TS EN IEC 60812
Failure modes and effects analysis (FMEA and FMECA)
IEC 60812:2018 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. This third edition cancels and replaces the second edition published in 2006. This edition constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: a) the normative text is generic and covers all applications; b) examples of applications for safety, automotive, software and (service) processes have been added as informative annexes; c) tailoring the FMEA for different applications is described; d) different reporting formats are described, including a database information system; e) alternative means of calculating risk priority numbers (RPN) have been added; f) a criticality matrix based method has been added; g) the relationship to other dependability analysis methods have been described. Keywords: failure modes and effects analysis (FMEA), failure modes effects and criticality analysis (FMECA)
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About This Item
TS EN IEC 60812 is the standard that explains how failure modes and effects analysis, together with the FMECA variant, is planned, performed, documented and maintained. It helps teams examine how a product, system or process may lose its intended function so that appropriate treatments can be identified.
How FMEA and FMECA differ
FMEA identifies possible failure modes and the local and system-level effects they can produce. Within the same analytical framework, causes of failure may also be considered. FMECA adds criticality ranking, meaning that failure modes are prioritised using at least the severity of consequences and often other significance measures as well. In practice, that distinction supports structured decisions about which issues deserve attention first.
Where the standard fits in practice
The document applies to hardware, software, processes including human action, and interfaces in any combination. In general engineering use, FMEA is a familiar dependability tool for design refinement, maintenance planning and process improvement. It may also support safety analyses and regulatory work, although this generic standard does not prescribe a safety-specific method.
- Provides a general framework for planning, carrying out and maintaining the analysis.
- Describes different reporting formats, including a database information system.
- Explains tailoring for different application areas.
- Includes alternative ways to calculate risk priority numbers and a criticality matrix-based method.
- Describes the relationship to other dependability analysis methods.
- Publication Date: 19.11.2018
- Standard Status: U (Yürürlükteki Standard/Standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 03.120.01 Kalite (Genel) ; 03.120.30 İstatistiksel Metotların Uygulanması; 21.020 Makina, Cihaz ve Ekipmanların Özellikleri ve Tasarımı
- Pages: 85
- Source Standard: EN IEC 60812:2018
- International Equivalents: EN IEC 60812-EQV; IEC 60812-EQV
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