What is included in a risk assessment study, according to regulations EU 402/2013


RAMS equipment of Leedeo Engineering will regularly develop Safety Studies for customers who, when executing the modification of a railway installation within a work or a project, are required to submit a Safety Case according to Implementing Regulation 402/2013 -relative to the adoption of a common safety method for evaluation and assessment of the impact of a change-.

Anyway, regarding Safety activities, accompaniment of clients began many earlier: we support our clients from tender process of the public tender, providing -technical-economic offer for the project- a description of Safety and RAM activities being developed during the course of the project. This technical documentation is included by our clients in the tender delivery work, leaving this part of the project perfectly covered and described in the report.

It is increasingly important to develop a robust proposal of Safety and RAM activities within a technical memorandum of a public tender, that will be carried out during the execution of the project.

Scheme of a Safety Report for compliance with Regulation (EU) No 402/2013

    • Introduction. In this first section of the Report, we will define the object, the background and the scope of both the modification and the Safety Study itself. 
    • Identification of change. One of the most important parts of the Report describes in detail modification(s) that will be carried out, including actions associated with this change.
    • Quality procedures. As it is well known, it is not possible to manage Safety without proper quality management. Thus, a Report section will be automatically included, providing evidence that the project has been managed according to the company's Quality Management System.
    • Safety procedures. In the same way, it is expressed in the Report that the organization and the procedures applied to evaluate the impact on safety of the change -most of which are from Leedeo- are adequate and that CENELEC standards are met. In the same way, criteria of frequency, severity and level of risk that have been used for risk assessment are presented.
    • Presentation of the Hazard Log without any open threat.
    • Verifying and validating. Presentation of test protocol ensuring the correct functioning of change, roll-back program and development of new application conditions and exported risks (if any).
    • Conclusions where activities carried out and non-affectation on Safety levels and conditions being prior to change are summarized.

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