The company’s cultural transformation moves it from FDA warning to Plant of the Year.
Manufacturing operators at Bard Shannon's plant in Puerto Rico conduct a kaizen event.
Things were not looking good for Bard Shannon's Puerto Rico plant in 2008. The plant, which manufactures 40 medical devices serving the vascular, urology and oncology markets, received a warning letter from the FDA.
If corrections were not made, the FDA could move to shut down the plant. A drastic change was needed. “Once we understood that we needed to create a culture of continuous improvement, we developed a number of rigorous processes that gave us a structure through which everyone, at all levels, could understand both the importance of this tool and how to implement it,” explains Oscar Rivera, business excellence manager.
Applying the same precision needed to manufacture life –saving devices, the company constructed a path to improvement. A Business Excellence Department was formed using strategies such as True North, Hoshin Kanri, Lean Six Sigma and Kaizens.
“Kaizens have turned into an extremely important activity for employees,” Rivera observes. “The process of working in a team, creating a process and solving a problem allows for the concept of continuous improvement to become embedded in how we approach our jobs.”
Kaizens offer a means through which employees can develop creative solutions which are turned into cost and time-saving projects that are fed into a company-wide competition. The dedication and enthusiasm for these projects was quite evident as employees delighted in explaining to an IndustryWeek editor the problems they were able to fix at the company’s Summit Kaizen Competition in December.
Humacao, Puerto Rico
Total Square Footage: 260,000
Primary Product/Market: Medical Devices
Start-up Date: 1981
Employee suggestions represented 22% of overall plant savings for 2014.
59% improvement in first pass yield in past three years.
77% reduction in in-plant defect rate within past three years.
The kaizens are part of an overall strategy that provides a roadmap to achieve a continuous improvement environment. A Leadership Academy, which provides job specific training, and the Bard Operating Success System are pillars of that strategy.
“One of the main improvements we made was to be more specific in the metrics that each team was to work on,” explained Felipe Mendez, plant manager. “In fact we turned this into a competition across lines.” An award program, called BARD Circuit, recognizes superior achievements in the areas of service, quality, financials and business excellence.
“The result of our new culture is a complete turnaround of our plant,” says Mendez. “We had not been launching products from this site prior to our transformation. Now, with our new role in R&D, we will take ownership of developing products and processes for new product introductions.”
The high level of quality produced by this plant has been recognized by the parent company who named it Plant of the Year in 2013 and 2014.
“Communication is key to our success,” explains Mendez. “There are many meetings and opportunities to ensure that we discuss issues, as we view ourselves as problem solvers.
“Everyone in this plant is aware that at the end of the day we save lives. The implantable devices are with patients for the rest of our lives, so they must be perfect,” says Mendez.