Johnson & Johnson's (J&J's) Global Pharmaceutical Supply Group (GPSG)/Centocor division, located in Malvern, PA, recently completed what some in the maintenance world might consider a minor miracle. This 400-employee operation, maker of the bulk biopharmaceutical product used to formulate the rheumatoid arthritis drug Remicade, successfully replaced its existing CMMS with SAP's PM maintenance function — and it's thrilled with the outcome. No cries of "Why me?" or "No! No! No!" Just a heightened sense of accomplishment and, oh yes, SAP-related savings that have paid for the $3.2-million investment in less than two years.
"It's phenomenal to be able to do your work so easily now, which is one way to put it," says Deb DeRosa, general manager of the Malvern operations. "It's also phenomenal that we immediately started seeing those successes," she adds (successes that are being duplicated in other J&J facilities around the globe as the company embarks on a new course of SAP standardization).
If you're shaking your head at this point, you're not the only one. Plenty of head-shaking went on at this operation. Though the plant used SAP elsewhere, things seemed to be going along well enough in the maintenance department without it. Located in a well-manicured business park 25 miles west of Philadelphia, the 116,000-sq.-ft. GPSG/Centocor facility was built in 1999 and went online in 2001. The biopharmaceutical process it uses to make the bulk material for the popular Remicade drug involves cell reproductions and enzyme generation. The plant's final output, in frozen bulk form, is shipped to another J&J facility for liquid reformulation, aseptic filling, vial packaging and labeling and distribution to hospitals and clinics.
Thousands of patients with inflammatory disorders, including rheumatoid arthritis, Crohn's disease and plaque psoriasis, among others, have Remicade administered via infusion bag by their practitioners at costs that can reach $10,000 per patient, per year. Growing demand has created a $3.6-billion worldwide market for Remicade, 60% of which is supplied by the Malvern facility. Another J&J plant in Leiden, The Netherlands, manufactures the rest.
Much of the value of this multi-billion dollar market is driven by the high cost of production. Remicade, for example, can only be made in clean rooms. Maintaining clean-room integrity, as well as the systems and procedures needed for FDA, EMEA and Canada and Japan GMP (good-manufacturing practices) compliance, keeps extraordinary pressure on bottom-line results in biopharmaceutical operations such as GPSG/Centocor's. From this perspective, it made sense that the plant's maintenance function was scrutinized and eventually deemed a good candidate for improvement.
The SAP Plant Maintenance function matches those typically found in freestanding CMMS programs, but is designed to integrate with other SAP modules, such as Materials Management, Production, Sales and Distribution, Personnel Management and Controlling. Because of the integration, maintenance processes can be triggered in other areas. Similarly, maintenance personnel can use SAP-PM both to track information related to their jobs, such as costs and parts availability, as well as actively enter real-time cost and procurement information for access by other departments.For the record, SAP stands for “Systeme, Andwendungen, Produkte in der Datenverarbeitung,” which, in English, translates to “Systems, Applications, Products in Data Processing.” SAP AG is headquartered in Walldorf, Germany, near Heidelberg, with subsidiaries in more than 50 countries.
Setting the stage
"Before SAP, we were not able to do planning and scheduling, and we had very limited report functionality," recalls Felix Velez, recently promoted to GPSG's Lean director from associate director of Maintenance Systems. "Most data entry was paper-based and there was a lack of tracking of cost and time." Upon his arrival at the facility in 2002,
Velez says his challenge had been to educate the relatively young, 31-member maintenance crew on how to become a world-class facility.
"Maintenance here had been basically fire-fighting," he notes. "It was a very reactive mode, with no planning and a lot of inventory in the stockroom. People were also working a lot of overtime. It was very challenging." Velez and associate Jim Bell, now director of Engineering and Maintenance, and hired at the same time as Velez, began implementing work planning and scheduling, putting metrics in place and driving continuous improvement. These efforts led to the introduction of Six Sigma and Lean, Kaizen projects, 5S, RCM II and root-cause analysis.
But in a plant that was already running SAP with success in other departments, maintenance stood out. "When we estimated our potential savings from doing this, we could see that the easiest savings would come from reducing spare parts," DeRosa says. At one time, she remembers, everyone across the site hoarded spare parts-especially maintenance. With full management backing, it was decided that the plant would pursue an SAP-PM (plant maintenance) implementation in the Malvern Maintenance Department, with the goal of rolling out the same process in four other J&J biopharmaceutical plants. Though non-SAP options were considered, the decision to go with SAP was simplified by the fact that it was already in use in Malvern and was licensed company-wide by J&J. Bell notes that the existing budget also would not cover the cost of acquiring another stand-alone system. The project began in September 2005 with an evaluation of SAP implementers.
