Jim Stommen , Contributing Writer09.05.12
It isn’t an event, or even a series of events. It’s a journey—a way of life, if you will. Whether it’s applied in manufacturing or in other business processes, the activity known as Lean is defined as much by what it isn’t as what it is.
Those with whom Medical Product Outsourcing talked for this year’s update on who’s doing what with Lean and Six Sigma took great pains to emphasize that, while Kaizen events and 5S programs may very much be a part of putting such efforts into motion and keeping them going, it’s the sum of the parts that’s most important, with that sum being reflected in the overall culture at a participating company.
That’s why Jim Parker, director of operational excellence at Bethlehem, Pa.-based B. Braun Medical, said the company “sees Lean and Six Sigma specifically as a means to drive customer satisfaction through the efficient approaches brought to us through continuous improvement methodologies.”
Or why Jim VanBuskirk, continuous improvement manager at Tegra Medical in Franklin, Mass., said, “The key driving factors for anyone using Lean and Six Sigma are based around performance improvements. How can we perform better for our customers and internally as a group for each other?”
And why Scott Ford, master black belt for Healthcare global business unit of Clinton, Mass.-based injection molding company Nypro, said that “we have customized and adjusted the program to optimize our business and best serve the needs of our customers as they evolve. We’ve been successful, but we’re still fairly early in a never-ending continuous improvement journey.”
And why Jeff Arnold, the business excellence site leader for the Grand Rapids, Mich., plant of Vention Medical, also cited “the Lean journey” as “a continual process.”
Or, as Lani Watson, corporate Lean director for Orchid Orthopedics in Holt, Mich., put it: “Sustainability has been the most challenging aspect, and culture is key to sustainability. Our approach is to make problems visible, help the stakeholders solve them using PDCA—plan, do, check, act.”
Helping Drive Customer Satisfaction
Parker said that B. Braun globally has been practicing Lean since 2006.
“Here in the Americas region we’ve been practicing it since 2008. Six Sigma is brand new to B. Braun. We launched wave one in mid-2011, and we plan on blending Lean and Six Sigma together into our curriculum in 2013. We launched Lean product development earlier in 2012 and design for Six Sigma will launch later this year. Anytime you deploy change management or a continuous improvement platform, it requires strength and vision, and certainly resilience. So now, 18 months into our redeployment, there is more pull than resources, and our op-ex (operational excellence) lexicon is becoming standard lingo.”
When asked about the steps taken to make Lean part of the company’s culture, he said officials listened to our internal customers.
“We observed cultural norms,” he said. “We tried to understand the willingness to change, and probably the most important aspect was to make sure we communicated an appreciation for the work that had been done historically.”
From that input came “a tailored playbook, if you will, to help the organization see how all of the tools and applications fit together—kind of an overall scheme. That really helped people to be able to see themselves in the initiative.” The next step, he said, was to “go where the pull was.”
Parker’s team began to serve parts of the organization that wanted to use continuous improvement tools and techniques.
“From that, we created what I call ‘beachheads’—places where we could take others, the naysayers or people that were hard to move, and show them what’s possible,” Parker explained.
He said the other key piece is leadership by example.
“We talk about immersion here,” he said. “That is our operations leadership team and others in the C suite being a part of continuous improvement activities as participants, not just as leaders.”
He said that management commitment and employee buy-in are essential, “but the most important key for any change-management undertaking is communication; you just can’t communicate enough. No matter where you are up and down the organization, you have to be able to see that you’re part of something bigger than yourself.”
As for employee empowerment, Parker said the goal is, “at some point, as you begin to build your skill sets in the company, then more and more command and control is relinquished from the senior leaders and put into the hands of those who do the work every day. Our people are our greatest asset, and employee involvement is really the key to Lean.”
Noting that Lean initiatives are being moved beyond the manufacturing environment, he said, “A core value at B. Braun—in fact, it’s on the flag we fly—is sharing expertise, and that’s at the heart of how we’re able to replicate and share from manufacturing to other parts of the organization. Every continuous improvement activity that we do is packaged and available for the rest of the company to utilize.”
