RISK MANAGEMENT SYSTEM EVALUATION

The Romanian Railway Safety Authority - ASFR was designated by OMT no. 1501/2014, to exercise the powers of a nationally recognized assessment body, for all areas of competence within the railway system, in accordance with the Implementing Regulation (EU ) no. 402/2013.

The company or organization responsible for implementing a change in the railway system (the "proposing party") must assess the impact of the change on safety levels and compliance with safety requirements.

The party submitting the proposal is responsible for the application of Regulation (EU) no. 402/2013, including the assessment of the importance of the change based on the criteria set out in Article 4, as well as the implementation of the risk management process set out in Annex I.

The evaluation is applied in the case of changes to the railway system, which may be of a technical, operational or organizational nature. In the case of organizational changes, only changes that could affect the operating conditions are taken into account. The party submitting the proposal decides the degree of importance of the change, by requesting the opinion of experts and based on the criteria established in art. 4 paragraph (2) letter (a) ÷ (f) of Regulation (EU) no. 402/2013.

ASFR through the Risk Management System Evaluation Service can evaluate , when the party submitting the proposal requests this, the conformity of the way in which the party submitting the proposal documented the decision regarding the framing of the significant change against the criteria established in art. 4 paragraph (2) letter (a)÷(f) of the Implementing Regulation (EU) no. 402/2013 and whether the analyzed change is framed correctly or not by the party submitting the proposal.

When a change is classified as significant, the risk assessment must be carried out by the party submitting the proposal, through a structured risk management process, provided for in Annex I of Regulation (EU) no. 402/2013.

The process must be properly described by SMS procedures and its application documented for all relevant stages.

After the completion of the iterative risk management process, the party submitting the proposal requests that ASFR, in the role of Assessment Body, assess the adequacy of the application of the risk management process and its results, described and justified by the documentation submitted by the party submitting the proposal, regarding the degree of compliance with that described in Annex I to Implementing Regulation (EU) no. 402/2013 of the Commission of April 30, 2013.

Based on the safety assessment report, the party submitting the proposal accepts or not the significant change and if it is accepted, formulates the declaration provided for in art. 16 of Regulation (EU) no. 402/2013.