Corrective and Preventive Action Control Procedure纠正及预防措施控制程序 A1

Contac Solutions AB文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 1 of 12Document 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 Management Procedure不符合纠正预防措施控制程序Approvals（批准）Responsible （负责）NameSignatureDate （日期）Originator （制作）Department Leader（部门负责人）MR（管理者代表）GM （总经理）Contac Solutions AB文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 2 of 12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 procedureLivia HeDennis Huang:contao POWERFUL SOLUTIONSContac Solutions AB文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 3 of 121.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 eliminateexisting 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 preventive action taken for the quality and EMS in CONTAC.3. 定义 Definition纠正及预防措施（C /PAR）：-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 easeof control, a “Corrective and preventive report C/PAR Status Report” is used to record the request and statusof implementation.4. 责任 Responsibility品质部负责:Quality & Environment Department is responsible fora）接收CONTAC以外的投诉及储存有关资料;Contac Solutions AB. POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 4 of 12Receiving 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；Issuing 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 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 corrective 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.Contac Solutions AB. POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 5 of 12Summarizing all NCP & C/PARs, and other corrective & preventive action report, then reporting the summary to 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/PARoInternal 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 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 of 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.Contac Solutions AB. POWERFUL SOLUTIONS CSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 6 of 122）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；Nonconformity 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 results of data analysis10）环境的监测数据.Contac Solutions AB. POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 7 of 12Environmental monitoring data5.2 客户投诉 Customer Complaint5.2.1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 customer 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 results 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8DBased on “Incoming Inspection report” or other information, Quality Department may issue a NCP & C/PAR and 8D to supplier which existed quality problems.Contac Solutions AB. POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 8 of 125.4 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-conformity 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，并经彻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 Quality 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（如2010年3月记作201003） ; xx : NCP & C/PAR的序列号从01开始.Contac Solutions AB . POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 9 of 12YY: 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2010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 be 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 endorsement.Contac Solutions AB. POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 10 of 12一行动的最后期限；Due Response Date: 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源因分析”、“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 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 & 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/PARoOn the follow-up date, reporter and QA Engineer shall audit if committed actions are implemented and effective and then fill in and sign on the NCP & C/PAR to signify its closure.Contac Solutions AB . POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 11 of 125.12 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 & 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 & C/PAR and 叩 date “NCP & C/PAR Status Report”. The QA Engineer then issues a new NCP & C/PAR with the same NCP & C/PARnumber 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动，按文件控制程序中有关更改的规定进行。.Contac Solutions AB. POWERFUL SOLUTIONSCSS-QP-09 Rev A2文件名称：不符合纠正预防措施控制程序Name: Non-Conformance, Corrective & Preventive Action Management ProcedurePage 12 of 12If 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