By Douglas Bartholomew, Contributing EditorLong treated as the orphan child of enterprise software applications, manufacturing execution systems (MES) are starting to grab attention among pharmaceutical manufacturers eager to reduce errors, shorten cycle times, and automate compliance routines. "We’ve had excellent success with MES," says Rob Ottenjohn, project manager at Patheon Pharmaceuticals, a Cincinnati-based contract manufacturer of 700 different kinds of tablets, capsules, lozenges, and liquids for more than 100 clients. "It’s helped us reduce errors, improve efficiency, and automate processes," he says.In the last couple of years, a number of large pharmaceutical companies have adopted MES software to replace cumbersome homegrown systems or error-prone manual control procedures. The shift is yet another indicator of a broader effort to streamline and optimize production and manufacturing practices throughout the industry. Often referred to as shop-floor control systems, MES software serves as the bridge between plant-floor operations and enterprise resource planning (ERP) systems. "We have interfaced our MES with our SAP ERP system, which also has further reduced errors at our facilities by eliminating a step of keying in information," adds Ottenjohn.Reducing human error, in fact, was one of the prime business drivers behind Aventis Pharmaceuticals, Inc.’s (Bridgewater, N.J.) adoption of Honeywell’s POMS MES system. "We also wanted to reduce cycle time, but one of the key driving factors for the MES project was achieving a significant reduction in human errors related to documentation," says Ross Benson, former manager of manufacturing information systems at Aventis’ Kansas City plant. "We had âtraveler packets’ that would follow an order or batch through the plant, and these would often have signatures or time stamps missing, meaning that, for each packet, someone would have to go back and track down that person."The new MES did away with a lot of these common problems by enforcing and automating both the time stamp and signature processes. "That was our biggest savings from MES, by significantly reducing the human errors we’d been plagued by," says Benson, a Blue Springs, Mo.-based MES expert who left the company in June and plans to do his dissertation for a Ph.D. in IT on the role of MES in manufacturing.A typical MES allows manufacturers to track orders, monitor processes, control product formulations, and gather data on errors and defects. For drug manufacturers, however, MES offers an added sweetener: the capability of automatically enforcing certain steps and routines on the plant floor. The MES ensures that procedures are followed accurately and in the proper sequence, without any data omissions, while recording each time activities are completed for compliance purposes.Compliance a Driver"With MES, the bottom line for the pharmaceutical industry is that it enforces compliance," says Roddy Martin, vice president of consumer package goods and life sciences industry strategies at AMR Research in Boston. "Having an MES is a means of enforcing standards to achieve compliance in the lowest cost way."The software’s ability to track orders in progress is another benefit of MES, allowing companies to check the progress of a given customer order instantly and accurately. While this may not be an issue for most large companies dealing with large batches of product, for many contract manufacturers handling small jobs or custom orders, knowing exactly where the product is in the process can be very helpful. "Historically, the pharmaceutical industry has not been good at inventory visibility," Martin notes. "MES is one of the key enablers to improve that visibility and reduce inventory in pharmaceutical manufacturing."Aside from enforcing compliance during production, one of the biggest payoffs for drug makers is error reduction. In an industry that, according to one estimate, is plagued by an error rate of five to 10 percent-i.e., a significant amount of medicine doesn’t meet specifications and must be reworked or treated as waste-mistakes in manufacturing are a massive problem.The typical pharmaceutical firm spends 36 percent of its operating budget on manufacturing-more than double what it spends on R&D-and a large piece of that expense can be traced to waste due to errors in production. Botched batches, omitted signatures, improperly filled out forms, and a host of other blunders large and small each contribute to manufacturing delays, rework, and scrapped material.While MES alone is no panacea for poor manufacturing practices, if carefully implemented with adequate buy-in and training of production operators, it can serve as a catalyst for change, forcing companies to streamline processes, automate compliance measures, and trim lengthy cycle times.Reducing CAPA DelaysOne way an MES helps manufacturers with errors is by automatically requiring employees to take immediate action when a problem occurs, thereby reducing delays in the corrective and preventive action (CAPA) remedial process. "You want the MES to launch a CAPA process so that there are no excessive lag times in that batch," Martin says. "The MES forces a response to the noncompliance problem."Without an MES that tracks every step of a production process, he says, it often takes companies "days" to find the information they need to fix the problem. He recalls the case of one large pharmaceutical firm that held up a $4 million batch of a new product for 90 days before resolving a production problem. "With an MES, you can have role-based, event-driven information that pushes information to the person charged with doing something about it." The idea, he says, is to identify problems as they occur and resolve them before the batch is complete.MES software is in line with efforts underway at many drug manufacturing facilities today, such as Pfizer’s "Right First Time" (Pharmaceutical Manufacturing, June, p. 37), to reduce error and waste in their production processes. "The leaders, such as Hoffman-LaRoche, have been successful in putting in place MES systems to help them do this," adds Martin.Other pharmaceutical manufacturers that are rolling out MES systems to their plants on a global basis include Baxter Laboratories and Novartis, which is using Werum’s platform. Novartis started to implement MES at its Suffern, N.Y. plant almost two years ago and recently extended MES to its packaging operations."It’s letting us work more efficiently, using more robust processes that are repeatable," says MES business process champion Richard Lemire. It also eliminated the "multiple checking" of signatures, calculations, and other data required by paper-based orders and instructions. The facility has also rolled out an SAP platform and is integrating the two.Industry Still Paper-DependentIf MES is so great, why is it that shop-floor control systems haven’t exactly taken the industry by storm? One reason is that too many manufacturers continue to depend on homegrown