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

This is the second 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 has been broadly misunderstood. Yet it is possible to operate along Deming’s original management philosophy, as exemplified by Sanofi Pasteur. Let’s keep exploring, through Deming’s points #2 and #3, what the pharma industry could do better.

2. “…management must awaken to the challenge, must learn their responsibilities, and take on leadership for change”

How it’s been misunderstood: Leadership has been reduced to management. The burden of processes and control stifles leaders’ capabilities to lead change. “Change management” is done for the others to change.

What it really means: Replace control by trust. Grow network leadership. Invite leaders to change themselves and operate as co-facilitators for systemic improvement.

Try to think back to 1978. How the world worked technology wise. That’s almost 40 years ago. It was the year where the US GMPs went into effect — and they haven’t changed significantly since while the rest of the world and the workforce certainly have. As leaders our work styles must cater and adapt to every generation, every person in the workplace.

Unfortunately, those who are the last to see the need for change and actually change themselves are senior leaders. There are probably a number of reasons for this.

Machiavelli wrote in ‘The Prince’ almost 500 years ago (1536): “It ought to be remembered that there is nothing more difficult to take in hand, more perilous to conduct, or more uncertain in its success, than to take the lead in the introduction of a new order of things. Because the innovator has for enemies all those who have done well under the old conditions, and lukewarm defenders in those who may do well under the new. This coolness arises partly from fear of the opponents, who have the laws on their side, and partly from the incredulity of men, who do not readily believe in new things until they have had a long experience of them.”

And haven’t we all experienced what Machiavelli writes; organizations change all the time. Many times it seems like senior leaders think that by creating a new governance structure or a new organization problems will be solved. But are we as senior leaders ready to change what really needs to change to make the whole organization and the system improve sustainably? We believe not. When you think about it the real work in a manufacturing company takes place at the shop floor, but all these organizational changes are usually taking place at the top levels only, and not by changing how the top leaders work to improve the system.

Our role as leaders has changed. Leadership focused on being at the top of a hierarchical pyramid is outdated no matter whether or not we are willing to accept it. 21st Century leaders “…have a way of building community and bringing people together to co-create solutions…They don’t talk about how their organization is structured, they focus on bringing their shared purpose to the world through their communities” (Ayelet Baron, author of ‘Our Journey Towards Corporate Sanity’)

In our work at Sanofi Pasteur, we ask ourselves the question “What will I do differently today to save more lives tomorrow?” More often than not, discussions about change start with what others should change. Or people try to make change happen by using the same old recipes (project management… change initiatives… communication campaigns…) — but as Myron Rogers writes: “the process to get to the future is the future you get”. Change is not an externality you add to a task; it is by doing this task differently, that you create change. Replacing control by trust is a big change that impacts how you operate as a leader but also how you see yourself as a leader. It entails giving up what has made you successful until now, taking risks, adopting new habits.

For change to be successful, we need to move away from our employees doing things only because they ‘have to’ and instead provide the conditions to bring change because people individually ‘want to’. Volunteerism is the new way of bringing about change in the work place. This is well described by John Kotter and is a cornerstone in his work with the ‘dual operating system’ (‘Accelerate’). On the one side sits the traditional management structure which is robust and reliable, good at managing ‘complicatedness’, but heavy and slow. On the other side, almost operating like multiple internal startups, volunteer networks and communities of practice bring speed and agility, engagement and adoption. How close these two operating systems work together is critically important to the success of the overall system and — for our work — has been the absolute key part of the culture change. For it to work, every single leader in our organization has had to change habits and really ask themselves: “What will I do differently today to save more people’s life tomorrow?”

3. “Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place”.

How it’s been misunderstood: Release testing of the final product is still the norm

What it really means: Quality by Design everywhere — built-in quality, effective Knowledge Management

This may be one of the 14 points where we as an industry have done best. We have started work on Quality by Design, we validate processes, use LEAN, 6 Sigma, Process Analytical Technology etc. However, we still perform release testing (‘inspection’) of all batches produced. In the vaccine industry, which we work in, additional testing is done by health authorities. This creates huge redundancy of work and creates bottlenecks that slow down or even limit the availability of vaccines. Several authorities and manufacturers have started to brainstorm together about how to evolve towards limiting release testing, or even making it unnecessary, as quality would be built in to the manufacturing processes. This is a very promising path. For this to happen, we must really improve in how we manage knowledge and be able to implement innovative technologies timely, without the need for heavy regulatory oversight.

Knowledge Management is one of the two enablers described in ICH Q10 (Pharmaceutical Quality System, PQS). We all know that it only takes one person’s mistake to cause the rejection of a batch of drug product. Deming talks about the importance of engaging the ENTIRE organization in Quality assurance activities. To do so each employee must feel that they own the processes, which is actually possible to obtain if you are willing to trust the employees to be able to co-create.

As an industry, we are notoriously lagging behind in the pace with which we implement innovative new technologies. One of the reasons is that the regulatory approval processes for any change after the initial product approval is extremely cumbersome and very lengthy (up to 5 years per change) bordering impossible. How would it look like if Apple had to wait for every single country’s approval for changes to the iPhone or a new version — and wait up to 5 years for such approvals? Yes, innovation would be killed. The solution here includes to establish more trust both in the company’s Pharmaceutical Quality System and between countries regulatory agencies so that each actor accepts to depend more on each other’s assessments.

A knowledgeable workforce and an effective Pharmaceutical Quality System are keys to getting closer to Deming’s 3rd Point of Management.

(Stay with us! To be continued in next post)