Manufacturing Execution Systems
MES can help manufacturers achieve reduced cycle times, zero-error production, and automated compliance-data management.
Norbert Sparrow
Manufacturing execution systems (MES) is an umbrella term for software that creates and manages complete process specifications, executes the master record that integrates process equipment and operators, and stores data that can be accessed for analysis and compliance procedures. According to Manufacturing Execution Systems International (MESA; Pittsburgh, PA, USA), an MES can reduce average cycle times by more than 50% and improve plant performance by 30%. Batch deviations typically drop by 90% and data entry can be slashed 75%, adds the nonprofit organization, which was established by software vendors to raise awareness of MES. Not surprisingly, statistics such as these have piqued interest in MES among manufacturers producing high-volume products within regulated industries
Defining MES
MES is a rather nebulous term, says Brian Palmer, programme manager at Cobe Cardiovascular Inc. (Arvada, CO, USA). In fact, when Cobe installed an MES at facilities where the company produces its cardiopulmonary devices and autologous blood recovery products, they renamed the system eDHR (electronic device history record). "MES didn't convey the meaning we had in mind, and no one really understood what it meant," says Palmer.
Part of the confusion is a consequence of the fragmented nature of MES products, suggests Mike Beauvais, sales and marketing director at Via Information Tools (Rochester Hills, MI, USA), which has developed the MAN-IT system. "There are a multitude of products that fall under the MES heading, several of which focus on niche interests," says Beauvais. "Some manufacturers prioritize scheduling, others want to deal primarily with traceability, data collection, or sequencing, and there are MES products designed to specifically address those needs."
But one of the things that sets MES apart from other systems is its ability to perform these and many other functions in a single package.
Location Is Key
"MES maintains everything that is relevant to the manufacturing recipe in a very detailed manner," explains Brian Adams, director of business development Europe at POMS (Brussels), a supplier of MES solutions to regulated industries. "The system transfers the orders or batches from the enterprise resource planning (ERP) or materials resource planning (MRP) system to the shop floor. Programmed to recognize that a particular product needs to be manufactured, MES will look at the recipe, match the product that is going to be made against what is required, and then explode that data into however many thousands of instructions are necessary to achieve that," explains Adams. "MES covers the entire
"MES resides in the middle ground between ERPs and control systems on the plant floor," adds Robert Johnson, project manager at Raytheon Consulting and Systems Integration Inc. (Philadelphia, PA, USA). Johnson and other MES advocates stress that these systems should not be perceived as one more self-contained piece of software.
"Historically, manufacturers have developed islands of information . . . computing systems that are independent of other information systems," says Palmer. "MES fits between the planning systems and the plant floor control systems, passing information between them," he says. A typical dialogue, if you will, may begin with MRP passing a bill of materials and routing data to MES, which transfers work orders for execution to the plant floor. "As the work order is executed, MES feeds status information back to MRP, which automatically performs inventory transactions," explains Palmer.
Being able to access comprehensive real-time data is one of the key benefits of an MES, according to Beauvais. "It gives you granularity," he says, "a real-time view of what's happening on the plant floor." Because it identifies manufacturing issues and communicates the information to relevant personnel immediately, problems can be rapidly resolved. "Our system error-proofs the production process," explains Beauvais. "For example, it verifies that the operator working on the machine has the required skill set, that the routing procedure has been followed, and that the proper bill of materials has been specified." MES oversight extends to what Adams calls asset management.
"Other systems are not necessarily conscious of human beings, materials, or important assets like containers," notes Adams. "As you move through a particular manufacturing process, you might well put your product into another container that may have to be sterilized and cleaned. So you will want a system that can track associated items and resources. In addition to batch, recipe, and materials management, MES performs asset management, which could be defined as a room, a machine, or people."
This capability may be of particular interest to device manufacturers, especially in relation to traceability and the capture and management of compliance data.
Automating the Documentation Process
"An MES electronically records every instruction and generates an electronic batch record at the completion of an operation," notes Adams. The user can always go back to any point in the process, he adds, and identify deviations that may have occurred. Beauvais adds that traceability is a core feature of his company's MAN-IT system.
"Let's suppose one of your suppliers informs you that he sent some bad parts," Beauvais says. "You can punch in the batch number and instantly know where those parts are. If they have been used in a product, it will tell you which ones they were installed in and where those products were shipped. One advantage is that you can limit your exposure in terms of product recalls," says Beauvais.
