Medical device manufacturer, medi Manufacturing, is committed to delivering medical garments that consumers feel safe and confident wearing. Therefore, it is vital that the company employs an effective quality program to ensure that its compression products, orthopedics and prosthetics have the right fit.
At its Whitsett, North Carolina, facility, medi was using its own proprietary software for collecting data and monitoring quality in its manufacturing processes. However, error codes in the software produced a large amount of paperwork because operators could not make changes to incorrectly entered information. Making corrections often took as long as 90 minutes 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 The homegrown system was outdated and medi was uncertain if it could satisfy the strict validation requirements.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 at the same time facilitating the validation process.
A ProFicient Solution
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 licenses for 30 users. To provide medi’s shop-floor operators with a more intuitive experience, InfinityQS customized and configured ProFicient’s graphical user interface. Prior to the “go-live,” a third-party affiliate validated the software to ensure compliance with industry regulations. Previously, validation would have taken six months (with medi’s own staff), whereas it took only a week due to the inclusion of an established template and work instructions with the software to guide the process.
With InfinityQS’ Dynamic Scheduler, medi’s operators 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 the amount of manual input and ultimately save more than 500 labor hours per year, medi integrated a number of its machines with ProFicient, to collect data across its departments, including knitting, dyeing, sewing, finishing, returns and final inspection. medi even integrated some machines to feed measurements directly into the database. A key integration is with the CMD-100 machine, which checks stockings’ compression. medi’s stockings have multiple levels of compression tolerance that are dependent upon the severity of affliction—it is important to make sure there is not too much compression, which can be harmful.
In the returns department, quality assurance managers are using ProFicient to track returns and customer complaints, such as whether stockings are too tight or too long, are susceptible to holes, or if they have inaccurate product measurements. medi can then export this information into a graph, like 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 the processes involving the products in question.
medi also uses ProFicient in its final inspection department where the company requires 100-percent inspection of its stockings. Inspectors can now easily scan a barcode that pulls a stocking’s measurements from the database, quickly determining if it passes or fails the inspection.
Realizing Results & ROI
In addition to streamlining compliance with industry regulations, InfinityQS ProFicient has helped medi gain control over product quality and safety with a systematic approach to data collection. With this information and reporting capabilities, quality assurance managers are better able to make data-based, informed decisions that drive continuous improvement.
The software has also enabled medi to instill a more preventative—rather than responsive—approach to maintaining its equipment and processes by monitoring error codes and attaching Assignable Cause and Corrective Action notations to each event. Errors codes can help to indicate if a machine requires maintenance or if it 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, it took four hours to generate a report, whereas it now takes 5-10 minutes.
Also, medi has minimized 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. Notably, the company achieved a return on investment (ROI) within 10 months of implementing the software.
Looking ahead, medi plans to introduce ProFicient to gather and compare quality-related data from multiple departments for real-time insight into its manufacturing processes, or Manufacturing Intelligence. medi also hopes to implement lot genealogy to trace the root causes of quality issues back to suppliers and vendors. These continuous improvement efforts will play a key role in ensuring consumer safety and satisfaction now and in the future.