Guest Column | November 4, 2015

Taking GMP Training From Painful To Practical

Joanna Gallant

By Joanna Gallant, owner/president, Joanna Gallant Training Associates, LLC

Taking GMP Training From Painful To Practical

For many, GMP training is an event where attendees are herded into a room and are read the contents of the regulations or asked to watch a video. This video is often the same slides or video year after year.  Then, after this nice little break, everyone goes back to their jobs, forgetting about it until the next time the necessary evil called “GMP training” is required.

However, there are several ways to make GMP training more practical, and this can be accomplished through orientation, initial task training, and refresher training.

First Of all: Why Do We Need To Provide GMP Training?

The easy answer is because it is required. The GMPs mandate that people be taught the GMP requirements that are applicable to their activities – and then, ensure they remain familiar with those requirements.

It’s also the reason why it’s so often painful.  Often, companies take the fastest, easiest way out. But why is GMP training even a requirement in the first place?

Because people need to know the legal requirements and expectations so that they can perform in accordance with them when they perform their tasks – akin to attending driving school (driver’s ed) where they learned the rules of the road prior to being licensed to drive.

Learning The “Rules Of The Road”

So let’s run with that comparison: I remember spending almost 40 hours in a driver’s ed classroom course over several weeks that included:

  • An overview of the basics of the rules of the road – with an embedded expectation that I was to read my state’s driver’s manual outside of class, preparing to be tested on that knowledge to obtain a license.
  • Watching scenarios – mostly of accidents and bad driving habits – and then identifying what the drivers had done wrong, what they should have done, and postulating what would have happened with those different actions.

The course addressed the rules and their real-life application, delivered by a knowledgeable instructor who could talk about both.

Now imagine what driver’s ed would have been like if the instructor had simply read us the state’s driver’s manual.  Excruciating – right?

So why do we so often sit our new employees down and simply read them a bunch of presentation slides about the GMPs?  It’s no different.

Worse, our programs often only cover the regulations and leave out the application piece that gets us the practical value.  (Or, if it covers both, it’s not in a way that resonates with the trainees.

Our GMP training should include not only our GMP “rules of the road” but:

  • Why we need the GMPs, from an industry history perspective, and cases of where things went wrong that led to changes – like the scenarios in the driver’s ed course
  • The rationale for why the regulations cover what they do, and how they apply to the trainees and the company operations
  • The framework we operate within and how to do so successfully - including basics like needing to follow procedures and complete training, along with expectations for how to operate in a world of change control, deviations, contamination control, and regulatory inspections (at a minimum)

So think about your company’s GMP orientation program – not the business side of onboarding with the HR and legal elements, etc. Simply think about the GMP portion.

  • How much time is allotted to it, what’s covered, and how? (To include all of the elements mentioned above, the allotted time may need to be expanded.)
  • Does it start the person off with an understanding of a GMP work environment and how they’re expected to behave in it?
  • Do you expect people to actually read the regulations? And how do we know they understand them?
  • Do you have the right people – those who have knowledge of the regulations, the rationale, and the behavioral expectations in the environment – delivering the training?

Hitting The Road

The second part of driver’s ed taught us to drive the car which could only happen hands on.  We signed up for time outside of class with the instructor who taught us about the vehicle, how to drive it, and provided feedback on what we did right or wrong, linking back to what we discussed in the classroom.

We were also required to practice outside of driver’s ed with another licensed driver because the limited time with the instructor wasn’t enough to completely prepare us to demonstrate our driving ability to an assessor.

Then, we took the licensing test. Our knowledge of the rules of the road and our ability to apply them to a variety of situations was assessed, which was followed by a road test with an official who assessed our actual performance.

Think about what’s encompassed in the above:

  • The content from the classroom was a foundation for and was linked to/used in, task training
  • Practice was expected because applying what we learned and developing the skills, knowledge, and appropriate situational reactions takes time and repetition.
  • The ultimate end goal was to be able to get a license by demonstrating that we had – and could use – the knowledge and skills independently!

So let’s apply this to our GMP training – with a series of questions:

  • Does your training process link what people learn in GMP training to the operations they perform in their daily jobs? Or do you ascribe to the “never the twain shall meet” approach, where the training department teaches the GMP content, and the functional area teaches the tasks – with no overlap or support of one by the other?

Our procedures define how we have built GMP requirements to a specific task or process, and our goal is to teach people to follow those procedures. But, part of knowing how to do a job well is knowing why you do what you do and how things could go wrong.

