电子烟质量标准

1、Research & DevelopmentQuality AssuranceElectronic Cigarette Quality Policy and Procedures电子烟质量方针和规程July 1st, 电子烟质量标准第1页Electronic Cigarette Quality Policies and Procedures Copyright JTI JTI Quality Guideline Contents JTI质量指导标准内容21.GENERAL INFORMATION基本信息1.1Introduction介绍1.2JTI Quality Policy质量方针2.QU

2、ALITY STANDARDS质量标准2.1General instructions基本指导2.2Physical Quality Criteria物理质量标准2.3Chemical Quality Criteria化学质量标准2.4Electrical Quality Criteria电子质量标准2.5Functional Quality Criteria功效质量标准2.6Visual Quality Criteria外观质量标准3.PRODUCT DEVELOPMENT & LAUNCH产品开发和导入3.1General Instructions for Specifications规格基

3、本要求3.2Specification Change Process规格变更流程4.PRODUCT MAINTENANCE产品维护4.1Incoming Material Inspection & Defect Management来料检验和不良管理4.2Supplier Qualification and evaluation供给商资格和评定4.3Shelf Life Policy保质期政策5.PRODUCT MONITORING产品监控5.1Finished Goods Inspection成品检验5.2Sample submission to JTI提交给JTI样品5.3Sample S

4、hipping Instructions样品运输要求5.4Quality Measuring Equipment and Methods质量检验设备和方法6.PROCESS CONTROL过程控制6.1Change Over Procedure换线程序6.2Manufacturing Quality Plan制造质量计划6.3QUIP ProcedureQUIP程序7.QUALITY MANAGEMENT质量管理7.1Hygiene management卫生管理7.2Consumer/Customer Complaint Handling Procedure消费者/客户投诉处理程序7.3Ser

5、ious Quality Incident Management严重质量事故管理7.4Traceability追溯性7.5Training 培训电子烟质量标准第2页Electronic Cigarette Quality Policies and Procedures3 Copyright JTI 1. GENERAL INFORMATION基本信息Background 背景Manufacture of E-Cigarettes and tank products will be in 3rd party factories电子烟和雾化器将在第三方工厂生产JTI quality require

6、ments need to be clearly communicated in order to meet consumer and regulatory requirements 要将JTI质量要求沟通清楚，以到达消费者和法规要求Objective目标Introduce and align quality parameters/procedures介绍质量参数和程序并与供给商达成一致Production of a clear and concise reference document on JTI Quality Policies and Procedures for use by 3r

7、d party manufacturers第三方制造商了解并执行清楚简明JTI质量方针和程序Quality Policy and Procedures质量方针和程序3电子烟质量标准第3页Electronic Cigarette Quality Policies and Procedures4 Copyright JTI Purpose目标Clearly understood essential quality parameters for JTI products明白JTI质量参数Acceptable Quality Limit for defects detected during lot

8、inspection不良可接收程度样品Applicable to finished product适合用于成品Parameters concerned with the critical quality characteristics of the product关键参数Examples:Physical, chemical, electrical, functional and visual criteria物理，化学，电子，功效和外观标准42. QUALITY STANDARDS质量标准PhysicalChemicalElectricalFunctionalVisualLength长度Di

9、ameter直径E-Liquid weight烟液重量Chemical components of vapor 化学成份Cartomizer resistance烟弹阻值Battery capacity电池容量Device activation on puffing能够出烟LED lightingLED亮灯Chargeability可充电Cracks/scratches划痕Peeling stickers标签脱落E-liquid leakage漏液电子烟质量标准第4页Electronic Cigarette Quality Policies and Procedures Copyright J

10、TI All defects/deviations are assigned a defect code.不良有不良代码A Defect: Defect is not too obvious to consumer (defect not easily noticed by consumer & consumer perception of JTI product quality not affected)A类不良：不良不轻易被发觉B Defect:Defect may damage JTI brand image (defect is easily noticed by consumer &

