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DataSure in Medical Products Manufacturing

Volume 2, No. 2

Summer, 2008

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Quality, Precision, Innovation

T&L Sharpening, Inc. was founded 30 years ago by Mr. Thomas All. It is located near Warsaw, Indiana -- a hotbed of manufacturing for Orthopedics. The company specializes in precise orthopedic cutting tools. In particular, T&L Sharpening has gained recognition as a pioneer of hand-ground bone rasps.

Over time, T&L transitioned from hand grinding bone rasps, to CNC technology, and then to specialized machinery. Today, they produce a number of different surgical tools including rasps, twist drills, reamers, end mills and taps, mostly for medical-based customers.

Data Collection with Wired Tools
In its 7,000 square foot manufacturing area, T&L Sharpening runs jobs that range from one piece to three- or four-thousand.  Parts are typically inspected with gages such as calipers, micrometers and scopes. Accuracy and quality control are particularly important in medical industry manufacturing, with many jobs requiring 100% inspection.

T&L Sharpening had multiple inspectors working at a station with hard-wired measurement devices. However, the wires got crossed, hampering productivity and sometimes created a safety hazard. Their manual in-process inspection procedure utilized handwritten notes, at times relying on an inspector's memory to record quality information.

An interim solution was implemented that consisted of entering data into spreadsheets, then compiling Cpk range, X-bar and R data. But, there were still the wires to contend with.

As a contractor of tools that are not implants that remain in the body after surgery, T&L does not need to conform to the FDA requirements that typically affect OEMs, so not all of their customers demanded full statistical process control. However, at times T&L Sharpening does need to provide material certification, heat treat certification, and perform passivation for rust prevention. Some OEMs also stipulate ROHS compliance for control and use of hazardous substances.

“Although the industry is not currently requesting full SPC from surgical tool manufacturers, it may invariably move that way. Regardless, our goal is to attain this anyway, because SPC inevitably promotes better quality, productivity, and fewer errors,” explained Mr. Thomas All, President of T&L Sharpening.

It was with this goal in mind, in addition to removing wires that T&L Sharpening began to investigate available data collection options. Their objectives were to reduce wire clutter and increase mobility for their quality control inspectors.

Solution – DataSure
When Starrett presented its DataSure Wireless Data Collection System to T&L Sharpening, they were immediately sold on the concept.

 “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,” commented T&L Quality Manager Tom Herr.

The DataSure installation went without a hitch. They attached DataSure End Nodes to the data output ports of six of their electronic tools. Even though their calipers and micrometers are not Starrett tools, they were 100% compatible with the DataSure system.

Next, they set up a DataSure Router that extended the range of their system by 100 feet. Then, they connected a DataSure Gateway to a PC. This is the central point for data collection and tool management. “We were extremely pleased with the DataSure implementation,” stated Herr. “Once we had things set up and ready to go, there was very little adjustment time required. We were up to speed within an hour or two with very little training.”

Benefits of DataSure Wireless Data Collection
Utilizing radio transmission, DataSure can cover thousands of square feet while reliably preserving the integrity of measurement data. DataSure is compatible with major brands of electronic measuring tools and software, and its interface easily installs on PCs running Windows XP Professional.

The system automates data collection, improving speed and accuracy when compared to manual recording. Also, by replacing costly and cumbersome wiring scenarios, DataSure lets users bring the gage to the work for more application flexibility and safety.

T&L Sharpening inspectors can now 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 significantly with the elimination of the wires that previously cluttered the area. This has increased safety by reducing the incidence of accidents and injuries. In addition, their data collection is both accurate and real time.

“Our productivity, flexibility and accuracy improved right away versus our previous system,” said Herr. “We have reduced our average inspection, collection and documentation time by 25% and considerably improved our throughput and reliability.”

The R.O.I. on implementing the DataSure system was fast. T&L Sharpening estimates their annual savings at $50,000.00, without full implentation. They anticipate greater savings as they continue to expand their DataSure network.

“DataSure has proven to be a very useful 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,” remarked Mr. All. “And when the industry wants full SPC for surgical instruments, we'll be ready.”

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