Risk management - Risk assessment techniques

This International Standard is a supporting standard for ISO 31000 and provides guidance on selection and application of systematic techniques for risk assessment. Risk assessment carried out in accordance with this standard contributes to other risk management activities. The application of a range of techniques is introduced, with specific references to other international standards where the concept and application of techniques are described in greater detail. This standard does not provide specific criteria for identifying the need for risk analysis, nor does it specify the type of risk analysis method that is required for a particular application.

Gestion des risques - Techniques d'évaluation des risques

CEI 31010:2009 est un logo double CEI/ISO, pr�fixe seul CEI, norme d'accompagnement de l'ISO 31000 et fournit des lignes directrices permettant de choisir et d'appliquer des techniques syst�matiques d'�valuation des risques. La pr�sente norme n'est pas destin�e � �tre utilis�e � des fins de certification, de r�glementation ou contractuelles.
NOTE: La pr�sente norme ne traite pas sp�cifiquement de la s�curit�. C'est une norme g�n�rale de gestion des risques et toute r�f�rence � la s�curit� est purement de nature informative. Les lignes directrices sur l'introduction des aspects de s�curit� dans les normes CEI est d�finie dans le Guide ISO/CEI 51.

Obvladovanje tveganja - Tehnike ocenjevanja tveganj

Ta mednarodni standard je podporni standard za ISO 31000 in zagotavlja vodilo za izbor in uporabo sistematičnih tehnik ocenjevanja tveganja. Ocenjevanje tveganja, ki poteka v skladu s tem standardom, prispeva k drugim dejavnostim upravljanja tveganja. Vpeljana je uporaba nabora tehnik s specifičnim sklicevanjem na druge mednarodne standarde, kjer sta koncept in uporaba tehnik podrobneje opisana. Ta standard ne zagotavlja posebnih meril za prepoznavanje potrebe po analizi tveganja niti ne določa vrste metode analize tveganja, ki je potrebna za določeno vrsto uporabe.

General Information

Status
Withdrawn
Publication Date
09-Mar-2011
Withdrawal Date
01-Sep-2019
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
20-Aug-2019
Due Date
12-Sep-2019
Completion Date
02-Sep-2019

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IEC/ISO 31010
Edition 1.0 2009-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Risk management – Risk assessment techniques

Gestion des risques – Techniques d'évaluation des risques

IEC/iSO 31010:2009

---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC/ISO 31010
Edition 1.0 2009-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Risk management – Risk assessment techniques

Gestion des risques – Techniques d'évaluation des risques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XD
CODE PRIX
ICS 03.100.01 ISBN 2-8318-1068-2

---------------------- Page: 3 ----------------------
– 2 – 31010 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .7
4 Risk assessment concepts .7
4.1 Purpose and benefits .7
4.2 Risk assessment and the risk management framework .8
4.3 Risk assessment and the risk management process .8
4.3.1 General .8
4.3.2 Communication and consultation .9
4.3.3 Establishing the context.9
4.3.4 Risk assessment .10
4.3.5 Risk treatment .10
4.3.6 Monitoring and review .11
5 Risk assessment process .11
5.1 Overview .11
5.2 Risk identification .12
5.3 Risk analysis .12
5.3.1 General .12
5.3.2 Controls Assessment.13
5.3.3 Consequence analysis.14
5.3.4 Likelihood analysis and probability estimation .14
5.3.5 Preliminary Analysis .15
5.3.6 Uncertainties and sensitivities .15
5.4 Risk evaluation.15
5.5 Documentation .16
5.6 Monitoring and Reviewing Risk Assessment.17
5.7 Application of risk assessment during life cycle phases .17
6 Selection of risk assessment techniques .17
6.1 General .17
6.2 Selection of techniques .17
6.2.1 Availability of Resources .18
6.2.2 The Nature and Degree of Uncertainty.18
6.2.3 Complexity .19
6.3 Application of risk assessment during life cycle phases .19
6.4 Types of risk assessment techniques .19
Annex A (informative) Comparison of risk assessment techniques .21
Annex B (informative) Risk assessment techniques .27
Bibliography.90

Figure 1 – Contribution of risk assessment to the risk management process .11
Figure B.1 – Dose-response curve.37
Figure B.2 – Example of an FTA from IEC 60-300-3-9.49
Figure B.3 – Example of an Event tree.52

