanagement7DefinitionConfiguration:Interrelatedfunctionalandphysicalcharacteristicsofaproductasdefinedintechnicaldocuments(productconfigurationinformation)Configurationbaseline:Configurationofaproduct,formallyestablishedataspecificpointintime,whichservesasreferenceforfurtheractivities(establishedwhenevernecessary)8Configurationboard(CB):Groupoftechnicalandadministrativeexpertswithassignedauthorityandresponsibilitytomakedecisionsontheconfigurationanditsmanagement,alsoknownasCCB.Configurationcontrol:Activitiescomprisingthecontrolofchangestoaconfigurationitemafterformalestablishmentofitsconfigurationdocuments9Configurationidentification(CI):EntitywithinaconfigurationthatsatisfiedanendusefunctionProductconfigurationinformation:Requirementsforproductdesign,realization,verification,operationandsupport(comprisesbothproductdefinition&productoperationalinformation)10Configurationstatusaccounting(CSA):Formalizedrecordingandreportingoftheestablishedconfigurationdocuments,thestatusofproposedchangesandthestatusoftheimplementationofapprovedchangesConfigurationitem(CI):Aggregationofhardware,software,processedmaterials,services,oranyitsdiscreteportions,thatisdesignedforconfigurationmanagementandtreatedasasingleentityintheCMprocess11ObjectivesTodocumentandprovidefullvisibilityoftheproduct’spresentconfigurationandonthestatusofachievementofitsphysicalandfunctionalrequirements.Anotherobjectiveisthateveryoneworkingontheprojectatanytimeinitslifecycleusescorrectandaccuratedocumentation12CMProcessConfigurationidentificationChangecontrolConfigurationstatusaccountingConfigurationauditing13OrganizationofCMCMshouldbeorganizedwithdefinedresponsibilitiesandsufficientindependenceandauthoritytoachievetherequiredCMobjectives14ConfigurationboardIthasthecorrectauthorityinrelationtotherelevantconfigurationbaselines15CMplansandprocedureCMP:documented,approved,controlled,procedure,definedR&A,conveyedtosuppliersFocusoncustomerrequirementsfortheproducts,CMprocessbedetailedinaCMplanCMplanmaybeastand-alonedocument,orapartofanotherdocument,orcomposedofseveraldocuments16ConfigurationIdentificationAfamilytreeofproductstructureandselectionofconfigurationitemsDocumentationofconfigurationitemsProductconfigurationinformationEstablishmentofconfigurationbaselines17SelectionofCiRegulatory&statutoryrequirementsNewormodifiedtechnology,designordevelopmentCriticalityintermsofhighrisks,safetyInterfaceswithotherconfigurationitemsSupportandservice18SelectionofCiProcurementconditionsLogisticsandmaintenanceaspectsCIsshouldbeinitiatedasearlyaspossibleintheproductlifecycle19DocumentationofCiAllphysicalandfunctionalcharacteristicsnecessarytodefineaCIthroughoutitslifecycleshouldbedocumentedIncludespecs,designdocuments,list,softwaredata,manualCIdependsonthelevelofcontrolneeds20ConfigurationbaselinesConsistsofallapproveddocumentsthatpresentthedefinitionoftheproductataspecificpointBeestablishedwheneveritisnecessarytodefineareferenceconfigurationduringtheproductlifecyclewhichservesasastartingpointforfurtheractivities21ChangecontrolDocumentandjustifythechangesEvaluateconsequencesofthechangeApproveordisapprovethechangeImplementandverifythechangeProcessdeviationsandwaivers22ChangecontrolprocedureAllchangeproposalsshouldbedocumented:*Config.items&relateddocumentstobechanged,name(s)&revisionstatus*Nameoftheindividualpreparingtheproposal,theorganizationanddateprepared*Reason&descriptionforthechange*Urgency23EvaluationofchangeThetechnicalmeritsoftheproposedchangeTheimpactoninterchangeability,interfaces,andthenecessityforre-identificationTheimpactonregulatory,risk,contract,schedule,cost,manufacturing,test,inspectionmethod,purchases,stocks,maintenance,userhandbooks,spareparts,spare-partmanuals,deliveryandcustomersupportrequirements.24DispositioningAuthorityPriortoapprovalofachange,shouldverify:ThechangeisnecessaryTheconsequencesareacceptableThechangehasbeenproperlydocumentedandclassifiedTheplanfortheimplementationofthechangeintodocuments,HW/SWissatisfactoryAlsobecalledaCCB25ApprovalofchangeTheR&AshouldbedefinedTheauthorityforapproval/disapprovalmayvarydependingonthesig