電子煙質(zhì)量標(biāo)準(zhǔn) E-cigarette Quality Standards

Research&DevelopmentQualityAssuranceElectronicCigarette

QualityPolicyandProcedures電子煙質(zhì)量方針和規(guī)程

July1st,2015

1?CopyrightJTI2012JTIQualityGuidelineContentsJTI質(zhì)量指導(dǎo)原則內(nèi)容21.

GENERALINFORMATION基本信息1.1

Introduction介紹1.2

JTIQualityPolicy質(zhì)量方針2.

QUALITYSTANDARDS質(zhì)量標(biāo)準(zhǔn)2.1

Generalinstructions基本指導(dǎo)2.2

PhysicalQualityCriteria物理質(zhì)量標(biāo)準(zhǔn)2.3

ChemicalQualityCriteria化學(xué)質(zhì)量標(biāo)準(zhǔn)2.4

ElectricalQualityCriteria電子質(zhì)量標(biāo)準(zhǔn)2.5

FunctionalQualityCriteria功能質(zhì)量標(biāo)準(zhǔn)2.6

VisualQualityCriteria外觀質(zhì)量標(biāo)準(zhǔn)3.

PRODUCTDEVELOPMENT&LAUNCH產(chǎn)品開發(fā)和導(dǎo)入3.1

GeneralInstructionsforSpecifications規(guī)格的基本要求3.2

SpecificationChangeProcess規(guī)格變更流程4.

PRODUCTMAINTENANCE產(chǎn)品維護(hù)4.1

IncomingMaterialInspection&DefectManagement來料檢驗(yàn)和不良管理4.2

SupplierQualificationandevaluation供應(yīng)商資格和評估4.3 ShelfLifePolicy保質(zhì)期政策5.

PRODUCTMONITORING產(chǎn)品監(jiān)控5.1

FinishedGoodsInspection成品檢驗(yàn)5.2

SamplesubmissiontoJTI提交給JTI的樣品5.3

SampleShippingInstructions樣品運(yùn)輸要求5.4

QualityMeasuringEquipmentandMethods質(zhì)量檢驗(yàn)設(shè)備和方法6.

PROCESSCONTROL過程控制6.1

ChangeOverProcedure換線程序6.2

ManufacturingQualityPlan制造質(zhì)量計(jì)劃6.3

QUIPProcedureQUIP程序7.

