Measurement in Medical
suring programs used to drive CMMs and other automated me- trology 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 requirements. The FDA requires that the parts programs themselves be approved. Once approved they cannot be revised. “Once you have a parts program,” Smokov- itz said, “the question becomes how do you keep that con- trolled? 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 critical 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, soft- ware. “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. The paperless record archive—which configures any docu- ments in any format—can be attached to any one of the parts programs configured in the MCC. These could explain what the measuring program does. Other auxiliary data can also be attached. It also tracks who accesses measure- ment results with a time stamp, and provides a searchable database. “This is especially important if you are measuring upwards of 500 or 1000 parts a week and want to find that data again,” Smokovitz said. The database is real-time and
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