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
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
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