From the Editor: Blasting Down the Barriers

Teams may be a new concept for pharma, but they’re already transforming its “silo” culture. 2005 Team of the Year finalists offer a glimpse into the future of pharmaceutical manufacturing.

By Agnes Shanley, Editor in Chief

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Critics charge that pharmaceutical manufacturing today is marked by “silos.” Individual departments work hard to improve their own performance, but often fail to see the larger picture, and how their work affects the entire effort. Their numbers may be trending up, but they’re often focusing on the wrong key performance indicators (KPIs) — only they just don’t know it yet.

What changes this mindset? Sometimes, basic market realities sound a harsh wakeup call. Two of our Team of the Year finalists’ facilities had become so uncompetitive that they were on the brink of being closed down.

In other cases, an “outsider” from another industry shakes things up, and brings new ways of thinking. Or else, corporate “operational excellence” programs spread the word about continuous improvement and quality systems and translate those Japanese terms we hear so often — Kaizen, Kanban, Poka Yoke — into practical procedures.

In this issue, we present the ultimate antidote to the bad news about the industry that we hear every day — the quality assurance problems and product recalls, insufficient safety testing, slipping public opinion, Michael Moore’s new movie.

With our Team of the Year competition, we look instead at the glass half full and celebrate the positive changes and difficult work that manufacturing teams are undertaking to change “business as usual.” Collectively, their efforts promise to make a huge dent in the $90 billion currently spent on drug manufacturing each year, and to lower product costs and improve public opinion.

Each of our finalists has achieved results that seemed impossible. Imagine trying to streamline a process that involved every department within a large facility. At its North Cove facility in Marion, N.C., Baxter Healthcare’s 1-liter IV team had to do just that. Stand-alone silos and an inefficient “push production” system had led to capacity constraints and poor financial performance. “Upstream wouldn’t stop production even though downstream was having trouble,” says project superintendent Beverly Smith. Now everyone on the team is singing the praises of Lean, and singing from the same hymnbook, says the line’s manufacturing manager, Terry Foxx. Cycle time has improved by 75% and time from end of fill to product release now averages only 1.9 days. Solution container scrap on the fill line has been cut by $15,000 per month, and in-process inventory has been greatly reduced.

Then there’s Bristol-Myers Squibb’s Indiana Technical Operations, comprising 550 people in two facilities. Once marked for closing, the plants and their team have become a benchmark for the corporation, reducing cycle times by 80% and more than doubling productivity. Transparency and open communications have been critical. Cross-training and rotational staff development are cornerstones of the program, as is an IT platform that allows everyone from operators to managers to see KPIs in real time.

Or consider Novartis’s sole U.S. manufacturing facility in Suffern, N.Y. Three years ago, the plant’s future was unclear, but the tables have turned dramatically. Its parent company is modeling global Lean and team efforts and other initiatives based on its successes, which include a $40 million cost reduction in two short years. The site has pilot PAT and RFID projects underway, and WHO has selected it to manufacture a new malaria drug, which will double plant output in 18 months. Plant management knows its new structure will be flexible enough to handle increased demands, says Novartis executive Walter Markl.

Smaller companies are also achieving miraculous results. When it moved from manufacturing food grade to pharma grade calcium carbonate, Nutri Granulations had to boost output. Where the standard capacity utilization figure is 60%, and the benchmark 80%, the company’s California facility improved utilization to 110% of rated capacity through teamwork.

Teams needn’t focus on sweeping changes. Often, small but focused programs can translate, incrementally, into huge savings. At Vacaville, Calif., an Alza team used the principles of Lean, Kaizen and 5-S to improve commercialization of a new combined drug-device product slated for commercialization next year. Wyeth’s team in Montreal, Canada focused on ergonomic and other improvements, eliminating 27 major accidents per year and reducing 700 lost workdays, while two Pfizer teams led by Right First Time leader Jill June eliminated two “black hole” issues at its Kalamazoo, Mich., facility that had drained resources and couldn’t be solved.

And manufacturers aren’t the only ones facing silos and improving pharmaceutical manufacturing. Just imagine changing FDA’s mindset around the word “control.” FDA’s PAT team, whose members come from various departments within the Agency, has been doing just that, spurring internal change while challenging manufacturers to expand their own definitions of process control and quality. Team members are working more closely than ever. “When issues come up, we actually share the burden, like different fingers of the same hand working together,” says team member Ali Afnan. “We’re encouraging each other to do better.”

This is the essence of teamwork, and we celebrate it. In this issue, we profile all the finalists in our Team of the Year competition. Stay tuned next month, when we announce the winners. But each one of these featured teams, and all teams that were nominated, are winners in the battle to improve efficiency.

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