PFMEA作业指导书(中英文).doc

PFMEA作业指导书1 PURPOSE（目的）The purpose of this work instruction is to provide a method for continuous improvement through the use of PFMEAs.此作业指导书的目的是为运用制程失效模式及效果分析达到持续改善目的提供方法。

2SCOUPE（范围）This work instruction applies to any manufacturing process that has a customer requirement for failure modeeffect analysis or any process at FLEX (Doumen) where management requires a PFMEA.适用于客户要求或管理要求而需要做失效模式及效果分析的所有制程。

3 DEFINITIONS（定义）3.1 PFMEA: Process Failure Mode and Effect Analysis. It should describe all thepotential failure modes which may occur in process and their correspondingfailure effects; evaluate and rank the severity, occurrence and detection of the failures.It should also describe the current control method, recommend corrective action,person responsible responsibility and due date.PFMEA--制程失效模式及效果分析。

它应列出制程中所有可能出现的潜在失效模式以及相应的失效结果，评价和评定其严重度、发生度、检测度的等级分数。

同时指出当前的控制方法和建议的改善行动以及相应的责任者和完成期限。

3.2QE: Quality EngineerQE:品质工程师3.3SQE: Supplier Quality EngineerSQE:供应商管理品质工程师3.4PE: Process EngineerPE:工艺工程师3.5ME: Manufacturing EngineerME:制造工程师3.6TE: Test EngineerTE:测试工程师3.7EE: Equipment EngineerEE:设备工程师3.8DCC: Document Control centerDCC:文件控制中心3.9RPN: Risk Priority NumberRPN:风险优先系数4. REFERENCE（参考文件）4.1 DMP-010 Corrective and Preventive Action 纠正与预防措施5. RESPONSIBILITY（职责）5.1 Quality Engineer: PFMEA Team Leader, holds the PFMEA meeting, prepare andupdate PFMEA base on team discussion result, apply PFMEA issue.品质工程师 : PFMEA 团队之领导者。

主导制程失效模式及效果分析 , 举行制程失效模式及效果分析会议，根据团队讨论结果准备和更新报告，申请报告发行。

5.2 Manufacturing Engineer, Process Engineer, TE, EE, SQEand Production are Process PFMEAteam member, prepare PFMEAreport together with Quality Supervisor Engineer.制造工程师，工艺工程师，测试工程师，设备工程师，供应商管理品质工程师和生产主管是制程失效模式及效果分析之组员，同品质工程师一起准备潜在失效模式及效果分析报告。

5.3 DCC: Control the PFMEA files and keep in DCC.DCC: 负责控制及保存制程失效模式及效果分析文件。

6. PROCEDURE（程序）6.1 Operating Procedure操作程序6.1.1 A PFMEAteam is madeup of the Quality Engineer, Manufacturing Engineer, ProcessEngineer, TE, EE, SQE and the appropriate Production Supervisor. PFMEA小组由品质工程师 , 制造工程师，工艺工程师，测试工程师，设备工程师，供应商管理品质工程师和相应的生产主管组成。

6.1.2 Quality Engineer initiates a PFMEA during New Product Introduce whenrequired.在新产品导入时而且需要时，品质工程师应该发起PFMEA。

6.1.3During the mass production, based on feedback of daily quality report,abnormal notice, CAR, PERand so on. Quality Engineer summarize abnormity fromprocess within 3 month and have a meeting to analyze Failure Effect, Failure Cause,Current Process Control.在量产过程中 , 基于每日品质报告、异常问题通知单、纠正措施报告、问题评估报告等的反馈更新制程失效模式及效果分析文件。

品质工程师三个月进行总结一次，并召开会议对其进行失效影响和原因 , 当前控制方法加以分析。

6.1.4 Evaluates the RPNnumber. Determine score of RPNand classify High Risk,Medium Risk and Low Risk per different process and product. Suggest toclassify High Risk (above 100), Medium Risk (60~100), Low Risk (Below 60).评估 RPN数值，可根据不同的制程和产品来决定高风险, 中风险和低风险的分数。

建议对于 RPN值进行高低分类：高风险（ 100 分以上） , 中风险（在 60 和 100 分之间） , 低风险（在 60 分以下）。

6.1.5 High risk priority number (RPN) is targeted for reduction through teameffort.And determine Recommended Action,Responsibility,TargetCompletion Date and Action Taken, and record them on the Failure ModeandEffect Analysis sheet. Medium risk priority number (RPN) is targeted foroptional reduction through team effort.高风险系数的失效是小组努力降低的目标, 需要决定所采取的相应纠正行动人及完成日期记录在制程失效模式及效果分析表中。

中风险系数的失效是小组可选择降低的目标。

, 责任6.1.6Relative responsibility should take recommended action.相关责任人应对所推荐的纠正行动加以实施。

6.1.7Follow Up and Review of the PFMEA: The PFMEA is a living document andshould always reflect the latest status of relevant actions. So the PFMEAreview needs to be organized by QEwithin the project team at least 3 monthsand updated according to the actual status. It's recommended that PFMEAreview meeting can be performed during the CIP (Continual ImprovementProgram) meeting.PFMEA的跟进及评审 : PFEMA 是一种活的且需不断更新的文件从而反映最新的状态。

因此 , 各项目内的品质工程师应每三个月一次组织PFMEA团队依据最新的情况进行一次评审并对PFMEA进行相应的更新。

建议在各项目的持续改善会议中对PFMEA进行评审。

6.2 Rating Factor Guidelines: 评分指南表6.2.1 The PFMEA Severity Evaluation Criteria.PFMEA 严重度评估标准。

6.2.2 The PFMEA Occurrence Evaluation Criteria.PFMEA 发生率评估标准。

6.2.3 The PFMEA Detection Evaluation Criteria.PFMEA可检出率评估标准。

6.2.1 PFMEA Severity Evaluation CriteriaRating Description Definition级别描述定义Dangerously High Failure would be noticeable to the customer and would10 drastically affect the customers process or product特别高对客户来说是显而易见的，且会严重影响客户的制程和产品。

Failure would be readily apparent to the customer, but9 Extremely high would have major effects on the customer's process or 极高product.对客户来说是容易见到的，且主要会影响客户的制程和产品。