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
1.1.2. This iterative risk management process:
(a) shall include appropriate quality assurance activities and be carried out by
competent staff;
(b) shall be independently assessed by one or more assessment bodies.
[G 1] The railway undertaking and infrastructure manager safety management system (SMS) sets
out the process and procedures that:
(a) monitor the system continues to be safe during its entire life-cycle (i.e. during its
operation and maintenance);
(b) ensure a safe dismantling or replacement of the related system.
This process is not part of the CSM on risk assessment
[G 2] To implement the CSM, it is necessary that all parties involved are competent (i.e. have
proper skills, knowledge and experience). There is a steady need for competence
management within the organisations of the actors of the rail sector:
(a) for the infrastructure managers and railway undertakings, this is covered by their safety
management system (SMS) under Annex III (2)(e) of the Railway Safety Directive
{Ref. 1};
(b) for the other actors whose activities may impact the safety of the railway system,
although the SMS is not obligatory, in general at least at the project level (see
point [G 1] in section 5.1) they have a quality management process (QMP) and/or a
safety management process (SMP) which covers that requirement.
[G 3] The following sections of the CENELEC EN 50 126-1 standard {Ref. 8} set out guidance on
the competence:
(a) by virtue of § 5.3.5.(b): "all personnel with responsibilities within the" risk "management
process" need to be "competent to discharge those responsibilities";
(b) § 5.3.5.(d): the requirements of the risk management and risk assessment need to be
"implemented within business processes supported by a quality management system
(QMS) compliant with the requirements EN ISO 9001, EN ISO 9002 or EN ISO 9003
appropriate for the system under" assessment. An example of aspects controlled by the
quality management system is given in section § 5.2. of EN 50 129 standard {Ref. 7}.
These cover the quality assurance activities, as well as the competence and training for the
staff/persons, required for supporting the process covered by the CSM.
[G 4] Very often the risk assessment process is followed up by an assessment body from the very
beginning of the project, but unless required by a national law in a Member State such an
early involvement of the assessment body is not mandatory although it is advised. The
opinion of the independent assessment body could be useful before switching over from one
step of the risk assessment to the next one. Refer to Article 6 for further details on the
independent assessment
1.1.3. The proposer in charge of the risk management process required by this Regulation
shall maintain a hazard record according to section 4.
[G 1] Additional explanation is not judged necessary.
Reference: ERA/GUI/02-2008/SAF Version: 1.1 Page 24 of 105
File Name: Collection_of_RA_Ex_and_some_tools_for_CSM_V1.1.doc
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