1、Corrective and Preventive Action Control Procedure纠正及预防措施控制程序 A1Document Number and Revision文件编号及版本：CSS-QP-09 Rev A2Document Title 文件题目：Non-Conformance, Corrective & Preventive Action ManagementProcedure不符合纠正预防措施控制程序Approvals(批准)Responsible（负责）Name （名字）Signature （签名）Date (日期)Originator（制作）Department
2、 Leader(部门负责人)MR(管理者代表)GM （总经理）生效日期Effective date：Feb. 1, 2015Revision History （更改历史）：Revision From To更改Date日期Revision Description/更改内容Changed by/更改人Checked by/复核A12014/6/5首版发行 First IssueAllen PuDennis HuangA22015/2/1Add the EMS non-conformance corrective & preventive actionin the procedure Livia H
3、eDennis Huang1. 目的Purpose此份文件制定了控制修正性及预防性行动的方法，这些行动用于修正及杜绝现有及潜在的不合规格事项。This document defines the control of corrective action and preventive action taken to correct and eliminate existing and potential non-conformance.2. 范围Scope该程序适用于CONTAC与品质和EMS相关的修正及预防行动。This procedure applies to corrective and p
4、reventive action taken for the quality and EMS in CONTAC.3. 定义Definition纠正及预防措施（C/PAR）：一份要求相关部门进行纠正行动的要求。为容易控制纠正行动要求及实行状况均需记录于C/PAR状态报告内。Corrective Action Request (C/PAR): A request for corrective action to be taken by and action party. For ease of control, a “Corrective and preventive report C/PAR
5、Status Report” is used to record the request and status of implementation. 4. 责任Responsibility 品质部负责 : Quality & Environment Department is responsible for a) 接收CONTAC以外的投诉及储存有关资料;Receiving those complaints from outside of CONTAC and keeping relevant information.b) 发NCP & C/PAR给公司相关部门或外部相关方要求修正行动;Iss
6、uing NCP & C/PAR to related departments within company or external interested party for corrective actions. c) 若品质问题与供应商有关，则发出NCP & C/PAR给该供应商; 若与客户投诉有关，则按客户要求回复客户；Issuing a NCP & C/PAR to the supplier for the case of supplier quality problem; if it is customer complaint, reply customer according to
7、 customers requirement.d) 编配NCP & C/PAR的编号;Assigning a NCP & C/PAR number to each NCP & C/PAR in CONTAC. e) 保持NCP & C/PAR的状况登记;The maintenance of NCP & C/PAR status. f) 将所有发出的NCP & C/PAR存档; Keeping a file of all NCP & C/PARs issued.g) 监察NCP & C/PAR上记载的修正行动实施情况;Monitoring the implementation of correc
8、tive actions.h) 审核实施的修正行动及预防性行动后，确定是否有必要修改程序文件;Reviewing the necessity of procedure changes as a result of implementing corrective and preventive actions.总结所有发出的NCP & C/PAR或其它纠正措施报告并在管理评审会议上报告.Summarizing all NCP & C/PARs, and other corrective & preventive action report, then reporting the summary t
9、o the Management Review Meeting.内部审核员负责向内部审核发现的不符合项发出相应的NCP & C/PAR。Internal Auditor is responsible for performing internal quality audit or environment audit and issuing a NCP & C/PAR according to the Non Conformity.如果关键的测量指标的最低要求还没有达到时，则需向相关部门发出纠正行动的要求。If the minimum requirement of key measurement
10、 is not achieved, a NCP & C/PAR shall be issued to related department.资格及培训 Qualification And Training内部审核员一定要在接受正式之审核技巧培训后才可以进行内部审核。Internal Auditor must receive formal training in auditing techniques before being assigned to conduct internal audit.5. 程序Procedure5.1发出纠正行动要求(NCP & C/PAR)Initiation o
