While you read this article, about 60 deviations will be logged within global GMP environments*. Half of them would have been caused by “human error”. Most of these will end with “retraining” as one of the corrective actions.
How to deal with deviations caused by human error:
Option 1) Classroom Training: with a trainer using a PowerPoint presentation compiled from multiple web pages. If you are lucky, the trainer has a decent understanding of the topic, and articulates the information that connects well with the trainee. More often, you are not lucky, and the trainer simply reads the material out loud, causing “death by PowerPoint.”
The trainees are then subjected to a “training evaluation quiz”. Remember, it is essential for the trainer to conclude this quickly, so him and the trainees can move on with their day. The quiz will include questions directly copied from the SOP with answers so obvious that it defeats the purpose of “evaluation”.
Option 2) Computer based training: This most often involves a pdf copy of SOP being presented. If you have a Learning Management System (LMS), the content may be both audio and visual. Both will include an evaluation quiz, not very different from the paper based one. It is rare to find questions which require the trainee to interpret the material.
In both options, training records will be updated to show an adequate number of correct answers to the “evaluation”. These will be made available for future audits, to demonstrate compliance and corrective action on the original deviation.
Is compliance adequacy really our business need?
While this strategy has worked in past with most auditors, it did nothing to help the trainee in obtaining a detailed understanding of the “Why” of the process. Obviously, the organization did not see a reduction in future deviations overall.
Why should an incubator temperature be set at 25 +/- 0.5⁰C? Why is identification of microbes important for control of cleanroom environments? What are the potential areas of failure in each procedure?
Training content rarely provide answers to these questions. However, it is only through answering the “why” that trainees can address unexpected circumstances, and suggest revisions to procedures – contributing to reduced human error.
“Train to comply” Or “Train to think”?
Quality of the training content and trainer can transform this retraining exercise from rote compliance to a thought-provoking learning experience. While availability of good human trainers is always a challenge, even organizations with modern LMS often end up utilizing their computer-based systems only for displaying PDF or Powerpoint SOPs.
This situation is like watching standard digital content on a 4K Ultra HD-TV, because you have not invested in 4K content.
It is essential for management to fully understand the value of good training design, and invest in training for thinking vs training for compliance. Once the organization adopts the thinking culture, compliance will follow automatically.
*Reference: “Human Error” Deviations: How You Can Stop Creating (Most Of) Them By Ben Locwin, Ph.D. October 9, 2017, Pharmaceutical Online
(About CRAMbridge: CRAMbridge is a group of experienced industry professionals working to bridge GMP learning gap by developing content that make the trainees think)