Human hearts have their own electrical systems, controlling every aspect that goes into pumping blood throughout our bodies. Like any system, when a heart’s internal structure is disrupted, it cannot function. Defibrillators treat irregular heartbeats with electronic pulses. The life-saving power behind each shock lies within its battery.
At one of its U.S. facilities, a global medical device manufacturer makes these batteries and other components, such as high-voltage capacitors, feedthroughs and electrodes. Recently, the company anticipated an increase in product demand that would require doubling its current output at the site. Yet, the company’s manual assembly process was experiencing delays and challenges that forced the company to consider a new, lean path.
Before components go into medical devices, the manufacturer must validate its product design and manufacturing process to meet federal regulations. Additionally, the company’s production facility must maintain less than 2 percent humidity at all times due to the reactionary potential of the batteries. Making any changes in this environment would be a costly investment. To verify personnel tackle the root cause of cycle delays, the company videotaped processes in action and what it found was astonishing.
“What we discovered was that it would take up to 25 seconds to acquire a mass during the simple weighing process,” said a process-development engineer for the manufacturer. “Operators were staring at their screens waiting for the MES transaction to take place. The automated system that we owned was obviously wasting time.”
Between waiting for the completion of each MES transaction and assembling devices, operators looked up at the screens so frequently that many left work with sore necks and stiff muscles. “We noticed operators’ heads bowing up and down, looking up at screens,” the engineer added. “Your own neck would get sore watching them.”
Once the company recognized the challenges, the team concluded that 40 percent of the current operational duties were not adding value to the product.
‘No Fault Forward’ Production
While on the hunt for a solution for the facility, the manufacturer’s engineers attended the Rockwell Automation TechED™ user training event. One of them attended a session by Cybertrol Engineering, a Solution Partner for control, process and information within the Rockwell Automation PartnerNetwork™ program. The application outlined in the Cybertrol case study discussed the concept of “no fault forward” production, giving the engineer hope that Cybertrol could offer a fresh perspective to the company’s challenges.
With the help of Cybertrol, the medical device maker implemented a manufacturing solution standardizing on Allen-Bradley® CompactLogix™ programmable automation controllers (PACs), even in areas where the assembly was entirely manual. Now, instead of operating 12 workstations and seven different data collection apps, operators can use one of seven identical workstations. The controller manages the interaction with the existing, company-built MES, so the operator is not required to engage – or wait – directly.
“The sequence is the same for every process,” the process-development engineer said. “The basic six things happen no matter what the process is – automated or manual assembly. The programmable logic controller is there to enforce the standard sequence of events to know that everything is happening in the right order, every single time. If a step is skipped or any event is not recorded, the operators aren’t allowed to move the product forward until the issue is resolved – no fault forward.”