发布时间 : 星期一 文章RX-QP-04PFMEA控制程序PFMEA Procedure更新完毕开始阅读7ada8d70abea998fcc22bcd126fff705cc175c09
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: 4 /22 产
品（即：老产品），项目组根据其系列分类、相同的工艺流程/过程和相同的产品/过程特性（特别是其相同的产品/过程特殊特性）建立和制定其通用的过程失效模式及后果分析（PFMEA）。
A) As to new products, the project group shall establish and formulate separate process failure mode and effects analysis (PFMEA); as to routine products (that is: old products), the project group shall establish and formulate universal process failure mode and effects analysis (PFMEA) according to their series and classification, the same technical process and the same product/process features (especially the same project/process special features).
B)项目组应列出产品生产过程流程图的清单，过程失效模式及后果分析（PFMEA）从产品整个 过程的流程图开始，该产品的流程图应确定与每一工序相关的产品/过程特性。如果有的话，相应的设计FMEA中所明确的一些产品影响后果应包括在该产品的过程流程图中；项目组将用于该产品过程FMEA准备工作的流程图纸的复印件附在该产品过程FMEA分析表之后，以作为进行该产品过程FMEA分析之依据。
B) The project group shall give the list of project production process flow chart; process failure mode and effects analysis (PFMEA) shall begin with the flow chart of the whole process of the product; the flow chart of the product shall determine the product/process features relevant to each working procedure. If any, the product effects defined in corresponding design FMEA shall be included in the product process flow chart; the project group shall attach the copies of the flow drawing of the product process FMEA preparation work after the product process FMEA analysis table so as to taking it as the basis for product process FMEA analysis.
C)项目组在进行过程失效模式及后果分析（PFMEA）前应根据该产品的过程流程图先完成 PFMEA过程流程图风险评定表的风险分析和评估，该风险分析和评估必须考虑从单个部件到总成的所有制造工序，过程失效模式及后果分析（PFMEA）和过程流程/风险评定表应包括从进料检验到出货的所有过程的特殊特性。并分析产品在制造过程中的每一个工序步骤操作评定过程的风险（如：高、中、低风险）；对评定为高风险（即：RPN≧100或严重度≧8）的工序/项目和特殊特性应优先采取纠正与预防措施；当顾客有要求或公司认为需要的中等风险，也应对其纠正与预防措施。在确定了潜在的失效模式之后，应采取纠正/预防措施来消除潜在失效模式或不断减少它们发
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: 5 /22 生的可能性。
C) The project group shall finish risk analysis and assessment specified in the risk assessment table of the PFMEA process flow chart according to the process flow chart of the product before the process failure mode and effects analysis (PFMEA); the risk analysis and assessment shall take consideration of all manufacturing working procedures from a single part to the assembly; the process failure mode and effects analysis (PFMEA) and the process flow/risk assessment table shall include the special features in all processes from incoming quality control to shipment. It shall assess the process risk by analyzing each working procedure and step in the manufacturing process of the product (e.g.: high, moderate and low risk); as to the working procedure/project and special features with high risk (that is: RPN≧100 or severity ≧8), corrective and preventive measures shall be taken first; where the customer requires or the company thinks that moderate risk is needed, corrective and preventive measures shall also be taken. After potential failure mode is determined, corrective and preventive measures shall also be taken to eliminate the potential failure mode or reduce the possibility of occurrence.
D)在进行过程失效模式及后果分析（PFMEA）时，应假定所设计的产品能够满足设计要求，因 为设计缺陷和薄弱环节所产生的潜在失效模式可包括在过程失效模式及后果分析（PFMEA）中，但它们的影响/后果及避免措施由设计失效模式及后果分析（DFMEA）来解决。
D) When conducting process failure mode and effects analysis (PFMEA), it shall suppose that the product designed can meet the design requirement, because the design defect and the potential failure mode occurring in weak link can be included in the process failure mode and effects analysis (PFMEA), but their influence/effects and preventive measurements shall be solved by design failure mode and effects analysis (DFMEA).
