1、Research & DevelopmentQuality AssuranceElectronic Cigarette Quality Policy and Procedures電子煙質量方針和規程July 1st, 2015Electronic Cigarette Quality Policies and Procedures Copyright JTI 2012JTI Quality Guideline Contents JTI質量指導原則內容21.GENERAL INFORMATION基本信息1.1Introduction介紹1.2JTI Quality Policy質量方針2.QUAL

2、ITY STANDARDS質量標準2.1General instructions基本指導2.2Physical Quality Criteria物理質量標準2.3Chemical Quality Criteria化學質量標準2.4Electrical Quality Criteria電子質量標準2.5Functional Quality Criteria功能質量標準2.6Visual Quality Criteria外觀質量標準3.PRODUCT DEVELOPMENT & LAUNCH產品開發和導入3.1General Instructions for Specifications規格的基本

3、要求3.2Specification Change Process規格變更流程4.PRODUCT MAINTENANCE產品維護4.1Incoming Material Inspection & Defect Management來料檢驗和不良管理4.2Supplier Qualification and evaluation供應商資格和評估4.3Shelf Life Policy保質期政策5.PRODUCT MONITORING產品監控5.1Finished Goods Inspection成品檢驗5.2Sample submission to JTI提交給JTI的樣品5.3Sample S

4、hipping Instructions樣品運輸要求5.4Quality Measuring Equipment and Methods質量檢驗設備和方法6.PROCESS CONTROL過程控制6.1Change Over Procedure換線程序6.2Manufacturing Quality Plan制造質量計劃6.3QUIP ProcedureQUIP程序7.QUALITY MANAGEMENT質量管理7.1Hygiene management衛生管理7.2Consumer/Customer Complaint Handling Procedure消費者/客戶投訴處理程序7.3Ser

5、ious Quality Incident Management嚴重質量事故管理7.4Traceability追溯性7.5Training 培訓Electronic Cigarette Quality Policies and Procedures3 Copyright JTI 20121. GENERAL INFORMATION基本信息Background 背景Manufacture of E-Cigarettes and tank products will be in 3rd party factories電子煙和霧化器將在第三方工廠生產JTI quality requirements

6、need to be clearly communicated in order to meet consumer and regulatory requirements 要將JTI質量要求溝通清楚，以達到消費者和法規的要求Objective目標Introduce and align quality parameters/procedures介紹質量參數和程序并與供應商達成一致Production of a clear and concise reference document on JTI Quality Policies and Procedures for use by 3rd par

7、ty manufacturers第三方制造商理解并執行清晰簡明的JTI質量方針和程序Quality Policy and Procedures質量方針和程序3Electronic Cigarette Quality Policies and Procedures4 Copyright JTI 2012Purpose目的Clearly understood essential quality parameters for JTI products明白JTI質量參數Acceptable Quality Limit for defects detected during lot inspection

8、不良的可接受的限度樣品Applicable to finished product適用于成品Parameters concerned with the critical quality characteristics of the product關鍵參數Examples:Physical, chemical, electrical, functional and visual criteria物理，化學，電子，功能和外觀標準42. QUALITY STANDARDS質量標準PhysicalChemicalElectricalFunctionalVisualLength長度Diameter直徑E

9、-Liquid weight煙液重量Chemical components of vapor 化學成分Cartomizer resistance煙彈阻值Battery capacity電池容量Device activation on puffing能夠出煙LED lightingLED亮燈Chargeability可充電Cracks/scratches劃痕Peeling stickers標簽脫落E-liquid leakage漏液Electronic Cigarette Quality Policies and Procedures Copyright JTI 2012All defects/

10、deviations are assigned a defect code.不良有不良代碼A Defect: Defect is not too obvious to consumer (defect not easily noticed by consumer & consumer perception of JTI product quality not affected)A類不良：不良不容易被發現B Defect:Defect may damage JTI brand image (defect is easily noticed by consumer & consumer perce

11、ption of JTI product quality is slightly affected)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現C Defect:Defect damages JTI brand image (defect is clearly noticed by consumer & consumer perception of JTI product quality is negatively impacted)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現D Defect: Defect may seriously damag

12、e 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類不良：嚴重影響JTI品牌形象，產品不能出貨Physical, chemical, electrical, functional and visual criteria52. QUALITY STANDARDSElectronic Cigarette Quality Pol

