SIST EN IEC 60812:2018
(Main)Failure modes and effects analysis (FMEA and FMECA) (IEC 60812:2018)
Failure modes and effects analysis (FMEA and FMECA) (IEC 60812:2018)
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.
Ausfalleffektanalyse (FMEA und 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)
Analiza vrste okvar in njihovih učinkov (FMEA in FMECA) (IEC 60812:2018)
Ta dokument pojasnjuje, kako je treba načrtovati, izvajati, dokumentirati ter vzdrževati analizo vrste okvar in njihovih učinkov (FMEA), vključno z različico analize vrst okvar, njihovih učinkov in kritičnosti (FMECA).
Namen analize vrste okvar in njihovih učinkov je ugotoviti, v katerih primerih elementi ali procesi ne opravljajo svoje funkcije, da se lahko oblikujejo potrebni ukrepi. Analiza vrste okvar in njihovih učinkov podaja sistematično metodo za prepoznavanje vrst okvar skupaj z njihovimi učinki na element ali proces (lokalno in globalno). Vključuje lahko tudi prepoznavanje vzrokov za vrste okvar. Vrste okvar so lahko prednostno obravnavane za podporo pri sprejemanju odločitev o ukrepih. Kadar stopnja kritičnosti vključuje vsaj resnost posledic (in pogosto druge pomembne ukrepe), je analiza označena kot
analiza vrst okvar, njihovih učinkov in kritičnosti (FMECA).
Ta dokument se uporablja za strojno opremo, programsko opremo, procese, ki vključujejo dejanja oseb, in njihove vmesnike (ali poljubno kombinacijo teh elementov).
Analiza vrste okvar in njihovih učinkov se lahko uporablja v sklopu varnostne analize za regulativne ter druge namene, vendar ta splošni standard ne podaja posebnih smernic za varnostne načine uporabe.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60812:2018
01-december-2018
1DGRPHãþD
SIST EN 60812:2007
$QDOL]DYUVWHRNYDULQQMLKRYLKXþLQNRY )0($LQ)0(&$ ,(&
Failure modes and effects analysis (FMEA and FMECA) (IEC 60812:2018)
Ta slovenski standard je istoveten z: EN IEC 60812:2018
ICS:
03.120.01 Kakovost na splošno Quality in general
21.020 =QDþLOQRVWLLQQDþUWRYDQMH Characteristics and design of
VWURMHYDSDUDWRYRSUHPH machines, apparatus,
equipment
SIST EN IEC 60812:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60812:2018
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SIST EN IEC 60812:2018
EUROPEAN STANDARD EN IEC 60812
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2018
ICS 03.120.01; 03.120.30; 21.020 Supersedes EN 60812:2006
English Version
Failure modes and effects analysis (FMEA and FMECA)
(IEC 60812:2018)
Analyse des modes de défaillance et de leurs effets (AMDE Ausfalleffektanalyse (FMEA und FMECA)
et AMDEC) (IEC 60812:2018)
(IEC 60812:2018)
This European Standard was approved by CENELEC on 2018-09-14. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60812:2018 E
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SIST EN IEC 60812:2018
EN IEC 60812:2018 (E)
European foreword
The text of document 56/1775/FDIS, future edition 3 of IEC 60812, prepared by IEC/TC 56
"Dependability" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 60812:2018.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-06-14
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2021-09-14
document have to be withdrawn
This document supersedes EN 60812:2006.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60812:2018 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60300-1 NOTE Harmonized as EN 60300-1
IEC 60300-3-1 NOTE Harmonized as EN 60300-3-1
IEC 60300-3-12 NOTE Harmonized as EN 60300-3-12
IEC 60300-3-11 NOTE Harmonized as EN 60300-3-11
IEC 61025 NOTE Harmonized as EN 61025
IEC 61078 NOTE Harmonized as EN 61078
IEC 61165 NOTE Harmonized as EN 61165
IEC 61508 series NOTE Harmonized as EN 61508 series
IEC 61709 NOTE Harmonized as EN 61709
IEC 62061 NOTE Harmonized as EN 62061
IEC 62308 NOTE Harmonized as EN 62308
IEC 62502 NOTE Harmonized as EN 62502
IEC 62508 NOTE Harmonized as EN 62508
IEC 62551 NOTE Harmonized as EN 62551
IEC 62740 NOTE Harmonized as EN 62740
IEC 62741 NOTE Harmonized as EN 62741
ISO 9000 NOTE Harmonized as EN ISO 9000
ISO 13849-1 NOTE Harmonized as EN ISO 13849-1
2
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SIST EN IEC 60812:2018
EN IEC 60812:2018 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60050-192 - International electrotechnical vocabulary - - -
Part 192: Dependability
3
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SIST EN IEC 60812:2018
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 60812:2018
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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
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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
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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
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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
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
FAILURE MODES AND EFFECTS ANALYSIS (FMEA and FMECA)
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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.
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IEC 60812:2018 © IEC 2018 – 7 –
The text of this International Standard is based on the following documents:
FDIS Report on voting
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
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
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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 contr
...
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