电子烟质量标准 E-cigarette Quality Standards

Research&DevelopmentQualityAssuranceElectronicCigarette

QualityPolicyandProcedures电子烟质量方针和规程

July1st,2015

1©CopyrightJTI2012JTIQualityGuidelineContentsJTI质量指导原则内容21.

GENERALINFORMATION基本信息1.1

Introduction介绍1.2

JTIQualityPolicy质量方针2.

QUALITYSTANDARDS质量标准2.1

Generalinstructions基本指导2.2

PhysicalQualityCriteria物理质量标准2.3

ChemicalQualityCriteria化学质量标准2.4

ElectricalQualityCriteria电子质量标准2.5

FunctionalQualityCriteria功能质量标准2.6

VisualQualityCriteria外观质量标准3.

PRODUCTDEVELOPMENT&LAUNCH产品开发和导入3.1

GeneralInstructionsforSpecifications规格的基本要求3.2

SpecificationChangeProcess规格变更流程4.

PRODUCTMAINTENANCE产品维护4.1

IncomingMaterialInspection&DefectManagement来料检验和不良管理4.2

SupplierQualificationandevaluation供应商资格和评估4.3 ShelfLifePolicy保质期政策5.

PRODUCTMONITORING产品监控5.1

FinishedGoodsInspection成品检验5.2

SamplesubmissiontoJTI提交给JTI的样品5.3

SampleShippingInstructions样品运输要求5.4

QualityMeasuringEquipmentandMethods质量检验设备和方法6.

PROCESSCONTROL过程控制6.1

ChangeOverProcedure换线程序6.2

ManufacturingQualityPlan制造质量计划6.3

QUIPProcedureQUIP程序7.

