Like anyone else, when I plan for the new year, I need to set aside time for reflection and anticipation. I look back and ask, “Have I made a difference in anyone’s life?” I look forward and ask, “What do I want to change that I either have control over or can influence?” For people working in the pharmaceutical industry, these questions are not only personal but also professional.

The quality assurance professional should always have the sense of a high calling. That calling needs to go beyond being the “checker” who culls out the defects to being the applied scientist or engineer who helps to design quality into the product.

This reminds me of the dear soul who proudly showed me the bucket of discarded product that she plucked off the conveyor belt. The occasion was a plant tour to understand how this company saw the role of the quality function. The next stop on the tour was the QC lab that was backed up with samples. Analysts were randomly selecting their favorite tests to squeeze in before their next coffee break. It didn’t take long to determine that the view of the quality function at this client was anchored in… approximately the 1950s.

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