Some time ago I was lucky enough to be invited to tour the Mercedes AMG Petronas Formula One (F1) team headquarters in Brackley, Northamptonshire, UK – just a stone’s throw from the legendary Silverstone motor racing circuit – and to watch the Monaco Grand Prix from their viewing suite, complete with live timing and technical data telemetry.

I remember reflecting upon the steps an F1 team takes to manage quality, and the parallels with our own industry.

During the tour I was able to see many of the areas involved in the development, manufacture and testing of a modern F1 car. I was struck by just how many resources were dedicated to quality. For example, whatever could be manufactured in-house was done so in order to maximise process control. Any manufacture or process that was subcontracted had to comply with a stringent set of requirements.

Inspection of each and every newly-made component took place at microscopic level to ensure any defects were identified before the component went into the race cars. The entire track-side team was replicated back at the factory in Brockley to ensure any activities that needed to be completed could be undertaken rapidly, and replacement components shipped to the track as quickly as possible – if necessary, in the hand luggage of a team member – and that analysis of every possible permutation of race outcome was conducted.

As the 2019 F1 season gets underway I am reminded of that visit and what our industry might be able to learn from F1’s winners (and losers). I was put very firmly in mind of the ‘triple constraint’ of time/cost/quality. No expense was spared by Mercedes to address the time and quality constraints, with the objective of winning or (in this case) retaining a championship.

This was deeply impressive, even in an industry where hundreds of thousands of pounds are spent shaving a tenth of a second off a lap time because of the impact on team and driver standings, prize money and sponsorship.

What impressed me even more when I visited Mercedes was that, when Lewis Hamilton went on to win the race after a bungled Red Bull pit stop, every member of the team congratulated each heartily, whatever their role and however small it had been – giving life to that oft-used and abused phrase “quality is everyone’s responsibility”.

It still surprises me, given the vast amounts of money it takes to develop a new medicinal product (actually not that dissimilar to running an F1 team), that our own industry does not take a similarly dedicated approach to resourcing quality. To paraphrase Bill Shankly, “it’s not a matter of life and death, its much more serious than that”.

If you would like to discuss how ADAMAS can help in your quest for quality please contact us.

Matt Barthel

Head, Computer Systems Compliance & Data Protection Officer
ADAMAS Consulting Ltd
Matt.Barthel@adamasconsulting.com

The ADAMAS Corporate Brochure 2016

 

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

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ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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