IEC 60812:2018

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)

Analyse des modes de défaillance et de leurs effets (AMDE et AMDEC)

IEC 60812:2018 explique comment l’analyse des modes de défaillance et de leurs effets (AMDE), comprenant la variante d’analyse des modes de défaillance, de leurs effets et de leur criticité (AMDEC), est planifiée, réalisée, documentée et maintenue. L'analyse des modes de défaillance et de leurs effets (AMDE) vise à établir dans quelle mesure des entités ou des processus sont susceptibles de ne plus s’acquitter de leur fonction, de manière à pouvoir identifier tout traitement exigé. Une AMDE offre une méthode systématique d'identification des modes de défaillance et de leurs effets sur l'entité ou le processus, tant au niveau local que global. Elle peut également inclure l’identification des causes des modes de défaillance. Les modes de défaillance peuvent être hiérarchisés pour aider au choix du traitement à appliquer. Lorsque le classement de la criticité concerne au moins la sévérité des conséquences, et souvent d'autres mesures d'importance, l’analyse est appelée analyse des modes de défaillance, de leurs effets et de leur criticité (AMDEC). Le présent document s'applique aux matériels, aux logiciels, aux processus incluant les actions humaines et à leurs interfaces, ou à toute combinaison de ceux-ci. Une AMDE peut être utilisée dans le cadre d'une analyse de sécurité avec des objectifs réglementaires ou autres. Toutefois, la présente norme étant générique, elle ne donne pas de recommandations particulières relatives aux applications de sécurité. Cette troisième édition annule et remplace la deuxième édition parue en 2006. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) le texte normatif est générique et couvre toutes les applications;
b) des exemples d'applications pour la sécurité, le secteur automobile, les logiciels et les processus (service) ont été ajoutés sous forme d'annexes informatives;
c) l'adaptation de l'AMDE à différentes applications est décrite;
d) différents formats de génération de rapport sont décrits, y compris un système d'informations de base de données;
e) d'autres méthodes de calcul des nombres prioritaires de risque (NPR) ont été ajoutées;
f) une méthode reposant sur la matrice de criticité a été ajoutée;
g) les relations avec d'autres méthodes d'analyse de la sûreté de fonctionnement sont décrites.
Mots clés: modes de défaillance et de leurs effets (AMDE), analyse des modes de défaillance de leurs effets et de leur criticité (AMDEC)

General Information

• Status: Published
• Publication Date: 09-Aug-2018
• ICS: 03.120.01 - Quality in general
• ICS: 03.120.30 - Application of statistical methods
• ICS: 21.020 - Characteristics and design of machines, apparatus, equipment
• Technical Committee: TC 56 - Dependability
• Drafting Committee: MT 5 - TC 56/MT 5
• Current Stage: PPUB - Publication issued
• Start Date: 10-Aug-2018
• Completion Date: 03-Aug-2018

Relations

• Revises: IEC 60812:2006 - Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
• Effective Date: 05-Sep-2023

Overview

IEC 60812:2018 is an international standard published by the International Electrotechnical Commission (IEC) that provides comprehensive guidance on Failure Modes and Effects Analysis (FMEA) and its variant, Failure Modes, Effects and Criticality Analysis (FMECA). This third edition introduces technical revisions and enhancements to improve the planning, execution, documentation, and maintenance of FMEA/FMECA across various industries.

The primary aim of IEC 60812:2018 is to enable organizations to systematically identify potential failure modes in items, systems, or processes, assess the effects of these failures both locally and globally, and prioritize them to inform effective risk treatments. The standard applies broadly to hardware, software, processes (including human factors), and their interfaces. It supports applications in safety analysis, regulatory compliance, reliability engineering, and maintenance optimization.

Key Topics

• FMEA Methodology and Process
  Detailed steps to plan, perform, and document an FMEA, including:

  • Defining scope, boundaries, and objectives
  • Sub-dividing systems or processes into manageable elements
  • Identifying functions, failure modes, causes, and effects
  • Evaluating detection methods and existing controls
  • Prioritizing failure modes based on severity and likelihood

• Tailoring FMEA for Different Applications
  Guidance on adapting the FMEA approach depending on factors such as the design maturity, innovation degree, project phase, and industry-specific requirements.

