Integrating 21st century metrology into FDA-mandated quality systems provides many benefits. Here are just a few…
In our three years serving the medical device industry, we at L3I have closely studied the FDA’s exacting Good Manufacturing Practice (GMP) and quality system requirements in light of our many prior years of experience serving the aerospace industry. Aerospace manufacturers, being just as tightly regulated as medical device manufacturers, already know the many advantages that Computer Aided Inspection (CAI) can provide in their ongoing efforts to build better engines and airfoils at a faster turnaround.
We’ve narrowed the many advantages of CAI to six broad categories of greatest interest to medical device manufacturers.
Advantage:
Benefit:
Secure andArchiveable
CAI tools save comprehensive surface data instantly. You can keep your measurement data for decades, ensuring a lasting command of your company’s legacy intellectual property for future revisions or study. This also simplifies the process of ensuring compliance with the strict and changing archive requirements imposed by many countries.
Auditable for regulatory inquiries
Given correct information technology practice, CAI data are immune from tampering. When secured in a database that cannot be changed once logged, you have incontrovertible evidence of a watertight quality system when FDA inspectors knock on your door. If necessary, CAI can allow you to prove that every surface point of your product was within spec at every point during manufacture.
Traceable for staff accountability
Gauge R&R studies demonstrate that CAI incorporates no operator-dependent error. All manufacturing and quality personnel can be held accountable for their respective step in recording engineering data. Every step in manufacturing is linked to a comprehensive dimensional inspection process, and no measurements are taken by anonymous users.
Trackable for failure analysis
CAI allows manufacturers to track inspection data through the process to find the root causes of failures systematically, rather than by trial and error. Intelligent surface data analysis provides quick and effective tracking from why-gate through why-gate. There is no longer any need (or excuse) for multiple iterations.
SPC Trendable
CAI data are immediately and continuously transferable into statistical process control (SPC) frameworks. By trending dimensional changes, manufacturers can catch emerging anomalies before they grow into costly problems. And by driving these new insights upstream into design, prototyping, and tooling, manufacturers can improve their understanding of tool and machine wear, reducing the frequency of planned shutdowns.
Admissible in litigation
High-profile court cases (based on questionable premises) have proliferated against the industry in recent years. With Computer Aided Inspection (CAI) data, manufacturers now have a powerful defensive tool in depositions or the courtroom. CAI provides incontrovertible evidence that every surface point of your part was within spec, when questioned by plaintiffs’ attorneys.
Over the next several months, we’ll be sending a series of informational messages to elaborate on these advantages to help our medical device friends and partners move forward into comprehensive integration of CAI into their processes and workflow.