11、 consumer perception of JTI product quality is slightly affected)B类不良：不良会轻微影响JTI品牌形象，不良轻易就被消费者发觉C Defect:Defect damages JTI brand image (defect is clearly noticed by consumer & consumer perception of JTI product quality is negatively impacted)C类不良：不良会给JTI品牌形象造成负面影响，不良轻易就被消费者发觉D Defect: Defect may se

12、riously damage JTI brand image (defect is the most critical & consumer perception of JTI product quality is seriously impacted); these products are not to be shipped to marketD类不良：严重影响JTI品牌形象，产品不能出货Physical, chemical, electrical, functional and visual criteria52. QUALITY STANDARDS电子烟质量标准第5页Electroni

13、c Cigarette Quality Policies and Procedures Copyright JTI AQL is defined in ISO 2859-1: Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection.使用ISO2859-1It is the maximum tolerable process average of % defects ob

14、served.是最大允许不良数An AQL of 0.65 is set for B and C class defects combined, and an AQL of 0.15 is set for C class defects. 0.65适合用于B，C类加起来不良，0.15适合用于C类不良A class defects are regarded for process quality improvement.A类不良需要品质提升D class defects are not tolerated at any level.D类不良不允许Examples of D Class defec

15、ts:比如Wrong material 错料Missing products/components少料，少零件E-liquid contamination 烟液污染Acceptable Quality Limit (AQL) 62. QUALITY STANDARDS电子烟质量标准第6页Electronic Cigarette Quality Policies and Procedures Copyright JTI Specifications define all recognizable and measurable factors required to manufacture a p

16、roduct. They cover: 规格要求了全部生产产品需要要素Material specifications原材料规格Product specifications 产品规格Process specifications 过程参数Specifications are defined by specification owner and cannot be modified by the manufacturer without appropriate authorisation.规格是产品全部者制订，制造商没有授权不得修改E-cigarette manufacturer is respon

17、sible for maintaining the factory specification system, ensuring product is manufactured according to specification and reporting any deviations to the specification owner and JTI R&D QA. 按照规格生产，有任何差异需要向JTI R&D品质汇报Specification control73. PRODUCT DEVELOPMENT & LAUNCH电子烟质量标准第7页Electronic Cigarette Qu

18、ality Policies and Procedures Copyright JTI All production materials must be inspected before entering the production process to ensure that they meet specification.来料必须检验Batches of materials and components must be isolated on arrival and not removed from quarantine until compliance has been assured

19、.待检物料必须隔离直到检验合格Inspection must be carried out according to documented procedures and results per batch retained.依据操作规程检验，并保持每批检验统计Responsibility for inspection is split according to material: 分两类原材料E-liquids are released by JTI R&D QA and do not require detailed quality inspection by the e-cigarette

20、 manufacturer. 烟液由JTI提供，不需要制造商检验All other components are inspected and released by the e-cigarette manufacturer.其它需要制造商检验Incoming Material Inspection (IMI) General requirements84. PRODUCT MAINTENANCE电子烟质量标准第8页Electronic Cigarette Quality Policies and Procedures Copyright JTI General process基本过程E-liq

21、uid compounder produces a batch of E-liquid dedicated for JT Group products and sends representative samples to JTI R&D for batch release testing.JTI负责测试JTI R&D QA releases a batch of e-liquid for JT Group product and E-Liquid compounder ships it after receiving the QA release to the E-Cigarette man

22、ufacturer.测试后发货给制造商E-cigarette manufacturer receives the batch, checks for any visual defects or undesirable odors.外观检验，气味检验If any deviations are noted, the batch should be quarantined and R&D QA contacted with full details for further action.发觉不良，隔离烟液，JTI处理Incoming Material Inspection (IMI) E-liqui

23、ds烟液检验94. PRODUCT MAINTENANCE电子烟质量标准第9页Electronic Cigarette Quality Policies and Procedures Copyright JTI General processIt is the responsibility of the E-cigarette manufacturer to design and implement IMI plans for all non-E-liquid components to assure that received materials comply with specificat