13、icies and Procedures Copyright JTI 2012AQL 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 observed.是最大的允許的不良數An

14、 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適用于B，C類加起來的不良，0.15適用于C類不良A class defects are regarded for process quality improvement.A類不良需要品質提升D class defects are not tolerated at any level.D類不良不允許Examples of D Class defects:例如Wrong materia

15、l 錯料Missing products/components少料，少零件E-liquid contamination 煙液污染Acceptable Quality Limit (AQL) 62. QUALITY STANDARDSElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012Specifications define all recognizable and measurable factors required to manufacture a product. They cover: 規格規定

16、了所有的生產產品需要的要素Material specifications原材料規格Product specifications 產品規格Process specifications 過程參數Specifications are defined by specification owner and cannot be modified by the manufacturer without appropriate authorisation.規格是產品所有者制定，制造商沒有授權不得修改E-cigarette manufacturer is responsible for maintaining

17、the factory specification system, ensuring product is manufactured according to specification and reporting any deviations to the specification owner and JTI R&D QA. 按照規格生產，有任何差異需要向JTI R&D品質匯報Specification control73. PRODUCT DEVELOPMENT & LAUNCHElectronic Cigarette Quality Policies and Procedures Co

18、pyright JTI 2012All production materials must be inspected before entering the production process to ensure that they meet specification.來料必須檢驗Batches of materials and components must be isolated on arrival and not removed from quarantine until compliance has been assured.待檢物料必須隔離直到檢驗合格Inspection mu

19、st be carried out according to documented procedures and results per batch retained.根據操作規程檢驗，并保持每批檢驗記錄Responsibility for inspection is split according to material: 分兩類原材料E-liquids are released by JTI R&D QA and do not require detailed quality inspection by the e-cigarette manufacturer. 煙液由JTI提供，不需要制

20、造商檢驗All other components are inspected and released by the e-cigarette manufacturer.其他需要制造商檢驗Incoming Material Inspection (IMI) General requirements84. PRODUCT MAINTENANCEElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012General process基本過程E-liquid compounder produces a batch of

21、 E-liquid dedicated for JT Group products and sends representative samples to JTI R&D for batch release testing.JTI負責測試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 manufacturer.測試后發貨給制造商E-cigarette man

22、ufacturer receives the batch, checks for any visual defects or undesirable odors.外觀檢查，氣味檢查If any deviations are noted, the batch should be quarantined and R&D QA contacted with full details for further action.發現不良，隔離煙液，JTI處理Incoming Material Inspection (IMI) E-liquids煙液檢驗94. PRODUCT MAINTENANCEElect

23、ronic Cigarette Quality Policies and Procedures Copyright JTI 2012General 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 specifications.檢驗標準有制造商自己根據JTI的標準制定On receipt of m

24、aterial batches, correct documentation should be assured, samples taken from the shipment and acceptance testing carried out according to documented procedures收料，抽樣，測試Documentation examples:文件舉例Supplier QC report 供應商QC報告MSDSRoHS Declaration of Conformity，RoSH符合性聲明Battery safety test reports電池安全測試報告M

25、aterials should not be allowed to enter production until satisfactory IMI results are observed檢驗合格方能上線Incoming Material Inspection (IMI) Non E-Liquid components非煙液原材料檢驗104. PRODUCT MAINTENANCEElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012Shelf life: maximum age of the compon

26、ent or finished good in which it can still be considered suitable for use in production or shipping to market保質期就是原材料和產品適合生產和出貨General rule: materials/finished goods should be used in production or shipped to market as soon as possible after receipt or manufacture. Items exceeding shelf life should

27、not be used in production or shipped to market. 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 should be used first原材料生產日期和收貨日期要記錄，先進先出Maximum s

28、helf life of components should be as indicated by the supplier. Shelf life of finished goods should be no more than 12 months 原材料供應商要提供原材料的保質期，成品保質期不得超過12個月 Shelf life of sealed e-liquid containers is 12 months from date of manufacture. Once containers are opened, the contents must be used within 30

29、 days.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Shelf life and storage policy保質期和存儲規定114. PRODUCT MAINTENANCEElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012Adverse storage conditions (heat, light, humidity, mechanical stress) are a prime driver for deterioration of quality 不利的存儲條件（熱，光

30、，濕度，重壓）會導致不良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. 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-free e-liquid must be stored separately fro

