Now Eugenio will present his case study "How to manage process deviations and showcase your data" at this Quality Assurance Pharma & Biotech online conference. As a short preview, we have asked Eugenio a few questions regarding his current topic:
Are pharma companies paying close enough attention to deviations?
Yes, for sure they are, the big question is whether they are doing so in the most effective way.
What are the basic steps in deviation management?
Most Quality Organizations are very focused on root cause analysis and defining corrective and preventive actions (CAPAs). I would argue that unless the data is gathered and analyzed correctly, this might not really bring the expected benefits. If your trending analysis never shows you any issues, are you looking at the right data?
How can we expect or predict particular deviations?
Generally speaking, wherever manual intervention is present in a process, you will sooner or later have human errors. Might not happen very often, but given equal opportunities for failure, it will happen. The fact that you have been lucky so far does not make your process robust forever.
What are the most common mistakes in deviation management?
Blaming your employees for their mistakes. You should be addressing the flawed process that has allowed them to make that mistake, and with their input, change it to eliminate those situations. A classic example is that you cannot start an automatic transmission car unless your foot is on the brake. This eliminates the situation of the user forgetting to engage the brake and possibly hitting a wall. Blaming them afterwards might be very costly.