文件制（修）訂申糾正和預(yù)防措施程序

1、文件類型document type品質(zhì)管理體系程序qms procedure 應(yīng)用范圍application scope通用general修訂記錄revision history版本rev.修改內(nèi)容 revised contents作者author生效日期eff. dateainitial releasing with iso/ts16949 requirementsxxxnov.07,2006b change the title from “改正和預(yù)防行動程序correctiveand preventive action procedure” to “糾正和預(yù)防措施程序 procedure

2、for corrective & preventive action”xxxjan.10th, 2009crevised the procedure to meet iso13485 regulations (china) & cfr21 fda 21 cfr qsr(quality system regulation) 820 (usa) requirementsxxx15-07-2014文件審批 approval本文件須經(jīng)相關(guān)部門工程師（或主管）簽批，請作者指定。this document shall be reviewed by iso coordinator and. the auth

3、or shall determine.編寫部門originate dept.相關(guān)部門relevant dept.部門名稱dept. titleqamanufacturingmachiningengineeringpe工程師姓名name of engineer工程師簽署signature經(jīng)理姓名name of manager經(jīng)理簽署signature管理者代表簽署 signature of m.r.ditto總經(jīng)理簽署 signature of gm.拒簽理由 reason of reject:文件分發(fā) distribution部門 dept.數(shù)量 qty部門 dept.數(shù)量qty部門 dept

4、.數(shù)量qtyengineeringassemblyoffqa1platingsourcinghrstampingfinancemaintenancemolding1 目的 purpose 本程序規(guī)范了為消除存在或潛在的不合格而采取糾正預(yù)防措施的流程，以確保類似不合格不再發(fā)生或潛在不合格的發(fā)生，促進質(zhì)量管理體系的持續(xù)改進。this procedure define the process of taking corrective and or preventive actions to eliminate existing or potential non-conformity, to prev

5、ent similar non-conformity fromreoccurring or occurring of potential non-conformity. promote continuous improvement of quality systems.2 范圍 scope 本程序適用于公司質(zhì)量管理體系范圍內(nèi)糾正和預(yù)防措施的制定、實施與驗證。 this procedure is applicable to the formulation, implementation and verification of corrective action and preventive ac

6、tion in the company quality management systems3 定義 definition3.1 不合格：未滿足指定要求?！耙蟆笔侵该魇镜?、通常隱含的或必須履行的需求或期 望，如法規(guī)、行業(yè)標準要求，公司文件要求等 non-conformity: non-fulfillment of a specified requirement. “requirement” refers to the explic it, usually implicit, or the need or expectation is a must to fulfill. such as re

7、gulation,industry requirement,company documents etc. 3.2 關(guān)鍵不符合 ：違反法定工藝、超出內(nèi)控質(zhì)量標準或違反生產(chǎn)相關(guān)法規(guī)規(guī)定，將會造 成產(chǎn)品整批報廢、產(chǎn)品召回、重大客戶投訴. 不符合關(guān)系到安全、企業(yè)的品牌形象和產(chǎn)品的市場影響。 critical non-conformity : violate legal process, beyond standard of internal control or violation of related regulation requirement , which will cause scrap o

8、f the whole batch products, recall of product,major customer complains, the non-conformity related to safety , brand image of enterprise and negative market impact of product. 3.3 糾正：存在不合格的處置包括修理，返工或調(diào)整。 correction: repair, rework, or adjustment relates to the disposition of an existing nonconformity

9、. 3.4 糾正措施：消除已發(fā)生的不符合或者其他不期望的情況的原因的措施。 corrective action: the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence. 3.5 預(yù)防措施：消除潛在不符合或者其他不期望的情況的原因的措施。 preventive action: action taken to eliminate the cause of a potentia

10、l nonconformity, defect, or other undesirable situation in order to prevent occurrence.一個不符合或者潛在不符合可能有多個原因。there can be more than one cause for non-conformity or a potential non- conformity.備注1) 糾正和糾正措施是有區(qū)別的，糾正是針對不符合的，而糾正措施是針對不符合的原因的。correction and corrective actions are different. correction is aga

11、inst non- conformity whereas corrective action is against the cause of non conformity.備注2) 糾正措施用于防止不符合再發(fā)生，而預(yù)防措施用于防止不符合發(fā)生。corrective action is taken to prevent recurrence of non conformity whereas preventive action is taken to prevent occurrence of non-conformity. 3.6 趨勢分析- 一種數(shù)據(jù)分析，是指通過對capa的輸入以及輸入之間交

