7th Annual Essential Guide to Manufacturing Software: Think of 21 CFR as win-win
On December 6, 2004, the FDA released its final rule on the Establishment and Maintenance of Records to Enhance the Security of the US Food Supply Under the Bioterrorism Act. In a nutshell, it says that if you are a food manufacturer or a transporter, you must maintain records that trace and track the source(s), manufacturing processes, and destination of every product. The good news is that application software vendors are ready with products to help food and beverage manufacturers meet the FDA's demands. The added bonus is that these products will also help get manufacturing processes and inventory under control and save on energy costs.
According to the FDA, the deadline to have systems in place is the end of 2005 for large companies (500+ employees), middle of 2006 for smaller companies (11-499 employees), and the end of 2006 for very small companies (under ten employees). (For more information, see Beyond the Bioterrorism Act on page 41 in this issue.) What specifically does the FDA want? According to Jim Brown, VP of strategic sales at Wonderware, "Food manufacturers must be able to correlate their products back to the source(s) of all ingredients, the dates received, the trucking company that delivered them-in short, all the information about each and every ingredient." Brown says information concerning plant floor insecticides, handwashing programs for employees, screens on docks, and detailed process information needs to be included as well. And of course, producers will have to keep records of where all their products go and what carriers are used.
According to the FDA, manufacturers will have 24 hours in which to respond to a call for records. (Earlier, there was discussion to make the time as short as four hours.) Keep in mind that the more granular the records (e.g., every four hours), the better the chances of narrowing a search and keeping potential product recalls as small as possible.
To meet 21 CFR rules on record keeping, you could use a clipboard, paper, and pen to record the tracking and tracing histories of incoming ingredients, manufacturing processes, packaging operations, and shipping destinations. Risk-analysis studies based on your manual tracking system will help you estimate potential losses if you're forced to recall products. Or you might consider using appropriate software applications that will collect, aggregate, sort, and supply this information to the FDA at a moment's notice.
Why use the software approach? Because it can help you solve other problems as well. For example, you can't seem to synchronize your inventory and manufacturing schedule with orders. Your customers want status information on their orders "now," but you have to make three phone calls before you have the information. For some odd reason, your products-out plus your waste and scrap never seem to balance the ingredients you used. Where's the missing "stuff?"
Suppose the FDA asks you to produce records because it thinks one of your key ingredient suppliers may have shipped a batch laden with bacteria. If you have more than one supplier for the same ingredient, software-driven tracking and tracing may help you find the affected ingredient much sooner, saving you money by not recalling good products.
The right software can give you accurate reports on a timely basis to meet the FDA deadline, and that same software can help get your product development and planning, inventory, manufacturing, orders and shipping under control and on schedule. And there are some other software products that can optimize your entire manufacturing process.
Minneapolis-based Sopheon Corporation, with customers such as Cadbury Schweppes and Mott's, is one such company, offering software that enables compliance with 21 CFR 11. Its product portfolio and process management solution, Accolade, includes document routing and approval features that help product development team members circulate and track project documentation in accordance with compliance regulations. The software ensures that key deliverables in the development process are formally reviewed and approved via electronic signatures, then stores them as proof of compliance.
Global issuesIn a web forum, ARC Advisory Group's John Blanchard, director of research, food and pharmaceutical industries, noted that because food and beverage products are sourced and sold globally, "the impact of malicious or non-malicious contamination of food or food ingredients for human or animal consumption can no longer be solved through geographic isolation. The financial impact on a company can potentially be devastating." Yet, according to Best Software's Senior Account Executive, Chris Knapp, several of his smaller to medium-sized customers aren't prepared at all to meet the new regulations, and many seem to have their own interpretation of the FDA's rule or lack a thorough understanding of it. For some of these customers, Knapp says there is a tendency to put a comptroller in charge of compliance, but unfortunately that's not the right person. Large companies will usually find someone who is specialized in regulatory compliance to make sure the company meets all the requirements.
Ironically, trying to save money by sticking to paper and pen could cost big bucks in the long run. According to John Cavalenes, Citect Americas' director of MES solutions, some manufacturers will actually play the percentages. A number of companies will do a risk analysis to see how often a recall might occur and what it might cost them. If the manufacturer's insurance company suggests the possibility of one recall in five years, they may opt to stay with the manual routine-especially if they figure while they may not be able to get to the granular data that the FDA wants, they can at least get the overview within the FDA's deadline. However, without the granular data to pinpoint a defective ingredient from one supplier, it might be necessary to recall several unaffected batches of products-a very expensive proposition.