• Criticality Analysis Methods
  Enhanced techniques for ranking failure modes including:

  • Risk Priority Numbers (RPN) and alternative calculation methods
  • Criticality matrices and plots to visualize and assess failure criticality

• Documentation and Reporting
  Recommendations for generating structured FMEA reports and utilizing database information systems to manage and track analysis data effectively.

• Application Examples and Annexes
  Informative annexes demonstrate FMEA applications across sectors such as automotive, software, safety-critical systems, and service processes. They also cover relationships with other dependability analyses and integration with safety and reliability programs.

Applications

IEC 60812:2018 is applicable to a wide array of industries and sectors, offering practical value in:

• Product Design and Development
  Improving reliability by identifying and mitigating potential product or system failures early in the design phase.

• Safety and Regulatory Compliance
  Supporting safety analyses and meeting regulatory requirements by systematically assessing failure impacts.

• Software and Process Engineering
  Extending traditional FMEA concepts to software units and business or manufacturing processes, including human factors.

• Maintenance and Reliability-Centered Maintenance (RCM)
  Informing maintenance strategies by highlighting critical failure modes and their effects on system availability.

• Complex Systems and Critical Infrastructure
  Managing failure risks in systems with multiple components and reliability allocations, such as power generation, automotive electronics, and transportation controls.

Related Standards

IEC 60812:2018 complements a suite of international standards that cover reliability, safety, and risk management, including:

• IEC 61508 – Functional safety of electrical/electronic systems
• IEC 62061 – Safety of machinery – Functional safety of safety-related control systems
• ISO 31000 – Risk management principles and guidelines
• ISO 9001 – Quality management systems – Requirements

These related standards collectively support the implementation of robust failure analysis frameworks and ensure alignment with global best practices in dependability and safety engineering.

---

By adopting IEC 60812:2018, organizations can enhance product reliability, safety, and performance through a structured approach to failure mode identification, assessment, and prioritization-making this standard an essential reference for engineers, quality managers, and safety professionals worldwide.

Standards Content (Sample)

IEC 60812 ®
Edition 3.0 2018-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Failure modes and effects analysis (FMEA and FMECA)

Analyse des modes de défaillance et de leurs effets (AMDE et AMDEC)

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IEC 60812 ®
Edition 3.0 2018-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Failure modes and effects analysis (FMEA and FMECA)

Analyse des modes de défaillance et de leurs effets (AMDE et AMDEC)

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 03.120.01  03.120.30  21.020 ISBN 978-2-8322-5915-3

– 2 – IEC 60812:2018 © IEC 2018
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms, definitions and abbreviated terms . 9
3.1 Terms and definitions . 9
3.2 Abbreviated terms . 13
4 Overview . 14
4.1 Purpose and objectives . 14
4.2 Roles, responsibilities and competences . 14
4.3 Terminology . 15
5 Methodology for FMEA . 15
5.1 General . 15
5.2 Plan the FMEA . 17
5.2.1 General . 17
5.2.2 Define the objectives and scope of analysis . 17
5.2.3 Identify boundaries and scenarios . 17
5.2.4 Define decision criteria for treatment of failure modes . 19
5.2.5 Determine documentation and reporting requirements . 20
5.2.6 Define resources for analysis . 21
5.3 Perform the FMEA . 22
5.3.1 General . 22
5.3.2 Sub-divide item or process into elements . 22
5.3.3 Identify functions and performance standards for each element . 23
5.3.4 Identify failure modes . 23
5.3.5 Identify detection methods and existing controls . 23
5.3.6 Identify local and final effects of failure modes . 24
5.3.7 Identify failure causes . 25
5.3.8 Evaluate relative importance of failure modes . 26
5.3.9 Identify actions . 28
5.4 Document the FMEA . 29
Annex A (informative) General considerations for tailoring an FMEA . 30
A.1 General . 30
A.1.1 Overview . 30
A.1.2 Start point for FMEA in the hierarchy . 30
A.1.3 Degree of detail in analysis . 31
A.1.4 Prioritization of failure modes . 32
A.2 Factors influencing FMEA tailoring . 33
A.2.1 Reuse of data/information from analysis of similar item . 33
A.2.2 Maturity of item design and project progress . 34
A.2.3 Degree of innovation . 34
A.3 Examples of FMEA tailoring for items and processes . 34
A.3.1 General . 34
A.3.2 Example of tailoring an FMEA for an office equipment product . 35
A.3.3 Example of tailoring an FMEA for a distributed power system . 35
A.3.4 Example of tailoring an FMEA for medical processes . 36

