Challenge

A major part of the manufacturing process for this major medical device manufacturer based in the Twin Cities is the packaging of the devices that are delivered to hospitals for use. If they put the device into the wrong box, they could be charged substantial fines and have traceability issues making accuracy very important. It is imperative that the same unique product information is on the product and paperwork, as well as internal and external packaging in the event of recalls. As the company grew, they discovered they needed a better system to ensure packaging was done correctly and accurately.

Solution

Coridian’s software application team developed a validation program for this manufacturer that cross checks different items for specific information. The program validates that the work order, product, pouch label and the box label all match. It looks for the expiration data, lot number and reference number, and if any of these fields don’t match the work order, an error is displayed and it must be corrected before starting the process over again. The program also stores data to confirm that the validation has been done and the time and date it was completed. Coridian not only developed this program for the company, they also helped design a custom set label. This set label contains various labels that are used on pouches, paperwork and boxes. This set label travels with the product from the start to end of the process and labels are taken from the set as required. Having one label set with all the needed labels as one piece helps ensure the unique serial number doesn’t get applied to another product.

Results

With this new validation program, the company can be sure they are sending the correct part to the hospital. This fulfills their FDA requirements, and ensures the hospitals have the correct devices, which is very important to patient safety. The company’s increased efficiencies protect their brand and add value to their organization.

Download Case Study PDF