Human Error: the True Root Cause of a Deviation?

Quality Culture is paramount in pharmaceutical manufacturing. This concept is becoming increasingly important for regulatory authorities and companies are investing resources in systems and personnel to promote particular attention to quality processes and product quality.
During the root cause analysis typically the 6M are considered (Method, Material, Machine, Milieu, Measurement and Manpower). Notably for “Manpower” this is not the endpoint to really understand the root cause of a problem/deviation.
Each individual working in manufacturing is called upon to embrace a quality-centric mindset in daily tasks, not merely following procedures mechanically but being proactive—identifying weaknesses, flagging inconsistencies, acknowledging mistakes, and suggesting improvements. In this way, every individual is accountable for the quality of the output, irrespective of their position or experience level, and should be entrusted with maximum responsibility for this crucial aspect.

This training is an awareness session to provide some insights into Quality Culture in pharmaceutical manufacturing and to realize how “Manpower” or “Human Error” may be further considered in understanding the true root cause of a deviation in pharmaceutical production processes. This will result in the choice and implementation of efficacious CAPAs able to minimize the risk that the deviation will re-occur.