Six companies were considered for the Malvern implementation, including SAP itself, another well-known international business-solutions provider and ABB, the global provider of power and automation technology solutions. Smaller contenders were dismissed first, followed by SAP's withdrawal from consideration. This narrowed the field to two. Based on its deeper experience in maintenance and reliability, ABB won the contract.
ABB had expressed a willingness to break with preconceived ideas about how SAP implementations should take place. Velez had been unimpressed by the standard approach — which, he believes has helped confirm SAP's reputation in maintenance circles as little more than an elaborate accounting system. "Most SAP
implementations take the standard SAP configuration and adapt the business process to that," he says. This model, however, can create imperfect maintenance systems, something the Malvern site was determined to avoid. "We did not want to repeat the errors of the past," Velez says. "Instead of allowing the implementation to be driven by IT, the business managed the process and said, ‘These are my requirements, and you, IT, figure out how to build the solution.'" The Malvern team now credits this radically different approach with making the implementation a success.
Among various unique requirements was the group's desire to implement electronic approvals — without the need to complete a time-consuming digital signature pop-up screen and its requirement of additional ID and password inputs. Because Centocor is a biotech company, there are numerous GMP and FDA constraints in the production process, many of which require approvals for processes to continue. "We developed a way to do electronic approval without having the classical digital signature," Velez explains. To do it, his team used different basic functionalities from SAP and were able to manage electronic approval and comply with all requirements without having to invest a lot of money to build a digital-signature functionality. "In most cases," he states, "this is not included in the standard SAP product."
Implementation was also customized in the critical area of instrument calibration. This was probably the biggest challenge of the project — and the aspect of which Velez is most proud. A key requirement was to build and deliver a calibration solution that was not only fully integrated with the maintenance function, but also was paperless and in compliance with all GMP requirements.
The complexity of this challenge occupied the Malvern group up to the May 2007 go-live date. But, with ABB's tireless assistance — and a pivotal decision to use GuiXT software, a non-SAP program that allows for SAP customization and simplification without affecting its operation — the team learned to successfully streamline and customize SAP.
A result of this effort was the "calibration dashboard," which combines all calibration transactions on one screen. Velez likens it to "working an ATM where you just push buttons and know exactly what to do." The dashboard is built around a template that requires maintenance technicians — all of whom are equipped with personal laptops and SAP access — simply to fill in blanks. As soon as they fill the blanks and select the calibration standard they are using to do that calibration, they press a button and the system does the calculations for them. "We are the only ones I know using SAP for calibrations in a completely paperless system," Velez says.
Aware that the paperless calibration concept was a departure from SAP methodology, the Malvern team initially sought counsel from SAP itself to determine if they were headed down a technological blind alley. With SAP's North American headquarters only 12 miles away in Newtown Square, PA, it was easy for the Malvern team to pay a visit.
"We sat down with the U.S. product director for Plant Maintenance at SAP," says Jerry Cline, manager of Information Management at Malvern, "and told him what we wanted to do. He told us we couldn't." Instead, the team was encouraged to use regulatory asset-management software to build an interface. "We said we didn't want to maintain interfaces and would do it all internally," Cline recalls. He speculates that if they had been able to meet with "the guys who make it work" at SAP, instead of those several levels removed, the software giant would likely have seen the value of what Malvern wanted to do and offered a path to solution. Instead, he says, "We went back to ABB and asked, ‘How can we solve these problems?' and they had good answers."
One of the chief sticking points, according to Cline, was the complexity of dealing with 5000 different instrumen-calibration formats, each of which is an FDA-auditable process and had to be laid out "real clean." Individual calibration parameters are determined by the device being calibrated, the number of readings being taken, at what points they're taken and how the process is defined. "With all of these combinations," he says, "we would have needed 5000 different templates. In creating the calibration dashboard and some customized programs, ABB helped us design a process where we have a small handful of core templates, and we store data in SAP that defines, for each functional location, exactly what the calibration criteria would be. ABB wrote a program that says, if this is what you need to do, I'll build a form on the fly that does what you need to do. It was brilliant."
According to Jim Bell, the technical implementation ultimately succeeded because "We truly functioned as a team, not just as area representatives. There were times when Felix, the business owner, worked with ABB to resolve configuration issues, and when Jerry, the IT owner, challenged the business process to make it more efficient." As Bell describes it, this rare combination of a technically oriented business owner and a business-minded IT owner proved to be a winning one for Malvern.
The SAP Plant Maintenance function matches those typically found in freestanding CMMS programs, but is designed to integrate with other SAP modules, such as Materials Management, Production, Sales and Distribution, Personnel Management and Controlling. Because of the integration, maintenance processes can be triggered in other areas. Similarly, maintenance personnel can use SAP-PM both to track information related to their jobs, such as costs and parts availability, as well as actively enter real-time cost and procurement information for access by other departments.