A.3.5 Example of tailoring an FMEA for electronic control systems . 36
A.3.6 Example of tailoring an FMEA for a pump hydro block . 37
A.3.7 Example of tailoring an FMEA for a wind turbine for power generation . 37
Annex B (informative) Criticality analysis methods . 38
B.1 General . 38
B.2 Measurement scales for criticality parameters . 38
B.2.1 General . 38
B.2.2 Scale definition . 38
B.2.3 Assessing likelihood . 39
B.3 Assigning criticality using a matrix or plot . 40
B.3.1 General . 40
B.3.2 Criticality matrix . 40
B.3.3 Criticality plots . 41
B.4 Assigning criticality using a risk priority number . 42
B.4.1 General . 42
B.4.2 Risk priority number . 42
B.4.3 Alternative risk priority number method . 44
Annex C (informative) Example of FMEA report content . 46
C.1 General . 46
C.2 Example of generation of reports from a database information system for an
FMEA of a power supply unit . 46
Annex D (informative) Relationship between FMEA and other dependability analysis
techniques . 52
Annex E (informative) Application considerations for FMEA . 53
E.1 General . 53
E.2 Software FMEA . 53
E.3 Process FMEA . 55
E.4 FMEA for design and development . 56
E.5 FMEA within reliability centred maintenance . 56
E.6 FMEA for safety related control systems . 56
E.6.1 General . 56
E.6.2 FMEA in planning a safety application . 57
E.6.3 Criticality analysis including diagnostics . 57
E.7 FMEA for complex systems with reliability allocation . 58
E.7.1 General . 58
E.7.2 Criticality assessment for non-repairable systems with allocated
unreliability . 58
E.7.3 Criticality assessment for repairable systems with allocated availability . 59
Annex F (informative) Examples of FMEA from industry applications . 60
F.1 General . 60
F.2 Health process application for drug ordering process . 60
F.3 Manufacturing process application for paint spraying . 60
F.4 Design application for a water pump . 61
F.4.1 General . 61
F.4.2 Item function . 61
F.4.3 Item failure modes . 61
F.4.4 Item failure effects . 61
F.5 Example of an FMEA with criticality analysis for a complex non-repaired
system . 62

– 4 – IEC 60812:2018 © IEC 2018
F.6 Software application for a blood sugar calculator . 63
F.7 Automotive electronics device . 63
F.8 Maintenance and support application for a hi-fi system . 64
F.9 Safety related control system applications . 65
F.9.1 Electronic circuit . 65
F.9.2 Automated train control system . 65
F.10 FMEA including human factors analysis . 65
F.11 Marking and encapsulation process for an electronic component . 66
Bibliography . 76

Figure 1 – Overview of FMEA methodology before tailoring . 16
Figure B.1 – Example of a qualitative criticality matrix . 40
Figure B.2 – Examples of criticality plots . 41
Figure C.1 – Database information system to support FMEA report generation . 47
Figure C.2 – Diagram of power supply type XYZ . 47
Figure C.3 – Criticality matrix for FMECA report in Table C.5 created as a two
dimensional image without taking into account detectability . 51
Figure E.1 – General software failure model for a component software unit (CSU) . 55
Figure E.2 – Allocation of system failure probabilities . 59
Figure F.1 – Hierarchy of a series electronic system, its subsystems and assemblies
with allocated unreliability values, F(t) . 62
Figure F.2 – Automotive air-bag part . 64

