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MouldqualificationtrainingincludinglearningfromEnergyproject
By:RachainTa-ieng
WorakanyaVisitsartPackagingDevelopment-RTCSkinSEAContent:I.BasicinMouldqualification(MQ)processII.StatisticalcontroluseinMQIII.EnergyMouldqualification:Sharelearning100ml/120mlcapandbottle50mlcapandbottleQ&AExpectationToprovideunderstandingofhow
important“MouldQualification”isTobeabletoconduct
MouldQualificationproperlyandunderstandthestatistictoolusedinMouldQualificationTounderstandhowtoanalyzetheoutcomefromthesoftwareTosharethelearningfromEnergyprojectBasicinMouldqualification
(MQ)process
ExecuteProtocols(StepI,StepIIandStepII)Collect/InterpretDataPrepareSummaryReportsReview/ApproveReportsTestingChangeandChangeControlOngoingReviewOperations/MaintenanceThreePhasesoftheQualificationLifeCycleDefineProcess/EquipmentDevelopProcedures/SpecificationsWriteProtocols(StepI,StepIIandStepII)gnDefinition/DesignI.MouldQualification(MQ)WhatisMouldQualificationAseriesofactivitiestodeterminewithahighdegreeofstatisticalconfidencethataprocesscanconsistentlyproduceconformingplasticpackage(bottle,jar,cap,etc.)Keyfactorseffectingmouldingqualityare;MouldOperators(People)Machine(IncludingProcess)andMeasurementObjectivesof
MouldQualificationNot
toacceptorrejectanyspecificlots.BUTToconfirmthatthemouldandmachinebeingqualifiedcanprovidetherequiredoutput.Toconfirmthecapabilityofcontrolthemouldingprocess.Then,toconfirmthattheprocessconditionisrepeatableinthelatershift.Alltheanalysesandconfirmationsconductedinmouldqualificationaredonewithstatisticmethod.MouldQualificationProgramPASDocumentPASDocumentPASDocumentDimension/Parameters/Attributes/FunctionsAllAllAllCavities16hours8hours1hrDuration17175#ofSubgroup1piecepercavityeveryhour1piecepercavityeveryhalfhour1piecepercavityevery15minutesSampleSizepercavity(Subgroup)STEP3ProductionQualificationSTEP2ProcessQualificationSTEP1FirstArticleRoles&Responsibilitiesin
MouldQualificationRTC-Skin,DevelopmentPreparethePAS(PackagingActionStandard)Prepare
QualificationProtocol&SamplingplanProvideprotocoltrainingandqualificationtrainingtoinvolvingpeopleEvaluateresultsandsamplesStatisticallyanalyzethefinalresultsProvideimprovementsuggestionsAdjustspecificationtoenablemouldingprocesstobemorecapabilitystableRedothequalificationifnecessaryConcludethe
QualificationresultRoles&Responsibilitiesin
MouldQualificationMouldingSupplierSupportinformationtoprepareQualificationProtocolPre-testmouldbeforestartingFirstArticlestep.Preparesufficientresin,masterbatchandotheradditivesforthequalificationprocessMixand/ordryingredientstobereadyforthequalificationstepSetupmould&machineandpre-warmthesystemtobereadyformouldqualificationRoles&Responsibilitiesin
MouldQualificationMouldingSupplier(Cont’)ProcessmouldinallmouldqualificationstepswithRTC-skinTeam.PreparesamplesfromallstepsInspectthesampleswithRTC-skinagreedtestmethodsInputinformationintotheanalysis
software
forstatisticalanalysisFirstlyanalyzeandprepare
qualificationreportfor
RTC-skin.forfinalconclusionandapproval.Thisshouldonlybedoneoncethesupplierhasexperience&knowledgeofthesoftware&process.ImportantFactorsin
MouldQualification:MouldMouldmustbecheckedandformallyconfirmedthatitiscorrectaccordingtothemoulddrawingImportantFactorsin
