精品糾正措施需求程序

1、永得利科技(無錫)有限公司ETLA Technology (Wuxi) Co., Ltd福根集團(tuán)成員企業(yè)Corrective Actio n Request糾正措施需求程序Revision版本Date日期Description 扌苗述Originator制定者M(jìn)anagement Representative 管理者代表General Manager 總經(jīng)理002010-03-10Update document per IS09001:2008 根據(jù)ISO9001:2008改版collincollinchunsiong012011-02-01Update companyaddress公司地址變

2、更江蘇省無錫市新加坡工業(yè)園錫興路266號郵編214028Correct Action Flow：糾正措施流程圖：Resp on sibility/Authority1.0職責(zé)/權(quán)限：initiating actions to prevent potential nonconformities.個(gè)人收集整理 勿做商業(yè)用途本程序用來規(guī)范不合格項(xiàng)的調(diào)查和執(zhí)行活動(dòng)，以及識別并采取對潛在不合格項(xiàng)目的預(yù)防活動(dòng)。SCOPE范圍This procedure applies to all departme nts in which corrective actio n request impleme ntati

3、 on is required.個(gè)人收集整理 勿做商業(yè)用途本程序適用于所有需要采取糾正措施需求的部門。DEFINITIONS 定義Supplier: this refers to material supplier, direct service supplier (subc on tract ing works).個(gè)人收集整理勿做商業(yè)用途供應(yīng)商：指材料供應(yīng)商、直接服務(wù)供應(yīng)商(外包工作)。CAR : Corrective Action RequestCAR :糾正措施需求單REFERENCES 參考NIL無RESPONSIBILITIES 職責(zé)The Man ageme nt Represe

4、ntative is resp on sible to prepare, impleme nt and mai ntai n this procedure.個(gè)人收集整理 勿做商業(yè)用途管理者代表負(fù)責(zé)本程序的制定、執(zhí)行和維護(hù)。PROCEDURE 程序Action for product nonconformities encountered in-house內(nèi)部不合格的纟片正 個(gè)人收集整理勿做商業(yè)用途1、For product nonconformity& potential nonconformity found, QA Dept is to be notified anddecide if i

5、ssu ing of CAR to resp on sible departme nt is required to provide the corrective action.個(gè)人收集整理勿做商業(yè)用途發(fā)現(xiàn)不合格/潛在不合格現(xiàn)象時(shí)，通知質(zhì)量部門，質(zhì)量部根據(jù)異常情況判定是否要開出“糾正預(yù)防措施報(bào)告”給相關(guān)部門進(jìn)行糾正預(yù)防。個(gè)人收集整理勿做商業(yè)用途2、Respective Dept is responsible to analysis and identify the root cause, and appropriatecorrective/preve ntive actio n is gen

6、erated to preve nt recurre nce/preve nt pote ntial nonconformity, within given time line.Department Supervisor to ensure the above is recorded on Corrective Action Request(CAR) form.個(gè)人收集整理勿做商業(yè)用途責(zé)任部門分析問題產(chǎn)生的原因，制定解決問題的措施與預(yù)防措施，并在規(guī)定時(shí)間內(nèi)提交 質(zhì)量部。部門主管應(yīng)確保所有的信息都填寫在糾正預(yù)防措施報(bào)告。個(gè)人收集整理勿做商業(yè)用途3、QA Dept is to follow up

7、with the progress of corrective action implemented, and reverify the outcome. Data collection is required in order to effectively illustrate validation. 個(gè)人收集整理勿做商業(yè)用途質(zhì)量部應(yīng)根據(jù)措施進(jìn)度隨時(shí)了解情況，并在規(guī)定時(shí)間內(nèi)進(jìn)行驗(yàn)證，盡量用數(shù)據(jù)說明問題，以便有 效驗(yàn)證。Actio n for noncon formity from supplier外部不合格糾正(供應(yīng)商)1、When rejects found during Incoming

8、 Quality Check, Quality Engineer to decide if issuing of CAR to the supplier is requiredfor corrective and preventive action.個(gè)人收集整理 勿做商業(yè)用途來料檢驗(yàn)發(fā)現(xiàn)不良時(shí)，由供應(yīng)商質(zhì)量工程師根據(jù)異常情況判定是否要開出“糾正預(yù)防措施 報(bào)告”給供應(yīng)商進(jìn)行糾正。2、Corrective Action Request when issued to the supplier, it should be return to the companywithin 5 working da

9、ys. It is followed by Purchasing Dept.個(gè)人收集整理 勿做商業(yè)用途供應(yīng)商應(yīng)該實(shí)施糾正措施需求，并將CAR在5個(gè)工作日內(nèi)回復(fù)給本公司，采購部門負(fù)責(zé)跟催QA responsible to verify if there are issues for the corrective action, it should be returned back to supplier for new corrective action. 個(gè)人收集整理 勿做商業(yè)用途質(zhì)量部門負(fù)責(zé)對供應(yīng)商原因分析和對策可行性進(jìn)行確定，如不可行則退回供應(yīng)商重新制 疋QA Departme nt to

10、 follow up and verify the actio n impleme nted to en sure effective ness (i.e. no recurrenee of nonconformity), and closed the CAR.個(gè)人收集整理 勿做商業(yè)用途質(zhì)量部門根據(jù)后期產(chǎn)品質(zhì)量情況來驗(yàn)證供方糾正措施是否有效，并結(jié)案確認(rèn)If there is no improveme nt see n through mon itori ng of performa nee for 3 mon ths, Man ager (Purchas in g)may recomme nd

