Incident introduction and The case study

Abstract

Our group has studied the ideal state of deviation control and CAPA handling at the pharmaceutical manufacturing. It is important to detect minor deviations and incidents earlier and respond promptly, which promotes “Speak-up” culture and allocating resources according to the risk of the deviations.

This paper proposes a Double-Loop Method for managing incidents according to the procedure that investigation, disposition whether it is an incident or not, PDCA cycle will be implemented with record of incidents, list as deviation, and observing incidents.

Two examples of incidents are introduced for deeper understanding. One is packaging abnormalities of raw material, and the other is data loss in environmental monitoring systems.