P F M E A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。 2 SCOUPE（范围） This work instruction applies to any manufacturing process that has a customer requirement for failure mode effect 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。 3.2 QE: Quality Engineer QE:品质工程师 3.3 SQE: Supplier Quality Engineer SQE: 供应商管理品质工程师 3.4 PE: Process Engineer PE: 工艺工程师 3.5 ME: Manufacturing Engineer ME:制造工程师 3.6 TE: Test Engineer TE: 测试工程师 3.7 EE: Equipment Engineer EE: 设备工程师 3.8 DCC: Document Control center DCC:文件控制中心 3.9 RPN: 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, SQE and Production Supervisor are Process PFMEA team member, prepare PFMEA report together with Quality 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