11、f Corrective Action Request(NCP & C/PAR) 下列情况均可发出NCP & C/PAR: NCP & C/PAR may be required under following situations:1) 管理评审会议;Management Review Meeting. 2) 生产线上发现的品质问题;Quality problem identified in production. 3) 内部质量环境管理体系审核所发现的不合格;Nonconformity identified in internal audit.4) 外部审核所发现的不合格;Nonconfo
12、rmity identified in external audit.5) 供应商的品质问题报告;Supplier quality problem report. 6) 关键衡量指标的最低要求没有达到;The minimum requirement of key measurable is not achieved.7) 法律法规和其他要求变更引起的不符合。Nonconformity caused by the change of legal and other requirements.8) 数据分析的结果The results of data analysis9) 员工的合理化建议The
13、results of data analysis10) 环境的监测数据Environmental monitoring data5.2客户投诉 Customer Complaint 5.2.1当品质部收到客户投诉后，与相关部门确认该投诉，品质部在需要的情况下可向客户要求进一步的资料；Upon receiving customer complaint, Quality Department shall confirm this complaint with related departments. Quality Department can ask more details from cust
14、omer if necessary.5.2.2若客户投诉被确认，品质部可就该投诉发出8D报告或按客户要求制定相应的纠正及预防措施;Once customer complaint is confirmed, Quality Department shall issue an “8D Report” or other corrective & preventive action which be required by customer. 5.2.3品质部回复客户纠正行动的结果.Quality Department shall keep the customer informed the resu
15、lts of corrective actions.5.3供应商的来料品质问题Material Quality Problem from supplier:5.3.1供应商来料检验问题一般由QC识别；Material inspection problem from material supplier is usually identified by Quality Control (QC).5.3.2根据来料检验报告或其它类似资料，品质部可向有品质问题的供应商发出NCP & C/PAR.和8D Based on “Incoming Inspection report” or other inf
16、ormation, Quality Department may issue a NCP & C/PAR and 8D to supplier which existed quality problems.5.4内部审核发现的不合规格事项Non-conformity identified in Internal Audit. :5.4.1内审时，内审员会识别哪些是品质系统不容许的项目，该内审员就相关问题发出NCP & C/PAR,细节参照内部审核控制程序。During internal audit, the internal auditor may identify the non-confo
17、rmity of quality system. The internal auditor can issue NCP & C/PARs according to audit results, for details, please refer to “Internal Audit Control Procedure”.5.5 其它发出NCP & C/PAR来源Others Sources for NCP & C/PAR Initiation:5.5.1 NCP & C/PAR可由任何人发出，并经他/她的部门主管复核之后发出，发出前须在QA工程师处登记并编号管理。如有争议，需由品质部最终确认裁
18、决。NCP & C/PAR的发出者需对NCP & C/PAR进行跟进直至结案。NCP & C/PAR can be initiated by any employee, he/she needs send the prepared NCP & C/PAR to his/her department head for review, the NCP & C/PAR need be registered with a number at QA engineer to manager. For any controversy, it should be judged and decided by Q
19、uality Department. NCP & C/PAR initiator shall follow up the NCP & C/PAR until case closure. 5.6 准备NCP & C/PAR Preparation of NCP & C/PAR:5.6.1 每一份NCP & C/PAR都有品质部给出的登记编号，其组成如下：A NCP & C/PAR number is assigned to each NCP & C/PAR by Quality Department and identified as follows: NCP-YYMMxxYY: 年份MM:月份
20、(如2010年3月记作201003) ; xx： NCP & C/PAR的序列号从01开始.YY: Year. MM: month (e.g. Year 2010/March is recorded as 201003; xx: NCP & C/PAR number, begin with 01.B. 客户投诉8D报告编号：8D number is assigned to each 8D by Quality Department and identified as follows: CONTACxxCSAB-8D- YYMM -xxCSS-8D- YYMM -xxYY: 年份MM:月份(如2
