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)