By Stephen Phelan
In this chapter of the Food Safety blog, we will look at how software can help manufacturers meet the regulatory burdens that FSMA imposes, but with the expectation that compliance can actually reduce costs and improve productivity.
Some of FSMA’s provisions will require specific software for all but the smallest companies. That software falls into many categories, but five leap out at us – track and trace, quality and testing, reporting and analytics, new-product development, and farm management. All but new product development are explicitly mentioned in the act.
Track and Trace
Although much of FSMA is still in the process of public comment on details of regulations yet to be issued by the FDA, some things are clear. In particular, everyone participating in the food chain will have to be able to identify unambiguously the source of everything that touches the food – and where it went. Practically speaking, this means that a company must trace everything coming into the plant, everything in the plant, and everything leaving the plant (even wastewater, though that is usually covered by other regulations). In turn, that means tracking all foods, food ingredients, and packaging by lot code. Some Enterprise Resource Planning (ERP) systems have built-in lot tracking, particularly those oriented to batch processing. The batch cockpit functionality in the SAP ERP application, for example, makes it easy to see the complete lot “tree,” both root and branch, of any lot-tracked material. But what if you use a manufacturing execution system on the plant floor that doesn’t track materials by lot? The SAP Global Batch Traceability application will allow you to track any material, whether or not the systems involved in the movement and transformation of that material use SAP software, provided the necessary data is available somewhere. The ability to track materials by lot is absolutely crucial in finding the source of contaminated materials and knowing exactly where they went. This applies to elements of packaging too. The requirement to track materials by lot is also being driven by “big box” stores, whose reputation can be seriously damaged by a recall, and who consequently want to know exactly where everything came from and went to.
The Food Chain can be highly complex, starting with the primary producers (farms) on the left, and passing through many steps of transport and stages of processing and storage, to arrive at the consumers on the right. Currently, this chain is not reliably documented at every step, making it impossible to identify every consumer who receives a contaminated product.
There are numerous other programs designed to handle some or all of the lot track and trace problem. For example, the Smart-Trace™ Cold Chain Monitoring Solution (www.smart-trace.com) provides an end to end platform consisting of disposable sensor tags, cellular or satellite transmitters, central data storage, cell phone alarming, and web-based on-demand access. Another company, SafetyChain Software (www.safetychain.com), sells software that enforces safety and quality compliance requirements at every point along the food supply and value chain... inbound, during production and outbound. There are literally dozens of other companies and programs. It is important to note, however, that tight integration with existing IT systems is critically important in any software, and particularly so in the case of mission- and time-critical functions.
Interestingly, we now are beginning to see consumer apps designed to show where a particular portion of seafood came from, an outgrowth of the Deepwater Horizon oil spill in the Gulf of Mexico. Clearly, consumers are becoming more and more aware of the food distribution problems, and want better information more quickly. A quick look at the iPhone app store will show many consumer programs dealing with the quality and origins of food.
The primary goal of FSMA’s track-and-trace requirements is to allow the FDA to recall contaminated products as fast as possible. Several incidents over the last few years have highlighted the fact that recall speed is essential in preventing illness and death caused by contaminated products. In 2011, according to the Centers for Disease Control and Prevention , 146 people in 28 states were infected with Listeria monocytogenes caused by cantaloupe from a single farm in Colorado. It is characteristic of our modern food distribution system that so much of the US could be affected by produce from a single farm – the food chain is now truly global. Only a small percentage of our food is sourced locally anymore.
The cantaloupe recall resonates with me personally – I purchased three of the cantaloupes that were recalled. When I got a robocall from the big-box retailer where I bought the fruit, I was simultaneously pleased that I had been contacted very promptly (I had bought the melons only the day before), and annoyed that no specific reason was given for the recall (my family had eaten them the night before – would we die that day?). As it happens, my immediate family and I were unaffected. But another more distant relative was one of the 30 fatalities caused by the outbreak. The ability to instantly track the affected cantaloupe from farm to fork would have saved lives in this case, and in other food recalls as well.
Recalling cantaloupes is much more difficult than recalling cars, especially in identifying the consumers involved, but the process can certainly be improved. One particular problem area is likely to be among co-manufacturers and co-packers, who might not have systems as sophisticated as those of larger companies. Some may be small enough to be exempt from some FSMA requirements, yet the larger companies they work with must still provide complete data on the parts of the food chain they control. This potential gap must be bridged for instant recalls to be plausible.
