纠正与预防措施控制程序(中英文)

1、纠正与预防措施控制程序Corrective and Preventive Action Control Procedure目的 Purpose ：及时发现不符合，并采取有效的纠正和预防措施，以消除存在或潜在的不符合原因， 实现管理体系的不断完善和持续改进。To found non-conformity in time, and to take effective corrective and preventive action that remove the actual or potential non-conformity reasons, to realize the managemen

2、t system is constantly improved and continually improved.范围 Scope ：适用于管理体系运行过程中的改进、纠正和预防措施的制定、实施和验证。This documentapplies to the improvementin the process of managementsystem, formulation, implementation and verification of corrective and preventive action. 3.术语 Terms ：纠正为消除已发现的不符合所采取的措施。Corrective -

3、 the action taken to remove the non-conformity founded. 纠正措施为消除已发现的不合格或其他不期望情况的原因所采取的措施。Corrective action - the action taken to remove the reason of the non-conformity founded or other not expected situation.预防措施为消除潜在的不合格或其他潜在不期望情况的原因所采取的措施。Preventive action - the action taken to remove the reason o

4、f the potential non-conformi or other not expected potential situation.重大事故出现了人员伤亡或造成环境污染或经济损失大于 5 万元；Major accident - person casualty appearedor environment pollutionor morethan￥50000 economic loss;一般事故未出现人员伤亡或未造成环境污染或经济损失少于 5 万元；Ordinary accident - no person casualtyappeared or no environment poll

5、utionor less than ￥50000 economic loss;4.过程分析 Process analysis：输入 Input输出 Output顾客退货/ 顾客抱怨/ 反馈；Customerreturns /customer complaints / feedback; 内审结果； The result of audit;质量改进计划 The plan of quality improvement持续改进报告 The report of continue improvement 改进的产品和过程 Products and processes improved管理评审结果； Th

6、e result of management review;二、三方审核结果；Theresultof second-party or third-party audit;重大/ 重复性质量问题； Major or repetitivequality problems;环境安全事件Any incident in HSE过程指标 Process measurement indicator：项目Item监视方法和频次Monitoring method & frequency测量部门Department responsible for measurement纠正和预防措施准时完成数量 纠正和预防措施数

7、量*100%纠正和预防措施准时完成率Numberof correctiveandpreventive actionsRateof correctiveandpreventivecompleted in time Numberof correctiveandCTOactions completed in timepreventive actions*100%每年Annually职责 ResponsibilityCTO、CAO 分别负责对质量体系、HSE 体系的不符合、纠正/预防措施的归口管理，负责组织体系纠正和预防措施实施的跟踪验证，并组织监督检查；负责组织本部门不符合的原因分析，制订和实施纠正

8、/预防措施；CTO(CAO focus HSE system) is responsiblefor centralizedmanagement of system non-conformityand corrective/ preventiveactions,is responsiblefororganizationthe tracking and verifyingof system correctiveand preventive actions, and organize supervisionand check; is responsible for analyzing the rea

9、son of own department non-conformity, formulating and implementing corrective / preventive actions.COO 负责组织对较大以上（含较大）质量事故、生产事故、不合格（含顾客投诉）、潜在不合格，制定纠正和预防措施，跟踪验证实施效果。Manufacture Departmentis responsible for organizationformulatingcorrectiveand preventive actions, tracking and verifying the implement ef

10、fectiveness, for larger or m ( includinglarge ) qualityaccident,manufacture accident,non-conformity( including customer complaints ), potential non-conformity.责任部门负责按要求进行不符合的原因分析、制订与实施相应的纠正和预防措施；负责传递有关数据和信息。Each department is responsible for analyzing the reason of non-conformity according the requi

11、rement, formulate and implement relatedcorrectiveand preventive actions;is responsible for passing related data and information.活动程序 Activity procedure不符合的识别判定 Identification and judgement of non-conformity违反法律、法规和其他要求；Laws 、 regulations and other requirements are bro；ken管理体系文件不符合标准要求；Document of ma

12、nagement system dont conform the standard requireme；nt违反体系运行标准要求，造成质量、环境污染、安全、生产、设备或其他事故。The requirement of system standard is bro，ketnhat causes the accidents of quality, environmental pollution, safety, manufacture, equipment or others.未按规定要求开展质量、环境、安全、测量管理活动或其活动不符合规定要求。The management actions of q

13、uality, environment, safety, measurement dont implement as the specifircequirement or the actions dont conform the specific requirement.体系某要素缺失或部分缺失。Certain or part element of the system is missed.不符合相关方、顾客的合理要求。The reasonable requirement of interested party or customer are not conformed.不符合的信息来源 Th

14、e source of non-conformity information作业过程中的监测及各项检查与监测。Monitor of operation process and each inspection and monitor.对事故、事件（含未遂过失）调查分析。The investigation and analysis for accidents, incidents ( including near misses).相关方的反馈（包括顾客满意度调查、顾客投诉）。The feedback of interestedparty ( includingcustomer satisfacti

