The purpose of Failure Modes and Effects Analysis (FMEA) is to establish how items or processes might fail to function so that treatments can be identified. An FMEA provides a systematic method for identifying modes of failure together with their effects, and possibly their causes, on the item or process, both locally and globally. 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 process is known as Failure Modes, Effects and Criticality Analysis (FMECA). This International Standard explains how FMEA, including the FMECA variant, can be planned, performed, documented and maintained. This International Standard is applicable to hardware, software, processes including human action, and their interfaces, in any combination thereof. An FMEA can be used in a safety analysis, for regulatory and other purposes, but this is a generic standard and does not give specific guidance for safety applications.