Originally Published MDDI October
2004
Software
MES:
A Look Back, a Look Forward
Regulations and higher-quality standards have made manufacturing execution systems a necessity for staying competitive in the 21st century.
 |
| Several components for an MES can be viewed on a single display (click to enlarge). |
In the old days, when management needed signatures for product signoffs, the
approach could be almost quaintly low-tech.
“One of our customers had a little cart to roll around on the shop floor
and a binder to record data,” says Bo Priesing, director, life sciences
for Datasweep (San Jose). “As the cart went along to different workstations,
the operators would sign off. Then management would go down to a document storage
vault and archive it. When you consider you’ve got hundreds of devices
going out, and each device has hundreds of documents attached to it, it can
add up.”
After filling up the storage vault, the company outsourced to a large warehouse
to stockpile its data, Priesing adds. Even with the extra space, the storehouse
faced the same problem all paper-based filing systems do: accidentally going
up in smoke. “Those warehouses have to have good fire protection,”
Priesing says.
As manufacturing execution systems (MES) have revolutionized the medical device
industry, the above scenario seems almost fit for a Norman Rockwell painting.
The ability of an MES to integrate information from every area of manufacturing,
including plant maintenance, laboratory information management systems, and
document control, into one coherent system has streamlined the way medical device
companies do business. Electronic recordkeeping and electronic signature capabilities
have replaced the “cart and binder” methods of the past. FDA audits
that used to take two weeks now take two hours, and paperwork loads that could
reach the height of the Empire State Building are now the size of a phone book.
According to a white paper from the Manufacturing Enterprise Systems Association
(MESA) International (Chandler, AZ), MES is “a system that consists
of a set of integrated software and hardware components that provide functions
for managing production activities from job order launch to finished products.
Using current and accurate data, an MES initiates, guides, responds to, and
reports on production activities as they occur. An MES provides production activity
information to other engineering and business activities in the enterprise and
its supply chain via bidirectional communications.”
In this way, an MES enables companies to reduce cycle times, labor costs, and
inventory waste because it communicates inefficiencies, errors, and other problems
to key personnel the moment they happen. If a product is defective, then management,
quality control, or shop-floor operators can fix the situation immediately,
without a large time gap.
Device History, Recalls, and Conformance
One of the main benefits of an MES for medical device companies is that it allows
users to look at a device’s entire history. The serial number, the components
that make up the device, the operator who worked on it, and its manufacture
date can be called up instantly without searching dozens of file cabinets. It
also reduces the considerable time a paper search could take. Product throughput,
quality, start and finish times, and inventory reports can also be stored and
analyzed. MESA International estimates that this technology can cut manufacturing
cycle time by 45%.
In the case of a recall, the time saved can be the difference between an acceptable
loss and a financial catastrophe. With an MES, recalls can also be made with
more surgical precision. Traits shared by failed products can be discerned without
sifting through a mountain of paper data.
“With recalls the old-fashioned way,” says John Beans, vice president
of marketing for Datasweep, “a customer would call in and say ‘this
product failed.’ When you investigate, if all you’ve got are paper
records that you have to go through by hand, sometimes it can take two to three
weeks to see what’s going on.”
Keeping such close tabs on product manufacturing can also improve conformance
and product quality. An MES can guide workers through manufacturing processes
and verify whether they were performed correctly. Corrective and preventive
action (CAPA) systems can also be integrated with an MES to ensure regulatory
compliance.
Additionally, an MES has a direct personnel component that assigns the workers
with the most relevant skills to work-specific operations. The right system
can reduce training costs significantly.
Information in Real Time
Information is at a premium. One of the goals of an MES is to get shop-floor
information into the hands of management, engineers, and workers in the time
it takes to send and receive an e-mail. Better resource management, scheduling,
and decision making are the by-products of a successfully integrated MES.
Information on incoming shipments, outgoing products, raw materials, and inefficiencies
such as bottlenecks can be funneled directly to the right personnel, allowing
them to make the necessary changes before a line-stop occurs. Checks can be
set up to alert management via horns, cell phones, pagers, PDAs, and e-mail
alerts. As Milan Bhalala, director of marketing at Camstar Systems (San
Jose), puts it: “You can slice and dice the information to see it how you
want it.
You can set up proactive controls,” he adds. “If an average yield
goes below [a certain percentage], then I want to be notified. It’s like
a stock portfolio control: if a stock falls below this price, then I want to
sell it.”
An MES enables companies to forecast their business requirements by providing
information on process management, dispatching, labor synchronization, and resource
availability. Machine repair schedules can also be coordinated to prevent breakdowns.
