Lean Means Green
Top-down push is an important factor in keeping Lean/Six Sigma initiatives fresh in workplaces of medical device contract manufacturers.
“Lean” is one of the great buzzwords of contemporary business life. Simply put, Lean manufacturing or Lean production or just plain Lean is a production practice focused on preserving or enhancing value—as it applies to a company’s customers—with less work.
Broadly speaking, the focus is on getting the right things to the right place at the right time in the right quantity to achieve perfect work flow, while minimizing waste and being flexible and able to change. But there are, of course, varying approaches to achieving this, which got us to thinking, now that the basic concepts of Lean have been in existence for more than two decades, how do companies keep Lean initiatives fresh? In other words, after implementing a few generations of Lean manufacturing or Six Sigma quality projects, how do you continue to find ways to streamline?
And there’s another basic question as well: Is there a finite amount of waste—time or money—that can be squeezed out of any given project or procedure?
While the basics of Lean manufacturing are built on its origins at Toyota, the concepts have proven to work best when companies have weaved their own needs into the theoretical concepts, so we also wondered what lessons some companies have learned.
As for Six Sigma, its focus on quality improvement began with manufacturing, but now seems to provide a foundation for innovation throughout any given organization, so its role in the company structure also interested us.
Interesting questions to ponder, so out went the call to some folks with interest in the subject, who offered up perspectives based on their particular positions in what we might grandly dub the Lean Continuum.
Freshness as a Matter of Course
Plexus Corp., a well-known electronics contract design and manufacturing company headquartered in Neenah, Wis., rolled out a trio of persons with responsibilities in the Lean manufacturing area. Asked how a company such as Plexus, which dates its involvement with Lean manufacturing back to the late 1990s, keeps its lean initiatives fresh, Tim Taber, director of manufacturing solutions for the company’s medical sector, said, “Plexus is the product realization company, we interact with original equipment manufacturers in all different areas of what we call the Product Realization Value Stream. Plexus looks at Lean not as an event but as a process that is interwoven into our business model.”
He told Medical Product Outsourcing that Plexus “made a concentrated effort in the late 1990s to make Lean part of the culture. How we made it part of our culture is through education, employee engagement and employee recognition.” The Product Realization Value Stream concept “brings an ever-changing mix of service requirements from our customers to provide the best solution to bring their products to market,” he said. “With that, we are able to keep our Lean initiatives fresh.”
Tim Murphy, Lean Sigma Champion for the Engineering Solutions group at Plexus, said, “I’m on the product development side. A lot of companies start their Lean Sigma initiatives on the manufacturing side, and we did as well, so one way to keep it fresh is to move it to other areas within the organization. We are four years into our Lean Sigma journey within Engineering Solutions and we have seen a lot of value in implementing Lean initiatives; it’s very fresh, and we are making a lot of progress.”
Joe Palmeri, Lean Sigma Champion for the company’s Chicago, Ill., manufacturing site, said, “Because the mix of products and customers within a given manufacturing site is always changing, there always are new opportunities. Some of the core things like 5S workplace organization and value stream map creation, we’ve pretty much got down now to where it’s a fact of life in the manufacturing facilities. So in order to keep it fresh, what we do is roll out new initiatives such as error proofing, standard work development, things of that nature.”
Buy-in by the workforce is an important element.
“Not only have we educated the employees on how to use the tools in the system,” Taber said, “but we have empowered them to do a Kaizen event on the floor, stop the line, identify the issue, get the proper support and then to follow up with that, we have an employee recognition program for those efforts. Oftentimes it’s the pat on the back that they’re looking for, but it’s also making their work environment more efficient and building a higher-quality product.”
He said that sometimes when Lean has not been successful in companies it is because top management has not embraced Lean as a culture.
“Plexus’s executive leadership team is actually driving Lean processes throughout the organization,” Taber said. “They were the first ones to receive Lean training and now are using the empowerment, recognition and engagement throughout all aspects of our organization.”
That leadership is important, according to Murphy.
“It’s key that it’s driven from the top of our organization,” he said. “You really need that broad engagement and empowerment by all employees.”
Palmeri said that as economic times have become tougher, “it has become easier to get the buy-in, because our associates see Lean Sigma as a tool we can use to keep us competitive in the industry. The customers have cost pressures, which means that we have to continually look for improvements in our processes as a way to pass on savings to our customers.”
