Tracking Hidden Training

If it isn't documented, it isn't done!!  This adage especially applies to employee training.  Most companies are doing an excellent job keeping up with training documentation.  Here are a few questions to ask yourself to see how your training documentation system measures up!

Is your training documentation current?  Do you have copies of the same record in several locations?  What system do you have to ensure that all copies of training documentation are current and contain the same information, regardless of where that documentation is kept?  What about your retrieval process?  Can you access information in a reasonable time frame if an FDA inspector should ask for it as part of a routine GMP inspection?

What exactly will the FDA look for when reviewing training documentation?  They will look to see if you have training programs in place to make sure all your employees have the necessary training, education, and experience to perform their jobs to the best of their abilities.  The Drug regulation states that employees must have training in the GMP regulations "with sufficient frequency to assure that employees remain familiar with the cGMP requirements applicable to them."  The Medical Device has a similar requirement, but even if it isn't as clearly described in the regulation you follow, we believe that it would be wise to comply with that requirement for your training system.  The FDA will check to see how your training has been documented and if your employees are following procedures and performing tasks as they have been trained to do.  For this reason, its very important that training information is supplied to the employee's supervisor so he or she may be part of the reinforcement activities.  It will ensure that training translates into learning and improved performance.

When employees first join an organization their files are usually up to date with all pertinent education and background information.  How about after they have been with the company for five years?  During that time they may have developed skills and abilities on their own without notifying the HR department.  Chances are, if courses are job related and reimbursed by the company, the HR department will know about it and add the information to the employee file, but what about courses that don't qualify for reimbursement, yet  still provide the employee with new skills?  How are courses  conducted off site, especially extension school programs, workshops, or conferences attended by professional staff, captured in your documentation?  At the GMP Institute, we provide a Training Record which lists the content of the workshop.  Many companies also require employees to produce a "Workshop Report" describing what took place and how it relates to their job.

Do you record memberships in trade associations (like ISPE) or note trade journals employees read on a regular basis?  Industry groups and publications are often the main source of continued learning for busy professionals, and a chief way of keeping current with industry changes.

Finally, we find employees frequently have hidden talents that have not been documented.  Do you have a system in place where your employees are routinely asked to update their own training, education, and background?  By creating a method to retrieve this kind of information, you may discover some hidden assets!!