QUALITYMANAGEMENT質(zhì)量管理7.1

Hygienemanagement衛(wèi)生管理7.2

Consumer/CustomerComplaintHandlingProcedure消費(fèi)者/客戶投訴處理程序7.3

SeriousQualityIncidentManagement嚴(yán)重質(zhì)量事故管理7.4

Traceability追溯性7.5

Training培訓(xùn)2?CopyrightJTI20121.GENERALINFORMATION基本信息

Background背景ManufactureofE-Cigarettesandtankproductswillbein3rdpartyfactories電子煙和霧化器將在第三方工廠生產(chǎn)JTIqualityrequirementsneedtobeclearlycommunicatedinordertomeetconsumerandregulatoryrequirements要將JTI質(zhì)量要求溝通清楚，以達(dá)到消費(fèi)者和法規(guī)的要求Objective目標(biāo)Introduceandalignqualityparameters/procedures介紹質(zhì)量參數(shù)和程序并與供應(yīng)商達(dá)成一致ProductionofaclearandconcisereferencedocumentonJTIQualityPoliciesandProceduresforuseby3rdpartymanufacturers第三方制造商理解并執(zhí)行清晰簡明的JTI質(zhì)量方針和程序QualityPolicyandProcedures質(zhì)量方針和程序33?CopyrightJTI2012Purpose目的ClearlyunderstoodessentialqualityparametersforJTIproducts明白JTI質(zhì)量參數(shù)AcceptableQualityLimitfordefectsdetectedduringlotinspection不良的可接受的限度樣品Applicabletofinishedproduct適用于成品Parametersconcernedwiththecriticalqualitycharacteristicsoftheproduct關(guān)鍵參數(shù)Examples:Physical,chemical,electrical,functionalandvisualcriteria物理，化學(xué)，電子，功能和外觀標(biāo)準(zhǔn)42.QUALITYSTANDARDS質(zhì)量標(biāo)準(zhǔn)PhysicalChemicalElectricalFunctionalVisualLength長度Diameter直徑E-Liquidweight煙液重量Chemicalcomponentsofvapor化學(xué)成分Cartomizerresistance煙彈阻值Batterycapacity電池容量Deviceactivationonpuffing能夠出煙LEDlightingLED亮燈Chargeability可充電Cracks/scratches劃痕Peelingstickers標(biāo)簽脫落E-liquidleakage漏液4?CopyrightJTI2012Alldefects/deviationsareassignedadefectcode.不良有不良代碼ADefect:Defectisnottooobvioustoconsumer(defectnoteasilynoticedbyconsumer&consumerperceptionofJTIproductqualitynotaffected)A類不良：不良不容易被發(fā)現(xiàn)BDefect: DefectmaydamageJTIbrandimage(defectiseasilynoticedbyconsumer&consumerperceptionofJTIproductqualityisslightlyaffected)B類不良：不良會輕微影響JTI的品牌形象，不良輕易就被消費(fèi)者發(fā)現(xiàn)CDefect: DefectdamagesJTIbrandimage(defectisclearlynoticedbyconsumer&consumerperceptionofJTIproductqualityisnegativelyimpacted)C類不良：不良會給JTI的品牌形象造成負(fù)面影響，不良輕易就被消費(fèi)者發(fā)現(xiàn)DDefect:DefectmayseriouslydamageJTIbrandimage(defectisthemostcritical&consumerperceptionofJTIproductqualityisseriouslyimpacted);theseproductsarenottobeshippedtomarketD類不良：嚴(yán)重影響JTI品牌形象，產(chǎn)品不能出貨Physical,chemical,electrical,functionalandvisualcriteria52.QUALITYSTANDARDS5?CopyrightJTI2012AQLisdefinedinISO2859-1:Samplingproceduresforinspectionbyattributes–Part1:Samplingschemesindexedbyacceptancequalitylimit(AQL)forlot-by-lotinspection.使用ISO2859-1Itisthemaximumtolerableprocessaverageof%defectsobserved.是最大的允許的不良數(shù)AnAQLof0.65issetforBandCclassdefectscombined,andanAQLof0.15issetforCclassdefects.0.65適用于B，C類加起來的不良，0.15適用于C類不良Aclassdefectsareregardedforprocessqualityimprovement.A類不良需要品質(zhì)提升Dclassdefectsarenottoleratedatanylevel.D類不良不允許ExamplesofDClassdefects:例如Wrongmaterial錯(cuò)料Missingproducts/components少料，少零件E-liquidcontamination煙液污染AcceptableQualityLimit(AQL)62.QUALITYSTANDARDS6?CopyrightJTI2012Specificationsdefineallrecognizableandmeasurablefactorsrequiredtomanufactureaproduct.Theycover:規(guī)格規(guī)定了所有的生產(chǎn)產(chǎn)品需要的要素Materialspecifications原材料規(guī)格Productspecifications產(chǎn)品規(guī)格Processspecifications過程參數(shù)Specificationsaredefinedbyspecificationownerandcannotbemodifiedbythemanufacturerwithoutappropriateauthorisation.