The best place to manage risk is during the design phase, not when it comes time for product testing. The most important tool here is Failure Modes and Effects Analysis (FMEA).
FMEA identifies all the possible ways a product could fail, potential consequences and existing controls to prevent failure. The tool allows you to calculate detection ratings and risk levels, providing quantitative risk information to prioritize risk mitigation efforts.
Within your Compliance Management System, you can use FMEA applications to:
• Create different types of control plans and control plan templates.
• Link FMEA records with existing controls.
• Incorporate FMEA as part of your change management process.