For the record, SAP stands for “Systeme, Andwendungen, Produkte in der Datenverarbeitung,” which, in English, translates to “Systems, Applications, Products in Data Processing.” SAP AG is headquartered in Walldorf, Germany, near Heidelberg, with subsidiaries in more than 50 countries.
A culture is born
Creating the custom SAP-PM implementation solution was, of course, only part of the Malvern team's challenge. Convincing the maintenance crew and others in the facility of its value was the other part. Not only did SAP have a long-standing reputation for user-unfriendliness, the implementation would tie maintenance systems to all other site functions, including procurement and quality. While procurement posed few problems, quality was another story.
"In pharma," Jerry Cline explains, "a level of autonomy exists in maintenance and in the QA organizations, which have to approve everything. Sometimes it was easier to convince the maintenance guys because they can see the benefit and you can talk to them in terms of benefit. Some of the quality folks said they weren't going to change or didn't have the time to change, so there were some real roadblocks."
Velez was a strong advocate of the new plan and "very aggressive" in meetings with QA, according to Cline — particularly in those regarding the sensitive issue of electronic approval. "Felix would say, ‘Here it is, tell me why it won't work.' The result was that we had to develop security roles that are very unique," with regard to the system's ability to quickly recognize and approve those at the various levels of clearance.
Velez's confidence grew in part from the groundwork he and Bell had laid with their staff. "Maintenance was probably ahead of the game compared with the rest of the site," he notes. "This was because we worked hard from 2005 to 2008 to change the mentality and culture, implement planning and scheduling, and optimize the spare-parts stockroom. We did all of that without having SAP implemented, so when we went live with SAP, that mentality was already in place."
The maintenance crew clearly was determined to make the implementation work. "Just consider the technology leap of one day," Jim Bell recalls. "They went from writing paper work orders one day to using a wireless laptop for real-time transactions in SAP the next. That could have been a disaster."
The super users
Velez, Cline and Bell, who had previous, hands-on SAP-implementation experience with a former pharma employer, credit much of Malvern's SAP success to what they call the "super users." This is the hoped-for group of self-reliant and inquisitive team members whose knowledge, persistence and sheer enthusiasm for exploring the many aspects of SAP drive its usage — and its expected efficiencies — deeper into the organization. Malvern is fortunate to have super users Katie Wanczyk, manager of Maintenance Systems Support, and Yvan Francois, manager of Work Planning and Control, among others. Both say the only way to benefit from SAP is to dig in and get to know it.
"With any new system, there are learning pain points," Wanczyk advises. "But you learn as you go. Now that we're two years into it, these things make sense. Every day I find another way to do something because there are at least four different ways to do it in SAP. Some people see that as confusing, but I see it as being flexible."
For Francois, it's about breaking the fear of a new approach. "If you're not adventurous, you won't learn anything," he says. "You have to expose yourself to it." When the SAP project began in Malvern, he was a QA contact and, admittedly, one of those saying that moving to SAP would not be possible. "But," as he puts it, "when I transitioned to the Maintenance group and we started the new initiative, it all clicked."
Part of the "clicking" is learning to communicate SAP-style. Wanczyk says she now speaks a different language in her job, referring to her ability to discuss events using SAP's four-character transaction codes, such as "TECO" for "technically complete," and "FLOC" for "functional location." The codes, though, are probably one of the easier aspects of SAP to master. She acknowledges that learning the full scope of any SAP installation may not be possible. Francois agrees. "Every day I realize I know more than yesterday, but I still have a long way to go." Velez compares the plant's knowledge of SAP with learning to use "the car of my dreams, a BMW 755. Right now," he notes, "we just know how to turn the engine on, and probably how the radio plays."
Nonetheless, Velez believes the maintenance crew knows it is better off than previously — when crew members needed to fill out lots of paperwork. Now they can do transactions in the field. If they need a standard operating procedure, it can be pulled directly from the computer. If they need a drawing, they can pull that, too. "From that standpoint," he says, "they feel we delivered something to them with a high value."
Cline adds, "The things we've done here have been great from a maintenance perspective." He's referring both to the gains in Malvern and the fact that its SAP configuration is being rolled out to other company facilities. "When we started, bio was pretty much a separate business," he says. "Now we've become more a part of the overall pharma sector, and we're taking this concept to the next level."
The idea that the Malvern team accomplished what it did despite a culture that didn't support standardization and didn't support some of the things the team included in its rollout strategy is intriguing to Cline. "This multiplies the value of what we've done many times over," he says. "The fact that we can take all the wins built into this product and drop them into another site relatively inexpensively might be common in some industries," he notes, "but not in pharma. Here, it's a new concept." MT