AS/NZS IEC 60812:2020 pdf free.Failure modes and effects analysis (FMEA and FMECA).
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. 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60050-192, International electrotectinical vocabulary — Part 192: Dependability (available at http:/lwww.electropedia.org)
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60050-192 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http:i/www.iso.orglobp
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 prioritizatlon 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 (IEC 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.AS/NZS IEC 60812 pdf free download.