At 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.

How process improvement is managed, however, is the tricky part. It depends on a company’s size, culture, and resources, as well as the scope of the envisioned improvements. What’s most important, process improvement experts say, is not who is in charge, but rather the commitment from top executives and the cooperation from departments involved in the changes.

“It’s very important to get buy-in from senior management and the people it’s going to be affecting,” says Dirk Baldwin, a business professor at the University of Wisconsin-Parkside. “For the transition to go smoothly, everybody’s input is critical.”

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.

Gendler

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.

IT: A Logical Candidate

At many companies the IT manager is a natural candidate for leading process improvements. Conventional wisdom is that the more automated processes are, the harder it is for employees to deviate from them—hence the consultants’ calls for more automation of SOX controls—but the University of Wisconsin’s Baldwin offers three more reasons why IT is a good place to start.

First, many process improvement projects involve deploying organization-wide IT support systems that are fundamental to driving the larger changes envisioned. Second, the IT department tends to be one of the few units that regularly supports all parts of an organization, and often IT managers can see opportunities for improvement across departments that managers in other functions might miss. Finally, IT experts historically are trained in project management and other tasks that support large-scale, complex change.

“Usually you think of IT as being the change agent for many of these kinds of projects,” Baldwin says. “We’ve been building systems for people for a long time, and there’s a methodology for doing that. That methodology is useful for changing people processes in addition to IT processes.”

For example, one common process improvement project these days is the integration of an organization’s departments through the deployment of enterprise resource planning software systems, Baldwin says. This essentially amounts to an IT implementation, and by definition it touches every aspect of an organization.

Baldwin cautions, however, that IT, even when serving as the agent for change, must cultivate effective partnerships with managers in all affected functional areas.

“If the project is seen as totally an IT project, then it might not have that much support in the organization,” Baldwin says. “If IT is seen as both advocating and owning the project, it’s not likely to succeed.”

Operations: Command Medical Products

The key, process improvement experts agree, is to make sure that such projects are driven primarily by business and operational goals. They should not take on the biases or limited perspective of any given division, be it IT, legal compliance, financial reporting, or even a distinct process improvement unit.

“I always suggest that a company needs to take a look at how it does business,” says Chet Kagel, partner with the consulting firm HPK Group. Process improvement “is very dependent on how much commitment it gets from the top, and it’s also got to fit the culture of the company. We call it top-down and bottom-up.”

At Command Medical Products, a 120-employee manufacturer of disposable medical devices, process improvement began recently under the direction of Founder and CEO David Slick. He put the project in the hands of the vice president of operations, Joyce Vytlacil.

The operational goals for the project boil down to better pricing and shorter lead times, Vytlacil says. “You’re cutting out the non-value added parts of the process itself,” she says. “It’s costing us less to make it.”

With Slick’s backing, Command Medical has the needed top-down support for process improvement. To ensure the “bottom-up” cooperation, Slick directed every department head and supervisor to review the literature on process improvement before the project even began. Then he brought in Kagel to conduct training.

Kagel specializes in production environments where process improvement is often led by quality control, with “champions” in functional areas throughout the company. To bring all stakeholders on board at Command Medical, supervisors, production staff, sales staff, and administrative staff were involved early in the training process.

“In a little organization like this, if the communication is proper and people understand and trust the organization, they normally will buy in,” Slick says. “It looks to me like we have across-the-board buy-in on this first application.”

Command Medical’s first application of process improvement, resulting in reduced production time for disposable tubing sets, is expected to eliminate $100,000 in costs, Slick says, adding that he plans to apply similar improvements to at least eight other product lines.

“I could kick myself for not starting this seven or eight years ago,” he quips.

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