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.
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
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
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.