Resources > APICS Magazine > March 2005 > Medical Miracles

Medical Miracles
Adaptable MES heightens quality and speeds production

ZOLL Medical Corporation has been making life-saving contributions to cardiac resuscitation technology for more than 20 years. Custom-built to accommodate specific environmental, power, and language requirements, ZOLL’s products are widely used in hospitals, emergency vehicles, airplanes, and many public places throughout the world.

Demand began to rise dramatically in 1998, when the company introduced the first complete system for all levels of resuscitation needs. After several years of racing to keep up with new orders—using expensive and time-consuming paper-based processes —ZOLL leaders realized it was time for a complete overhaul of its manual quality and compliance systems.

Today, the company relies on the InSite manufacturing execution system (MES) from Camstar Systems to speed production and automatically satisfy stringent regulatory requirements. Implemented in just six months, the MES delivers a dramatic return on ZOLL’s investment in terms of quality improvements and manufacturing efficiencies.

Re-engineering the process
Time and quality are the critical factors when treating victims of cardiac arrest. Whether professionals or public first responders, rescuers need access to devices that are easy to understand and work the first time. ZOLL provides portable, self-standing, dual-purpose resuscitation and defibrillation units that visually and audibly coach the rescuer through all steps of the American Heart Association’s Chain of Survival.

Time and quality also are critical when it comes to manufacturing these devices. Recognizing this, ZOLL’s production and quality management teams set an ambitious goal: Re-engineer the entire process to automatically comply with regulations—and not just as an overlay to an existing paper-based process. The idea was to integrate the device history record (DHR) so seamlessly into the production process that an accurate electronic device history record (eDHR) could be produced with as little effort as possible. Knowing that the company stood to double certain aspects of its production capacity, ZOLL management demanded results in six to twelve months—a tall order for a regulated manufacturer.

Real-time data
Although improving first-pass yields is always important, the top priority for ZOLL was to enhance product quality by allowing operators and managers to focus on product, not paper. “Any investment that delivers yield improvement without quality improvement isn’t worth a dime,” asserts Larry Dubé, ZOLL’s director of manufacturing engineering.

Manufacturing Class 3 Medical Devices—devices that have the potential to save a life—requires the highest quality standards and complete DHRs. The amount of paperwork required to comply with related FDA regulations is enormous. “We had 25,000 square feet in document storage alone, and up to 50 percent of the manufacturing cycle time was consumed in processing documentation,” recalls Dubé. “We needed to bring overhead costs down by converting manual compliance processes to automated, paperless processes based on the eDHR.”

Building to hundreds of custom specifications in a demand-to-forecast environment means that one model of a product can be converted to another model, and test processes must be adapted to the complex options. This requires operators to have easy and reliable access to work instructions, process routings, and bills of material. Similarly, specifications for new products must be in place quickly so the company can stay ahead of the market. ZOLL’s existing paper-based system was much too cumbersome for this type of process.

An adaptable solution
Naturally, an information-based problem required an information-based solution. Furthermore, the system would have to be easy to configure, maintain, and validate. ZOLL’s team determined that the problem only could be solved if the solution removed all—not most—of the paperwork. “Coming close but not completely replacing old processes ran the risk of adding, rather than reducing, cost,” says Dubé.

After thorough evaluation of several products, ZOLL selected Camstar’s InSite MES “based on breadth of functionality and the company’s experience in manufacturing, quality, and regulatory issues,” explains Dubé. ZOLL leadership especially appreciated Camstar’s philosophy and architecture, which enable the company to model manufacturing processes and set business rules centrally with minimal programming and revalidation. Operator-user interfaces entail only a browser, so maintenance and upgrades are not required at the workstations.

Since the time frame was so aggressive, ZOLL supplemented its implementation team with experienced team members from Camstar. The ZOLL team wrote many of the validation plans but also used some of Camstar’s predeveloped procedures and documentation templates to accelerate the process. Following a streamlined validation, the company switched over to the paperless DHR.

Multiple products on multiple lines are now processed and tracked using eDHR, eliminating the need to double-check for correct processing and operator signatures. Test data is collected automatically from the equipment, minimizing human error and avoiding potential “test escapes.” Every unit shipped has a step-by-step, multilevel history, including operators, test results, subassemblies, materials, rework, and date and time stamps.

The wealth of data collected through the eDHR also provides real-time shop floor visibility, yield and quality monitoring, cycle time reporting, work order prioritization, and serial number/lot level tracking of material use. Units at the material review board stage—a process used to decide if a questionable product will be scrapped, reworked, or released—are attended to quickly, and issue analysis and problem correlation are systematic and fast. Since data is collected and verified in real time, ZOLL quickly can identify and resolve manufacturing issues.

The payoff
Six months after it began, the first phase of the re-engineering project went live, on time and within budget. The DHR and compliance processes are now entirely paperless, eliminating 40,000 paper DHRs and delivering an annual savings of more than $500,000—a 43 percent reduction in the total cost of compliance. For example, the estimated cost of reporting labor has been reduced by $244,000; paperwork management is down by $88,000; and paper, reproduction, and box expenses have been cut by $29,000. In addition, quality assurance review, which used to last 30 minutes, now takes about 5 minutes. “Camstar’s solution allowed us to take control of the cost of compliance so we could focus on quality,” says Dubé. “A well-designed process that is well-managed is by default compliant.”

Cost savings are paired with dramatic quality improvements, shortened cycle times, and elimination of cumbersome paper storage and handling. Specifically, paperwork is now 99 percent error-free; overall line yield increased by 13 percent; and, at quality assurance review, cycle time decreased by 60 percent and throughput increased by 150 percent.

Dubé says that “the rapid and significant payback of the first phase of the implementation” caused them to expect additional cost savings and quality improvements. In fact, ZOLL leaders were so impressed with the results of the initial implementation that they immediately began work on a second phase, during which ZOLL implemented Camstar’s SPC (statistical process control) and CAPA (corrective and preventative action) modules.

SPC analysis enables operators to monitor real-time conditions, generating automatic “out of control” alerts to prevent quality problems and provide the data necessary to analyze historical trends. ZOLL’s field service group can access a complete device history to speed failure analysis and alert manufacturing and quality personnel to “out of tolerance” conditions.

CAPA automatically alerts the appropriate individuals when an issue requires attention. Simple rules defined by ZOLL enforce how these problems are resolved, and the system will not allow shipment of any unresolved product. As a result, quality and regulatory compliance are streamlined even further.