Guidance for Use of CSM Recommendation - ERA - Europa

European Railway Agency
Collection of examples of risk assessments and of some possible tools
supporting the CSM Regulation
identified "restrictions of use" (i.e. safety related application conditions) that are applicable to
the related generic products (respectively generic application). Therefore, whenever a
generic product and a generic application are used in operation in a specific application, the
compliance with all these assumptions (10) and "restrictions of use" (or safety related
application conditions) needs to be demonstrated in each specific application.
1.1.6. The first step of the risk management process shall be to identify in a document, to be
drawn up by the proposer, the different actors‟ tasks, as well as their risk management
activities. The proposer shall coordinate close collaboration between the different actors
involved, according to their respective tasks, in order to manage the hazards and their
associated safety measures.
[G 1] Very often, unless it is differently agreed in the contracts at the beginning of the project, each
project has a document that describes the risk management activities. The relevant
document is updated and reviewed whenever significant modifications are made to the
original system.
[G 2] Such a document sets out the organisational structure, the allocated staff responsibilities, the
processes, procedures and activities which together ensure that the system under
assessment satisfies the specified safety levels and safety requirements. The document
needs to be compliant with the CSM as it supports and provides guidance to the assessment
body. The CENELEC standards advise that this type of information is included in a safety
plan or, in another document with a part dedicated to those topics.
[G 3] The proposer's safety plan in particular, or any other relevant document, presents the overall
project organisation. It describes how the roles and responsibilities are shared between the
involved actors. For detailed information, reference can be made to the safety plans or
safety organisations of the different involved actors. Usually, the sharing of responsibilities
between the different actors is discussed and agreed during the preliminary system definition
(i.e. at the beginning of the project), if there is one.
[G 4] The safety plan is a living document that is updated when necessary during the project life.
[G 5] More details can be found in the EN 50 126-1 standard {Ref. 8} and its associated 50 126-2
Guideline {Ref. 9} about the content of a safety plan.
1.1.7. Evaluation of the correct application of the risk management process described in this
Regulation falls within the responsibility of the assessment body.
[G 1] Additional explanation is not judged necessary.
Continuation of the footnote
If for a specific application, the compliance with some assumptions and restrictions of use cannot be
achieved at a sub-system level (e.g. in case of operational safety requirements), the corresponding
assumptions and restrictions of use can be transferred to a higher level (i.e. usually at system
level). These assumptions and restrictions of use are then clearly identified in the "specific
application safety case" of the related sub-system. This is essential to ensure in such examples of
dependency that the safety related application conditions of each safety case are fulfilled in the
higher-level safety case, or else are carried forward into the safety related application conditions of
the highest-level safety case (i.e. system safety case).
Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 28 of 105
File Name: Collection_of_RA_Ex_and_some_tools_for_CSM_V1.1.doc
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