規(guī)格是產(chǎn)品所有者制定，制造商沒有授權(quán)不得修改E-cigarettemanufacturerisresponsibleformaintainingthefactoryspecificationsystem,ensuringproductismanufacturedaccordingtospecificationandreportinganydeviationstothespecificationownerandJTIR&DQA.按照規(guī)格生產(chǎn)，有任何差異需要向JTIR&D品質(zhì)匯報(bào)Specificationcontrol73.PRODUCTDEVELOPMENT&LAUNCH7?CopyrightJTI2012Allproductionmaterialsmustbeinspectedbeforeenteringtheproductionprocesstoensurethattheymeetspecification.來料必須檢驗(yàn)Batchesofmaterialsandcomponentsmustbeisolatedonarrivalandnotremovedfromquarantineuntilcompliancehasbeenassured.待檢物料必須隔離直到檢驗(yàn)合格Inspectionmustbecarriedoutaccordingtodocumentedproceduresandresultsperbatchretained.根據(jù)操作規(guī)程檢驗(yàn)，并保持每批檢驗(yàn)記錄Responsibilityforinspectionissplitaccordingtomaterial:分兩類原材料E-liquidsarereleasedbyJTIR&DQAanddonotrequiredetailedqualityinspectionbythee-cigarettemanufacturer.煙液由JTI提供，不需要制造商檢驗(yàn)Allothercomponentsareinspectedandreleasedbythee-cigarettemanufacturer.其他需要制造商檢驗(yàn)IncomingMaterialInspection(IMI)Generalrequirements84.PRODUCTMAINTENANCE8?CopyrightJTI2012Generalprocess基本過程E-liquidcompounderproducesabatchofE-liquiddedicatedforJTGroupproductsandsendsrepresentativesamplestoJTIR&Dforbatchreleasetesting.JTI負(fù)責(zé)測試JTIR&DQAreleasesabatchofe-liquidforJTGroupproductandE-LiquidcompoundershipsitafterreceivingtheQAreleasetotheE-Cigarettemanufacturer.測試后發(fā)貨給制造商E-cigarettemanufacturerreceivesthebatch,checksforanyvisualdefectsorundesirableodors.外觀檢查，氣味檢查Ifanydeviationsarenoted,thebatchshouldbequarantinedandR&DQAcontactedwithfulldetailsforfurtheraction.發(fā)現(xiàn)不良，隔離煙液，JTI處理IncomingMaterialInspection(IMI)E-liquids煙液檢驗(yàn)94.PRODUCTMAINTENANCE9?CopyrightJTI2012GeneralprocessItistheresponsibilityoftheE-cigarettemanufacturertodesignandimplementIMIplansforallnon-E-liquidcomponentstoassurethatreceivedmaterialscomplywithspecifications.檢驗(yàn)標(biāo)準(zhǔn)有制造商自己根據(jù)JTI的標(biāo)準(zhǔn)制定Onreceiptofmaterialbatches,correctdocumentationshouldbeassured,samplestakenfromtheshipmentandacceptancetestingcarriedoutaccordingtodocumentedprocedures收料，抽樣，測試Documentationexamples:文件舉例SupplierQCreport供應(yīng)商QC報(bào)告MSDSRoHSDeclarationofConformity，RoSH符合性聲明Batterysafetytestreports電池安全測試報(bào)告MaterialsshouldnotbeallowedtoenterproductionuntilsatisfactoryIMIresultsareobserved檢驗(yàn)合格方能上線IncomingMaterialInspection(IMI)NonE-Liquidcomponents非煙液原材料檢驗(yàn)104.PRODUCTMAINTENANCE10?CopyrightJTI2012Shelflife:maximumageofthecomponentorfinishedgoodinwhichitcanstillbeconsideredsuitableforuseinproductionorshippingtomarket保質(zhì)期就是原材料和產(chǎn)品適合生產(chǎn)和出貨Generalrule:materials/finishedgoodsshouldbeusedinproductionorshippedtomarketassoonaspossibleafterreceiptormanufacture.Itemsexceedingshelflifeshouldnotbeusedinproductionorshippedtomarket.

