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

1、Research & DevelopmentQuality AssuranceElectronic Cigarette Quality Policy and Procedures電子煙質(zhì)量方針和規(guī)程July 1st, 2015Electronic Cigarette Quality Policies and Procedures Copyright JTI 2012JTI Quality Guideline Contents JTI質(zhì)量指導(dǎo)原則內(nèi)容21.GENERAL INFORMATION基本信息1.1Introduction介紹1.2JTI Quality Policy質(zhì)量方針2.QUAL

2、ITY STANDARDS質(zhì)量標(biāo)準(zhǔn)2.1General instructions基本指導(dǎo)2.2Physical Quality Criteria物理質(zhì)量標(biāo)準(zhǔn)2.3Chemical Quality Criteria化學(xué)質(zhì)量標(biāo)準(zhǔn)2.4Electrical Quality Criteria電子質(zhì)量標(biāo)準(zhǔn)2.5Functional Quality Criteria功能質(zhì)量標(biāo)準(zhǔn)2.6Visual Quality Criteria外觀質(zhì)量標(biāo)準(zhǔn)3.PRODUCT DEVELOPMENT & LAUNCH產(chǎn)品開發(fā)和導(dǎo)入3.1General Instructions for Specifications規(guī)格的基本

3、要求3.2Specification Change Process規(guī)格變更流程4.PRODUCT MAINTENANCE產(chǎn)品維護(hù)4.1Incoming Material Inspection & Defect Management來料檢驗(yàn)和不良管理4.2Supplier Qualification and evaluation供應(yīng)商資格和評估4.3Shelf Life Policy保質(zhì)期政策5.PRODUCT MONITORING產(chǎn)品監(jiān)控5.1Finished Goods Inspection成品檢驗(yàn)5.2Sample submission to JTI提交給JTI的樣品5.3Sample S

4、hipping Instructions樣品運(yùn)輸要求5.4Quality Measuring Equipment and Methods質(zhì)量檢驗(yàn)設(shè)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(zhì)量計(jì)劃6.3QUIP ProcedureQUIP程序7.QUALITY MANAGEMENT質(zhì)量管理7.1Hygiene management衛(wèi)生管理7.2Consumer/Customer Complaint Handling Procedure消費(fèi)者/客戶投訴處理程序7.3Ser

5、ious Quality Incident Management嚴(yán)重質(zhì)量事故管理7.4Traceability追溯性7.5Training 培訓(xùn)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(chǎn)JTI quality requirements

6、need to be clearly communicated in order to meet consumer and regulatory requirements 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)Introduce and align quality parameters/procedures介紹質(zhì)量參數(shù)和程序并與供應(yīng)商達(dá)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(zhí)行清晰簡明的JTI質(zhì)量方針和程序Quality Policy and Procedures質(zhì)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(zhì)量參數(shù)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(guān)鍵參數(shù)Examples:Physical, chemical, electrical, functional and visual criteria物理，化學(xué)，電子，功能和外觀標(biāo)準(zhǔn)42. QUALITY STANDARDS質(zhì)量標(biāo)準(zhǔn)PhysicalChemicalElectricalFunctionalVisualLength長度Diameter直徑E

9、-Liquid weight煙液重量Chemical components of vapor 化學(xué)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(biāo)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(fā)現(xiàn)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(fèi)者發(fā)現(xiàn)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(fù)面影響，不良輕易就被消費(fèi)者發(fā)現(xiàn)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(yán)重影響JTI品牌形象，產(chǎn)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(shù)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(zhì)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(guī)格規(guī)定

16、了所有的生產(chǎn)產(chǎn)品需要的要素Material specifications原材料規(guī)格Product specifications 產(chǎn)品規(guī)格Process specifications 過程參數(shù)Specifications are defined by specification owner and cannot be modified by the manufacturer without appropriate authorisation.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-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(guī)格生產(chǎn)，有任何差異需要向JTI R&D品質(zhì)匯報(bào)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(yàn)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(yàn)合格Inspection mu

19、st be carried out according to documented procedures and results per batch retained.根據(jù)操作規(guī)程檢驗(yàn)，并保持每批檢驗(yàn)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(yàn)All other components are inspected and released by the e-cigarette manufacturer.其他需要制造商檢驗(yàn)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(fù)責(zé)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(fā)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(fā)現(xiàn)不良，隔離煙液，JTI處理Incoming Material Inspection (IMI) E-liquids煙液檢驗(yàn)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(yàn)標(biāo)準(zhǔn)有制造商自己根據(jù)JTI的標(biāo)準(zhǔn)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(yīng)商QC報(bào)告MSDSRoHS Declaration of Conformity，RoSH符合性聲明Battery safety test reports電池安全測試報(bào)告M

