A new manufacturing quality software system is a money and time saver at Oregon Freeze Dry LLC, Albany, OR. The company has installed a Synergy 2000 SE system from Zontec Inc. that is designed for companies that need to implement the most stringent access and security controls on their quality and safety data. Synergy 2000 SE satisfies the needs of industries regulated by the U.S. Food & Drug Administration that must be in full compliance with Title 21 Code of Federal Regulations (CFR) Part 11.
Synergy 2000 SE includes a closed security layer. Its unique electronic records/electronic signatures implementation includes date/time-stamped audit trails, logging and tracking of changes to original data, password "aging" provisions and an electronic signature pad to digitally capture and display handwritten signatures alongside the SPC data. Now, individual signatures can confirm accountability for every quality control sample entered.
With a menu of more than 500 items, Oregon Freeze Dry LLC says it is the world's largest custom processor of freeze-dried products. In addition to providing private-label manufacturing, the company features a full-line of ingredients used by some of America's largest food companies. It is a major supplier of field rations to the U.S. military, and it markets its own line of backpacking foods under the Mountain House brand.
The company has more than 20-million kg of drying capacity at its three facilities, representing about 70 percent of North America's total freeze-ndrying capacity. Tim Stutzman, manufacturing systems analyst for Oregon Freeze Dry, says, "We freeze-dry products, anywhere from food products to pharmaceuticals."
Oregon Freeze Dry decided to implement Synergy as a tool that would empower its operators to proactively manage the process. Stutzman says, "We needed a tool for operators so that they would know whether or not they were in control. Prior to Synergy, operators had no real-time way to tell whether or not their step in the process was in control."
Synergy software was selected also to help meet management's objectives of less rework and tighter controls. Management wanted to run machines at lower targets so less product would be overpacked.
With Synergy's capabilities, Oregon Freeze Dry can be more precise in the filling ranges it allows for packaging.
Stutzman says, "Considering we are running five packaging lines a day and our packaging runs are in the thousands, reducing our range by a gram saves a lot of money. Without Synergy, we would not be able to set such tight tolerances."
For the operators, using Synergy is very straight forward. "We found that Synergy was the easiest to convert and to train," Stutzman says. "The product has a lot of useful features, and it is simple to use. One click, and you have a run chart."
Decreased rework also saves money. According to Stutzman, "The other way we are saving money is the fact that we have decreased considerably the amount of rework we are performing. Now we have the visibility to see when a process is trending toward going out of control, and we can make adjustments. This saves us a tremendous amount of repackaging."
Stutzman commented that Synergy helps him by freeing up his time. "It saves me a lot of time, because the files are easy to set up. I can set up a file in a couple of minutes. If there is something new the packaging engineer wants to do, I can set it up quickly. Synergy is an easy program to use, and it is easy to train. I haven't seen an operator yet that didn't learn how to use it quickly. The program is efficient and runs smoothly; it is quick and easy to understand."
Oregon Freeze Dry also uses Synergy to test out new products. "The packaging engineer really likes the charting features-like the histograms and standard deviation charts-to make determinations about new products," Stutzman says. "He uses Synergy to help him determine whether or not existing machines can make a new product. He will do a test run, enter the statistical process control (SPC) data into Synergy, and then use the graphing capability in Synergy to test whether the machine is capable or not."
Zontec Inc., 866-955-0088. www.zontec-spc.com