Responsibilities, adoption:
The national working committee DKE/K 132 "Reliability" of the DKE German Commission for Electrical, Electronic & Information Technologies in DIN and VDE (www.dke.de/en) is responsible for this German standard. At international level, IEC 31010 was developed by IEC/TC 56 "Dependability" together with ISO/TC 262 "Risk management". IEC 31010:2019 was adopted unchanged as a European standard (without a mandate, therefore it is not a harmonized standard) EN IEC 31010:2019.
Overview:
This standard deals with the selection and application of various procedures in connection with risks. Such procedures are used when
- knowledge of existing risks or a specific risk is required
- decisions have to be made in which a number of options involving a risk have to be compared or optimized, and
- as part of a risk management process that leads to a measure to manage a risk.
In the field of technology, risk assessment methodologies have been established for many years and have been published in standards (e.g. ISO 12100, ISO 14971) or guidelines (e.g. CENELEC Guide 32).
Over time, the procedures and methodologies for risk assessment have constantly evolved. This standard introduces selected procedures and compares possible applications, their advantages and limitations. References are provided for sources of further information.
This document provides an introduction and compares their possible applications, benefits and limitations. References are also provided for sources with more comprehensive information.
The target audience for this standard is
- Every person involved in risk assessment and risk management,
- involved in the development of guidance on how to assess risk in specific contexts,
- who need to make decisions where there is uncertainty, including:
- Those who commission risk assessments or evaluate their results,
- those who need to understand the results of the assessments, and
- those who need to select assessment procedures to achieve specific objectives.
ISO 31000:2018 "Risk management - Guidelines" (implemented nationally as DIN ISO 31000:2018-10) describes principles for managing risks as well as the basic principles and organizational arrangements that allow risks to be managed. The standard defines a process that allows risks to be identified, understood and, if necessary, changed in accordance with criteria defined as part of the procedure. Risk assessment procedures can be applied within this structured approach, which includes continuous monitoring, review, communication and consultation, reporting and recording, setting the context and assessing and managing the risk. Figure A.1 of DIN EN IEC 31010 illustrates this process and provides examples. Table A.3 evaluates the applicability of numerous procedures for this process in accordance with ISO 31000.
Author
Dipl.-Ing. (FH) Michael Loerzer
Regulatory Affairs Specialist
TERMS AND ABBREVIATIONS
DKE: Deutsche Kommission Elektrotechnik Elektronik Informationstechnik / German Commission for Electrical, Electronic & Information Technologies from the →
VDE: VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V. / VDE Association for Electrical, Electronic & Information Technologies registered association based in Offenbach
DIN: Das Deutsche Institut für Normung e.V. / Standards organization, The German Institute for Standardization registered association
IEC: International Electrotechnical Commission
ISO: International Organization for Standardization
OJEU: Official Journal of the EU
CENELEC: European Committee for Electrotechnical Standardization
