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medi Manufacturing is one of the world’s leading manufacturers of medical compression products, orthopedics, prosthetics, and compression sportswear. Headquartered in Bayreuth, Germany, medi applies 60 years of German design, research, and manufacturing to garments for people who suffer from venous disease, lymphedema, swelling, and varicose veins. medi’s products are available through distributors, pharmacies, retailers, and hospitals in more than 125 countries.
As a Medical Device manufacturing company, medi is committed to delivering quality garments that consumers feel safe and confident wearing. At its Whitsett, North Carolina, facility, medi was using its own proprietary software for data collection and quality monitoring in its manufacturing processes. However, error codes in the software produced a large amount of paperwork because operators could not easily make changes to incorrectly entered information. Making corrections often took as long as an hour and a half, and duplicate data entry created variations in reporting.
Also, in order to maintain compliance with medical safety regulations on technology used in manufacturing, medi needed to validate its software to demonstrate its reliability and effectiveness. The homegrown system was outdated, and medi was uncertain whether it could satisfy the strict validation requirements. Rather than continue with its homegrown software, medi sought a new solution that could drive quality improvements and increase efficiency while facilitating the validation process.
medi found its answer in InfinityQS®
ProFicient™, an enterprise quality hub powered by a Statistical Process Control (SPC) analysis engine. medi installed ProFicient on its Whitsett facility’s terminal server and purchased 30 user licenses. To provide medi’s shop-floor operators with an intuitive experience, InfinityQS custom-configured ProFicient’s graphical user interface. Before the “go-live,” an InfinityQS third-party affiliate validated the software to ensure compliance with industry regulations. Validation by medi’s own staff would have taken six months; with InfinityQS’s thorough template and work instructions, it took only a week.
With InfinityQS’s Dynamic Scheduler, medi’s operators now obtain a shop-floor checklist for scheduled quality checks and receive notifications when data collection is needed. Dynamic Scheduler automatically notifies key personnel if data collection is not performed, ensuring quality checks are completed in a timely manner.
To reduce manual input, save over 500 labor hours per year, and improve data collection, medi integrated a number of its machines with ProFicient: knitting, dyeing, sewing, finishing, returns, and final inspection. In some cases, medi enabled measurements to feed directly into the database. A key integration is with the CMD-100 machine, which checks stocking compression. medi’s stockings have multiple levels of compression to accommodate different severities of affliction; too much compression can be harmful.
In the returns department, quality assurance managers use ProFicient to track returns and customer complaints (stockings too tight or too long, susceptible to holes, or with inaccurate measurements). medi can then review a Pareto chart to identify patterns and pinpoint which items are producing a high number of returns or complaints. From there, medi can make corrections to their processes.
medi also uses ProFicient in its final inspection department, where the company requires 100% inspection of its stockings. Inspectors can now easily scan a barcode that pulls a stocking’s measurements from the database, enabling a quick pass-or-fail determination.
- Completed software validation in just a week, a task that typically would have taken medi’s staff six months
- Minimized errors and paperwork by increasing the accuracy and efficiency of data collection
- Enabled continuous improvement through advanced reporting and charts
- Saved the 100-person manufacturing staff approximately 300-350 man-hours per year in data corrections and accuracy
- Eliminated more than 500 labor hours per year by integrating many production machines with ProFicient
- Achieved ROI within 10 months of implementing the software
In addition to streamlining regulatory compliance, ProFicient has helped medi gain control over product quality and safety with a systematic approach to data collection. With advanced reporting capabilities, quality assurance managers are better able to make data-based, informed decisions that drive continuous improvement.
By monitoring error codes and addressing them with Assignable Cause and Corrective Action, medi takes a more preventative — rather than responsive — approach to maintaining its equipment and processes. Error codes can help indicate if a machine requires maintenance or is about to break down. If a specific machine is repeatedly producing errors, a report is issued and quality assurance managers can notify mechanics to address the problem before the machine fails. Previously, generating such reports took four hours; now, it takes between five and 10 minutes.
Also, ProFicient has helped medi minimize errors and paperwork by increasing the accuracy and efficiency of data collection. Without the need to correct errors or enter duplicate data, medi estimates that it is saving 300-350 man-hours per year. Moreover, the company achieved a return on investment (ROI) within 10 months of implementing the software.
medi plans to introduce ProFicient’s Data Management System to gather and compare quality-related data from multiple departments for real-time insight into its manufacturing processes. medi also hopes to implement ProFicient's Lot Genealogy to trace the root causes of quality issues back to suppliers and vendors.
Sedrick Bigelow, medi’s Quality Assurance Manager, 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.”
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