As to whether there is a finite amount of waste that can be squeezed out of a given project or process, Taber said, “In general, there’s not a finite amount of waste, but there are diminishing returns on what we can get by squeezing the same process repeatedly. But based on the nature of our organization and the number of customers and the number of products and the ever-changing mix of products, that’s not a problem we have to deal with.”
From Murphy’s standpoint, the answer is yes.
“There would be a finite amount of waste, but we certainly haven’t seen that yet,” he explained. “We try to drill home the fact that Lean is a never-ending journey, and you’re never done.”
He said that from a product development perspective, “oneof the key lessons that we’ve learned is the struggle of balancing the production work—actually making the products—with theimprovement work, and how to balance resources across them. Another one is the challenge of sustaining gains that have been made—that take a lot of time and a lot of effort.”
Palmeri said, “We look at the Lean side to focus on waste elimination and the Six Sigma side at reducing process variation. Because we manufacture medical products, many of our processes are validated, so there are limits to changes within the validated process flow. However, we do look at the internal processes such as the flow of material to the floor, motion and material management waste.”
As for working within a regulated environment, he said that from the manufacturing side, “it actually helps us in a lot of ways. While we do focus on the elimination of waste, the Six Sigma process is really important in the validation of the products that we build, especially on the test side, when we validate the test processes.”
Murphy said that also helps on the product development side. “It helps us focus on standardizing our processes, and that aligns with the (expectations for) medical business as well. I think we have an advantage up-front in that, after we’re done developing, we have to verify and validate the product, so we have a little more flexibility up-front in making changes, as long as we’re verifying and validating that before it gets released into production.”
Taber said, “We traditionally started Lean within manufacturing, as with probably 95 percent of everybody who creates this initiative, but the lesson we learned is there is equal if not greater value in the other elements of the business such as Engineering Solutions, Finance, Human Resources; so we have integrated it into all of our operations. We also ensure that we have cross-functional teams in all of our events. The broader the environment that we can get involved in that, the more creative our solutions have become.”
Growing Lean Through GROWTTH
Another company with Lean experience is Helix Medical LLC, a global contract manufacturer with headquarters in Carpinteria, Calif., active in the medical/healthcare/biotech space. Divisional Lean Manager Keith Inglis came to the company three and half years ago with experience gained in industries that are very mature when it comes to Lean and Six Sigma.
Inglis noted that his primary focus has been the implementation of a parent company-endorsed GROWTTH program (Get Rid Of Waste Through Team Harmony).
“We’ve been implementing that driven by our parent company for just over three years now,” he said. “How do we keep it fresh? It kind of keeps itself fresh; when you’re changing the culture, it just becomes part of what we do. It’s not really Lean or Six Sigma. It’s just, ‘We’ve got a problem, and how can we fix it? What’s the biggest business need?’ So it becomes part of the culture through training.”
Inglis told MPO that a key to success is top-down support.
“As long as we have the top-down support, then it is kept fresh by the senior leadership team driving it down through the company,” he said. Another thing that has a big impact is “through the parent company, we have a GROWTTH summit where all the business leaders get together and they discuss how it is going to be implemented and if there are any new concepts that we want to present this year.
And there is an awards program for both Lean and Six Sigma projects and programs. We also have a portal with a best-practices archive, so any new approach within the company is communicated, and I latch onto those ideas and try to develop them further.”
Inglis said buy-in across the organization is an important part of keeping things fresh and moving along.
“We have created what we call a white belt program—the program gives people knowledge of the seven types of waste, and one of the basic tools, 5S, but also shows them how to use it to eliminate waste in their daily jobs.” He said, “The program really took hold, and right now we have 95 percent of our employees in white belt status on the floor, all throughout the organization, so everyone in the organization has been touched with it. We have people who have asked to be involved in the green belt Lean system program. We have 12 people training for a green belt this year, and we had double that number wanting to be involved, particularly people from the floor who were familiar with the basic concepts and wanted to learn more.”
On a recent 3-P (production preparation process) event, “we were able to take a new product that’s coming in and we design it in a lean manner before it even gets to the shop floor. We decide how we are going to build it, we work out what the cycle times need to be, and then we make the product flow with the help of the operators. It definitely gets them participating and really gets them excited about what we’re doing.”