Quality and Testing
FSMA also prescribes requirements around quality and testing. Although the final regulations are not yet promulgated, they will probably require mandatory testing of some foods, both in-house and by external accredited laboratories. These tests represent the trip wire in food safety, the first warning that something is amiss, long before the product reaches the consumer. As such, the results of food tests must be available to the FDA quickly. This implies an integrated quality control and testing system, capable of routing test failures to the responsible safety officer for immediate action. Again, for all but the smallest companies, that means integrated exception reporting and automatic workflow routing of all exceptions. This functionality is available in most modern software today, but that doesn’t mean it has been turned on and that the processes needed to support it are in use. Therefore, a thorough review of implemented software and support processes is in order, perhaps by an outside consultant knowledgeable in food safety areas. Integrated software also allows manufacturers to link quality-test results to lot tracing, allowing immediate access to all relevant data up and down the food chain. Since the most common points of food contamination occur on the vendor end of the food chain, this end-to-end integration greatly simplifies and accelerates a manufacturer’s response to off-spec or contaminated incoming materials.
As part of the FDA’s overall emphasis on prevention rather than cure, some of the new testing must be handled by outside accredited laboratories, as noted in the FDA summary of FSMA:
FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards 
The program to accredit these laboratories, both in the US and abroad, is the last of the FSMA requirements that will be implemented, with a mandated 2-year timeframe. It is obviously important for external testing systems to be completely integrated with internal tracking systems already mentioned, since product is sometimes shipped in advance of final reports on bacteriological tests in particular, given that these tests often take a long time.
Reporting and Analytics
An overarching capability in most of the FSMA requirements is a good reporting system, coupled with automatic workflow routing. The reporting system must be capable of integrating data from all parts of the food manufacturing process at least one step back and one step forward, and also presenting the data in a form that is instantly understandable. The information must be available both internally, to the company’s employees and safety personnel, and externally to the FDA. It would be valuable if that information were also available remotely, perhaps on mobile devices. In the case of workflow routing, the company officers responsible for making crucial safety decisions might be anywhere when a decision is needed. A workflow routing system must be able to reach them instantly and to record and store their responses. A robust workflow system is integrated with a company’s Human Resources system, ensuring that when a critical message is routed to a manager on vacation, it is also routed to his or her backup officer, accelerating critical event responses. Another FSMA documentation requirement has to do with maintaining and making instantly available a control plan for the evaluation of risks and their efficient mitigation. Clearly, this is a good idea in any plant, and many companies have already developed written risk-mitigation strategies and responses, long before they became a matter of law and regulation. This is just sensible business practice. These are just two examples of the many record-keeping and inspection requirements that FSMA calls for. For most companies, that translates into a good analytics system with a broad reach and an integrated workflow system incorporating enterprise mobility.
New Product Development
Finally, products should be designed with safety in mind. That includes defining detailed material specifications available not just to vendors but to internal and external quality and testing people – and, of course, to the FDA. It includes the ability to know before any product is actually made whether there may be allergens present and in what quantities. (Here, the term “allergens” should be understood to be anything to which people might be sensitive, not just classical allergens. Indeed, that embraces “organic,” “all natural,” and “kosher” materials as well – anything that might trigger a recall, even when it is not a safety issue as such. ) Knowing exactly what goes into a product is an issue even for nonfood consumer products, like perfumes and detergents. Good new-product development software, usually embedded in an end-to-end product lifecycle management (PLM) application, will minimize the risks. This is particularly true when the software can automatically generate accurate and complete product-label information along with safe manufacturing instructions.
Another piece of FSMA deals with farm management, in particular, the safe harvesting of farm products. Contamination of food products can occur at virtually any point from farm to fork, but many of the recent outbreaks of contaminated foods have occurred at the farm, particular the fresh produce farm. As consumers demand more and more fresh, natural and organic products, there are more and more opportunities for serious errors in the food chain. To quote the FDA summary of FSMA:
FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. 
Along with the external testing laboratory accreditation mentioned above, this provision of FSMA has a 2-year implementation timeframe, meaning that the FDA should begin implementation in January, 2013. In fact, given the delays in the Office of Management and Budget, it seems unlikely that the farm management requirements will be enforced before 2014. Nevertheless, these provisions mean that growers all over the US will have to comply with a number of new requirements. Given the FDA’s new power to block food imports at the border unless foreign suppliers comply with FSMA in important respects, it means that foreign growers will also have to pay attention to the FSMA safe harvest provisions.
Software can help here as well, particularly in establishing action plans with specific steps and procedures, then ensuring them with soil amendments, hygiene, temperature controls, and other areas called out by FSMA, to mention just a handful of the integrated capabilities of the package.
There are dozens of other specific points where software can assist companies in complying with FSMA, but in many cases it is difficult to be specific until the details of the new regulations are released. Because of the complexity of the modern food supply chain and the systems that support it, outside consulting expertise can be of great value in finding weak points in a company’s food safety posture. It is not too soon to begin the process of examining your company’s systems to be sure you can comply with the Food Safety Modernization Act.
In the next chapter of this blog, we will take a look at how compliance with FSMA is not just another expense, but in fact should yield reductions in costs, and should therefore be looked at as an investment in the future.
 Center for Disease Control and Prevention, 8 December, 2011: http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/index.html
 U.S. FDA, 14 November, 2011: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm239907.htm
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