Handling of Typical Deviations in API Manufacturing
Some typical shop floor deviations are discussed. The focus of investigation should revolve around the root cause. Handling of deviations is a post-mortem investigation. FTA- Fault Tree Analysis tool from Quality Risk Management guide – Q9 is very useful for such investigations. There should be a recommendation to include FTA tool for investigation into your SOP on handling of deviations. – Ramalinga Prasad Kuppa