AS/NZS IEC 60812:2020 pdf free.Failure modes and effects analysis (FMEA and FMECA).
4 Overview
4.1 Purpose and objectives
An FMEA is a method in which an item or a process is broken down into elements and, for each element in turn, failure modes and effects are identified and analysed. This is to identify any required improvements by eliminating adverse effects or reducing their likelihood or severity. The purpose of adding a criticality analysis is to enable prioritization of the failure modes for potential treatment.
The reasons for which FMEA is undertaken include the following:
• to identify those failure modes which have unwanted effects on system operation, for example preclude or significantly degrade operation or affect the safety of the user and other persons;
• to improve the design and development of items or processes in a cost effective manner by intervening early in the development programme;
• to identify risks as part of a risk management process (ISO 31000);
• to satisfy statutory and business obligations by demonstrating that foreseeable risks have been identified and accounted for;
• to provide a foundation for other dependability analyses (Annex D discusses the relationship between FMEA and other dependability analysis methods);
• to develop and support a reliability test programme;
• to provide a basis for planning maintenance and support programmes such as through reliability centred maintenance (lEG 60300-3-11);
• as a key process within an asset management system (ISO 55000).
In general, FMEA is a method to analyse the effect of single failures. If FMEA is used to analyse failure of interdependent items, then these can be considered, with limitations, in the analysis (5.3.6 and 5.3.7.2).
4.2 Roles, responsibilities and competences
An FMEA requires a person or persons (e.g. team) to take responsibility for the following:
• managing the process of conducting the FMEA;
• deciding the form of the FMEA so that it is tailored for the application context;
• identifying and analysing the failure modes and effects of the item or process;
• determining required treatments;
• reporting the FMEA including treatments and recommendations.
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’.AS/NZS IEC 60812 pdf download.