電子煙質量標準 E-cigarette Quality Standards

Research&DevelopmentQualityAssuranceElectronicCigarette

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

July1st,2015

1?CopyrightJTI2012JTIQualityGuidelineContentsJTI質量指導原則內容21.

GENERALINFORMATION基本信息1.1

Introduction介紹1.2

JTIQualityPolicy質量方針2.

QUALITYSTANDARDS質量標準2.1

Generalinstructions基本指導2.2

PhysicalQualityCriteria物理質量標準2.3

ChemicalQualityCriteria化學質量標準2.4

ElectricalQualityCriteria電子質量標準2.5

FunctionalQualityCriteria功能質量標準2.6

VisualQualityCriteria外觀質量標準3.

PRODUCTDEVELOPMENT&LAUNCH產品開發(fā)和導入3.1

GeneralInstructionsforSpecifications規(guī)格的基本要求3.2

SpecificationChangeProcess規(guī)格變更流程4.

PRODUCTMAINTENANCE產品維護4.1

IncomingMaterialInspection&DefectManagement來料檢驗和不良管理4.2

SupplierQualificationandevaluation供應商資格和評估4.3 ShelfLifePolicy保質期政策5.

PRODUCTMONITORING產品監(jiān)控5.1

FinishedGoodsInspection成品檢驗5.2

SamplesubmissiontoJTI提交給JTI的樣品5.3

SampleShippingInstructions樣品運輸要求5.4

QualityMeasuringEquipmentandMethods質量檢驗設備和方法6.

PROCESSCONTROL過程控制6.1

ChangeOverProcedure換線程序6.2

ManufacturingQualityPlan制造質量計劃6.3

QUIPProcedureQUIP程序7.