基本原則：原材料盡快生產(chǎn)，成品盡快出貨，超過保質(zhì)期的原材料和成品不能使用和出貨Dateofproduction/receiptshouldberecordedformaterialbatchesandinventorycontrolexercisedtoensurefirst-in/firstout(FIFO);theoldestmaterialbatchesshouldbeusedfirst原材料生產(chǎn)日期和收貨日期要記錄，先進(jìn)先出Maximumshelflifeofcomponentsshouldbeasindicatedbythesupplier.Shelflifeoffinishedgoodsshouldbenomorethan12months原材料供應(yīng)商要提供原材料的保質(zhì)期，成品保質(zhì)期不得超過12個(gè)月Shelflifeofsealede-liquidcontainersis12monthsfromdateofmanufacture.Oncecontainersareopened,thecontentsmustbeusedwithin30days.密封煙液保質(zhì)期是12個(gè)月，煙液密封桶被打開后，必須在30天內(nèi)使用完Shelflifeandstoragepolicy保質(zhì)期和存儲規(guī)定114.PRODUCTMAINTENANCE11?CopyrightJTI2012Adversestorageconditions(heat,light,humidity,mechanicalstress)areaprimedriverfordeteriorationofquality不利的存儲條件（熱，光，濕度，重壓）會導(dǎo)致不良E-liquidmustbestoredbelow25oC.Openedcontainersmustberesealedassoonaspracticallypossibleafteropening,anditisnotpermittedtoreturndecantede-liquidbackintoamastercontainer.煙液低于25度存儲，開封的煙液桶盡快重新封閉，不允許分出來的煙液倒回大桶里Nicotine-freee-liquidmustbestoredseparatelyfromnicotine-containinge-liquid.尼古丁和非尼古丁煙液必須分開儲存Allothermaterialsmustbestoredaccordingtosuppliers’recommendations其他原材料按照供應(yīng)商的建議存儲Finishedproductmustbestoredat20±5oCand60±15%relativehumidity成品必須在20±5oC和60±15%條件下存儲Shelflifeandstoragepolicy124.PRODUCTMAINTENANCE12?CopyrightJTI2012Objective目標(biāo)ToensurethatfinishedgoodsmeetJTIProductQualityStandards滿足JTI要求Process過程Followingproductionoffinishedgoodssamplesaretakenforinspection抽檢ThenumberofsamplesrequiredisdefinedinISO2859-1,andisrelatedtobatchsizeandlevelofsampling(normal,reduced,tightened)根據(jù)ISO2859-1Acceptability/unacceptabilityofthebatchisdeterminedbythenumberofdefectsobservedduringinspection接受與否決定于檢查出的不良數(shù)目E-cigarettemanufacturerisresponsibleforphysical,electrical,functionalandvisualtesting制造商負(fù)責(zé)物理化學(xué)功能和外觀測試Finishedgoodsinspection–Generalprocess成品檢驗(yàn)-基本步驟135.PRODUCTMONITORING13?CopyrightJTI2012Samplingisinitiatedasnormalinspectionforthefirstinspectedlot.第一批成品作為normal（正常）來檢驗(yàn)SwitchingtoreducedortightenedinspectionshouldbecarriedoutoncethecriteriagiveninSection9ofISO2859-1aremet.ISO2859-1的第九章符合后切換到reduced（減少）或者tighten（加嚴(yán)）檢驗(yàn)ReducedinspectioncanbeintroducedaftermultipleinspectedlotswhichwouldhavebeenacceptedatalowerAQL.Reduced（減少）的檢驗(yàn)要在多批次檢驗(yàn)合格后才能導(dǎo)入Tightenedinspectionmustbeintroducedif2/5consecutivelotsaredeemedunacceptableonfirstinspection.連續(xù)5批中有2批不合格就要導(dǎo)入加嚴(yán)檢驗(yàn)Finishedgoodsinspection–Samplingscheme145.PRODUCTMONITORING14?CopyrightJTI2012E-CigarettemanufacturerisrequestedtoproviderepresentativesamplesofeachproductmanufacturedduringaproductionmonthtoJTIR&DQA.每月送樣給JTI研發(fā)質(zhì)量部JTIR&DQAwillclearlyindicatetherequiredproducts,quantitiesandshippingaddresstotheE-Cigarettemanufacturer.JTI會告知機(jī)種，數(shù)量和達(dá)到地址E-cigarettemanufacturerwillarrangeshippingbythemostexpeditiousmeans(normallyairfreight)withallrequiredshippingdocumentation.制造商準(zhǔn)備好快捷的貨運(yùn)（一般是空運(yùn)），隨貨備好裝運(yùn)文件JTIR&DQAwillbeinformedofdispatchandshipmenttrackinginformationbyE-cigarettemanufacture.告知JTI貨運(yùn)信息155.PRODUCTMONITORINGMonthlySampleSubmission月度送樣15?CopyrightJTI2012Objective

