Deming, Finally! — Part 8

Pharma Industry Has Misunderstood Deming for 30 Years but Can Catch Up

This is the last of an eight-post series, by Anders Vinther, Sanofi Pasteur Chief Quality Officer and Celine Schillinger, Sanofi Pasteur Head of Quality Innovation & Engagement.

Part 1 introduced why we believe Edwards Deming’s thinking has been only partially implemented by the pharmaceutical industry. By focusing on processes, control and exhortations, manufacturers have missed the essence of Deming’s message. Deming advised us to actually put the Human at the center of quality and to focus on how the system works. Out of Deming’s “14 points of management”, the first thirteen (Part 1, Part 2, Part 3, Part 4, Part 5, Part 6, Part 7) have been broadly misunderstood. Yet it is possible to operate along Deming’s original management philosophy, as exemplified by Sanofi Pasteur. Let’s wrap up our exploration, through Deming’s point #14 and conclude about what the pharma industry could do better.

14. “Put everybody in the company to work to accomplish the transformation. The transformation is everybody’s job”.

How it’s been misunderstood: Change is still seen as the top leaders’ job, helped by consultants, change management experts, or a few internal “change agents”

What it really means: Everyone can be a leader and own transformation — not just a change in how people feel at work, but how the system works. People own what they help create

We are back to the very first Point, the importance of a common purpose. In Deming’s later work he talks about the appreciation of the system itself. We call it the living quality ecosystem. An ecosystem because it is not static but dynamic, it has several ‘stakeholders’ and you can’t optimize the system by optimizing it just for one stakeholder. At the same time we want to reduce variation of processes and leverage the difference between our employees. At the end of the day, pharmaceutical drugs are made by humans.

When people feel a shared purpose it is easier through corporate activism to mobilize everyone to accomplish the transformation. You can’t demand people to own the transformation (‘have to’); it must happen through volunteerism (‘want to’) in order for the transformation of culture to be sustainable. We have started our culture change (the system) with a movement centered around what we call our Big Opportunity (our aim) based on the work of John Kotter combined with social media, Myron Rogers Maxims and things we have picked up elsewhere and which have proven to work for us.

Deming said that the “definition of Quality Assurance evolves to include “How the ENTIRE” organization is managed”. He also said that “Quality starts in the Board room”. The leadership’s role includes building competencies of the workforce and empowering employees throughout the organization to share ownership in the purpose/identity.


Although Deming’s 14 Points of Management have been around for more than 25 years, as an industry we still can learn from his wisdom — and in particular when we combine the 14 Points with his System of Profound Knowledge. The pharmaceutical industry has implemented many of Deming’s ideas, however focusing on the technical quality side of his teaching. It is time to put the human beings in the center. It is time to implement the ‘full Deming’ and not only the 20 % related to technical quality. Deming explained this when he said that “A change in philosophy requires unlearning industrial thinking evident in departmentalization, scarcity of knowledge and information competitiveness”.

At the 2017 PDA FDA Conference on Quality Metrics David Churchward, MHRA, spoke about quality culture and discussed an incident causing 5 people to die due to contaminated infusion fluids at a hospital in England in 1972. In the report published to the Parliament after the incident in the conclusion it was stated that “The committee heard of no imminent technological advance in the field of production of intravenous fluids which eliminate the need for skillful men devoted to their work”. This is still valid. (The report also spoke about the importance of adequate skills/competencies of employees.)

We started a change that was needed to improve quality performance in our company and have shown results that were previously not achieved. We chose to work differently together and to invest massively in education. We were encouraged and helped by several great people sharing their experience. In the midst of all this work we re-read Deming’s 14 points of management and the System of Profound Knowledge. What was striking to us is how we feel that the pharmaceutical industry has only implemented a limited part of Deming’s message by focusing on processes, control and exhortations. When you put the Human at the center and focus on how the system works, reading Deming takes on a much bigger and important meaning. We have shared that in this series of posts and hope that you will start the necessary discussions in your workplace to engage every employee, improve your system, and ultimately improve public health by ensuring a sustainable supply of high quality medicines.

In short our learnings are that:

· People engage around a common purpose and identity; not around an organizational or company setup
· Real culture change starts with leaders changing the way they work moving from control to trust of people; facilitating relationship building, sharing of information, and leveraging volunteering — where people contribute because they want to (not because they have to). And of course by setting the strategic direction for the company
· Sustainable quality performance is only achievable if you engage the entire organization (every employee) to co-create solutions
· The currency of motivation for employees is rarely company financial performance, but more in how each one contributes to a bigger objective like improving public health
· Continual improvement can come from everyone at all levels, all positions — as leaders we must foster an environment of idea sharing
· Traditional learning methods have limited effectiveness, the importance of knowing the ‘why’ of what your job function requires cannot be underestimated; spending time coaching on the shopfloor is how people often learn the best way
· Human errors are learning experiences — treat them that way and reward effort and not only results
· Creating social media networks for informal information sharing and relationship building is needed to accelerate connection between people
· Humans are not machines; when we leverage differences between people to enhance creativity and agility the business results improve
· Engage people’s head and heart
· Rank ordering of people doesn’t achieve engagement and performance improvements in the longer run

Many thanks to Kelly Allan and John Kotter for their thoughtful advice on writing this article.