operational systems, manual procedures, and paper-based records. "We still have more of a manual system," says Phil Lofty, computer systems manager for quality assurance at Watson Pharmaceuticals, Inc. (Corona, Calif.). "But I’m hopeful we will get an MES, because it’s one of the goals of our five-year plan."In an earlier position, Lofty consulted with a Johnson & Johnson subsidiary that installed an MES, resulting in significant process improvements. "It was faster and more accurate, and it helped the plant produce a more consistent product," he says.Another reason the MES wave has been slow to hit pharmaceutical firms, analyst Martin suggests, is that the departments that would typically champion or shepherd a campaign for the purchase and adoption of MES are operations, quality control, and engineering. "You have relatively low-level engineers trying to build a bottom-up business case for purchasing an MES," Martin explains.MES could more easily be sold to senior management, Martin believes, if engineers, operations chiefs, and quality control managers more strongly present its case as a technology that can help reduce manufacturing costs by slashing errors, reducing inventories, and making supply needs more predictable.Staff Training an IssueAnother detriment to MES adoption is the concern that the installation process can impair production. Processes may need to be adapted. Staff must be trained to use the new system. And therein lies the rub for drug manufacturers, who invariably have a strong dislike for making changes at the production level. "With a validated operation, MES is not easy to install," Martin admits. He suggests that instead of attempting a risky, big-bang global rollout through all plants, companies first try installing the system in a pilot location to get some gains and experience under their belts. "Pharmaceutical companies are worried that when they revalidate their operations, what happens if the FDA does not approve all the changes they made?" he points out. "They perceive a potential production and operations risk when putting in new technology. And there is a downside risk if you haven’t got your processes under control." Patheon’s Ottenjohn agrees that companies should not underestimate the validation effort surrounding an MES installation. "The effort to implement and validate the MES is large," he says. "You need a good project methodology. And you need a plan laid out as to how you are going to go through this process. And finally you need a dedicated full-time project manager to run it."At Patheon, that was Ottenjohn’s role. He came out of the company’s manufacturing ranks and had a solid knowledge of its production processes. "I’d lean toward having a manufacturing person run the project, rather than an IT person, because they can relate to the users," he says.Training operators to use MES is another area where pharmaceutical companies tend to err on the weak side, and later suffer the consequences. "There was a significant amount of apprehension and fear among the employees when we put in our MES back in 1997," former Aventis manager Benson says. "And even when we did our upgrade, there was still quite a learning curve."Get User Buy-in from the StartGetting users involved from the beginning is the most important single factor for a successful MES project, Benson believes. "You’ve got to have their buy-in and acceptance and input from the inception." Aventis created its own training manuals, requiring employees to attend a three-part, 12-hour training program. The company made sure to assign a "power user" of the system to each shift.Integration with ERP is another big issue drug firms face when putting in MES. Sure, it’s great to have a sophisticated shop-floor system, but what good is it if it can’t connect with the order process and the inventory management system? Unfortunately, not all MES systems offer a full and complete interface with the popular ERP systems. The result is that pharmaceutical firms often end up developing their own interfaces.To help with integration, the consulting firm ARC Advisory Group (Dedham, Mass.) has teamed up with the ERP software vendor SAP AG (Waldorf, Germany) on workshops designed to help users define standard ways to integrate business and production systems. The workshops, held over the course of two days last summer, brought end users together with SAP and production management software suppliers. The users had a chance to, among other things, give input and share concerns with the suppliers. A loosely connected working group which grew out of the meetings continues to work on small projects, says Robert Mick, vice president of emerging technology at ARC.Patheon Pharmaceuticals was fortunate in that some of the interfaces it needed were already developed under its prior legacy system, and the company was able to transfer these. Other interfaces from MES to ERP were custom built by the MES vendor, in this case Rockwell Automation’s PMX Propack team.When an order is created in SAP at Patheon, it triggers the initiation of a manufacturing order in the MES. Correspondingly, when the MES in turn assigns raw material to a batch, the MES sends that transaction to SAP, so that the materials are deducted from inventory. Yet another interface the company maintains is the various bills of materials in MES and ERP. "It’s important that the bill of materials is synched and that we upload it to the ERP system," Ottenjohn says."We’re very confident that the MES has improved our manufacturing process," he adds. "Every pharmaceutical company should be using MES. It’s a no-brainer." Tips on Installing a Manufacturing Execution SystemHere are some suggestions from pharmaceutical manufacturing executives and industry analysts for companies looking to install a new MES or upgrade from an older system:
- Be sure to first have commitment from senior management to support the project, as well as a guarantee that they understand its scope.
- Assign a full-time project manager.
- Set up a global multidisciplinary team representing all units of the company.
- Find a smaller operation that can serve as a test or pilot site for the new MES. Learn from this installation.
- Design a template and use it to roll out the system across all sites. Above all, avoid customization of the software whenever possible. "Do everything you can to eliminate customizations," Patheon’s Ottenjohn warns.
- Be sure to take into account how processes should be changed or reengineered before implementing MES. Patheon, for instance, simplified the batch record process before automating it with the MES. "MES is a catalyst for process improvement," says Ottenjohn.
- Emphasize input from end users from the beginning. Get all users involved. By engaging those who ultimately will use the system, they are more likely to be committed to its success.
- Employ a "train the trainer" approach. First train a core group of "super users," who then go out and train larger groups of employees throughout the company.