12、叉關(guān)系分析，根 據(jù)趨勢分析潛在質(zhì)量問題. trend analysis one type of data analysis, through cross relationship analysis between capa inputs, identify the potential quality issues based on the trend analysis. 3.7 風(fēng)險控制在特定的水平內(nèi), 經(jīng)過討論采取保護措施以降低或控制對人、財產(chǎn)或環(huán)境 的風(fēng)險的過程。 risk control- in the specific level, per discussion the process

13、 taken protective actions to reduce or control risk on human, property or environment 3.8 糾正預(yù)防措施 負責(zé)人：負責(zé)協(xié)調(diào)某一特定糾正預(yù)防措施報告的決定和實施的個人。 capa responsibility: the person who is responsible for coordination of the specific capa report decision and implementation 4. 職責(zé)和權(quán)限 responsibility and authority 4.1問題產(chǎn)生的主管

14、部門負責(zé)主導(dǎo)對不合格執(zhí)行分析、制定、執(zhí)行相應(yīng)的糾正措施，對潛 在不合格負責(zé)實施預(yù)防措施。 the department in which issues arising from is responsible for leading of analyzing, formulating and implementing corresponding corrective actions for the existing nonconformities, and take preventive actions for the potential nonconformities. 4.2 質(zhì)量管理部門全

15、面負責(zé)糾正措施與預(yù)防措施的運行： qa is responsible for the centralized management of capa report 品質(zhì)文員負責(zé)糾正措施與預(yù)防措施報告編號, 歸檔管理 qa clerk is responsible for the coding, registration and archive management. qa工程師確定不符合是否需要有capa流程，糾正與預(yù)防措施計劃的審批及定期的統(tǒng) 計分析, 跟蹤糾正預(yù)防措施的實施過程并驗證其有效性。 qa engineer is responsible for the determination

16、if capa is needed, periodical statistical analysis, follow up the implementation of corrective & preventive actions and verify the effectiveness 品質(zhì)經(jīng)理負責(zé)所有capa 糾正預(yù)防措施計劃及capa關(guān)閉的審核。 quality manager is responsible for review of all corrective & preventive plan and closure of capa. 4.4 公司總經(jīng)理負責(zé)capa 糾正預(yù)防措施計

17、劃及capa關(guān)閉的的最終審批。 site leader is responsible for the final approval of all corrective&preventive plan and closure of capa 4.5 公司管理層負責(zé)對糾正預(yù)防措施進行年度評審 company management team is responsible for the annual review of corrective actions and preventive actions.工作流程working flow chart5. 程序 procedure 5.1 糾正預(yù)防措施輸

18、入: input of corrective &preventive actions 5.1.1糾正預(yù)防措施來自于質(zhì)量管理體系范圍內(nèi)，引起產(chǎn)品不合格或潛在不合格或者其他 質(zhì)量問題的各過程。其輸入有以下幾個方面： the sources of capa are from each process that caused non-conformity or potential non- conformity in the quality management system includes: 5.1.1.1和原材料, 半產(chǎn)品, 成品有關(guān)的接收活動, the inspection activitie

19、s related to raw materials, in process products and finished goods, 5.1.1.2客戶投訴, 產(chǎn)品退回等問題 customer complaints, products return etc. issues 5.1.1.3質(zhì)量審核 quality audit 5.1.1.4管理評審 management review 5.1.1.5安全問題 safety issues 5.1.1.6其他必要的分析數(shù)據(jù)other analysis data as necessary 5.2 分析糾正預(yù)防措施輸入 analyze capa sou

20、rce of data 5.2.1質(zhì)量工程師根據(jù)分析糾正預(yù)防措施的輸入, 如果是關(guān)鍵的質(zhì)量問題, 則需馬 上啟動糾正預(yù)防措施,如果是非關(guān)鍵問題,則應(yīng)對該問題進行分析之后確定是否啟動 糾正預(yù)防措施。 quality engineer refer to the attachment i to analyze the input of capa. for the key non- conformities, capa shall be launched immediately, for non- key non-formalities, need conduct analysis on the is

21、sues, then determine if capa is needed to launch.5.2.2所有的審核發(fā)現(xiàn)的不合格, 客戶投訴，fqc退貨以及管理評審將馬上啟動糾正預(yù)防 措施。 for all non-conformities raised during audit, customer complaints, fqc rejections and non- conformities from management review, capa shall be launched immediately5.2.3必要時, 運用適當?shù)慕y(tǒng)計方法識別重復(fù)發(fā)生的質(zhì)量問題。 appropria

22、te statistical methodology shall be employed where necessary to detect recurring quality problems 統(tǒng)計方法包括statistical methodology includes: 柏拉圖pareto charts 運行圖run charts 控制圖control charts 平均值和標準偏差mean and standard deviation 比較t檢驗t tests for comparisons 實驗設(shè)計experimental design (doe) 圖形方法（魚刺圖，直方圖，散布圖，電