QUALITYMANAGEMENT質量管理7.1

Hygienemanagement衛(wèi)生管理7.2

Consumer/CustomerComplaintHandlingProcedure消費者/客戶投訴處理程序7.3

SeriousQualityIncidentManagement嚴重質量事故管理7.4

Traceability追溯性7.5

Training培訓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JTIqualityrequirementsneedtobeclearlycommunicatedinordertomeetconsumerandregulatoryrequirements要將JTI質量要求溝通清楚，以達到消費者和法規(guī)的要求Objective目標Introduceandalignqualityparameters/procedures介紹質量參數(shù)和程序并與供應商達成一致ProductionofaclearandconcisereferencedocumentonJTIQualityPoliciesandProceduresforuseby3rdpartymanufacturers第三方制造商理解并執(zhí)行清晰簡明的JTI質量方針和程序QualityPolicyandProcedures質量方針和程序33?CopyrightJTI2012Purpose目的ClearlyunderstoodessentialqualityparametersforJTIproducts明白JTI質量參數(shù)AcceptableQualityLimitfordefectsdetectedduringlotinspection不良的可接受的限度樣品Applicabletofinishedproduct適用于成品Parametersconcernedwiththecriticalqualitycharacteristicsoftheproduct關鍵參數(shù)Examples:Physical,chemical,electrical,functionalandvisualcriteria物理，化學，電子，功能和外觀標準42.QUALITYSTANDARDS質量標準PhysicalChemicalElectricalFunctionalVisualLength長度Diameter直徑E-Liquidweight煙液重量Chemicalcomponentsofvapor化學成分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的品牌形象造成負面影響，不良輕易就被消費者發(fā)現(xiàn)DDefect:DefectmayseriouslydamageJTIbrandimage(defectisthemostcritical&consumerperceptionofJTIproductqualityisseriouslyimpacted);theseproductsarenottobeshippedtomarketD類不良：嚴重影響JTI品牌形象，產品不能出貨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類不良需要品質提升Dclassdefectsarenottoleratedatanylevel.D類不良不允許ExamplesofDClassdefects:例如Wrongmaterial錯料Missingproducts/components少料，少零件E-liquidcontamination煙液污染AcceptableQualityLimit(AQL)62.QUALITYSTANDARDS6?CopyrightJTI2012Specificationsdefineallrecognizableandmeasurablefactorsrequiredtomanufactureaproduct.Theycover:規(guī)格規(guī)定了所有的生產產品需要的要素Materialspecifications原材料規(guī)格Productspecifications產品規(guī)格Processspecifications過程參數(shù)Specificationsaredefinedbyspecificationownerandcannotbemodifiedbythemanufacturerwithoutappropriateauthorisation.規(guī)格是產品所有者制定，制造商沒有授權不得修改E-cigarettemanufacturerisresponsibleformaintainingthefactoryspecificationsystem,ensuringproductismanufacturedaccordingtospecificationandreportinganydeviationstothespecificationownerandJTIR&DQA.按照規(guī)格生產，有任何差異需要向JTIR&D品質匯報Specificationcontrol73.PRODUCTDEVELOPMENT&LAUNCH7?CopyrightJTI2012Allproductionmaterialsmustbeinspectedbeforeenteringtheproductionprocesstoensurethattheymeetspecification.來料必須檢驗Batchesofmaterialsandcomponentsmustbeisolatedonarrivalandnotremovedfromquarantineuntilcompliancehasbeenassured.待檢物料必須隔離直到檢驗合格Inspectionmustbecarriedoutaccordingtodocumentedproceduresandresultsperbatchretained.根據(jù)操作規(guī)程檢驗，并保持每批檢驗記錄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Allothercomponentsareinspectedandreleasedbythee-cigarettemanufacturer.其他需要制造商檢驗IncomingMaterialInspection(IMI)Generalrequirements84.PRODUCTMAINTENANCE8?CopyrightJTI2012Generalprocess基本過程E-liquidcompounderproducesabatchofE-liquiddedicatedforJTGroupproductsandsendsrepresentativesamplestoJTIR&Dforbatchreleasetesting.JTI負責測試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94.PRODUCTMAINTENANCE9?CopyrightJTI2012GeneralprocessItistheresponsibilityoftheE-cigarettemanufacturertodesignandimplementIMIplansforallnon-E-liquidcomponentstoassurethatreceivedmaterialscomplywithspecifications.檢驗標準有制造商自己根據(jù)JTI的標準制定Onreceiptofmaterialbatches,correctdocumentationshouldbeassured,samplestakenfromtheshipmentandacceptancetestingcarriedoutaccordingtodocumentedprocedures收料，抽樣，測試Documentationexamples:文件舉例SupplierQCreport供應商QC報告MSDSRoHSDeclarationofConformity，RoSH符合性聲明Batterysafetytestreports電池安全測試報告MaterialsshouldnotbeallowedtoenterproductionuntilsatisfactoryIMIresultsareobserved檢驗合格方能上線IncomingMaterialInspection(IMI)NonE-Liquidcomponents非煙液原材料檢驗104.PRODUCTMAINTENANCE10?CopyrightJTI2012Shelflife:maximumageofthecomponentorfinishedgoodinwhichitcanstillbeconsideredsuitableforuseinproductionorshippingtomarket保質期就是原材料和產品適合生產和出貨Generalrule:materials/finishedgoodsshouldbeusedinproductionorshippedtomarketassoonaspossibleafterreceiptormanufacture.Itemsexceedingshelflifeshouldnotbeusedinproductionorshippedtomarket.