“When companies do their maintenance planning, an MES can sync their product
needs with their maintenance needs,” says Bhalala. “An MES will find
anomalies in the system before they become an issue and cause a line stop.”
Walk Before You Run
The obstacles involved in installing an MES may seem overwhelming. The cost
of setting up an MES can range from $15,000 to as much as $500,000. Successful
implementation requires management, shop-floor workers, and engineers to work
together. Before upgrading, companies must ask themselves whether an out-of-the-box
system is compatible with the business or whether a custom-built
solution is required. Technical considerations between a smaller, faster system
and a more-comprehensive but slower system must also be taken into account.
Often MES programs have a hard time getting off the ground. Reasons may include
not budgeting enough money, having too many procedures in the initial run, and
underestimating the complexity of the system. The last thing management wants
is to discover that its newly purchased MES is too complicated or ill-suited
to the company’s day-to-day operations.
Some MES providers offer alternatives to an overnight switch to a paperless
system. Datasweep offers to install its MES for single projects so customers
can get a feel for the technology before making broad changes. According to
Carolyn Hughes, Datasweep PR manager, this “get your feet wet” approach
includes a plant tour walk, case assessment, and examples of what industry peers
have done with MES programs.
“We advise new customers to start small but think big,” she says.
“We tell them not to try to do everything at once. We take one issue and
work on that first.”
Another complication to installing an MES is the issue of compliance. Some companies
may be apprehensive about changing systems if they are already compliant and
have been putting out the same product line for a few years. However, given
the increasingly rigorous FDA standards and auditing processes, the advantages
of implementing an MES are becoming more of a necessity.
“FDA can’t demand that companies implement an MES, but they realize
that an electronic system is more easily tracked,” says Hughes.
As companies become more familiar with the technology, they can expand its integration
into the manufacturing process. An MES is built to grow—as many as 10 plants
can run on one MES, according to Beans, and the number of manufacturing resources,
personnel, and step-by-step processes that can be added to the software is limitless.
The only limitation is the computer’s speed.
Web-based servers have helped ease the burden of coordinating large amounts
of data. All relevant information is stored on the Web, which means that maintenance,
installation, and validation are less of a headache. “We’ve embraced
the Web from the beginning,” Beans says. “It needs to be done right,
but you don’t want to have to travel to Ireland to install software.”
Beyond the Web, some foresee a future in which large companies with divisions
worldwide store data in one large, centralized information hub. “All the
information [will be] sent to that center,” says Priesing. “It’ll
run different kinds of applications and then dump it in the Web.” Companies
will then be able to draw the information they need from that one location,
Priesing adds.
Building a Better MES
As the advent of the MES has improved medical device production, the standard
of quality has gone up, and, as FDA regulations become more stringent, the technology
will have to keep pace. In the constant struggle to do things better, faster,
and cheaper several issues will continue to push MES technology forward.
Mobility is one of the driving factors behind MES improvement. The ability to
walk around a shop floor with a device’s entire history at the press of
a button is not yet a reality. Success with Tablet PC technology has been spotty;
and PDAs, across the board, are not powerful enough to handle all the data.
According to Emmanuel Fretti, vice president of sales and marketing for Elan
Software Systems Inc. (Princeton, NJ), mobility might be the only advantage
that paper has over an electronic system.
“One advantage of paper is that you can walk around with it,” Fretti
says. “It’s very difficult to bring your desktop computer around to
show to other people. . . we need to see a combination between PDA and Tablet
PC.”
The ability of an MES to grow and change with a company’s manufacturing
needs is also essential. Flexibility, data analysis, and knowledge management
are fast becoming indispensable components of MES, as opposed to raw data collection.
Companies must know what the data mean once they have them, so the need for
decision-support tools to be integrated into the software is greater than ever
before.
Durability is another issue at the heart of MES improvement. In a heavy industrial
environment, portable computers must be able to take a beating and keep on functioning.
“These things need to be made so you can run a forklift over them,”
says Bhalala.
Conclusion
The purpose of an MES is to make manufacturing more efficient, raise product
quality, and, ultimately, help companies run a better business. However, there
is no one-size-fits-all product suite to fulfill all of a company’s needs.
Management must look at the company’s individual
requirements to find a program that works best for them. Flexibility, adaptability,
and user friendliness are just a few elements to consider. A company should
understand that the cost of an MES system is not just monetary; it is also an
investment in time, organization, and cooperation for employees and management.
It’s best to keep expectations “in the real world,” says Beans.
“You don’t want to buy 12 systems to manage your products. Make sure
your MES integrates with other systems and that they come together well.”
Copyright ©2004 Medical Device & Diagnostic Industry
