Deming, Finally! — Part 6

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

This is the sixth 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 nine (Part 1, Part 2, Part 3, Part 4, Part 5) have 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 #10 and #11, what the pharma industry could do better.

10. “Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Eliminate work standards (quotas) on the factory floor. Substitute leadership. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership”.

How it’s been misunderstood: Management by objective is stronger than ever. Quality is very much a Red/Green world: red indicators trigger exhortations to turn them to green. Belief that quality culture can be turned into an equation.

What it really means: Move from ‘Have to’ to ‘Want To’ so that quality result from people’s will, not submission. Stop with slogans, exhortations and targets. Understand that humans can never be put into equations.

In our view the human element has been taken out of much of the Operational Excellence activities in the Pharmaceutical industry, and we have left it to experts and management consultants to run our business focused on cost reductions, rather than our leaders leading the work focusing on quality. We seem to believe that operational performance can be achieved through some sort of equation and measured in a few quality metrics. It couldn’t be more wrong. The red/green metrics have become a mere race to get to green without the underlying focus on continually improving the system.

Variation should be reduced for equipment, systems, and processes to ensure consistent output batch after batch. However we can’t apply the same approach to our employees. They are humans, not machines. Instead, variation of individuals should be leveraged to continuously co-create and improve quality. When people are involved in findings solutions and are not feeling ‘standardized’ that is when quality will improve.

Obviously, it would be neat if quality performance was an output of a simple equation, and even if quality culture could be achieved through a few metrics, but we all know that is not the case. FDA’s current thinking on the topic of quality metrics is summarized in a draft guidance for industry document. Our view on metrics is that metrics are good when a company wants to focus on a certain area and only picks a few metrics. This could be to improve timeliness, effectiveness or similar of an element of the PQS (Pharmaceutical Quality System). However, the quality metrics should not be static in which case there seems to be a tendency to focus on everything and nothing at the same time. In our view the metrics focus should be dynamic and based on which specific areas the company would like to improve. Also, continual improvement is more important than actual numbers.

11. “Remove barriers that rob the hourly worker of his right to pride of workmanship”.

How it’s been misunderstood: Shop floor employees are expected to work in a standardized manner, take orders and following procedures like it was common 40 years ago. We assume employees are pure rational minds that just need “information” to do their work (“Head” only).

What it really means: Create space for anyone, at any level in the organization, to bring about ideas and improvement. Write procedures in a modern fashion with diagrams, videos, etc. Celebrate achievements, cultivate motivational dignity. Engage both Head and Heart, to achieve sustainable performance.

Most companies write standard operating procedures like it were common 40 years ago — page after page of details. However, today people want to see flow diagrams, pictures, videos — and help create these procedures. Just think about your own preference — when was the last time you read a manual to solve an issue vs ‘google’ it?

In one of our workshops involving volunteers of all levels, one woman suddenly broke in tears. A long time shop floor employee, she was comforted by the other volunteers and asked about why she’d cried. I have been working here for twenty five years… I have never been asked for my opinion before” she said. How successful can an industry be if shop floor employees are not considered worthy of opinions? How much does it affect these people’s self-image, dignity at work, engagement and motivation? It certainly has a limiting effect on their ability to avoid errors, to respond adequately to the unexpected, to bring about improvements.

People in general come to work to do a good job. They are more effective when they engage both head and heart at work. “Getting people to ‘want to’ requires that you speak to both reason and emotion, and this is what it means to focus on both the head and the heart of the change you are asking for”.

It may sound uncommon to older generations to speak about ‘heart’ at work. But times have changed, and so have expectations of the workforce (and consumers as well). “We’ve gone from an Industrial Economy — where we hired hands — to a Knowledge Economy — where we hired heads — to what is now a Global Human Economy — where we hire hearts” (D. Seidman, Forbes, April 2015)

As stated previously less and less employees work for a company but rather for a purpose and a cause. Try to ask your employees if they feel pride in their work, and see both what they respond and with what level of energy they respond.

Instead of work-life balance, more and more are talking about work-life integration: people now want to be their whole self at work, not fragmented as one at work and another off-work, and don’t want to be just told. As supervisors and managers it is important to work with each individual as a person with unique personality, skills, competences and thoughts. When each person is listened to and feel that they help co-create, that’s where real change takes place in the workplace.

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