Guidance for Use of CSM Recommendation - ERA - Europa

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European Railway Agency Collection of examples of risk assessments and of some possible tools supporting the CSM Regulation ANNEX I - EXPLANATION OF THE PROCESS IN THE CSM REGULATION 1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS 1.1. General principles and obligations 1.1.1. The risk management process covered by this Regulation shall start from a definition of the system under assessment and comprise the following activities: (a) the risk assessment process, which shall identify the hazards, the risks, the associated safety measures and the resulting safety requirements to be fulfilled by the system under assessment; (b) demonstration of the compliance of the system with the identified safety requirements and; (c) management of all identified hazards and the associated safety measures. This risk management process is iterative and is depicted in the diagram of the Appendix (of the CSM Regulation). The process ends when the compliance of the system with all safety requirements necessary to accept the risks linked to the identified hazards is demonstrated. [G 1] The risk management framework for the CSM and the associated risk assessment process are illustrated in Figure 1. When judged necessary, each box/activity of this figure is described further in a specific section of this document. [G 2] CENELEC advises that the risk management and risk assessment processes are described in a safety plan. But if this is not convenient for the project, the associated description can be included in any other relevant document. Refer to section 1.1.6. [G 3] The risk assessment process starts from a preliminary system definition. During the project development, the preliminary system definition is updated progressively and is replaced by the system definition. If there is no preliminary system definition, the formal system definition is used for performing the risk assessment. But then, it is useful that all the actors concerned by the significant change meet at the beginning of the project in order: (a) to agree on the overall system principles, system functions, etc. In principle this could be described in a preliminary system definition; (b) to agree on the project organisation; (c) to agree on the sharing of the roles and responsibilities between the different actors already involved, including the NSA, NOBO and ISA where relevant. Such a co-ordination, during the preliminary system definition for example, provides the opportunity to the proposer, the sub-contractors, NSA, NOBO and ISA, if relevant, to agree at an early stage regarding the codes of practice or reference systems that are acceptable to use within the project Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 22 of 105 File Name: Collection_of_RA_Ex_and_some_tools_for_CSM_V1.1.doc European Railway Agency ● Boulevard Harpignies, 160 ● BP 20392 ● F-59307 Valenciennes Cedex ● France ● Tel. +33 (0)3 27 09 65 00 ● Fax +33 (0)3 27 33 40 65 ● http://www.era.europa.eu
INDEPENDENT ASSESSMENT System Definition Review in function of the identified Safety Requirements HAZARD IDENTIFICATION AND CLASSIFICATION HAZARD MANAGEMENT European Railway Agency Collection of examples of risk assessments and of some possible tools supporting the CSM Regulation PRELIMINARY SYSTEM DEFINITION Significant Change? YES SYSTEM DEFINITION (Scope, Functions, Interfaces, etc.) RISK ASSESSMENT HAZARD IDENTIFICATION (What can happen? When? Where? How? Etc. RISK ANALYSIS HAZARD CLASSIFICATION (How critical?) Broadly Acceptable Risk? NO YES Selection of Risk Acceptance Principle CODES OF PRACTICE Application of Codes of Practice SIMILAR REFERENCE SYSTEM(S) Similarity Analysis with Reference System(s) EXPLICIT RISK ESTIMATION Identification of Scenarios & associated Safety Measures Qualitative Safety Criteria? Quantitative Estimate Frequency Estimate Severity Estimate Risk Implicit Risk Acceptance Criteria (RAC) (Conditions to fulfil by CoP & Ref. Syst.) Comparison with Criteria Comparison with Criteria Explicit Quantitative or Qualitative RAC required Criteria required RISK EVALUATION Comparison with Criteria NO Acceptable Risk? NO Acceptable Risk? NO Acceptable Risk? YES YES YES Safety Requirements (i.e. the Safety Measures to be implemented) Demonstration of Compliance with the Safety Requirements Figure 1 : Risk management framework in the CSM Regulation {Ref. 3}. Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 23 of 105 File Name: Collection_of_RA_Ex_and_some_tools_for_CSM_V1.1.doc European Railway Agency ● Boulevard Harpignies, 160 ● BP 20392 ● F-59307 Valenciennes Cedex ● France ● Tel. +33 (0)3 27 09 65 00 ● Fax +33 (0)3 27 33 40 65 ● http://www.era.europa.eu
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Guidance for Use of CSM Recommendation - ERA - Europa

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