23、子表格等） graphical methods (fishbone diagrams, histograms, scatter plots, spreadsheets, etc.)5.3糾正預(yù)防措施的啟動 launch of capa 5.3.1經(jīng)過對糾正預(yù)防措施輸入分析并確認必要性后, 質(zhì)量工程師將填寫糾正預(yù)防措施 報告，完成以下部分： quality engineer shall fill in per analysis on capa input 巨and confirm the necessity, the input includes: 5.3.1.1指定一個糾正預(yù)防措施控制號。編號

24、規(guī)則為：糾正預(yù)防措施/年/號碼順序。 例：capa14001 (capa=糾正預(yù)防措施, 14=2014, 001=這一年的第一份報告)。 specify one code# of capa, coding rule as: capa/year/the sequence of code#. for example: capa14001 (capa=corrective actions & preventive actions, 14=2014, 001=the first report of the year. 5.3.1.2填寫“提出人”和提出日期。 fill in “sponsor” an

25、d sponsor date 5.3.1.3對糾正預(yù)防措施問題進行描述。盡可能詳細地參考相關(guān)程序，規(guī)定和客戶要求 等。附上所有有幫助的其他信息資料。 describe the issue in as much detail as possible reference to relevant procedures, specification and customer requirements, attach other supporting data. 5.3.2質(zhì)量工程師對糾正預(yù)防措施報告進行復(fù)制存放于糾正預(yù)防措施文檔中以做跟蹤之 用。并將糾正預(yù)防措施報告原件，發(fā)給糾正預(yù)防措施負責(zé)人。 qu

26、ality engineer copy capa report and store in the folder for follow up and send the original capa report to the responsible person. 5.3.3同時質(zhì)量工程師應(yīng)在糾正預(yù)防措施跟蹤記錄表中記錄報告編號、發(fā)出人、發(fā)出時 間、質(zhì)量問題類型及問題的描述以便于跟蹤。 quality engineer shall record capa code, sponsor, time, quality issue types and issue 5.3.4問題產(chǎn)生的主管部門負責(zé)主導(dǎo)糾正預(yù)

27、防措施的調(diào)查及措施制定直到完成。除非得 到質(zhì)量管理部負責(zé)人的確認,糾正預(yù)防措施調(diào)查分析/制定措施必須在7個工作日 內(nèi)完成。 department functional leader is responsible for the investigation and actions of the capa until the completion.capa root cause investigation and actions shall be completed within 7 workdays unless it is confirmed by quality manager.5.4不合格

28、根源調(diào)查以確定根本原因 root cause analysis of non-conformities to identify the root cause 5.4.1調(diào)查有關(guān)產(chǎn)品，過程, 品質(zhì)系統(tǒng)不合格的原因 investigate the cause of nonconformities relating to product, process, and the quality system. 5.4.2 確定問題和特性 identify problem and characterize, 5.4.3 確定范圍和影響 determine scope and impact 5.4.4 調(diào)查要

29、根據(jù)人、機、料、法、環(huán)可能的影響因素 investigate refer to man, machine, material, method, environment etc. factors. 5.4.5 問題根源分析工具 root cause analysis tools -魚刺圖fishbone diagrams - 5個為什么5”whys” -故障樹分析fault-tree analysis -其它among others 5.4.6 確定問題根源 determine root cause 指定一個根本原因以用于趨向分析。 specify root cause for the tren

30、d analysis. 5.5確定糾正預(yù)防措施 identify corrective and preventive actions 5.5.1問題根源產(chǎn)生的主管部門針對根本原因制定全面的、適當?shù)募m正和預(yù)防性措施, 采 取糾正和預(yù)防性措施消除或減少存在的或潛在的不合格程度應(yīng)與不合格的影響以 及風(fēng)險等級一致。 the department responsible for the non-conformities shall define comprehensive, appropriate corrective and preventive actions based on the root c

31、ause. the degree of corrective and preventive actions taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered.5.5.2在糾正預(yù)防措施報告中記錄將要采取的措施，指定責(zé)任人，并對每個措施計劃 指定完成日期，并要求責(zé)任人簽字確認。 record the actions in th

32、e capa report, define the responsible person and completion date for each action, request responsible person to sign for confirmation.5.5.3在完成上述步驟后，糾正預(yù)防措施負責(zé)人會在報告的“capa 負責(zé)人”處簽署姓名 和日期，并提交給部門經(jīng)理審核及簽名。然后糾正預(yù)防措施負責(zé)人把此份capa報 告提交質(zhì)量工程師以供其審核。 after the above steps are completed, capa responsible person shall si

