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1、文件类型Document Type品质管理体系程序QMS PROCEDURE 应用范围Application Scope通用GENERAL修订记录REVISION HISTORY版本Rev.修改内容 Revised Contents作者Author生效日期EFF. DateAInitial releasing with ISO/TS16949 requirementsXXXNov.07,2006B Change the title from “改正和预防行动程序Correctiveand Preventive Action Procedure” to “纠正和预防措施程序 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文件审批 APPROVAL本文件须经相关部门工程师（或主管）签批，请作者指定。This document shall be reviewed by ISO Coordinator and. The auth
3、or shall determine.编写部门ORIGINATE DEPT.相关部门RELEVANT DEPT.部门名称DEPT. TITLEQAManufacturingMachiningEngineeringPE工程师姓名NAME OF ENGINEER工程师签署SIGNATURE经理姓名NAME OF MANAGER经理签署SIGNATURE管理者代表签署 SIGNATURE OF M.R.Ditto总经理签署 SIGNATURE OF GM.拒签理由 Reason of reject:文件分发 DISTRIBUTION部门 DEPT.数量 QTY部门 DEPT.数量QTY部门 DEPT
4、.数量QTYEngineeringAssemblyOFFQA1PlatingSourcingHRStampingFinanceMaintenanceMolding1 目 Purpose 本程序规范了为消除存在或潜在不合格而采取纠正预防措施流程，以确保类似不合格不再发生或潜在不合格发生，促进质量管理体系持续改进。This procedure define the process of taking corrective and or preventive actions to Eliminate existing or potential non-conformity, to prevent s
5、imilar non-conformity fromReoccurring or occurring of potential non-conformity. Promote continuous Improvement of quality systems.2 范围 Scope 本程序适用于公司质量管理体系范围内纠正和预防措施制定、实施与验证。 This procedure is applicable to the formulation, implementation and verification of Corrective action and preventive action i
6、n the company quality management systems3 定义 Definition3.1 不合格：未满足指定要求。“要求”是指明示、通常隐含或必须履行需求或期 望，如法规、行业标准要求，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 regulation,
7、industry requirement,company documents etc. 3.2 关键不符合 ：违反法定工艺、超出内控质量标准或违反生产相关法规规定，将会造 成产品整批报废、产品召回、重大客户投诉. 不符合关系到安全、企业品牌形象和产品市场影响。 Critical non-conformity : Violate legal process, beyond standard of internal control or violation of related regulation requirement , which will cause scrap of the whole
8、 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 纠正：存在不合格处置包括修理，返工或调整。 Correction: repair, rework, or adjustment relates to the disposition of an existing nonconformity. 3.4 纠正措施：消
9、除已发生不符合或者其他不期望情况原因措施。 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 预防措施：消除潜在不符合或者其他不期望情况原因措施。 Preventive action: action taken to eliminate the cause of a potential nonconformity, de
10、fect, or other undesirable situation in order to prevent occurrence.一个不符合或者潜在不符合可能有多个原因。There can be more than one cause for non-conformity or a potential non- conformity.备注1) 纠正和纠正措施是有区别，纠正是针对不符合，而纠正措施是针对不符合原因。Correction and corrective actions are different. Correction is against non- conformity wh
11、ereas corrective action is against the cause of non conformity.备注2) 纠正措施用于防止不符合再发生，而预防措施用于防止不符合发生。Corrective action is taken to prevent recurrence of non conformity whereas preventive action is taken to prevent occurrence of non-conformity. 3.6 趋势分析- 一种数据分析，是指通过对CAPA输入以及输入之间交叉关系分析，根 据趋势分析潜在质量问题. Tre
12、nd 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 风险控制在特定水平内, 经过讨论采取保护措施以降低或控制对人、财产或环境 风险过程。 Risk control- In the specific level, per discussion the process taken protective actions T
13、o reduce or control risk on human, property or environment 3.8 纠正预防措施 负责人：负责协调某一特定纠正预防措施报告决定和实施个人。 CAPA Responsibility: the person who is responsible for coordination of the specific CAPA report decision and implementation 4. 职责和权限 RESPONSIBILITY AND AUTHORITY 4.1问题产生主管部门负责主导对不合格执行分析、制定、执行相应纠正措施，对潜