目的Topreparethemanufacturingprocessforanewproductioninacontrolledmanner控制生產(chǎn)過程Benefits

好處Eliminatepotentialforwrongmaterialusage,incorrectassemblyorproductcontamination防止錯(cuò)料，不正確的裝配和生產(chǎn)污染Process過程Removeallmaterialsfrompreviousproductionfromshopfloor清除所有上次生產(chǎn)的物料Cleanmachineryasnecessary有必要的時(shí)候清潔機(jī)器Checkmaterialsfornewproductionaccordingtospecification檢查原材料規(guī)格Prepareworkinstructionsfornewproduction準(zhǔn)備好作業(yè)指導(dǎo)書Setupmachineryandproductionline準(zhǔn)備好機(jī)器和生產(chǎn)線Changeoverprocedure166.PROCESSCONTROL16?CopyrightJTI2012Process(continued)過程Calibratemeasurementequipment校準(zhǔn)測試設(shè)備Startproductionline,performstart-upinspection開線，開線檢查Commencefullproductionwhenrequiredspecificationswithintolerancesareobserved開線檢查合格開始生產(chǎn)Changeoverprocedure換線程序176.PROCESSCONTROL

17?CopyrightJTI2012TheManufacturingQualityPlan(MQP)isadetaileddocumentcoveringthemeasurementplansandprocesscontrolguidelinesnecessarytodeliverproductconformingtoJTIstandards生產(chǎn)質(zhì)量控制計(jì)劃涵蓋測試計(jì)劃和過程管控以達(dá)到JTI標(biāo)準(zhǔn)TheMQPshouldbedesignedandimplementedbytheE-cigarettemanufacturer制造商負(fù)責(zé)制定和實(shí)施生產(chǎn)質(zhì)量控制計(jì)劃IPC-A-610D(level2)mustbeincorporatedintotheMQPandfollowedduringthemanufacturingprocessIPC-A-610D（第二等級）必須包含進(jìn)生產(chǎn)質(zhì)量控制計(jì)劃MQPmustbesharedandalignedwithJTIR&DQA,andanysubsequentchangessharedinadvance.MQP要與JTI共享并保持標(biāo)準(zhǔn)一致FullrecordsofinspectionsmadeaccordingtotheMQPmustbemadeandretainedfor5years.檢驗(yàn)的全部記錄必須保留5年。ManufacturingQualityPlan生產(chǎn)質(zhì)量控制計(jì)劃186.PROCESSCONTROL18?CopyrightJTI2012QUIPcoverstheprocessofQualityUnsurefinishedproductinspection.Itisactivatedwhenproductnotconformingtospecificationsorfailingtomeetqualitycriteriaisobserved.QUIP涵蓋品質(zhì)不確定成品檢查，當(dāng)成品不符合規(guī)格時(shí)啟動(dòng)QUIPBenefits好處Ensuresdefectiveproductisnotshipped確保不良品沒有出貨Clearguidelineforeffectiveandefficientdecisionmaking清晰的規(guī)范來做出高效的決定E-cigarettemanufacturerisresponsibleforfollowingguidelinesandsettingandmaintainingfactorynon-conforming/blockingprocedures制造商負(fù)責(zé)設(shè)定和維護(hù)工廠不合格品管理Actiontakenisrelatedtodefectlevel根據(jù)不良的等級來采取措施QUIPProcedure196.PROCESSCONTROL

19?CopyrightJTI2012DClassdefectsrequirestoppingtheproductionline,takingimmediatecorrectiveactionandcarryingout100%inspectiontothelastgoodcheck.D類不良要求停線，立刻采取措施，100%全檢直到檢查到上一批次完全合格ForBorCclassdefects,productshouldberesampledandrecheckedtoconfirmtheissueB，C類不良，產(chǎn)品應(yīng)該重新抽樣確定不良BClass:Managementverifyifdefectisconsumer-noticeable.Ifyes,shutdownproductionline,fixproblemandsample/inspectcasebycasebacktothelastgoodcheck.B類不良，管理層檢查是否是客戶能夠察覺到的不良，如果是，停線，解決問題，抽樣檢查直到上一批次完全合格Cclass:Shutdownproductionline,fixproblemandsample/inspectcasebycasebacktothelastgoodcheck.C類不良，停線，解決問題，抽樣檢查直到上一批次完全合格TheQUIPeventshouldberecordedanddetailssenttoJTIR&DQAQUIP事件應(yīng)該被記錄并發(fā)給JTI研發(fā)質(zhì)量部QUIPProcedure206.PROCESSCONTROL

20?CopyrightJTI2012Correcthygienemanagementisessentialtomitigatetheriskofforeignmattercontamination衛(wèi)生管理有助于降低外來物質(zhì)污染