Parker said Six Sigma is a methodology that enables B. Braun to enhance its organizational capability as a “fact-based, data decision-making organization. We’re very careful not to portray Six Sigma as something else that you do. Rather, it’s a part of the DNA of the organization. We measure the success of Lean/Six Sigma through our vision statement, which is ‘op-ex in everything we do—every person, every minute, every day.’”
In Pursuit of Performance Improvements
VanBuskirk said his experience with Lean at Tegra Medical began early this year.
“We’ve started the transformation of Tegra to adopt the Lean principles and some of the Six Sigma tools to help improve our performance for our customers,” he said. “We went right to the basics with a real strong 5S initiative, trained every employee in the company, and every group is responsible for doing a 5S project every week and driving improvement from the ground up.”
He characterized the cultural transformation as a long process.
“As I tell everybody, it’s a way of life. It’s not like we’re going to make this improvement and then we’re done. When you really want to embark on Lean manufacturing and practice the philosophy and the techniques, which are a set of tools that you use, it’s a way of life. Continuous improvement never stops,” VanBuskirk said. “Early on, there’s a lot of energy. People see a lot of results quickly, because you go in and make a lot of improvements and employees—the people doing the work on the floor—really benefit from it, so they participate for the most part.”
The hard part, he said, comes when you get into some of the more difficult tasks of implementing the next level of improvements. The tasks get a little harder because it takes more and more discipline from everyone involved, at all levels of the organization. Part of the degree of difficulty is in the discipline, having to stay focused on improving the culture. As a result, continual training is part of the recipe for success.
“We don’t just say, ‘Here’s a 5S tool. Here’s how we do it.’ We try to gear our training around simulation,” VanBuskirk explained. “Then as we’re making the changes on the floor, they can relate to it and understand what we’re doing and why we’re doing it. Once the employees start seeing that their suggestions are being taken seriously and adopted, you get a lot more energy for your cultural change.”
Asked whether either management commitment or employee buy-in is a more important aspect of a Lean program, Van Buskirk said, management involvement from the top is more important “in that they need to signal their support to the employees, because this stuff doesn’t just happen—it takes real human resources to turn these ideas into reality. Our management is committed; they’re dedicating people, dedicating resources to implement this, and the employees can see it.”
While employee empowerment is important to the success of a Lean program, he added that the word “empowerment” is “thrown around loosely” in too many organizations.
“It comes back to the discipline of understanding what to improve, when and why,” VanBuskirk said.
“The focus needs to be on the next steps to improve this process. If you go too fast, you miss real fundamental foundations and important steps in the overall growth curve. It’s that continuous improvement attitude of ‘I’m going to get better 1 percent every day’ that makes sure improvements are sustained before going on to the next level.”
When asked about moving Lean initiatives beyond manufacturing operations, he said the most neglected area in most organizations is transactional processes and trying to “Lean out” those processes within your support staff.
“If you look at the entire process from quote to order release and do a value stream map, I think you’d find the most waste between the processes—what takes place, for instance, from Process A to Process B? What are all the steps from when Process A stops and Process B starts? A lot of people underestimate how much waste there is in that area,” VanBuskirk said. He stressed the importance of Lean and Six Sigma being seen internally as part of the organizational focus versus being a series of events. “You can’t do one without the other,” he added. “Lean is a toolbox, a continuous improvement process. Six Sigma is a quality program that is integral to Lean; they’re integral to each other.”
Continuous Improvement Journey
Ford said that when he joined Nypro about four-and-a-half years ago, the company had a basic Lean program in place, and he was hired to help drive the development of the Lean/Six Sigma program.
One of the keys, Ford said, in establishing a solid Lean initiative is making sure it is fully integrated into the company’s culture.
“Many companies try to take on too many initiatives, whatever they might be, as point solutions in a project-based approach, but, unless it is part of the way we manage the business, it really doesn’t take hold,” he said. “It is about becoming part of the management rhythm, not just something we do on the side when we have a chance. When we have site leaders that have embraced Lean concepts and it is part of our daily, weekly, monthly rhythm, ongoing improvements to our Lean skills becomes natural. Keeping things fresh requires ongoing learning and research by our management team and Lean leaders. Our new Lean Management System is the result of basic Lean being embraced by key leaders and our LSS (Lean/Six Sigma) leaders working to understand the needs of both internal and external customers.”
