- December 10, 2015
- Case Study
MES helps medical device manufacturer save 300+ man-hours a year, drive continuous improvements, maintain compliance, and achieve ROI in 10 months.
December 10, 2015 - Medi Manufacturing has streamlined data collection and improved quality assurance with InfinityQS ProFicient. Using the enterprise quality software at its Whitsett, North Carolina, facility the medical device manufacturer saved over 500 man-hours a year, enabled continuous improvements, maintained compliance with industry regulations, and achieved ROI in 10 months.
With InfinityQS ProFicient, an enterprise quality hub powered by a centralised Statistical Process Control (SPC) software engine, medi has enhanced control over product quality and safety with a systematic approach to data collection. The software’s Dynamic Scheduler provides operators with a list for scheduled quality checks and notifies them when data collection is needed. Also, by integrating ProFicient with its shop-floor machines, medi has reduced its manual, paper-based processes and enabled real-time data collection and analysis across departments – eliminating more than 500 labour hours per year. In addition, by monitoring error codes and addressing them with Assignable Cause and Corrective Action, medi is taking a more proactive, rather than reactive, approach to maintaining its equipment and processes.
Sedrick Bigelow, quality assurance manager, medi, said, “InfinityQS ProFicient was an ideal fit for replacing our homegrown quality system. It not only met our initial requirements for software validation and ease of use, but has also extended our data collection and reporting capabilities to support our continuous improvement efforts. We are able to use the insight, or Manufacturing Intelligence, acquired from the data we collect to continue ensuring customer satisfaction and safety.”
Notably, in just one week, medi validated ProFicient to ensure compliance with industry regulations. With an InfinityQS third-party affiliate and InfinityQS’ thorough template and work instructions, the process was quick and simple, whereas it would have taken six months if performed by medi’s own staff.
Michael Lyle, president and CEO, InfinityQS, said, “With a growing number of regulations, like the Federal Drug Administration’s (FDA) 21 CFR Part 11 and Part 820, medical device manufacturers face increased pressure to meet compliance requirements, while maintaining quality. With enterprise quality management software, manufacturers like medi can easily collect, access and analyse the data needed to not only satisfy reporting requirements, but also to uncover opportunities to improve processes and keep consumers safe.”
InfinityQS ProFicient enables global manufacturers to proactively monitor, analyse, and report on manufacturing processes to improve quality, decrease costs, and make smarter business decisions. ProFicient’s flexible deployment makes it an ideal manufacturing software solution for various industries, such as food & beverage, automotive, medical & pharmaceuticals, packaging, aerospace & defense and general manufacturing.
About InfinityQS International, Inc.
InfinityQS International, Inc. is the global authority on Manufacturing Intelligence and enterprise quality. The company’s Manufacturing Intelligence platform, ProFicient, delivers real-time visibility from the shop floor, across the enterprise and into the supply chain, allowing top manufacturers to take control of quality. Powered by a centralized statistical process control (SPC) analytical engine, ProFicient manufacturing quality software leverages Manufacturing Intelligence to help global manufacturers improve product quality, decrease costs, maintain compliance and make smarter, data-driven business decisions. Headquartered near Washington, D.C., with offices in Seattle, London, Koblenz, Beijing and Shanghai, InfinityQS was founded in 1989 and now services more than 40,000 active licenses with over 2,500 of the world’s top manufacturers including Kraft Foods, Ball Corporation, Boston Scientific, Graham Packaging, and Medtronic.Learn More
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