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 Table of Contents DOCUMENT INFORMATION ................................................................................................... 2 Amendment Record ............................................................................................................................... 2 Table of Contents .................................................................................................................................. 4 List of Figures ........................................................................................................................................ 5 List of Tables ......................................................................................................................................... 6 0. INTRODUCTION ................................................................................................................ 7 0.1. Scope ........................................................................................................................................ 7 0.2. Outside the scope ..................................................................................................................... 7 0.3. Principle for this document ........................................................................................................ 8 0.4. Document description ............................................................................................................... 8 0.5. Reference documents ............................................................................................................... 9 0.6. Standard definitions, terms and abbreviations.......................................................................... 9 0.7. Specific definitions .................................................................................................................. 10 0.8. Specific terms and abbreviations ............................................................................................ 10 EXPLANATION OF THE ARTICLES OF THE CSM REGULATION ..................................... 11 Article 1. Purpose ....................................................................................................................... 11 Article 2. Scope .......................................................................................................................... 11 Article 3. Definitions ................................................................................................................... 13 Article 4. Significant changes ..................................................................................................... 14 Article 5. Risk management process ......................................................................................... 16 Article 6. Independent assessment ............................................................................................ 16 Article 7. Safety assessment reports ......................................................................................... 18 Article 8. Risk control management/internal and external audits .............................................. 19 Article 9. Feedback and technical progress ............................................................................... 19 Article 10. Entry into force ............................................................................................................ 20 ANNEX I - EXPLANATION OF THE PROCESS IN THE CSM REGULATION ...................... 22 1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS ..... 22 1.1. General principles and obligations .......................................................................................... 22 1.2. Interface management ............................................................................................................ 29 2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS .............................................. 32 2.1. General description - Correspondence between the CSM risk assessment process and the CENELEC V-cycle ............................................................................................................ 32 2.2. Hazard identification ................................................................................................................ 38 2.3. Use of codes of practice and risk evaluation .......................................................................... 41 2.4. Use of reference system and risk evaluation .......................................................................... 43 2.5. Explicit risk estimation and evaluation .................................................................................... 44 3. DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS .................... 48 4. HAZARD MANAGEMENT ............................................................................................... 51 4.1. Hazard management process ................................................................................................. 51 4.2. Exchange of information ......................................................................................................... 52 5. EVIDENCES FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS ... 55 Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 4 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 ANNEX II TO THE CSM REGULATION ................................................................................ 58 Criteria which must be fulfilled by the Assessment Bodies ................................................................. 58 APPENDIX A: ADDITIONAL CLARIFICATIONS ................................................................... 59 A.1. Introduction .............................................................................................................................. 59 A.2. Hazard classification ............................................................................................................... 59 A.3. Risk acceptance criterion for technical systems (RAC-TS).................................................... 59 A.4. Evidence from safety assessment .......................................................................................... 68 APPENDIX B: EXAMPLES OF TECHNIQUES AND TOOLS SUPPORTING THE RISK ASSESSMENT PROCESS .............................................................................................. 71 APPENDIX C: EXAMPLES .................................................................................................... 72 C.1. Introduction .............................................................................................................................. 72 C.2. Examples of application of significant change criteria in Article 4 (2) .................................... 72 C.3. Examples of interfaces between rail sector actors ................................................................. 73 C.4. Examples of methods for determining broadly acceptable risks ............................................ 74 C.5. Risk assessment example of an organisational significant change ....................................... 75 C.6. Risk assessment example of an operational significant change – Change of driving hours........................................................................................................................................ 77 C.7. Risk assessment example of a technical significant change (CCS)....................................... 79 C.8. Example of Swedish BVH 585.30 guideline for risk assessment of railway tunnels .............. 82 C.9. Example of risk assessment at a system level for Copenhagen Metro .................................. 84 C.10. Example of OTIF guideline for the calculation of risk due to railway transport of dangerous goods .................................................................................................................... 87 C.11. Risk assessment example of an application for approval of a new rolling stock type............ 89 C.12. Risk assessment example of an operational significant change –Driver only operation ....... 91 C.13. Example of the use of a reference system for deriving safety requirements to new electronic interlocking systems in Germany ........................................................................... 93 C.14. Example of an explicit Risk acceptance criterion for FFB Radio-based Train Operation in Germany .................................................................................................................................. 95 C.15. Example of applicability test of the RAC-TS ........................................................................... 96 C.16. Examples of possible structures for the hazard record .......................................................... 97 C.17. Example of a generic hazard list for railway operation ......................................................... 104 List of Figures Figure 1 : Risk management framework in the CSM Regulation {Ref. 3}. ...................................................... 23 Figure 2 : Harmonised SMS and CSM. ........................................................................................................... 25 Figure 3 : Examples of dependencies between safety cases (drawn from Figure 9 in EN 50 129 standard). .......................................................................................................................................... 27 Figure 4 : Simplified V-Cycle of Figure 10 of EN 50 126 standard. ................................................................. 32 Figure 5 : Figure 10 of EN 50 126 V-Cycle (CENELEC system life-cycle). ..................................................... 33 Figure 6 : Selection of adequate safety measures for controlling risks. .......................................................... 38 Figure 7 : Broadly acceptable risks ................................................................................................................. 40 Figure 8 : Filtering out of hazards associated with broadly acceptable risk. ................................................... 40 Figure 9 : Pyramid of risk acceptance criteria (RAC). ..................................................................................... 46 Figure 10 : Figure A.4 of EN 50 129: Definition of hazards with respect to the system boundary. ................ 48 Figure 11 : Derivation of the safety requirements for lower level phases. ...................................................... 49 Figure 12 : Structured documentation hierarchy. ............................................................................................ 55 Figure 13 : Redundant Architecture for a Technical System........................................................................... 61 Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 5 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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