Table 1 – Example of terms commonly associated with levels of hierarchy. 15
Table A.1 – Characteristics of top-down and bottom-up approaches to FMEA . 31
Table A.2 – General application of common approaches to FMEA . 33
Table C.1 – Example of fields selected for FMEA report of power supply based on

database information . 48
Table C.2 – Example of report of component FMEA . 49
Table C.3 – Example of report of parts with possible common cause failures . 50
Table C.4 – Example of report of FMECA using RPN criticality analysis . 50
Table C.5 – Example of report of FMECA using criticality matrix for global effect . 51
Table F.1 – Extract from FMEA of the process of ordering a drug from a pharmacy . 60
Table F.2 – Extract from FMEA of paint spraying step of a manufacturing process . 61
Table F.3 – Allocation and assessment of unreliability values for different criticality
categories of failure modes for the electronic system represented in Figure F.1 . 63
Table F.4 – Allocation and assessment of unreliability values for different criticality
categories of failure modes for subsystem 2 of the system represented in Figure F.1 . 63
Table F.5 – Hazards and safe/dangerous failures in an automated train control system . 65
Table F.6 – Extract from FMEA of the process of monitoring blood sugar (1 of 2) . 67
Table F.7 – Extract of automotive electronic part FMEA . 69
Table F.8 – Extract from system FMEA for a remote control for a hi-fi system . 70
Table F.9 – Extract from design FMEA for a remote control for a hi-fi system . 70
Table F.10 – Extract from process FMEA for a remote control for a hi-fi system . 71
Table F.11 – Extract from maintenance service FMEA for a remote control for a hi-fi

system . 71

Table F.12 – Extract from an FMEDA for an electronic circuit in a safety control system
(1 of 2) . 72
Table F.13 – Extract from an FMEA for a coffee-maker . 74
Table F.14 – Extract from an FMEA for an electronic component marking and
encapsulation process . 75

– 6 – IEC 60812:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
FAILURE MODES AND EFFECTS ANALYSIS (FMEA and FMECA)

FOREWORD
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International Standard IEC 60812 has been prepared by IEC technical committee 56:
Dependability.
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.

The text of this International Standard is based on the following documents:
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56/1775/FDIS 56/1782/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
The committee has decided that the contents of this document will remain unchanged until the
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– 8 – IEC 60812:2018 © IEC 2018
INTRODUCTION
Failure modes and effects analysis (FMEA) is a systematic method of evaluating an item or
process to identify the ways in which it might potentially fail, and the effects of the mode of
failure upon the performance of the item or process and on the surrounding environment and
personnel. This document describes how to perform an FMEA.
The purpose of performing an FMEA is to support decisions that reduce the likelihood of
failures and their effects, and thus contribute to improved outcomes either directly or through
other analyses. Such improved outcomes include, but are not limited to, improved reliability,
reduced environmental impact, reduced procurement and operating costs, and enhanced
business reputation.
FMEA can be adapted to meet the needs of any industry or organization. FMEA is applicable
to hardware, software, processes, human action and their interfaces, in any combination.
FMEA can be carried out several times in the lifetime for the same item or process. A
preliminary analysis can be conducted during the early stages of design and planning,
followed by a more detailed analysis when more information is available. FMEA can include
existing controls, or recommended treatments, to reduce the likelihood or the effects of a
failure mode. In the case of a closed loop analysis, FMEA allows for evaluation of the
effectiveness of any treatment.
FMEA can be tailored and applied in different ways depending on the objectives.
Failure modes may be prioritized according to their importance. The prioritization can be
based on a ranking of the severity alone, or this can be combined with other measures of
importance. When failure modes are prioritized, the process is referred to as failure modes,
effects and criticality analysis (FMECA). This document uses the term FMEA to include
FMECA.
This document gives general guidance on how to plan, perform, document and maintain an
FMEA by:
a) describing the principles;
b) providing the steps in analysis;
c) giving examples of the documentation;
d) providing example applications.
FMEA may be used in a certification or assurance process. For example, FMEA may be used
in safety analysis for regulatory purposes but, as this document is a generic standard, it does
not specifically address safety.
FMEA should be conducted in a manner that is consistent with any legislation, which is in
effect within the scope of FMEA, or the type of risks involved.
Primary users of this document are those who are leading or participating in the analysis.

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. 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 electrotechnical vocabulary – Part 192: Dependability (available
at http://www.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://www.iso.org/obp
3.1.1
failure mode
DEPRECATED: fault mode
manner in which failure occurs
Note 1 to entry: A failure mode may be determined by the function lost or other state transition that occurred.

