Eberhard into a continuous-improvement mode. “We can now have conversations with our customers if we see an order come in that is out of ordinary. Is there a spike in need, or was there an order entry mistake somewhere? If a spike, then we can talk about how to handle it. At the end of 2006, the single largest order in company history came in. We were able to push it through with relatively little pain. Previously, we would have had to increase capacity temporarily. Today, we’re well on our way to becoming a flexible, nimble, competitive company poised to face Asian competition.We can compete not only on price, but now also with delivery and quality.”

Customers’ reactions today are “Wow, look at the new Eberhard,” Collela observes.

Operational excellence strategies such as Lean Manufacturing and Six Sigma need not be confined to discrete manufacturing. Process manufacturing operations such as those found in the pharmaceutical industry also can be greatly improved when managers think about their operations and applying leading-edge tools to efficiency problems.

Michelle Adkins, industry operational excellence consultant for Austin, Texas-based automation supplier Emerson Process Management, has seen it happen. She has witnessed pharmaceutical industry adoption begin with Six Sigma programs, then move on to adoption of Lean Thinking, and eventually merging the two strategies into a hybrid of sorts, from her office in Royersford, Pa. She sees them as complementary strategies, as Six Sigma focuses on variability while Lean focuses on waste.

She begins with a client by interviewing employees to define a process map. Clients need to define what they want out of the process before proceeding to train some of their employees. The Emerson OpX Advantage program uses a six-step, data-driven methodology that proceeds from initial assessment through a detailed study, report and recommendations, project implementation and results analysis with an on-going control feedback loop to assure continued benefits.

Adkins’ experience and practice centers in pharma. The important thing in pharma manufacturing is deviation, that is, things that will hold up products from being released. This often centers around paperwork. “We have a saying in pharma that there are two products—the drug and the paperwork,” she quips. “There are lots of documents, so we look at the batch records to analyze them and then make them more user friendly. Perhaps instead of just long lists in text, we will put some text in boxes and so forth. These print documents must be taken around the plant for review and approval by many people. Sometimes, there are people who spend all their time running around seeking people. Some plants even draw a ‘spaghetti chart’ that traces the travels of these people. Some have even moved offices to shorten the trips. We can do a value stream analysis and they’ll say, ‘Oh my gosh, we’ve got a lot of people doing non-value-add work.’ ”

One place, please

An MES application—in this case Emerson’s ComplianceSuite—can interface to the batch records and to enterprise and laboratory information software to pull information into one place. At one client who had a mix of Emerson DeltaV controllers and third-party programmable logic controllers in a manual and automated process, she determined that the first order of business was good data management. That can be labor intensive, so automating it into a historian such as PI from OSIsoft, a San Leandro, Calif., software provider, which integrates with ComplianceSuite, has worked well. Adkins has seen client benefits range from $300,000 to $500,000 per year on the low side, to one client that saved, conservatively, $3 million per year. “It just depends on where they started and how much automation they want to put in.”

There is no doubt that implementing proven strategies can have significant impact on the bottom line in manufacturing. Help in the form of software tools and consultants can be a boost for getting started.