Managing Your Process Improvement Efforts

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by Caron Carlson

The Alcon Manufacturing Ltd. plant in Sinking Spring, Pa., process improvement is led by the quality assurance division. At Command Medical Products in Ormand Beach, Fla., the same chore is overseen by the vice president of operations. At other companies, management might try to involve anyone and everyone, down to the shop floor.

Process improvement is one of those things everyone in the C-suite and the boardroom talks about; indeed, the point of the Sarbanes-Oxley Act, data privacy rules, and a host of other regulations is to force companies to examine their business processes for flaws, and management gurus constantly say companies should use the opportunity to improve processes while they're at it.

Alcon's Pennsylvania facility, which employs roughly 500, makes tiny surgical devices. The company, known for its eye care products, is subject to Food and Drug Administration regulations, and its process improvement initiatives are lead by the quality assurance unit, which includes regulatory affairs and compliance.

Among the many federal regulations Alcon complies with, an FDA rule known as 21 CFR Part 11 is one of the most stringent, says Curt Gendler, senior validation engineer at Alcon. The rule requires companies to maintain electronic records that are secure, traceable, and quickly retrievable.

About three years ago, the quality assurance department began deploying statistical process control software from InfinityQS International to automate data collection and analysis. The software uses statistical analysis to generate data via control charts and alerts. At the same time it improves processes for the purpose of compliance, it also helps improve operational efficiencies, Gendler says. Because many of the tiny medical components made at the plant must be crafted by hand, the company faces considerable challenges generating process improvement through automation.

"Our engineers are always looking at how the human does this and how we can do it a little faster and still maintain the artisan approach," Gendler says. "We won't forego quality for speed. That will never happen."

The InfinityQS software allowed Alcon to improve speed by incorporating quality control into its manufacturing. The product is inspected at each step of production, rather than at the end only. Production workers have more control over the process, and the potential for errors is reduced. The first implementation reduced inspection time by about 50 minutes per lot, saving the company the equivalent of one full-time employee, Gendler says.

While Alcon's quality assurance experts lead process improvement, projects are always a team effort, with a heavy reliance on IT for support, Gendler says; his own position, while officially deemed one of quality assurance, in reality involves equal doses of quality assurance and IT. Gendler is a certified project manager, Microsoft Certified Systems Engineer, and Certified Software Quality Engineer.