Ford said system-wide implementation can be challenging because Nypro’s Healthcare has eight facilities in the Americas and Europe, and the needs of each facility are slightly different.
“We use many of the same tools, concepts and problem-solving methodologies across the company, but the needs of each of the factories differ based on the culture of that site and the customers the site supports,” he explained. “The better we set up basic Lean tools for how we manage the business and basic problem-solving on the office and factory floor, the more people get engaged and the more management learns how to empower their employees. It’s a learning process, and it involves developing tools and culture over time, but it also involves making managers not just managers, but coaches as well.”
Asked if Six Sigma is easier to implement because of the regulated nature of healthcare product manufacturing, Ford said, “I don’t know if it’s easier or not, but when you get a quality issue in a healthcare environment, the costs and risks can be much higher just because of the nature of the business. In some cases, working with our customers, it may take several months or years to get a product to market, so when you come upon a quality problem, which Six Sigma tools can help us resolve, then it’s very important that we clean up those quality issues very quickly and understand the root cause of the problem.”
Incorporating Best Practices Through Change
Vention Medical’s Arnold noted that trying to get everyone on the same page across numerous manufacturing sites can be intimidating, but that the emphasis on Lean must starting from the top down, getting the buy-in and support at the management level.
Vention Medical conducts a week-long Lean Academy course where employees from all the different sites and functional groups are taught how to “think Lean.”
In today’s business climate, growth very often is the result of acquisitions or mergers rather than organic expansion, and that, of course, can impact broader Lean implementation within a newly combined firm. Vention, like many other medical device contract manufacturers, is no stranger to such challenges.
“It’s interesting when combining companies that may already have had some form of a Lean program in place,” Arnold said. “We try to meld the Lean programs together and get the thinking aligned. If they’ve had a program in place, you want to make sure you don’t destroy the progress they’ve made, so you try to combine the programs together and incorporate the same Lean teachings throughout the entire organization, including putting together the best practices from each area.”
A best-practices approach is important.
“We really try to piggyback on the ideas of each other to come up with our overall best practices for the organization,” he said. “It’s been very beneficial for us; it has helped get a lot of ideas on the table and has been a good learning experience for everyone on the team.”
Arnold also noted that Vention is moving its Lean efforts beyond the manufacturing area.
“That’s a big focus for us,” he said. “A majority of the waste you find in most organizations actually isn’t on the factory floor, even though that’s where everyone goes to look. There’s plenty of opportunity out there to improve those things, but the majority of opportunities for true change are going to come on the administrative side. We’re taking a large focus on that area.”
He said having Lean as an organizational focus is paramount. “It’s not about how many Kaizen events you hold or how many people are trained on this competency or that. It’s about the cultural change and really driving that in the company. It’s all about focusing on ridding ourselves of waste right from the start. The other things will fall into place.”
Emphasis on Motivation
Watson said Orchid Orthopedics has been working on implementing Lean since 2007 with varied success. “We have taken a three-pronged approach focusing on the tools, management infrastructure as well as mind sets and behaviors,” she said. “Each facility starting its Lean acceleration has a diagnostic phase that considers the starting condition in each of the three critical areas before design, plan and implementation.”
As to whether either management commitment or employee buy-in is more important than the other, she said, “I think it starts a step earlier with motivation. What is the need to change, what is the purpose of what we are trying to do, what is everyone’s part in the change and how does satisfying the customer help me secure what is important to me? This vision/mission is critical for alignment of the whole organization.”
Watson said she sees employee empowerment differently than others might: “If an employee understands how satisfying the customer will enable them to secure what is important to them, empowerment is how do we as management make them successful in delivering customer satisfaction? Being able to do their own problem solving and deciding what to work on would be part of this.”
She noted that the company’s approach to Lean includes management infrastructure. “This opens it up to all areas of management supporting manufacturing such as purchasing, scheduling, quality, finance, engineering, and human resources especially considering the importance of having the correct culture,” she explained.
