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 the

potential failure modes which may occur in process and their corresponding

failure 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 Engineer

QE:品质工程师

3.3SQE: Supplier Quality Engineer

SQE:供应商管理品质工程师

3.4PE: Process Engineer

PE:工艺工程师

3.5ME: Manufacturing Engineer

ME:制造工程师

3.6TE: Test Engineer

TE:测试工程师

3.7EE: Equipment Engineer

EE:设备工程师

3.8DCC: Document Control center

DCC:文件控制中心

3.9RPN: Risk Priority Number

RPN: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 and

update 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, Process

Engineer, 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 when

required.

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 from

process 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 to

classify 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 team

effort.And determine Recommended Action,Responsibility,Target

Completion Date and Action Taken, and record them on the Failure Modeand

Effect Analysis sheet. Medium risk priority number (RPN) is targeted for

optional 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 and

should always reflect the latest status of relevant actions. So the PFMEA

review needs to be organized by QEwithin the project team at least 3 months

and updated according to the actual status. It's recommended that PFMEA

review meeting can be performed during the CIP (Continual Improvement

Program) meeting.