31、m nicotine-containing e-liquid.尼古丁和非尼古丁煙液必須分開儲存All other materials must be stored according to suppliers recommendations其他原材料按照供應商的建議存儲Finished product must be stored at 205C and 60 15% relative humidity成品必須在205C 和 60 15%條件下存儲Shelf life and storage policy124. PRODUCT MAINTENANCEElectronic Cigarette

32、Quality Policies and Procedures Copyright JTI 2012Objective目標To ensure that finished goods meet JTI Product Quality Standards滿足JTI要求Process過程Following production of finished goods samples are taken for inspection抽檢The number of samples required is defined in ISO 2859-1, and is related to batch size

33、and level of sampling (normal, reduced, tightened)根據 ISO 2859-1Acceptability/unacceptability of the batch is determined by the number of defects observed during inspection接受與否決定于檢查出的不良數目E-cigarette manufacturer is responsible for physical, electrical, functional and visual testing制造商負責物理化學功能和外觀測試Fin

34、ished goods inspection General process成品檢驗-基本步驟135. PRODUCT MONITORINGElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012Sampling is initiated as normal inspection for the first inspected lot.第一批成品作為normal（正常）來檢驗Switching to reduced or tightened inspection should be carried out o

35、nce the criteria given in Section 9 of ISO 2859-1 are met.ISO2859-1的第九章符合后切換到reduced（減少）或者tighten（加嚴）檢驗Reduced inspection can be introduced after multiple inspected lots which would have been accepted at a lower AQL.Reduced（減少）的檢驗要在多批次檢驗合格后才能導入Tightened inspection must be introduced if 2/5 consecuti

36、ve lots are deemed unacceptable on first inspection.連續5批中有2批不合格就要導入加嚴檢驗Finished goods inspection Sampling scheme145. PRODUCT MONITORINGElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012E-Cigarette manufacturer is requested to provide representative samples of each product manufa

37、ctured during a production month to JTI R&D QA.每月送樣給JTI研發質量部JTI R&D QA will clearly indicate the required products, quantities and shipping address to the E-Cigarette manufacturer.JTI會告知機種，數量和達到地址E-cigarette manufacturer will arrange shipping by the most expeditious means (normally air freight) with

38、 all required shipping documentation.制造商準備好快捷的貨運（一般是空運），隨貨備好裝運文件JTI R&D QA will be informed of dispatch and shipment tracking information by E-cigarette manufacture.告知JTI貨運信息155. PRODUCT MONITORINGMonthly Sample Submission月度送樣Electronic Cigarette Quality Policies and Procedures Copyright JTI 2012Obj

39、ective 目的To prepare the manufacturing process for a new production in a controlled manner控制生產過程Benefits 好處Eliminate potential for wrong material usage, incorrect assembly or product contamination防止錯料，不正確的裝配和生產污染Process過程Remove all materials from previous production from shop floor清除所有上次生產的物料Clean ma

40、chinery as necessary有必要的時候清潔機器Check materials for new production according to specification檢查原材料規格Prepare work instructions for new production準備好作業指導書Setup machinery and production line準備好機器和生產線Changeover procedure166. PROCESS CONTROLElectronic Cigarette Quality Policies and Procedures Copyright JTI

41、 2012Process (continued)過程Calibrate measurement equipment校準測試設備Start production line, perform start-up inspection開線，開線檢查Commence full production when required specifications within tolerances are observed開線檢查合格開始生產Changeover procedure換線程序176. PROCESS CONTROLElectronic Cigarette Quality Policies and

42、Procedures Copyright JTI 2012The Manufacturing Quality Plan (MQP) is a detailed document covering the measurement plans and process control guidelines necessary to deliver product conforming to JTI standards生產質量控制計劃涵蓋測試計劃和過程管控以達到JTI標準The MQP should be designed and implemented by the E-cigarette manu

43、facturer制造商負責制定和實施生產質量控制計劃IPC-A-610D (level 2) must be incorporated into the MQP and followed during the manufacturing processIPC-A-610D（第二等級）必須包含進生產質量控制計劃MQP must be shared and aligned with JTI R&D QA, and any subsequent changes shared in advance.MQP要與JTI共享并保持標準一致Full records of inspections made ac

44、cording to the MQP must be made and retained for 5 years.檢驗的全部記錄必須保留5年。Manufacturing Quality Plan生產質量控制計劃186. PROCESS CONTROLElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012QUIP covers the process of Quality Unsure finished product inspection. It is activated when product not