E-cigarettemanufacturershould:制造商應(yīng)該Ensurestate-of-the-artsanitationmanagement確保最新要求的衛(wèi)生管理Implementandmaintainaforeignmattercontrolprogram實(shí)施外來污染管理程序Maintaindocumentedproceduresandinspectionrecords維護(hù)程序保持檢驗(yàn)記錄Examples:例子Uniform(cap,coat,gloves,mask)服裝（帽子，外套，手套，口罩）Standardisedcleaningandinspection標(biāo)準(zhǔn)化的清潔和檢查Standardisedbuildingmaintenance標(biāo)準(zhǔn)化的廠房維護(hù)Clearlyorganisedworkstationswithnounnecessarymaterials整潔有序的工作臺，沒有雜物HygieneManagement衛(wèi)生管理217.QUALITYMANAGEMENT21?CopyrightJTI2012Standardprocessfordealingwithcommunicationexpressingdissatisfactionwithproductquality標(biāo)準(zhǔn)處理流程JTIcollect,categoriseandevaluatecomplaintsfromconsumersJTI收集，分類和評估客戶抱怨DividedintoRoutineandSpecialcomplaints分成一般和嚴(yán)重客戶抱怨Routine:productperformance,normalvisualqualitydefects一般：產(chǎn)品性能，一般外觀不良Special:Health/legalrelatedcomplaints嚴(yán)重：健康和法律相關(guān)的抱怨Detailsofmanufacturing-relatedcomplaintsarecommunicatedtoe-cigarettemanufacturerforfurtheraction詳細(xì)信息會通知到制造商ConsumerComplaints客戶抱怨227.QUALITYMANAGEMENT22?CopyrightJTI2012E-cigarettemanufacturerisresponsiblefor:制造商負(fù)責(zé)Corrective/preventativeactionforcomplaintsrelatedtomanufacturingprocess糾正和預(yù)防措施實(shí)施在生產(chǎn)過程TimelyreportsandfeedbacktoR&DQA及時(shí)匯報(bào)給JTI研發(fā)品質(zhì)部Continuousimprovementofmanufacturingquality持續(xù)改進(jìn)生產(chǎn)過程質(zhì)量ReimbursementorreplacementofdefecteddevicestoJTI 賠償或者換貨ConsumerComplaints客戶抱怨237.QUALITYMANAGEMENT

23?CopyrightJTI2012SeriousQualityIncidentscover:嚴(yán)重質(zhì)量事故包括Healthandsafetyrelatedrisks(actualorpotentialconsumerinjury)健康和安全相關(guān)的風(fēng)險(xiǎn)（發(fā)生的和潛在的對消費(fèi)者的傷害）Corporaterisks(productnotregisteredforsale,confidentialproductshipped)公司風(fēng)險(xiǎn)（產(chǎn)品沒注冊，保密產(chǎn)品出貨）Contamination/ForeignMatter污染和外部物質(zhì)摻入SeriousManufacturingDefects嚴(yán)重的產(chǎn)品不良IncaseofSeriousQualityIncidentinmarket,JTIR&DQAwillinforme-cigarettemanufacturerforimmediateinvestigationandaction一旦發(fā)生嚴(yán)重質(zhì)量事故，JTI要求制造商立刻調(diào)查

SeriousQualityIncidentManagement247.QUALITYMANAGEMENT24?CopyrightJTI2012E-cigarettemanufacturerisresponsiblefor:制造商負(fù)責(zé)Corrective/preventativeactionashighestpriority糾正和預(yù)防措施當(dāng)做最重要的事情來做ReportandfeedbacktoJTIR&DQAassoonasitispracticallypossible一旦發(fā)生立即通知JTI研發(fā)質(zhì)量部ReimbursementorreplacementofdefecteddevicestoJTI賠償或者換貨IncaseE-cigarettemanufacturer’sinternalinvestigationsindicatethepossibilityforaSeriousQualityIncident,theyshouldproactivelyinformJTIR&DQAwithdetailsandtherangeofproductswhichmaybeaffected制造商內(nèi)部調(diào)查的內(nèi)容及影響到的產(chǎn)品范圍需要主動(dòng)告知JTI研發(fā)品質(zhì)部SeriousQualityIncidentManagement嚴(yán)重質(zhì)量事故管理257.QUALITYMANAGEMENT25?Copyrigh