As senior director, MES and validation, for Wyeth Pharmaceuticals (www.wyeth.com), he is currently embarking on his third major, multiple-site manufacturing execution system (MES) development project.
Schaff—who joined Wyeth in March and who previously led MES projects at Aventis Pharmaceuticals—was one of several speakers to address the MES topic at an International Life Sciences Symposium May 7-8 in Chicago, sponsored by Milwaukee-based Rockwell Automation. Rockwell’s Propack Data unit ( www.propack-data.com), which the company acquired in 2002, provides products and services for the life sciences industries.
The affair featured presentations by several industry consultants who noted that MES and automation offer major opportunities for pharmaceuticals makers. But several speakers also challenged manufacturing managers, executives and suppliers to do a better job.
“There are great opportunities in manufacturing. The problem is that we’ve really made a mess of putting systems in place,” said Roddy Martin, a vice president at AMR Research (www.amrresearch.com), Boston, who covers process, consumer packaged goods and life sciences industries. Among other things, Martin said that pharmaceuticals manufacturing remains a silo of many information islands, which companies must do a better job of pulling together and integrating with other business systems and with supply chain partners.
John Blanchard, a principal analyst for Dedham, Mass.-based ARC Advisory services (www.arcweb.com), told attendees that manufacturing has become a bottleneck in the pharmaceuticals industry. In an era of increased competition from generics, stepped-up regulatory requirements and other pressures, “manufacturing excellence and time-to-market will be vital to future success,” he said, citing a need for improved use of technology, including automation, as a way to meet those goals.
Several end-user representatives focused on the benefits of multi-site MES implementations and provided tips for making such projects a success.
Robert Fretz, head of process automation and MES for Hoffman-La Roche (www.roche.com ), a Swiss-based pharmaceuticals and healthcare firm, noted that a global, multi-site MES initiative can pay major benefits compared to a “roll-your-own” approach in which each plant site develops its own MES solution. Roche has recently completed and evaluated a core MES solution at a pilot plant, and the company now intends to roll out that basic solution across other manufacturing plants. “With the core system approach, we think that you can have 80 percent to 90 percent of your solution out-of the box from the vendor,” Fretz said, which means that much of the wheel need not be reinvented at each site. The benefits, according to Fretz, include faster implementation, lower investment costs, unified enterprise integration and business process harmonization.
While a MES installation can help a company achieve regulatory compliance, it can also reduce costs, Fretz pointed out. “It may vary by site, but we believe that total operational costs will be reduced by at least 5 percent.” At Roche, reduction in manufacturing deviations is expected to account for the biggest savings, while improvements in manual dispensing and in Quality Assurance releases are other big contributors, Fretz said.
Wyeth’s Schaff also cited cost benefits from MES implementation, including typical seven- to 10-day cycle time reductions, 5 percent to 10 percent reductions in work-in-process and decreases in deviations that can sometimes approach 50 percent.
Practical MES Insights
Further, Schaff provided a number of practical insights and tips for those contemplating MES implementations, ranging from how to organize a global MES project to effectively managing a multi-site MES after it “goes live.” Many of these tips could apply to MES projects in any manufacturing industry. Following are a few of Schaaf’s insights:
• Complete commitment from the organization is crucial, starting from the top down. Find at least one person within senior management who will champion the project, said Schaff. “If they just give you lip service but you don’t see them backing that up with actions, then you need a different person.”
• Never underestimate cultural differences. “When you go into a project with multiple sites across geographic regions, you have to be aware of the cultural differences and remember what history has told us,” said Schaff. “Geopolitical history in Europe is still alive and well. When you tell people they’ve got to change the way they’re doing business, and that idea is coming from somebody they haven’t liked for 500 years, you’d better be ready to deal with that.”
• Make sure that your project leader comes from a manufacturing background, for credibility. The MES project leader must interface with manufacturing people, so he or she must be able to understand their language and know what they deal with daily. “Manufacturing guys are tough. I used to be one,” Schaff observed. “And the last thing I wanted to see was somebody come in who’d never been in my shoes trying to tell me what to do.” The project leader should also have past MES experience, be a good salesperson and know the corporate culture and landscape.
• Individuals that Schaaf calls “site focal points” play key roles on a MES project team. They are the main change agents for the sites, he said. “If they’re convinced that it [MES] will work, they’ll be the propaganda arm for you, and they’ll drive site ownership.” These individuals should come from the business side of the enterprise, Schaaf said, and it is important that they be empowered to speak for the site. “What you don’t want is somebody who merely comes to meetings and sits there and says, ‘I can’t answer that. I have to go back and check with my boss.’ ”
• Remember that the MES will impact shop-floor personnel more than anyone else, and that these workers have varying degrees of computer literacy. Be prepared to offer basic personal computer training. “What you don’t want is for somebody to get scared or panicked or afraid of the machine, so that they hit the off button,” Schaaf observed.
• When determining the scope of a multi-site, MES project, don’t bite off more than is practical, based on the technology and automation levels already present at the sites. “The site that has the lowest level of technology is going to determine how big your scope is and what you really can do,” Schaaf advised. “You can’t educate and bring people 10 years forward into the world of technology in a one-year project.”
• After a MES goes live, Schaaf said, certain shop-floor workers can play a vital role as first responders to problems. He advised singling out personal computer-proficient shop-floor operators for additional training as “super users.” Equipped with beepers, these super users can then be summoned for quick-response help by coworkers who encounter problems.
• Like Roche’s Fretz, Schaaf recommended developing a core MES solution that can be rolled out at multiple sites with only minor local site changes. A realistic goal is 85 percent to 90 percent standard, he said. “Be firm on sticking to the goal of a common design,” he advised. “You’re going to get a lot of push back for scope creep. Be tough. You’ve got to put an S on your chest and don’t let anything get through.”
A MES “changes everything,” Schaaf told Symposium attendees. “Within manufacturing, MES is probably the most critical application that you’ll ever install,” he said. “It probably has a higher potential to shut you down than anything else you’re going to do.”