Watson noted that Six Sigma as an approach relies on statistical process control, “but is generally used by only a few practitioners in the organization. We believe true strength is in creating a learning organization where everyone is a problem-solver, learning by testing their hypothesis using plan, do, check, act.”
Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.
Those with whom Medical Product Outsourcing talked for this year’s update on who’s doing what with Lean and Six Sigma took great pains to emphasize that, while Kaizen events and 5S programs may very much be a part of putting such efforts into motion and keeping them going, it’s the sum of the parts that’s most important, with that sum being reflected in the overall culture at a participating company.
That’s why Jim Parker, director of operational excellence at Bethlehem, Pa.-based B. Braun Medical, said the company “sees Lean and Six Sigma specifically as a means to drive customer satisfaction through the efficient approaches brought to us through continuous improvement methodologies.”
Team members from Nypro’s facility in Ireland participate in Lean training. Photo courtesy of Nypro. |
And why Scott Ford, master black belt for Healthcare global business unit of Clinton, Mass.-based injection molding company Nypro, said that “we have customized and adjusted the program to optimize our business and best serve the needs of our customers as they evolve. We’ve been successful, but we’re still fairly early in a never-ending continuous improvement journey.”
And why Jeff Arnold, the business excellence site leader for the Grand Rapids, Mich., plant of Vention Medical, also cited “the Lean journey” as “a continual process.”
Or, as Lani Watson, corporate Lean director for Orchid Orthopedics in Holt, Mich., put it: “Sustainability has been the most challenging aspect, and culture is key to sustainability. Our approach is to make problems visible, help the stakeholders solve them using PDCA—plan, do, check, act.”
Helping Drive Customer Satisfaction
Parker said that B. Braun globally has been practicing Lean since 2006.
“Here in the Americas region we’ve been practicing it since 2008. Six Sigma is brand new to B. Braun. We launched wave one in mid-2011, and we plan on blending Lean and Six Sigma together into our curriculum in 2013. We launched Lean product development earlier in 2012 and design for Six Sigma will launch later this year. Anytime you deploy change management or a continuous improvement platform, it requires strength and vision, and certainly resilience. So now, 18 months into our redeployment, there is more pull than resources, and our op-ex (operational excellence) lexicon is becoming standard lingo.”
When asked about the steps taken to make Lean part of the company’s culture, he said officials listened to our internal customers.
“We observed cultural norms,” he said. “We tried to understand the willingness to change, and probably the most important aspect was to make sure we communicated an appreciation for the work that had been done historically.”
From that input came “a tailored playbook, if you will, to help the organization see how all of the tools and applications fit together—kind of an overall scheme. That really helped people to be able to see themselves in the initiative.” The next step, he said, was to “go where the pull was.”
Parker’s team began to serve parts of the organization that wanted to use continuous improvement tools and techniques.
“From that, we created what I call ‘beachheads’—places where we could take others, the naysayers or people that were hard to move, and show them what’s possible,” Parker explained.
He said the other key piece is leadership by example.
“We talk about immersion here,” he said. “That is our operations leadership team and others in the C suite being a part of continuous improvement activities as participants, not just as leaders.”
He said that management commitment and employee buy-in are essential, “but the most important key for any change-management undertaking is communication; you just can’t communicate enough. No matter where you are up and down the organization, you have to be able to see that you’re part of something bigger than yourself.”
As for employee empowerment, Parker said the goal is, “at some point, as you begin to build your skill sets in the company, then more and more command and control is relinquished from the senior leaders and put into the hands of those who do the work every day. Our people are our greatest asset, and employee involvement is really the key to Lean.”
Noting that Lean initiatives are being moved beyond the manufacturing environment, he said, “A core value at B. Braun—in fact, it’s on the flag we fly—is sharing expertise, and that’s at the heart of how we’re able to replicate and share from manufacturing to other parts of the organization. Every continuous improvement activity that we do is packaged and available for the rest of the company to utilize.”
Parker said Six Sigma is a methodology that enables B. Braun to enhance its organizational capability as a “fact-based, data decision-making organization. We’re very careful not to portray Six Sigma as something else that you do. Rather, it’s a part of the DNA of the organization. We measure the success of Lean/Six Sigma through our vision statement, which is ‘op-ex in everything we do—every person, every minute, every day.’”