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31010 © IEC:2009 – 3 –
Figure B.4 – Example of Cause-consequence analysis .55
Figure B.5 – Example of Ishikawa or Fishbone diagram .57
Figure B.6 – Example of tree formulation of cause-and-effect analysis.58
Figure B.7 – Example of Human reliability assessment .64
Figure B.8 – Example Bow tie diagram for unwanted consequences .66
Figure B.9 – Example of System Markov diagram .70
Figure B.10 – Example of State transition diagram.71
Figure B.11 – Sample Bayes’ net .77
Figure B.12 – The ALARP concept.79
Figure B.13 – Part example of a consequence criteria table.84
Figure B.14 – Part example of a risk ranking matrix .84
Figure B.15 – Part example of a probability criteria matrix .85

Table A.1 – Applicability of tools used for risk assessment .22
Table A.2 – Attributes of a selection of risk assessment tools .23
Table B.1 – Example of possible HAZOP guidewords .34
Table B.2 – Markov matrix .70
Table B.3 – Final Markov matrix.72
Table B.4 – Example of Monte Carlo Simulation .74
Table B.5 – Bayes’ table data .77
Table B.6 – Prior probabilities for nodes A and B .77
Table B.7 – Conditional probabilities for node C with node A and node B defined .77
Table B.8 – Conditional probabilities for node D with node A and node C defined .78
Table B.9 – Posterior probability for nodes A and B with node D and Node C defined .78
Table B.10 – Posterior probability for node A with node D and node C defined .78

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– 4 – 31010 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

RISK MANAGEMENT –
RISK ASSESSMENT TECHNIQUES


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
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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consensus of opinion on the relevant subjects since each technical committee has representation from all
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC/ISO 31010 has been prepared by IEC technical committee 56:
Dependability together with the ISO TMB “Risk management” working group.
The text of this standard is based on the following documents:
FDIS Rapport de vote
56/1329/FDIS 56/1346/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 17 member
bodies out of 18 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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31010 © IEC:2009 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
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the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition;
• 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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– 6 – 31010 © IEC:2009
INTRODUCTION
Organizations of all types and sizes face a range of risks that may affect the achievement of
their objectives.
These objectives may relate to a range of the organization's activities, from strategic
initiatives to its operations, processes and projects, and be reflected in terms of societal,
environmental, technological, safety and security outcomes, commercial, financial and
economic measures, as well as social, cultural, political and reputation impacts.
All activities of an organization involve risks that should be managed. The risk management
process aids decision making by taking account of uncertainty and the possibility of future
events or circumstances (intended or unintended) and their effects on agreed objectives.
Risk management includes the application of logical and systematic methods for
• communicating and consulting throughout this process;
• establishing the context for identifying, analysing, evaluating, treating risk associated with
any activity, process, function or product;
• monitoring and reviewing risks;
• reporting and recording the results appropriately.
Risk assessment is that part of risk management which provides a structured process that
identifies how objectives may be affected, and analyses the risk in term of consequences and
their probabilities before deciding on whether further treatment is required.
Risk assessment attempts to answer the following fundamental questions:
• what can happen and why (by risk identification)?
• what are the consequences?
• what is the probability of their future occurrence?
• are there any factors that mitigate the consequence of the risk or that reduce the
probability of the risk?
Is the level of risk tolerable or acceptable and does it require further treatment? This standard
is intended to reflect current good practices in selection and utilization of risk assessment
techniques, and does not refer to new or evolving concepts which have not reached a
satisfactory level of professional consensus.
This standard is general in nature, so that it may give guidance across many industries and
types of system. There may be more specific standards in existence within these industries
that establish preferred methodologies and levels of assessment for particular applications. If
these standards are in harmony with this standard, the specific standards will generally be
sufficient.

