The applicant can be any legal entity requesting the issuing of a safety assessment report. These are typically: infrastructure managers, entities performing the tasks of a manager, railway undertakings, entities in charge of maintenance.

The Public Agency of the Republic of Slovenia for Railway Transport (AŽP) is responsible for issuing the safety assessment report of the assessment body.

The application must be submitted in writing by post or in person to the Public Agency of the Republic of Slovenia for Railway Transport–Javna agencija za železniški promet Republike Slovenije, Kopitarjeva ulica 5, Maribor or in digitalised form to gp.azp@azp.si. 

The documentation produced by the proposer shall at least include:

• a description of the organisation and the experts appointed to carry out the risk assessment process;
• results of the different phases of the risk assessment and a list of all the necessary safety requirements to be fulfilled in order to control the risk to an acceptable level;
• evidence of compliance with all the necessary safety requirements;
• all assumptions relevant for system integration, operation or maintenance, which were made during system definition, design and risk assessment.

Assessment and risk management process

If the proposed change has an impact on safety, the proposer shall decide, by expert judgement, on the significance of the change based on the following criteria

• failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system under assessment;
• novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new for the organisation implementing the change;
• complexity of the change;
• monitoring: the inability to monitor the implemented change throughout the system life-cycle and intervene appropriately;
• reversibility: the inability to revert to the system before the change;
• additionality: assessment of the significance of the change taking into account all recent safety-related changes to the system under assessment and which were not judged to be significant.

When, on the basis of an assessment in accordance with the criteria, the change is considered significant, the risk management process set out in Annex I to Regulation 402/2013 shall be applied. In some specific cases, the application of Regulation 402/2013 may be included in a TSI requirement. In this case, the same assessment procedure is applied as for a significant change. The risk management process is described in Annex I of Regulation 402/2013 and further details are provided below.

The risk assessment process is the overall iterative process that comprises:

• the system definition;
• the risk analysis including the hazard identification;
• the risk evaluation.

The system definition shall address at least the following issues:

• system objective (intended purpose);
• system functions and elements, where relevant (including human, technical and operational elements);
• system boundary including other interacting systems;
• physical (interacting systems) and functional (functional input and output) interfaces;
• system environment (for example energy and thermal flow, shocks, vibrations, electromagnetic interference, operational use);
• existing safety measures and, after the necessary relevant iterations, definition of the safety requirements identified by the risk assessment process;
• assumptions that determine the limits for the risk assessment.

The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk acceptance principles:

• the application of codes of practice;
• a comparison with similar systems (reference systems);
• an explicit risk estimation.

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 suitability of both the application of the risk management process and of its results are accessible to an assessment body.

The assessment body shall establish its conclusion in a safety assessment report as defined in Annex III of Regulation 402/2013.

The safety assessment report of the assessment body shall contain at least the following information:

• identification of the assessment body;
• the independent assessment plan;
• the definition of the scope of the independent assessment as well as its limitations;
• the results of the independent assessment including in particular:

      – detailed information on independent assessment activities for checking the compliance with the provisions of the Regulation 402/2013;
      – any identified cases of non-compliances with the provisions of the Regulation 402/2013 and the assessment body’s recommendations;

The documentation produced by the proposer shall at least include:

• a description of the organisation and the experts appointed to carry out the risk assessment process;
• results of the different phases of the risk assessment and a list of all the necessary safety requirements to be fulfilled in order to control the risk to an acceptable level;
• evidence of compliance with all the necessary safety requirements;
• all assumptions relevant for system integration, operation or maintenance, which were made during system definition, design and risk assessment.

Assessment and risk management process

If the proposed change has an impact on safety, the proposer shall decide, by expert judgement, on the significance of the change based on the following criteria:

• failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system under assessment;
• novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new for the organisation implementing the change;
• complexity of the change;
• monitoring: the inability to monitor the implemented change throughout the system life-cycle and intervene appropriately;
• reversibility: the inability to revert to the system before the change;
• additionality: assessment of the significance of the change taking into account all recent safety-related changes to the system under assessment and which were not judged to be significant.

When, on the basis of an assessment in accordance with the criteria, the change is considered significant, the risk management process set out in Annex I to Regulation 402/2013 shall be applied. In some specific cases, the application of Regulation 402/2013 may be included in a TSI requirement. In such a case, the same assessment procedure is applied as for a significant change. The risk management process is described in Annex I of Regulation 402/2013 and further details are provided below.

The risk assessment process is the overall iterative process that comprises:

• the system definition;
• the risk analysis including the hazard identification;
• the risk evaluation.

The system definition shall address at least the following issues:

• system objective (intended purpose);
• system functions and elements, where relevant (including human, technical and operational elements);
• system boundary including other interacting systems;
• physical (interacting systems) and functional (functional input and output) interfaces;
• system environment (for example energy and thermal flow, shocks, vibrations, electromagnetic interference, operational use);
• safety measures and, after the necessary relevant iterations, definition of the safety requirements identified by the risk assessment process;
• assumptions that determine the limits for the risk assessment.

The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk acceptance principles:

• the application of codes of practice;
• a comparison with similar systems (reference systems);
• an explicit risk estimation.

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 suitability of both the application of the risk management process and of its results are accessible to an assessment body.

The assessment body shall establish its conclusion in a safety assessment report as defined in Annex III of Regulation 402/2013.

The safety assessment report of the assessment body shall contain at least the following information:

• identification of the assessment body;
• the independent assessment plan;
• the definition of the scope of the independent assessment as well as its limitations;
• the results of the independent assessment including in particular:

      – detailed information on the independent assessment activities for checking the

          – compliance with the provisions of Regulation 402/2013,

        – any identified cases of non-compliances with the provisions of Regulation 402/2013 and     

         – the assessment body’s recommendations;

• the conclusions of the independent assessment.

There is no time limit for preparing the safety assessment report.

Pursuant to the Administrative Fees Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 106/10–officially consolidated text, 14/15–ZUUJFO, 84/15–ZZelP-J, 32/16, 30/18–ZKZaš and 189/20–ZFRO; Numbers 1 and 35 of the schedule of fees), an administrative fee of EUR 679.80 is payable for the preparation of the safety assessment report. The fee shall be payable by the applicant upon receipt of a payment order.

The decision of the assessment body may be appealed against in writing, electronically at gp.azp@azp.si or orally at the AŽP on the record.