1、纠正文件制修订申纠正和预防措施程序文件类型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
2、预防措施程序 Procedure 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 Coordina
3、tor and. The author 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
4、DEPT.数量QTY部门 DEPT.数量QTYEngineeringAssemblyOFFQA1PlatingSourcingHRStampingFinanceMaintenanceMolding【关键字】纠正1目的 Purpose 本程序规范了为消除存在或潜在的不合格而采取纠正预防措施的流程，以确保类似不合格不再发生或潜在不合格的发生，促进质量管理体系的持续改进。This procedure define the process of taking corrective and or preventive actions to Eliminate existing or potential
5、non-conformity, to prevent similar 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的制定、实施与验证。 This procedure is applicable to the formulation, implementation and verification of Corrective a
6、ction and preventive action in the company quality management systems3 定义 Definition3.1 不合格：未满足指定要求。“要求”是指明示的、通常隐含的或必须履行的需求或期 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
7、 to fulfill. Such as regulation,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、企业的品牌形象和产品的市场影响。 Critical non-conformity : Violate legal process, beyond standard of internal control or violation of related regulation requirement , w
8、hich will cause scrap of 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 纠正：存在不合格的处置包括修理，返工或调整。 Correction: repair, rework, or adjustment relates to the disposition of an
9、 existing nonconformity. 3.4 纠正措施：消除已发生的不符合或者其他不期望的情况的原因的措施。 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 预防措施：消除潜在不符合或者其他不期望的情况的原因的措施。 Preventive action: action taken to eliminate
10、the cause of a potential nonconformity, defect, 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的，纠正是针对不符合的，而纠正措施是针对不符合的原因的。Correction and corrective actions are differ
11、ent. Correction is against non- conformity whereas 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
12、析，是指通过对CAPA的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. 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 风险控制在特定的水平内, 经过讨论采取保护措施以降低或控制对人、财产或环境 的风险的过程。 Risk control- In the specific level, per d
13、iscussion the process taken protective actions To 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的决定和实施的个人。 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
14、 AUTHORITY 4.1问题产生的主管部门负责主导对不合格执行分析、制定、执行相应的纠正措施，对潜 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 nonconf
15、ormities. 4.2 质量管理部门全面负责纠正措施与预防措施的运行： QA is responsible 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的审批及定期的统 计分析, 跟踪纠正预防措施的实施过程并验证其有效性。 QA engineer is responsible f
16、or the determination if CAPA is needed, periodical Statistical 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关闭的审核。 Quality manager is responsible for review of all corrective & preventive plan and Closure of CAPA. 4.
17、4 公司总经理负责CAPA 纠正预防措施计划及CAPA关闭的的最终审批。 Site leader is responsible 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
18、Procedure 5.1 纠正预防措施输入: Input of corrective &preventive actions ，引起产品不合格或潜在不合格或者其他 质量问题的各过程。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: , 半产品, 成品有关的接收活动, The inspection activities related to
19、raw materials, in process products and finished goods, , 产品退回等问题 Customer complaints, products return etc. issues Quality audit Management review Safety issues analysis data as necessary 5.2 分析纠正预防措施输入 Analyze CAPA source of data , 如果是关键的质量问题, 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。 Qualit
20、y 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 launch., 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
21、 raised during audit, customer complaints, FQC rejections and non- Conformities from management review, CAPA shall be launched immediately, 运用适当的统计方法识别重复发生的质量问题。 Appropriate statistical methodology shall be employed where necessary to detect recurring Quality problems 统计方法包括Statistical methodology i
22、ncludes: 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, histograms, scatter plots, spreadsheets, etc.)5.3纠正预防措施的启动 Launch of CAPA , 质量工程师将填写纠
23、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: 例：CAPA14001 (CAPA=纠正预防措施, 14=2014, 001=这一年的第一份报告)。 Specify one code# of CAPA, coding rule as: CAPA/Year/the sequence of code#. For example: CAPA14001 (CAPA=Corrective actions &
24、Preventive actions, 14=2014, 001=the first report of the year. Fill in “sponsor” and sponsor date ，规定和客户要求 等。附上所有有帮助的其他信息资料。 Describe the issue in as much detail as possible reference to relevant procedures, Specification and customer requirements, attach other supporting data. 用。并将纠正预防措施报告原件，发给纠正预防
25、措施负责人。 Quality engineer copy CAPA report and store in the folder for follow up and Send the original CAPA report to the responsible person. 间、质量问题类型及问题的描述以便于跟踪。 Quality engineer shall record CAPA code, sponsor, time, quality issue types and issue 到质量管理部负责人的确认,纠正预防措施调查分析/制定措施必须在7个工作日 内完成。 Department
26、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 identify the root
27、cause ，过程, 品质系统不合格的原因 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、环可能的影响因素 Investigate refer to man, machine, material, method, environment
28、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 preventive actions , 采 取纠正和预防性措施消除或减
29、少存在的或潜在的不合格程度应与不合格的影响以 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 eliminate or minimize actual or Potential nonconformities mu
30、st be appropriate to the magnitude of the problem and Commensurate with the risks encountered.，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 Date for each action, request responsible person to sign for confirmation.，纠正预防措施负责人会在报告的“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 functional leader for review and signature. Qualit
