Passive versus Active Training
If you’re starting work at a medical device facility, there is a very high probability you will be training on some or several procedures before you get through your first week at work. Even the existing employees get caught up in new revisions of the production procedures in their training plan, or Corrective and Preventative Action (CAPA) activities. But what type of training are you receiving, and is it effective?
Most companies still seem to prefer read and understood methods. Some use written documents, others use electronic files for training and testing. Both methods are still considered passive in my opinion. This means the person reads/watches something and there is no direct involvement with the actual process being discussed. Active Training is where the person is taught with ‘hands on’ or simulated methods in the area they would be assigned. The testing portion would also be done in the area they would be assigned to demonstrate their knowledge of what they should have learned, and is verified by a trained observer they are competent at the level needed to pass the process being tested.
For example: If a ‘new’ operator is being considered for an opening and states they can run a $85,000 piece of equipment, I would want a supervisor or senior operator to test the employee using a pre-approved checklist (that is part of the Quality System) to demonstrate the employees knowledge of the machine without even turning it on yet. If they pass this part, then the second phase or a third phase to demonstrate their ability to run the equipment would be further tested. Each item on the list has a ‘Pass’, ‘Needs Training’, or ‘Fails’ column to document each activity. A full ‘Pass’ for all items is needed before an employee can be left alone to run production. Any items in the ‘Needs Training’ or ‘Fails’ column should require hands-on training on that piece of equipment or simulated training, and a repeat of the active testing checklist. This checklist should cover not only running the equipment, but all safety considerations to protect the operator and surrounding employees.
This Active Training method is very different than giving the same proposed operator a manual to read, maybe some standard operating instructions, and/or work and safety instructions to ‘Read and Understand’. By accessing what the working and safety requirements should be for a piece of equipment or a process with qualified users, the essential knowledge needed to safely and effectively make products will be identified, documented, and taught to ‘new’ employees via ‘hands-on’ or simulated methods.
This Active Training method allows the proposed operator(s) to demonstrate their knowledge visually before they have a chance to hurt themselves, other employees, or damage the equipment by overstating their knowledge and potentially damaging a productive piece of equipment.
The Active Training method could also be used in production labs for Biologics, CNC Machine shops, Additive Manufacturing (metal printing) sites, Molding companies, Casting facilities, etc. I have used it successfully in my career and I would invite others to consider using a more effective and work relevant method at their company.