07-12-2019

Kaizen: The Japanese term commonly used for lean improvement workshops. Its meaning expresses what it’s all about: change for the better.

In life sciences, we tend to associate change with change control, which is usually justified because there are plenty common reasons why you need to be in control of every detail. But most of the time we don’t really change anything significantly at all because it’s ‘complicated’ and we go on like before.  In lean, change implies improving. Measuring and demonstrating success as you move on and leaving your current state behind for a new and improved one. The Kaizen specifically has proven itself in many different situations and in many businesses and has the very beneficial side-benefit that people feel heard, engaged and empowered.

For example, taking a number of people to one of their warehouses to "go see what’s actually going on there". They will probably experience that the people who actually work there are surprised when asked what could be improved. This is exactly the essence of Kaizen: not talking about but with your staff.  

What to improve

So to get started. The first step is identifying the area you want to improve on, or in lean terminology: define the problem. There’s plenty of formal tools to make the best choice like value stream mapping.  For instance, creating a complete map following a biopharmaceutical product including the receipt of materials, upstream and downstream processing, aseptic filling, release, and shipment to a customer. This map could show you that something like the water production is the actual bottleneck you’ve been looking for (and now you can improve it). Or it may be the time you need for batch record review or product release. Conclusions like these are usually the result of a Kaizen and are fully data-driven and, therefore, (most of the time) fully supported by the whole team. You can also brainstorm with a group of people and pick one improvement project. Most of the time people actually already know very well which areas can be improved on. Data-driven conclusions may be different from team-based intuition though, obviously.

Secure a sponsor

The next step is identifying your sponsor. If there is none who wants to support you, stop. Basically, there’s no way of organizing a proper Kaizen without sponsorship. Let’s say the event/deviation handling process in a packaging department needs to be improved and the involved Quality Officer doesn’t have time for the Kaizen.  As a result, he or she isn’t very likely to be engaged and in all probability not the most likely person to agree on the proposed improvements. Therefore, you need a sponsor to make sure that every stakeholder actively participates in the event and facilitate a unanimous agreement.

Prepare prepare prepare

After having made sure there is a sponsor it’s your role as facilitator to actually organize the Kaizen. Preparation is key, so agree with your sponsor on things like the definition of the problem, the scope of the Kaizen, would be considered a successful outcome, who’s on the team and the planning. Once these aspects are all settled, you can proceed with data collection.

Start with a plan and try to balance between the needed data and the effort to collect it. This depends mostly on what you want to improve, or in lean: what is problem? If you want to improve the workplace, like the warehouse, for example, observation is your best friend, in a QA release process data collection is more likely the preferred route and in other cases, you might want to focus on material movement. More generally, it may even be refreshing to actually observe what people are doing on their computer.

The Kaizen

At last, the day of your Kaizen has arrived. Make sure that all stakeholders show up and ask your sponsor for help to assure this. These sessions get cancelled occasionally simply because people don’t show up. At least you could tell yourself you’ve defined your first problem if that’s the case.

Your role as a facilitator is key during the Kaizen and you should try to focus on keeping the process going as planned. DMAIC is a very helpful tool here because you’ve already agreed with your sponsor upon the problem, scope, timelines, team, and Kaizen; thus, you already completed D(efine) and because you collected data, you also completed M(easure).

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The kaizen is all about direct observation:  M(easure) and determine the root causes and complete the A(nalyses).  Flip-overs and post-its are most useful to support the analyze phase, e.g. to map the process and to prepare a fishbone, a cause and effect diagram which helps to identify root causes by visually displaying the many potential causes for a specific problem or effect.

To keep the process on track is one thing, to keep people on track is a completely different ball game:

• People can become frustrated with each other in which case you’ll have to address this to some extent, otherwise people get disengaged.
• Sometimes the subject matter experts seem to know everything about the topic at hand and tend to dominate team discussions. Unfortunately, there is a lot of “I think that”, “I believe that” or boldly “This is how it works” behavior in many companies. And because of this, you will need the data you previously collected to either confirm or reject statements.

Question, question, question and conclude. Make sure that everyone is heard and guide the entire group towards one eventual, consensual conclusion. Other “tools” you definitively need are enthusiasm, energy and humor.

In the traditional approach, all stages are done in five days but it depends very much on the company whether this is necessary or even realistic. You may also choose to end the Kaizen with root causes and solutions identified. In that case, implementation and control become part of business “as usual”.

Evaluation of the Kaizen

Make sure you get tangible and sustainable results. That’s critical. For sure, a properly executed Kaizen boosts team morale, but the hard work starts afterward. And this is all about project management and implementation. The reward, however, is an improved process with tangible results, e.g. errors decreased by 30%, lead time reduced with 40% and yield increased by 10%. And when the team experiences that their daily work has become easier, you can count on it that they won’t be able to wait for the next Kaizen to start.

Tip: If you’d like to experience Lean Six Sigma yourself have a look at our Lean Game of have a look at the Yellow and Green Belt training we provide with the Biotech Training Facility.

Blog by: Marc Stegeman - Certified Black Belt at Xendo