In Pursuit of Performance Improvements
VanBuskirk said his experience with Lean at Tegra Medical began early this year.
“We’ve started the transformation of Tegra to adopt the Lean principles and some of the Six Sigma tools to help improve our performance for our customers,” he said. “We went right to the basics with a real strong 5S initiative, trained every employee in the company, and every group is responsible for doing a 5S project every week and driving improvement from the ground up.”
He characterized the cultural transformation as a long process.
“As I tell everybody, it’s a way of life. It’s not like we’re going to make this improvement and then we’re done. When you really want to embark on Lean manufacturing and practice the philosophy and the techniques, which are a set of tools that you use, it’s a way of life. Continuous improvement never stops,” VanBuskirk said. “Early on, there’s a lot of energy. People see a lot of results quickly, because you go in and make a lot of improvements and employees—the people doing the work on the floor—really benefit from it, so they participate for the most part.”
The hard part, he said, comes when you get into some of the more difficult tasks of implementing the next level of improvements. The tasks get a little harder because it takes more and more discipline from everyone involved, at all levels of the organization. Part of the degree of difficulty is in the discipline, having to stay focused on improving the culture. As a result, continual training is part of the recipe for success.
“We don’t just say, ‘Here’s a 5S tool. Here’s how we do it.’ We try to gear our training around simulation,” VanBuskirk explained. “Then as we’re making the changes on the floor, they can relate to it and understand what we’re doing and why we’re doing it. Once the employees start seeing that their suggestions are being taken seriously and adopted, you get a lot more energy for your cultural change.”
Asked whether either management commitment or employee buy-in is a more important aspect of a Lean program, Van Buskirk said, management involvement from the top is more important “in that they need to signal their support to the employees, because this stuff doesn’t just happen—it takes real human resources to turn these ideas into reality. Our management is committed; they’re dedicating people, dedicating resources to implement this, and the employees can see it.”
While employee empowerment is important to the success of a Lean program, he added that the word “empowerment” is “thrown around loosely” in too many organizations.
“It comes back to the discipline of understanding what to improve, when and why,” VanBuskirk said.
“The focus needs to be on the next steps to improve this process. If you go too fast, you miss real fundamental foundations and important steps in the overall growth curve. It’s that continuous improvement attitude of ‘I’m going to get better 1 percent every day’ that makes sure improvements are sustained before going on to the next level.”
When asked about moving Lean initiatives beyond manufacturing operations, he said the most neglected area in most organizations is transactional processes and trying to “Lean out” those processes within your support staff.
“If you look at the entire process from quote to order release and do a value stream map, I think you’d find the most waste between the processes—what takes place, for instance, from Process A to Process B? What are all the steps from when Process A stops and Process B starts? A lot of people underestimate how much waste there is in that area,” VanBuskirk said. He stressed the importance of Lean and Six Sigma being seen internally as part of the organizational focus versus being a series of events. “You can’t do one without the other,” he added. “Lean is a toolbox, a continuous improvement process. Six Sigma is a quality program that is integral to Lean; they’re integral to each other.”
Continuous Improvement Journey
Ford said that when he joined Nypro about four-and-a-half years ago, the company had a basic Lean program in place, and he was hired to help drive the development of the Lean/Six Sigma program.
One of the keys, Ford said, in establishing a solid Lean initiative is making sure it is fully integrated into the company’s culture.
“Many companies try to take on too many initiatives, whatever they might be, as point solutions in a project-based approach, but, unless it is part of the way we manage the business, it really doesn’t take hold,” he said. “It is about becoming part of the management rhythm, not just something we do on the side when we have a chance. When we have site leaders that have embraced Lean concepts and it is part of our daily, weekly, monthly rhythm, ongoing improvements to our Lean skills becomes natural. Keeping things fresh requires ongoing learning and research by our management team and Lean leaders. Our new Lean Management System is the result of basic Lean being embraced by key leaders and our LSS (Lean/Six Sigma) leaders working to understand the needs of both internal and external customers.”
