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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- Language: English
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About This Item
TS EN IEC 60812 is a general standard for failure modes and effects analysis (FMEA) and the criticality-oriented variant FMECA. It explains how to assess, in a systematic way, how a product, software element, process, or human action may fail to perform its intended function, with the aim of identifying the treatments or actions that may be needed.
How FMEA differs from FMECA
FMEA focuses on identifying failure modes and understanding their local and system-level effects. In practice, it may also consider the causes of those failure modes. FMECA extends the analysis by introducing criticality ranking, using at least consequence severity and often additional importance measures to prioritise failure modes. In general technical terms, FMEA answers “what can fail and what happens if it does?”, while FMECA adds “which failures matter most?”.
Where this standard applies
The document applies to hardware, software, processes including human action, and interfaces in any combination. It also covers the planning, performance, documentation and maintenance of the analysis, and describes tailoring for different applications, reporting formats, alternative ways of calculating risk priority numbers, a criticality-matrix approach, and the relationship to other dependability methods. As a broad technical context, FMEA is widely used in quality, reliability and risk-based decision making, including safety-related work; however, this standard is generic and does not provide specific guidance for safety applications.
This edition is a technical revision that replaces the previous edition. Its practical value is in giving teams a disciplined structure for exposing weak points early and keeping the analysis usable over the life of the item or process.
- 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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