Jason McGlynn, director at industrial metrology specialist The Sempre Group, explores how quality 4.0 can revolutionise medical plastics measurement.
The dimensions of medical-grade, biocompatible plastics and polymers are critical for ensuring medical device functionality, quality and compliance. But what is best practice for their measurement, and how can manufacturers improve the management of quality data?
When using any measurement system to assess plastic medical components, if they operate in silos, key quality data can become isolated. While manufacturers can still collect the data required to validate parts, if systems are kept separate, they are unable to glean insights that can help improve medical device production quality, increasing the risk of unexpected defects or worse, recalls.
A quality management system (QMS) is essential for managing measurement data in line with industry standards. Industry 4.0 has introduced a solution to potentially siloing, by centring upon a data-driven approach that can help medical device manufacturers improve decision making and facilitate communication between their automated measurement systems.
The future of quality management works on these same principles — Quality 4.0 digitises and connects the entire process from drawing to reporting. This approach removes the challenge of integrating data from fragmented sources, reduces human error and improves productivity. So, what does Quality 4.0 involve?
From drawing to final product
Every plastic surgical component, device casing or housing begins with a conceptual drawing. Converting 2D drawings into functioning medical components traditionally required engineers to manually outline all the individual dimensions and create a ballooned image that acts as a guide when manufacturing the final product. As Quality 4.0 capabilities evolve, manufacturers are using automated solutions like High QA Inspection Manager to automatically populate First Article Inspection (FAI), Production Part Approval Process (PPAP) and Initial Sample Inspection Reports (ISIR).
By automating the ballooning process, medical device manufacturers can monitor process control more effectively, identify trends and reduce errors. This means healthcare facilities and other customers can be confident in the plastic part’s compliance and ability to meet the application’s needs. Automation also removes the risk of human error caused by engineers inputting the wrong data.
Following the ballooning stage, augmented reality (AR) systems like ARKITE can guide operators through the assembly process, by projecting instructions for them to follow. As well as reducing assembly error, this digitally confirms when every operation is complete and records data for full traceability.
Improved visibility
Prolink SPC universal data collection and analysis software is a good example of manufacturers bringing all of their measurement data together. Prolink allows manufacturers to automatically collect data from any metrology or manufacturing system and outputs the results in the same format for reporting. This plug and play platform extracts real-time result data from any machine, enabling full visibility across multiple site locations.
Quality 4.0 provides medical device manufacturers with a 360-degree view, so they can use data generated insights to improve the production process.