As per defined in the Risk Manageme

As per defined in the Risk Management Plan, any hazard analysis item exceeding acceptable RPN value as defined in [1] is subject to further actions for risk control and is herein analyzed to justify nature of the actions or rationale for not taking any action.178 DFMECA Component179 In the context of Form Fit Ankle, acceptable risk was defined in [1] and is when risk was below RPN level 20.180 It is herein considered that any risk identified that exceeds the RPN level indicated above shall be addressed unless a strong rationale exist to mitigate known effects on the user safety.181 Each FMECA table entry documented exceeding the RPN level should have be thoroughly analyzed to justify the acceptability of the residual risk, in the case where such residual risk would be considered acceptable.