Located an hour and a half outside of Warsaw, IN, considered by many to be the orthopedic manufacturing capital of the world, T&L Sharpening Inc. (Monticello, IN) provides manufacturing, sharpening, reconditioning and modification services primarily to the orthopedic industry. T&L’s products include a number of different surgical tools, such as rasps, twist drills, reamers, end mills and taps.
Tired of Being WiredIn its 7,000-square-foot manufacturing area, T&L runs jobs that range from one to 4,000 pieces. Ninety-five percent of its work is done in stainless steel using computer numerical control (CNC) machining, Swiss turning and grinding machines, and quality controlled with gages such as calipers, micrometers and scopes. Accuracy is key when manufacturing for the medical industry, which means quality control is paramount.
T&L is a small shop with 20 employees, five of whom are quality control inspectors. As is often the case with small businesses, employees wear more than one hat. Inspectors also may do finish work such as buffing, polishing, de-burring and conducting visual inspections for defects. Or a machinist may double as a setup person or an operator and may even do some inspection work.
T&L had multiple inspectors working at a station with hard-wired measurement devices. The wires were constantly getting crossed, hampering productivity and creating a safety hazard. Then take into account the completely manual in-process inspection procedure of recording raw data on paper-sometimes relying on an inspector’s memory or handwritten notes-and it is easy to see how quality control on a large job would be a daunting task. Providing low and high readings or 100% inspection of a lot frequently proved painstaking. An interim solution was to enter data in Excel spreadsheets to compile process capability index (cpk) range, X-bar and R data. But there were still the wires to contend with.
No Strings AttachedBecause T&L is a contract manufacturer and its tools are not implants that remain in a body after surgery, they do not need to conform directly to the myriad of FDA requirements that typically affect medical device OEMs. Thus, some medical manufacturers still are not demanding full statistical process control (SPC) for T&L’s surgical cutting tools.
However, sometimes T&L does need to provide material certification, heat treat certification, perform passivation for rust prevention, and Restriction of Hazardous Substances Directive (RoHS) compliance for control and use of hazardous substances.
“Although the industry is not currently requesting full SPC from surgical tool manufacturers, it may move that way,” says Thomas All, president of T&L. “Regardless, our goal is to attain this anyway, because SPC inevitably promotes better quality, productivity and fewer errors.”
It was with this goal in mind, in addition to removing wires, that T&L began to investigate data collection options. The objectives were to reduce wire clutter and increase motility for quality control inspectors. When the L.S. Starrett Co. (Athol, MA) presented its DataSure wireless data collection system to T&L, the company was sold on the concept right from the start.
“It wasn’t a matter of if we were going to go with the Starrett DataSure system. Instead, it was a question of how quickly we could get it up and running,” says Tom Herr, quality manager at T&L.
The DataSure installation went without a hitch. T&L set up six miniature end nodes that connect to the data output ports of its electronic tools. Even though the calipers and micrometers that T&L uses are not Starrett tools, they were 100% compatible with the DataSure system. Next, T&L set up a wireless signal router that extended the range of the system by 100 feet. Had the manufacturing environment been larger, T&L could have used additional routers to extend coverage. Finally, T&L set up a gateway that connects to one of its PCs and acts as the central point for data collection and tool management.
“We were extremely pleased with the DataSure implementation,” says Herr. “Once we had things set up and ready to go, there was very little time spent adjusting to the new system. We were up to speed within an hour or two with very little training.”
Fast ROIT&L inspectors now can move about freely with their measuring devices, making it easier to have several inspectors working in the same area simultaneously. The work environment has improved greatly with the elimination of all wires that previously cluttered the area, which has increased safety by reducing the incidence of accidents and injuries. And now data collection is not only accurate-it is instant, in real time.
“Our productivity, flexibility and accuracy improved right away versus our previous system,” says Herr. “We have reduced our average inspection, collection and documentation time by 25% and considerably improved our throughput and reliability.”
The return on investment (ROI) after implementing the DataSure system came quickly. T&L estimates its annual savings at $50,000-and that is without using the system to its fullest. The company still does some hand documentation because it has been too busy to fully implement SPC. But because some customers will not require 100% inspection if SPC documentation is provided, the company is heading that way.
“DataSure has proven to be a very handy and convenient system for us. Having the freedom to conduct quality control inspections from different points in the shop has been such an improvement to the work environment,” says All. “And when the industry comes knocking, demanding full SPC for surgical instruments, we’ll be ready.”
- The L.S. Starrett Co.