Automation of the data entry process and a reduction in errors was one of the driving forces that led Cobe Cardiovascular, which was recently acquired by Sorin Biomedica S.p.A., to invest in an MES system. "Enormous competitive pressures were requiring us to build our products faster, cheaper, and better," says Palmer. "At the same time, regulatory compliance issues demanded more-stringent recordkeeping and verification. The only way to solve the regulatory issues seemed to be to keep throwing more people at the problem," recalls Palmer. Squaring that circle, Palmer concluded, meant implementing an MES that would automate the maintenance of device history records.
Completing a device history record consumes a lot of operator time, says Palmer, and it must be reviewed meticulously for errors. When an error is found, the product is held until the problem is resolved. Then the paperwork is sent to the quality assurance department for yet another review. If more inconsistencies are spotted, the product could again be placed on hold. "Just to use round figures, if it takes us a week to build a product, it could take us two weeks to clear up the paperwork," says Palmer.
Since installing the MES, named eDHR by the company to explicate its function, Cobe has reduced its headcount through attrition by 10%, says Palmer, simply by eliminating the rampant double- and triple-checking of documents that used to occur. "That alone justified the investment," he says. But the system also brought other benefits, including increased manufacturing yields and a reduced inventory.
Yield was increased through a reduction of scrap, explains Palmer. An MES typically collects data that can be used to determine where and why high scrap rates are occurring. "The system can resolve questions that otherwise are not answerable," says Palmer.
Inventory reduction was achieved as planners became confident in the accuracy of the data. "Many manufacturers are plagued by inaccurate MRP data," says Palmer. As they lose trust in the information, planners tend to increase their safety stock, he adds. Because MES automatically sends material consumption transactions to MRP at each manufacturing operation, upstream data is accurate at all times. "This has the tangible benefit of restoring confidence in MRP inventory levels," says Palmer.
Perhaps the greatest measure of the system's success, adds Palmer, is how it is viewed within the company. "The quality department sees eDHR as a quality system, while the manufacturing people consider it to be a manufacturing tool," he says. "Well, it really is both. It's helping manufacturing work more efficiently while allowing the quality side to meet US FDA and European requirements," he says.
Is It Worth It?
The price of an MES system starts at US$250,000 and it can go into the millions of dollars, so all but the most profligate of companies will want to engage in a thorough cost-justification before considering this type of investment. When trying to determine whether an MES makes sense for your company, one indicator suggested by Beauvais is the number of data collection points in a firm.
"If you're doing volume production and you have 25 or more data collection points in your facility—and these could be performing repetitive operations—I would say it's a necessity." Adams notes that POMS has found considerable success installing MES in biotechnology firms, which tend to be small in size, but where regulatory compliance is a primary concern. "MES should really be investigated by anyone in the device industry who is dealing with electronic signatures and electronic batch records and who wants to reduce cycle times," says Adams.
Implementation StrategiesIntroducing a new system into the manufacturing stream can be fraught with obstacles. We asked MES vendors and Brian Palmer, programme manager at Cobe Cardiovascular Inc., which recently installed an MES at its plants, for advice on how to ensure a successful transition. Establish a dedicated team. A key element that contributed to the success of the project at Cobe, according to Palmer, was the decision to assemble a team exclusively focused on bringing the project to completion in a timely manner. "Personnel from the computer and the manufacturing side were recruited into a new department that was dedicated to this project. They were able to devote their full attention to the project without being distracted by other responsibilities." Involving people from outside the information technology arena, he adds, was also a critical factor. Resist scope creep. "There are generally two or three issues that a manufacturer needs to deal with," says Mike Beauvais of Via Information Tools. "Map them out and look for the MES product that resolves those specific issues," he stresses. A common reason that systems fail, he adds, is because people ask a system to do too many things. "They go crazy on the scope and lose sight of what should really be driving their installation," says Beauvais. Don't try to do everything at once. "If a project is too encompassing, it takes too long to implement," says Robert Johnson, project manager at Raytheon Consulting and Systems Integration Inc. "Go after the smaller, quicker hits, and as you become familiar with the system, expand it into the manufacturing process," says Johnson. You should aim for a six- to nine-month implementation cycle, adds Brian Adams, director of business development Europe at POMS. "If something looks like it will take longer, break it up into smaller projects." Avoid unnecessary customization. "People get excited when they see all of the things MES can do, and they tend to start adding custom requirements that drive up the cost and installation time," says Adams. "If the standard product works—and it certainly does for a lot of people—you need to challenge those in your company who want to do things differently," stresses Adams.
Practise risk management. "Rather than ignoring problems that loom on the horizon, team members should be prepared to identify risks that need to be addressed," says Palmer. This must be done on a regular basis at each phase of the project, he adds. |