24、ions.检验标准有制造商自己依据JTI标准制订On receipt of material batches, correct documentation should be assured, samples taken from the shipment and acceptance testing carried out according to documented procedures收料，抽样，测试Documentation examples:文件举例Supplier QC report 供给商QC汇报MSDSRoHS Declaration of Conformity，RoSH符合

25、性申明Battery safety test reports电池安全测试汇报Materials should not be allowed to enter production until satisfactory IMI results are observed检验合格方能上线Incoming Material Inspection (IMI) Non E-Liquid components非烟液原材料检验104. PRODUCT MAINTENANCE电子烟质量标准第10页Electronic Cigarette Quality Policies and Procedures Copyr

26、ight JTI Shelf life: maximum age of the component or finished good in which it can still be considered suitable for use in production or shipping to market保质期就是原材料和产品适合生产和出货General rule: materials/finished goods should be used in production or shipped to market as soon as possible after receipt or m

27、anufacture. Items exceeding shelf life should not be used in production or shipped to market. 基本标准：原材料尽快生产，成品尽快出货，超出保质期原材料和成品不能使用和出货Date of production/receipt should be recorded for material batches and inventory control exercised to ensure first-in/first out (FIFO); the oldest material batches shou

28、ld be used first原材料生产日期和收货日期要统计，先进先出Maximum shelf life of components should be as indicated by the supplier. Shelf life of finished goods should be no more than 12 months 原材料供给商要提供原材料保质期，成品保质期不得超出12个月 Shelf life of sealed e-liquid containers is 12 months from date of manufacture. Once containers are

29、 opened, the contents must be used within 30 days.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Shelf life and storage policy保质期和存放要求114. PRODUCT MAINTENANCE电子烟质量标准第11页Electronic Cigarette Quality Policies and Procedures Copyright JTI Adverse storage conditions (heat, light, humidity, mechanical stress) are a pr

30、ime driver for deterioration of quality 不利存放条件（热，光，湿度，重压）会造成不良E-liquid must be stored below 25C. Opened containers must be resealed as soon as practically possible after opening, and it is not permitted to return decanted e-liquid back into a master container. 烟液低于25度存放，开封烟液桶尽快重新封闭，不允许分出来烟液倒回大桶里Nico

31、tine-free e-liquid must be stored separately from nicotine-containing e-liquid.尼古丁和非尼古丁烟液必须分开储存All other materials must be stored according to suppliers recommendations其它原材料按照供给商提议存放Finished product must be stored at 205C and 60 15% relative humidity成品必须在205C 和 60 15%条件下存放Shelf life and storage poli

32、cy124. PRODUCT MAINTENANCE电子烟质量标准第12页Electronic Cigarette Quality Policies and Procedures Copyright JTI Objective目标To ensure that finished goods meet JTI Product Quality Standards满足JTI要求Process过程Following production of finished goods samples are taken for inspection抽检The number of samples required i

33、s defined in ISO 2859-1, and is related to batch size and level of sampling (normal, reduced, tightened)依据 ISO 2859-1Acceptability/unacceptability of the batch is determined by the number of defects observed during inspection接收是否决定于检验出不良数目E-cigarette manufacturer is responsible for physical, electri

34、cal, functional and visual testing制造商负责物理化学功效和外观察试Finished goods inspection General process成品检验-基本步骤135. PRODUCT MONITORING电子烟质量标准第13页Electronic Cigarette Quality Policies and Procedures Copyright JTI Sampling is initiated as normal inspection for the first inspected lot.第一批成品作为normal（正常）来检验Switchin

35、g to reduced or tightened inspection should be carried out once the criteria given in Section 9 of ISO 2859-1 are met.ISO2859-1第九章符合后切换到reduced（降低）或者tighten（加严）检验Reduced inspection can be introduced after multiple inspected lots which would have been accepted at a lower AQL.Reduced（降低）检验要在多批次检验合格后才能

