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

1、,Research 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 shelf life of components should be as indicated by the supplier. Shelf life of finished goods should be no more than 12 months 原材料供應(yīng)商要提供原材料的保質(zhì)期，成品保質(zhì)期不得超過(guò)12個(gè)月 Shelf life of sealed e-liquid containers is 12 months f

2、rom date of manufacture. Once containers are opened, the contents must be used within 30 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(chǔ)規(guī)定,11,4. PRODUCT MAINTENANCE,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Adverse storage conditions (heat, l

3、ight, humidity, mechanical stress) are a prime driver for deterioration of quality 不利的存儲(chǔ)條件（熱，光，濕度，重壓）會(huì)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 conta

4、iner. 煙液低于25度存儲(chǔ)，開封的煙液桶盡快重新封閉，不允許分出來(lái)的煙液倒回大桶里 Nicotine-free e-liquid must be stored separately from nicotine-containing e-liquid.尼古丁和非尼古丁煙液必須分開儲(chǔ)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(chǔ) Finished product must be stored at 205C and 60 15% relative humidit

5、y成品必須在205C 和 60 15%條件下存儲(chǔ),Shelf life and storage policy,12,4. PRODUCT MAINTENANCE,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Objective目標(biāo) To ensure that finished goods meet JTI Product Quality Standards滿足JTI要求 Process過(guò)程 Following production of finished goods samples are t

6、aken for inspection抽檢 The number of samples required is defined in ISO 2859-1, and is related to batch size and level of sampling (normal, reduced, tightened)根據(jù) ISO 2859-1 Acceptability/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-ci

7、garette 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(cè)試,Finished goods inspection General process成品檢驗(yàn)-基本步驟,13,5. PRODUCT MONITORING,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Sampling is initiated as normal inspection

8、for the first inspected lot.第一批成品作為normal（正常）來(lái)檢驗(yàn) Switching to reduced or tightened inspection should be carried out once 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

9、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 consecutive 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 scheme,14,5. PRODUCT MONITORING,Electronic Cigarette Quality Policies and

10、Procedures, Copyright JTI 2012,E-Cigarette manufacturer is requested to provide representative samples of each product manufactured 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 manufac

11、turer.JTI會(huì)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 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)

12、信息,15,5. PRODUCT MONITORING,Monthly Sample Submission月度送樣,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Objective 目的 To prepare the manufacturing process for a new production in a controlled manner控制生產(chǎn)過(guò)程 Benefits 好處 Eliminate potential for wrong material usage, incorrect a

13、ssembly or product contamination防止錯(cuò)料，不正確的裝配和生產(chǎn)污染 Process過(guò)程 Remove all materials from previous production from shop floor清除所有上次生產(chǎn)的物料 Clean machinery 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 m

14、achinery and production line準(zhǔn)備好機(jī)器和生產(chǎn)線,Changeover procedure,16,6. PROCESS CONTROL,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Process (continued)過(guò)程 Calibrate measurement equipment校準(zhǔn)測(cè)試設(shè)備 Start production line, perform start-up inspection開線，開線檢查 Commence full production whe

15、n required specifications within tolerances are observed開線檢查合格開始生產(chǎn),Changeover procedure換線程序,17,6. PROCESS CONTROL,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,The Manufacturing Quality Plan (MQP) is a detailed document covering the measurement plans and process control gu

16、idelines necessary to deliver product conforming to JTI standards生產(chǎn)質(zhì)量控制計(jì)劃涵蓋測(cè)試計(jì)劃和過(guò)程管控以達(dá)到JTI標(biāo)準(zhǔn) The MQP should be designed and implemented by the E-cigarette manufacturer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

17、級(jí)）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 according 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,18,6. PROCESS CONTROL,Electroni

18、c Cigarette Quality Policies and Procedures, Copyright JTI 2012,QUIP covers the 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(dòng)QUIP Benefits好處 Ensures defe

19、ctive product is not shipped確保不良品沒(méi)有出貨 Clear guideline for effective and efficient decision making清晰的規(guī)范來(lái)做出高效的決定 E-cigarette manufacturer is responsible for following guidelines 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 l

20、evel根據(jù)不良的等級(jí)來(lái)采取措施,QUIP Procedure,19,6. PROCESS CONTROL,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,D Class defects require stopping the production line, 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

21、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 yes, 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

22、夠察覺(jué)到的不良，如果是，停線，解決問(wèn)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(wèn)題，抽樣檢查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事件應(yīng)該被記錄并發(fā)給JTI研發(fā)質(zhì)量部,QUIP Procedure,20,6. PROCESS CONTROL,Elec

23、tronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Correct hygiene management is essential to mitigate the risk of foreign matter contamination衛(wèi)生管理有助于降低外來(lái)物質(zhì)污染 E-cigarette 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 for

24、eign matter control program實(shí)施外來(lái)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 inspection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 unnecessar

25、y materials整潔有序的工作臺(tái)，沒(méi)有雜物,Hygiene Management衛(wèi)生管理,21,7. QUALITY MANAGEMENT,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Standard process for dealing with communication expressing dissatisfaction with product quality標(biāo)準(zhǔn)處理流程 JTI collect, categorise and evaluate complaints from

26、 consumers JTI收集，分類和評(píng)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)的抱怨 Details of manufacturing-related complaints are communicated to e-cigarette manufacturer

27、for further action詳細(xì)信息會(huì)通知到制造商,Consumer Complaints客戶抱怨,22,7. QUALITY MANAGEMENT,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,E-cigarette manufacturer is responsible for:制造商負(fù)責(zé) Corrective/preventative action for complaints related to manufacturing process糾正和預(yù)防措施實(shí)施在生產(chǎn)過(guò)程 Timel

28、y 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(guò)程質(zhì)量 Reimbursement or replacement of defected devices to JTI賠償或者換貨,Consumer Complaints客戶抱怨,23,7. QUALITY MANAGEMENT,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Serious Qual

29、ity 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(duì)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(méi)注冊(cè)，保密產(chǎn)品出貨） Contamination/Foreign Matter 污染和外部物質(zhì)摻入 Serious Manufacturing Defects嚴(yán)重的產(chǎn)品不良 I

30、n 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 Management,24,7. QUALITY MANAGEMENT,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,E-cigarett

31、e 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(lái)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 devices to JTI賠償或者換貨 In case E-cigarette manufacturers internal

32、 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(dòng)告知JTI研發(fā)品質(zhì)部,Serious Quality Incident Management嚴(yán)重質(zhì)量事故管理,25,7. QUALITY MANAGEMENT,Electronic Cigarette Q

33、uality Policies and Procedures, Copyright JTI 2012,E-cigarette manufacturer must ensure full traceability of finished JTI product and materials used in their production追溯產(chǎn)品和原材料 Benefits:好處 Supports root cause analysis in case of defects/complaints不良可以協(xié)助原因分析 Enhanced shelf life control加強(qiáng)保質(zhì)期管理 Support

34、s product recall process支持產(chǎn)品召回 Material traceability原材料追溯 Manufacturer must take records to track the flow of each material batch from delivery and IMI to finished product batch.形成記錄追溯原材料從進(jìn)料到成品的過(guò)程,Traceability,26,7. QUALITY MANAGEMENT,Electronic Cigarette Quality Policies and Procedures, Copyright JTI 2012,Finished product traceability成品追溯 Manufacturer must utilise a product date coding schematic which allows traceability back to :使用產(chǎn)品日期編號(hào)系統(tǒng)可以追溯到 Date of manufacture出廠日期 Production date生產(chǎn)日期 Details of the product da