MouldQualification:
OperatorsOperatorsincludeallpeoplewhorunthemouldingprocess,pullandinspectthesamples.Alloperatorsmustbeproperlytrainedinthequalificationprocedure,mouldingprocess,&testingprocedures(accordingtotheirresponsibilities),andhavethetrainingrecord.Processingoperatorsshouldbethesamepersonsthroughthequalificationprocesstomaintainconsistency.Sampleinspectors,too,shouldbethesamepersonsthroughthequalificationprocesstomaintainconsistency.ImportantFactorsin
MouldQualification:MachineMachinesincludethemouldingmachineitself,otherequipmentandequipmentsetup.Allthemachineandequipmentconditionsmustbestable(insteadystate)beforestartingmouldqualification.Duringthequalification,theremustbenoprocesschanges.Ifanychangeismade,thequalificationmustberestarted.ImportantFactorsin
MouldQualification:MeasurementSamplecavity,pullingtime,andsubgroupnumbermustbemarkedoneachsample.Samplesmustbekeptatleast1hour,toallowthemtocooldown,beforeanymeasuring.Allsamplesmustbekeptuntilthequalificationiscompletedandapproved.Samemeasurementtoolandmethodologymustbeusedforeverysample.MouldQualificationStepI
FirstArticleSamplespercavity:1sample/every15minutesNumberof
Subgroups:
5SubgroupsRunningduration:
60min.(after
mouldreaches
steadystate)Checkingcavity:All
CavitiesInspectingtopics:ProcessparametersDimensionsasperDrawingandPASAttributesasperPASFunctionaltestasperPASMouldQualificationStepII&IIISamplespercavities:1sample/eachpullingtimeNumberofsubgroups:
17SubgroupsRunningduration(after
mouldreaches
steadystate):
8hrsforProcessQualification(StepII)and
2consecutiveshiftsforProductionQualification(StepIII).Checkingcavity:All
CavitiesInspectingtopics:ProcessparametersDimensionsasperDrawingandPASAttributesasperPASFunctionalityasperPASProcessqualificationandproductionqualificationareputheretogetherbecauseallanalysesaresimilar.Onlythesteptimeframesaredifferent(8hrsforprocessqualificationand2consecutiveshiftsforproductionqualification).StatisticalcontroluseinMQ
Definitions:II.StatisticalcontroluseinMouldQualificationAverage(Avg)orX-bar:(ΣnXn/n)whileXnisnthdataandnisnumberofdata.[eg.(1+2+3+4)/4=2.5]Average:calculatedfromalldataMaximum(Max)andMinimum(Min):Likeaverage,theMaxandMinforeachcavitywillbeconsideredforstatisticpurpose.[eg.fromabovesample,max=4andmin=1]Range,R-bar(?):RangeisthedifferencebetweenmaximumandminimumvalueandR-barisaverageofallranges.[eg.fromabovesample,range=4-1=3]SpecificationLimit:Themaximumandminimumnumbersthataresetastheacceptablevalues,shouldbeidentifiedbasedoncustomerrequirements.LowerSpecificationLimit(LSL)UpperSpecificationLimit(USL)ControlLimit:Thisiscalculatedbasedonthespecificationlimits.Controllimitrangeisnormallysmallerthatthespecificationlimitrange.LowerControlLimit(LCL,X-bar+2.66R-bar)UpperControlLimit(UCL,X-bar-2.66R-bar)Definition(Cont’)Histogram:Apictureofthedistributionofdata.Toanalyzetheprocesscapabilityrequiredinmouldqualification,histogrammustbeanormaldistribution.