IEC 60812:2018 explains how Failure Mode and Effect Analysis (FMEA), including the Failure Mode, Effect and Criticality Analysis (FMECA) variant, is planned, performed, documented and maintained. The purpose of failure mode and effects analysis (FMEA) is to determine how items or processes fail to perform their function so that necessary actions can be identified. An FMEA provides a systematic method for identifying failure modes and their effects on the item or process, both locally and globally. It can also include identifying the causes of failure modes. Failure modes can be prioritized to support treatment decisions. When the criticality classification includes, at a minimum, severity of consequences and often other measures of importance, the analysis is referred to as failure modes, effects, and criticality analysis (FMECA). This document is applicable to hardware, software, processes, including human actions, and their interfaces in any combination. An FMEA can be used in a safety analysis for regulatory and other purposes, but because it is a general standard, it does not provide specific guidance for safety applications.