QUALITYMANAGEMENT质量管理7.1

Hygienemanagement卫生管理7.2

Consumer/CustomerComplaintHandlingProcedure消费者/客户投诉处理程序7.3

SeriousQualityIncidentManagement严重质量事故管理7.4

Traceability追溯性7.5

Training培训2©CopyrightJTI20121.GENERALINFORMATION基本信息

Background背景ManufactureofE-Cigarettesandtankproductswillbein3rdpartyfactories电子烟和雾化器将在第三方工厂生产JTIqualityrequirementsneedtobeclearlycommunicatedinordertomeetconsumerandregulatoryrequirements要将JTI质量要求沟通清楚，以达到消费者和法规的要求Objective目标Introduceandalignqualityparameters/procedures介绍质量参数和程序并与供应商达成一致ProductionofaclearandconcisereferencedocumentonJTIQualityPoliciesandProceduresforuseby3rdpartymanufacturers第三方制造商理解并执行清晰简明的JTI质量方针和程序QualityPolicyandProcedures质量方针和程序33©CopyrightJTI2012Purpose目的ClearlyunderstoodessentialqualityparametersforJTIproducts明白JTI质量参数AcceptableQualityLimitfordefectsdetectedduringlotinspection不良的可接受的限度样品Applicabletofinishedproduct适用于成品Parametersconcernedwiththecriticalqualitycharacteristicsoftheproduct关键参数Examples:Physical,chemical,electrical,functionalandvisualcriteria物理，化学，电子，功能和外观标准42.QUALITYSTANDARDS质量标准PhysicalChemicalElectricalFunctionalVisualLength长度Diameter直径E-Liquidweight烟液重量Chemicalcomponentsofvapor化学成分Cartomizerresistance烟弹阻值Batterycapacity电池容量Deviceactivationonpuffing能够出烟LEDlightingLED亮灯Chargeability可充电Cracks/scratches划痕Peelingstickers标签脱落E-liquidleakage漏液4©CopyrightJTI2012Alldefects/deviationsareassignedadefectcode.不良有不良代码ADefect:Defectisnottooobvioustoconsumer(defectnoteasilynoticedbyconsumer&consumerperceptionofJTIproductqualitynotaffected)A类不良：不良不容易被发现BDefect: DefectmaydamageJTIbrandimage(defectiseasilynoticedbyconsumer&consumerperceptionofJTIproductqualityisslightlyaffected)B类不良：不良会轻微影响JTI的品牌形象，不良轻易就被消费者发现CDefect: DefectdamagesJTIbrandimage(defectisclearlynoticedbyconsumer&consumerperceptionofJTIproductqualityisnegativelyimpacted)C类不良：不良会给JTI的品牌形象造成负面影响，不良轻易就被消费者发现DDefect:DefectmayseriouslydamageJTIbrandimage(defectisthemostcritical&consumerperceptionofJTIproductqualityisseriouslyimpacted);theseproductsarenottobeshippedtomarketD类不良：严重影响JTI品牌形象，产品不能出货Physical,chemical,electrical,functionalandvisualcriteria52.QUALITYSTANDARDS5©CopyrightJTI2012AQLisdefinedinISO2859-1:Samplingproceduresforinspectionbyattributes–Part1:Samplingschemesindexedbyacceptancequalitylimit(AQL)forlot-by-lotinspection.使用ISO2859-1Itisthemaximumtolerableprocessaverageof%defectsobserved.是最大的允许的不良数AnAQLof0.65issetforBandCclassdefectscombined,andanAQLof0.15issetforCclassdefects.0.65适用于B，C类加起来的不良，0.15适用于C类不良Aclassdefectsareregardedforprocessqualityimprovement.A类不良需要品质提升Dclassdefectsarenottoleratedatanylevel.D类不良不允许ExamplesofDClassdefects:例如Wrongmaterial错料Missingproducts/components少料，少零件E-liquidcontamination烟液污染AcceptableQualityLimit(AQL)62.QUALITYSTANDARDS6©CopyrightJTI2012Specificationsdefineallrecognizableandmeasurablefactorsrequiredtomanufactureaproduct.Theycover:规格规定了所有的生产产品需要的要素Materialspecifications原材料规格Productspecifications产品规格Processspecifications过程参数Specificationsaredefinedbyspecificationownerandcannotbemodifiedbythemanufacturerwithoutappropriateauthorisation.规格是产品所有者制定，制造商没有授权不得修改E-cigarettemanufacturerisresponsibleformaintainingthefactoryspecificationsystem,ensuringproductismanufacturedaccordingtospecificationandreportinganydeviationstothespecificationownerandJTIR&DQA.按照规格生产，有任何差异需要向JTIR&D品质汇报Specificationcontrol73.PRODUCTDEVELOPMENT&LAUNCH7©CopyrightJTI2012Allproductionmaterialsmustbeinspectedbeforeenteringtheproductionprocesstoensurethattheymeetspecification.来料必须检验Batchesofmaterialsandcomponentsmustbeisolatedonarrivalandnotremovedfromquarantineuntilcompliancehasbeenassured.待检物料必须隔离直到检验合格Inspectionmustbecarriedoutaccordingtodocumentedproceduresandresultsperbatchretained.根据操作规程检验，并保持每批检验记录Responsibilityforinspectionissplitaccordingtomaterial:分两类原材料E-liquidsarereleasedbyJTIR&DQAanddonotrequiredetailedqualityinspectionbythee-cigarettemanufacturer.烟液由JTI提供，不需要制造商检验Allothercomponentsareinspectedandreleasedbythee-cigarettemanufacturer.其他需要制造商检验IncomingMaterialInspection(IMI)Generalrequirements84.PRODUCTMAINTENANCE8©CopyrightJTI2012Generalprocess基本过程E-liquidcompounderproducesabatchofE-liquiddedicatedforJTGroupproductsandsendsrepresentativesamplestoJTIR&Dforbatchreleasetesting.JTI负责测试JTIR&DQAreleasesabatchofe-liquidforJTGroupproductandE-LiquidcompoundershipsitafterreceivingtheQAreleasetotheE-Cigarettemanufacturer.测试后发货给制造商E-cigarettemanufacturerreceivesthebatch,checksforanyvisualdefectsorundesirableodors.外观检查，气味检查Ifanydeviationsarenoted,thebatchshouldbequarantinedandR&DQAcontactedwithfulldetailsforfurtheraction.发现不良，隔离烟液，JTI处理IncomingMaterialInspection(IMI)E-liquids烟液检验94.PRODUCTMAINTENANCE9©CopyrightJTI2012GeneralprocessItistheresponsibilityoftheE-cigarettemanufacturertodesignandimplementIMIplansforallnon-E-liquidcomponentstoassurethatreceivedmaterialscomplywithspecifications.检验标准有制造商自己根据JTI的标准制定Onreceiptofmaterialbatches,correctdocumentationshouldbeassured,samplestakenfromtheshipmentandacceptancetestingcarriedoutaccordingtodocumentedprocedures收料，抽样，测试Documentationexamples:文件举例SupplierQCreport供应商QC报告MSDSRoHSDeclarationofConformity，RoSH符合性声明Batterysafetytestreports电池安全测试报告MaterialsshouldnotbeallowedtoenterproductionuntilsatisfactoryIMIresultsareobserved检验合格方能上线IncomingMaterialInspection(IMI)NonE-Liquidcomponents非烟液原材料检验104.PRODUCTMAINTENANCE10©CopyrightJTI2012Shelflife:maximumageofthecomponentorfinishedgoodinwhichitcanstillbeconsideredsuitableforuseinproductionorshippingtomarket保质期就是原材料和产品适合生产和出货Generalrule:materials/finishedgoodsshouldbeusedinproductionorshippedtomarketassoonaspossibleafterreceiptormanufacture.Itemsexceedingshelflifeshouldnotbeusedinproductionorshippedtomarket.