14、在不合格负责实施预防措施。 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 质量管理部门全面负责纠正措施与预防措施运行： QA is responsib
15、le for the centralized management of CAPA report 品质文员负责纠正措施与预防措施报告编号, 归档管理 QA clerk is responsible for the coding, registration and archive management. QA工程师确定不符合是否需要有CAPA流程，纠正与预防措施计划审批及定期统 计分析, 跟踪纠正预防措施实施过程并验证其有效性。 QA engineer is responsible for the determination if CAPA is needed, periodical Stati
16、stical analysis, follow up the implementation of corrective & preventive actions and Verify the effectiveness 品质经理负责所有CAPA 纠正预防措施计划及CAPA关闭审核。 Quality manager is responsible for review of all corrective & preventive plan and Closure of CAPA. 4.4 公司总经理负责CAPA 纠正预防措施计划及CAPA关闭最终审批。 Site leader is respons
17、ible for the final approval of all corrective&preventive plan and Closure of CAPA 4.5 公司管理层负责对纠正预防措施进行年度评审 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 纠正预防措施输入: Input of corrective &preventive act
18、ions 5.1.1纠正预防措施来自于质量管理体系范围内，引起产品不合格或潜在不合格或者其他 质量问题各过程。其输入有以下几个方面： 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, 半产品, 成品有关接收活动, The inspection activities related to raw materials, in process p
19、roducts and finished goods, 5.1.1.2客户投诉, 产品退回等问题 Customer complaints, products return etc. issues 5.1.1.3质量审核 Quality audit 5.1.1.4管理评审 Management review 5.1.1.5安全问题 Safety issues 5.1.1.6其他必要分析数据Other analysis data as necessary 5.2 分析纠正预防措施输入 Analyze CAPA source of data 5.2.1质量工程师根据分析纠正预防措施输入, 如果是关键
20、质量问题, 则需马 上启动纠正预防措施,如果是非关键问题,则应对该问题进行分析之后确定是否启动 纠正预防措施。 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 issues, then determine if CAPA is needed to l
21、aunch.5.2.2所有审核发现不合格, 客户投诉，FQC退货以及管理评审将马上启动纠正预防 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必要时, 运用适当统计方法识别重复发生质量问题。 Appropriate statistical methodology shall be employed wh
22、ere necessary to detect recurring Quality problems 统计方法包括Statistical methodology includes: 柏拉图Pareto charts 运行图Run charts 控制图Control charts 平均值和标准偏差Mean and standard deviation 比较t检验T tests for comparisons 实验设计Experimental design (DOE) 图形方法（鱼刺图，直方图，散布图，电子表格等） Graphical methods (fishbone diagrams, his
23、tograms, scatter plots, spreadsheets, etc.)5.3纠正预防措施启动 Launch of CAPA 5.3.1经过对纠正预防措施输入分析并确认必要性后, 质量工程师将填写纠正预防措施 报告，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指定一个纠正预防措施控制号。编号规则为：纠正预防措施/年/号码顺序。 例：CAPA14001 (CAPA=纠正预防措施, 14=
24、2014, 001=这一年第一份报告)。 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填写“提出人”和提出日期。 Fill in “sponsor” and sponsor date 5.3.1.3对纠正预防措施问题进行描述。尽可能详细地参考相关程序，
25、规定和客户要求 等。附上所有有帮助其他信息资料。 Describe the issue in as much detail as possible reference to relevant procedures, Specification and customer requirements, attach other supporting data. 5.3.2质量工程师对纠正预防措施报告进行复制存放于纠正预防措施文档中以做跟踪之 用。并将纠正预防措施报告原件，发给纠正预防措施负责人。 Quality engineer copy CAPA report and store in the f
26、older for follow up and Send the original CAPA report to the responsible person. 5.3.3同时质量工程师应在纠正预防措施跟踪记录表中记录报告编号、发出人、发出时 间、质量问题类型及问题描述以便于跟踪。 Quality engineer shall record CAPA code, sponsor, time, quality issue types and issue 5.3.4问题产生主管部门负责主导纠正预防措施调查及措施制定直到完成。除非得 到质量管理部负责人确认,纠正预防措施调查分析/制定措施必须在7个工
