Using Lean principles, one of Bayer Healthcare’s fermentation and media teams at the company’s biotech manufacturing center in Berkeley, California, is creating a culture of improved communication, training and shared process ownership.
Efforts began two years ago and have already brought about a significant decrease in batch record errors, improved overall staff proficiency by over 20%, boosted productivity by 50% and eliminated OSHA incidents, the last of which occurred in May 2007.
Pharmaceutical Manufacturing spoke with Saulye Sherrel, an émigrée from Kazakhstan with a degree in genetics who oversees production in two media and fermentation departments at Berkeley. She led this project at one department and is now taking it to the entire facility.
Saulye started at Bayer as a general manufacturing supervisor, becoming operational excellence Leader across multiple sites and the maintenance shop. Three years later, she joined Genentech to lead a Lean implementation which reportedly saved $12 million in six months. She returned to Bayer two years ago, as a manufacturing production manager. Very early in her career, she worked with BIOS, Inc., in Alma Ata, where her responsibilities included milking vipers and fractionating their venom using HPLC, and she also worked in the DNA section of the Las Vegas Police Department’s forensic lab.
We asked her about the Berkeley program, how it came to be and what results are being seen.
PhM: What led the company to change the way it was handling training, and to incorporate Lean?
S.S.: When I came to work for Bayer Healthcare, I took a production job because I felt that it would be a good challenge. After I’d been working at the site for a few quarters, the V.P introduced me to Lean. I had never heard about it before.
I then spent two to three years implementing different Lean tools at Bayer and Genentech. At this point, I began to realize that American businesses tend to focus too much on tools. We do not always understand the philosophical background behind these tools, and why Toyota developed them back in the 1940s.
In order for organizations to have a sustainable change of culture, an independent OpEx group cannot be pushing these efforts alone. Management must be involved in the concept and project.
PhM: So how did you get involved in this project at Bayer?
S.S.: Two years ago, while working as an OpEx manager at Genentech, I received a call from the same Bayer VP who had introduced me to Lean, who offered me a production manager position. My interview was largely about how I would roll out “The Toyota Way” at the site. I came in knowing that I would be piloting not only implementation of Lean tools but the Toyota Way. I’m not trying to follow the Toyota execution manual, but to see how Toyota’s tools can be used and tailored for what we do.
PhM: Is this program only going on in the cell culture operations, or is it a mandate tied into a larger corporate initiative?
S.S.: It started as a pilot, but the company has been watching results closely, and now the entire site will implement this approach. Right now, as a beginning step, everyone is getting to a very consistent implementation of standard work. Standard work is so often misunderstood. Some people just see it as a repeatable schedule to adhere to. I’d like to have them understand that it’s really about thinking more in the context of a process flow.
PhM: How did you get buy-in from the production floor?
S.S.: We did roll out some different Lean tools, but these efforts met with mixed response. If you just roll out tools, people don’t understand that the overall Lean philosophy should be long term and that it should be about continuous improvement and cultural change. You can get good results without taking the long-term view, but once the project champion leaves the site, results can’t be sustained.[pullquote]
When the pilot began, I realized that, like most U.S. businesses, we were stuck in this very mature management model. Most of today’s American management concepts were developed by Henry Ford. We do not have anything new.
At the start, the organization was very hierarchical, very bureaucratic. Morning meetings with QA and engineering were led by management, and they were like ping pong matches. You’d sit in the ivory tower and discuss what happened on the floor, but you weren’t on the floor. Information took several days to filter up to management and the same amount of time to go from management to the plant floor.
I saw that people were siloed, not only in QA, engineering and manufacturing, but even within different shifts. We are one of the few biotech companies to use unionized labor at the facility, and, often, unionized labor is all about comfort. The result can often be firefighting, and when you see that, you know that people will be fundamentally unhappy.
We now have “safe” meetings where operators are free to bring up concerns without supervisors being present. I started asking people why they had such high batch record errors and so many OSHA citations.
I learned that they had no feedback on these errors. There was no democracy of information flow. Whatever improvements or issues that operators brought forth were either addressed very slowly or not at all.
I knew that I could get people to move from the old “I’m only responsible from 8 to 9 then all hell can break loose” approach to taking ownership by doing something very simple: asking them what hurt.
We held a Toyota Way Lean training program. This program touched on very basic things, such as how to see things as a flow. We did a quick and dirty process flow map and I asked operators and supervisors about the top issues affecting them and their departments. We came up with a list of over 100 different issues, which we prioritized, agreeing to focus on 10-15 projects that we’d execute right away.
I told operators from the beginning that I needed them to take on responsibilities. The natural leaders came forward, particularly those who had felt they had not received adequate response from management in the past.
Good managers must play coach. We meet with every operator monthly to discuss training they need and overall project management, and whether they needed introduction to people in QA engineering and other support functions at the site.
PhM: What results have you seen so far?
S.S.: When we started the program, our technical proficiency matrix measurement was in the 70’s. After training, and monthly meetings with operators to see how they could handle standard work, we took that level to 93-95%.
Our productivity increased by more than 50%, as a result of these discussions of issues with operators. This improvement was significant because, when we started the pilot, we could not understand why productivity was lagging. We created a task force including representatives from manufacturing sciences, plant engineers and operations to identify bottlenecks. People felt they were empowered and part of an interdependent structure. They could talk to people within manufacturing science face to face and go through different scenarios.
Errors on batch records also went down significantly due to the same approach. We educated people on the errors and how to analyze trends and causes, and how to cooperate with QA release functions. Since we run continuously, 24/7, representatives from QA release would come on the floor monthly, in one morning and one evening meeting to provide feedback to all shifts. Feedback and face-to-face discussions are critical.
