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Software System Improves Medtech Process Control

By compelling operators to document every step of the manufacturing process, a software system ensures process compliance, enhanced quality control, traceability, and increased productivity.

Kyle O'Reilly

Using a production information form to enter the work order, quantity, and takt time associated with a job, a manufacturer can achieve part traceability.

In the medical device field, quality is paramount; there is no room for defective finished products. Thus, while medical device companies are always looking for ways to maintain productivity, they must also strive for good quality control and standardized processes. To achieve these objectives, they need to employ the right software.

One such option is VKS, a browser-based application that was originally developed to provide an easy solution for building and viewing manufacturing work instructions. Built and developed by a manufacturer, the software now goes beyond simple work instructions. It can also guarantee process compliance, provide full traceability for all parts used in a plant, and ensure that manufacturing processes conform to best practices.

Most medical device manufacturers collect QC data manually on spreadsheets—a cumbersome procedure that hinders them from fully exploiting the data for process control purposes. In contrast, VKS allows companies to embed their inspection points directly into the work instructions, enabling full custom frequencies ranging from time and workpiece to part count and the specific manufacturing step. Authors composing work instructions can use standard templates to document such specifics as nonconformance, final inspections, and critical dimensions, or they can create custom forms from scratch.

Using an assembly work instruction form, an operator can follow along and insert screws into a part. In this step, the operator's tool is connected with the software system.

Customizable checklists, questionnaires, or data-input fields, the forms are important because they not only collect live quality data directly from the shop floor but also promote operator accountability. When prompted by a form in-process to complete an inspection, operators may not skip over it and proceed to the next step. To proceed, they must fill out the form and save it, which acts as a digital signature. Because all operators must sign in using their own log-in information, the system is always aware of who is doing what and when. By filling out and saving their forms, operators promote accountability and ensure the traceability of all jobs being run. And by compelling the operators to fill out the forms, the system also ensures that scheduled inspections take place on time, ensuring process compliance and enhanced quality control.

All of the data collected in the forms are stored in the software’s reporting section, enabling managers to see who is logged in and what jobs they are processing. Anytime a job is opened, a report is generated for the specific work order or part number, allowing managers to search for completed jobs while ascertaining who worked on them, when they were worked on, when they were finished, how many parts were manufactured, and how long it took to manufacture them. The system also documents efficiency markers, cycle times, and takt times. In addition, it provides a screenshot of every form that appeared throughout a job, when it appeared, and how it was filled out, providing 100% traceability for every job.

Kyle O'Reilly is sales and marketing manager at Visual Knowledge Share Ltd. (VKS), based in Chateauguay, Quebec, Canada. Reach him at [email protected].

To learn more about process control software,
visit VKS at
MD&M East,
New York City, June 9–11, booth 345.

TAGS: News
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