Supplement the Swag
Boston is one of my favorite places on the East Coast. Something about the energy of the city inspires me. Maybe it’s the students packed into the bars and cafés solving the world’s challenges over bubble tea? Or maybe the Irish legacy of true hospitality through human connection? Maybe it’s a confluence of root causes. Either way, it’s cool, and a place to live in the moment.
At the Bruins vs. Kraken game last night, I struck up a conversation with the folks sitting to my left, a father and son, and once learning I was visiting from Texas, couldn’t help but make me feel right at home. Explaining the history of the team, and making sure my beverage holder was never empty. This place is simply inspiring and stimulates creativity in any visitor. As I boarded the plane back to Austin, I started searching the audiobook library for something to cap off my work week, and came across David Brooks’ latest work: “How to Know a Person: The Art of Seeing Others Deeply and Being Deeply Seen”. In the first chapter, David discusses his emotional awakening, and references several studies and publications along the way. One caught my attention, which I had briefly reviewed a year or two ago: the 2021 McKinsey study titled “‘Great Attrition’ or ‘Great Attraction’? The choice is yours”. I couldn’t help but make the connection to what the regulators are trying to inspire in both the Data Governance and Quality Management Maturity (QMM) initiatives. As I fly somewhere over western Virginia, here are my thoughts:
According to the study, “forty percent of the employees in our survey said they are at least somewhat likely to quit in the next three to six months.” Many of these responded that they would leave even without another job in hand… This suggests a significant trend in the post-pandemic working environment. Chatting with folks across the world in workshops and conferences (disclaimer: very limited sample size), I also notice a common thread that aligns with the McKinsey conclusions: a human search for purpose and meaning in labor. I feel an energy in the air when a team develops and presents a strategy for managing a hybrid system using a risk-based governance approach. Why? Because we have ditched the concepts of “inspection readiness” and “compliance”, and have rather unleashed critical thinking and focused on why we do what we do; we facilitated ownership.
You can feel ownership within five minutes of a facility walkthrough: folks are excited to present their strategy for managing their workflows. They are nowhere near perfect, but that was never an option anyway, and they understand that. They present a workflow that contributes to improving a patient’s quality of life, or perhaps even saving a life. Compliance and inspection readiness (old-school buzz words) create an environment of fear and uncertainty, because they command perfection. But we and our systems are all flawed, it is one of the universal realities. Remember the second law of thermodynamics from high school chemistry?: disorder only increases (or at least stays the same) with time!
FDA has spent over a decade researching the concept of Quality, and has had a few false starts (remember “Quality Metrics”?) along the way. In the latest attempt, we see the introduction of the five elements of Maturity. One of which is titled “employee engagement and empowerment”. I think we are now close to getting it right. Just read the mood in the room full of employees and you will understand why. I am sure many industry executives find this ridiculous [QMM], and have most certainly submitted comments against its implementation, as they cannot envision the connection between “empowerment” and “compliance”. This rejection [by management] aligns with the McKinsey study, as managers surveyed responded that the causes for employee departure were primarily transactional (e.g., search for better salary). Shocker: they were not.
FDA is first and foremost an agency acting to “protect and promote public health”. Drugs are manufactured and tested by employees, and our workflows are highly manual (and therefore variable). It is these employees that directly impact patient safety (not the C-Suite). Someone has to stand up for employees and (unfortunately) force management to take quality culture seriously, as it appears many sites remain siloed and disconnected. The “Quality Culture” mugs are cool (don’t get rid of them), just complement the swag with action.
Considering the current challenges to public health: drug shortages, severe departures from regulatory expectations, and continued globalization and supply chain complexity: the agency basically has two options to address the common root cause of poor manufacturing and quality practices (see recent FDA Warning Letters and 2019 Drug Shortage Whitepaper for any doubts). These two options are:
· Revise and enhance the GMP regulation (210/211)
· Revise and enhance regulatory guidance (the “C” in CGMP)
The latter is the obvious first choice, as it is exponentially more agile and allows for flexibility, considering the diversity of drug and biologic products. If this doesn’t work, however, the GMP regulation must be next. The ICH Q’s, DI/DG Guidance, QMM, and the Drug Shortage Whitepaper highlight the key enablers to achieve “employee engagement and empowerment”: here they are:
· Data Governance: workflow (vs. system) validation to achieve a “right environment” and meaning in labor
· Knowledge Management: building a library of knowledge to facilitate problem solving and stimulate innovation
· Risk Management: focusing limited employee resources on areas of greatest risk and reducing wasted efforts
An investment in people via the three enablers, in my opinion, addresses the faults found in the McKinsey study. Invest in compliance and you will see short-term benefits (e.g., GMP certification), but you will struggle to remain relevant in the future. Invest in people and you will reap benefits for generations and leave a legacy of good in this world.
Pete