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31010 © IEC:2009 – 7 –
RISK MANAGEMENT –
RISK ASSESSMENT TECHNIQUES



1 Scope
This International Standard is a supporting standard for ISO 31000 and provides guidance on
selection and application of systematic techniques for risk assessment.
Risk assessment carried out in accordance with this standard contributes to other risk
management activities.
The application of a range of techniques is introduced, with specific references to other
international standards where the concept and application of techniques are described in
greater detail.
This standard is not intended for certification, regulatory or contractual use.
This standard does not provide specific criteria for identifying the need for risk analysis, nor
does it specify the type of risk analysis method that is required for a particular application.
This standard does not refer to all techniques, and omission of a technique from this standard
does not mean it is not valid. The fact that a method is applicable to a particular circumstance
does not mean that the method should necessarily be applied.
NOTE This standard does not deal specifically with safety. It is a generic risk management standard and any
references to safety are purely of an informative nature. Guidance on the introduction of safety aspects into IEC
standards is laid down in ISO/IEC Guide 51.
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO/IEC Guide 73, Risk management – Vocabulary – Guidelines for use in standards
ISO 31000, Risk management – Principles and guidelines
3 Terms and definitions
For the purposes of this document, the terms and definitions of ISO/IEC Guide 73 apply.
4 Risk assessment concepts
4.1 Purpose and benefits
The purpose of risk assessment is to provide evidence-based information and analysis to
make informed decisions on how to treat particular risks and how to select between options.
Some of the principal benefits of performing risk assessment include:
• understanding the risk and its potential impact upon objectives;

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– 8 – 31010 © IEC:2009
• providing information for decision makers;
• contributing to the understanding of risks, in order to assist in selection of treatment
options;
• identifying the important contributors to risks and weak links in systems and organizations;
• comparing of risks in alternative systems, technologies or approaches;
• communicating risks and uncertainties;
• assisting with establishing priorities;
• contributing towards incident prevention based upon post-incident investigation;
• selecting different forms of risk treatment;
• meeting regulatory requirements;
• providing information that will help evaluate whether the risk should be accepted when
compared with pre-defined criteria;
• assessing risks for end-of-life disposal.
4.2 Risk assessment and the risk management framework
This standard assumes that the risk assessment is performed within the framework and
process of risk management described in ISO 31000.
A risk management framework provides the policies, procedures and organizational
arrangements that will embed risk management throughout the organization at all levels.
As part of this framework, the organization should have a policy or strategy for deciding when
and how risks should be assessed.
In particular, those carrying out risk assessments should be clear about
• the context and objectives of the organization,
• the extent and type of risks that are tolerable, and how unacceptable risks are to be
treated,
• how risk assessment integrates into organizational processes,
• methods and techniques to be used for risk assessment, and their contribution to the risk
management process,
• accountability, responsibility and authority for performing risk assessment,
• resources available to carry out risk assessment,
• how the risk assessment will be reported and reviewed.
4.3 Risk assessment and the risk management process
4.3.1 General
Risk assessment comprises the core elements of the risk management process which are
defined in ISO 31000 and contain the following elements:
• communication and consultation;
• establishing the context;
• risk assessment (comprising risk identification, risk analysis and risk evaluation);
• risk treatment;
• monitoring and review.
Risk assessment is not a stand-alone activity and should be fully integrated into the other
components in the risk management process.

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31010 © IEC:2009 – 9 –
4.3.2 Communication and consultation
Successful risk assessment is dependent on effective communication and consultation with
stakeholders.
Involving stakeholders in the risk management process will assist in
• developing a communication plan,
• defining the context appropriately,
• ensuring that the interests of stakeholders are understood and considered,
• bringing together different areas of expertise for identifying and analysing risk,
• ensuring that different views are appropriately considered in evaluating risks,
• ensuring that risks are adequately identified,
• securing endorsement and support for a treatment plan.
Stakeholders should contribute to the interfacing of the risk assessment process with other
management disciplines, including change management, project and programme management,
and also financial management.
4.3.3 Establishing the context
Establishing the context defines the basic parameters for managing risk and sets the scope
and criteria for the rest of the process. Establishing the context includes considering internal
and external parameters relevant to the organization as a whole, as well as the background to
the particular risks being assessed.
In establishing the context, the risk assessment objectives, risk criteria, and risk assessment
programme are determined and agreed.
For a specific risk assessment, establishing the context should include the definition of the
external, internal and risk management context and classification of risk criteria:
a) Establishing the external context involves familiarization with the environment in which the
organization and the system operates including :
• cultural, political, legal, regulatory, financial, economic and competitive environment
factors, whether international, national, regional or local;
• key drivers and trends having impact on the objectives of the organization; and
• perceptions and values of external stakeholders.
b) Establishing the internal context involves understanding
• capabilities of the organization in terms of resources and knowledge,
• information flows and decision-making processes,
• internal stakeholders,
• objectives and the strategies that are in place to achieve them,
• perceptions, values and culture,
• policies and processes,
• standards and reference models adopted by the organization, and
• structures (e.g. governance, roles and accountabilities).
c) Establishing the context of the risk management process includes
• defining accountabilities and responsibilities,
• defining the extent of the risk management activities to be carried out, including
specific inclusions and exclusions,

