BS EN IEC 60812 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 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. BS EN IEC 60812 includes 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 FMECA.
BS EN IEC 60812 is applicable to hardware, software, processes including human action, and their interfaces, in any combination. An FMEA can be used in safety analysis, for regulatory and other purposes.
Note: BS EN IEC 60812, does not give specific guidance for safety applications.
BS EN IEC 60812 on Failure modes and effects analysis is useful for:
FMEA is a systematic method of evaluating an item or process to identify the ways in which it might potentially fail and the effects of the mode of failure upon the performance of the item or process and on the surrounding environment and personnel. BS EN IEC 60812 describes how to perform an FMEA. The purpose of performing an FMEA is to support decisions that reduce the likelihood of failures and their effects and thus contribute to improved outcomes either directly or through other analyses. Such improved outcomes include, but are not limited to, improved reliability, reduced environmental impact, reduced procurement, and operating costs, and enhanced business reputation.
FMEA can be adapted to meet the needs of any industry or organization. FMEA can be carried out several times in the lifetime for the same item or process. A preliminary analysis can be conducted during the early stages of design and planning, followed by a more detailed analysis when more information is available. FMEA can include existing controls, or recommended treatments, to reduce the likelihood or the effects of a failure mode. BS EN IEC 60812 uses the term FMEA to include FMECA. BS EN IEC 60812 gives general guidance on how to plan, perform, document and maintain an FMEA by:
EN 61753-131-3:2011
IEC 60812:2018
EN IEC 60812:2018