基本原则：原材料尽快生产，成品尽快出货，超过保质期的原材料和成品不能使用和出货Dateofproduction/receiptshouldberecordedformaterialbatchesandinventorycontrolexercisedtoensurefirst-in/firstout(FIFO);theoldestmaterialbatchesshouldbeusedfirst原材料生产日期和收货日期要记录，先进先出Maximumshelflifeofcomponentsshouldbeasindicatedbythesupplier.Shelflifeoffinishedgoodsshouldbenomorethan12months原材料供应商要提供原材料的保质期，成品保质期不得超过12个月Shelflifeofsealede-liquidcontainersis12monthsfromdateofmanufacture.Oncecontainersareopened,thecontentsmustbeusedwithin30days.密封烟液保质期是12个月，烟液密封桶被打开后，必须在30天内使用完Shelflifeandstoragepolicy保质期和存储规定114.PRODUCTMAINTENANCE11©CopyrightJTI2012Adversestorageconditions(heat,light,humidity,mechanicalstress)areaprimedriverfordeteriorationofquality不利的存储条件（热，光，湿度，重压）会导致不良E-liquidmustbestoredbelow25ºC.Openedcontainersmustberesealedassoonaspracticallypossibleafteropening,anditisnotpermittedtoreturndecantede-liquidbackintoamastercontainer.烟液低于25度存储，开封的烟液桶尽快重新封闭，不允许分出来的烟液倒回大桶里Nicotine-freee-liquidmustbestoredseparatelyfromnicotine-containinge-liquid.尼古丁和非尼古丁烟液必须分开储存Allothermaterialsmustbestoredaccordingtosuppliers’recommendations其他原材料按照供应商的建议存储Finishedproductmustbestoredat20±5ºCand60±15%relativehumidity成品必须在20±5ºC和60±15%条件下存储Shelflifeandstoragepolicy124.PRODUCTMAINTENANCE12©CopyrightJTI2012Objective目标ToensurethatfinishedgoodsmeetJTIProductQualityStandards满足JTI要求Process过程Followingproductionoffinishedgoodssamplesaretakenforinspection抽检ThenumberofsamplesrequiredisdefinedinISO2859-1,andisrelatedtobatchsizeandlevelofsampling(normal,reduced,tightened)根据ISO2859-1Acceptability/unacceptabilityofthebatchisdeterminedbythenumberofdefectsobservedduringinspection接受与否决定于检查出的不良数目E-cigarettemanufacturerisresponsibleforphysical,electrical,functionalandvisualtesting制造商负责物理化学功能和外观测试Finishedgoodsinspection–Generalprocess成品检验-基本步骤135.PRODUCTMONITORING13©CopyrightJTI2012Samplingisinitiatedasnormalinspectionforthefirstinspectedlot.第一批成品作为normal（正常）来检验SwitchingtoreducedortightenedinspectionshouldbecarriedoutoncethecriteriagiveninSection9ofISO2859-1aremet.ISO2859-1的第九章符合后切换到reduced（减少）或者tighten（加严）检验ReducedinspectioncanbeintroducedaftermultipleinspectedlotswhichwouldhavebeenacceptedatalowerAQL.Reduced（减少）的检验要在多批次检验合格后才能导入Tightenedinspectionmustbeintroducedif2/5consecutivelotsaredeemedunacceptableonfirstinspection.连续5批中有2批不合格就要导入加严检验Finishedgoodsinspection–Samplingscheme145.PRODUCTMONITORING14©CopyrightJTI2012E-CigarettemanufacturerisrequestedtoproviderepresentativesamplesofeachproductmanufacturedduringaproductionmonthtoJTIR&DQA.每月送样给JTI研发质量部JTIR&DQAwillclearlyindicatetherequiredproducts,quantitiesandshippingaddresstotheE-Cigarettemanufacturer.JTI会告知机种，数量和达到地址E-cigarettemanufacturerwillarrangeshippingbythemostexpeditiousmeans(normallyairfreight)withallrequiredshippingdocumentation.制造商准备好快捷的货运（一般是空运），随货备好装运文件JTIR&DQAwillbeinformedofdispatchandshipmenttrackinginformationbyE-cigarettemanufacture.告知JTI货运信息155.PRODUCTMONITORINGMonthlySampleSubmission月度送样15©CopyrightJTI2012Objective

