Without a trace
Enterprise integration key to track and trace success
By Dennis Brandl
Our food supply chain is large, complex, and diverse, and traceability in food and pharmaceutical products is a life-critical issue. Counterfeit drugs containing little if any active ingredients, counterfeit raw materials found in pharmaceutical manufacturing, contaminated peanuts, peppers, and meat have all led to sickness and death. The food industry needs an over-arching, global food traceability system that can link all food products and provide results in seconds. But the problem of traceability does not stop at the plant door. In order to meet the real requirements for traceability and recall control, some sort of method is required for cross-enterprise traceability.
Traceability means producers must keep track of where they obtained their raw materials and where they shipped their product. This is complicated because lots split and combine during production. The end product on a store shelf probably came from several different raw material lots from several different sources. A single container of mixed-berry yogurt might have fruit from two sources, milk from a third source, and culture from a fourth source. A packaged meal might have meat from one source and vegetables and fruit from multiple sources. The supplier might have combined the vegetables and fruits from different suppliers. Even the municipal water being used in production should have an identifying lot number associated with the day or even shift of use. Complete traceability might require multiple companies to combine their traceability information and share lot numbers across the entire supply chain.
Within a plant, the main issue of traceability is to determine exactly which lots went into the final product. While lot assignments are the norm in drug manufacturing, food and beverage production schedules do not specify which raw material lots to use. It is at the discretion of operators to pick the appropriate material lot for each batch. In-plant traceability requires identification of ingredients as they are added and identification of final products at lot boundaries.
Packing and labeling is where track and trace has the biggest impact. The packing line is where manufacturers label products, add RFID tags, apply bar codes, and add other external tracking information. As more products require tracking and traceability, including food, tires, electronics, car parts, pharmaceuticals, consumer products, and even toys, additional demands fall on packaging equipment. This usually requires automation of the packaging lines to individually print labels and program RFID tags. It also requires integration with corporate systems to download tracing information and upload manufacturing information associated with the items.
The old days of putting a product in a box, slapping on a label, and sending it to shipping does not work anymore. A product’s packaging is an integral part of a product specification. The package provides external traceability through the supply chain, speeding recalls and replacement. Packaging also calls for intelligent routing of products within supply centers to maintain shipping schedules and minimal distribution costs.
Current government regulations do not ensure quick traversing of links through the supply chain, making a time-consuming task of determining source issues in the event of a contamination. Some vertical tracking systems are starting to emerge within segments of the industry, but once cross-segment components mix (putting strawberries in yogurt or eggs in cookies), the links can once again become time-consuming to trace.
Without accurate information regarding which products might be impacted in a contamination concern, recalls fall on the side of caution and safety, severely impacting entire product types, which are later found to be unrelated to the actual issue.
Efforts by World Food Trace, OpenO&M, and ISA95 to provide cross-enterprise integration through world-wide traceability are critical in the food and pharmaceutical manufacturing of today. Such efforts rely on internally integrated business and production systems to generate genealogy data. They also need evolving standards for the cross-enterprise exchanges world-wide that tracking and tracing require.
Cross-enterprise traceability requires assignment of globally unique IDs to individual lots, similar to globally unique IDs assigned to phone numbers, Internet addresses, and vehicle identification numbers. Current standardized ID methods deal with identifying the product, not the specific lots.
Traceability of the components of these products is now the law of the land in quite a few countries. The U.S. has the Bioterrorism Act, Public Law 107-188, and the EU has the European Health and Consumer Protection Directorate 178/2002. These regulations allow government agencies to quickly address contamination issues and other food scares and to mitigate bioterrorism attacks.
The basic concept: It should be possible to identify every ingredient in any food and trace the ingredients back to its source. This allows for faster and more focused recalls, less risk to the general public, and less risk to manufacturers.
In addition to bioterrorism and food safety issues, several countries have developed mandatory labeling laws for foods containing ingredients derived from genetically modified (GM) crops. To comply with these labeling laws, food manufacturers must be able to document the genetic purity of GM and non-GM ingredients. They can do this either by preserving the identity of a crop from seed to final product or by tracing from the final product to the crops from which ingredients were manufactured.
While the current U.S. Bioterrorism Act requires traceability known as “one up and one down,” recent food scares such as contaminated peanuts and peppers have demonstrated true recalls and safety announcements will require multiple producer cooperation.
In 2008, from April to June, a salmonella outbreak sickened over 150 people and caused the Food and Drug Administration (FDA) to recall tomatoes and fresh tomato products on 3 June. A week later, authorities cleared the tomatoes as the cause, but still had no identified source. Finally, on 21 July, the FDA announced jalapeno peppers grown in Mexico were the cause. In the end, 1442 people from 40 states became ill, and falsely implicated tomato growers lost an estimated $450 million after 12 weeks had gone by. This incident illustrates how our ability to quickly and correctly identify the source of food-borne contamination needs improvement.
In November and December 2008, a salmonella outbreak led to eight deaths, sickened over 600 people, and caused Peanut Corporation of America (PCA) to recall its products. Six months later, products were still being identified as containing peanuts from PCA. With the total of over 3,200 products, 470 separate company recall notices, and the cost of millions to companies, nobody was assured the search to find all uses of PCA peanuts in the food supply chain was complete.
