CAPA Procedure 纠正和预防措施程序.doc

文件类型 Document Type 品质管理体系程序QMS 应用范围 Application Scope 通用G 修订记录REVISION HISTORY 版本Rev. 修改内容 Revised Contents 作者Author 生效日期EFF. Date Initial releasing with ISO/TS16949 requirements XXX Nov.07,2006 B Change the title from “改正和预防行动程序Corrective and Preventive Action Procedure” to “纠正和预防措施 程序 Procedure for Corrective Preventive Action” XXX Jan.10th, 2009 C Revised the procedure to meet ISO13485 regulations (China) CFR21 FDA 21 CFR QSR(Quality System Regulation) 820 (USA) requirements XXX 15-07-2014 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 author shall determine. 编写部门 ORIGINATE DEPT. 相关部门RELEVANT DEPT. 部门名称 DEPT. TITLE QA Machining Engineering PE 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 Q’TY 部门 DEPT. 数量Q’TY 部门 DEPT. 数量Q’TY Engineering Assembly OFF QA 1 Plating Sourcing HR Stamping Finance Maintenance Molding 目的 Purpose This procedure define the process of taking corrective and or preventive actions to Eliminate existing or potential non-conformity, to prevent similar non-conformity from Reoccurring or occurring of potential non-conformity. Promote continuous Improvement of quality systems. 2 范围 cope 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 action and preventive action in the company quality management systems 3 定义 Definition 3.1 指定“要求”是指明示的、通常隐含的或必须履行的需求或期 望， 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,industry requirement,company documents etc. 3.2 关键不