纠正措施需求程序.doc

Quality ProcedureTitle: Corrective and Preventive ActionNumber: CWE-EP02 Effective Date: Revision: Page: 01-Feb-2011 01 7 of 7 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公司地址变更江苏省无锡市新加坡工业园锡兴路266号 邮编214028Propriety Confidential InformationPrinted copies without “CONTROLLED” stamp or bearing this footnote are for reference only. Always check the network for the latest copy.Correct 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 Department 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 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 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 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。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) 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。 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 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. 质量部门根据后期产品质量情况来验证供方纠正措施是否有效，并结案确认5. If there is no improvement seen through monitoring of performance for 3 months, Manager (Purchasing) may recommend the supplier for disqualification with approval by the General Manager.如果在3个月内看不到改进的业绩，（采购）经理可以向总经理提出取消此供应商合格资格。1.3Action for nonconformity from customer 外部不合格纠正（客户）1. When received reject/complaint from customer, Program Dept needs to forward the information to QA by email or print copies of customer feedback form. QA Dept to form up a team including Engineering, Production and responsible department, using Cause and Effect Diagram or other engineering tools to find out the actual root cause of defect and apply corrective and preventive measures for the non-conformity.当顾客有投诉时，由项目部以邮件或顾客信息反馈单等的形式通知质量部。质量部应在24小时内组织工程、生产等相应的部门，运用因果图等手段分析不合格产生的根本原因，针对不合格的原因，采取相应的纠正/预防措施2、The 8D Report (in customers format or internal format if they have no requirements) should be sent to the customer within 3 days, when requested.对于顾客有要求回复8D时，须三天之内回复8D report给客户（以客户格式为主，如客户无格式要求，以公司8D报告回复）3、If the customer has no 8D requirement, the non-conformity reason analysis and corrective measures should be communicated with customers within 2 days.顾客无8D要求时，二天内将原因分析和采取措施与顾客沟通。4、QA Dept is in charge of verifying and closing the corrective and preventive measures.质量部门负责纠正预防措施的验证关闭1.4 Preventive Action Process预防措施1、 Preventive action information is to statistic and analyze the applicable informationsource collected from all departments, to identify and analyze the potential nonconformity and the reason according to the trend of conformity. The information could include as below:利用各部门适当的信息来源进行统计分析，依据不良品趋势，发现分析潜在的不合格及其原因。即为预防措施信息，可包括：a. Inspection and test record检验和测试记录 b. PFMEA analysis PFMEA分析 c. Process monitoring record过程监视记录 d. External information feedback外部信息反馈 e. Management Review record管理评审记录2、 Significant preventive action should be submitted to be reviewed.重大的预防措施要提交管理评审 3、When preventive action needs document standardization, document updated follows “ Document Control Procedure”.当预防措施有文件标准化要求时，相关文件更新按“文件控制程序”执行1.5. Problem Solving Methods 解决问题的方法1、Where appropriate, structured problem solving methods shall be employed in corrective and preventive action process. In general, problem solving process involves: 适当时，在执行纠正和预防措施过程中时应该采用的方法，包括： - Collection of sufficient information/data and definition of problem.收集充足的信息/资料并确定问题点- The use of appropriate QA/brainstorming tools such as control charts, histogram, Pareto diagram, charts, cause and effect diagram and other applicable methods for analysis. Common sources of nonconformance could be the variations caused by material, equipment, human, method and environment.可以采用各种质量管理工具来分析问题，例如：头脑风暴法、控制图、直方图、柏拉图、表格、因果图以及其它质量控制工具。造成不合格项的原因通常会包括材料、设备、人员、方法以及环境等。- Identifying as many probable causes as possible, using the process of elimination to weed out unlikely cause through collective experience, i.e. identifying the most probable ones or the vital few.尽可能多的找出可能的原因，然后通过排除法以及集体的经验来排除次要原因，以便识别出最有可能的或者“关键的少数” 原因。-Identifying solutions to rectify the root cause/most probable cause found from the elimination process and using mistake-proofing methodology wherever p