RX-QP-04PFMEA控制程序PFMEA Procedure

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: 20 /22 2) Revise the material standard;

3)试验设计(尤其是存在多重或相互作用的起因时或其它解决问题的技术)；

3) Design of experiment (especially multiple or interactive causes or other technology used to

solve problems exist); 4)修改试验计划。

4) Revise the experiment program. D)只有设计更改才能导致严重度的降低。

D) Only change in design can reduce the severity.

只有通过设计更改消除或控制失效模式的一个或多个起因/机理才能有效地降低频度。增加设计 确认/验证措施仅能导致探测度值的降低。由于增加设计确认/验证不是针对失效模式的严重度和频度的，所以这种工程措施是不太期望采用的。对于一个特定的失效模式/起因/控制的组合，如果工程评价认为无需采用建议措施，则在该栏中填写“无”，予以明确注明。

The occurrence can be reduced effectively only by changing the design to eliminate or control one or more causes/mechanisms of the failure mode. To increase design confirmation/verification measures can only decrease the detection value. Because increase of design confirmation/verification does not aim at the severity and occurrence of the failure mode, these engineering measures are not expected to be used. As to a specific failure mode/cause/control combination, if engineering assessment thinks that no recommended measure is needed to be taken, fill \

5.8.20建议措施的责任：填入每一项建议措施的责任组织的名称和个人的姓名以及目标完成的日期。

5.8.20 Responsibility of the recommended measures: fill in the name of the responsible organization and person of each recommended measures and the date reaching the aim. 5.8.21采取的措施：在措施实施之后，填入实际措施的简要说明以及生效日期。

5.8.21 Measures adopted: After the measures are implemented, fill brief instruction and effectsive date of the actual measures.

5.8.22纠正后的RPN：当确定了预防/纠正措施以后，估算并记录纠正后的严重度、频度和探测度

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: 21 /22 值的结果。计算并记录纠正后的RPN值的结果。如果没有采取任何措施，将“纠正后的RPN”档和对应的取值栏目空白即可。所有纠正后的定级数值都应进行复查和评审，而且如果有必要采取进一步措施的话，应重复5.8.19至5.8.22的步骤。

5.8.22 RPN after correction: After preventive/corrective measures are determined, estimate and record the results of severity, occurrence and detection after correction. Calculate and record the RPN value after correction. If no measure is taken, leave a blank at the “RPN after correction” column and its corresponding value column. All the grading values after correction shall be reexamined and reviewed; however, if it is necessary to take further measures, step 5.8.19 to 5.8.22 shall be repeated.

5.9项目小组应负责保证所有的建议措施已被实施或已妥善落实。FMEA是一个动态文件，它不仅应体现最新的设计水平，而且还应体现最新采取的有关措施，包括开始生产后发生的设计更改和措施。可采用以下几种方式来保证找出所关注的问题得到明确并且所建议的措施得到实施，这些方式包括但不限于下列情况：

5.9 The project group shall ensure that all the recommended measures have been implemented or put into practice properly. FMEA is a dynamic document, which shall not only reflect the latest design level but also latest related measures taken, including change in design and measure after production begins. The following several methods can be used to ensure that key issues found out are made clear and the recommended measures are implemented, which include but not limited to the following cases:

1)保证设计要求得到实现；

1) Ensure to realize the design requirements; 2)评审工程图样和规范；

2) Review the engineering drawing and standard; 3)确认这些已反映在装配/生产文件之中；

3) Confirm that these have been reflected in the assembly/production documents; 4)评审过程FMEA和控制计划。

4) Review process FMEA and control plan.

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: 22 /22 5.10新产品在试生产、正式投产后或旧产品在批量生产后或接受到顾客投诉（抱怨）/退货，出现新的失效模式时，项目小组应及时进行失效模式及后果分析（FMEA）更新FMEA相关资料。 5.10 If new failure mode appear after new product is gone into trial production and put into production or old product is gone into quantity production or complaint/return of goods of the customer is received, the project group shall conduct failure mode and effects analysis timely and change related FMEA data.

5.11 项目组成员需要每年一次定期更新FMEA. FMEA shall be update regularly once a year.

6、相关文件Reference documents

序号文件编号No. Document ID 6.1 RX-QP-03 文件名称 Document Name 产品质量先期策划程序 序号No. 文件编号Document ID 文件名称 Document Name 7、相关记录Records

序号记录编号 No. Document ID 7.1 RX-QP-04-R-01-01 记录名称 Document Name FMEA框图 序号记录编号No. Document ID 记录名称 Document Name

PFMEA控制程序 文件编号Document ID.: 版次Version: A/0 RX-QP-04

8、附件 Annex

修改日期Revision Date: 页次Page: 23 /22 附 录A 流程图 Annex A: Flow Chart

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: 24 /22 PFMEA控制程序顾客各部门工程部相关记录顾客需求提出公司内部需求提出确定过程流程图/风险评定图填写FMEA框图FMEA框图进行FMEA分析PFMEA表不断降低RPN值动态更新