An AMR study found over 50% of food companies participated in health and safety recalls within the past year. It took an average of 14 days to sense the need for the recall and over 30 days to enact it. Authorities could actually recall less than 40% of the product, and the financial impact of the recalls totaled hundreds of millions of dollars. Companies who did their best at recalls had multiple-enterprise tracking, manufacturing automation, mature supply chains, lot-level tracking, and cross-functional team reviews of quality.
Pharmaceutical manufacturers have similar traceability problems. In April 2009 in Korea, patients died after taking drugs made with talc that contained asbestos from China. In 2008, there were deaths due to heparin contamination.
The 2006 Compliance Policy Guide for the Prescription Drug Marketing Act refers to a drug pedigree as a “statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.” An e-pedigree is an electronic document that satisfies a pedigree requirement. Its main purpose is to protect consumers from contaminated medicine or counterfeit drugs.
Industry mitigation efforts
In the pharmaceutical and biotech industries, much of the effort to address traceability problems lies in companies’ internal tracking. But the food industry is establishing cross-functional organizations, some of which deal with specific food products, such as fresh fruit and produce growers and shippers through HarvestMark (www.harvestmark.com) and eProduce (www.eproduce.biz). Similar efforts are in place for direct-from-farm meat products.
One organization is approaching the cross-enterprise traceability issue for all produced foods (dairy, fruit, produce, meat, and the like) direct to consumer and through processed food manufacturers. World Food Trace (www.worldfoodtrace.org) is a non-profit organization that uses registered databases for cross-enterprise traceability.
Some of these organizations are working with industry groups as well as national and international standards organizations. The ISA88 standard committee already has a standard in place for batch production records, which can be a source of traceability data. The ISA95 standard is extended to the batch production record standard to include all aspects of production, including discrete and continuous production, packaging, shipping, and receiving.
Traceability system requirements
The requirements for systems to provide traceability are fairly straightforward:
- Create a food supply chain traceability system that identifies all source component ingredients of a food product applicable broadly in all industry segments within seconds.
- Enable forward tracing of any ingredient to identify all associated products within seconds.
- Ensure a smooth and rapid implementation with recommended practices to aid food industry manufacturers and processors in the application and use of the system.
- Address public safety concerns regarding the nation’s ability to track and trace food products.
- Provide a traceability system with the lowest possible cost and burden on the industry.
- Be an asset to industry as a self-sustaining system with the ability to support other food safety initiatives.
Meeting these goals will require a standard lot identifier for all food and food components as well as record-keeping guidelines and guidance criteria for implementers that will allow for small and large entity success. Manufacturers will also need registered data concatenation centers, which hold the traceability information for access by authorized agencies and for individual company traceability actions. A registration mechanism is required for information service providers to ensure global search capability.
ABOUT THE AUTHOR
Dennis Brandl (email@example.com) is president of BR&L Consulting, Inc. in Cary, N.C.
Standard lot identification needed
A variety of lot code markings and systems are prevalent in the industry now, making a singular traceability system unworkable. The industry needs a new universal 16-character code as a consistent method of identification for all food products. The manufacturer should be able to self-generate each code, but still identify the lot’s origin with absolute guarantees of no lot duplication. This code should fit into a simple bar code, and must be mathematically proven to last globally for every lot of food produced until at least the year 2100.
World food IDs can be uniquely keyed with the first seven characters to food processing exit points as registration sites in the food supply chain. This provides over 1 trillion possible production lines. The remaining nine characters form a time/date stamp for lot uniqueness. This provides over 5 trillion possible production lots. A manufacturer with four packaging lines would register four world food IDs, one for each line to uniquely identify the production line as well as the lots coming off the line. At some interval, all produced lot IDs would go to a registered data center for secure and protected storage.
The collection of world food IDs from all registered data centers would form a traceability map of the entire supply network. This allows for forward and backward traceability. Standardized interfaces to the data centers, through secure web services, would provide authorized legal entities access to the entire supply map. These goals require identification of each raw material source and each product exit point.
When a product generates at an exit point, the producer must submit a product lot record to a registered data center. In recording the lot, the producer captures the IDs of all the contributing components of his lot and associates them with the new product’s ID. This linking to component globally unique IDs is the foundation of the instantaneous traceability within the system.
This system requires an independent non-profit agency to register the data centers. Agencies must provide a set of criteria that licensed information service providers must meet in order to be official licensed data centers. The worldwide community of data centers thus forms a distributed database of global food supply-chain information.
Using commercial data centers instead of a single universal database means a competitive environment for data services and allows food producers to choose a data center that fits their needs. Large manufacturers can even obtain a license for their own information technology department as an approved data center. With proper authority and access, agencies can query the global network of data centers to investigate and respond to food contamination concerns at Internet speeds.
More requirements include:
Source: Dennis Brandl (firstname.lastname@example.org) is president of BR&L Consulting, Inc. in Cary, N.C.