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– 10 – 31010 © IEC:2009
• defining the extent of the project, process, function or activity in terms of time and
location,
• defining the relationships between a particular project or activity and other projects or
activities of the organization,
• defining the risk assessment methodologies,
• defining the risk criteria,
• defining how risk management performance is evaluated,
• identifying and specifying the decisions and actions that have to be made, and
• identifying scoping or framing studies needed, their extent, objectives and the
resources required for such studies.
d) Defining risk criteria involves deciding
• the nature and types of consequences to be included and how they will be measured,
• the way in which probabilities are to be expressed,
• how a level of risk will be determined,
• the criteria by which it will be decided when a risk needs treatment,
• the criteria for deciding when a risk is acceptable and/or tolerable,
• whether and how combinations of risks will be taken into account.
Criteria can be based on sources such as
• agreed process objectives,
• criteria identified in specifications,
• general data sources,
• generally accepted industry criteria such as safety integrity levels,
• organizational risk appetite,
• legal and other requirements for specific equipment or applications.
4.3.4 Risk assessment
Risk assessment is the overall process of risk identification, risk analysis and risk evaluation.
Risks can be assessed at an organizational level, at a departmental level, for projects,
individual activities or specific risks. Different tools and techniques may be appropriate in
different contexts.
Risk assessment provides an understanding of risks, their causes, consequences and their
probabilities. This provides input to decisions about:
• whether an activity should be undertaken;
• how to maximize opportunities;
• whether risks need to be treated;
• choosing between options with
...

SLOVENSKI STANDARD
SIST ISO/IEC 31010:2011
01-april-2011
Obvladovanje tveganja - Tehnike ocenjevanja tveganj
Risk management - Risk assessment techniques
Gestion des risques - Techniques d'évaluation des risques
Ta slovenski standard je istoveten z: ISO/IEC 31010:2009
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
SIST ISO/IEC 31010:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST ISO/IEC 31010:2011

---------------------- Page: 2 ----------------------

SIST ISO/IEC 31010:2011

IEC/ISO 31010
Edition 1.0 2009-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Risk management – Risk assessment techniques

Gestion des risques – Techniques d'évaluation des risques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XD
CODE PRIX
ICS 03.100.01 ISBN 2-8318-1068-2

---------------------- Page: 3 ----------------------

SIST ISO/IEC 31010:2011
– 2 – 31010 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .7
4 Risk assessment concepts .7
4.1 Purpose and benefits .7
4.2 Risk assessment and the risk management framework .8
4.3 Risk assessment and the risk management process .8
4.3.1 General .8
4.3.2 Communication and consultation .9
4.3.3 Establishing the context.9
4.3.4 Risk assessment .10
4.3.5 Risk treatment .10
4.3.6 Monitoring and review .11
5 Risk assessment process .11
5.1 Overview .11
5.2 Risk identification .12
5.3 Risk analysis .12
5.3.1 General .12
5.3.2 Controls Assessment.13
5.3.3 Consequence analysis.14
5.3.4 Likelihood analysis and probability estimation .14
5.3.5 Preliminary Analysis .15
5.3.6 Uncertainties and sensitivities .15
5.4 Risk evaluation.15
5.5 Documentation .16
5.6 Monitoring and Reviewing Risk Assessment.17
5.7 Application of risk assessment during life cycle phases .17
6 Selection of risk assessment techniques .17
6.1 General .17
6.2 Selection of techniques .17
6.2.1 Availability of Resources .18
6.2.2 The Nature and Degree of Uncertainty.18
6.2.3 Complexity .19
6.3 Application of risk assessment during life cycle phases .19
6.4 Types of risk assessment techniques .19
Annex A (informative) Comparison of risk assessment techniques .21
Annex B (informative) Risk assessment techniques .27
Bibliography.90

Figure 1 – Contribution of risk assessment to the risk management process .11
Figure B.1 – Dose-response curve.37
Figure B.2 – Example of an FTA from IEC 60-300-3-9.49
Figure B.3 – Example of an Event tree.52

