Guidance for Use of CSM Recommendation - ERA - Europa

04.07.2015 Views
European Railway Agency Collection of examples of risk assessments and of some possible tools supporting the CSM Regulation [G 3] The safety case describes and summarises how the project documents resulting from the application of the company or project quality and/or safety management processes interrelate within the system development process to demonstrate the system safety. Usually, the safety case does not include large volumes of detailed evidence and supporting documentation but provides precise references to such documents. [G 4] Safety case for technical systems: CENELEC standards can be used as guidelines for writing and/or for the structure of safety cases: (a) see EN 50 129 standard {Ref. 7} for "Railway Applications - "Communication, Signalling and Processing Systems & Safety related electronic Systems for Signalling"; Appendix H.2 of the EN 50 126-2 Guideline {Ref. 9} also proposes a structure for the safety case of signalling systems; (b) see Appendix H.1 of the EN 50 126-2 Guideline {Ref. 9} for the structure of the safety case for rolling stock; (c) see Appendix H.3 of the EN 50 126-2 Guideline {Ref. 9} for the structure of the safety case of infrastructures As it appears in these references, the safety case structure for technical systems, as well as its content, depends on the system for which the demonstration of the safety compliance is to be provided. The safety case outlined in Appendix H of the EN 50 126-2 Guideline {Ref. 9} provides only examples, and may not be suitable for all systems of the given kind. Therefore, the outline needs to be used with appropriate judgement of what fits to each specific application. [G 5] Safety case for organisational and operational aspects in railway systems: At present, there is not any dedicated standard providing the structure, the content and a guideline for writing the safety case for organisational and operational aspects of a railway system. However, as the safety case aims to demonstrate in a structured way the system compliance with its safety requirements, the same kind of safety case structure can be used as for technical systems. Indeed, the references in point [G 4] of section 5.1 provide advises and a checklist of items to address regardless the type of the system under assessment. The management of organisational and operational changes do require the same kind of quality management and safety management processes as the technical changes, with a demonstration of the system compliance with the specified safety requirements. Requirements from CENELEC standards not applicable to organisational and operational aspects are the ones purely related to technical system design facilities, as for example "inherent hardware fail-safety" principles, electromagnetic compatibility (EMC), etc. 5.2. The document produced by the proposer under point 5.1. shall at least include: (a) description of the organisation and the experts appointed to carry out the risk assessment process, (b) results of the different phases of the risk assessment and a list of all the necessary safety requirements to be fulfilled in order to control the risk to an acceptable level. [G 1] Depending on the complexity of the system, these evidences can be gathered in one or several safety cases. Refer respectively to points [G 4] and [G 5] of section 5.1 for the structure of the safety case for technical systems and for operational and organisational aspects. [G 2] Refer also to section A.4. in Appendix A for possible examples of evidences. Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 56 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 [G 3] The lifetimes of technical systems and subsystems in the railway sector are generally expected to be around 30 years. During such a long period of time it is plausible to also expect a number of significant changes to these systems. Further risk assessments could thus be conducted for these systems and their interfaces with the accompanying documentation that will need to be reviewed, supplemented and transferred between different actors and organisations using hazard records. This implies rather strict requirements on documentation control and configuration management. [G 4] It is then helpful that the company which archives all the risk assessment and risk management information guarantees that the results/information are stored on a physical support that can be read/accessible during the complete system life(-cycle) (e.g. during 30 years). [G 5] The main reasons for this requirement are among others: (a) to ensure that all the safety analyses and safety records of the system under assessment are accessible during the complete system life. Thus: (1) in case of further significant changes to the same system, the latest system documentation is available; (2) in case of any problem during the system life, it is useful to be able to go back into the associated safety analyses and safety records; (b) to ensure that the safety analyses and the safety records of the system under assessment are accessible in case it is used in another application as a similar reference system. Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 57 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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