How to Use the Interactive Risk Analysis Template

A Practical Tool to Structure, Evaluate, and Document Product Risks

When developing a new electrical or electronic product, risk analysis is not just a regulatory formality, it’s your design compass. The Interactive Risk Analysis Template helps you build a compliant, structured, and audit-ready risk evaluation file directly aligned with international standards like IEC 62368-1, ISO 14971, and ISO 12100.

This tool guides you through three essential steps: identifying risks, planning mitigation actions, and calculating residual risks. The spreadsheet is ideal for product managers, engineers, and compliance professionals working on early-stage concepts, certification prep, or ongoing risk reviews.

Best Practices When Using This Tool

• Use realistic, evidence-based values for probability (e.g., failure data, test results).

• Be specific and expand broad risks into their constituting parts, it will help to implement the solution

• Don’t underestimate low-severity risks that have high probability, they often result in field failures and warranty costs.

• Revisit and update the file at every design change, test report, or field feedback.

• Keep the document version-controlled. It’s part of your compliance evidence.