目的Topreparethemanufacturingprocessforanewproductioninacontrolledmanner控制生产过程Benefits

好处Eliminatepotentialforwrongmaterialusage,incorrectassemblyorproductcontamination防止错料，不正确的装配和生产污染Process过程Removeallmaterialsfrompreviousproductionfromshopfloor清除所有上次生产的物料Cleanmachineryasnecessary有必要的时候清洁机器Checkmaterialsfornewproductionaccordingtospecification检查原材料规格Prepareworkinstructionsfornewproduction准备好作业指导书Setupmachineryandproductionline准备好机器和生产线Changeoverprocedure166.PROCESSCONTROL16©CopyrightJTI2012Process(continued)过程Calibratemeasurementequipment校准测试设备Startproductionline,performstart-upinspection开线，开线检查Commencefullproductionwhenrequiredspecificationswithintolerancesareobserved开线检查合格开始生产Changeoverprocedure换线程序176.PROCESSCONTROL

17©CopyrightJTI2012TheManufacturingQualityPlan(MQP)isadetaileddocumentcoveringthemeasurementplansandprocesscontrolguidelinesnecessarytodeliverproductconformingtoJTIstandards生产质量控制计划涵盖测试计划和过程管控以达到JTI标准TheMQPshouldbedesignedandimplementedbytheE-cigarettemanufacturer制造商负责制定和实施生产质量控制计划IPC-A-610D(level2)mustbeincorporatedintotheMQPandfollowedduringthemanufacturingprocessIPC-A-610D（第二等级）必须包含进生产质量控制计划MQPmustbesharedandalignedwithJTIR&DQA,andanysubsequentchangessharedinadvance.MQP要与JTI共享并保持标准一致FullrecordsofinspectionsmadeaccordingtotheMQPmustbemadeandretainedfor5years.检验的全部记录必须保留5年。ManufacturingQualityPlan生产质量控制计划186.PROCESSCONTROL18©CopyrightJTI2012QUIPcoverstheprocessofQualityUnsurefinishedproductinspection.Itisactivatedwhenproductnotconformingtospecificationsorfailingtomeetqualitycriteriaisobserved.QUIP涵盖品质不确定成品检查，当成品不符合规格时启动QUIPBenefits好处Ensuresdefectiveproductisnotshipped确保不良品没有出货Clearguidelineforeffectiveandefficientdecisionmaking清晰的规范来做出高效的决定E-cigarettemanufacturerisresponsibleforfollowingguidelinesandsettingandmaintainingfactorynon-conforming/blockingprocedures制造商负责设定和维护工厂不合格品管理Actiontakenisrelatedtodefectlevel根据不良的等级来采取措施QUIPProcedure196.PROCESSCONTROL