15、onsurvey, customer complaints ).测量设备检定或校准的结果。Verification or calibration result of measurement equipment.质量健康安全环境方针和目标。Quality & HSE policy and object.数据分析。Data analysis.质量健康安全环境体系的审核和管理评审。Audit and management review of quality & HSE system.体系文件的执行情况。Implementation performance of system document.纠正和

16、预防措施分级 The level of corrective and preventive actions发生下列情况时由业务主管部门组织采取纠正措施：The business departments need to adopt corrective actions when one of the following situation is happened:发生较大及以上质量事故时； Larger or more quality accident happened;发生较大及以上设备事故时； Larger or more equipment accident happened;发生重伤及以

17、上生产安全事故时； Serious injuryor above manufacture safety accident happened;发生重大及以上环境污染事故时；Serious or aboveenvironment pollution accident happened;发生生产事故时； Manufacture accident happened;顾客对产品质量有较大投诉；Customerhavelarger complaints about the product quality;体系审核中（内审、外审）开具不符合项时； Non-conformity from system aud

18、it ( internal audit, external audit );管理评审提出纠正措施要求时； Managementreview proposes requirement of corrective actions;业务主管部门对所得数据和信息分析认为过程活动没有达到预期结果时。Thebusiness departments through analyze the data and information obtained, consider that processactivities dont achieve the intended.results发生下列情况时由业务主管部门组

19、织采取预防措施：The business departments need to adopt preventive actions when one of the following situation is happened:体系发生变化，预见可能发生不符合时； As system has change, to estimate that non-conformity may be happened;法规发生变化，预见可能发生不符合时； As regulation has change, to estimate that non-conformity may be happened;已采取过

20、纠正措施的项目，预见可能发生不符合时； To estimate the item that corrective has been taken may occurs non-conformity, ;顾客认为必须采取预防措施时；Customerconsiders that preventive actions must be taken;管理评审提出采取预防措施时； Managementreview presents that preventive actions need be taken;归口管理部门对数据和信息分析认为需采取预防措施时； Through analyze dataand i

21、nformation, the centralized management department considers that preventive actions need be taken;发生下列情况时，由责任部门组织采取纠正或预防措施：As one of the following situationis happened,the correctiveor preventive actions should betaken by responsible department:发生一般质量事故时； General quality accident;发生一般设备事故时； General

22、equipment accident;发生轻伤生产安全事故时； Minor manufacture safety accident;发生一般环境污染事故时； General environment pollution accident;异议损失金额一批次小于 5 万元而需要采取纠正措施时； The objectionlossesmoney that a batch is less than 50000, so the preventive actions need to be taken;本部门对数据和信息分析认为过程活动没有达到预期目的时；To analyze the data and in

23、formation, own department considers that process activitty adcohnieve the prospection target;本部门对数据和信息分析认为需采取预防措施时；Thoughanalyze data andinformation, own department considers that the preventive actions need to be taken;日常活动中内审员、管理员提出需采取措施时； In dailyactivityt,he auditoror administrator put forward t

24、hat action need be taken;体系审核提出观察项时。System audit put forward observation items.产品质量事故（指产品在生产过程或运输过程中出现的不符合）分级按照产品质量事故管理办法执行。According to“Product quality accident management syste”m, to grade product quality accident, just including nonconformity product arosein production processor transportation pr

25、ocess.采取措施的流程 The process of actions taken由业务主管部门组织采取措施的流程The departments in charge of business organize the process of actions taken.业务主管部门将不符合信息以不符合报告的形式传递给不符合发生部门。Thedepartment in charge of business pass the nonconformity informationto the department happened nonconformityby the form of “nonconfo

26、rmity report”.责任部门在 1 个工作周内进行以下工作：The responsible departments carry out the following work within one work week:评审不符合，并找出其产生的原因；To review the non-conformity, and find out the reasons causing non-conformity;拟定措施，报部门领导审核；To draw up actions plan, and pass the actions plan to department leader checkin；g

27、业务主管部门对责任部门的原因分析及所拟定的措施进行评价，并批准，如未获得批准,重新进行原因分析及措施制订； The department in charge of business verifies the reason analysis and the actions planed from responsible department, and ap，proivfethe approval has been got, return to reason analysis and action plan; d.实施批准的措施； To implement the approved action；

28、se.责任部门进行效果自验，验证效果达到预期目的后报请下达该项不符合报告的业务主管部门验证。The responsible department takes effect self-inspection, after the result verified achieves the prospection target, asks the department in charge of business who issues the non-conformity report to verify.责任部门在分析原因有困难时，可申请业务主管部门召集有关部门共同研究、分析，并制订措施。Theres

29、ponsible department hasdifficulttyo analyze the reason, canapply thedepartment in charge of business to convene related department to re，seancahlyze， and planning actions.对需增加资源的措施，责任部门提请由业务主管部门组织有关部门研究、审查， 报公司主管领导或管理者代表批准。责任部门按审批后的措施计划实施。For the actions that resources need be increased, responsible

