Joining forces

The terms Lean and Six Sigma have been used in pharmaceutical manufacturing for a number of years. Now there’s a new concept on the block that melds the two. Bayer’s Edgar Sur fills us in.

“It’s important to ensure that you’re talking the same language – not reinventing the wheel – and making sure that your goals and objectives are aligned”
-Edgar Sur, Bayer

According to Edgar Sur, Head of Bayer’s Operational Excellence for North America, Lean Six Sigma is a combination of Lean, which is focused on removing waste, plus the value-added step of Six Sigma, which is all about reducing variation. “Both use the same approach in solving the problems,” he explains. “In Lean, we use the approach of plan, do, check, act; and in Six Sigma, it’s called DMAIC, which is define, measure, analyse, improve and control. It’s about putting rigor in the approach of problem solving with the flexibility of using some Lean tools and some Six Sigma tools.”

The advantage of putting the two together, says Sur, is to prevent people from seeing them as two separate sets of toolboxes, but instead thinking of Lean and Six Sigma as a complement for each other: “In Lean there are a lot of things that you can immediately address and solve. For example, when you’re involved in a project, there may be things that would normally take three to six months. When you go through Lean, you can go to the improve phase in one week, as opposed to in Six Sigma, where you’ll probably get in an improve phase in three months or even less. But certainly, there’s the shorter variation of period in time in addressing these things.”

Another advantage is increased efficiency. “You increase the cash flow through the reduction of your inventory,” Sur says. “Everything is data driven, so it can be defended when it’s questioned. There is a rigor, again, to the approach of solving the problem, which you don’t get from one phase to the other without completing or having the deliverables on prior phases.

“It also forces people to partner, because you can’t do this in a silo; this is more of a cross-functional group of people that need to make things happen. Another advantage is that you focus on the customers – we always ask what is critical to quality for the customer. It’s not a shotgun approach where you try to hit everything. You go through the data to tell you what to do, and you ask the customers what is critical to them, and you go after those things.”

Challenges
That doesn’t mean there aren’t challenges involved in implementing Lean Six Sigma in the pharmaceutical sector. “It’s a highly regulated environment,” Sur points out. “There is a mindset and a culture that change cannot happen because it is not allowed. You continually want to challenge these things and ask the right questions, while ensuring that you stay in compliance with what the regulatory agency is asking us to do.

“The other big thing that I see in a lot of companies is that because the profit margin is so high, there is really no pain and so there is no motivation to improve until it’s too late. And trying to build a culture that is sustainable is also a challenge. The other piece is also allowing time for people to have closure of the old ways of doing things and embrace the change ¬– the new paradigm of how we approach things. Having the sense of urgency as opposed to taking our time as we did in the past.”

Sur says there is also a challenge related to building the credibility and the impact of Lean Six Sigma. In the beginning, he explains, many operational excellence organisations will try to build their credibility by tackling the biggest problem projects that no one has been able to solve, which can obviously take some time.

The issue of needing to gain credibility can arise from the fact that people are not always familiar with the process, and there is a certain amount of learning involved. “In Lean Six Sigma, there are also soft skills that you have to learn. It’s a change management piece where you don’t just drive change and hope that everybody will buy into it. It’s what I normally call the wilderness, where you allow people to just wallow and have closure on how they used to do things, so they can embrace the new things that are about to happen. Until they have had the time to have closure, this new approach can’t be effective.”

There are also challenges in implementing Lean Six Sigma across different sites or different business units, as Sur explains. “One of these challenges is creating one voice, one roadmap that everyone can follow and measure themselves against to track progress. When you’re deploying Lean Six Sigma in many different sites, some sites will be in different stages of the process or of the deployment. What you need to do is make sure there’s one roadmap that they can follow. It doesn’t really matter what stage of the process they are at in their implementation, they need to know that in the end it will be a similar approach to what everyone has done, so that you have the consistency. Everything’s standardised and it’s one voice, and everyone can share and benchmark off each other.”

Implementation
Sur explains that when you’re implementing something like Lean Six Sigma, it’s important to integrate that into an overall operational excellence rollout, again because of the need for consistency. “It’s important to ensure that you’re talking the same language – not reinventing the wheel – and making sure that your goals and objectives are aligned and not conflicting each other. Again, if you don’t have that alignned approach, there is the chance that there may be conflicting goals and objectives that can go against each other, and that would not add any value to the process.”

In operational excellence at Bayer, Sur is working to build a culture that is sustainable. “In a way, I’m trying to work myself out of a job, so that the ownership and accountability transitions from the OE organisation to the site because that’s the only way you can have a sustained program, if the ownership and accountability is back to the site.

Sur has experience in carrying out similar programs in different industries and sectors, including aerospace and IT in a technology environment, and he believes a lot of what is done around operational excellence is transferable from industry to industry.

“It’s sometimes difficult when you go to the healthcare sector where if you don’t have the background around healthcare, normally they’ll say, ‘It’s not applicable, what your skill sets are,’ but that’s where the misnomer is in sometimes trying to retain some of these skill sets that other individuals have going forward. When there’s a process that needs to be addressed, OE is has a place for it and whether you use Lean or Six Sigma, it’ll get you to the same end result,” he says.

He is also keen to point out that Lean Six Sigma is just not used in operations. “We’ve done this in an HR environment. We’ve done this in global supply chain as well as procurement. I’d just like to get the message out to all the practitioners that this is applicable to just about anything and everything.”

Future
The original concepts of Lean and Six Sigma have been around and been developing for a while. How does Sur see them continuing to transform in the future? “I think they will continue to grow and expand,” he confirms. “There’s always a need for these types of programs. There’s a need to stay competitive with other companies cost-wise because, going forward, the need for quality and efficacy will be a given in our industry. A lot of the opportunities are the speed to market, the response to customer needs, and reducing costs so that we can transfer some of these savings to the patients.”

Edgar Sur is Head of Bayer’s Operational Excellence for North America.