Within Good Manufacturing Practice (GMP), we both love and hate them. On the one hand, they are a valuable source of information on how we should arrange our processes, on the other hand managing them can be quite a challenge. More specifically: deviations. Often seen as something negative and probably one of the biggest burdens within the quality system. But what if you could increase the quality of deviation reports and reduce the time you spend resolving them? Let’s have a look at some examples on how we can apply Lean Six Sigma in achieving these goals.
Reoccurring deviations are amongst the leading causes of losing control of a deviation management system, resulting in a build-up of deviations that are not closed in time, ultimately putting your processes, products or even patients at risk. It sounds easy: stop deviations from reoccurring. But, for example, identifying and preventing reoccurring deviations is easily forgotten in the daily routine of closing them. This is where a Green or Black Belt can help. By analysing deviations, grouping them and using Pareto charts, for instance, it becomes clear what the reoccurring issues are. To do so, besides Lean and GMP knowledge, you will need the knowledge of the Subject Matter Experts (SME), especially those who actually perform the process on a daily basis. This is where the Kaizen becomes an essential tool. The Kaizen is a multi-day workshop in order to improve a process or to solve a problem. Identifying the most reoccurring issues and solving them can be done with a multi-disciplinary team during a Kaizen of a few days, making this investment in time well worth it.
Improved root cause analysis
In order to prevent deviations from reoccurring, we need to address the underlying problem causing the deviation. This is what is called the root cause. After the root cause is identified, defining corrective and preventive actions (solving the problem) is often straight forward. However, putting CAPAs in place that aren't addressing the true root cause can result in losing control even further. Just think of a boat with a leak: pumping out the water is a great short term solution, but meanwhile, the leak is probably getting worse. In the end, the pump won’t be enough anymore to keep afloat, so we need to install a bigger pump. This is called ‘tampering’, and this also often done solving deviations. In order to improve the quality of root cause investigations and thus prevent tampering, a vast array of the 150 Lean Six Sigma tools is at your disposal. Depending on the issue just think of applying Lean group exercises with your SMEs like Process mapping, making a SIPOC, performing Kaizens or Gemba walks (shop floor visits) in order to increase your understanding of the problem. You can support your findings with aspect from the Six Sigma spectrum: data gathered from sampling or test runs. So defining metrics and detailed data collection plans in order to investigate the extent of the problem and identifying process variation can boost your investigations. By applying such an approach, the quality of investigations will improve, lead times will reduce and (maybe most important) teamwork will be improved.
So what if you already have a build-up of deviations and a large backlog? Where to start? How to get activated again? Instead of looking at an endless list, we need to find a starting point. Compare it to a shop floor. If it is one big mess with lots of equipment in a room, execution of work in there won’t be efficient. Here we can apply the lean concept of 5S
- Sort: Sort out everything that is really needed in that room and what is not (take these out of the room).
- Set: Arrange all items at the place where they are needed
- Shine: Clean the place since we made room to do so
- Standardize: define a process/best practice in order to maintain the improved situation
- Sustain: Ensure the new standards are met.
But, why not apply this to your deviation system? One thing we have learned is that there is plenty of low-hanging fruit within most deviation systems, investigations that are almost finished or a bunch of relatively easy deviations to solve. Sorting deviations, stratifying them and giving them a place (priority/group) will give you a good starting point to reduce the backlog. Also here, by applying a Kaizen approach you will be able to achieve much in a short period of time. It can be helpful to use visual management in such a case: for example, develop an overview of all deviations to be closed in the Kaizen and apply colour coding (red, yellow, green) to show statuses, priority’s or deadlines. This way, you always know the status of a project and you remain in control. For a long term solution, think of a best practice to improve the process including a thorough definition of roles and responsibilities within the process. By applying these concepts, solving a backlog will be like a walk in the park.
Deviation process improvement
Altogether, a deviation handling process that is fit for purpose is what you need. Not just a procedure, but especially how it’s done in practice. It often happens that in practice we are doing additional steps compared to what is required according to a procedure. This is what we call a ‘process around the process’. But why do we end up with such a waste in the system? Practical limitations compared to the theoretical procedure, or even tampering to make a process more efficient in the short term is what we often see as causes. This is one of the biggest causes of excessive workloads and increased lead-times related to deviation management. Situations like these can be addressed by applying the DMAIC process, which means:
Define the problem
Measure the extent
Analyse the data gathered
Improve the process
Control (check/sustain) the new situation.
Truly understanding current deviation processes facilitates working towards a much leaner situation. Standardization and visual management can prove to be your best friends in order to solve problems in a sustainable manner.
So where to start?
In the end, having deviations is not the problem in GMP. It’s part of a healthy, working quality system. The way we handle the deviations determines whether it becomes a challenge or not. This is where you can make a real difference by applying the basics of Lean Six Sigma on both the system as well as individual deviation investigations. See deviation management as ‘a problem’ itself: the system will only work if you really know the process behind it. Map the process, define the essential process steps, apply clear roles and responsibilities with those involved and from that, proceduralise it. Next, incorporating the DMAIC structure in your root cause investigations will leverage them and definitively solve the deviations. Finally, applying visual management will give you the edge in keeping control of your deviation management system once and for all.
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: Stefan van Dam - Consultant & Green Belt