E)过程失效模式及后果分析（PFMEA）并不是依靠改变产品设计来克服过程中的缺陷和薄弱环 节的，但它的确要考虑与计划的制造或装配过程有关的产品设计特性，以最大限度的保证产品能满足顾客的要求和期望。
E) The process failure mode and effects analysis (PFMEA) does not rely on changing project design to overcome the defect and weak link in the process by, but it needs to consider the
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: 6 /22 product design features related to the planned manufacturing or assembling process indeed so as to ensure to meet the requirement and expectation of the customer to the utmost.
F)公司必须对每一个过程中所涉及到的产品和/或过程的特殊特性进行过程失效模式与后果分
析
（PFMEA），并寻找最佳改善方法努力改进过程，以防止发生缺陷和预防潜在失效发生，而不是依靠检测找出缺陷和失效。
F) The company shall conduct process failure mode and effects analysis (PFMEA) to the special features of the product and/or process involved in each process and find the best improvement method to improve the process so as to prevent defect and potential failure from occurring, not to find out defect and failure by relying on detection.
5.2失效模式及后果分析（FMEA）和其流程图/风险评定表中的风险分析和评估应包括从单个零件的所有产品特性（即：产品的外观、尺寸、功能和性能等）到总成的所有产品特性（即：产品的外观、尺寸、功能和性能等）。
5.2 Risk analysis and assessment in the failure mode and effects analysis (FMEA) and its flow chart/risk assessment table shall be conducted from all product features (that is: appearance, size, function and performance of the product, etc.) of single parts and components to all product features of the assembly ((that is: appearance, size, function and performance of the product, etc.).
5.3如顾客有要求时，FMEA分析从所要分析的系统、子系统或零部件的FMEA环境极限框图开始，FMEA框图指示了信息、能源等的流程。其目的是要明确向方框交付的内容（输入），方框中完成的过程（功能）以及由方框所交付的内容（输出）。FMEA框图说明了分析中的各项目之间的主要关系，并建立了分析的逻辑顺序。在FMEA准备工作中所有的框图的复制件应伴随FMEA过程。 5.3 If the customer requires, FMEA analysis shall begin with the systems, subsystems or FMEA environment limit block diagram of the parts and components needed to be analyzed, and the FMEA block diagram shall indicate the information and energy flows. Its purpose is to define the content (input) delivered to the box, process (function) finished in the box and content (output) delivered by the box. The FMEA block diagram states main relation among the items in analysis
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: 7 /22 and establishes the logical order of the analysis. Copies of all block diagrams in the FMEA preparation work shall go with the FMEA process.
5.4失效模式及后果分析（FMEA）应从整个产品设计过程或生产过程中的流程图/风险评定开始，流程图应确定与每个系统、子系统或零部件有关的产品特性参数，并分析产品在设计过程中的每一个步骤评定过程的风险；对评定为高风险的项目和特殊特性应优先采取纠正与预防措施；当顾客有要求或公司认为需要的中等风险，也应对其纠正与预防措施。
5.4 Failure mode and effects analysis (FMEA) shall begin with the flow chart/risk assessment in the whole product design or production processes; the flow chart shall determine the product feature parameters related to each systems, subsystems or parts and components and analyze the risk of each step assessment process in the design process of the product; as to projects and special features with high risk, corrective and preventive measures shall be taken first; where the customer requires or the company thinks that moderate risk is needed, corrective and preventive measures shall also be taken.
5.4.1在确定了潜在的失效模式之后，应采取纠正/预防措施来消除潜在失效模式或不断减少它们发生的可能性，并寻找最佳改善方法努力改进过程，以防止发生缺陷和预防潜在失效发生，而不是依靠检测找出缺陷和失效。
5.4.1 After determining the potential failure modes, corrective and preventive measures shall be taken to eliminate the potential failure modes or reduce their possibility of occurrence continuously and find the best improvement method to improve the process so as to prevent defect and potential failure from occurring, not to find out defect and failure by relying on detection.
5.5在FMEA分析过程中被评价列为高RPN（RPN≧100）的项目或严重度≧8的项目，公司必须将其列为特殊特性；同时对所有被评价为高RPN（RPN≧100）的项目或严重度≧8的项目公司必须制定纠正/预防措施，对不可降低的高RPN项目或严重度≧8的项目必须附有明确的探测方法。对PFMEA要定期进行评审，不断降低RPN值。
5.5 As to projects with high RPN (RPN≧100) or with the severity ≧8 in the FMEA analysis process, the company shall list them as special features; while, the company shall formulate