Improve your GxP Compliance with these 6 Mindset Shifts

by TLM


How to Infuse GxP Into Your Organization’s DNA

by Troy Fugate, Vice-President

Is it true that people have a natural resistance to change? If you have ever tried to change the mindset (or culture) of a company in trouble with the FDA, you might say yes – even though people all agree that change is needed.

Dig a little deeper and you might discover that resistance to change is one of two things. One, that people have a natural resistance to feeling incompetent. Two, that people are stuck in a habit that was ingrained into their “DNA” for years. Either way,

  1. Humiliation is a deep fear we all possess; we don’t want to feel or look incompetent and change has the potential to activate that feeling.
  2. Habit is second nature – like breathing; we do it without even thinking. If you have ever driven to the office and thought “Wow – I don’t even recall the drive here”, then you are just going to the office by natural habit.

But what if we conditioned ourselves or others to feel comfortable about pushing our personal boundaries? What if our fear of feeling incompetent was less than our desire to learn something new? What if we really wanted to change our habit? To change our DNA?

We humans have the potential to change. If a goose wanted to fly west for the winter, it couldn’t do it. Why? It is programmed into the DNA of the animal!

This change won’t happen naturally. It has to be “infused” into your DNA. And it has to be maintained on a regular basis. If not, we will slowly drift into losing our curiosity, and with that, our drive. Inquisitiveness atrophies over time. Our natural bent toward laziness is exacerbated by inactivity. Contentment is a great virtue, but its shadow side is apathy. It’s natural to grow accustomed to our surroundings, but as John F. Kennedy once said, “The time to repair the roof is when the sun is shining.” The time to “repair any GxP inefficiency or deficiency is when all seems to be going well.”

Learn to value change, questions and people shaking their heads. That’s where our greatest growth takes place. It’s in the discomfort zone where we grow and learn. Here’s the truth: Discomfort doesn’t lead to breakdown. It leads to breakthrough. By avoiding discomfort, we can survive. Stepping into it is how we thrive.

How do you infuse GxP into your DNA? Start by developing these six habitudes (habits + attitudes):

Question the GxP status quo.

By doing this, you will be facilitating the skill of critical unlearning. What do we need to stop doing? What do we need to start doing? What do we need to leave behind? What do we need to forget? What do we need to ignore? This is important if we want to grow and go forward.

Challenge your assumptions.

Just because that’s how we’ve always done it doesn’t mean that we should keep doing it the same way. This can lead to the bias of experience, that the way we’ve done it is still the right way to do it.

  1. If you want to go somewhere new, you have to act/think somehow new.
  2. Go below the surface and discover the belief that is driving that behavior. What is the belief behind the habit or process we were taught? Even if the belief is right, does it have a different application today? If it’s valid, our commitment will go even deeper. If it’s not, we might need to do some innovating.

Try something new.

  1. This often leads to something better. Occasionally it comes through association with others. What seemed like an impediment to progress became a breakthrough in efficiency. Sometimes it’s as simple as trying an unfamiliar approach. Experiment, test, expose.

Repurpose something old.

  1. Sometimes the pearl gets lost in the process. The principle is good, but the delivery system is outdated. Don’t miss the reliable because it’s cluttered and camouflaged with irrelevance. This is more than recycling. It’s also about ideas, attitudes, emotional intelligence, money, simplicity and wisdom.

Connect with the bigger picture.

  1. Synthesizing your life illuminates your path. Learning and growing is about capacity and skill. But it’s also about connecting the dots. That is hard to do without knowing the bigger purpose of who we are and where you want to take the department, the site or the company. This takes learning to a whole new level. You are no longer just a teacher. You are on your way to becoming an MVP Worker.

Trust what you know.

Trusting what you know gives you the courage to try new things. Here’s what I know:

  • The sun will come up tomorrow.
  • What I am going through right now will pass.
  • With one exception (you), the world is composed of other people.
  • People make mistakes.
  • You get out of life what you put in it.
  • What you focus on becomes your reality whether it’s true or not.
  • Bitterness is a downward spiral.
  • The only difference between a rut and a grave is the depth.

Developing ourselves includes developing our minds. This does not happen without seeking a guide for some …well… guidance.

Let me provide some complimentary guidance. Here’s some simple tips on setting goals to be in compliance.


  1. The list should be SMART (Specific, Measurable, Attainable, Relevant, Timed)
  2. Plan to do some work
  3. Have a management system for the changes
  4. Have reinforcements

For an in-depth discussion of infusing GxP’s into your organization’s DNA, we can provide a customized 2-hour briefing. For more details, email me a request for information on the Three Sins of GMP Work Systems. You can reach me at