Internal Traceability Is the Keystone for Successful Product Tracing under May, FSMA 2012

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1 TECHNOLOGIES Internal Traceability Is the Keystone for Successful Product Tracing under May, FSMA 2012 By Bob Bunsey President Internal Traceability is the Keystone for Successful Product Tracing under FSMA In architecture, a keystone serves a critical function: it is a wedge shaped stone placed in the center of an arch that keeps the arch from falling in on itself. It separates and balances both sides of the arch and is the final stone placed during construction to lock all the stones in place. In much the same way, a facility s Internal Traceability system is the keystone to effective traceability within the global food supply chain. Product Tracing, per the FDA According to the FDA, a Product Tracing system involves documenting the production and distribution chain of products so that in case of an outbreak, or evidence of contaminated food, a product can be traced backward to a common source and/or forward through the distribution channels. This definition implies a Product Tracing system that would span the entire food supply chain, encompassing all trading partners in the food network, from growers to consumers. It follows the path of food among trading partners; from one trading partner to the next in the supply chain. Within the overall Product Tracing system, an Internal Traceability system operates inside the 4 walls of a food facility. Internal Traceability refers to documenting all food items that pass through the facility. It follows the detailed path of all food items inside a particular food facility. The Who, What, When, Where and Why Internal Traceability provides the critical who, what, when, where, why details that a food facility needs when a quality problem arises, to determine exactly: what items have been received from vendors; what items have been used in the creation of new products; what items have been shipped to customers; what items still remains in the facility. Within the 4 walls of a food handling facility, Internal Traceability acts as a keystone between Receiving and Shipping, and between the 1 up and 1 back reporting requirement for supply chain trading partners, per the Bioterrorism Act of 2002.

2 In addition, Internal Traceability acts as a keystone in the supply chain Product Tracing system because it provides the missing inside the food facility data linkage necessary to fully identify the suspected food item when an outbreak occurs, and to locate all units of the suspected item (and its ingredients) that may still reside in the chain, at risk of human or animal consumption. Lack of Internal Traceability Presents Several Risks Without access to the critical data that an Internal Traceability system provides, efforts to identify and recall all suspect product in the food supply chain may produce a variety of undesirable and potentially damaging results, including: 1. The wrong ingredients may be finger pointed as the culprit of an outbreak. 2. A recall may be too broad, and involve more units of finished product pulled from store shelves than is necessary. 3. Entire product families, e.g. all peppers may be indicted, when only a specific type of pepper from a particular growing area may be the cause. 4. A specific brand, or even a product family, may be permanently damaged by negative publicity, even though it was not at fault. However, the most damaging possibility to result from poor Internal Traceability is the threat to public safety. When an outbreak occurs, time is of the essence in identifying and locating all suspect product, and analyzing the source and cause of the problem. Without accurate Internal Traceability records, much valuable time may be wasted attempting to collect, organize and analyze relevant data. Or, an analysis may be flawed due to missing critical data leading to blind alleys, backtracking, and restarting the analytical process while the suspect product continues to move through the supply chain. Both scenarios increase the likelihood that the rate of human sickness, and even the death count, will rise as a result of the outbreak. Internal Traceability and Critical Tracking Events Internal Traceability means linking all the data associated with food products: 1. Starting when the products are accepted at the receiving dock into a food facility; 2. Continuing as the products go through an internal manufacturing and/or transformation process performed on the Input Products to create an Output Product ; 3. Ending at the shipping dock with the loading of a trailer, or other conveyance, bound for a customer site or the next stop in the food supply chain. 2

3 In other words, Internal Traceability is the documenting of all changes to the food products that happen between receiving of inbound items to shipping of finished product. This documenting includes recording data at key internal processes, such as: Receiving Accepting Inspecting Producing/creating Aggregating Splitting Mixing Packing Re packing Storing Shipping Recording events at these key internal processes where food items are changed is crucial to the tracking of an item. For purposes of traceability, these internal events are referred to as Critical Tracking Events or CTEs. When food is changed, a CTE should be recorded to document it. Critical Tracking Events at Receiving and Shipping A workgroup of IFT (Institute of Food Technologists) has identified the most important CTEs that are found in the supply chain. CTEs at Receiving and Shipping are most commonly documented. As food items are moved or transferred between trading partners, custody or ownership of the items changes, and the Receiving CTE and Shipping CTE documents the transfer. Food Distribution Centers fit this scenario. They record Receiving CTEs when accepting inbound items and record Shipping CTEs when dispatching them as outbound items. Critical Tracking Events at Transformation But many trading partners are also food manufacturers that transform food items to create a new food item. This product creation process can be as simple as re packing an input product from one container into a different output container, as in going from a larger container to smaller packages. This is an example of a simple Transformation process. One Transformation CTE would record the food item number and lot number at the beginning of this process (to document the items in the large container), and another Transformation CTE would be recorded at the end of the process (to document the newly packaged food item number and its own lot number). The two CTEs in this example would be linked together by a common reference number, such as batch/lot number, date/time, or a production run number, etc. By linking the Input and Output CTEs together, the Input food item numbers and their lot numbers could be deduced from the Output food item number and its lot number. This is the data linkage that outbreak 3

