The Three ‘Cs’ of Successful Training

Congratulations, you have just been hired/appointed to be the trainer for a pharmaceutical work team/department. Never been a trainer before? Or, even worse, only been a trainer in another industry? Don’t know what’s different about pharmaceuticals? Not sure where to start? Don’t worry. Just follow the three ‘Cs’: compliance, competence, consultant.

Compliance

I know what you experienced, non-pharmaceutical trainers are thinking: “That’s not where you start the training development process!” I understand, but one of the things that is unique about the pharmaceutical industry is that, unless you are a green-field start-up that’s not yet making any salable product, you are required to be in compliance at all times. So if you’re not in compliance, your first responsibility is to get there.

“I’m new here. I don’t even know what ‘in compliance’ is.” That’s easy. If you were lucky enough to inherit a training plan, then that’s your definition of what’s required to be in compliance. Do the training that is necessary in order for your workforce to have documented proof that they did the training that is required according to their training plan.

If you don’t have a training plan, it’s only a little harder. Good manufacturing practice (GMP) requires that everyone working in a GMP area “ . . . shall have the education, training, and experience . . . to enable that person to perform the assigned functions.” The minimum an auditor would expect is at least some general GMP training and training on the standard operating procedures (SOPs) associated with the job. Do the training necessary for your workforce to have documented proof that they have had GMP training and they know the SOPs required for what they are doing.

Now you are in compliance. People are trained to do their jobs, and you have documented proof of it. Wasn’t that easy?

Competence

For those of you with other training experience, you are probably already familiar with this one. Now you focus on either creating or updating your training plan. What are the things that people need to know and do in order to do their jobs correctly every time? This is where the KSAs – knowledge, skills and abilities – come into play. What do they have to learn? What do they have to do? What do they have to be able to do? For you experienced folks, do a needs analysis. Talk with the subject matter experts and people who perform the jobs and determine what KSA each task requires.

Now create or revise your training plan and ensure it includes all the training appropriate to the KSA. If your training plan is nothing more than lists of the SOPs for a job, that’s a fine starting place – those are definitely required. It will meet the minimum requirements for compliance. Now take it to the next level. A good training plan does more than meet minimum requirements; it guides people to getting KSAs necessary for successful performance of their jobs.

One thing that can really improve your training plan is to consider how the training is organized. Does it follow the flow of a process or task? Does it make good learning sense? Training will usually be at the mercy of the production schedule but, when possible, you want to design a training plan that facilitates learning. Do you have the easiest tasks first, working up to the more difficult ones? For example, it is usually easier to run a machine than to take it apart or put it together. I can drive a car, but I can’t build one. Start with that. First, teach me how to run it. Once I know that, what should be next? This will vary for different pieces of equipment. It could be troubleshooting, or it may be easier to learn troubleshooting after I’ve learned how to assemble the equipment – because I have a much better understanding of how it all works.

It might be easier to take the equipment apart than to put it together, but I may need to know how to put it together in order to take the right parts apart. You are going to have to determine what the best learning sequence is for every piece of equipment. The challenge is that your subject matter experts probably know how to put it together, run it, troubleshoot it, then take it apart and clean it. Since they know it has to be done in that order, it may be difficult for them to think of training in a different order. Recent trainees can be an excellent resource here. What were they trained on that really didn’t make sense until they learned something else? Getting this right may take some trial and error and it might not even be the same for everyone.

The goal is to provide a training plan that works best most of the time. You will have to change it sometimes due to production, and you may want to change it sometimes to match the needs of an individual learner, but design your plan to best suit the learning needs of your average trainee.

Ultimately you want to end up with a robust training plan that minimizes the amount of time it takes for a person to achieve competence. Performance and learning criteria may be added. These can include how quickly one should perform the task, and guidance on how quickly one is expected to be able to learn the task. If the task is supposed to take an hour and it takes me all day, I need more training. Also, if the rest of the staff learned to do this task in a week and I haven’t learned it after 6 months of trying, perhaps this job is not a good fit for me.

Now you are in compliance and you have a training plan that brings people from hire to competent as efficiently as possible. You are ready to move on to the third C.

Consultant

This is the most interesting part, and it is optional. In some organizations it may be handled by human resources, in other organizations it may be outsourced to external consultants. I don’t mean you have to quit your job and go into consulting, but now you can work as an internal performance consultant for the people you support. You are in an ideal position to do this, even if the initiatives are led by HR or external consultants, because you have a good understanding of your workforce and the issues in their jobs.

Here are some of the situations for which you want to provide performance consulting: an atypical event occurs and we think it might be related to human error; Joe works twice as fast as John and makes fewer mistakes – we want to understand why and see if we can get everyone to perform as well as Joe; we’re getting a new product/process/piece of equipment and we need to figure out what training it will require; we’ve got a new business initiative (for example: Lean Manufacturing) and we need to figure out how to implement it and still get the job done; we need to improve our productivity on this line; etc.

Usually the first request you get is, “We had an atypical human error and we need you to retrain everyone.” The correct response is, “Great. Let me look into it and find out exactly what the issue is so that I train on the right things.” Now you can help them to see that sometimes, what looks like the problem at first pass is not the underlying problem that led to the situation they observed. You’ve succeeded when you can demonstrate that you’ve saved time (and money) by not doing training that doesn’t add value. Eventually their statements will change from, “We need training,” to “Help us with this.”

That’s all there is to it. Three Cs. First, get in compliance. Until you are, little else matters. Second, competence – the right training at the right time for doing the job successfully. Finally, consulting, where you can help with all the human performance improvement opportunities.

Training in the pharmaceutical industry can present some unique challenges, but it also presents a wealth of opportunities. It is a critical part of a critical industry. In today’s world, trainers share in the responsibility of making everything we do as efficient as possible. These three Cs will help you to do that effectively.

About Donna Butchko

Donna is VP of Leadership Systems. She has done training and development within major pharmaceutical firms for over 20 years, most recently at Merck and Hoffmann-LaRoche. She is also a past-president of the GMP Training and Education Association. She can be reached at dbutchko@leadershipsys.com