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 (f) demonstration of the system compliance with safety requirements [section 3]: (1) managerial and technical efforts compliant with the complexity of the system for demonstrating the system safety; (2) apportionment of system safety requirements down to technical sub-systems and civil works, as well as to all safety related metro functions; (3) demonstration that each sub-system fulfils, as constructed, its safety requirements,; (4) for safety functions performed by more than one sub-system, the demonstration of compliance to the safety requirements could not be concluded at sub-system level. It was performed at the system level by integrating the different sub-systems, tools and procedures; (5) demonstration that the overall system complies with the high level safety requirements; (g) hazard management [section 4.1]: The identified hazards, the associated safety measures and the resulting safety requirements were registered and managed through a central hazard record. The overall safety manager of the project was responsible for this hazard record. The operational hazards raised during design and installation, as well as hazards related to operation and maintenance were included in the hazard record; (h) evidences from risk management and risk assessment [section 5]: The risk assessment results were formally documented and supported by a safety case in compliance with the requirements of the CENELEC standards: (1) overall system safety case; (2) safety case for each technical sub-system (including signalling sub-systems and civil works); (3) safety case for civil works (stations, tunnels, viaducts, embankments); (4) installation safety case; (5) vehicles safety case; (6) operator safety case (supporting the RU and IM SMS certification, i.e. demonstration of the proposer ability to operate and maintain safely the system); (i) independent assessment [Article 6]: The overall process was followed up and assessed by an independent safety assessor, acting with a delegation from the Technical Supervisory Authority (i.e. Danish Ministry of Transportation). The roles of the independent safety assessor are outlined in a relevant code of practice. This included: (1) the check of correct risk management and risk assessment; (2) the check that that the system is suitable for purpose, and that it will be operated and maintained safely during the complete life-cycle; (3) recommendation of approval to the Technical Supervisory Authority. C.9.4. C.9.5. The complete project was supported by an appropriate quality management process. In the project, the evidences from the suppliers (i.e. safety cases and detailed supporting documentation for the technical sub-systems and civil work) were provided to the proposer safety manager. These evidences were then reviewed by the safety management organisation, as well as by the independent safety assessor whose conclusions were reported in an assessment report. The independent safety assessment report was reviewed by the proposer safety management and submitted to proposer who forwarded all the files to Technical Supervisory Authority (i.e. Danish Ministry of Transportation) for final approval. Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 86 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
European Railway Agency Collection of examples of risk assessments and of some possible tools supporting the CSM Regulation C.9.6. The example shows that the principles required by the common safety method are existing methods in the railway sector. The risk assessment in the example fulfils all the requirements from the CSM. In particular, it uses all three risk acceptance principles allowed by the harmonised approach of the CSM. C.10. C.10.1. C.10.2. Example of OTIF guideline for the calculation of risk due to railway transport of dangerous goods Remark: this example of risk assessment was not produced as a result of the application of the CSM process; it was carried out before the existence of CSM. The purpose of the example is: (a) to identify the similarities between the existing risk assessment methods and the CSM process; (b) to give traceability between the existing process and the one requested by the CSM; (c) to provide justification of the added value of performing the additional steps (if any) required by the CSM. It must be stressed that this example is given for information only. Its purpose is to help the reader understanding the CSM process. But the example itself shall not be transposed to or used as a reference system for another significant change. The risk assessment shall be carried out for each significant change in compliance with the CSM Regulation. The overall OTIF guideline philosophy is in line with the purpose of the CSM, but the guideline has a reduced scope. The objective of the OTIF "guideline is to obtain a more uniform approach for the risk assessment of transport of dangerous goods in the COTIF Member States and consequently make individual risk assessments comparable". It supports thus the cross acceptance, between the COTIF member states, of risk assessments of the transport of dangerous goods by rail. C.10.3. Compared with the CSM and the flowchart in Figure 1: (a) the OTIF guideline presents the following common points: (1) it is a common approach for risk assessment, nevertheless only based on explicit risk estimation (i.e. the third CSM risk acceptance principle); (2) the OTIF risk assessment is composed of: (i) a risk analysis phase that includes: a hazard identification phase; a risk estimation phase; (ii) a risk evaluation phase based on risk (acceptance) criteria which are not yet harmonised. Indeed, a lot of national specificities can influence those criteria; (b) the OTIF guideline differs in the following aspects: (1) the scope of application is different. Whereas the CSM have to be applied only for significant changes to the railway system, the OTIF guideline should be applied for assessing the risks of transporting dangerous goods by rail, whether this constitutes a significant change or not to the railway system; (2) there is no possibility to chose among three risk acceptance principles for controlling the risk(s). The third principle, i.e. explicit risk estimation, is the only allowed one. Furthermore, is must be based exclusively on a quantitative estimation rather than on a qualitative one. The qualitative risk analysis may only be suitable for comparing options of (safety) measures for risk reduction; Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 87 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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