4 analysts wants to know, so they can weave backwards though the external supply chain and also through any internal processing to help identify a potential ingredient as a possible source of the adulterated food. The diagram below shows a more complex Transformation process with 3 different ingredients as inputs, producing one final output product. The table shows the input to output linkage. The table above shows the CTE records that need to be captured. Only some of the CTE data is shown. Other data, such as quantity, date/time, facility location, etc. are not shown in this table. These Transformation CTEs, one for each of the different inputs and one for the output of the transforming process, are perhaps the most important CTEs for supply chain traceability because they link the output food items to their ingredients. It is here, at this point of Transformation within a food manufacturer, that an outbreak analysis might proceed in one direction or take another, depending upon the ingredients or input items that were used in the creation of the suspected output product. Since these Transformation CTEs are only collected as a function of accurate Internal Traceability, it is this critical juncture that could make or break the reliability and timeliness of an outbreak analysis. All food handlers that engage in any food transformation, regardless of the size of the facility, must accurately record the Transformation CTE data that links the input items used to create the output items. In the above table, the batch number 123 links the 3 inputs to the output item, allowing trace back from a finished product to its ingredients. Food facilities must store the Transformation CTE data and share it with the investigators to aid their outbreak analysis. Capturing the Label Data on the Inputs to Transformation In the diagram above, note that one of the input items has barcoded data in addition to the human readable. Ideally, the Item Number and Lot Number would be in barcode format on the label of every input item, enabling this data to be easily captured, in real time, by scanning the 4

5 barcode. Scanning would ensure that the Lot and Item Numbers are recorded accurately in the CTE, and would automatically create a readily accessible electronic record, immune to the illegibility problems that handwritten documents pose. It is possible, however, that smaller upstream suppliers may not have the capability to barcode their item containers, as the diagram shows for the suppliers of Item 1 and Item 2. Agreements between trading partners will eventually move to a requirement that every product label be barcoded so that electronic capture of data for CTEs is the standard practice throughout the supply chain. But in the interim, it is necessary for a downstream food facility to be able to capture and record their CTEs either from human readable data or barcoded data. Labeling the Outputs from Transformation Just as important as collecting the Transformation CTEs, the Output items of a Transformation process must be labeled appropriately by the food facility so that trading partners downstream in the supply chain can use the label information on the products to record their own Receiving CTEs. At a minimum, the label information needs to include the Item Number and its Lot Number in human readable format. But in addition, the label should also have this information in a barcoded format, so the downstream trading partner can use electronic data collection equipment to quickly read the label data and record their own CTEs, if they have that capability. First the Trace-back, then the Trace-forward The trace back process begins with interviews of the victims of the outbreak to determine the commonality of consumed food. When the outbreak analysis finally points to the source of the affected food item, the trace forward process can begin, whereby the other trading partners who received any affected products are then identified. Trace forward involves the analysis of shipping CTEs and customer invoices at the source partner who introduced the adulteration, and then the subsequent analysis of the receiving, manufacturing and shipping CTEs at each of the customers who received the affected food items. The trace forward process at the customer(s) may point to further trace forward analyses needed at even lower downstream levels of trading partners in the supply chain. The ultimate downstream level, or endpoint in the supply chain, is the consumer. The traceforward process is just as complex as the trace back analysis. Accurate Internal Traceability is required in each trading partner involved in a trace forward process, just as it is in the original 5

6 trace back process. CTEs in Receiving, Transformation, and Shipping need to be analyzed in each trading partner just as they were in the upstream trace back process. During the trace forward process, a recall may be ordered to pull out any affected products still resident within the supply chain. But accomplishing this quickly can be very difficult. The trace forward process may be too late to recall all affected products at some trading partners, as the affected products may have already moved on. The Cost of Compliance for Internal Traceability It merits emphasis that both small food businesses (which may record their data on paper records today) and large businesses (which likely have enterprise systems that record data electronically) both need to accurately collect CTE data within their own 4 walls in order for supply chain traceability to work well. But smaller businesses may not have an Inventory Control System (ICS) in place that is capable of collecting CTE data. Small businesses may still be using paper forms to record data in their Receiving, Transformation, and Shipping processes and then store those forms in file cabinets. So they would have a higher burden to transcribe their CTE data into an electronic format and meet the expected 24 hour response time requirement of the FDA. The data on their paper forms would need to be converted into electronic form by some type of CTE retention software at the end of each production shift. This retention software could accept data keyed from the paper forms (or scanned via Optical Character Recognition) and store the appropriate CTEs in their proper electronic formats for fast response to an inquiry. The CTE retention software could run on a local PC or over the Internet per the Software as a Service model. The resultant CTE data records could be stored in a local database, or could be hosted on the Internet and stored in the cloud. In a cloud implementation, the food facility would not need to manage the CTE database, yet it would be always ready for fast access. For small facilities that do not have their own real time ICS and continue using paper based methods to record CTE data, the commercial software marketplace will likely rise to the need and supply cost effective CTE retention software solutions that smaller businesses can afford. Therefore it is our opinion that the cost of compliance for Internal Traceability, at least for the software, should not be prohibitive for the smaller business. The cost of compliance will reflect the ongoing labor needed to accurately: record the Item Numbers and their Lots at Receiving, record Item Numbers and Lots used as inputs to (and outputs from) Transformation, record Item Numbers and Lots at Shipping. If the smaller facility is not already recording data at these process points, then there would be an added labor cost. However, it should be noted that the Bioterrorism Act 2002 requires the 6

