精品纠正措施需求程序

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 Actio n Request纠正措施需求程序Revision版本Date日期Description 扌苗述Originator制定者Management Representative 管理者代表General Manager 总经理002010-03-10Update document per IS09001:2008 根据ISO9001:2008改版collincollinchunsiong012011-02-01Update companyaddress公司地址变

2、更江苏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：Resp on sibility/Authority1.0职责/权限：initiating actions to prevent potential nonconformities.个人收集整理 勿做商业用途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 departme nts in which corrective actio n request impleme ntati

3、 on is required.个人收集整理 勿做商业用途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 (subc on tract ing works).个人收集整理勿做商业用途供应商：指材料供应商、直接服务供应商(外包工作)。CAR : Corrective Action RequestCAR :纠正措施需求单REFERENCES 参考NIL无RESPONSIBILITIES 职责The Man ageme nt Represe

4、ntative is resp on sible to prepare, impleme nt and mai ntai n this procedure.个人收集整理 勿做商业用途管理者代表负责本程序的制定、执行和维护。PROCEDURE 程序Action for product nonconformities encountered in-house内部不合格的纟片正 个人收集整理勿做商业用途1、For product nonconformity& potential nonconformity found, QA Dept is to be notified anddecide if i

5、ssu ing of CAR to resp on sible departme nt is required to provide the corrective action.个人收集整理勿做商业用途发现不合格/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。个人收集整理勿做商业用途2、Respective Dept is responsible to analysis and identify the root cause, and appropriatecorrective/preve ntive actio n is gen

6、erated to preve nt recurre nce/preve nt pote ntial nonconformity, within given time line.Department Supervisor to ensure the above is recorded on Corrective Action Request(CAR) form.个人收集整理勿做商业用途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。个人收集整理勿做商业用途3、QA Dept is to follow up

7、with the progress of corrective action implemented, and reverify the outcome. Data collection is required in order to effectively illustrate validation. 个人收集整理勿做商业用途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。Actio n for noncon formity from supplier外部不合格纠正(供应商)1、When rejects found during Incoming

8、 Quality Check, Quality Engineer to decide if issuing of CAR to the supplier is requiredfor corrective and preventive action.个人收集整理 勿做商业用途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 companywithin 5 working da

9、ys. It is followed by Purchasing Dept.个人收集整理 勿做商业用途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QA responsible to verify if there are issues for the corrective action, it should be returned back to supplier for new corrective action. 个人收集整理 勿做商业用途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 疋QA Departme nt to

10、 follow up and verify the actio n impleme nted to en sure effective ness (i.e. no recurrenee of nonconformity), and closed the CAR.个人收集整理 勿做商业用途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If there is no improveme nt see n through mon itori ng of performa nee for 3 mon ths, Man ager (Purchas in g)may recomme nd

11、 the supplier for disqualificati on with approval by the General Manager.个人收集整理勿做商业用途如果在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。Actio n for non co nformity from customer外部不合格纠正(客户) 个人收集整理 勿做商业用途1、When received reject/complai nt from customer, Program Dept n eeds to forward thein formatio n to QA by e

12、mail or print copies of customer feedback form. QA Dept to form up a team in clud ing Engin eeri ng, Producti on and resp on sible departme nt, using Cause and Effect Diagram or other engin eeri ng tools to find out the actual root cause of defect and apply corrective and preventive measuresfor the

13、non-conformity. 个人收集整理 勿做商业用途当顾客有投诉时，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/预防措施个人收集整理勿做商业用途2、The 8D Report(in customer format or internal format if they have no requirements)should be sent to the customer within 3 days, when requested.个人收集整理 勿做商业用途对于

14、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) 个人收集整理勿做商业用途3、If the customer has no 8D requirement, the non-conformity reason analysis andcorrective measures should be com muni cated with customers within 2 days.个人收集整理 勿做商业用途顾客无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 verifyin

15、g and closing the corrective and preventive measures. 个人 收集整理勿做商业用途个人收集整理仅供参考学习质量部门负责纠正预防措施的验证关闭Preve ntive Actio n Process 预防措施1、 Preve ntive actio n in formatio n is to statistic and an alyze the applicable in formatio n个人收集整理勿做商业用途source collected from all departme nts, toide ntify and an alyze t

16、he pote ntial noncon formity and the reas on accordi ng to the trend of con formity. The in formatio n could include as below:个人收集整理 勿做商业用途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：个人收集整理勿做商业用途Inspection and test record 检验和测试记录PFMEA an alysisPFMEA 分析Process mon itori ng record 过程监视记录Ex

17、ter nal in formatio n feedback夕卜部信息反馈Man ageme ntReview record 管理评审记录2、Significant preventive action should be submitted to be reviewed. 个人收集整理 勿做商业用途 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 ”个人收集整理勿做商业用途当预防措施有文件标准化要求

18、时，相关文件更新按“文件控制程序”执行1.5. Problem Solvi ng 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 invoIves:个人收集整理 勿做商业用途适当时，在执行纠正和预防措施过程中时应该采用的方法，包括：Collectio n of sufficie nt in formatio

19、n/data and defi niti on of problem.个人收集整理勿做商业用途收集充足的信息/资料并确定问题点The use of appropriate QA/bra in storm ing tools such as con trol charts, histogram, Pareto diagram, charts, cause and effect diagram and other applicable methods for an alysis. Common sources of noncon forma nee could be the variati ons

20、 caused by material, equipme nt, huma n, method and environment.个人收集整理勿做商业用途 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。个人收集整理勿做商业用途Ide ntify ing as many probable causes as possible, using the process of elim in ati on to weed out un likely cause through

21、 collective experie nee, i.e. identifying the most probable ones or the个人收集few 勿做商业用途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。个人收集整理勿做商业用途Ide ntify ing solutio ns to rectify the root cause/most probable cause found from the elimination process and using mistake-proofing methodology wherever practicable 个人收集整理勿做商业用途确定解决方案，以矫正识别出来的最有可能的或者“关键的少数”原因，并尽可能采取预防措施。Applyi ng where applicable these soluti