27、作日 内完成。 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不合格根源调查以确定根本原因 Root cause analysis of non-conformities to
28、 identify the root cause 5.4.1调查有关产品，过程, 品质系统不合格原因 Investigate the cause of nonconformities relating to product, process, and the quality System. 5.4.2 确定问题和特性 Identify problem and characterize, 5.4.3 确定范围和影响 Determine scope and impact 5.4.4 调查要根据人、机、料、法、环可能影响因素 Investigate refer to man, machine, ma
29、terial, method, environment etc. factors. 5.4.5 问题根源分析工具 Root cause analysis tools -鱼刺图Fishbone diagrams - 5个为什么5”whys” -故障树分析Fault-tree analysis -其它Among others 5.4.6 确定问题根源 Determine root cause 指定一个根本原因以用于趋向分析。 Specify root cause for the trend analysis. 5.5确定纠正预防措施 Identify corrective and preventi
30、ve actions 5.5.1问题根源产生主管部门针对根本原因制定全面、适当纠正和预防性措施, 采 取纠正和预防性措施消除或减少存在或潜在不合格程度应与不合格影响以 及风险等级一致。 The department responsible for the non-conformities shall define comprehensive, Appropriate corrective and preventive actions based on the root cause. The degree of corrective and preventive actions taken to
31、 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在纠正预防措施报告中记录将要采取措施，指定责任人，并对每个措施计划 指定完成日期，并要求责任人签字确认。 Record the actions in the CAPA report, define the responsible person and completion Dat
32、e for each action, request responsible person to sign for confirmation.5.5.3在完成上述步骤后，纠正预防措施负责人会在报告“CAPA 负责人”处签署姓名 和日期，并提交给部门经理审核及签名。然后纠正预防措施负责人把此份CAPA报 告提交质量工程师以供其审核。 After the above steps are completed, CAPA responsible person shall sign his (her) name And date and submit the report to department f
33、unctional leader for review and signature. 5.5.4质量工程师将在纠正预防措施追踪表上记录“措施计划接收日期”。 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 for review.5.6 执行纠正预防措施 Implementation corrective and preventive a
34、ctions 5.6.1责任部门负责人负责纠正预防措施实施。 The responsible department manager is responsible for the implementation of CAPA and Record changes. 5.6.2如果纠正措施没有在计划日期内实施，质量工程师应将该情况报告给质量经 理。如果在跟踪后3个工作日之后没有进展，质量经理应将该情况报告给总经理 并开出一份新CAPA 报告 If CAPAs are not implemented within the defined schedule, quality engineer shal
35、l 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 核实及确认纠正预防措施有效性 Verify or validate the effectiveness of corrective and preventive actions 5.7.1 质量工程师核实及确认纠正预防措施是否有效
36、，对产品没有负面影响，确认包括： 纠正预防措施是否有效？ 是否可能产生别潜在不良？ 评审数据是否关联到核实及确认活动？措施实施后类似问题是否存在？ 在纠正预防措施报告中记录验证方法和计划验证日期。 Quality engineer verify or validate the corrective and preventive actions to ensure that such Actions are effective and do not adversely affect the products，The verification or validation Activity incl
37、udes: 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 verification method and date in The CAPA report. 5.7.2如果质量工程师验证纠正预防措施是有效，不需要修
38、改，质量工程师会在纠正预 防措施报告处签署姓名和日期, ,并提交CAPA 报告给品质经理审批。 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 or her name and date in the CAPA report, and submit the CAPA report for
39、 QA manager Approval 5.7.3 质量经理提交其批准CAPA 报告给公司总经理作最终评审及签名。 Quality manager submit the CAPA report to site leader for final review and signature. 5.7.4 对关键不符合CAPA 纠正预防措施，需要上升到ITT ICS 运作总监审批 For critical non-conformities, CAPA shall be escalate to ITT ICS operation director for Approval. 5.7.5如果质量工程师验证纠正预防措施是无效，此纠正预防措施报告需上升到公司总 经理采取进一步行动计划。 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:对措施计划修改可根据实际情况在纠正预防措施开启任何时间内进行。 Note: The mod