36、导入Tightened inspection must be introduced if 2/5 consecutive lots are deemed unacceptable on first inspection.连续5批中有2批不合格就要导入加严检验Finished goods inspection Sampling scheme145. PRODUCT MONITORING电子烟质量标准第14页Electronic Cigarette Quality Policies and Procedures Copyright JTI E-Cigarette manufacturer is r

37、equested to provide representative samples of each product manufactured during a production month to JTI R&D QA.每个月送样给JTI研发质量部JTI R&D QA will clearly indicate the required products, quantities and shipping address to the E-Cigarette manufacturer.JTI会通知机种，数量和到达地址E-cigarette manufacturer will arrange

38、shipping by the most expeditious means (normally air freight) with all required shipping documentation.制造商准备好快捷货运（普通是空运），随货备好装运文件JTI R&D QA will be informed of dispatch and shipment tracking information by E-cigarette manufacture.通知JTI货运信息155. PRODUCT MONITORINGMonthly Sample Submission月度送样电子烟质量标准第1

39、5页Electronic Cigarette Quality Policies and Procedures Copyright JTI Objective 目标To prepare the manufacturing process for a new production in a controlled manner控制生产过程Benefits 好处Eliminate potential for wrong material usage, incorrect assembly or product contamination预防错料，不正确装配和生产污染Process过程Remove al

40、l materials from previous production from shop floor去除全部上次生产物料Clean machinery as necessary有必要时候清洁机器Check materials for new production according to specification检验原材料规格Prepare work instructions for new production准备好作业指导书Setup machinery and production line准备好机器和生产线Changeover procedure166. PROCESS CONT

41、ROL电子烟质量标准第16页Electronic Cigarette Quality Policies and Procedures Copyright JTI Process (continued)过程Calibrate measurement equipment校准测试设备Start production line, perform start-up inspection开线，开线检验Commence full production when required specifications within tolerances are observed开线检验合格开始生产Changeover

42、 procedure换线程序176. PROCESS CONTROL电子烟质量标准第17页Electronic Cigarette Quality Policies and Procedures Copyright JTI The Manufacturing Quality Plan (MQP) is a detailed document covering the measurement plans and process control guidelines necessary to deliver product conforming to JTI standards生产质量控制计划涵盖

43、测试计划和过程管控以到达JTI标准The MQP should be designed and implemented by the E-cigarette manufacturer制造商负责制订和实施生产质量控制计划IPC-A-610D (level 2) must be incorporated into the MQP and followed during the manufacturing processIPC-A-610D（第二等级）必须包含进生产质量控制计划MQP must be shared and aligned with JTI R&D QA, and any subseq

44、uent changes shared in advance.MQP要与JTI共享并保持标准一致Full records of inspections made according to the MQP must be made and retained for 5 years.检验全部统计必须保留5年。Manufacturing Quality Plan生产质量控制计划186. PROCESS CONTROL电子烟质量标准第18页Electronic Cigarette Quality Policies and Procedures Copyright JTI QUIP covers the

45、 process of Quality Unsure finished product inspection. It is activated when product not conforming to specifications or failing to meet quality criteria is observed.QUIP涵盖品质不确定成品检验，当成品不符合规格时开启QUIPBenefits好处Ensures defective product is not shipped确保不良品没有出货Clear guideline for effective and efficient

46、decision making清楚规范来做出高效决定E-cigarette manufacturer is responsible for following guidelines and setting and maintaining factory non-conforming/blocking procedures制造商负责设定和维护工厂不合格品管理Action taken is related to defect level依据不良等级来采取办法QUIP Procedure196. PROCESS CONTROL电子烟质量标准第19页Electronic Cigarette Quali

47、ty Policies and Procedures Copyright JTI D Class defects require stopping the production line, taking immediate corrective action and carrying out 100% inspection to the last good check.D类不良要求停线，立刻采取办法，100%全检直到检验到上一批次完全合格For B or C class defects, product should be resampled and rechecked to confirm

48、the issueB，C类不良，产品应该重新抽样确定不良B Class: Management verify if defect is consumer-noticeable. If yes, shut down production line, fix problem and sample/inspect case by case back to the last good check.B类不良，管理层检验是否是客户能够觉察到不良，假如是，停线，处理问题，抽样检验直到上一批次完全合格C class: Shut down production line, fix problem and sam