– 10 – IEC 60812:2018 © IEC 2018
Note 2 to entry: Examples of hardware failure modes might be for a valve, "does not open", or for an engine,
"does not start".
Note 3 to entry: A human failure mode is determined by the function lost as a result of human action, whether
committed or omitted.
[SOURCE: IEC 60050-192:2015, 192-03-17, modified — Note 1 has been modified, Note 2
and Note 3 have been added.]
3.1.2
failure effect
consequence of a failure, within or beyond the boundary of the failed item
Note 1 to entry: For some analyses, it may be necessary to consider individual failure modes and their effects.
Note 2 to entry: Failure effect also covers the consequence of a failure, within or beyond the boundary of the
failed process.
[SOURCE: IEC 60050-192:2015, 192-03-08, modified — Note 2 has been added.]
3.1.3
system
combination of interacting elements organized to achieve one or more stated purposes
Note 1 to entry: A system is sometimes considered as a product or as the services it provides.
Note 2 to entry: In practice, the interpretation of its meaning is frequently clarified by the use of an associative
noun, e.g., aircraft system. Alternatively, the word “system” is substituted simply by a context-dependent synonym,
e.g., aircraft, though this potentially obscures a system principles perspective.
[SOURCE: ISO/IEC/IEEE 15288:2015, 4.1.46, modified — Note 3 has been deleted.]
3.1.4
item
subject being considered
Note 1 to entry: The item may be an individual part, component, device, functional unit, equipment, subsystem, or
system.
Note 2 to entry: The item may consist of hardware, software, people or any combination thereof.
Note 3 to entry: The item is often comprised of elements that may each be individually considered.
Note 4 to entry: IEC 60050-191:1990 (now withdrawn; replaced by IEC 60050-192:2015) identified the term “entity”
as an English synonym, which is not true for all applications.
Note 5 to entry: The definition for item in IEC 60050-191:1990 (now withdrawn; replaced by IEC 60050-192:2015)
is a description rather than a definition. This new definition provides meaningful substitution throughout this
document. The words of the former definition form new note 1.
[SOURCE: IEC 60050-192:2015, 192-01-01]
3.1.5
process
set of interrelated or interacting activities that transforms inputs into outputs
[SOURCE: IEC 60050-192:2015, 192-01-08]
3.1.6
hierarchy level
level of sub-division within a system, item or process hierarchy
Note 1 to entry: Hierarchy level may also be known as the indenture level [see IEC 60050-192:2015, 192-01-05].

Note 2 to entry: Top-level and low-level corresponds to the highest and lowest levels of the hierarchy,
respectively. Mid-level corresponds to levels between the highest and lowest levels.
3.1.7
element
level of sub-division of a system, item or process hierarchy at which failure modes are to be
identified
3.1.8
scenario
possible sequence of specified conditions under which the system, item or process functions
are performed
Note 1 to entry: Conditions may include activities or factors outside the defined item or process boundaries under
study which may affect the performance of the item or process.
Note 2 to entry: Physical conditions include all environmental factors such as temperature, humidity, light levels,
shock, contamination, radiation levels.
Note 3 to entry: Organizational conditions include factors such as staffing levels, physical/psychological stresses.
3.1.9
failure cause
set of circumstances that leads to failure
Note 1 to entry: A failure cause may originate during specification, design, manufacture, installation, operation or
maintenance of an item.
Note 2 to entry: Examples of a failure cause may be contamination or inadequate lubrication which leads to the
failure mode of bearing seizure.
Note 3 to entry: Failure causes for a process might include human error mechanisms such as stimulus overload,
memory failure, misunderstanding, false assumption.
[SOURCE: IEC 60050-192:2015, 192-03-11, modified — Note 2 and Note 3 have been added.]
3.1.10
failure mechanism
process that leads to failure
Note 1 to entry: The process may be physical, chemical, logical, psychological or a combination thereof.
[SOURCE: IEC 60050-192:2015, 192-03-12, modified — Note 1 has been reworded.]
3.1.11
likelihood
chance of something happening
Note 1 to entry: In this document, the term “likelihood” is used to refer to the chance of something happening,
whether defined, measured or determined objectively or subjectively, qualitatively or quantitatively, and described
using general terms or mathematically [such as probability or a frequency over a given time period].
Note 2 to entry: The English term “likelihood” does not have a direct equivalent in some languages; instead, the
equivalent of the term “probability” is often used. However, in English, “probability” is often narrowly interpreted as
a mathematical term. Therefore, in terminology used in this document, the term “likelihood” is used with the intent
that it should have the same broad interpretation as the term “probability” has in many languages other than
English.
[SOURCE: ISO Guide 73:2009, 3.6.1.1, modified — Note 1 and Note 2 have been reworded.]
3.1.12
severity
relative ranking of potential or actual consequences of a failure or a fault
Note 1 to entry: The severity may be related to any consequence.

