Information Technology Reference
In-Depth Information
2.1
How should the requirements from the CSM Regulation be
fulfilled
In order to enable the mutual recognition of the results of risk assessments
and to ensure that the existing safety levels are maintained in the Community
rail system, the CSM harmonises the process for risk assessment. It specifies
what
requirements must be fulfilled
without
specifying
how
to fulfil them.
This is an important property of the CSM, since the current practices for
risk management vary between the different Member States. Usually, different
tools are established and different practices for the assessment and evaluation
of risks exist. Moreover, the specific physical and historical properties of the
railways around Europe request different activities in their given context.
Therefore, it is necessary for the proposers to be able to comply with
the CSM requirements, paying attention to their local particularities and
adjusting their activities to the particular context of their work. In their
activities, this freedom and flexibility are considered to be very important.
2.2
Significant change
The CSM on risk assessment shall apply to any safety related change of the
railway system in a Member State, which is considered to be significant.
If there are no notified national rules defining whether a change is signif-
icant or not in a Member State, the proposer shall decide, by expert judge-
ment, on the significance of the change. This decision is based on the following
criteria that are provided in Article 4 of the CSM on risk assessment:
- failure consequence;
- novelty used in implementing the change;
- complexity;
- monitoring;
- reversibility of the change.
If the change is not significant, the CSM application is not mandatory, but
the decision needs to be documented. This would allow the national safety
authority to check it during its supervisions of the proposer's safety manage-
ment system.
For non significant changes, attention on the possible additionallity ef-
fects needs to be paid. This means that the expert judgement shall always
evaluate, if when added up, the sum of all non significant changes since the
last application of the CSM becomes a significant change.
In the scope of the dissemination of the CSM, discussions took place, on
the question, if it is viable to provide a harmonised list of all changes in the
railway system, which are considered to be significant. On one hand such a
checklist would avoid the need to count on expert judgement when deciding
on the significance of a change and would thus bring some strict rules to the
answer of this question. On the other hand, having such a predefined list in
a harmonised piece of European legislation would, by a way, take away the
