Formula Won or Formula None?
Formula Won or Formula None?
This weekend Suzuka, Japan will host the next round in the Formula One calendar. I am a Formula One nut, religiously following my favourite drivers as they push technology and bodily endurance to the maximum. F1 as a sport has always been an early adopter of technology, leveraging the power of data analytics and root cause analysis for decades. Racing teams employ hundreds of scientists, engineers, and mathematicians (to name just a few disciplines), working together to find those extra thousandths of a second that can help secure that coveted pole position. To win the Team Championship, all members of the team (drivers, mechanics, scientists, management) must be fully aligned with respect to car design, racing strategy, and team culture. Formula One may crown an individual World Champion, but the true success of the organization will always be measured by the overall success of the Team.
When I founded The Quality Consortium one of my key goals was to show that a well-designed Quality Management System (QMS) should maximize operational efficiency. A well-designed QMS, however, will never generate this desired efficiency unless it can be implemented across the organization with the same level of understanding and risk management. It must be fully operable regardless of the compliance challenge.
It was with this mindset that I have been intrigued with the recent challenges experienced by the Red Bull Racing team. Red Bull, and their leading driver Max Verstappen, have been dominant for several years, with Verstappen crowned World Champion for the last four years. The recent models of the Red Bull car have also been streets ahead of its rivals. Full transparency, I am not a huge fan of Red Bull or Verstappen, but even I must admire their ability and give full credit to their achievements.
Over the last year or so, however, things have not gone at all perfect for the Red Bull team. Although Verstappen successfully defended his title as World Champion, the 2024 campaign was far from dominant for Red Bull and the McLaren team ended up winning the Team Championship. McLaren’s success was only possible because of the significant drop off in the performance of Verstappen’s teammate Sergio Perez. After finishing runner up to Verstappen in 2023, Perez finished eighth, with the second half of the season characterized by slow times and handling errors. Perez is an accomplished driver, yet most were quick to attribute this poor performance to driver error. Perez was dropped in favour of Liam Lawson for the 2025 season. Although a rookie, Lawson was highly acclaimed and a superstar in the making. Lawson lasted two races before being demoted to the Racing Bulls team in favour of Yuki Tsunoda, another experienced F1 driver eager to show his ability. Lawson, like Perez before him, had issues with the Red Bull car’s drivability, recording slower times and finding it hard at times to stay on the circuit. These same driveability issues were echoed by Tsunoda during practice and qualification at Suzuka.
So, what is going on? One driver, admittedly the best in the world, can achieve success with the Red Bull car, but three very accomplished drivers can not, and its not even a close thing. Why such a variation in performance when the cars they drive are identical? Verstappen is an aggressive driver, with a driving style that pushes his car and team to the limit. It would be natural for focus their car design and set up in a manner that would give Verstappen, their lead driver, the best chance at winning – but at the sacrifice? Overall team performance? Have they created a car that only Verstappen can drive?
Aerodynamics are for people who can’t build engines.
Enzo Ferrari
Great analysis, I hear you say, but what does this have to do with pharmaceutical quality? The same philosophy that drives the success of a high performing F1 team should also form the foundation of every Quality Management System (QMS) used within Pharma. The pharma team that utilizes the QMS must be united in their approach to quality philosophy and risk management, and everybody, not just the Quality Unit, must be able to operate it and in doing so ensure compliance and drive efficiency. It is only the combined success of Operations and Quality that together will truly generate a compliant organization. After all a QMS that only the Quality Unit can operate may get you though a few audits, but ultimately at what cost to the patient.
In Formula One a high functioning Team functioning as a single unit can be the difference between pole position and another disappointing Sunday. In Pharma, a high functioning team functioning as a single unit can be the difference between product release and product recall.