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Engineering Systems and Capabilities Improvement

Updated: Nov 29, 2020

After a pharmaceutical company failed their pre-approval inspection from the FDA, Process Alliance was contacted to help and sent over consultants Dave Kahn and Ernie Perkins.


What was initially thought to be a smaller project turned out to be a much larger one, as Kahn and Perkins began working with the company full time from May until September. Due to the

failed inspection, the factory had updated its equipment, added new personnel, and updated all of their procedures. However, this left a larger issue: There were gaps in training between the employees, and the current system provided no way to discern who had been trained fully and where more training needed to be done.


The first step to solving the issue was for Kahn and Perkins to investigate the training gap. After assessing the staff, the Process Alliance team began building and adjusting the existing training courses. With the new and old machinery, it was important that each employee knew how to safely operate and use each instrument.


The levels of training varied. Some pieces of information need only be read by the staff, and then confirmed that they are understood. Others used traditional classroom training. More complex procedures required employees to demonstrate that they are aware of the steps and processes needed to complete certain tasks. In the last few months of their stay, a higher-level training system was begun that explained how equipment functioned and the science behind it.


Another key problem with the preexisting system was a lack of documentation. Kahn and Perkins increased the level of documentation and added a level of verification by requiring that a second staff member confirm steps had been done correctly after the initial employee has performed them.


In the end, the company was left with better-trained employees, more efficient systems, and higher levels of production. The company redid the batches they submit to the FDA and met their deadline of resubmitting within 12 months in order to keep their expedited status. The higher level of documentation showed that the staff was trained, and the multiple methods of training ensured that the education was reflected in their work. The plant is currently waiting for the FDA to come for a pre-approval inspection, but this story will be updated when more information becomes available.

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