Noting that “when you have rank-and-file involved and everybody understands what we need to do, you don’t have to spend time and energy trying to convert people and talk them into it,” Inglis added. “They’ve already bought in, and we can use that time more efficiently to find better solutions that carry over to the customer faster and deliver better quality.”
He said the waste-cutting process obviously includes working with Helix customers. “We can offer customers a value analysis and value engineering processes up-front, before the design is locked in, where we look at the value of each component and what waste is in there.”
As for lessons learned in the first three-plus years of working on Lean at Helix Medical, he said, “Toyota provides us with a framework, but the rest depends on your business need. So you have the tools of Lean, then you add the business need, then you need top-down support. The people on the floor can only actefficiently if your senior management team is behind it.”
Top-Down Push a Key to Success
Susan Mucha, president of Powell-Mucha Consulting Inc., based in El Paso, Texas, said that, as is the case with most business disciplines, some companies do Lean well and others not so well.
She told MPO that from her experience, the companies that have the most effective implementation of Lean “are the ones that really do it top-down, meaning they’ve got very established goals at a corporate level—not just for implementing a Lean program, but for what Lean is going to do for them.”
Conversely, “the ones that are least effective are when someone in the quality organization says this is a good thing to improve manufacturing and it becomes a series of small activities on the floor rather than the focus of the organization.”
Mucha, whose firm works with companies in the electronics manufacturing services (EMS) industry, many with major medical-products businesses, said an example of a big goal that would really drive good implementation “would be when a company says ‘We’re out of factory floor space. Let’s go re-evaluate our factory and see if implementation of Lean manufacturing will free up the space we need.’ When companies take an approach that is that big, they usually get some very good things from Lean.”
Mucha said another reason companies commit to Lean might be because they want to offer their customers more flexibility from a schedule standpoint.
“That type of Lean implementation isn’t going to simply be Lean initiatives on the production floor; it’s going to be Lean in the supply chain, in design, and may even include equipment modifications to give them more flexibility,” she said.
The bottom line, she said, “is that generally when Lean really works, it’s more than taping squares on the floor and having 5S principles in place—it’s changing the entire organizational strategy.”
She added that top management doesn’t need to become certified experts in Lean. “I think the key issue is that they need to have a vision of what they want Lean to do for the company and let the people who should be experts in Lean help them get there.”
She added: “If you’re saying, for example, I want 30 percent more space on my factory floor, you don’t need to be the expert that can get you there, you just need to listen to your team in terms of what the road map is for that plan, and then plow the road for them so that they have the resources they need.”
Mucha said companies often will do what they need to in order to improve efficiencies, but won’t make a major philosophical change, and that’s where programs break down.
She offered the reminder that “Lean and Six Sigma are both tools, and they’re tools that can work together. Fundamentally, what you’re really doing is going back to your workforce and saying, we want to be as efficient as possible, setting goals for how you define that efficiency, and then bringing in Lean or Six Sigma or a combination to give them the toolset they need to achieve the goal.”
A key point—maybe the key point—“is on where you are in the program,” Mucha said. “How many black belts you train for Six Sigma or how many green belts you have or how many projects they’re working on, versus ‘Here’s our overriding goal that this activity is supposed to help us achieve and here’s our progress toward that goal.’”
She said, “I think that’s really the difference between an ineffective program and an effective program. Employees will buy into a goal that helps them improve their company when they can really see what the improvement is.”
Mucha said another area where companies can see a payback that doesn’t show in a unit price is additional flexibility.
“A truly Lean factory is going to be able to react to changes in demand much faster than a non-Lean factory, so that means you have more flexibility without necessarily carrying more inventory.”
The whole point about quality obviously is all the more important when you’re in a highly regulated industry, she said. “For medical, this is bread and butter.”
As for keeping Lean initiatives fresh, “When you’re dealing with 30-something customers, your Lean initiatives to a certain extent are fresh, in that every new product that comes from a customer is going to have opportunities for improvement in terms of integrating it into your overall Lean process.”
Mucha said the biggest point to underscore “is that Lean is a tool, not a be-all and end-all. If you really want to get something out of Lean, the end answer is to pick the problem you want to solve and then figure out how Lean relates to that problem. Don’t pick Lean and then look for problems to solve.”
Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.