7 keeping of Receiving and Shipping records already, so the net new labor increase should be only the additional labor to record CTEs during the Transformation process. Cost and Risks of Inadequate Internal Traceability By not implementing a data collection solution that will keep timely electronic records of all its CTEs, a food business will risk eventual damage to their brand. If an outbreak occurs and the food business becomes a multi day bottleneck during a trace back analysis of the source of adulteration, then the delay due to the poor or non existent recordkeeping may actually increase the person count of sickness or death. Even if the source of adulteration is not within the food business itself, but is determined to have originated upstream in the supply chain, the delay in the traceability analysis at the food business may cause a subsequent delay in the recall of the adulterated foods. Typically, it is very time consuming to manually collect, sort, and analyze paper records of receipts, recipes and shipments. This is especially true when these paper records are casually stored in file cabinets. Often they are dumped on a conference room table, all co mingled like a giant jigsaw puzzle, while the clock is ticking. The possibility that a company may be singled out as the cause of needless delay is not going to help the brand or the image of their business. Damage to a brand can impact other supply chain partners, and the sustainability of their food business, too. Another serious consideration is legal liability. If a food business with inadequate Internal Traceability is found to have caused delay in the federal traceability analysis, it could be sued for negligence by the families of the outbreak victims. It may only be a matter of time before traceability lawsuits become commonplace. Compliance May Yield an Opportunity for ROI Although the initial cost of a real time Inventory Control System (ICS) may be high for a small business, there is usually an economic justification in the long term for implementing one. For example: The CTEs in Receiving, Transformation, and Shipping will be automatically recorded as inventory is moved. An ICS requires less labor because items are scanned with electronic equipment such as barcode scanners. At some point in time, it will be more cost effective to install an ICS than to continue using paper forms and key the data into CTE retention software. An ICS would record all inventory at receiving, in the warehouse, in manufacturing, in finished goods, and at shipping. The CTEs would be recorded as a by product of inventory moves. 7

8 An ICS would allocate inventory to customer orders based on FIFO (or other criteria), and validate that orders are picked accurately and loaded on trailers accurately. Further benefits include automatically recording production totals, scrap totals, inventory inspections, physical and cycle counts, inventory holds, inventory releases, and other critical inventory control data. An ICS could also be interfaced to a HACCP system. The increased efficiency and realtime visibility of inventory and operations far outweigh the ongoing cost of using manual paper records and transcribing them into electronic CTE records via CTE retention software. The Key to FSMA Success is Internal Traceability Without Internal Traceability operating every day, in every food facility in the supply chain, reaching the goal of efficient tracing of food will be a long way off into the future. Without Internal Traceability there will be a big gap in the timely availability of critical data needed by the FDA and CDC to expedite a successful, efficient outbreak analysis and any necessary product recalls. Outbreaks may linger on and health risks may be increased due to breaks in the chain of data. And key to Internal Traceability is the recording of Critical Tracking Events, especially those CTEs in the Transformation process for facilities involved in food processing. All trading partners need to record the appropriate CTEs as food items and packaging pass through their facility. At a minimum, there will be the Receiving and Shipping CTEs common to all trading partners that need to be electronically recorded. In a manufacturer, there will also be Transformation CTEs. At a retail outlet, there will be endof supply chain CTEs as the food items are consumed or pass through a Point of Sale register. But inside every facility, there is the need to electronically record the CTEs in order to ensure that a traceability effort, and a potential recall effort, can be accomplished as fast as possible. In Summary Internal Traceability is the keystone to the success of supply chain traceability. Each trading partner is an arch that supports the traceability roadway that winds its way through the entire supply chain. If one of the arches fails, the traceability roadway may become obstructed or even impassible, causing delays or dead ends in analyzing the source of the food borne outbreak. And such delays and dead ends could be to the serious detriment of a food business, the food supply chain and especially the consumer. 8