Managers concoct all sorts of pretexts for not adopting or, in some cases, even investigating Six Sigma practices. One major pharm/biotech company, when asked about participating in this article, responded almost defiantly, “we’re not a Six-Sigma culture.“ R&D organizations are prone to think that Six Sigma does not apply to research, highly regulated industries, or biological systems. “None of those excuses are ever valid,“ says Soman.
“I have applied Lean and/or Six Sigma to operations involving complex mechanical systems, all the way to very soft products, and it has worked every time. GE has claimed billions of dollars in savings by implementing these tools in very disparate business segments.“
It is a mistake to view Six Sigma and Lean as exclusive to “hard“ manufacturing, says Dr. Dilts. Much of science involves protocols. Six Sigma can help organizations discover which aspects or components of a protocol add value to the overall experiment. When applied correctly, Six Sigma will also help identify fast failures, indicators that a research program is on the wrong track. “Six Sigma doesn’t inhibit creativity, it frees creative activity for more productive work,“ he says.
According to Soman, any end result that can be quantified will benefit from Six Sigma. “It doesn’t matter if you’re streamlining manufacturing or inventing a new molecule. If you can define what you’re going after and quantify those factors that are critical to quality, you can apply Lean Six Sigma.“
Typical manufacturing metrics are defect rate and cycle time. In drug discovery, the metric may be the number of molecules advanced per thousand screened compounds or the percentage of compounds from medicinal chemistry or combinatorial libraries meeting specific pharmacokinetic or toxicology criteria. “No matter what you’re doing, it’s possible to complement scientific knowledge and experimentation with analytical and statistical methods to weed out practices that get you where you want to go faster.“
Like GE Healthcare, West Pharmaceutical Services (www.westpharma.com) has adopted a Lean/Six Sigma approach which, says resident Black Belt Tom Capitanio, helps achieve performance and efficiency breakthroughs more quickly than with Six Sigma alone.
West is more of a discrete manufacturer than GE Healthcare or most biotech firms, supplying vials, stoppers, seals, closures, and containers for sterile pharmaceutical products. The company applies Lean/Six Sigma to many of its manufacturing operations, as well as to paperwork, customer service, and corporate business.
To Capitanio, the biggest challenge to implementing a Lean/Six Sigma program is to integrate it into day-to-day operations and further develop it around Rapid Improvement Events, projects that achieve immediate, short-term resolution and are followed by exposure to more organic, longer-term improvement.
West’s components must meet mechanical, safety, and regulatory requirements. Unexpected, sporadic defects may cause a disruption to the customer’s manufacturing line. West views these events as more than simple opportunities to satisfy one customer. The company’s Six Sigma experts analyze the cost of such incidents to determine how extensively, beyond fixing the immediate problem, they need to go.
In some situations the component cost plus the time handling the complaint and similar problems in the future dictate a thorough Six Sigma treatment.
When that project is completed and its results applied to the manufacture of other closure systems, that problem’s resolution often leads to improvements on subsequent projects.
With Lean/Six Sigma firmly entrenched among pharmaceutical and biotech manufacturers, the next frontier is likely to be pure research organizations. It is only a matter of time, says Dr. Dilts, before they see the light or risk extinction. “Companies that ignore Lean and Six Sigma risk going the way of the Oldsmobile,“ he says.