33、gn his (her) name and date and submit the report to department functional leader for review and signature. 5.5.4質(zhì)量工程師將在糾正預(yù)防措施追蹤表上記錄“措施計劃接收日期”。 quality engineer shall record the receipt date of capa in capa tracking log sheet. then capa responsible person submit the capa report to quality engineer fo

34、r review.5.6 執(zhí)行糾正預(yù)防措施 implementation corrective and preventive actions 5.6.1責(zé)任部門負責(zé)人負責(zé)糾正預(yù)防措施的實施。 the responsible department manager is responsible for the implementation of capa and record changes. 5.6.2如果糾正措施沒有在計劃的日期內(nèi)實施，質(zhì)量工程師應(yīng)將該情況報告給質(zhì)量經(jīng) 理。如果在跟蹤后3個工作日之后沒有進展，質(zhì)量經(jīng)理應(yīng)將該情況報告給總經(jīng)理 并開出一份新的capa 報告 if capas are

35、 not implemented within the defined schedule, quality engineer shall report the situation to quality manager, if no any progresses of 3 workdays after follow up, quality manager shall report the situation to site leader and issue a new capa report.5.7 核實及確認糾正預(yù)防措施有效性 verify or validate the effectiven

36、ess of corrective and preventive actions 5.7.1 質(zhì)量工程師核實及確認糾正預(yù)防措施是否有效，對產(chǎn)品沒有負面影響，確認包括： 糾正預(yù)防措施是否有效？ 是否可能產(chǎn)生別的潛在不良？ 評審數(shù)據(jù)是否關(guān)聯(lián)到核實及確認活動？措施實施后類似的問題是否存在？ 在糾正預(yù)防措施報告中記錄驗證方法和計劃驗證日期。 quality engineer verify or validate the corrective and preventive actions to ensure that such actions are effective and do not adver

37、sely affect the products，the verification or validation activity includes: effectiveness: did the actions work? did it create other potential nonconformance? review data associated with verification or validation activities, if similar quality problems exist after implementation. record the verifica

38、tion method and date in the capa report. 5.7.2如果質(zhì)量工程師驗證糾正預(yù)防措施是有效的，不需要修改，質(zhì)量工程師會在糾正預(yù) 防措施報告處簽署姓名和日期, ,并提交capa 報告給品質(zhì)經(jīng)理審批。 if quality engineer verified or validated the corrective and preventive actions to be effective, the capa reports are not needed to revise, and then quality engineer shall sign his o

39、r her name and date in the capa report, and submit the capa report for qa manager approval 5.7.3 質(zhì)量經(jīng)理提交其批準的capa 報告給公司總經(jīng)理作最終評審及簽名。 quality manager submit the capa report to site leader for final review and signature. 5.7.4 對關(guān)鍵不符合capa 糾正預(yù)防措施，需要上升到itt ics 運作總監(jiān)審批 for critical non-conformities, capa shal

40、l be escalate to itt ics operation director for approval. 5.7.5如果質(zhì)量工程師驗證糾正預(yù)防措施是無效的，此糾正預(yù)防措施報告需上升到公司總 經(jīng)理采取進一步行動計劃。 if quality engineer verified or validated the corrective and preventive actions to be not effective, then capa report shall be escalated to site leader for further action plans. 注意:對措施計劃的

41、修改可根據(jù)實際情況在糾正預(yù)防措施開啟的任何時間內(nèi)進行。 note: the modification of actions plan can be done at any time of launching of capa based on the actual situation. 5.8文件化糾正預(yù)防措施及變更 document the corrective and preventive actions and change5.8.1 糾正預(yù)防措施經(jīng)證實有效后，行動責(zé)任人需文件化糾正預(yù)防措施及變更及知會，培訓(xùn)相 關(guān)人員。 action owners shall document the a

42、ctions and changes after the corrective and preventive actions are verified effective and disseminate or train related employees.5.9 糾正預(yù)防措施報告的關(guān)閉 capa report closure 5.9.1 確認批準的糾正預(yù)防措施已經(jīng)全部完成，糾正預(yù)防措施的合理性、有效性和充分性證 實后，capa 報告應(yīng)予以關(guān)閉。品質(zhì)工程師并在capa驗證人簽署姓名和日期。然后提 交給品質(zhì)經(jīng)理，公司總經(jīng)理評審簽名。 confirm the approved corrective and preventive actions to be completed and actions are verified as rationale, effectiveness, sufficiency, the capa report can be closed. quality engineer shall sign his /her name and date in the report. then submit to quality manager and site leader for signature. 注意:如果糾正預(yù)防措施無效,則該糾正預(yù)防措施不予關(guān)閉，質(zhì)量工程師