Step-by-Step: How to Apply the EU 402/2013 Regulation

The EU 402/2013 regulation, also known as the Common Safety Method for Risk Evaluation and Assessment (CSM RA), is a vital framework for ensuring safety in the railway industry. In this guide, we’ll break down the steps to apply the regulation effectively and help you navigate its complexities.

Why is EU 402/2013 Important?

The regulation provides a structured approach to identifying, assessing, and managing risks in railway operations. It ensures compliance with European safety standards and fosters a uniform approach to risk evaluation across all member states.

Step 1: Define the Scope

• What to Do: Clearly identify the system under assessment (e.g., a new railway component, a vehicle upgrade, or an operational change).
• Tips: Document the system boundaries, interfaces, and assumptions.

Step 2: Identify Hazards

• What to Do: Use systematic techniques like HAZOP, FMEA, or brainstorming sessions to identify potential hazards.
• Tips: Involve multidisciplinary teams to ensure no potential risks are overlooked.

Step 3: Classify Risks

• What to Do: Evaluate the risks using qualitative or quantitative methods and classify them based on severity and likelihood.
• Tools: Risk matrices or specialized software can help streamline this process.

Step 4: Apply Risk Acceptance Principles

• What to Do: Use one or more of the following principles:
  1. Codes of Practice: Check if the hazard can be managed using an existing standard.
  2. Comparison with Reference Systems: Determine if a similar system has managed the same risk effectively.
  3. Explicit Risk Estimation: Quantify the risk and ensure it meets acceptable thresholds.
• Tips: Always document your rationale for the selected principle.

Step 5: Develop Safety Measures

• What to Do: Propose and implement measures to mitigate risks to an acceptable level.
• Examples: Engineering solutions, operational controls, or additional training.

Step 6: Independent Assessment

• What to Do: Engage an independent assessor to verify that the risk evaluation meets the regulatory requirements.
• Tips: Provide clear documentation and evidence to support your analysis.

Step 7: Document Everything

• What to Do: Maintain detailed records of all steps, including the methodology, results, and justifications.
• Why It’s Important: Proper documentation ensures transparency and facilitates future audits or assessments.