基本原則：原材料盡快生產，成品盡快出貨，超過保質期的原材料和成品不能使用和出貨Dateofproduction/receiptshouldberecordedformaterialbatchesandinventorycontrolexercisedtoensurefirst-in/firstout(FIFO);theoldestmaterialbatchesshouldbeusedfirst原材料生產日期和收貨日期要記錄，先進先出Maximumshelflifeofcomponentsshouldbeasindicatedbythesupplier.Shelflifeoffinishedgoodsshouldbenomorethan12months原材料供應商要提供原材料的保質期，成品保質期不得超過12個月Shelflifeofsealede-liquidcontainersis12monthsfromdateofmanufacture.Oncecontainersareopened,thecontentsmustbeusedwithin30days.密封煙液保質期是12個月，煙液密封桶被打開后，必須在30天內使用完Shelflifeandstoragepolicy保質期和存儲規(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制造商負責物理化學功能和外觀測試Finishedgoodsinspection–Generalprocess成品檢驗-基本步驟135.PRODUCTMONITORING13?CopyrightJTI2012Samplingisinitiatedasnormalinspectionforthefirstinspectedlot.第一批成品作為normal（正常）來檢驗SwitchingtoreducedortightenedinspectionshouldbecarriedoutoncethecriteriagiveninSection9ofISO2859-1aremet.ISO2859-1的第九章符合后切換到reduced（減少）或者tighten（加嚴）檢驗ReducedinspectioncanbeintroducedaftermultipleinspectedlotswhichwouldhavebeenacceptedatalowerAQL.Reduced（減少）的檢驗要在多批次檢驗合格后才能導入Tightenedinspectionmustbeintroducedif2/5consecutivelotsaredeemedunacceptableonfirstinspection.連續(xù)5批中有2批不合格就要導入加嚴檢驗Finishedgoodsinspection–Samplingscheme145.PRODUCTMONITORING14?CopyrightJTI2012E-CigarettemanufacturerisrequestedtoproviderepresentativesamplesofeachproductmanufacturedduringaproductionmonthtoJTIR&DQA.每月送樣給JTI研發(fā)質量部JTIR&DQAwillclearlyindicatetherequiredproducts,quantitiesandshippingaddresstotheE-Cigarettemanufacturer.JTI會告知機種，數(shù)量和達到地址E-cigarettemanufacturerwillarrangeshippingbythemostexpeditiousmeans(normallyairfreight)withallrequiredshippingdocumentation.制造商準備好快捷的貨運（一般是空運），隨貨備好裝運文件JTIR&DQAwillbeinformedofdispatchandshipmenttrackinginformationbyE-cigarettemanufacture.告知JTI貨運信息155.PRODUCTMONITORINGMonthlySampleSubmission月度送樣15?CopyrightJTI2012Objective

目的Topreparethemanufacturingprocessforanewproductioninacontrolledmanner控制生產過程Benefits

好處Eliminatepotentialforwrongmaterialusage,incorrectassemblyorproductcontamination防止錯料，不正確的裝配和生產污染Process過程Removeallmaterialsfrompreviousproductionfromshopfloor清除所有上次生產的物料Cleanmachineryasnecessary有必要的時候清潔機器Checkmaterialsfornewproductionaccordingtospecification檢查原材料規(guī)格Prepareworkinstructionsfornewproduction準備好作業(yè)指導書Setupmachineryandproductionline準備好機器和生產線Changeoverprocedure166.PROCESSCONTROL16?CopyrightJTI2012Process(continued)過程Calibratemeasurementequipment校準測試設備Startproductionline,performstart-upinspection開線，開線檢查Commencefullproductionwhenrequiredspecificationswithintolerancesareobserved開線檢查合格開始生產Changeoverprocedure換線程序176.PROCESSCONTROL

17?CopyrightJTI2012TheManufacturingQualityPlan(MQP)isadetaileddocumentcoveringthemeasurementplansandprocesscontrolguidelinesnecessarytodeliverproductconformingtoJTIstandards生產質量控制計劃涵蓋測試計劃和過程管控以達到JTI標準TheMQPshouldbedesignedandimplementedbytheE-cigarettemanufacturer制造商負責制定和實施生產質量控制計劃IPC-A-610D(level2)mustbeincorporatedintotheMQPandfollowedduringthemanufacturingprocessIPC-A-610D（第二等級）必須包含進生產質量控制計劃MQPmustbesharedandalignedwithJTIR&DQA,andanysubsequentchangessharedinadvance.MQP要與JTI共享并保持標準一致FullrecordsofinspectionsmadeaccordingtotheMQPmustbemadeandretainedfor5years.檢驗的全部記錄必須保留5年。ManufacturingQualityPlan生產質量控制計劃186.PROCESSCONTROL18?CopyrightJTI2012QUIPcoverstheprocessofQualityUnsurefinishedproductinspection.Itisactivatedwhenproductnotconformingtospecificationsorfailingtomeetqualitycriteriaisobserved.QUIP涵蓋品質不確定成品檢查，當成品不符合規(guī)格時啟動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制造商負責設定和維護工廠不合格品管理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，產品應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事件應該被記錄并發(fā)給JTI研發(fā)質量部QUIPProcedure206.PROCESSCONTROL