---------------------- Page: 4 ----------------------

SIST ISO/IEC 31010:2011
31010 © IEC:2009 – 3 –
Figure B.4 – Example of Cause-consequence analysis .55
Figure B.5 – Example of Ishikawa or Fishbone diagram .57
Figure B.6 – Example of tree formulation of cause-and-effect analysis.58
Figure B.7 – Example of Human reliability assessment .64
Figure B.8 – Example Bow tie diagram for unwanted consequences .66
Figure B.9 – Example of System Markov diagram .70
Figure B.10 – Example of State transition diagram.71
Figure B.11 – Sample Bayes’ net .77
Figure B.12 – The ALARP concept.79
Figure B.13 – Part example of a consequence criteria table.84
Figure B.14 – Part example of a risk ranking matrix .84
Figure B.15 – Part example of a probability criteria matrix .85

Table A.1 – Applicability of tools used for risk assessment .22
Table A.2 – Attributes of a selection of risk assessment tools .23
Table B.1 – Example of possible HAZOP guidewords .34
Table B.2 – Markov matrix .70
Table B.3 – Final Markov matrix.72
Table B.4 – Example of Monte Carlo Simulation .74
Table B.5 – Bayes’ table data .77
Table B.6 – Prior probabilities for nodes A and B .77
Table B.7 – Conditional probabilities for node C with node A and node B defined .77
Table B.8 – Conditional probabilities for node D with node A and node C defined .78
Table B.9 – Posterior probability for nodes A and B with node D and Node C defined .78
Table B.10 – Posterior probability for node A with node D and node C defined .78

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SIST ISO/IEC 31010:2011
– 4 – 31010 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

RISK MANAGEMENT –
RISK ASSESSMENT TECHNIQUES


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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International standard IEC/ISO 31010 has been prepared by IEC technical committee 56:
Dependability together with the ISO TMB “Risk management” working group.
The text of this standard is based on the following documents:
FDIS Rapport de vote
56/1329/FDIS 56/1346/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 17 member
bodies out of 18 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition;
• 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
Organizations of all types and sizes face a range of risks that may affect the achievement of
their objectives.
These objectives may relate to a range of the organization's activities, from strategic
initiatives to its operations, processes and projects, and be reflected in terms of societal,
environmental, technological, safety and security outcomes, commercial, financial and
economic measures, as well as social, cultural, political and reputation impacts.
All activities of an organization involve risks that should be managed. The risk management
process aids decision making by taking account of uncertainty and the possibility of future
events or circumstances (intended or unintended) and their effects on agreed objectives.
Risk management includes the application of logical and systematic methods for
• communicating and consulting throughout this process;
• establishing the context for identifying, analysing, evaluating, treating risk associated with
any activity, process, function or product;
• monitoring and reviewing risks;
• reporting and recording the results appropriately.
Risk assessment is that part of risk management which provides a structured process that
identifies how objectives may be affected, and analyses the risk in term of consequences and
their probabilities before deciding on whether further treatment is required.
Risk assessment attempts to answer the following fundamental questions:
• what can happen and why (by risk identification)?
• what are the consequences?
• what is the probability of their future occurrence?
• are there any factors that mitigate the consequence of the risk or that reduce the
probability of the risk?
Is the level of risk tolerable or acceptable and does it require further treatment? This standard
is intended to reflect current good practices in selection and utilization of risk assessment
techniques, and does not refer to new or evolving concepts which have not reached a
satisfactory level of professional consensus.
This standard is general in nature, so that it may give guidance across many industries and
types of system. There may be more specific standards in existence within these industries
that establish preferred methodologies and levels of assessment for particular applications. If
these standards are in harmony with this standard, the specific standards will generally be
sufficient.

