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1、永得利科技(无锡)有限公司ETLA Technology (Wuxi) Co., Ltd 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collincollinchunsiong012011-02-01Update company address公司地址变更江苏
2、省无锡市新加坡工业园锡兴路266号 邮编214028Correct Action Flow：纠正措施流程图： Responsibility/Authority： 1.0 职责/权限：Potential/unusual issue潜在/异常问题 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 HOD2.0 责任部门经理&主管Issue CAR开出“纠正和预防措施报告告” 5.0 QA Department 质量部 6.0 QA Depa
3、rtment 质量部 3.0Analysis Root cause analysis and corrective action by responsible department责任部门进行原因分析和纠正 NO 4.0Verify of corrective action taken对纠正措施进行验证 5.0Close the CAR对纠正进行结案 6.0Data Analysis and filing数据分析以及存档PURPOSE 目的This procedure is defined for investigating and implementing actions of noncon
4、formities, 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。DEFINITIONS 定义Supplier: this refers to material s
5、upplier, 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NIL 无RESPONSIBILITIES 职责The Management Representative is responsible to prepare, implement and maintain this procedure.管理者代表负责本程序的制定、执行和维护。PROCEDURE 程序1.1 Action for
6、 product nonconformities encountered in-house 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
7、。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 the above is recorded on Corrective Action Request (CAR)
8、 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 illustrate 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。
9、 1.2 Action for nonconformity from supplier 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
10、 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 back to supplier for new corrective action.质量部门负责对供应商原因分析和对策可行性进行确定，如不可行则退回供应商重新制定 4. QA Department to follow up and verify the action implemented to ensure effectiveness (i.e. no recurrence of nonconformity), and closed the CAR.
