1. Pfizer’s experience demonstrates that correcting quality problems is often complex, time consuming, and expensive. Why, in your opinion, does it make sense for companies to invest time and money to make these corrections?

2. Search for “Six Sigma projects” on the Internet. What similarities do you see among the projects you found? What conclusions can you draw about organizations that undertake these projects?

Sigma quality initiative, manufacturing teams throughout the company often faced what it called black hole issues—chronic problems that seemed to suck up resources and ideas and yet never get resolved. One black hole was the cleaning of some of the company’s tri-blender machines. 

Tri-Blenders are machines specially designed to thoroughly and efficiently blend dry ingredients and liquids, while minimizing the air introduced into the process. Their performance is critical to producing high-quality pharmaceuticals, whether as pills or liquids. The tri-blenders for one key product at Pfizer’s Kalamazoo, Michigan, plant are cleaned about 400 times per year. The tri-blender cleaning could not be done safely with solvents. Instead, the equipment had to be taken down and parts cleaned by hand, put into an automated washer, then manually unloaded and dried. Every cleaning required a 100% inspection by the plant’s cleaning validation lab. This task alone consumed about a quarter of the lab’s time and resources. Part cleaning also had a high failure rate, necessitating extensive re-cleaning.

Tabitha Bratt, the cleaning validation lab manager with a Six Sigma Black Belt, was chosen to head up an eight-person cross-functional team to solve the tri-blender troubles. The team members met frequently and conducted several walkthroughs and mapped every step in the cleaning process. Each team member was responsible for a different step in the cleaning process, and they compared notes during the meetings. The group then began to develop a list of causes, starting with listening to the team members who worked on the floor. For example, one operator had been frustrated with the consistently poor cleaning of one particular small part. “Why don’t we just throw the thing away?” he wondered. That’s what they did, and Pfizer started to use disposable parts.

Eventually, the team drafted new operating procedures and videotaped the cleaning process for computer-based training for all operators. A few months later, the process was finally validated by demonstrating its reliability and effectiveness. The key was getting the operators involved from the start, said Jill June, the director of the “Right First Time” initiative at the plant. “You have to put people in positions of responsibility who understand what the problem is,” she explained. The operators were “living it, breathing it, and seeing it every day.” A key to the success of this Six Sigma project was getting the operators to become more accepting of change and willing to drive it. As a result, Pfizer’s Kalamazoo plant has established a new standard for cleaning and employing its tri-blenders, all supported by equipment operators.