19©CopyrightJTI2012DClassdefectsrequirestoppingtheproductionline,takingimmediatecorrectiveactionandcarryingout100%inspectiontothelastgoodcheck.D类不良要求停线，立刻采取措施，100%全检直到检查到上一批次完全合格ForBorCclassdefects,productshouldberesampledandrecheckedtoconfirmtheissueB，C类不良，产品应该重新抽样确定不良BClass:Managementverifyifdefectisconsumer-noticeable.Ifyes,shutdownproductionline,fixproblemandsample/inspectcasebycasebacktothelastgoodcheck.B类不良，管理层检查是否是客户能够察觉到的不良，如果是，停线，解决问题，抽样检查直到上一批次完全合格Cclass:Shutdownproductionline,fixproblemandsample/inspectcasebycasebacktothelastgoodcheck.C类不良，停线，解决问题，抽样检查直到上一批次完全合格TheQUIPeventshouldberecordedanddetailssenttoJTIR&DQAQUIP事件应该被记录并发给JTI研发质量部QUIPProcedure206.PROCESSCONTROL

20©CopyrightJTI2012Correcthygienemanagementisessentialtomitigatetheriskofforeignmattercontamination卫生管理有助于降低外来物质污染

E-cigarettemanufacturershould:制造商应该Ensurestate-of-the-artsanitationmanagement确保最新要求的卫生管理Implementandmaintainaforeignmattercontrolprogram实施外来污染管理程序Maintaindocumentedproceduresandinspectionrecords维护程序保持检验记录Examples:例子Uniform(cap,coat,gloves,mask)服装（帽子，外套，手套，口罩）Standardisedcleaningandinspection标准化的清洁和检查Standardisedbuildingmaintenance标准化的厂房维护Clearlyorganisedworkstationswithnounnecessarymaterials整洁有序的工作台，没有杂物HygieneManagement卫生管理217.QUALITYMANAGEMENT21©CopyrightJTI2012Standardprocessfordealingwithcommunicationexpressingdissatisfactionwithproductquality标准处理流程JTIcollect,categoriseandevaluatecomplaintsfromconsumersJTI收集，分类和评估客户抱怨DividedintoRoutineandSpecialcomplaints分成一般和严重客户抱怨Routine:productperformance,normalvisualqualitydefects一般：产品性能，一般外观不良Special:Health/legalrelatedcomplaints严重：健康和法律相关的抱怨Detailsofmanufacturing-relatedcomplaintsarecommunicatedtoe-cigarettemanufacturerforfurtheraction详细信息会通知到制造商ConsumerComplaints客户抱怨227.QUALITYMANAGEMENT22©CopyrightJTI2012E-cigarettemanufacturerisresponsiblefor:制造商负责Corrective/preventativeactionforcomplaintsrelatedtomanufacturingprocess纠正和预防措施实施在生产过程TimelyreportsandfeedbacktoR&DQA及时汇报给JTI研发品质部Continuousimprovementofmanufacturingquality持续改进生产过程质量ReimbursementorreplacementofdefecteddevicestoJTI 赔偿或者换货ConsumerComplaints客户抱怨237.QUALITYMANAGEMENT

23©CopyrightJTI2012SeriousQualityIncidentscover:严重质量事故包括Healthandsafetyrelatedrisks(actualorpotentialconsumerinjury)健康和安全相关的风险（发生的和潜在的对消费者的伤害）Corporaterisks(productnotregisteredforsale,confidentialproductshipped)公司风险（产品没注册，保密产品出货）Contamination/ForeignMatter污染和外部物质掺入SeriousManufacturingDefects严重的产品不良IncaseofSeriousQualityIncidentinmarket,JTIR&DQAwillinforme-cigarettemanufacturerforimmediateinvestigationandaction一旦发生严重质量事故，JTI要求制造商立刻调查

SeriousQualityIncidentManagement247.QUALITYMANAGEMENT24©CopyrightJTI2012E-cigarettemanufacturerisresponsiblefor:制造商负责Corrective/preventativeactionashighestpriority纠正和预防措施当做最重要的事情来做ReportandfeedbacktoJTIR&DQAassoonasitispracticallypossible一旦发生立即通知JTI研发质量部ReimbursementorreplacementofdefecteddevicestoJTI赔偿或者换货IncaseE-cigarettemanufacturer’sinternalinvestigationsindicatethepossibilityforaSeriousQualityIncident,theyshouldproactivelyinformJTIR&DQAwithdetailsandtherangeofproductswhichmaybeaffected制造商内部调查的内容及影响到的产品范围需要主动告知JTI研发品质部SeriousQualityIncidentManagement严重质量事故管理257.QUALITYMANAGEMENT25©Copyrigh