失效模式和效应分析(FMEA和FMECA

[中文适用范围]： 本文档解释了如何规划、执行、记录和维护故障模式和影响分析 (FMEA)，包括故障模式、影响和关键性分析 (FMECA) 变体。故障模式和影响分析 (FMEA) 的目的是确定项目或流程如何可能无法执行其功能，以便识别任何所需的处理方法。 FMEA 提供了一种系统方法，用于识别本地和全球的故障模式及其对项目或过程的影响。它还可能包括识别故障模式的原因。可以对故障模式进行优先级排序以支持治疗决策。如果关键性排名至少涉及后果的严重性，并且通常还涉及其他重要性衡量标准，则该分析称为故障模式、影响和关键性分析 (FMECA)。本文档适用于硬件、软件、流程（包括人类行为）及其界面的任意组合。 FMEA 可用于安全分析、监管和其他目的，但这是一个通用标准，并没有为安全应用提供具体指导。 [外文原描述]： IEC 60812:2018 explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained. The purpose of failure modes and effects analysis (FMEA) is to establish how items or processes might fail to perform their function so that any required treatments could be identified. An FMEA provides a systematic method for identifying modes of failure together with their effects on the item or process, both locally and globally. It may also include identifying the causes of failure modes. Failure modes can be prioritized to support decisions about treatment. Where the ranking of criticality involves at least the severity of consequences, and often other measures of importance, the analysis is known as failure modes, effects and criticality analysis (FMECA). This document is applicable to hardware, software, processes including human action, and their interfaces, in any combination. An FMEA can be used in a safety analysis, for regulatory and other purposes, but this being a generic standard, does not give specific guidance for safety applications. This third edition cancels and replaces the second edition published in 2006. This edition constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: a) the normative text is generic and covers all applications; b) examples of applications for safety, automotive, software and (service) processes have been added as informative annexes; c) tailoring the FMEA for different applications is described; d) different reporting formats are described, including a database information system; e) alternative means of calculating risk priority numbers (RPN) have been added; f) a criticality matrix based method has been added; g) the relationship to other dependability analysis methods have been described. Keywords: failure modes and effects analysis (FMEA), failure modes effects and criticality analysis (FMECA)