Common Safety Method for Risk Evaluation and Assessment

Scope

Defines the mandatory risk management process — system definition, hazard identification, and risk acceptance via codes of practice, reference systems or explicit risk estimation — to be applied whenever a technical, operational or organisational change to the EU railway system is deemed significant. It also requires independent evaluation by an accredited or recognised assessment body (AsBo), making it the core framework used by RUs, IMs, ECMs and suppliers to demonstrate safe change management.

The Common Safety Method for Risk Evaluation and Assessment (Implementing Regulation (EU) No 402/2013) lays down the mandatory risk management process that railway undertakings, infrastructure managers, entities in charge of maintenance and suppliers must follow whenever a technical, operational or organisational change to the EU railway system is judged significant. The process begins with system definition and hazard identification, followed by risk assessment using one of three permitted approaches: application of codes of practice, comparison with similar reference systems, or explicit risk estimation. Where explicit estimation is used, safety integrity requirements must be derived and allocated to the system under assessment. An independent assessment body -- accredited, recognised or acting as an in-house entity meeting the regulation's independence criteria -- must evaluate the application of the process and issue a safety assessment report before the change is accepted into service. Since the 2015 amendment, this CSM-RA process is the core framework referenced across the EU rail safety and interoperability regulatory package for demonstrating that change has been safely managed.