25、aterials should not be allowed to enter production until satisfactory IMI results are observed檢驗(yàn)合格方能上線Incoming Material Inspection (IMI) Non E-Liquid components非煙液原材料檢驗(yàn)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(zhì)期就是原材料和產(chǎn)品適合生產(chǎn)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(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(chǎn)日期和收貨日期要記錄，先進(jìn)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(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 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(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Shelf life and storage policy保質(zhì)期和存儲規(guī)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(dǎo)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(yīng)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(biāo)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(jù) 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(shù)目E-cigarette manufacturer is responsible for physical, electrical, functional and visual testing制造商負(fù)責(zé)物理化學(xué)功能和外觀測試Fin

34、ished goods inspection General process成品檢驗(yàn)-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(yàn)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(yán)）檢驗(yàn)Reduced inspection can be introduced after multiple inspected lots which would have been accepted at a lower AQL.Reduced（減少）的檢驗(yàn)要在多批次檢驗(yàn)合格后才能導(dǎo)入Tightened inspection must be introduced if 2/5 consecuti

36、ve lots are deemed unacceptable on first inspection.連續(xù)5批中有2批不合格就要導(dǎo)入加嚴(yán)檢驗(yàn)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(fā)質(zhì)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(jī)種，數(shù)量和達(dá)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(zhǔn)備好快捷的貨運(yùn)（一般是空運(yùn)），隨貨備好裝運(yùn)文件JTI R&D QA will be informed of dispatch and shipment tracking information by E-cigarette manufacture.告知JTI貨運(yùn)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(chǎn)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(chǎn)污染Process過程Remove all materials from previous production from shop floor清除所有上次生產(chǎn)的物料Clean ma

40、chinery as necessary有必要的時(shí)候清潔機(jī)器Check materials for new production according to specification檢查原材料規(guī)格Prepare work instructions for new production準(zhǔn)備好作業(yè)指導(dǎo)書Setup machinery and production line準(zhǔn)備好機(jī)器和生產(chǎn)線Changeover procedure166. PROCESS CONTROLElectronic Cigarette Quality Policies and Procedures Copyright JTI

41、 2012Process (continued)過程Calibrate measurement equipment校準(zhǔn)測試設(shè)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(chǎn)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(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)The MQP should be designed and implemented by the E-cigarette manu

43、facturer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 (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(jìn)生產(chǎn)質(zhì)量控制計(jì)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(biāo)準(zhǔn)一致Full records of inspections made ac

44、cording to the MQP must be made and retained for 5 years.檢驗(yàn)的全部記錄必須保留5年。Manufacturing Quality Plan生產(chǎn)質(zhì)量控制計(jì)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(zhì)不確定成品檢查，當(dāng)成品不符合規(guī)格時(shí)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(guī)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(fù)責(zé)設(shè)定和維護(hù)工廠不合格品管理Action taken is related to defect level根據(jù)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(chǎn)品應(yīng)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(yīng)該被記錄并發(fā)給JTI研發(fā)質(zhì)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(wèi)生管理有助于降低外來物質(zhì)污染 E-cigarette

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

51、tion標(biāo)準(zhǔn)化的清潔和檢查Standardised building maintenance標(biāo)準(zhǔn)化的廠房維護(hù)Clearly organised workstations with no unnecessary materials整潔有序的工作臺，沒有雜物Hygiene Management衛(wèi)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(biāo)準(zhǔn)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(yán)重客戶抱怨Routine: product performance, normal visual quality defects一般：產(chǎn)品性能，一般外觀不良Special: Health/legal related complaints 嚴(yán)重：健康和法律相關(guān)

53、的抱怨Details of manufacturing-related complaints are communicated to e-cigarette manufacturer for further action詳細(xì)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(fù)責(zé)Corrective/pr

54、eventative action for complaints related to manufacturing process糾正和預(yù)防措施實(shí)施在生產(chǎn)過程Timely reports and feedback to R&D QA及時(shí)匯報(bào)給JTI研發(fā)品質(zhì)部Continuous improvement of manufacturing quality持續(xù)改進(jìn)生產(chǎn)過程質(zhì)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(yán)重質(zhì)量事故包括Health and safety related risks (actual or potential consumer injury)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）Corporate risks (product not registered for sale, confidential product shipped)公司風(fēng)險(xiǎn)（產(chǎn)品沒注冊，保密產(chǎn)品出貨）Cont

56、amination/Foreign Matter 污染和外部物質(zhì)摻入Serious Manufacturing Defects嚴(yán)重的產(chǎn)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(fā)生嚴(yán)重質(zhì)量事故，JTI要求制造商立刻調(diào)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(fù)責(zé)Corrective/preventative action as highest priority糾正和預(yù)防措施當(dāng)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(fā)生立即通知JTI研發(fā)質(zhì)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(nèi)部調(diào)查的內(nèi)容及影響到的產(chǎn)品范圍需要主動告知JTI研發(fā)品質(zhì)部Serious Quality Incident Management嚴(yán)重質(zhì)量事故管理257. QUALITY MANAGEMENTElectronic Ciga