标准摘要
[中文适用范围]: 本标准描述了设计中的潜在失效模式与影响分析(DFMEA)、补充的FMEA-MSR以及制造和装配过程中的潜在失效模式与影响分析(PFMEA)。它通过提供适当的术语、要求、评级图表和工作表,帮助用户识别和减轻风险。作为标准,本文件包含要求(“必须”)和建议(“应该”),以指导用户完成FMEA过程。FMEA过程和文件必须符合本标准以及任何有关本标准的公司政策。对于偏差,需要记录理由并与客户达成一致,以便在客户或第三方审核期间证明新工作或更改方法的合理性。 [外文原描述]: This FMEA standard describes potential failure mode and effects analysis in design (DFMEA), supplemental FMEA-MSR, and potential failure mode and effects analysis in manufacturing and assembly processes (PFMEA). It assists users in the identification and mitigation of risk by providing appropriate terms, requirements, rating charts, and worksheets. As a standard, this document contains requirements—”must”—and recommendations—”should”—to guide the user through the FMEA process. The FMEA process and documentation must comply with this standard as well as any corporate policy concerning this standard. Documented rationale and agreement with the customer are necessary for deviations in order to justify new work or changed methods during customer or third-party audit reviews.
英文名称Potential Failure Mode and Effects Analysis (FMEA) Including Design FMEA, Supplemental FMEA-MSR, and Process FMEA