30、 department apply for that department in charge of business organizerelateddepartment to research and checkthe actions,andpass the actions plan to companymainleader or management representativeto approve. Theresponsible department implement according to the approved actions plan.业务主管部门按制订的措施计划对其实施跟踪

31、检查。Departments in charge of business implement tracking and verification according to the actions plan formulated.业务主管部门在接到验证申请后或在规定的验证时间对措施的实施效果进行验证，对没有达到预期效果的项目，责成责任部门重新提出措施，并按以上程序重新实施， 直至结果确认有效为止。After receive the verification application or in specified verification time, the depar in charge of

32、business verifythe implement effectof actions,for the projectsdo notachieve the desired effect, order the responsible departmernetpltaon the actions and re-implement as the above procedure, until the result is verified effect.对纠正或预防措施计划实施效果验证的内容包括：The content of the verificatioonf the implementary e

33、ffectof correctiveor preventive actions plan, include:计划中的各项措施是否都已完成； Whether each action in plan is finished;计划是否按规定日期完成； Whether the plan is finished within specified time; c.实施效果是否达到了预期的目的；Whether the implement effect has achieved the expectant target;d.同类情况是否都得到了解决。 Whether the same kind cases h

34、ave been solved.完成了上述程序的不符合报告要复制一份，复制件由责任部门保存，原件交业务主管部门保存。Thenon-conformity report that has beenfinishedthe aboveprocedure needcopyanother one, the copy one will be stored by responsible department, the original report will be passed department in charge of business to store.由责任部门自行采取措施的流程：The proce

35、dure of taking actions by responsible department:各部门自行组织的纠正和预防措施，由各部门参照上述程序自行组织实施和验证, 措施计划可只经本部门领导批准，验证由本部门内审员或贯标联络员实施。For the correctiveandpreventive actions organized byeachdepartment, each department organize implement and verification with reference to the above procedure, the actionsplan can be

36、 proved by itsowndepartment leader,the verificatiownillbe implemented by the auditor or coordinator of its own department.过程产生记录由本部门保存。The records produced by process should be stored by its own department.顾客、相关方投诉不符合的处置 Disposal of the non-conformities complained by customer and interested parties对

37、顾客投诉（或不符合相关方要求时）不符合所采取的纠正和预防措施，各部门应及时将采取的纠正和预防措施情况反馈给相关业务主管部门，由相关业务主管部门反馈给顾客（或相关方）。按客户投诉管理程序进行管理。About the correctiveand preventiveactions taken to the non-conformityof customer complained, each department shall timely feed back the status of correctiveand preventive actions taken to the relateddepa

38、rtment in charge of the business , the informationis fed back to customer ( or interestedparty ) by relateddepartment in charge of the business. It is managed“Caustomer complaint management procedure ”监督检查 Supervise and check专业主管部门对管理的过程内的纠正和预防措施实施情况进行监督检查，并及时收集、整理采取纠正和预防措施的有关情况，在每年管理评审前报 CTO。Profes

39、sion management department supervise and check the implement status of the correctiveand preventiveactionswhich is responsible for tphreocess managing, andcollect and arrange the related status of corrective and preventive actions taken in ti and report the related data to CTO before annual manageme

40、nt review.CTO、CAO 分别对质量体系、HSE 体系的纠正和预防措施实施情况进行监督检查，并对全年采取纠正和预防措施的有关情况进行分析、评价，写出总结，作为管理评审输入材料。CTO (CAO focus HSE system) supervise and check the implement status of correctiveand preventive actions of system, and analyze, verify the related situation of correctiand preventive action this year,and wri

41、te a summary, as the data of management review input.实施纠正和预防措施所引起的文件更改，按文件控制程序和工程变更管理程序执行。According to the “Documenctontrolprocedure” andE“ngineering change management procedure”,tiomplement the documentchangecaused by correctiveand preventive actions.记录的管理按记录控制程序执行；The management of records accord

42、to “Record controlprocedure”.记录 Records记录编号Record No.记录名称Record name保存地点Storage place保存期限Storage limit不符合项报告“ No-nconformity report”纠正/预防措施实施验证记录“Verification record of the implement of corrective / preventive action”s相关文件 References文件名称 Document name文件编号 Document No.文件控制程序“Document controlprocedure

43、”记录控制程序“Record management procedure ”内部审核控制程序“Internal audit control proce”dure过程审核指南“Process audit guid”e产品审核指南“Product audit guid”e工程变更管理程序“Engineering change management procedure ”过程设计和开发管理程序“Process design & development management procedure”产品质量事故管理办法“Product quality accident management syste”m流程图 Flow chart纠正/预防措施管理程序流程图Corrective & preventive actions management procedure flow chart流程Process部门Dept.支持文件Support document记录Record