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RISK MANAGEMENT –
RISK ASSESSMENT TECHNIQUES



1 Scope
This International Standard is a supporting standard for ISO 31000 and provides guidance on
selection and application of systematic techniques for risk assessment.
Risk assessment carried out in accordance with this standard contributes to other risk
management activities.
The application of a range of techniques is introduced, with specific references to other
international standards where the concept and application of techniques are described in
greater detail.
This standard is not intended for certification, regulatory or contractual use.
This standard does not provide specific criteria for identifying the need for risk analysis, nor
does it specify the type of risk analysis method that is required for a particular application.
This standard does not refer to all techniques, and omission of a technique from this standard
does not mean it is not valid. The fact that a method is applicable to a particular circumstance
does not mean that the method should necessarily be applied.
NOTE This standard does not deal specifically with safety. It is a generic risk management standard and any
references to safety are purely of an informative nature. Guidance on the introduction of safety aspects into IEC
standards is laid down in ISO/IEC Guide 51.
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO/IEC Guide 73, Risk management – Vocabulary – Guidelines for use in standards
ISO 31000, Risk management – Principles and guidelines
3 Terms and definitions
For the purposes of this document, the terms and definitions of ISO/IEC Guide 73 apply.
4 Risk assessment concepts
4.1 Purpose and benefits
The purpose of risk assessment is to provide evidence-based information and analysis to
make informed decisions on how to treat particular risks and how to select between options.
Some of the principal benefits of performing risk assessment include:
• understanding the risk and its potential impact upon objectives;

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• providing information for decision makers;
• contributing to the understanding of risks, in order to assist in selection of treatment
options;
• identifying the important contributors to risks and weak links in systems and organizations;
• comparing of risks in alternative systems, technologies or approaches;
• communicating risks and uncertainties;
• assisting with establishing priorities;
• contributing towards incident prevention based upon post-incident investigation;
• selecting different forms of risk treatment;
• meeting regulatory requirements;
• providing information that will help evaluate whether the risk should be accepted when
compared with pre-defined criteria;
• assessing risks for end-of-life disposal.
4.2 Risk assessment and the risk management framework
This standard assumes that the risk assessment is performed within the framework and
process of risk management described in ISO 31000.
A risk management framework provides the policies, procedures and organizational
arrangements that will embed risk management throughout the organization at all levels.
As part of this framework, the organization should have a policy or strategy for deciding when
and how risks should be assessed.
In particular, those carrying out risk assessments should be clear about
• the context and objectives of the organization,
• the extent and type of risks that are tolerable, and how unacceptable risks are to be
treated,
• how risk assessment integrates into organizational processes,
• methods and techniques to be used for risk assessment, and their contribution to the risk
management process,
• accountability, responsibility and authority for performing risk assessment,
• resources available to carry out risk assessment,
• how the risk assessment will be reported and reviewed.
4.3 Risk assessment and the risk management process
4.3.1 General
Risk assessment comprises the core elements of the risk management process which are
defined in ISO 31000 and contain the following elements:
• communication and consultation;
• establishing the context;
• risk assessment (comprising risk identification, risk analysis and risk evaluation);
• risk treatment;
• monitoring and review.
Risk assessment is not a stand-alone activity and should be fully integrated into the other
components in the risk management process.

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4.3.2 Communication and consultation
Successful risk assessment is dependent on effective communication and consultation with
stakeholders.
Involving stakeholders in the risk management process will assist in
• developing a communication plan,
• defining the context appropriately,
• ensuring that the interests of stakeholders are understood and considered,
• bringing together different areas of expertise for identifying and analysing risk,
• ensuring that different views are appropriately considered in evaluating risks,
• ensuring that risks are adequately identified,
• securing endorsement and support for a treatment plan.
Stakeholders should contribute to the interfacing of the risk assessment process with other
management disciplines, including change management, project and programme management,
and also financial management.
4.3.3 Establishing the context
Establishing the context defines the basic parameters for managing risk and sets the scope
and criteria for the rest of the process. Establishing the context includes considering internal
and external parameters relevant to the organization as a whole, as well as the background to
the particular risks being assessed.
In establishing the context, the risk assessment objectives, risk criteria, and risk assessment
programme are determined and agreed.
For a specific risk assessment, establishing the context should include the definition of the
external, internal and risk management context and classification of risk criteria:
a) Establishing the external context involves familiarization with the environment in which the
organization and the system operates including :
• cultural, political, legal, regulatory, financial, economic and competitive environment
factors, whether international, national, regional or local;
• key drivers and trends having impact on the objectives of the organization; and
• perceptions and values of external stakeholders.
b) Establishing the internal context involves understanding
• capabilities of the organization in terms of resources and knowledge,
• information flows and decision-making processes,
• internal stakeholders,
• objectives and the strategies that are in place to achieve them,
• perceptions, values and culture,
• policies and processes,
• standards and reference models adopted by the organization, and
• structures (e.g. governance, roles and accountabilities).
c) Establishing the context of the risk management process includes
• defining accountabilities and responsibilities,
• defining the extent of the risk management activities to be carried out, including
specific inclusions and exclusions,