49、ple/inspect case by case back to the last good check.C类不良，停线，处理问题，抽样检验直到上一批次完全合格The QUIP event should be recorded and details sent to JTI R&D QA QUIP事件应该被统计并发给JTI研发质量部QUIP Procedure206. PROCESS CONTROL电子烟质量标准第20页Electronic Cigarette Quality Policies and Procedures Copyright JTI Correct hygiene manag

50、ement is essential to mitigate the risk of foreign matter contamination卫生管理有利于降低外来物质污染 E-cigarette manufacturer should:制造商应该Ensure state-of-the-art sanitation management确保最新要求卫生管理Implement and maintain a foreign matter control program实施外来污染管理程序Maintain documented procedures and inspection records维护程

51、序保持检验统计Examples:例子Uniform (cap, coat, gloves, mask)服装（帽子，外套，手套，口罩）Standardised cleaning and inspection标准化清洁和检验Standardised building maintenance标准化厂房维护Clearly organised workstations with no unnecessary materials整齐有序工作台，没有杂物Hygiene Management卫生管理217. QUALITY MANAGEMENT电子烟质量标准第21页Electronic Cigarette Q

52、uality Policies and Procedures Copyright JTI Standard process for dealing with communication expressing dissatisfaction with product quality标准处理流程JTI collect, categorise and evaluate complaints from consumers JTI搜集，分类和评定客户埋怨Divided into Routine and Special complaints分成普通和严重客户埋怨Routine: product perfo

53、rmance, normal visual quality defects普通：产品性能，普通外观不良Special: Health/legal related complaints 严重：健康和法律相关埋怨Details of manufacturing-related complaints are communicated to e-cigarette manufacturer for further action详细信息会通知到制造商Consumer Complaints客户埋怨227. QUALITY MANAGEMENT电子烟质量标准第22页Electronic Cigarette

54、Quality Policies and Procedures Copyright JTI E-cigarette manufacturer is responsible for:制造商负责Corrective/preventative action for complaints related to manufacturing process纠正和预防办法实施在生产过程Timely reports and feedback to R&D QA及时汇报给JTI研发品质部Continuous improvement of manufacturing quality连续改进生产过程质量Reimbu

55、rsement or replacement of defected devices to JTI赔偿或者换货Consumer Complaints客户埋怨237. QUALITY MANAGEMENT电子烟质量标准第23页Electronic Cigarette Quality Policies and Procedures Copyright JTI Serious Quality Incidents cover:严重质量事故包含Health and safety related risks (actual or potential consumer injury)健康和安全相关风险（发生

56、和潜在对消费者伤害）Corporate risks (product not registered for sale, confidential product shipped)企业风险（产品没注册，保密产品出货）Contamination/Foreign Matter 污染和外部物质掺入Serious Manufacturing Defects严重产品不良In case of Serious Quality Incident in market, JTI R&D QA will inform e-cigarette manufacturer for immediate investigati

57、on and action一旦发生严重质量事故，JTI要求制造商立刻调查Serious Quality Incident Management247. QUALITY MANAGEMENT电子烟质量标准第24页Electronic Cigarette Quality Policies and Procedures Copyright JTI E-cigarette manufacturer is responsible for:制造商负责Corrective/preventative action as highest priority纠正和预防办法当做最主要事情来做Report and fe

58、edback to JTI R&D QA as soon as it is practically possible一旦发生马上通知JTI研发质量部Reimbursement or replacement of defected devices to JTI赔偿或者换货In case E-cigarette manufacturers internal investigations indicate the possibility for a Serious Quality Incident, they should proactively inform JTI R&D QA with details and the range of products which may be affected制造商内部调查内容及影响到产品范围需要主动通知JTI研发品质部Serious Quality Incident Management严重质量事故管理257. QUALITY MANAGEMENT电子烟质量标准第25页Electronic Cigarette Quality Polic