Your quality systems and procedures are in place, however no matter how much you try, people still don’t fully comply with them. These deviations and subsequent investigations lead to lost productivity. Typically you identify “human error” as the root cause and your corrective action is to train your team.
Having delivered advice and training to pharmaceutical and medical device companies for over 25 years, we’ve found that training doesn’t necessarily address the deviation because there is more to the root cause than just “human error”. Taking guidance from industries such as Nuclear Energy and Aviation (where there is an acute focus on human error) we have found that it is important to focus on:
- What is important to the person doing the work (and therefore how they will behave)
- How people learn and what sort of errors they commit at each stage of learning
- How the culture of the organisation itself influences behaviour
- The importance of systems in influencing and supporting changed behaviour
Contact us if you’re a Manager/Supervisor responsible for GMP compliance, CAPA, reducing deviations, conducting failure investigations or root cause analysis within the Pharmaceutical and Medical Device Industries for a discussion on how you can better tackle human error within your department.
Or you may be interested in our behavioural GMP training course.
