Which activity demonstrates compliance with risk management during design?

• A. Marketing plan development
• B. Reevaluating residual risk and updating the Risk Management File
• C. Choosing color palettes for the product
• D. Scheduling production runs

Answer: (B)

During design, risk management is an ongoing, iterative process: identify hazards, assess and control risks, and then reassess the remaining (residual) risk. Updating the Risk Management File after reevaluating residual risk shows you’re actively monitoring and documenting how risks stay under control as the design evolves. This documentation and re-assessment are what demonstrates compliance with risk management requirements, ensuring decisions are traceable and that the product remains within acceptable risk levels as changes occur.

The other activities don’t directly address risk assessment or maintaining risk documentation. Marketing plan development is about market strategy, choosing color palettes is an aesthetic/ergonomic choice, and scheduling production runs is a manufacturing activity. While all are important, they don’t embody the risk review and documented acceptance of residual risk that design-stage risk management requires.