6 essentials to introduce Lean Six Sigma in Life Sciences

#6 essentials to introduce Lean Six Sigma in Life Sciences

6 essentials to introduce Lean Six Sigma in Life Sciences

We have come a long way in lean manufacturing since its introduction by Toyota and we apply it in most industries today. We take into account many relevant factors, such as costs, efficiency, supply reliability, quality, and compliance, and we define, measure, analyse, improve and control them. Our field, the Life Sciences, is as diverse as it is well-regulated, meaning it is most certainly a challenge to comply with ever-changing regulations and guidelines (which may or may not contribute to patient safety, quality and/or efficacy). But though it may be challenging, there are most certainly gains to be made here.

To assist in the first steps of setting up lean manufacturing processes we have some best practices lines up for you to try out in your organisation:

1. Engagement

Make sure that everyone, from CEO to supervisor is engaged. It is like an upside down pyramid where the top enables improvement at the bottom. First of all, demonstrate your commitment. You know about biotech, pharma. Learn about Lean Six Sigma and combine these. It’s not only about the processes, metrics, and the production system, but most of all it’s about mindset and behaviour. We are all very much aware of GMP and compliance in life science. Combine with Lean 6 sigma and integrate. Try to implement it in your daily routines. Do regular walk-throughs in the areas where it all happens. The real improvement doesn’t happen in the manager’s office or a meeting room. Ask questions and listen. Be present at opening and close-outs of improvement workshops (kaizens) and be present at daily stand-up (tier) meetings. In other words, people in the work place have the most extensive knowledge about ongoing processes and experience with daily activities. Don’t come up with solutions by yourself, but make it work with them.

2. Sponsorship

Lack of sponsorship is the most likely reason for failure, so just a few more words on promoting taking responsibilities, the right mindset and behaviour. In the old hierarchical way of doing things the boss knows best and tells you what to do and how to do it. In the inclusive approach, you should ask questions such as ‘What is the problem? Where is the problem? Are you able to solve it? Do you need others? How much time do you need? How can I help you?’ The role of the sponsor is to ask these questions all the time and to make sure they get answered. If we’ve learned anything from programs on badly run restaurants, it’s that 9 out of 10 times the manager (sponsor) is the root cause of the problem. Again, ask integrative questions, e/g what does the change imply for GxP? Have we considered the regulatory impact?

3. Stabilize first

Deviations are symptoms of processes not running smoothly. However, in life sciences, we have made compliant procedures for handling deviations. Make sure to get rid of deviations by searching for and solving true root causes, not just fight the symptoms. A practical approach is a kaizen, a workshop of a couple of days to define the problem exactly, to look for true root causes and solve these. When done properly, they give a lot of positive energy and, of course, annihilate deviation recurrence. The concept is not new, however. Therefore, green and black belts should have the proper background to prepare and facilitate kaizens. In my view, those belts should also have an understanding of life science and the processes at hand. It is the way to connect with people and to gain support for improvement. Again, sponsorship is essential to make a team available and continued support for implementing and sustaining solutions.

4. Activate

Introduce visual management and short (15 min) daily stand-up meetings – and become actionable. In many meetings, we talk about things. You will be amazed that just standing in a meeting rather than sitting will make the mood more actionable. It also allows you to escalate any issues within a day to senior management. Applying visual management enables you to make problems more apparent and once visible you can start solving them. It usually starts with a shift transition at production (tier 1): Are we meeting our production schedule? Are we experiencing any issues with people, safety, quality, delivery, and/or costs? What do the facts and figures show us? Ok or not ok? Can we solve all issues or do we need to escalate? At the next level (tier 2), the supervisor discusses the more substantial problems with the production manager, QA, logistics and others who might be involved. Also, metrics at a higher level are shown. Finally, the production manager meets with the management team at tier 3 for escalation of major issues. And this is all done within one day. And once again, it is the integrated approach that works, not Lean Six Sigma for the sake of saving costs. Lean processes are also more GMP compliant, safer, and yield better quality at lower costs. On top of that, people working in these improved environments are generally experiencing less stress and more satisfaction in their work.

5. Shift the paradigm

Introduce a system where everybody in the organisation focuses on solving problems definitively, not just fire-fighting, tweaking, and fixing. Not just the green and black belts for solving the major issues, but for everybody, at yellow belt level, is continuous improvement part of the DNA and their daily job. Solving many small problems can also add up to a large sum. Again, it is the mindset. In one example, 30,000 A4 paper was saved every year, just by asking the question: Do we need to print all this? And not just: we need to do this to be GMP compliant. In lean companies, everybody is trained as a yellow belt. This the entry level of belt training. And it is also their daily work to improve small things. Link this improvement process with the stand-up meetings to ensure follow-up and to measure success.

6. Continue improving

Always, all the time, everywhere, everybody. And sponsor!

In the next blog, we will show examples of effective deviation reduction, while maintaining GMP.

If you want to learn more about applying Lean Six Sigma principles in the Life Sciences, please contact Xendo or take a look at the courses we provide together with the Biotech Training Facility (Yellow Belt & Green Belt).

Blog by: Marc Stegeman - Principal Consultant & Black Belt 


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