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Recognizing that managing a paper-based quality system was no longer practical, the company took steps to modernize with digital solutions.
May 5, 2021
By: David Butcher, Staff Writer, MasterControl
Weaver and Company manufactures two products that are routinely used in electroneurodiagnostic (EEG), neuromonitoring, and sleep study procedures. The medical device company’s mildly abrasive gel is used to prep a patient’s skin before electrodes are attached, while its conductive paste goes inside the small electrodes to ensure they remain attached to a patient’s scalp. Since its founding in 1978, the Aurora, Colorado-based company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the company has taken steps to modernize with digital solutions. Problems with Paper Before MasterControl, procedures and production records at Weaver and Company were printed out and completed by hand. Typed procedures also were printed as hard copies, and when a form was needed, someone had to “go find it, make copies of it, handwrite it or scan it, and try and type over it,” according to Nicholas Lee, Weaver and Company’s regulatory compliance manager. Collaboration was also a challenge, with personnel emailing files back and forth. A large driving force for digitizing with MasterControl was the risk of losing or damaging physical paper records during production—as vital documents move through various stages of the manufacturing process—or after—with the possibility of stored paper records being destroyed due to a natural disaster. Seamless Implementation Lee, who started in production before moving into his role overseeing quality at Weaver and Company, didn’t want to prolong the process of digitizing quality and production records more than necessary. As a company with 19 employees, two products, and two master production record templates, it made sense for Weaver and Company to implement MasterControl’s electronic quality management and electronic manufacturing solutions at the same time. He was impressed by how easy and seamless the whole process of digitizing these records was. “It’s kind of scary and a little bit daunting to think that we’re moving our entire QMS to the electronic world. But the way that it was implemented, methodically, worked for us—it was pretty simple,” according to Lee. “I was really happy with how quickly we were able to implement MasterControl’s quality and manufacturing solutions at the same time.” Immediate Information Access Weaver and Company bought a touchscreen computer for the mixing lab, where much of the work takes place, and got an iPad for everybody on the manufacturing floor. Employees in packaging and filling now also use iPads for mobility. Rather than fill out paper and sign documents, workers in the production area now electronically report all the inputs the company wants to document, going through the record right then and validating systems. Using digital solutions to remove paper in the production booth has improved access to real-time data and visibility of the entire production lifecycle. “I see record retrieval, the ease of access to information, as a big value for us,” according to the company’s president, David Weaver. “I’m very confident that MasterControl will add a lot of value, including in ways we don’t know about yet.” Fast Review and Release For Weaver and Company, the batch release process before using MasterControl took too long. “It would go through quality assurance (QA) testing, so we would have to walk the entire paperwork packet over to the lab. And then they’d do their testing, fill out the forms. And then it would come back to me, and then I would review it, and it would go to somebody else who would review it, do another accurate count of finished goods before they would release it in NetSuite,” Lee said. Using MasterControl’s electronic production records, Weaver and Company can easily release product every day without having to carry paperwork to different departments. The time to release a batch has roughly been halved because no time is spent waiting for somebody to add their information. “MasterControl is probably the greatest investment we’ve made for streamlining our processes and getting rid of paper,” Lee said.
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