During the last century, several come-back stories, each of them triumphs of the underdog making good in the global arena, pivot on the influence of one man, an American engineer. It was this man, W. Edwards Deming who helped Ford catch up with General Motors, and who helped Japanese auto manufacturers rebuild after WWII, by highlighting the value of quality management in conferring business performance and competitive advantage.
If that alone is not enough to convince you of the value of good quality management, then let’s look at how 21st century reality has developed from the foundation laid down by Deming.
- Today, Honda and Toyota, the beneficiaries of Deming’s expertise, now enjoy reputations that focus on quality and reliability, with sustained success over decades.
- The stock market rewards companies which show consistent growth and effective risk management. Boeing, once seen as a bastion of capability and reliability, learned this lesson the very hard way.
- Our shared, painful experience during the COVID 19 pandemic made us all aware of the value of reliability of supply and company agility at times of significant challenge.
Now, in 2025, just a few years after that same COVID 19 pandemic, we are seeing FDA, the government agency that regulates the pharmaceutical industry, greatly diminished in resources and, at least according to some, unable to effectively fulfill the role of enforcing regulations in our industry.
It’s interesting to note that those same regulations represent the minimum acceptable standard for the development and manufacture of pharmaceuticals. For a certain faction of that industry, the reduced fear of FDA enforcement means a latitude to do less than the legal minimum, at least for a while. However, the more enlightened amongst us know where that path leads… to increased manufacturing costs, reduced efficiency, longer batch disposition times and the associated increase in inventory value, and slower times to market for crucial products in development. But, in the short term, the “Cost of Quality” is reduced at the expense of the longer term realization of the “Value of Quality”. We save millions today, and in so doing, avoid making billions in the future.
For me, as a Quality professional, with 34 years in biopharma, I’ve dealt with the occasional challenge of “well, can’t you just do it cheaper?”. But for me, it’s never been about reducing cost. We can only go so far with a strategy of reduction… it self limits at zero dollars. Instead, it’s been about the pursuit of value.
Value to the patients we serve, who rely on available supply of safe effective medicines to keep them healthy (eg. Vaccines) or to help them beat otherwise terminal illness (eg. CAR-T treatment for cancer).
Value to our colleagues, so that they can do their best work, delivering scientific advance to patients quickly.
Value to ourselves and shareholders, to make an honest profit on a well-run business with a noble cause. We make money by realizing the potential of intellectual property. We make money by supplying medicines to those who need it. We make money based on our current and future performance potential in the stock of the company with which we work.
It takes a lot to run a successful pharmaceutical company. Good management is essential, and there are many disciplines of management. We can all understand good financial management. Many of us understand good risk management, good asset management and good human resource management too. Quality management is one more slice of that pie, with each slice being essential but not, on its own sufficient for success.
In today’s world of uncertain regulation, reduced FDA inspection schedules and diminished regulatory capacity, the worst thing we could do would be to chase the reduction of the “Cost of Quality”. It’s a fake pursuit, and our future selves always end up paying for it. Instead, we should pursue quality as Deming intended it, as a way of working, culture, processes and expertise, that confers advantage. Advantage in time to market, advantage in cost of goods, advantage in supply performance and ultimately advantage in company value.
While the regulatory landscape is uncertain, the demands of value generation have remained stoically and stubbornly constant. At QxP we have the benefit of access to literally centuries of experience in the pursuit of this value in our industry. We thought it would be interesting to ask our most experienced consultants about a time when they were faced with a Quality problem, and about what they did (or should have done) to solve it, to return to the path of generation of value. With a variety of backgrounds, disciplines and personal histories, they all have one thing in common… the belief that a focus on the Value of Quality to patients, colleagues and shareholders, is the path to sustained success.
Over the coming weeks, we’ll share their stories — some familiar, some outlandish, and some that may just make your blood boil — each offering powerful lessons on why a focus on quality remains the surest path to success.
Editor’s note: We’ll be adding new consultant stories here over the coming weeks — check back for updates!
Mark Roache, QxP VP of Cell and Gene Therapies, has spent his 30-plus year career in GXP. Mark was the Chief Quality Officer for AveXis (now Novartis Gene Therapies) at the time of Zolgensma launch. He was previously Senior VP of Quality for KBI (a CDMO with cell-therapy capabilities) and has held other senior Quality roles at Novartis, Merck and Bayer.
