The Quest for Quality

Ray Peacock

Process and discrete manufacturers have pursued quality assurance with varying degrees of intensity. The current creed, process analytical technology, has found a home in some industries and missed the mark in others. Guess who's onboard.

Pharma and Food Processing
My visit to INTERPHEX in April confirmed the predominance of process analytical technology (PAT) in the pharma and food-processing industries. The goal of PAT is to understand and control quality in manufacturing through statistical control processes.

The strong culture that embodies PAT has been built in less than 10 years under the urgings and dictates of the Food and Drug Administration (FDA). This culture is reinforced and spread through education programs, such as the 150 short courses and advanced seminars offered this year by The Institute for Applied Pharmaceutical Sciences of The Center for Professional Advancement.

Visits with sensor and control vendors at INTERPHEX showed me that the big automation system houses—such as ABB, GE, Emerson Process, Honeywell, Invensys, and Siemens—and smaller outfits and instrument specialty companies—such as Weed Instruments, WIKA, and Burns Engineering—are supporting PAT through a strong focus on the National Voluntary Laboratory Accreditation Program and products.

It's no wonder that PAT has such a strong hold on these industries. In addition to being in line with the economic interest of manufacturers and the well-being of consumers, PAT is mandated by FDA. That's more initiative than you get in most industries to do things right.

Automotive and Manufacturing
This is borne out by the clear distinction between the trend in the food-processing and pharma industries and similar efforts underway in the automotive and other manufacturing industries. In automotive, the evident foot-dragging by U.S. companies is reshaping the industry's hierarchy. Toyota has surpassed Ford in car volume and profits, and it may well do the same with GM on an annual basis very soon (it did so last quarter). Catch-up is really hard when the guys you are chasing are moving faster than you and making real money to boot.

I have plaques on my wall from courses I took from Tennessee Associates 17 years ago covering the same subjects, with the same goal: product quality assurance. I was working for a U.S. steel company at the time, and the quality initiative had been impressed upon us by the automotive industry. We called it statistical process control, or SPC, but the goals and the methods were the same.

My former employer went out of business five years ago because too many of its top and middle managers were not convinced of the truths in the quality initiative. In fact, the entire industry suffered. The initiative was not implemented very well, and the industry never really embraced it. They also didn't have an FDA to keep them on the straight and narrow path to success in product quality.

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