Validation - Risk Control Measures and Traceability

The purpose of risk control is to employ a process by which risks can be reduced to, or maintained within, acceptable safety levels. Risk control measures are defined and documented in the Risk Management File.

To ensure a high safety standard, it is also useful to provide a table illustrating the traceability of software hazards:

• Which software functionality caused the hazard
• Which software item in the functionality is the cause
• Which risk control measure mitigates the cause
• Verification of mitigation