An Interview with Lowell Quality Assurance Manager Alejandro Romero

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 21^st 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.