11、 the supplier for disqualificati on with approval by the General Manager.個(gè)人收集整理勿做商業(yè)用途如果在3個(gè)月內(nèi)看不到改進(jìn)的業(yè)績，(采購)經(jīng)理可以向總經(jīng)理提出取消此供應(yīng)商合格 資格。Actio n for non co nformity from customer外部不合格糾正(客戶) 個(gè)人收集整理 勿做商業(yè)用途1、When received reject/complai nt from customer, Program Dept n eeds to forward thein formatio n to QA by e

12、mail or print copies of customer feedback form. QA Dept to form up a team in clud ing Engin eeri ng, Producti on and resp on sible departme nt, using Cause and Effect Diagram or other engin eeri ng tools to find out the actual root cause of defect and apply corrective and preventive measuresfor the

13、non-conformity. 個(gè)人收集整理 勿做商業(yè)用途當(dāng)顧客有投訴時(shí)，由項(xiàng)目部以郵件或顧客信息反饋單等的形式通知質(zhì)量部。質(zhì)量部應(yīng)在24小時(shí)內(nèi)組織工程、生產(chǎn)等相應(yīng)的部門，運(yùn)用因果圖等手段分析不合格產(chǎn)生的根本原因，針 對不合格的原因，采取相應(yīng)的糾正/預(yù)防措施個(gè)人收集整理勿做商業(yè)用途2、The 8D Report(in customer format or internal format if they have no requirements)should be sent to the customer within 3 days, when requested.個(gè)人收集整理 勿做商業(yè)用途對于

14、顧客有要求回復(fù)8D時(shí)，須三天之內(nèi)回復(fù)8D report給客戶(以客戶格式為主，如客戶 無格式要求，以公司8D報(bào)告回復(fù)) 個(gè)人收集整理勿做商業(yè)用途3、If the customer has no 8D requirement, the non-conformity reason analysis andcorrective measures should be com muni cated with customers within 2 days.個(gè)人收集整理 勿做商業(yè)用途顧客無8D要求時(shí)，二天內(nèi)將原因分析和采取措施與顧客溝通。4、QA Dept is in charge of verifyin

15、g and closing the corrective and preventive measures. 個(gè)人 收集整理勿做商業(yè)用途個(gè)人收集整理僅供參考學(xué)習(xí)質(zhì)量部門負(fù)責(zé)糾正預(yù)防措施的驗(yàn)證關(guān)閉Preve ntive Actio n Process 預(yù)防措施1、 Preve ntive actio n in formatio n is to statistic and an alyze the applicable in formatio n個(gè)人收集整理勿做商業(yè)用途source collected from all departme nts, toide ntify and an alyze t

16、he pote ntial noncon formity and the reas on accordi ng to the trend of con formity. The in formatio n could include as below:個(gè)人收集整理 勿做商業(yè)用途利用各部門適當(dāng)?shù)男畔碓催M(jìn)行統(tǒng)計(jì)分析，依據(jù)不良品趨勢，發(fā)現(xiàn)分析潛在的不合格及其 原因。即為預(yù)防措施信息，可包括：個(gè)人收集整理勿做商業(yè)用途Inspection and test record 檢驗(yàn)和測試記錄PFMEA an alysisPFMEA 分析Process mon itori ng record 過程監(jiān)視記錄Ex

17、ter nal in formatio n feedback夕卜部信息反饋Man ageme ntReview record 管理評審記錄2、Significant preventive action should be submitted to be reviewed. 個(gè)人收集整理 勿做商業(yè)用途 重大的預(yù)防措施要提交管理評審3、When preventive action needs document standardization, document updated follows Document Control Procedure ”個(gè)人收集整理勿做商業(yè)用途當(dāng)預(yù)防措施有文件標(biāo)準(zhǔn)化要求

18、時(shí)，相關(guān)文件更新按“文件控制程序”執(zhí)行1.5. Problem Solvi ng Methods解決問題的方法1、Where appropriate, structured problem solving methods shall be employed in corrective and preventive action process. In general, problem solving process invoIves:個(gè)人收集整理 勿做商業(yè)用途適當(dāng)時(shí)，在執(zhí)行糾正和預(yù)防措施過程中時(shí)應(yīng)該采用的方法，包括：Collectio n of sufficie nt in formatio

19、n/data and defi niti on of problem.個(gè)人收集整理勿做商業(yè)用途收集充足的信息/資料并確定問題點(diǎn)The use of appropriate QA/bra in storm ing tools such as con trol charts, histogram, Pareto diagram, charts, cause and effect diagram and other applicable methods for an alysis. Common sources of noncon forma nee could be the variati ons

20、 caused by material, equipme nt, huma n, method and environment.個(gè)人收集整理勿做商業(yè)用途 可以采用各種質(zhì)量管理工具來分析問題，例如：頭腦風(fēng)暴法、控制圖、直方 圖、柏拉圖、表格、因果圖以及其它質(zhì)量控制工具。造成不合格項(xiàng)的原因通 常會(huì)包括材料、設(shè)備、人員、方法以及環(huán)境等。個(gè)人收集整理勿做商業(yè)用途Ide ntify ing as many probable causes as possible, using the process of elim in ati on to weed out un likely cause through

21、 collective experie nee, i.e. identifying the most probable ones or the個(gè)人收集few 勿做商業(yè)用途盡可能多的找出可能的原因，然后通過排除法以及集體的經(jīng)驗(yàn)來排除次要原 因，以便識別出最有可能的或者“關(guān)鍵的少數(shù)”原因。個(gè)人收集整理勿做商業(yè)用途Ide ntify ing solutio ns to rectify the root cause/most probable cause found from the elimination process and using mistake-proofing methodology wherever practicable 個(gè)人收集整理勿做商業(yè)用途確定解決方案，以矯正識別出來的最有可能的或者“關(guān)鍵的少數(shù)”原因，并盡可能采取預(yù)防措施。Applyi ng where applicable these soluti