Ford said system-wide implementation can be challenging because Nypro’s Healthcare has eight facilities in the Americas and Europe, and the needs of each facility are slightly different.
“We use many of the same tools, concepts and problem-solving methodologies across the company, but the needs of each of the factories differ based on the culture of that site and the customers the site supports,” he explained. “The better we set up basic Lean tools for how we manage the business and basic problem-solving on the office and factory floor, the more people get engaged and the more management learns how to empower their employees. It’s a learning process, and it involves developing tools and culture over time, but it also involves making managers not just managers, but coaches as well.”
Asked if Six Sigma is easier to implement because of the regulated nature of healthcare product manufacturing, Ford said, “I don’t know if it’s easier or not, but when you get a quality issue in a healthcare environment, the costs and risks can be much higher just because of the nature of the business. In some cases, working with our customers, it may take several months or years to get a product to market, so when you come upon a quality problem, which Six Sigma tools can help us resolve, then it’s very important that we clean up those quality issues very quickly and understand the root cause of the problem.”
Incorporating Best Practices Through Change
Vention Medical’s Arnold noted that trying to get everyone on the same page across numerous manufacturing sites can be intimidating, but that the emphasis on Lean must starting from the top down, getting the buy-in and support at the management level.
Vention Medical conducts a week-long Lean Academy course where employees from all the different sites and functional groups are taught how to “think Lean.”
In today’s business climate, growth very often is the result of acquisitions or mergers rather than organic expansion, and that, of course, can impact broader Lean implementation within a newly combined firm. Vention, like many other medical device contract manufacturers, is no stranger to such challenges.
“It’s interesting when combining companies that may already have had some form of a Lean program in place,” Arnold said. “We try to meld the Lean programs together and get the thinking aligned. If they’ve had a program in place, you want to make sure you don’t destroy the progress they’ve made, so you try to combine the programs together and incorporate the same Lean teachings throughout the entire organization, including putting together the best practices from each area.”
A best-practices approach is important.
“We really try to piggyback on the ideas of each other to come up with our overall best practices for the organization,” he said. “It’s been very beneficial for us; it has helped get a lot of ideas on the table and has been a good learning experience for everyone on the team.”
Arnold also noted that Vention is moving its Lean efforts beyond the manufacturing area.
“That’s a big focus for us,” he said. “A majority of the waste you find in most organizations actually isn’t on the factory floor, even though that’s where everyone goes to look. There’s plenty of opportunity out there to improve those things, but the majority of opportunities for true change are going to come on the administrative side. We’re taking a large focus on that area.”
He said having Lean as an organizational focus is paramount. “It’s not about how many Kaizen events you hold or how many people are trained on this competency or that. It’s about the cultural change and really driving that in the company. It’s all about focusing on ridding ourselves of waste right from the start. The other things will fall into place.”
Emphasis on Motivation
Watson said Orchid Orthopedics has been working on implementing Lean since 2007 with varied success. “We have taken a three-pronged approach focusing on the tools, management infrastructure as well as mind sets and behaviors,” she said. “Each facility starting its Lean acceleration has a diagnostic phase that considers the starting condition in each of the three critical areas before design, plan and implementation.”
As to whether either management commitment or employee buy-in is more important than the other, she said, “I think it starts a step earlier with motivation. What is the need to change, what is the purpose of what we are trying to do, what is everyone’s part in the change and how does satisfying the customer help me secure what is important to me? This vision/mission is critical for alignment of the whole organization.”
Watson said she sees employee empowerment differently than others might: “If an employee understands how satisfying the customer will enable them to secure what is important to them, empowerment is how do we as management make them successful in delivering customer satisfaction? Being able to do their own problem solving and deciding what to work on would be part of this.”
She noted that the company’s approach to Lean includes management infrastructure. “This opens it up to all areas of management supporting manufacturing such as purchasing, scheduling, quality, finance, engineering, and human resources especially considering the importance of having the correct culture,” she explained.
Watson noted that Six Sigma as an approach relies on statistical process control, “but is generally used by only a few practitioners in the organization. We believe true strength is in creating a learning organization where everyone is a problem-solver, learning by testing their hypothesis using plan, do, check, act.”
Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.