Plastics Technology - Dedicated to improving Plastics Processing.
Issue link: http://pty.epubxp.com/i/839458
Instead of an agreed-upon AQL (acceptable quality limit) sampling plan, where, for example, every four hours an inspector collects and examines parts, including critical dimensions, 100% automated inspec- tion means just that: Every single part is completely inspected. "We think 100% automated inspec- tion is where our business is heading," Sokoloski says. "We've already installed one line, but the more customers we talk to—especially in critical applications and high-volume applications—they're the ones that are really expressing more interest." By identifying a defective component the moment it's made, Freudenberg Medical can avoid deeper disruptions to its own and its customers' production. "If a bad part goes to the customer and the customer sees it, then it's a whole different scenario," Sokoloski says. "The customer has to stop its line, send the part back, and we have to stop our line. But if we catch it immediately, we don't even produce the next part; we fix it immediately." Even before outfitting a production line with visual inspec- tion equipment, Baldwin Park operated a full metrology lab to track critical dimensions on existing and upcoming projects. For new projects, the company performs full first-article inspec- tions, checking every dimension and devel- oping a measurement systems analysis (MSA) program that's sent to the produc- tion floor. The adherence to precision is necessitated by the tolerances Neelam and his team are asked to maintain: ±2 microns (0.0000787 in.) on credit-card-sized parts, for example. "Matching the 2 microns is the biggest challenge," Neelam says. "Making a part is one thing, but also being able to measure and maintain that is the challenge." In addition to molding and maintaining that level of accuracy, Freudenberg Medical is also tasked with creating complete transparency in its operations. Utilizing an SAP ERP system that's standardized throughout its operations, it can trace everything about a part from the lot of material used in its manufacture to the operator and machine that produced it, the cavity it came from, and who did final inspection. This supports the FDA's 2013 "final rule" on a unique device identifi- cation (UDI) system. "Everything is traceable," Sokoloski says. "That's what we're seeing with the UDI. We're now having to get down to individual traceability at the device level." At Baldwin Park, this has mani- fested itself in the installation of laser-marking equipment, which is used to give an ID to every component that comes off a machine. Sokoloski also stressed that Freudenberg Medical does not inspect quality into its products; it builds quality into its production via the installation qualification, operational quali- fication, and perfor- mance qualification (IQ/OQ/PQ) it under- takes with all new projects. "The trend we see is that even with IQ/OQ/PQ and six-sigma quality, defects are still created when producing millions of parts," Sokoloski says. "To a customer, a single defect is not acceptable. Therefore we are providing our customers with the added service of 100% automated inspec- tion—in addition to a validated process." EXPANDING A TOOL ROOM, THE 'LEAN' WAY In order to maintain and repair molds in a timely manner, Baldwin Park expanded its tool room, completing the installation of equipment at the start of this year. The new equipment was installed in the enlarged space only after Neelam and his team completed a lean 3P (production preparation process) study to determine the most efficient way to configure it in the given space. "You're basically planning for manufacturing," Sokoloski says of the 3P study. "How do you design and lay out the opera- tion so that it flows with minimal waste?" So Neelam and "By utilizing lean tools, we're able to get more out of the space that we currently have available." Freudenberg Medical has three separate molding bays meeting Class 7 and Class 8 clean-room standards. 36 JULY 2017 Plastics Technology PTonline.com Freudenberg Medical On-Site