45、conforming to specifications or failing to meet quality criteria is observed.QUIP涵蓋品質不確定成品檢查，當成品不符合規格時啟動QUIPBenefits好處Ensures defective product is not shipped確保不良品沒有出貨Clear guideline for effective and efficient decision making清晰的規范來做出高效的決定E-cigarette manufacturer is responsible for following guideli

46、nes and setting and maintaining factory non-conforming/blocking procedures制造商負責設定和維護工廠不合格品管理Action taken is related to defect level根據不良的等級來采取措施QUIP Procedure196. PROCESS CONTROLElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012D Class defects require stopping the production line

47、, taking immediate corrective action and carrying out 100% inspection to the last good check.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For B or C class defects, product should be resampled and rechecked to confirm the issueB，C類不良，產品應該重新抽樣確定不良B Class: Management verify if defect is consumer-noticeable. If y

48、es, shut down production line, fix problem and sample/inspect case by case back to the last good check.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C class: Shut down production line, fix problem and sample/inspect case by case back to the last good check.C類不良，停線，解決問題，抽樣檢查直到上一批次完全合格The QUIP eve

49、nt should be recorded and details sent to JTI R&D QA QUIP事件應該被記錄并發給JTI研發質量部QUIP Procedure206. PROCESS CONTROLElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012Correct hygiene management is essential to mitigate the risk of foreign matter contamination衛生管理有助于降低外來物質污染 E-cigarette

50、manufacturer should:制造商應該Ensure state-of-the-art sanitation management確保最新要求的衛生管理Implement and maintain a foreign matter control program實施外來污染管理程序Maintain documented procedures and inspection records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）Standardised cleaning and inspec

51、tion標準化的清潔和檢查Standardised building maintenance標準化的廠房維護Clearly organised workstations with no unnecessary materials整潔有序的工作臺，沒有雜物Hygiene Management衛生管理217. QUALITY MANAGEMENTElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012Standard process for dealing with communication expressin

52、g dissatisfaction with product quality標準處理流程JTI collect, categorise and evaluate complaints from consumers JTI收集，分類和評估客戶抱怨Divided into Routine and Special complaints分成一般和嚴重客戶抱怨Routine: product performance, normal visual quality defects一般：產品性能，一般外觀不良Special: Health/legal related complaints 嚴重：健康和法律相關

53、的抱怨Details of manufacturing-related complaints are communicated to e-cigarette manufacturer for further action詳細信息會通知到制造商Consumer Complaints客戶抱怨227. QUALITY MANAGEMENTElectronic Cigarette Quality Policies and Procedures Copyright JTI 2012E-cigarette manufacturer is responsible for:制造商負責Corrective/pr

54、eventative action for complaints related to manufacturing process糾正和預防措施實施在生產過程Timely reports and feedback to R&D QA及時匯報給JTI研發品質部Continuous improvement of manufacturing quality持續改進生產過程質量Reimbursement or replacement of defected devices to JTI賠償或者換貨Consumer Complaints客戶抱怨237. QUALITY MANAGEMENTElectro

55、nic Cigarette Quality Policies and Procedures Copyright JTI 2012Serious Quality Incidents cover:嚴重質量事故包括Health and safety related risks (actual or potential consumer injury)健康和安全相關的風險（發生的和潛在的對消費者的傷害）Corporate risks (product not registered for sale, confidential product shipped)公司風險（產品沒注冊，保密產品出貨）Cont

56、amination/Foreign Matter 污染和外部物質摻入Serious Manufacturing Defects嚴重的產品不良In case of Serious Quality Incident in market, JTI R&D QA will inform e-cigarette manufacturer for immediate investigation and action一旦發生嚴重質量事故，JTI要求制造商立刻調查Serious Quality Incident Management247. QUALITY MANAGEMENTElectronic Cigar

57、ette Quality Policies and Procedures Copyright JTI 2012E-cigarette manufacturer is responsible for:制造商負責Corrective/preventative action as highest priority糾正和預防措施當做最重要的事情來做Report and feedback to JTI R&D QA as soon as it is practically possible一旦發生立即通知JTI研發質量部Reimbursement or replacement of defected d

58、evices to JTI賠償或者換貨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研發品質部Serious Quality Incident Management嚴重質量事故管理257. QUALITY MANAGEMENTElectronic Ciga