(Moredetailwillbeprovidedlater.)NormalDistribution:PleaseseethenextpagesDefinition(Cont’)NormalDistributionWhichoneofthefollowingshowsnormaldistribution?NormalDistributionWhy?NormalDistributionMoreonNormalDistributionWhichnormaldistributionispreferred?MoreonNormalDistributionThisiswhatwewant!ProcessCapability[Cpk(acceptedat>1.33)]:Thisisanindextomeasurehowwellaprocesscanachievethetarget.ThehighertheCpk,themorenumbersofoutputclosetotargetandtheclosertheoutputistotarget.Definition(Cont’)StatisticalSoftware:Mouldingsupplier(IMCO,REXplast)usingtheSQCPack2000foranalyzethedata.NB:Mouldingsuppliershouldhavethestatisticalsoftwarethentheycanprepareandanalyzethedataforus.AnalysisfromSoftwareOutputHistogramisthefirstgraphtocheckbecauseifthisisnotanormaldistribution,theassumptiontocalculateprocesscapabilityisnottrue!CanyoustillrememberWhatanormaldistributionlookslike?Upperspecificationlimitandlowerspecificationlimit.AnalysisofBrimfulvolumeof120ml.Bottle:CpkanalysisHistrogramMouldQualificationrecordsheetofEnergyBottle120ml.MouldQualificationResult:MouldQualificationrecordsheetofEnergyCap100/120ml.MouldQualificationResult:MouldQualificationReportofEnergyBottle120ml.MouldQualificationReport:MouldQualificationReportofEnergyCap100/120ml.ConclusionHow
important“MouldQualification”is;Mouldwouldprovidethepkg.thatisclosetoourtargetThemouldandmouldingprocessarerepeatableandreproduciblePotentialproblemsinmouldandmouldingprocesscanbeidentifiedandsolvedHowtoconduct
MouldQualificationappropriatelyandunderstandthestatistictoolsusedinMouldQualificationHowtoanalyzetheoutcomefromthesoftwareEnergyMouldqualification
:Sharelearning
-100ml/120ml
capandbottle
-50mlcapandbottle
EnergyMouldqualification
:Sharelearning
-100mlcapandbottle
EnergyMouldqualification:Sharelearning
120mlBottle+cap1.LowCapretention/Capcomeoutafterdroptest.(Pilotmould)2.LidOpeningforceislowerthanspecification.(Pilotmould)3.TheplugsealODoncapcavity#8wasoutoffthespecification.(Productionmould16cavity)Caused:Thedesignofbottleneckpartandcap1.LowCapretention/Capcomeoutafterdroptest.(Pilotmould)ActiononBottlepart:ChangedtheneckprofileandincreasetheTdimensionOriginalModifiedChangedtheTdimensionfrom17.65tobe17.95mm.ActiononCappart:Changedcapdesignfrom1ribsupporttobe3ribssupporttripleribsOriginalModifiedSingleribActiononCappart:Increasethesnapbead0.1mmpersideCapsnapbeadOriginalModified2.LidOpeningforceislowerthanspecification.(Pilotmould) Caused:ThesealbeadisnotbigenoughActiononCappart:Increasedthesealbeaddiameter0.025mmperside3.TheplugsealODoncapcavity#8wasoutoffthespecification.(Productionmould16cavity)ActiononCapMould:Checkedthecoresleeveforallcapcavitiesandfoundthatonlythe#8isoverthespecificationthenIMCOhassentthepartbacktomouldmakerforcorrectthedimension.PhotoofCoreSleeveofcapcavity#8EnergyMouldqualification
:Sharelearning
-50mlcapandbottle
EnergyMouldqualification:Sharelearning
50mlBottle+cap1.NoClicksound&LowCapretention(Pilotmould)2.Leakage(Productionmould)3.Others -Slider -HairLineCrack -Hotrunner/Coldrunnermold
Caused1:Ufedidmodifythestructuralsupportforsnapbeadcollarfromthedesign(Theapproveddesignrib:3.66x8.5tobe1.4x7.5mm,WxH)Approvedcapdrawing1.NoClicksound&LowCapretentionAction1:Add2smallerribsoneachsideonsnapbeadcollar(1.4x8.5mm)toprovidetherequiredstructuralsupportandallowthickerslidertobeusedRe-designcapdrawing1.NoClicksound&LowCapretentionCaused2:Capsamplegave
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