The Future of Inspection, Part 1: Secure and Archiveable
Integrating 21st century metrology into FDA-mandated quality systems provides many benefits. Here are just a few...
Secure and verifiable data archiving, for years the standard in
aerospace inspection, is now under increasing demand for medical
Medical device manufacturers face a number of inspection challenges –
some common to all precision manufacturers, others unique to their
industry. Among these challenges are evolving design parameters and
manufacturing methods, a deficiency in legacy part knowledge, and
ever-stricter archiving standards imposed by many national regulatory
The truth is that today’s manufacturers should be archiving all inspection
data. Equally true is that design changes in the medical device
industry remain too slow and far too expensive. Faster innovation,
faster product development, and faster manufacturing process
optimization are keys to success in the increasingly demanding and
competitive industry. Manufacturers need legacy part information for
reference in designing current/future product lines – to say nothing of
reverse engineering legacy parts to make them better while using modern
computer-aided technologies for production. And with the glut of
lawsuits and regulatory inquiries, manufacturers need to arm themselves
with greater information resources and faster, easier access to their
own dimensional, quality, and other manufacturing data.
Traditional inspection methods don’t solve any of these problems.
CMM’s don’t archive data automatically (if at all), at best churning out
an unverifiable table of numbers. Optical comparators and fixed gauges
don’t output data, but instead rely on the non-reproducible eyes of
inconsistent shop floor employees. Fortunately, modern technological
solutions now exist that automatically and verifiably collect,
analyze, report, disposition and archive all dimensional manufacturing
process and resulting product information as decisionable data, for a
myriad of uses.
Such data can be made demonstrably tamper-proof for
defense against litigation and in regulatory requests for information,
via checksums and digital signatures. Manufacturers can review past
process and part data for quick and efficient reference, trending, SPC,
CAD model creation, and many other applications. Best of all,
self-contained integrated and automated Computer Aided Inspection (CAI)
systems can be installed in manufacturers’ facilities, minimizing
turnaround time, reducing iterations, and eliminating inspection delays.