As part of operational training, people should be taught the specific GMP requirements that drive the task along with what non-compliance would look like and mean to the task or the business as a whole.  (Good documentation practices and data integrity is a great example of this.)

This miss often happens for a couple of reasons: Trainers (either the OJT trainer or the GMP trainer) don’t know the operational or GMP piece of the content.  Or, we rush training to get the person working as soon as possible, and perceived “non-essential” or duplicate information is eliminated.

  • Does your training process allow for sufficient practice?

Think about what we’re asking people to do: Make batches of product worth millions of dollars using complex processes and equipment. Then, they need to assess whether it is safe to provide to patients based on decisions about whether it was processed in accordance with requirements.

And yet we rush people through developing the GMP knowledge and skills that enable them to do these things.

Would you give a license to someone who had only driven once? Probably not.

So why do we trust people to make decisions and take actions that can affect patients’ lives (or at minimum, affect the company), when we’ve provided the minimum possible training time and exposure to applying regulatory expectations to operations?

  • Does your process include a performance assessment that encourages the development of – and subsequently assesses the ability to use – the appropriate GMP skills, behaviors and knowledge?

Sufficient practice, along with observation of and feedback on performance, goes a long way to developing good skills and behavioral habits in a trainee. 

But what makes those habits stick is ensuring people have the knowledge to support good decision making. This enables them to make the right decisions when they’re on their own, and precludes bad habits from setting in.

Simply asking people why certain things are required (as part of the assessment) will lead them back to the GMP content associated with the task. 

I’ve had many conversations with people who tell me that someone “doesn’t know their GMP’s” – but when asked, the person can’t tell me what element of GMP the other person is violating – because they don’t know either.

Once the desired behaviors are learned, performance monitoring and reviews, along with environmental cues then reinforce the desired behaviors and ensure they don’t slip.  For example, one of my mentors had a sign in his office that read, “In God We Trust – all others bring data” – meaning, in this industry we operate on documentation and data as evidence. 

Staying Safe

So now we’re licensed – and yet, careless drivers cause accidents that lead to anything from minor traffic delays to loss of life.  Others break the law and face a variety of punishments depending on their offenses.  Some driving-related incidents are even newsworthy events.  

All licensed drivers see and hear reminders like these of the impact of disregarding the rules all the time, and it’s enough to keep most people practicing safe habits.  Sometimes those who didn’t develop proper habits get sent to traffic school to relearn what they should have known before getting behind the wheel.

In the GMP industries, we take more of a proactive approach – GMP refreshers.  On some predefined frequency, we want to remind people of the requirements and what they mean before violations occur.

So we sit people down and re-read the GMPs to them – sometimes even using the same slides we used with the new hires!  If it didn’t work then, why should it work now?

To gain practical benefit from refresher, think about approaching it differently. Plenty of information exists to enable discussion of the practical application of GMPs, along with GMP failures — for example:

  • Case studies from companies facing consent decrees or other regulatory issues
  • Specific product recalls & the reasons for recall
  • FDA inspection information (from 483s & warning letters)
  • Internal auditing observations
  • Internal performance metrics
  • FDA guidance documents

The most beneficial GMP refreshers will encompass activities based on real-life scenarios.  They lead to discussions of what happened and why, how it affected those involved (personnel, companies, and patients), what requirements were violated, and – even better – if something similar is happening within your own facilities and what to do about it.

Include company-specific information, and GMP training then becomes a way of communicating and discussing issues that can lead to improving performance, because it’s based on practical, specific, real life examples.

Moving From Painful To Practical

These are only a few suggestions of ways to give people a working knowledge of the GMPs and how they apply to operations – and they’re not difficult to factor into the things we’re already doing.

You’ll need to do two things for it to be successful, though.

First, be willing to expand training to cover these items – which may involve more time given to training activities.  The tradeoff is that your people will learn to develop and apply more of a GMP mindset to their activities.  Plus, it also gives them the ability to recognize issues in the operation which enables the continuous improvement mindset.

Those who deliver training need to be able to demonstrate both knowledge of, and a passion for the importance of the GMP elements and how they apply to daily operations. The ability to apply knowledge – from all sources – to operations is the foundation of a continuous improvement and quality systems culture. 

Our GMP training programs should provide the mindset, and be the foundation of this culture we need to cultivate, allowing personnel to put the regulations into practice. 

So is your GMP training helping build your culture?