Automation & Control / Facilty Design & Management

Maintenance Management Joins the Party

Pharmaceutical makers pursue more predictive and global technologies to improve output, ensure compliance.

By Doug Bartholomew, Contributing Editor

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.”

SAP is out to change that perception, says Kahn Ellis, the company’s director of solutions management for Enterprise Asset Management. It has made multiple improvements to its asset management system, including applying NetWeaver technology to enhance usability and making the system fully compliant with 21 CFR Part 11. “Basically, we have a fully functional, fully integrated enterprise asset management system” equal to that of competitors, Kahn says.

AstraZeneca is using IT innovatively to minimize equipment downtime at its Westborough, Mass. site. “The primary IT focus has been improving the uptime of our critical applications says IT manager Ken Sutton. “We’ve redesigned the network to provide a fault-tolerant secure infrastructure. We provide system design information to vendors to standardize components that integrate into the site, he says. “These are the building blocks that position the site to support PAT and other initiatives.”

The facility has automated work orders, using a new ISURF/SAP process. Astra-Zeneca Westborough is also using SAP’s FECS module to perform preventive maintenance and calibration scheduling and tracking. The module issues non-routine work orders, Sutton says, and the facility will move to a paperless system over the next few years.

Although IT is important, so is process control. Some companies such as Honeywell that perform engineering and automation services offer a comprehensive soup-to-nuts approach to maintenance management systems. The company maintains valves, meters, and other devices, as well as all kinds of production equipment for pharmaceutical companies, and even offers its own calibration system called DocuMint.

“If temperature is critical to the quality and efficacy of a product, and you need a temperature probe to maintain a tolerance of plus or minus 5 degrees, the company has to be able to calibrate that probe and prove that it’s working,” explains Kevin Sweeney, regulated industries account manager at Honeywell. “And when the FDA comes in to inspect the plant, they will want to see the calibration records for that device.”

Manufacturers must prove that these calibrations are performed to schedule. “For calibration of devices on the line, we bring the line down and our technicians perform the work, and the system tracks their time and activities,” says Sander of Schering-Plough.

Shift toward prediction

While in the past the most advanced concept for maintaining plant, equipment, vehicles and other assets was preventive maintenance, today the shift is toward systems that offer more predictive capabilities. “The idea is to do more trending and modeling and to use the data to look at the mean time between failures,” Datastream’s Osborn says. “Manufacturers would like to marry up a true preventive maintenance schedule with the history of how that asset has performed.”

Despite this goal, few manufacturers already have predictive systems in place throughout their manufacturing sites. “There is a desire to go to more predictive maintenance, but we will need more data before we are able to do this, and the systems we’ve recently installed will collect this data,” explains Schering-Plough’s Sander.

For Schering-Plough, the investment in upgrading its maintenance management systems is a strategic imperative not only to boost plant efficiency but also to ensure compliance with FDA regulations. In 2002, the company signed a consent decree with the FDA, paying a $500,000 fine and agreeing to resolve certain manufacturing deficiencies at its plants in New Jersey and Puerto Rico.

“It’s important to us to ensure that our plants are running efficiently and that we are utilizing our assets efficiently,” Sander says. “We also we have a huge regulatory commitment, and these automated systems help us meet those requirements. Maintenance management is a key piece of meeting the requirements of the consent decree.”

While regulatory compliance is critical, some say maintenance management’s real business benefit lies elsewhere. “The heart of it is the asset, and making sure those assets perform, whether they are motors or trucks,” says Osborn. “The goal is to help pharmaceutical companies produce more capacity.”

Risk of equipment failure

Without adequate systems and procedures in place, manufacturers run the risk of failures of key pieces of machinery on the production line. What’s worse, once a part or component burns out or breaks, if a replacement isn’t nearby, the company may be stuck with an idled production line until a new one can be shipped and delivered from the manufacturer.

“If companies don’t put the proper techniques in place, their equipment is going to fail, or their maintenance and repair costs will be too high,” Osborn says. “A maintenance management system helps a company’s maintenance department plan and schedule their work. It also helps them manage spare parts, track who worked on a piece of equipment, and who signed off on it.”

Of course, plant maintenance by definition also includes basic facility cleanliness. For instance, the regular changing of filters in the air circulation systems is essential to eliminate unwanted pollution or contamination.

“Clearly, being able to track cleaning activities is important,” Osborn says. “We are now seeing a lot more attention being paid to the whole level of maintenance in and around a pharmaceutical manufacturing facility — things like tracking filter changes and inspections on compressors to make sure they are not leaking oil. Pharmaceutical plants are expected to operate at a high level of cleanliness,” he adds, “but in reality, you find this is the case to a varying degree.”

Change management looms large

One issue pharmaceutical companies must grapple with when installing a maintenance management system is known euphemistically as change management—i.e., training people to change the way they do their jobs and to use the software. “In many cases these are tradesmen who perform the work, and there were challenges to rolling out this system,” says Sander of Schering-Plough.

Change management issues were critical for Aventis Pharma (now part of the Sanofi-Aventis Group), which operates several product sites throughout France. The company elected to go with MRO Software’s Maximo system to manage maintenance activities at its Compiegne, France facility, which manufactures a variety of antibiotic, anti-inflammatory and painkilling drugs, producing some five billion tablets and capsules annually.

“We wanted to select software with the most user-friendly interface, easy to configure and open for future evolution,” says Francois Videcoq, maintenance methods manager. “These conditions were vital to enable our maintenance field technicians to use it.”

Despite today’s heightened emphasis on improving production efficiency and the increased regulatory concerns for drug manufacturers, many companies remain slow to jump on the maintenance management bandwagon. “At the end of the day, how many people want to buy more maintenance?” asks Datastream’s Osborn.

They may not want it, but like a sick patient eyeing a bottle of bitter-tasting medicine, they sure need it. “The regulations give you the reason to go to management to ask them to write the check,” says Osborn, “but the real reason is that it will make the company money to have its assets working all the time and not failing.”

That certainly was the case at Aventis. “We set ourselves four main objectives: increase equipment availability, reduce maintenance costs, improve efficiency of operations and ensure total traceability of all equipment and work,” says Marcel Guillot, maintenance manager at the Compiegne site.

He says production equipment downtime due to equipment failures has been cut from 10 to 15 percent of downtime to under five percent. What’s more, the company’s corrective maintenance costs at the site have dropped by 200,000 Euros per month, from 450,000 to 250,000 Euros. The improvement came as a result of strict adherence to the monthly maintenance requirements for each of 3,000 pieces of equipment. Aventis uses a system that incorporates a predictive maintenance schedule that assigns a hierarchy based on the strategic or production-critical nature of a piece of equipment.

The bottom line, most experts agree, is that pharmaceutical makers had better get with the maintenance management program, and fast. As Osborn puts it, “In the end, companies whose assets are driven by proactive maintenance procedures are going to make more money.”

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