CAPA is a risk assessment and mitigation tool and by implementing a repeat risk measure, CAPA is reassessed and risk level is recorded. In case, the implemented risk measure becomes able to reduce the risk and bring it down to acceptable parameters, it is effective. Similarly, when the risk is not reduced and or is slightly reduced but is not within an acceptable parameter, correction of the measure become important. Using risk mitigation as a measure of effectiveness is extremely valuable for ensuring the CAPA has actually solved the problem.
By using this method, CAPA process turns out to be a incessant improvement cycle which involves investigation and risk assessment processes as the inputs to the process and utilizing reporting and risk mitigation history as the controls for effectiveness.