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• defining the extent of the project, process, function or activity in terms of time and
location,
• defining the relationships between a particular project or activity and other projects or
activities of the organization,
• defining the risk assessment methodologies,
• defining the risk criteria,
• defining how risk management performance is evaluated,
• identifying and specifying the decisions and actions that have to be made, and
• identifying scoping or framing studies needed, their extent, objectives and the
resources required for such studies.
d) Defining risk criteria involves deciding
• the nature and types of consequences to be included and how they will be measured,
• the way in which probabilities are to be expressed,
• how a level of risk will be determined,
• the criteria by which it will be decided when a risk needs treatment,
• the criteria for deciding when a risk is acceptable and/or tolerable,
• whether and how combinations of risks will be taken into account.
Criteria can be based on sources such as
• agreed process objectives,
• criteria identified in specifications,
• general data sources,
• generally accepted industry criteria such as safety integrity levels,
• organizational risk appetite,
• legal and other requirements for specific equipment or applications.
4.3.4 Risk assessment
Risk assessment is the overall process of risk identification, risk analysis and risk evaluation.
Risks can be assessed at an organizational level, at a departmental level, for projects,
individual activities or specific risks. Different tools and techniques may be appropriate in
different contexts.
Risk assessment provides an understanding of risks, their causes, consequences and their
probabilities. This provides input to decisions about:
• whether an activity should be undertaken;
• how to maximize opportunities;
• whether risks need to be treated;
• choosing between options with different risks;
• prioritizing risk treatment options;
• the most appropriate selection of risk treatment strategies that will bring adverse risks to a
tolerable level.
4.3.5 Risk treatment
Having completed a risk assessment, risk treatment involves selecting and agreeing to one or
more relevant options for changing the probability of occurrence, the effect of risks, or both,
and implementing these options.

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This is followed by a cyclical process of reassessing the new level of risk, with a view to
determining its tolerability against the criteria previously set, in order to decide whether
further treatment is required.
4.3.6 Monitoring and review
As part of the risk management process, risks and controls should be monitored and reviewed
on a regular basis to verify that
• assumptions about risks remain valid;
• assumptions on which the risk assessment is based, including the external and internal
context, remain valid;
• expected results are being achieved;
• results of risk assessment are in line with actual experience;
• risk assessment techniques are being properly applied;
• risk treatments are effective.
Accountability for monitoring and performing reviews should be established.
5 Risk assessment process
5.1 Overview
Risk assessment provides decision-makers and responsible parties with an improved
understanding of risks that could affect achievement of objectives, and the adequacy and
effectiveness of controls already in place. This provides a basis for decisions about the most
appropriate approach to be used to treat the risks. The output of risk assessment is an input
to the decision-making processes of the organization.
Risk assessment is the overall process of risk identification, risk analysis and risk evaluation
(see Figure 1). The manner in which this process is applied is dependent not only on the
context of the risk management process but also on the methods and techniques used to
carry out the risk assessment.
Establishing the context
Risk assessment
Risk identification
Monitoring
Communication
Risk analysis
and
and
review
consultation
Risk evaluation
Risk treatment
IEC  2061/09

Figure 1 – Contribution of risk assessment to the risk management process

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Risk assessment may require a multidisciplinary approach since risks may cover a wide range
of causes and consequences.
5.2 Risk identification
Risk identification is the process of finding, recognizing and recording risks.
The purpose of risk identification is to identify what might happen or what situations might
exist that might affect the achievement of the objectives of the system or organization. Once a
risk is identified, the organization should identify any existing controls such as design
features, people, processes and systems.
The risk identification process includes identifying the causes and source of the risk (hazard
in the context of physical harm), events, situations or circumstances which could have a
material impact upon objectives and the nature of that impact
Risk identification methods can include:
• evidence based methods, examples of which are check-lists and reviews of historical
data;
• systematic team approaches where a team of experts follow a systematic process to
identify risks by means of a structured set of prompts or questions;
• inductive reasoning techniques such as HAZOP.
Various supporting techniques can be used to improve accuracy and completeness in risk
identification, including brainstorming, and Delphi methodology.
Irrespective of the actual techniques employed, it is important that due recognition is given to
human and or
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