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1、文 件 制（修）订 申 请 单DOCUMENT INITIATED/CHANGED REQUEST(DICR)文件编号 Doc No.D0B0046版本 RevisionC页码 Page NO.Page 1 of 12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
2、.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 for Corrective & Preventive Action”XXXJan.10th, 2009CRevised the procedure to meet ISO13485 regulations (China) & CFR21 FDA 21 CFR QSR(Quality System Regulation) 820 (USA) requirementsXXX15-0
3、7-2014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 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 SIGNATUR
4、E 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.数量QTYEngineeringAssemblyOFFQA1PlatingSourcingHRStampingFinanceMaintenanceMolding所有没有红色“文件受控章”的打印文件仅供参考，并且不作更新。All the printed documents without red document control stamps are just for refer
5、ence only, and wont be updated.Form No.:Q1D0001B纠正和预防措施程序CAPA Procedure文件编号 Doc No.D0B0046版本 RevisionC页码 Page NO.Page 12 of 121 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
6、existing or potential 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 verifi
7、cation of Corrective action 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
8、 expectation is a must 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 regu
9、lation requirement , which 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
10、 the disposition of an 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: acti
11、on taken to eliminate 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 correc
12、tive actions are different. 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-con
13、formity. 3.6 趋势分析- 一种数据分析，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
