Medical Metrology
gaging, multigage fixtures, surface and roundness testing, as well as from devices equipped with wireless data transfer. “Mea- surlink can also bring in data from competitive equipment, such Starrett or Brown & Sharpe, among many others,” Criss said. Importantly for medical, Measurlink provides user authentica- tion and password protection to ensure that individual users are tracked and logged. Another important control discipline in medical device
manufacturing is tightly maintaining version control of the measuring programs used to drive CMMs and other automated metrology devices, according to Josh Smokovitz, product manager for Carl Zeiss Industrial Metrology (Maple Grove, MN). While important in other industries such as aerospace, he stressed it is especially important in medical device manufacturing to satisfy FDA reporting require- ments. Te FDA requires that the parts programs themselves be approved. Once approved they cannot be revised. “Once you have a parts program,” Smokovitz said, “the question becomes how do you keep that controlled? How do you control and keep track of revisions to the program, as well as the data the programs generate?” In larger organizations, it is easy for different programmers to tweak the program and get out-of-sync with other copies
in other locations. “If even one programmer in one of those facilities decides they need to change the tolerances to the program in response to, say, a print change, a number of is- sues arises,” Smokovitz said. “Was he correct in making those changes? What happens to the parts at the other facilities?” Other issues such as measurement strategies, selection of criti-
cal characteristics or features, or tolerance classes all must remain uniform and configured. Zeiss has an answer to this problem with their Master Control Center, or MCC, soſtware. “It supplies one master copy of parts programs, tightly controlled from a central server, with only password access,” Smokovitz said. In addition, MCC also has modules for onboard diagnos-
tics, machine data logging, and a paperless record archive. Te paperless record archive—which configures any documents in any format—can be attached to any one of the parts programs configured in the MCC. Tese could explain what the measur- ing program does. Other auxiliary data can also be attached. It also tracks who accesses measurement results with a time stamp, and provides a searchable database. “Tis is especially important if you are measuring upwards of 500 or 1000 parts a week and want to find that data again,” Smokovitz said. Te database is real-time and connects reports to barcode systems used to track individual parts or lots.
How big a network
can MCC control? “We currently have a cus- tomer in New York who has six or seven different labs across the US run- ning 30 Zeiss machines, and he can tell instan- taneously what pro- gram they’re running, how much time is leſt to completion of each [measurement] program, and if there is any error on that machine,” Smo- kovitz said.
Small Companies, Big Problems While large com-
Tightly maintaining version control of measuring programs and monitoring machines over large networks are important for medical device manufacturers. Shown here: MCC from Carl Zeiss Industrial Metrology.
78 Medical Manufacturing 2014
panies with multiple machines and facilities have unique problems of maintaining versions and control, small and medium-sized companies have additional prob- lems, especially at the beginning of production
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