IEC 60812:2018 pdf download.Failure modes and effects analysis (FMEA and FMECA)
1 Scope
This document 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. F ailure 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 document uses the following terms to describe the roles and responsibilities for conducting an FMEA.
a) Analyst
Person with responsibility for considering the suitability of FMEA, leading the tailoring of the FMEA, making sure that the FMEA method is followed and communicating with managers and other stakeholders. The analyst should be competent in FMEA and should have adequate technical understanding to challenge the other competent people involved in the analysis.
NOTE In case of a team effort, the role of challenging the people involved can be taken over by a person who sometimes is called 'facilitator'.
b) Persons with relevant competence
Persons with relevant knowledge and experience to cover all the aspects of the item or process to be analysed, including social, economic and environmental considerations, as required.
c) Manager
Person with responsibility for defining the purpose of the FMEA, for authorizing the use of resources, approving the tailoring, and handling treatment actions and recommendations,as required. This role may be undertaken by a manager who has the final design authority.
d) Stakeholders
Persons or organizations that can affect, be affected by, or perceive themselves to be affected by a decision or action. For example, stakeholders might include customers (e.g.contract owners), authorities (e.g. regulators), users (e.g. manufacturers and maintainers),suppliers (e.g. service providers, component suppliers) and those persons which might be adversely affected by failures.IEC 60812 pdf download.