过程FMEA程序-第五版

1.0 目的:/purpose:

评估产品/过程中失效的潜在技术风险，分析失效的起因和影响，记录预防和探测措施，针对降低风险的措施提出建议，FMEA形成文件并跟踪这些措施的实施情况，以降低风险。并介定后续维护中的提出、制订、执行及随后监察其有效性的责任。

Evaluate the potential techincal risks of failure of a product or process,analyze the

causes and effects of those failures,document preventive and detection actions,recommend

actions to reduce risk，the FMEA documents and tracks actions that are taket to reduce

risk, It also defines the responsibilities for the subsequent maintenance of the

proposal, formulation, implementation and subsequent monitoring of its effectiveness.

2.0 范围:/Scope:

适用于制作流程的检查与预防。

Applicable to the production process of the inspection and prevention.

注：根据APQP要求，并针对下述来源所发现的潜在缺陷，应采取相应的预防及纠正行动。

Note:according to the requirements of APQP, and according to the following sources found

potential defects, the corresponding preventive and corrective action should be taken.

以前产品认可时发出的偏差纠正；

Deviation from the previously approved products when correcting;

因设计、标准、物料更改导致产品变化；

Product changes caused by design, standard, material changes;

使用新指示或物料；

Using the new instructions or material;

使用新的或优化的工具，包括生产和客户提供的工具；

Use new or optimization tools, including production and provide the tools;

对原有工具和设备进行过翻新和重新布置；

The original tools and equipment for renovation and redecorating

生产流程、方法、组装、物流过程发生变动；

Production process, method, assembly, logistics process change;

工具和设备位置迁移；

Tools and equipment location migration;

部件、物料或服务的外发加工商变更；

Outward processing business changes of parts, materials or services;

工具停用一年后再次使用；

Tool downtime again a year later use;

由于产品质量原因，客户要求暂停出货；

Due to product quality, customer request to suspend shipment;

客户特殊特性；

Customer special features;

客户投诉；

Customer complaints;

交叉功能会议中所决定的特殊特性；

Cross functional meeting decided by the special features;

供应商提供的发现并修理的故障指示。

The discovery of suppliers and repair fault indicator.

危害分析和风险评估变更

Changes to the hazard analysis and risk assessment(HARA)

威胁分析和风险评估变更

Changes to the threat analysis and risk assessment(TARA)

产品监视过程中发现问题

Findings due to product monitoring

经验教训

Lessons learned

3.0 适用（参考）文件：/Apply (reference) file:

纠正和预防措施程序

Corrective and preventive action process

产品质量先期策划（APQP）程序

Advanced product quality planning (APQP) process

4.0 简称（定义）：/Abbreviation (definition)

FMEA意为缺陷模式及后果分析，也是一种预防行动。FMEA分为设计FMEA(DFEMA)及流程FMEA

(PFMEA)。

FMEA is defect mode and result analysis, is also a kind of preventive action. FMEA is

divided into design FMEA (DFEMA) and process FMEA (PFMEA).

5.0 权责:/Responsibilities:

5.1 交叉功能小组提出FMEA，明确介定潜在缺陷问题及负责采取行动的部门，以及跟进并验证提出的纠正预防行动，并记录其结果 。

5.1 FMEA, cross-functional team clear dielectric constant potential defects and to take

charge of to take action, and follow up the corrective and preventive actions and

verify, and record the results.

5.2 品质部负责提供前十二个月AOI/E-T/FQC缺陷不良数据。

5.2 Quality department is responsible for providing the first twelve months of AOI/E -

T/FQC defects of bad data.

5.3 PE工程师负责准备相应的FMEA及会议记录。

5.3 PE engineer is responsible for the preparation of the corresponding FMEA and meeting

record.

5.4 交叉功能小能授权代表审批FMEA及会议记录。

5.4 Cross functional small can FMEA and meeting records for examination and approval of

authorized representatives.

5.5 工序责任部门经理或主管应签名认可FMEA并负责纠正行动的执行。

5.5 Process responsibility department manager or supervisor should be endorsed FMEA and

responsible for the implementation of corrective actions.

PFMEA小组清单

核心团队成员

核心团队成员：准备FMEA系统分析(步骤1-3)并参加FMEA会议

1.提供相关产品和过程的相关经验知识

2.提供关于FMEA关注产品或过程的必要信息

3.提供现有FMEA已知经验 4.参与执行FMEA的7个步骤

5.参与编写商业案例

6.吸取经验教训

来自部门/组织 职位 组内角色 主要职责 专业知识/技能要求

工艺部 经理 PFMEA推进者 FMEA工作流程的协调和组织 小组能力矩阵表

生产中心 总监 PFMEA协调者 缓解冲突 小组能力矩阵表

品质部 高级工程师 质量/可靠性工程师 提供关于FMEA关注产品和过程的必要信息 小组能力矩阵表

工艺部 工程师 过程/制造工程师 参与执行FMEA的7个步骤 小组能力矩阵表

工艺部 高级工程师 过程验证工程师 参与编写商业案例 小组能力矩阵表

扩展团队成员

扩展团队成员：根据需要参与(由FMEA推进者或会议组织人协调)

1.提供有关特殊项目的补充资料

2.提供关于FMEA关注产品和过程的必要信息 3.参与编写商业案例

来自部门/组织 职位 组内角色 主要职责 专业知识/技能要求

生产部 主管 过程制造工程师 提供有关特殊项目的补充资料 小组能力矩阵表

品质部 工程师 质量/可靠性工程师 提供关于FMEA关注产品和过程的必要信息 小组能力矩阵表

The process FMEA Team list

Core Team Members

the Core team members prepare the FMEA system analysis (steps 1-3)and participate in the FMEA

meetings

1.Contribute knowledge from relevant product and

process experience

2.Contribute necessary information about the

product or process that is the focus of the FMEA

3.Contribution of existing experiences from previous

FMEAs already known 4.Participation in the execution of the 7 steps of FMEA

5.Involvement in the Preparation of the Business Case

6.Incorporating lessons leamed

From

department/organization Position Roles in the group Main duty Professional

knowledge/skills

requirements

PE manager PFMEA Facilitator coordination and

organization of the