ID FunctionFailure Mode
Effect of the Failure
Failure Cause
Probability
Consequence
(1-5) Initial
(1-5)
CAPA
Risk
Risk/(P
Arising
Risk
x C)Control
from Mitigation
Measures Action (R.A.M.A.)
1 Compute dCannot co Drug not dMissing or 5 4 20 List mandatN/A
2 Compute dWrong dosWrong dose Incorrect i 4 5 20 Match input3
3 Display patConfusing Wrong dataSimilar ap 3 4 12 Use clearlyN/A
Residual Probability
Residual Consequence
Residual RiskDetection
(P x C) (1-5)
RPN (S x P x D)
2 2 4 3 60
2 3 6 4 80
1 2 2 2 24