Like the shy kid at school who never got asked to the big dance, maintenance management always seemed to be the overlooked application on which few pharmaceutical manufacturers were eager to invest much time or money.
“Pharmaceutical companies haven’t put as much emphasis on obtaining efficiencies through maintenance management as some other industries have,” says Colin Masson, research director for chemicals and process manufacturing at AMR Research, an IT research firm in Boston.
No more. Maintenance management still may not be sexy, but it’s suddenly attractive enough to get dates and have some serious money spent on it by the pharmaceutical industry.
“Maintenance management is absolutely becoming more strategic to the enterprise, both from a compliance standpoint and a productivity standpoint,” says Mark Sander, senior director of global information technology for Schering-Plough Corp.'s manufacturing team within the Americas, based in Kenilworth, N.J.
As a result, Schering-Plough, with manufacturing operations at more than 30 facilities around the world, is moving toward a global approach to maintenance management. “We are currently working on a long-term strategy for maintenance management systems,” Sander adds.
Generally viewed as both the software as well as the procedures required to manage, report and analyze every activity surrounding the upkeep, repair and replacement of plant facilities and equipment, maintenance management today means a whole lot more than just “changing the oil and filter” every six months.
“In my view, a maintenance management package is an enterprise-like solution comprising work orders, scheduling, service requirements, data collection, parts and inventory management, and forecasting of parts and inventory needs,” Sander explains. In real terms, when a piece of manufacturing equipment needs regular servicing, that task automatically appears on a list of work to be done, and a plant technician will perform the work, making a note in the system that it was done, by whom, and when.Technology varies greatly
Most large pharmaceutical manufacturers perform maintenance management using sophisticated enterprise asset management or maintenance management software packages. Still, some individual plants of larger companies, as well as smaller drug manufacturers, still rely on Microsoft Excel or other spreadsheet-type software to manage their maintenance activities. “You see a wide variety of maintenance systems for tracking and recording maintenance activity,” notes Marty Osborn, vice president of product strategy at Datastream (Greenville, S.C.), a leading enterprise asset management software vendor.
That scenario is in flux, though, as more drug manufacturers accept the view of maintenance management as a global enterprise system. “Yes, there are still very fragmented maintenance applications at pharmaceutical companies, but that is changing,” observes Roddy Martin, vice president of research for pharmaceutical and consumer goods at AMR Research. “Now the game is about standardizing processes and procedures across all global manufacturing sites.”
The reasons are clear. Pharmaceutical firms that operate plants around the world without strict global enforcement of maintenance procedures to ensure both cleanliness of their facilities and quality of their products run the risk of quality failures.
In the most notable example, Chiron Corp. (Emeryville, Calif.) suffered from bacterial contamination of its Fluvirin influenza vaccine produced at its Liverpool, U.K. facility. British regulators suspended the company’s license last year, halting production, before the flu season had begun, creating a global shortage of vaccine. (See “Chiron’s Curse
,” January 2005.) In its October 2004 inspection of the site, the FDA cited not only a lack of standard operating procedures, but also inadequate environmental monitoring.
AMR’s Martin suggests the problem was too much local autonomy and a lack of global adherence to proper manufacturing procedures. “In this case, as a result of one site failing and being shut down, the whole company gets blamed,” Martin says. “These companies cannot afford to allow plants to operate independently any more.” A global maintenance management system and procedures, he says, is a step in the right direction.
Others agree that a global approach to maintenance management as a strategic application is critical for pharmaceutical firms to succeed. “The main issue is always the availability of all assets to guarantee the quality of the company’s activities and products,” says Eric Luyer, the Utrecht, Netherlands-based manager of pharmaceutical manufacturing in the industry marketing group at MRO Software.
An MRO user at some sites, Schering-Plough recently installed a new maintenance management system from Datastream at its two manufacturing plants in Kenilworth and Union, N.J. Currently the company operates a variety of maintenance systems at its various manufacturing facilities, including software from SAP and MRO.
It’s worth noting that the maintenance management software market currently is undergoing a struggle. “Pharmaceutical companies with a big investment in SAP are now asking themselves if they should get rid of Maximo and other independent applications and switch over to SAP’s maintenance management application, because of the benefits of its integration with the rest of the business,” AMR’s Martin notes.
But SAP has its own stigma to overcome. The Walldorf, Germany-based software firm often is perceived as being top-down, great for corporate office applications such as accounting and enterprise planning, but not as strong when it comes to connections to the shop floor. As AMR’s Masson points out, “One of the challenges companies have that go with SAP for maintenance management is that SAP does not really work very well on the shop floor.”