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"You think you know everything—but when you write it down, you see the small things," explains Rao Neelam, v.p. of opera- tions at Freudenberg Medical's Baldwin Park, Calif., medical- device manufacturing facility. The "small things" are a big deal at Freudenberg Medical's operation approximately 20 miles east of Los Angeles. The facility serves as a thermoplastic injection molding lead center for Freudenberg Medical's 12 manufacturing sites spread across the U.S., Costa Rica, Ireland, Germany, and China. As a lead center, Baldwin Park is the primary residence for all the company's thermoplastic injection molding technical expertise, developing and disseminating best practices for all of Freudenberg Medical's molding facilities, located in Gloucester, Mass., China, Germany, and Costa Rica. The "small things" Neelam is talking about are potential "undesirable effects" that have been written along one axis of a chart spread across multiple sheets of paper. These charts are taped to the wall of the main corridor in Baldwin Park, which acts as the primary artery for the facility, running its length and separating the company's various operations. On the chart's other axis, employees have written out "root causes" for the aforementioned "effects." All of this is part of a value-stream mapping operation undertaken continuously at Freudenberg Medical as part of its deeply ingrained lean-manu- facturing philosophy. At least twice a month, a cross-functional team undertakes a deep dive into a particular process, mapping out any potential bad outcomes and how they could occur, as a means to avoid them. "Lean" is very much a part of Freudenberg Medical's corporate culture, and its implementation internally is maintained via a more than 30-yr-old company initiative known as GROWTTH (Get Rid of Waste Through Team Harmony). "We have a very robust lean program here," says Ward Sokoloski, v.p. and general manager of Freudenberg Medical. " By utilizing lean tools, we're able to get more out of the space that we currently have available." Sokoloski explains that Baldwin Park has been able to implement one-piece flow throughout its processes, generating new floor space within its clean rooms and allowing the company to run more operations out of the existing footprint, which is a money saver in the very expensive Southern California real-estate market. The Baldwin Park operations cover 72,000 ft 2 , with 26,000 ft 2 of that made up of Class 7 and Class 8 clean rooms. Apart from the recently expanded tool room, all of Baldwin Park's operations— including inspection, assembly, decoration, post-mold curing/ annealing, and packaging—occur in a clean-room environment. When Plastics Technology visited, the plant was running around 60 Arburg and Toyo injection machines, from 28 to 350 tons, with a new Arburg on order. Baldwin Park has three two-shot machines with rotating platens, in vertical and hori- zontal configurations. There are close to 200 employees on staff, and the plant runs three shifts, 24/7. The plant is 100% devoted to medical molding and has ISO 13485 certification. In 2015, it completed FDA registration to move into production of several types of complete medical devices rather than only components. "Because California is such a wonderful area in which to grow the medical business, due to the large number of medical OEMs present here, we felt registration was a great opportunity to offer that device service here in Baldwin Park," Sokoloski says. 100% INSPECTION The trend toward miniaturization in medical, driven by mini- mally invasive surgeries where incisions are measured in mil- limeters instead of inches, is evident at Freudenberg Medical in the precision required by its customers. For one job, the accuracy requirements led Baldwin Park to install a 100% inspection system on a line running to 10 million parts annually. "We recognize that customers are expecting 100% good parts, every single time. Even though there might be a sample plan in place, the expec- tation is 100% good parts." For many jobs, Freudenberg Medical is required to sort parts by cavity, and the company builds all the equipment in-house, including specialized end-of-arm-tooling. @plastechmag 35 Plastics Technology On-Site Freudenberg Medical