The following summary was derived from a presentation at Rockwell’s Automation Fair 2009 in Anaheim, California.
A Swiss-based pharmaceutical company that's more than 100 years old with 80,000 employees on all continents, F. Hoffmann-La Roche (Roche) chose a global approach to its manufacturing execution system (MES) governance and implementation. "We try to standardize our processes," said Robert Fretz, global head of process automation and MES at Roche, where the global MES program is centrally managed to support local implementations. It includes a global competency center and implementation of standardized supply chain processes. A common, standard MES core application is rolled out at local sites, and the implementation is driven by business objectives.
"We start with a standard vendor system and we add limited customizations to it," said Fretz. "A little more than 10% of the system is customized. We start with a common system specification, and then we hand it over to Rockwell. If there are customizations, they will build them, and then it's handed back to us for testing and acceptance."
MES functionality evolves in incremental steps at Roche, but careful steps are in order, as the MES ultimately will be the only source for all batch review of related GMP data. "As far as the system architecture is concerned, each machine typically has older controls, or it is a little more process-oriented," explained Fretz. "We connect this to our corporate network through a firewall, which provides functionality for data and drives the MES clients, which are connected to the MES. Around MES, we have a collection of OPC and web servers and a data historian. This is collected to ERP. We also have LIMS, but we do not talk directly to the LIMS."
Data is interchanged between the ERP and the MES. Data from the MES clients are sent to the data historian, always attaching a batch context. "Then we can acquire it in the MES from the data historian, which allows us to do the batch report, where all data ends and we do the review," explained Fretz. "There is no paper, and all data is in one place for review."
After three years, compared to previous paper-based operation, Roche has seen a 95% reduction in errors related to the location of material and an 80% reduction of deviations related to incorrect material identification. "We expect, after we've rolled out the total solution, we'll reduce 90% of document errors caused by manual entry, and we would like to prevent actual errors before they happen by giving real-time quality alerts," said Fretz. "We also have performance improvements. We improved the way material moves from the warehouse to the shop floor."
Twenty percent of labor time was saved in the dispensing operations, and 50% of labor time was saved when compared to manual dispensing. "There also was an 80% reduction in the time required to review the dispensing documentation, and we expect a 50% reduction of production review time and an 80% reduction of QA review time," said Fretz. "We expect that, overall, two-thirds of the review time can be eliminated with the new solution."
Success with MES requires more than just a system, warned Fretz. "You need a technical setup and an organizational setup," he said.
The technical setup includes a prerequisite of electronic batch records and review of data acquisition from the shop floor. "Expect considerable effort to connect a diverse collection of already installed equipment," he cautioned. "Make sure the required product or site-specific changes are handled by configuration, not by program changes. And the way you create your procedure is important. Carefully design the structure of your procedure steps and expect significant effort to create and maintain them."
In the organizational setup, MES success is based on a thorough knowledge of production and business process knowledge. "Don't leave MES to the ‘techies,'" said Fretz. "Training and change management efforts are significant. Users will learn a lot about their own businesses. Have an MES champion on every site and in management."
