At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, Procter & Gamble Quality Leader and Leadership Coach Steve Greer provided a compelling, true story about a scuba diving incident and used the lessons learned as an analogy for how to ensure that pharma quality systems function properly. His full remarks follow.

I want to tell you a story about a diver who has performed lots of dives. We know it is the people who have the most experience that never gets in trouble. This diver had hundreds of dives. In fact, this diver is also a photographer who enjoys taking pictures underwater. And sometimes those pictures require you to get within three feet of the object that you are trying to take pictures of. This was one of those cases.

This is a picture the diver took that would not win any awards (Figure 1). The diver went on a shipwreck dive. In this case, the ship was at the bottom of the ocean, very deep. And for those of you who have gone diving before, you know when you go deep, it reduces the amount of time that you can spend enjoying the wreck.

Figure 1 Photograph of Shipwreck Taken by Diver

Always Pay Attention to Quality Metrics

The diver at this wreck was really enjoying the opportunity to shoot pictures of the propeller of the boat because it was just the right angle. The sunlight was coming in exactly right. But he was diving with buddies that he had never dove with before. You always have a buddy when you dive. I think there is a lot of wisdom in life to having a buddy, because you can look out for each other.

These buddies did not really look out for this diver. They realized that the time was growing short, that their air was growing short, and so they took off while this diver continued to take photographs of the propeller of the boat. Unfortunately, this diver was not paying attention to his quality metrics because he had a diving computer that told him how much time he had been down, how much air he had left, and importantly, how much time he had before he was going to get into trouble.

When our bodies are underwater and under pressure breathing gas, they absorb the nitrogen into their tissues. And if a person comes up too quickly without off-gassing that nitrogen, it can create big problems like the bends and other things that can lead to serious injury or even death.

This diver was unfortunately enjoying the photography to the point that he was not paying attention to all his quality metrics about the dive. Does anybody relate to the fact that in your operation you may miss paying attention to a critical quality metric? Has that ever happened to you? And then suddenly you find yourself in trouble.

Stranded in the Ocean

The other thing that happened on this dive was that the diver failed to notice the conditions around him were starting to change. The visibility was starting to drop. And the current was starting to pick up. When he finally paid attention to his quality metrics and realized that he needed to come up, there was no longer time to swim over to the anchor line and safely come up the line to get to the boat.

He had to come up in the middle of the ocean. And he had to get to a point where he could wait. We call it a safety stop. He had to stop at 15 or 20 feet and allow the nitrogen to come off his body. Unfortunately, as he started to come up to the surface, he lost sight of the boat. And the current that was running was getting stronger and stronger. As he continued to experience this dive, he started to wonder what it was going to turn out like.

Does anybody relate to the fact that in your operation you may miss paying attention to a critical quality metric?

The folks on the ship were looking for the diver. Visually, the diver was nowhere in sight. And when he got to the surface, the boat was an exceedingly small boat on the horizon. The photograph I showed could very easily have been the last photograph that diver ever took.

You have probably figured out that I was the diver. I was able to swim back to the boat before they picked up anchor and called the Coast Guard. But it came awfully close. And it taught me some valuable lessons.

What This Teaches Us About Quality Metrics

These are lessons that we can apply as we think about quality metrics and the performance of our organizations. I will try to summarize those in just a few questions for us to consider (Figure 2).

Figure 2 Questions for Consideration

First, are you staffed for success and is your team on board for quality excellence? Not just for compliance or doing the basics, but clearly on board for the excellence our patients deserve?

Secondly, how solid is your organization’s mastery? One of the leading causes of diving accidents is divers going beyond their abilities. This can happen in caves very easily where people want to explore a cave, but they were not trained to go into a cave and they never make it out. Or they have been trained, just like I was trained, and they fail to pay attention to the critical information around them. Is your organization ready for the stress and pressure that your business is placing on it?

How well do your quality systems handle changes in weather and changes in conditions? Are they robust? Can they handle changes like a new product that needs to be launched as quickly as possible or the change that just got approved by 50 countries around the world and now you are under a tight timeline to get that implemented?

How well does your dashboard keep your team focused on the things that are critical for a safe “dive?” We mentioned some things that are critical in terms of quality metrics. I would guess that many of our metrics are very much backward-looking. They tell us what happened in the past. They do not really allow us to look forward to the future. If we are always looking backward, is that a safe way to drive a car? No.

How about our quality metrics? Do we have the metrics that help us move forward and make sure we are navigating safely?

How well do you know the external environment? Does your company invest money in conferences like this where you can really hear what is changing?

And finally, are you monitoring those changes and adjusting your approach so that you can dive safely, and make it back to the boat?

I hope these will challenge all of us into not just thinking about quality metrics as something FDA is forcing on us, but something that can really help us drive our business and get back to the boat.

[Editor’s Note: Read Parts I and II from Steve Greer’s presentation on quality metrics.]