Cholestech Corp.: Quality College Imparts Valuable Lessons

OUTSTANDING QUALITY AND REGULATORY TEAMS

Attending a class to learn about company policies might not seem appealing at all. But at Cholestech Corp. (Hayward, CA), employees are enthusiastically embracing an innovative college concept.

Two years ago, the company's quality and regulatory team created a quality college where employees could learn how their various job functions fit into the quality policy puzzle. Since then, employees have not only been lining up to take courses at the college, but have also been eagerly teaching their peers.

The driving force behind the college was Cholestech's quality system upgrade to comply with ISO 13485:2003, which details requirements for quality management systems. “It required a pretty sizable change to the quality system,” says Barbara McAleer, vice president of quality and regulatory affairs at the diagnostics company.

Her staff looked for ways to effectively educate employees on the changes while rolling out a system that would become embedded in the fabric of the company. It was then that the concept of the quality college was born. Cholestech's 20-member quality and regulatory team has been responsible for the concept, development, and implementation of the college.

The interactive college has courses that range in length from one to four days. Topics extend across the company, from manufacturing to R&D to materials. Cholestech employees each receive a curriculum of courses that matches their responsibilities. “By tailoring it to each associate's job description, they only attend courses that are applicable to their job function,” says Shireen Khan, an R&D manager.

Once the courses are developed, management receives an outline of curriculum, along with which employees are right for each class. Employees sign up for classes, just as one would do at college. After registering, they receive an acceptance letter to the college and a course schedule. Because the college is held each year, the courses also discuss changes made during the previous 12 months. “Pretty much everyone attends quality college, including the president,” says McAleer.

The classes take examples of situations and turn them into case studies. By applying what they're learning to real-life scenarios, employees can grasp concepts and accomplish their jobs more effectively.

The professors are carefully selected and come from different functions and levels within the company, from entry-level associates up to vice presidents. McAleer points out that having a peer teach a class serves as motivation for many employees.

In the freshman year, courses include design control, complaint handling, nonconformance, engineering change orders, and the overarching quality management system. “Last year, the key area of focus was design control, because we rolled out a new product development process [which included design of experiments and process control],” says McAleer. “We took the con- cepts of black belt and Six Sigma and wove them into design control. It's not just a quality system that's strictly compliant with regulation.” The big emphasis was teaching people the new product development process.

Khan attended the course that focused on learning the new quality policy. She was in a class where they worked in teams with people from various areas in the company. Each person was required to rewrite each subsection of the quality policy in his or her own words.

“I got to hear how quality control would interpret the meaning of the quality policy, and how those in support functions such as finance and IT interpret the policy,” says Khan. “It was interesting because, when you first go in, you're not sure how everyone fits together under the quality policy umbrella. This gave us a great way to understand each other a little better.” Having employees understand their role and that of others in the company has helped build quality into the company's products as well as everyday procedures.

So far, the quality college has been a success. “The feedback has been incredibly positive,” says McAleer. “Our attendance rate is in the high 90s.” She adds that employees who aren't even registered for courses sometimes show up. “For me, those are signals that it's being well received, and people see the value of it.”

Kahn feels that industry could use the Cholestech team as a role model for demonstrating a commitment to success in spreading quality throughout a company.

McAleer describes her quality and regulatory group as “an incredibly talented, cohesive, and high-performing team. They've come together over the last two years and have raised the bar and lifted the entire performance of the quality and regulatory function. The quality college is a good reminder that we aren't just going through the motions but truly are looking for ways to add value to the organization.”

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