RX-QP-04PFMEA控制程序PFMEA Procedure

无锡荣鑫金属涂装有限公司

Wuxi Rongxin metal coating Co., Ltd.

PFMEA控制程序

文件名称Procedure Name:

PFMEA Procedure RX-QP-04 A/0

何桂生

日期Date：

文件编号Document ID: 文件版本Document Version: 发放号Issue No： 编 制：

Prepared by

2014-04-28

审 核：

Reviewed by

日期Date：

日期Date：

实施日期：

Implement date

批 准：

Approved by

发布日期：

Issue date: 会签栏

Countersignature Row 部门 Department 签核人 Countersign 部门 Department 签核人 Countersign 物流部 Logistic 人事部 HR 生产部

质量部 Quality 工程部 Engineering 采购部 Purchasing Production 财务部 Finance 业务部 Business 注意！Attention！

除签字批准的原版外，只有在公司内部网上的文件才是有效文件，打印出的文件只能作为参考。 This document is controlled by the database on company server. Print-outs are for reference only.

PFMEA控制程序 文件编号Document ID.: 版次Version: A/0 RX-QP-04 修改日期Revision Date: 页次Page: 1 /22 1、目的 1. Purpose

确定与产品相关的潜在的失效模式和潜在失效的机理/起因，评价潜在失效对顾客产生的后果和影响，采取控制来降低失效产生频度或失效条件探测度的过程变量和能够避免或减少这些潜在失效发生的措施。

It aims to determine potential failure modes related to the products and the

mechanisms/causes for potential failure, evaluate effects and influences caused by the potential failure to the customer, control to reduce the frequency occurring failure or the process variables of failure condition detection and take measure to avoid or reduce occurrence of these potential failures.

2、适用范围 2. Scope

适用于所有新产品或修改过的产品及应用或环境发生变更的原有产品的设计和生产。如客户有特殊要求，必须按照客户的要求执行。

It applies to design and production of all new products or modified ones and the original

products with application or environment changed. If the customer has special requirements, it shall be implemented according to the requirements of the customer.

3、定义 3. Definition

3.1FMEA：指Failure Mode and Effects Analysis（失效模式及后果分析）的英文简称。由负责制造/装配的工程师/小组主要采用的一种分析技术，用以最大限度地保证各种潜在的失效模式及其相关的起因/机理已得到充分的考虑和论述。

3.1 FMEA: It is the English abbreviation of Failure Mode and Effects Analysis. It is an analysis

technics mainly used by the engineer/group responsible for manufacturing/assembling to ensure to the utmost that all kinds of potential failure modes and related causes/mechanisms

PFMEA控制程序 文件编号Document ID.: 版次Version: A/0 RX-QP-04 修改日期Revision Date: 页次Page: 2 /22 have been considered and discussed fully.

3.2失效：在规定条件下（环境、操作、时间），不能完成既定功能或产品参数值和不能维持在规定的上下限之间，以及在工作范围内导致零组件的破裂卡死等损坏现象。

3.2 Failure: Damages that can not finish the established function or product parameter value or can not keep specified top and bottom limitation and cause parts and components fracture and sticking with the working range under specified conditions (environment, operation, time). 3.3严重度（S）：指给定失效模式最严重的影响后果的级别，是单一的FMEA范围内的相对定级结果。严重度数值的降低只有通过设计更改或重新设计才能够实现。

3.3 Severity (S): Refers to grade of the severest effects of a given failure mode, which is a relative grade with a single EMEA range. Reduction of the severity value can only be realized through design change or redesigning.

3.4频度（O）：指某一特定的起因/机理发生的可能发生，描述出现的可能性的级别数具有相对意义，但不是绝对的。

3.4 Occurrence (O): Refers to possible occurrence of a given cause/mechanism and the grades describing the occurrence possibility are with relative meaning but not absolute.

3.5探测度（D）：指在零部件离开制造工序或装配之前，利用第一种现行过程控制方法找出失效起因/机理过程缺陷或后序发生的失效模式的可能性的评价指标；或者用第二种过程控制方法找出后序发生的失效模式的可能性的评价指标。

3.5 Detection (D): Refers to the evaluation indicator to find out the failure cause/mechanism

process defect or possibility of follow-up occurrence of failure mode by using the first current process control method before the parts and components leaving manufacturing process or assembling; or refers to the evaluation indicator to find out the possibility of follow-up occurrence of failure mode by using the second process control method.

3.6风险顺序数（RPN）：指严重度数（S）和频度数（O）及不易探测度数（D）三项数字之乘积。 3.6 Risk priority number (RPN): Refers to the product of the severity (S), occurrence (O) and detection (D).

4、职责

PFMEA控制程序 文件编号Document ID.: 版次Version: A/0 RX-QP-04 修改日期Revision Date: 页次Page: 3 /22 4. Responsibilities

APQP小组负责失效模式及后果分析（FMEA）的制定与管理。

The APQP group shall be responsible for the formulation and management of the failure

mode and effects analysis (FMEA).

5、程序 5. Procedure

5.1项目组依《产品质量先期策划程序》在产品图纸/图样设计工作全部结束和完成之前及生产用工装准备之前，从所要分析的系统、子系统或零部件的框图开始（如顾客有要求时），对所有新产品、产品更改以及应用或环境有变化的沿用零件中的所有产品特性（特别是产品的特殊特性）进行FMEA框图/环境极限条件(如顾客有要求时)、FMEA流程图/风险评定表和FMEA分析，并将其填写于“FMEA框图/环境极限条件表”（如顾客有要求时）、“潜在的失效模式和后果分析（FMEA）”表中，然后经项目组组长审查核准，以防止在产品设计和开发过程及生产中发生缺陷。

5.1According to the Advanced Product Quality Planning Procedure, before the product drawing/pattern design is finished and completed and the process equipment used for production is prepared, from the block diagram of the systems, subsystems or components to be analyzed (if the customer requires), the project group shall conduct FMEA block diagram/environment extreme condition (if the customer requires) and FMEA flow chart/risk assessment and FMEA analysis to the product features (especially special features of the product) of all new products, changed products and components with application and environment change but continuing to be used , and fill it in the “FMEA block diagram/environment extreme condition table” (if the customer requires) and the “potential failure mode and effects analysis (FMEA)”, which shall be reviewed and approved by the project group leader so as to prevent defect from occurring in product design and development process and production. 5.1.1过程失效模式及后果分析

5.1.1 Process failure mode and effects analysis

A)针对新产品，项目组将建立和制订其单独的过程失效模式及后果分析（PFMEA）；针对常规