Human error. It is one of the most frequently-cited root causes during investigations, which is ironic, because the proper conclusion is rarely human error. Regulatory agencies globally understand this but, unfortunately, most firms don’t.
Global regulators have increased their focus on deviations and root cause analysis (RCA), and this process is one of the largest sources of inspection observations. Frequently identifying “Human Error” as a root cause and “Retraining” as a CAPA is a clear indication to the regulatory authorities that you’re not solving the quality issues and related problems that exist in your organization. Worse, it can give regulators the impression that your staff is ill-prepared, error prone, AND you don’t have a handle on the real causes of your deviations.
In this interactive webinar, we’ll explore a collection of conditions that can contribute to human error – including identifying the ONE condition where retraining may actually help.
Attendees will learn:
- Why “Human Error” as a root cause is a red flag – and what to do about it
- The ONE time when “retraining” is an appropriate corrective action – and why it isn’t most of the time
- Other areas to assess when a situation presents itself as “Human Error’ – to find the true cause of the problem, and generate better CAPAs
- How this process applies to our GMP-regulated environments – introduction and links to some research driving what we know about human performance