AS/NZS IEC 60812:2020 pdf download,Failure modes and effects analysis (FMEA and FMECA).
Failure modes and effects analysis (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. This document 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 is applicable to hardware, software, processes, human action and their interfaces, in any combination.
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. In the case of a closed loop analysis, FMEA allows for evaluation of the effectiveness of any treatment.
FMEA can be tailored and applied in different ways depending on the objectives.
Failure modes may be prioritized according to their importance. The prioritization can be based on a ranking of the severity alone, or this can be combined with other measures of importance. When failure modes are prioritized, the process is referred to as failure modes, effects and criticality analysis (FMECA). This document uses the term FMEA to include FMECA.
AS/NZS 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 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).
AS/NZS IEC 60812 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.