Railway risk assessment and the relationship between AsBo organisations
Since the establishment of interoperability requirements in the European Union, there have been a number of changes in the life of interoperability and related national regulations. In addition to the increasingly well-known NoBo (Notified Body) and DeBo (Designated Body) conformity assessment procedures, a new procedure has appeared which, unlike the usual certification of subsystems or constituents, provides a legal basis for the safe implementation of planned changes. As one of the few organisations in Hungary, RailCert Hungary Kft. has all three types of designation and notification.
Risk assessment in the railway area
Rail transport is one of the safest modes of transport and in order to maintain this, the European Union is continuously reviewing, developing and harmonising rail safety and interoperability standards.
As a result, Implementing Regulation No 402/2013/EU (hereinafter: the CSM Regulation) has been adopted, which provides the legal basis for the safe implementation of the planned changes. The Regulation harmonises the assessment of the impact of changes to security levels, the risk management procedures used and the interpretation of the results of their application and allows for the exchange of security-related information between participants of the industry.
Why is it important to manage change?
Change management is a structured process that should be applied to all changes that significantly affect security. It allows for systematic and proactive hazard identification and the definition of appropriate hazard level reduction measures. Continuous and proactive hazard identification is essential, as the implementation of changes might introduces new hazards into the system, influence the effectiveness of existing safety measures and the compliance of procedures, processes, products and services.
What is a significant change under the CSM regulation?
According to Article 4 of the CSM Regulation, if there is no national regulation and the change affects safety, it should be the Proposer’s own decision (with the assistance of an expert or experts) to decide whether the change can be considered significant or not. In all cases, the decision taken must be properly documented and supported.
Who are the actors of the Regulation?
The Proposer is responsible for the application of the CSM Regulation and for determining the significance of the change, and for ensuring that the risk posed by suppliers and service providers – and their subcontractors – is managed in accordance with the regulation. The Proposer can be a railway organisation which implements risk managment measures, or a body in charge of maintenance implementing measures, or a contracting entity or manufacturer which operates under the Directive, or an applicant for authorisation for placing in service of structural subsystems.
An important actor in the procedure is the independent risk assessment organisation, the AsBo organisation, which is designated in Hungary according to Government Decree 390/2020 (VIII. 12.). It is important to highlight the fact that the activities of AsBo are different from the conformity assessment activities of DeBo and NoBo designated organisations, however, independence and impartiality are essential for these organisations as well. AsBo acts as an independent actor for the entire process of risk assessment during a major change. It’s role is not to take operational decisions, carry out the risk assessment and perform the related activities, but to verify that the requirements of Annex I. of the CSM Regulation are correctly met and that the outcome of the risk assessment is appropriate. The risk assessment process does not end with a certificate, but with a safety assessment report, in which AsBo draws it’s final conclusions on the adequacy of the application of the CSM Regulation. At the end of the risk assessment of a significant change, it is the responsibility of the Proposer to decide how and to what extent to take into account the conclusions of the safety assessment report.
The risk assessment process set out in the CSM Regulation provides an opportunity to develop safer, more efficient and harmonised rail transport. Therefore, it is important that all the above-mentioned actors are aware of the tasks they are involved in with regard to the major railway investments and reconstructions that are being carried out.