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1、 Quality Procedure Title: Corrective and Preventive Action Number: CWE-EP02Effective Date: Revision: Page: 01-Feb-2011 01 1 of 7 Propriety Confidential Information Printed copies without “CONTROLLED” stamp or bearing this footnote are for reference only. Always check the network for the latest copy.
2、永得利科技永得利科技( (无锡无锡) )有限公司有限公司ETLA Technology (Wuxi) Co., Ltd 福根集团成员企业福根集团成员企业Corrective Action Request纠正措施需求程序Revision 版本Date 日期Description 描述Originator 制定者Management Representative 管理者代表General Manager 总经理002010-03-10Update document per ISO9001:2008 根据 ISO9001:2008 改版collincollinchunsiong012011-02-0
3、1Update company address 公司地址变更江苏省无锡市新加坡工业园 锡兴路266号 邮编214028Quality Procedure Title: Corrective and Preventive Action Number: CWE-EP02Effective Date: Revision: Page: 01-Feb-2011 01 2 of 7 Propriety Confidential Information Printed copies without “CONTROLLED” stamp or bearing this footnote are for ref
4、erence only. Always check the network for the latest copy.Correct Action Flow： 纠正措施流程图：纠正措施流程图：Responsibility/Authority：1.0 职责/权限：1.0 All Department 所有部门2.0 QA Department 质量部3.0 Responsible Department 责任部门4.0 Responsible Department HOD 2.0 责任部门经理&主管5.0 QA Department 质量部6.0 QA Department 质量部3.0NO4.05
5、.06.0Potential/unusual issue 潜在/异常问题Issue CAR 开出“纠正和预防措施报告告”Analysis Root cause analysis and corrective action by responsible department 责任部门进行原因分析和纠正Verify of corrective action taken 对纠正措施进行验证Close the CAR 对纠正进行结案Data Analysis and filing 数据分析以及存档Quality Procedure Title: Corrective and Preventive Ac
6、tion Number: CWE-EP02Effective Date: Revision: Page: 01-Feb-2011 01 3 of 7 Propriety Confidential Information Printed copies without “CONTROLLED” stamp or bearing this footnote are for reference only. Always check the network for the latest copy.PURPOSE 目的目的This procedure is defined for investigatin
7、g and implementing actions of nonconformities, and for initiating actions to prevent potential nonconformities. 本程序用来规范不合格项的调查和执行活动，以及识别并采取对潜在不合格项目的预防活动。SCOPE 范围范围This procedure applies to all departments in which corrective action request implementation is required. 本程序适用于所有需要采取纠正措施需求的部门。DEFINITION
8、S 定义定义Supplier: this refers to material supplier, direct service supplier (subcontracting works).供应商：指材料供应商、直接服务供应商（外包工作）。 CAR：Corrective Action Request CAR：纠正措施需求单REFERENCES 参考参考NIL 无RESPONSIBILITIES 职责职责The Management Representative is responsible to prepare, implement and maintain this procedure.
9、 管理者代表负责本程序的制定、执行和维护。PROCEDURE 程序程序1.1 Action for product nonconformities encountered in-house 内部不合格的纠正内部不合格的纠正1、For product nonconformity & potential nonconformity found，QA Dept is to be notified and decide if issuing of CAR to responsible department is required to provide the corrective action. 发现
10、不合格/潜在不合格现象时，通知质量部门，质量部根据异常情况判定是否要开出 “纠正预防措施报告”给相关部门进行纠正预防。Quality Procedure Title: Corrective and Preventive Action Number: CWE-EP02Effective Date: Revision: Page: 01-Feb-2011 01 4 of 7 Propriety Confidential Information Printed copies without “CONTROLLED” stamp or bearing this footnote are for ref
11、erence only. Always check the network for the latest copy.2、Respective Dept is responsible to analysis and identify the root cause, and appropriate corrective/preventive action is generated to prevent recurrence/prevent potential nonconformity, within given time line. Department Supervisor to ensure
12、 the above is recorded on Corrective Action Request (CAR) form. 责任部门分析问题产生的原因，制定解决问题的措施与预防措施，并在规定时间内提交 质量部。部门主管应确保所有的信息都填写在 纠正预防措施报告。3、QA Dept is to follow up with the progress of corrective action implemented, and re- verify the outcome. Data collection is required in order to effectively illustrat
13、e validation.质量部应根据措施进度随时了解情况，并在规定时间内进行验证，尽量用数据说明问题， 以便有效验证。1.2 Action for nonconformity from supplier 外部不合格纠正（供应商）外部不合格纠正（供应商）1、When rejects found during Incoming Quality Check, Quality Engineer to decide if issuing of CAR to the supplier is required for corrective and preventive action.来料检验发现不良时，由
14、供应商质量工程师根据异常情况判定是否要开出“纠正预防措施报告”给供应商进行纠正。2、Corrective Action Request when issued to the supplier, it should be return to the company within 5 working days. It is followed by Purchasing Dept.供应商应该实施纠正措施需求，并将 CAR 在 5 个工作日内回复给本公司，采购部门负责 跟催 3. QA responsible to verify if there are issues for the corrective action, it should be returned
