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Walk the floor, look at visual gauges, make checks on a clipboard, take a sample, analyze it, and calculate results. Forty-five minutes later [or even longer] when lab results are ready, there's either a whole lot of out-of-specification scrap, or the process may have done six other things since then.

By Mark T. Hoske, editor-in-chief November 1, 2004

Walk the floor, look at visual gauges, make checks on a clipboard, take a sample, analyze it, and calculate results. Forty-five minutes later [or even longer] when lab results are ready, there’s either a whole lot of out-of-specification scrap, or the process may have done six other things since then. This isn’t a recipe for repeatability, productivity, stringent quality control, nor for cost-effective manufacturing. Yet it’s how many processes operate, and it makes those who regulate foods and drugs, among others, very nervous.

The gap between what technologies offer and what’s being implemented in plants has prompted the U.S. Food and Drug Administration to encourage greater use of technologies, including more inline process analytics. The FDA report is called “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century.” (See link online.)

“There’s a realization that many people have no idea of what’s going on during a process,” much less the ability to make adjustments in realtime to ensure product quality, suggests Marijn E. Dekkers, president and CEO of Thermo Electron Corp. In a previous position, Dekkers was in charge of automation at a plastics plant that used offline sampling. “If we could have only measured in real time to see if we were making the right stuff.” Now it’s a bit unnerving that “we have many technologies ready to move to inline applications that haven’t made it yet into applications. [But] we’re making tremendous progress as an industry.”

Despite progress in offerings, Dekkers estimates perhaps 90% of installations are not using inline process technologies now available. That leads to lower quality, unnecessary scrap, and wasted resources. Does this impact productivity? Consider differences between a new plant with the latest controls versus 20-year-old controls. In the years following post-WWII reconstruction, newer Japanese manufacturing facilities eventually delivered a stern challenge to U.S. automotive manufacturers. Similarly, without upgrades, U.S. manufacturing could lose competitiveness compared to the newest plants now under construction in China and elsewhere.

Innovation is the heartbeat of any company and the number one concern of chief executive officers worldwide, Dekkers says. For the process industries, that includes getting more intimate with processes in real time.

Dekkers made the comments at the Measurement, Control, and Automation Association (MCAA) breakfast, during the ISA 2004 show in Houston; for more on product development, technology transfer from labs to real-time applications, and related links, read this online at www.controleng.com .

Mark T. Hoske, Editor-in-Chief

MHoske@cfemedia.com

Related reading
For more advice on innovation and a link to the FDA’s “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century,” read this from Control Engineering…
“MCAA: Innovation asks questions; new FDA report.”