Newfangled gizmos—field calibrators, process analyzers, lab notebooks, BlackBerries, you name it—have compliance and implementation hurdles, and simply take a while for operators to get used to.
The experience of Three Rivers Pharmaceuticals is a good example. Three Rivers (Warrendale, PA) is a specialty manufacturer that, unlike most, ships directly to pharmacies. To maintain a competitive advantage, the company decided to automate its data collection for receiving, inventory, shipping, and returns. It selected a compliance label manager solution from TAKE Supply Chain to work in concert with its Oracle database, and purchased point-and-shoot data collection devices for workers in the warehouse.
But there were challenges. ”Change is definitely difficult, especially in a validated environment,” says Christine Sheehy, Senior VP of Operations for Three Rivers. “We run a tight inventory system, double-checking on every pick and every pack. Going to an electronic system was good, but it has taken a lot of time to adopt new practices.”
Getting operators comfortable with the idea of new technologies was the first step. To ensure it selected the right mobile devices, Three Rivers asked vendors to send in sample devices, then assembled operators in a conference room and let them play with the collection for a few hours. The operators together chose the instruments they liked best—in this case, scanners from LXE.
The next hurdle was the necessary validation steps, says Sheehy. This took about three months, and so once clearance was given to use the new system, operators required another familiarization period.
Finally, new technologies present unforeseen issues. For Three Rivers, it was incorporating the wireless technology needed for the handheld scanners into its current network infrastructure. The scanners did not work well in all parts of the facility, and so plenty of tweaking was required to get things just right, Sheehy says.
On the whole, Three Rivers’ experience with going to electronic handheld devices was a challenge, but one that they had prepared for. Sheehy’s advice: Plan well, include operators in the process, and train them appropriately. If you don’t, you run the risk of implementing devices that will be fraught with problems and unwelcome by those that use them.