– 12 – IEC 60812:2018 © IEC 2018
[SOURCE: EN 13306:2010, 5.13, modified — “relative ranking” has been added.]
3.1.13
detection method
means by which a failure mode or incipient failure become evident
3.1.14
control
design features, or other existing provisions, that have the ability to prevent or reduce the
likelihood of the failure mode or modify its effect
Note 1 to entry: Controls can also be referred to as compensating provisions.
3.1.15
criticality
importance ranking determined using a specified evaluation criteria
Note 1 to entry: The criticality evaluation criteria normally refer to the effects of the failure mode on the top-level
in the system, item or process hierarchy.
Note 2 to entry: Criticality measures normally combine severity of effect with at least one other characteristic of a
failure mode.
Note 3 to entry: The specific meaning of criticality is dependent upon the evaluation method defined within an
analysis and is discussed in detail within this document.
Note 4 to entry: Criticality relates to the failure mode and not to the failure causes (if the latter are identified at
all).
3.1.16
treatment
action to modify the likelihood and/or effects of a failure mode
Note 1 to entry: Treatment is sometimes referred to as mitigation.
Note 2 to entry: Treatment may involve actions to eliminate the failure cause, change the likelihood of the failure
mode occurring, and/or change the consequences.
3.1.17
human error
discrepancy between the human action taken or omitted, and that intended or required
EXAMPLE Performing an incorrect action; omitting a required action; miscalculation; misreading a value.
[SOURCE: IEC 60050-192:2015, 192-03-14]
3.1.18
redundancy
provision of more than one means for performing a function
Note 1 to entry: The additional means of performing the function can be intentionally different (diverse) to reduce
the potential for common mode failures.
[SOURCE: IEC 60050-192:2015, 192-10-02]
3.1.19
common cause failures
failures of multiple items, which would otherwise be considered independent of one another
resulting from a single cause
Note 1 to entry: Common cause failures can also be "common mode failures".
Note 2 to entry: The potential for common cause failures reduces the effectiveness of system redundancy.

[SOURCE: IEC 60050-192:2015, 192-03-18]
3.1.20
common mode failures
failures of different items characterized by the same failure mode
Note 1 to entry: Common mode failures can have different causes.
Note 2 to entry: Common mode failures can also be “common cause failures”.
Note 3 to entry: The potential for common mode failures reduces the effectiveness of system redundancy.
[SOURCE: IEC 60050-192:2015, 192-03-19]
3.1.21
testability
degree to which an item can be tested, during and after operation to detect and
isolate failures/faults
[SOURCE: IEC 60050-192:2015, 192-09-20, modified — "during and after operation to detect
and isolate failures/faults" has been added.]
3.2 Abbreviated terms
ARPN alternative risk priority number
CCF common cause failure
COTS commercial off the shelf
CSU component software unit
DC diagnostic coverage
EMI electromagnetic interference
EMP electromagnetic pulse
ESD emergency shutdown
ETA event tree analysis
FIT failure in time
FTA fault tree analysis
FMEA failure modes and effects analysis
FMECA failure modes, effects and criticality analysis
FMEDA failure modes, effects and diagnostic analysis
MTBF mean operating time between failures
MTTR mean time to restoration
OEM original equipment manufacturer
RBD reliability block diagram
RCM reliability centred maintenance
RPN risk priority number
SFF safe failure fraction
SIL safety integrity level
SOD severity, occurrence and detectability

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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 (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
...