To expand its expertise in quality assurance and metrology for complex
medical devices, Lowell recently added Alejandro Romero as quality assurance
manager.
Alejandro brings more than 20 years of experience to the role, with
deep knowledge of test method validation; process, product and tool validation;
measurement system analysis; exploratory data analysis; geometric dimensioning and
tolerancing; and multi-sensor CMMs.
What is your background in
metrology?
Before starting at Lowell, I worked for Vention Medical, a medical
device manufacturer, where I was part of the Quality Corporate Group. I held
the subject matter expert role in metrology, supporting the seven device manufacturing
services facilities in the USA, Puerto Rico, Costa Rica and Ireland. I helped
design and implement a metrology platform that standardized the test methods in
order to provide portability and efficiency.
Prior to Vention Medical, I worked for SMC Inc. East Coast, where I was
the senior metrologist. I mainly focused on supporting the engineering and design
and development teams with metrology requirements, statistical analysis and the
development of robust test methods.
How are GD&T and metrology
influencing quality assurance?
Any human activity progresses as fast as tools do – quality assurance
it is not an exception. The acceptance of system solutions for quality
management and compliance with the ISO 13485 and 9000 series of standards means
that many companies have to face concepts such as uncertainty, calibration and metrological
traceability.
Coordinate metrology and GD&T provide a scientific basis for
carrying out measurements of 3D geometric objects. The accuracy and realization
time are matched to the manufacturing rhythm. Because of new technologies and scientific
developments, the scope of applications of these systems is constantly growing
and measurement accuracy is increasing.
It is important to note that just a few decades ago, the inspection
capabilities were dissociated. It was common to find a multi-step inspection
that was composed of results from contact-based devices (CMM Tactile/Contact),
optical (CMM Optical) devices and laser technology, among others tools. This
created long inspection times and excessive handling of the product. The modern
multi-sensor machines drastically reduce the inspection time since they provide
the possibility of different sensors working simultaneously under the same
datum reference frame setup.
Design for manufacturing and
additive manufacturing are two methods defining the future of medical device
manufacturing. How are you seeing these impact quality assurance?
A basic principle states that the manufacturing process dictates the final
product’s risk level, inherent to such process. Additive manufacturing – which
many specialists characterize as the first revolution of the 21st
century! – will certainly force quality assurance teams to adjust the
traditional techniques or, in some cases, even develop a completely new
approach. Unlike subtractive manufacturing methods that start with a solid
block of material and then cut away the excess to create a finished part,
additive manufacturing builds up a part (or features onto parts) layer by layer
from geometry described in a 3D design model.
The DFM (design for manufacturing) approach’s focus is to design for
lower cost. The cost is driven by time, so the design must minimize the time
required to not just machine the part, but also minimize the setup time of the
CNC machine, NC programming, fixturing and many other activities that are
dependent on the complexity and size of the part. It’s important to remember
that this method requires a well-defined strategy that unifies the technical,
commercial and regulatory goals.
What makes Lowell’s approach to
quality assurance unique?
We reach and exceed our customers’ expectations through experienced and
well-trained personnel and state-of-the-art test equipment, manufacturing
protocols, opportune preventive maintenance, and calibration and gage
management. These are integrated under the umbrella of precise and flexible
manufacturing cells. The addition of a world-class metrology control room and new
CMMs reinforce the Lowell Inc. commitment to precision as our priority.
What do you find most interesting about your work?
This line of expertise evolves constantly and its interaction with the
rest of the quality system always demands our complete commitment to maintain a
critical, proactive attitude all the time. Every product implies a challenge
and the company mission statement – “Our purpose is to manufacture value into
all that we do” – inspires me to work in harmony with it.
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