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Product development software can maintain regulatory musts in the manufacturing environment
by Steve Phelan
Food and beverage manufacturers must observe several broad-classes of compliance, with labeling perhaps being the most painful in terms of the number of errors and the impact on business. According to FDA, 51 percent of recent food and drug recalls were caused by a problem with the label, not with the product. Labeling has gotten more complicated in recent years as more federal and international requirements are added to an already long list of regulations. Most regulatory changes strive to balance the risks against the costs of reporting; a label that shows every conceivable risk factor is likely to be completely unreadable. However, even a small change in a regulation can have significant repercussions across the entire development and supply chain. One regulation stirring debate lately is the Food Allergen and Consumer Protection Act (FALCPA), which is intended to help consumers avoid ingredients that cause allergic reactions, ranging from mild to severe. Many people suffer from various grades of sensitivity to commonly used ingredients. In fact, some physicians believe that virtually everyone does so at some point in his or her life. Manufacturers must have in place good controls over both ingredients and manufacturing practices. Product formulators must be able to tell their manufacturing colleagues that there are potential problems with some of the ingredients they are using in their formulas, and to do that, they themselves must know the characteristics of the materials they are using. In turn, the suppliers of their raw materials must also have similar controls in place, up and down the entire supply chain. A single lapse can have literally fatal consequences. A surprisingly large number of companies have no controls in place. In a study by the FDA and Wisconsin and Minnesota food authorities, 25 percent of food manufacturers were found to have inadequate tracking and reporting systems in their operations. Specifically, the federal and state inspectors found unlabeled peanut and egg proteins in 23 of 118 samples of ice cream, baked goods and candy that they suspected were contaminated. Although this is a small non-random sample, it is still sufficient enough to give people with food allergies a cause for concern. Technology has developed an effective solution to the problem. A branch of the software market has emerged that specifically automates and integrates the product development process for food and beverage manufacturers. Most product development software includes functionality specifically designed to ensure an accurate technical statement of a product's content, whether on an ingredient statement, a nutrition panel or a manufacturing specification. The software achieves this by providing visibility all the way down to the characteristics of raw material components, and then rolling those characteristics up to the finished product level. Let's take a pizza manufacturer who buys raw dough from a preferred vendor. The vendor supplies information on the ingredients that make up the dough: 55 percent flour, 3 percent butter, 5 percent egg protein, 25 percent water, and so on. That information is processed by product development software as technical properties of the dough and is permanently stored. When the dough is used to make a finished pizza, the software will automatically calculate how much egg protein is present in the pizza by summing the contributions of each material from all sources (because there may also be egg protein in some of the other ingredients used) and reports the results. Once the system is primed with the necessary information, the ingredient labels are calculated and produced automatically upon demand. Whenever a formula or the characteristics of a raw material are changed, the software recalculates the content, ensuring accurate allergen reporting. This kind of label reporting and allergen management requires the software to do some fairly sophisticated data handling. First, a formula must be "exploded" to its constituents. A formula may have any number of intermediate levels, but the labeling regulations require just one ingredient list. The software automatically scans a formula to see if it contains any sub-formulas, then checks those sub-formulas for further levels of sub-formula, and so on. It needs to "combine" all the ingredients back together, so that if, for instance, water occurs in several places in the fully-exploded formula, the software would add all the contributions together to give the total amount of water. This combination step is a little tricky, though. Water might be represented by several distinct item codes, perhaps one for distilled water, another for tap water, yet another for Perrier. For manufacturing purposes, these are different inventory items with different characteristics and costs (especially Perrier), but for ingredient labeling purposes, they are the same thing. So this type of software combines all three items into a single code and quantity. Because label rules vary by markets, end use and end user, this is done with a simple, configurable rule that tells the software what items should be grouped. Sometimes a group might be applied for items that are really quite different, but that the labeler doesn't want to distinguish, like spices-think of Colonel Sanders' "Eleven Herbs and Spices" - or a group might be applied to keep the items in a separate section on the label, like allergens. As the software combines a formula, it can pick out all those materials that contain allergens (following an internal rule). The same rule may be used to warn the formulator that he or she has used an allergen in a new product. If the allergen is present at sufficiently small quantities, it may not be a cause for concern, so it can track the actual quantity used, as well as simple presence/absence. This can be very important for instance when a new product will be promoted as peanut-free. The formulator must be certain that no peanut products will be used at any level of the food supply chain, and everyone up and down the vendor and customer list must certify accurately the percentage of peanuts their products contain. Finally, because it is virtually certain that the rules will change, the software platform is a rules-driven system, with rules defined in the database, not in computer code. As rules or regulations change, the system administrator simply updates the existing rule or adds a new one, a process that takes only minutes. Once added or changed, it will immediately begin tracking the new requirement. Food and beverage manufacturers can no longer track these complicated process without the aid of technology. They need to look for solutions that can not only help their bottom line, but help with these complex compliance issues. With the right solution, food manufacturing companies can better manage the regulatory burden and reduce the cost and risk of compliance. -FQ
Steve Phelan is the founder and senior vice president of Formation Systems Inc. Reach him at Phone: 508-303-6200 or firstname.lastname@example.org.