Another important consideration, says Knapp, is that software in and of itself cannot be compliant with any FDA rules and regulations. It's up to the food manufacturer to apply the software tools properly to get the results necessary for compliance. And this is where most software companies and their resellers will assist in the training necessary to put together FDA-compliant programs.
Charley Rastle, solutions manager for Rockwell Automation, says that while many of his customers have already been routinely asked by FDA auditors how they're doing on the guidelines, they tell the auditors that they're putting software systems in place. But that's not the only purpose of the software. These manufacturers are also evaluating other benefits they can derive from a software system. Besides tracking and tracing to meet the FDA regs, many producers are taking a strong look at optimizing operations and improving inventory management. It's the more savvy manufacturers who are using software for more than just electronic tracking and reporting. They use it to add value to their operations.
An example is Bee Maid Honey (Winnipeg, Manitoba), which uses Best's BatchMasterPFW to track all its operations as it ships its honey around the world. According to Tom Banting, manager of information systems at Bee Maid Honey, "BatchMasterPFW allows us to divide districts into profit centers where we record internal production, marketing, sales, and transportation costs by region. We now prepare sales reports every month instead of every quarter, with data available three days after month-end closing. The software has allowed us to expand, because we can see exactly where costs can be trimmed and where we have opportunities for growth. The system's inventory control features alert us when items in stock are running low, so we will never run out of anything." Banting notes that since the costs of production are integrated with Bee Maid's financial system, he knows exactly how much each run costs.
For some manufacturers, a little integration might be necessary. "Some of our customers have been re-implementing their ERP systems and I suspect that's where things are headed in tracking," says Logility's VP, Manufacturing Planning John Slater, PhD. "But there are a couple of concerns. One is certifying the system of record, which is typically not a planning system but more often the ERP system. Another issue is that manufacturers tend to put a wall around all transactions in and out of the ERP system. This means paths must be improved to flow data in and out of the ERP system." Slater says that Logility needed some XML coding to move this data to and from the shop floor to the ERP system. It's very important to integrate this data so changes to lot numbers and orders follow through both systems. Manufacturers need to visualize their schedules for several weeks or months into the future rather than day-to-day. And schedules need to include sequencing, batch numbers, and bills of materials to control these operations better.
Fine tuning energy usage and assetsFood manufacturers are very concerned with keeping energy costs down, according to Siegfried Oblasser, Siemens VP of the Food and Beverage Center of Competence. With the cost of oil going up, manufacturers are faced with elevating transportation and electrical energy costs. Manufacturers want to know how to drive down the cost of energy in refrigeration, cooking, steaming, freezing, roasting, and other unit operations. One way is to use software that monitors current energy consumption and let it apply certain rules and configurations (down to lighting) to minimize peak demands and decrease overall energy usage.
Don't leave the back door openNot far down the list of concerns for software vendors and their customers is the issue of security. Various solutions are being offered to combat intrusion. For example, SoftPLC builds a software firewall into its controllers. According to SoftPLC VP, Cindy Hollenbeck, pre-built PLC firewall templates make it easy for users to configure the firewall. Another method to keep intruders out of process equipment, according to GE's Kok, is to use secure communication between network nodes through encryption and tables that define which nodes can talk to each other. Best's Knapp suggests that the same software used for 21 CFR applications can also be put to work monitoring who signs onto the system, what changes they make, which software modules they used, and what time they were on the system.
While food manufacturers are taking these and other high-tech steps to improve overall security, they sometimes forget the more practical issues. At least two software vendors remarked that while visiting customer sites, they noticed that the back doors to the plants were wide open, ready and waiting for anyone to come in off the street-or out of the fields. It's foolish to invest in the latest high-tech security tools when the lock on the back door has been ignored.
Today's software can simplify the daunting task of responding to FDA demands. It also can get your plant inventory and processes under control, help you with security issues, and with the proper I/O switch attached to the plant's back entrance door, it can sound an alarm that the back door is open.
Click here to see Food Engineering's 2005 Manufacturing Software Guide.