2020

MY QUALITY STORY

When Opportunity Knocks

You never know where your quality career might take you

by Lin Fu

Some of my friends have asked me, “How did you end up as a quality manager?” To be honest, I don’t know—I never planned to be a quality professional in the medical technology industry. What I do know is this: Always be prepared when an opportunity comes along.

Design of experiments

My first exposure to quality engineering was during my graduate studies in microbiology at Beijing Normal University, China. At the time, I had an opportunity to work with a biotech firm in Beijing developing a novel bioconversion process for agricultural waste.

Part of the project requirement was to optimize the bench-scale fermentation, which was associated with many condition variables, including the culture medium formula, temperature and agitation speed. The estimated number of trials I had to run was more than 1,000. This certainly sounded frustrating, so I asked the project team for help.

Thankfully, the director of quality advised me and introduced me to design of experiments (DoE), a powerful quality engineering tool for process optimization. With the help of DoE, I successfully optimized the fermentation process sooner than I expected and delivered my project on time and on budget.

Six Sigma and continuous improvement

After graduating with my master’s degree, I started my career as a research chemist at Dow Chemical Co. During my first-year research project rotation, I received lean Six Sigma training and certification. It was a fantastic learning experience because it not only provided me with a set of sharp tools for my work, but it also changed my understanding of what continuous improvement means.

Following my first year in Dow’s R&D center, I was assigned to lead a productivity improvement project in one of the organization’s plants. My technical background and continuous improvement mindset had prepared me well for leading this challenging project.

Without hesitation, I developed a working plan and assembled my first Six Sigma project team. Our team solved multiple technical challenges using Six Sigma techniques including DoE, failure mode and effects analysis, and root cause analysis. Most importantly, we made high-quality products at a production speed two times faster than the original goal.

My experience at Dow provided me with the scientific background necessary to ensure continuous improvement in production quality at my workplace, but I had never thought of quality management as a career.

A whole new world of quality engineering

About five years ago, I decided to make some changes in my life. I came to the United States and took a position as a production chemist at a small medical device manufacturer. A few months after I started, the organization went through its first U.S. Food and Drug Administration inspection. It also was my first time being part of an audit. Not knowing what to expect, I didn’t prepare.

Although the results were good and the auditor was friendly, I was nervous. I still remember how loud my heartbeat sounded during the audit—I couldn’t hear anything else.

That auditing experience made me realize that I needed to pursue quality management knowledge, techniques and methods. The support and encouragement from my employer convinced me to pursue ASQ quality engineer training and certification.

After six months of intense studying, I passed the exam on my first try—a feat of which I am still proud. Thanks to ASQ's training, I saw a whole new world of quality engineering applications and realized that my quality engineering journey had just begun.


Lin Fu is a quality manager at Innovative Surgical Designs in Bloomington, IN. Fu is a member of ASQ and an ASQ-certified quality engineer.


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