J
Hoping to get some clarification on this!
Currently our CAPA procedure requires a root cause investigation into all events regardless of their significance. FDA state that the level of investigation/actions can be commensurate with the risk. We would like to include a basic assessment of the risk/significance/impact of the event in our procedure. Is it sufficient to assign this as a simple qualitative measure i.e. low, medium, high? Many of our current deviations would be classified as low risk and no impact on product. Therefore we would negate the need for a timeconsuming and wasteful root cause investigations!
All deviations would be analysed for trends and investigation/action initiated if trends are identified.
Can anyone tell me if we would meet ISO/FDA requirements if we implement this?
Currently our CAPA procedure requires a root cause investigation into all events regardless of their significance. FDA state that the level of investigation/actions can be commensurate with the risk. We would like to include a basic assessment of the risk/significance/impact of the event in our procedure. Is it sufficient to assign this as a simple qualitative measure i.e. low, medium, high? Many of our current deviations would be classified as low risk and no impact on product. Therefore we would negate the need for a timeconsuming and wasteful root cause investigations!
All deviations would be analysed for trends and investigation/action initiated if trends are identified.
Can anyone tell me if we would meet ISO/FDA requirements if we implement this?