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

E-cigarettemanufacturershould:制造商應該Ensurestate-of-the-artsanitationmanagement確保最新要求的衛(wèi)生管理Implementandmaintainaforeignmattercontrolprogram實施外來污染管理程序Maintaindocumentedproceduresandinspectionrecords維護程序保持檢驗記錄Examples:例子Uniform(cap,coat,gloves,mask)服裝（帽子，外套，手套，口罩）Standardisedcleaningandinspection標準化的清潔和檢查Standardisedbuildingmaintenance標準化的廠房維護Clearlyorganisedworkstationswithnounnecessarymaterials整潔有序的工作臺，沒有雜物HygieneManagement衛(wèi)生管理217.QUALITYMANAGEMENT21?CopyrightJTI2012Standardprocessfordealingwithcommunicationexpressingdissatisfactionwithproductquality標準處理流程JTIcollect,categoriseandevaluatecomplaintsfromconsumersJTI收集，分類和評估客戶抱怨DividedintoRoutineandSpecialcomplaints分成一般和嚴重客戶抱怨Routine:productperformance,normalvisualqualitydefects一般：產品性能，一般外觀不良Special:Health/legalrelatedcomplaints嚴重：健康和法律相關的抱怨Detailsofmanufacturing-relatedcomplaintsarecommunicatedtoe-cigarettemanufacturerforfurtheraction詳細信息會通知到制造商ConsumerComplaints客戶抱怨227.QUALITYMANAGEMENT22?CopyrightJTI2012E-cigarettemanufacturerisresponsiblefor:制造商負責Corrective/preventativeactionforcomplaintsrelatedtomanufacturingprocess糾正和預防措施實施在生產過程TimelyreportsandfeedbacktoR&DQA及時匯報給JTI研發(fā)品質部Continuousimprovementofmanufacturingquality持續(xù)改進生產過程質量ReimbursementorreplacementofdefecteddevicestoJTI 賠償或者換貨ConsumerComplaints客戶抱怨237.QUALITYMANAGEMENT

23?CopyrightJTI2012SeriousQualityIncidentscover:嚴重質量事故包括Healthandsafetyrelatedrisks(actualorpotentialconsumerinjury)健康和安全相關的風險（發(fā)生的和潛在的對消費者的傷害）Corporaterisks(productnotregisteredforsale,confidentialproductshipped)公司風險（產品沒注冊，保密產品出貨）Contamination/ForeignMatter污染和外部物質摻入SeriousManufacturingDefects嚴重的產品不良IncaseofSeriousQualityIncidentinmarket,JTIR&DQAwillinforme-cigarettemanufacturerforimmediateinvestigationandaction一旦發(fā)生嚴重質量事故，JTI要求制造商立刻調查

SeriousQualityIncidentManagement247.QUALITYMANAGEMENT24?CopyrightJTI2012E-cigarettemanufacturerisresponsiblefor:制造商負責Corrective/preventativeactionashighestpriority糾正和預防措施當做最重要的事情來做ReportandfeedbacktoJTIR&DQAassoonasitispracticallypossible一旦發(fā)生立即通知JTI研發(fā)質量部ReimbursementorreplacementofdefecteddevicestoJTI賠償或者換貨IncaseE-cigarettemanufacturer’sinternalinvestigationsindicatethepossibilityforaSeriousQualityIncident,theyshouldproactivelyinformJTIR&DQAwithdetailsandtherangeofproductswhichmaybeaffected制造商內部調查的內容及影響到的產品范圍需要主動告知JTI研發(fā)品質部SeriousQualityIncidentManagement嚴重質量事故管理257.QUALITYMANAGEMENT25?Copyrigh