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 measures cannot be validated and the hazards associated to them not controlled in the hazard record of this organisation as long as the corresponding technical safety measures are not fully implemented. This needs to be ensured even if in the meantime the exported restrictions of use are put in place. (b) or the related technical safety measures will not be implemented in the design at a later stage. The system will thus continue to be used during all its life-cycle with the associated restrictions of use. In this case, the following may be done: (1) the organisation exporting the restrictions of use does not register the associated safety measures as "validated" in its hazard record. In this way, when using the related system as a reference system in other projects, the corresponding safety concerns will not be overlooked. So, even if another actor accepts to manage the associated risks differently, it is useful that the organisation exporting the restrictions of use clearly points out in its hazard record that the associated safety measures were not validated, or. (2) the system description can be changed to include the restrictions of use in the scope of application of the system (i.e. assumptions for the system) and in the safety requirements. This will enable to control the hazards. Thus, if using the system as a reference system in another application: (i) the new system will have to be used under the same conditions (i.e. to fulfil the restrictions of use associated to those assumptions), or; (ii) additional risk assessment shall be done by the proposer for the deviations against those assumptions. Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 54 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 5. EVIDENCES FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS 5.1. The risk management process used to assess the safety levels and compliance with safety requirements shall be documented by the proposer in such a way that all the necessary evidence showing the correct application of the risk management process is accessible to an assessment body. The assessment body shall establish its conclusion in a safety assessment report. [G 1] The infrastructure manager and railway undertaking safety management system (SMS) already addresses these requirements. For the other actors of the rail sector that are involved in the significant change, even if the SMS is not obligatory, in general at least at the project level they have a quality management process (QMP) and/or a safety management process (SMP). Both of these processes rely on a structured documentation hierarchy either within the company or at least within the project. They address also the RAMS management documentary needs. Such a structured documentation can be composed basically of the following (see also Figure 12): (a) Project plans elaborated to describe the organisation to put in place for managing an activity within a project. (b) Project procedures elaborated to describe in detail the way to achieve a dedicated task. Usually, procedures and instructions exist within the company and are used as such. New project procedures are only elaborated if there is a need to describe a specific task within the considered project. (c) Project development documents elaborated along the system lifecycle represented in Figure 5. (d) Company or at least project templates exist for the different types of documents to be produced. Project Plans Project Procedures Project Development Documents Templates Project Records Figure 12 : Structured documentation hierarchy. (e) Project records elaborated along the project and necessary to demonstrate the compliance with the company quality management and safety management processes. That is one way of achieving the needs of documented evidence. There may be other ways of doing this as long as it meets the criteria of the CSM. [G 2] CENELEC standards advise to demonstrate the system compliance with the functional and safety requirements in a safety case document (or in a safety report). Even if it is not mandatory, the use of a safety case provides in a structured safety justification document: (a) the evidence of quality management; (b) the evidence of safety management; (c) he evidence of functional and technical safety; It has at the same time the advantage to support and guide the assessment body (-ies) in the independent assessment of the correct application of the CSM. Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 55 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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