As a part of standard work, we identified and anchored responsibilities for real-time batch process record (BPR) review with supervisors. I saw an opportunity to improve by improving process flow ownership. BPR’s are filled out by operators but reviewed by supervisors. This seemed like another wasteful handshake in the process, so we decided to empower an operator to review the BPR’s that his or her shift created. We tried this approach and it worked.
PhM: Was there much pushback from supervisors?
S.S.: I felt that supervisors might feel threatened if we took their work away from them, so we talked about “servant leadership.” A typical talk with a supervisor would go along these lines. “Right now, you’re responsible for all these tactical items and you cannot add value to your resume, but if you step away and coach and develop your shift to where it becomes a self-directed group, you can actually develop more marketable skills.” Supervisors don’t review BPR’s now, but they do review standard work and compare with available time, for scheduling projects.
PhM: Do you have anything like a dashboard installed to show KPI’s?
S.S.: We have several different dashboards, for training, productivity and batch record errors. But the key mechanism for communicating KPI’s is really the “all hands” meeting we have once a month—four of them to cover all shifts—and involving representatives from manufacturing sciences, QA, and engineering. We talk about KPI’s right there. It’s so important that support functions get a platform.
PhM: Do you have a cross-training policy?
S.S.: My daily meeting takes place on the floor, so manufacturing sciences, QA and engineering come in, the operators and supervisors are encouraged to participate. Information dissemination happens right there. Two or three times a week there is an agreement that production and quality people walk the floor together. This serves a dual purpose: We learn from QA how they see the world, get an explanation of why they do things the way they do. At the same time, we bring our counterparts to a much deeper understand of the overall processes. We’ve found that this approach goes well beyond classroom training, which we also offer. Because these walkthroughs went so well, we now have QA stationed on the floor, 20 hours a day.
PhM: Did you find any areas where training was especially needed?
S.S.: For manufacturing sciences, our on-the-floor operator training was pretty good, but only a few people had sufficient troubleshooting experience, and the advanced technical knowledge required.
We reached out to our manager of manufacturing sciences, and set up an academy that provided training on topics, 1.5 hour monthly training sessions for each shift. These are very productive sessions with very well respected scientists who explain the technical background of different processes followed by a question and answer session.
That went on for over six months. Since then, academies have been established for other parts of the supply chain. I represent fermentation, but there’s now one for purification and another for fill and finish. Once we improved the overall level of understanding among operators, the next step was for some operators to become “supertechs,” an elite group that meets with manufacturing sciences SME’s once a week for a few hours to discuss the troubleshooting issues of the week, and how to address them.
The Manufacturing Sciences department issues a daily letter summarizing trends and issues, with suggestions (e.g. adjustments of fermenters). Operators provide feedback via email. The next morning, there’s a quick huddle between operators, supervisors and manufacturing sciences to discuss issues.
Enhanced communication between manufacturing sciences and operators has led to some great projects. For instance, we recently introduced a new piece of equipment that controls the flow of product out of the fermenter, reducing variability in fermenter performance. It was suggested by an operator, to improve sigma level.
And safety has improved considerably. We haven’t had any OSHA reportables since May 2007. Generally, we’re learning that, if you give your organization a robust framework within which to bring up issues, and if you have a mechanism in place for addressing them, people more feel empowered and part of a team. Their behavior reflects this change.
PhM: How do you handle Kaizen recommendations from the plant floor?
S.S.: We have several mechanisms in place, one of which is a 24/7 group. If any operator has an idea about how to improve operations, his or her supervisor has to respond quickly. Then, a path forward must be found—either “let’s do it,” or “let’s put it in the portfolio to prioritize it.”
The portfolio was necessary, as I learned during my second month . . . all these ideas were coming in and we needed to be transparent about how we were executing them.
One very organized operator became portfolio manager. He received some additional training in Microsoft Project and took charge of collecting ideas. Once we prioritized them, as a group, and assigned an operator to implement each idea, he updates and maintains the portfolio.
Everyone can put ideas in portfolio. They can talk directly to me, or to their supervisors.
Frankly the type of interaction that yields the most ideas is the monthly face to face meeting between operator, supervisor and manager. We hold these meetings for each operator to clarify and update training needs and determine proficiencies. In addition to having responsibilities for processing, we offer business process assignments. For instance, operators can receive additional training in such areas as SAP, root cause analysis (via fishbone diagramming) and in tracking batch record errors.
The question always comes up: Do you see any opportunities for improvement? For instance, if an operator points out issues with a specific piece of equipment, we give him or her opportunities for training on how that equipment works.
I’ve established a new KPI for all supervisors. I ask them to bring me three improvement ideas from their shifts each month, and to implement one.
PhM: How did you get interested in Toyota?
S.S.: My first Lean project was to lead an implementation of 5S. The project showed great results, and we passed an FDA inspection with flying colors. But I realized that results could not be sustained unless managers bought into the idea of empowering people, and thinking about how procedures would flow from shift to shift.
If they didn’t put the right mechanisms in place to deal with issues that would bubble up, the results could not be sustained.
After this experience, I felt that it was necessary to focus on the sustainability part of Lean. I realized that, especially in the U.S., a lot of people in biotech are engineers, and they think that they will succeed with Lean if they implement the tools. Well, they may succeed, but can that success be sustainable?
Human capital needs to be targeted. It’s variable and it’s not always logical. You can’t just take the tool without working on culture change and taking a long term focus.