21、010年3月记作201003) ; xx：8D的序列号从01开始.YY: Year. MM: month (e.g. Year 2010/March is recorded as 201003; xx: 8D number, begin withxx 从01开始 xx begin with 01.5.7 NCP & C/PAR的发出者需填写NCP & C/PAR表格，接受者需为负责执行纠正行动的部门主管.NCP & C/PAR originator shall fill the NCP & C/PAR Form. The NCP & C/PAR recipient shall either b
22、e the department /section head responsible to carry out corrective action. 5.8 发出者需在NCP & C/PAR表格内填写下列资料:A. NCP & C/PAR originator shall fill the following information in the NCP & C/PAR Form:B. 问题描述Nonconformity DescriptionC. 认可的签名Signature for endorsementD. 最后的期限: 接受者需提交短期性修正行动的最后期限;Due Response D
23、ate: due date for the recipient to reply the short term corrective action.E. 监督NCP & C/PAR的实行Monitoring of NCP & C/PAR Implementation5.9 在预定回复日期前，负责行动的部门需提交品质部已填写“原因分析”、“纠正行动”的NCP & C/PAR给品质部，上述各项行动均需写上开始日期、预期日期。On or before the NCP & C/PAR response due date, the action party shall submit to Quality
24、 Department the NCP & C/PAR with completed “Root Causes Analysis”、 “Corrective Actions”, together with the start dates and expected completion dates of these actions.5.10 当收到回复的NCP & C/PAR后, QA工程师将会：On receiving the NCP & C/PAR from action party, the QA Engineer shall:A. 更新NCP & C/PAR状态报告；Update NCP
25、 & C/PAR Status ReportB. 加入一合适的跟进日期于NCP & C/PAR状态报告内。Enter an appropriate follow-up date in the NCP & C/PAR Status Report.5.11 在跟进日那天，报告人和QA工程师要审查所承诺的行动是否已实施？是否有效？ 并于NCP & C/PAR的跟进栏里填写资料以完结这份NCP & C/PAR。On the follow-up date, reporter and QA Engineer shall audit if committed actions are implemented
26、and effective and then fill in and sign on the NCP & C/PAR to signify its closure.5.12 NCP & C/PAR的正本最终送给品质部，品质部按其编号存档。The original NCP & C/PAR is finally passed to Quality Department, who shall file the NCP & C/PAR according to the NCP & C/PAR number. 5.13 发出新的NCP & C/PAR Issue of Subsequent NCP &
27、C/PAR:如果在跟进复核时，发现不合格项仍未解决，QA工程师将显示这些资料于相应的NCP & C/PAR内及更新NCP & C/PAR状态报告； QA工程师需发出一份新NCP & C/PAR, 该新NCP & C/PAR的编号为原来的号码加上一个英文字母，由A开始，如一份NCP & C/PAR被退两次, 该不合格项需在管理层会议上讨论。If the follow-up audit indicates that the non-conformity has not been solved, QA Engineer shall indicate this in corresponding NCP
28、 & C/PAR and update “NCP & C/PAR Status Report”. The QA Engineer then issues a new NCP & C/PAR with the same NCP & C/PAR number adding a letter “A” to request corrective actions, if a NCP & C/PAR is rejected two times, the nonconformity shall be discussed in the Management Meeting.5.14 复核NCP & C/PAR
29、的状况 Review of NCP & C/PAR status:QA工程师需定期审查NCP & C/PAR状况以确定有没有如期完成项目。如有必要，要在管理层会议上提出讨论。QA engineer shall review NCP & C/PAR status regularly to identify any outstanding items and present them in the Management Meeting for considering further action, if necessary. 5.14 进一步行动Further Action:如纠正行动导致文件的变
30、动, 按文件控制程序中有关更改的规定进行。If corrective actions result in procedure change, document update shall be conducted per “Document control procedure”.6. 参考文件Reference Document 内部审核控制程序 Internal Audit Control Procedure 文件控制程序Document control procedure记录控制程序record control procedure7. 记录 Record纠正和纠正措施（预防措施）报告Correction and corrective action (preventive action) reportNCP & C/PAR状态报告 NCP & C/PAR Master List
