Traceability: Are you Recall Ready?
April 01, 2009
by Richard F. Stier
This article is the first in a 2-part series and reviews tracking and tracing methods and challenges when dealing with raw materia ls a nd finished goods goods go. Part 2 will appear in the May issue of Baking & Snack and will focus on recalls — constructing a plan, conducting mock recalls and committing to continuous training.
The tragedy of 9/11 changed many things, including how the food industry conducts business. One of the changes was enactment of the Bioterrorism Act of 2002 (21 CFR part 1.326-1.368), which includes recordkeeping requirements for industries regulated by the US Food and Drug Administration. Traceability is a major requirement of the act. Therefore, being able to track and recall products is not only good business, it is the law.
The past few years have seen many high-profile recalls — just look at the recent peanut butter debacle. Even baked foods, which are usually safe, have been involved. In fact, several incidents clearly left the industries involved with “egg on their face.” They were unable to properly track their raw materials and even some finished goods. Well-designed programs that allow processors to trace finished products forward and raw materials back though the system are good business.
Some companies assume the time and effort to build a recall and traceability program is a waste of money. They have never had problems, so why worry. But it is not if there will be a recall; it is more likely when. This is especially important with today’s baking and snack industry. Why? The answer is usually allergens. Except with the current incidents involving Salmonella-contaminated peanut butter, more product recalls are prompted by allergen concerns than any other reason.
Wheat, egg, soy and dairy are used in many baked foods and snacks. These products also often use peanuts, tree nuts and other ingredients such as sesame seeds and coconut that are allergens. Look at the FDA (www.fda.gov ) and the Canadian Food Inspection Agency (www.inspection.gc.ca/English/toce.shtml ) Web sites to see how many recalls or alerts are related to allergens. Recalls from allergens have been trending upwards for the past 20 years. (See “Allergen-related Recalls” on Page 44).
The 2008 data do not signal an improvement; they only reflect recalls from the first part of the year.
It is imperative that processors know what goes into their products and where those ingredients or packaging materials came from. There are a number of ways to track what is used in finished products; some are sophisticated and others simple. Sophisticated processors may use bar coding as a tool for ingredient traceability. When an ingredient comes in, the warehouse staff will enter the supplier, the ingredient and the lot code and generate a bar code for the item. As that item is used in production, the bar code is scanned into the production record. This code may also be used to track ingredients as they move in and out of the warehouse.
A more basic approach is to put the burden on production personnel. As an ingredient or lot of packaging material is used, the ingredient and lot number are entered on the production records. This entails more work for the production workers, and it makes a trace more difficult because visual examinations of records must be done.
The use of bulk ingredients throws a wrench into this system. Bakers and snack food manufacturers, even smaller operations, incorporate many different bulk materials. Flour, whole grains, masa, sweeteners, edible oils and juice concentrates are among the bulk materials used in the industry. With these materials, traceability can be a real issue. Most operators will comingle lots of the same ingredient. In other words, the new load of flour goes right into the silo with the previous lot or lots.
If an operator has established a program to completely empty and clean a silo once a year, say in December, one must assume that all lots put into that silo will be comingled for the next year. There are ways around this conundrum. Some operators use a series of bulk tanks or silos to ensure lots are not comingled, and they clean after each lot is used. This is expensive in terms of both capital costs and the time and effort involved in cleaning. Perhaps the best option is to conduct a risk assessment on bulk ingredients.
Look at past history, supplier performance and problems with the ingredient, and then develop a program based on risk. If the assessment indicates that a certain bulk material is a low risk and allows the operation to go long periods between cleaning silos or bulk tanks, so be it. If the risk is high, the company should develop options to reduce risk. The bottom line is that such an assessment demonstrates an understanding of the system and commitment to addressing risks.
Individual containers of foods must be properly coded, if they are going to be traced. How items are coded varies. No regulation mandates how products should be coded. For example, a snack food manufacturer may decide to use a “Best By” date given that fried snacks have a finite shelf life.
On the other hand, a company manufacturing dips or sauces to use with those snacks may use a Julian date code of production or the actual production date. Julian date codes are a very common coding scheme, but there are those who believe it is not consumer friendly. The Julian code incorporates the day and year of production.
Codes should incorporate much more information, however. Knowing what line on which an item was packed and/or a finite time period allows an operation to better isolate potential problems. If all product manufactured on an 8-hour shift is given the same code, then eight hours of product is at risk. For a company that produces hundreds or thousands of cases an hour, this means a large amount of product that must be placed on hold or recalled. If a code is changed at 2-hour intervals, the potential risk is much lower. Ink jet and laser coding systems allow the actual time of pack in military time to be incorporated into a code and will further help isolate potential concerns.
However, most tracking is based on cases, so it is imperative that both secondary (cases) and tertiary (pallets) components be marked with the same codes as the individual packages. This is another case where bar codes can be invaluable. And this is where the development of good warehouse practices can be invaluable. If a company establishes a policy of not mixing lots or codes on individual pallets, traceability will be much simpler. Of course, this is easier said than done.
A large processor that ships pallets to distribution centers will find this much easier than a small specialty operator whose business is supplying the local market. Its customers may only be buying a few cases of several items, which may complicate tracking. It is recommended, however, that date codes or some other codes that are easily readable by consumers be employed. Bar codes are not consumer friendly.
TRACKING FINISHED GOODS.
The key to traceability is knowing what is shipped and to whom. This has become much easier with computerized inventory systems and the adoption by many companies of systems such as SAP enterprise resource planning software. Again, bar coding is another tool that enhances an operation’s ability to track what is staged and shipped.
With computerized systems, the incorporation of lot numbers into shipping documents creates a situation whereby a company can almost instantaneously determine what has been shipped and to whom.
However, not everyone has such systems. There are still operations that manually stage products and have to write down what goes out the door. And surprisingly, there are even operations that do not incorporate lot numbers on their shipping documents.
The danger with this is that without lot numbers, if something happens to prompt a recall, one must assume that every piece shipped is now suspect. The recall just became much larger than it should have been.
Editor’s note: Part 2 of this series will appear in the May issue of Baking & Snack and will discuss developing a recall plan and preparing for a crisis.