Deming, Finally! — Part 1

The pharma industry can — and must — improve the way it does quality. How? By implementing fully what Edwards Deming said more than 30 years ago.

Photo credit The Deming Institute

Thirty years ago, W. Edwards Deming was recognized by the National Medal of Technology & Innovation by the President of the Unites States, marking the official recognition in America of his ground-breaking work initiated decades earlier in Japan. Today, everyone in the manufacturing quality world has read, heard, spoken about Deming. His vision for quality and “14 points of management” as well as the “System of Profound Knowledge” in particular are inescapable reference points.

However, Pharma may have got this all wrong for the last 30 years. 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. This is what Sanofi Pasteur has been doing systematically for the last two years, through corporate activism and a very structured approach to culture (mutual trust, empowerment), competencies (knowledge), and compliance. An in-house global social movement for change and quality, and a resolute investment in education have allowed the company to achieve unprecedented quality gains — out paying the investment by far. In the light of this experience, the authors* review Deming’s 14 points and highlight what the pharmaceutical industry has missed until today.

The father of modern quality” is what many say about W Edwards Deming. His thoughts and theory have been taken into use worldwide. He has brought a lot of structure to how we see quality, do our work and reduce variation in manufacturing operations. But it seems that there is one side of Deming’s work that at least the pharmaceutical industry has not fully tapped into: the human element — or the ‘psychology of change’ as Deming calls it in his book ‘The New Economics’. In particular, we may have overlooked the role of leadership.

Pharmaceutical companies have a tendency to go through cycles of ‘good’ and ‘bad’ Good Manufacturing Practice (GMP) compliance. Going bad can lead to Warning Letters or even adversely affect patients. The inflection point often comes with a change of leadership philosophy. Currently, as a pharmaceutical industry we talk about the link between quality metrics, quality culture, and quality performance as exemplified with FDA’s draft guidance on quality metrics. However, in all of this the human element and the role of leadership seem to have been almost forgotten. Or maybe more correctly — we talk about it, but in action as senior leaders we are often the last to see the need for change, including our own change needed. We most often talk about what others (‘they’) should change.

Almost three decades ago, Deming described the role of leadership to achieve sustainable quality performance in his ‘System of Profound Knowledge’ (in his book ‘The New Economics’, 1992), which follows the seminal ’14 points of management’ (described in ‘Out of the Crisis’, 1986). Our assumption is that most who read this post have already read these theories and believe they have implemented much of the teachings.

However, after having started a real cultural change with tangible results built on corporate activism, John Kotter’s 8 accelerators, Myron Rogers’ Maxims, significant investments in education using modern learning techniques, and our own experience we went back to Deming’ teachings and read them from a new angle — with the human element in focus. What intrigued — and excited — us is that we found a massive potential for ways in which the pharmaceutical industry could further improve how we work and perform. We may implement a fraction only of what Deming advised us to do a quarter of a century ago.

This series of posts is about how Deming’s 14 points, and his System of Profound Knowledge, can help achieve a sustainable quality performance, and change the culture of your company — provided you apply his teachings fully. We invite you to join us on our journey and learnings. In each post, we will first state each of Deming’s 14 points, then our interpretation and experience. Everything we write in these posts are our own views and interpretation of Deming’s theories.

1. “Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs”

How it’s been misunderstood: ‘purpose’ has morphed into soulless, top-down ‘mission/vision’ statements

What it really means: engage employees to co-create a purpose that connects everyone in the organization to the identity and true mission of the company

In the 21st Century, the company you work for is becoming less important than the cause it serves. On a continuum from ‘company most important’ to ’cause most important’ often the older generation (those who also in general have the senior most positions) are the ones weighing ‘company’ over ‘cause’, while the opposite is true for the younger generation entering the job market. Purpose in the job is becoming more and more important for employees. Increasingly, employees want to find meaning in what the company does, connect with its purpose. Dan Pontefract describes this in his book ‘The Purpose Effect’, John Kotter speaks about the need for establishing a ‘Big Opportunity’ (as the basis for need for change) in several of his books including ‘Accelerate’, and Myron Rogers talks about the importance of moving from ‘role to whole’ — each employee identifying themselves to more than their own role, to a larger community of action and purpose.

Many companies believe they address this need for purpose by rolling out corporate mission and vision statements — often shaped by communications professionals and elaborated behind the boardroom doors — cascaded out in the organization with very little impact on behaviors, and thus even less on quality. Interchangeable, soulless, the corporate mission & vision statements are far from the shared purpose (“the aim”) that Deming had in mind.

In our work, we have seen that without purpose you can’t engage people individually or collectively over the longer run. A purpose can’t be rolled out to people. And your purpose might be somewhat different from other employee’s purpose. In October 2014, we gathered about forty people from different sites and various levels in the organization, to co-create our purpose, our Big Opportunity. Many wondered why we spent time on this, since the company already had a “mission and vision” statement — and a great one. It is because when you find ways to develop collectively a shared purpose that people connect to individually, the possibilities are endless and the company becomes much more competitive through the results created at all levels. Our success is very much linked to the significant time we spent on co-creating a shared purpose, and on letting conversations happen around it. Peer-to-peer conversations made people relate authentically to it, and helped build energy for change. Spending time on purpose before focusing on issues and solutions is time well spent. Without including the employees in the process, your mission and vision remains a sequence of words on glossy paper and plaques stuck on walls in the C-suite.

(To be continued in next post)

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