Total Recall

January 6, 2005
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What's Your Action Plan? A thorough action plan to deal with a product recall will determine how forgiving customers and consumers will be.

Traceability is essential for effective recalls, and suppliers to customers such as McDonald’s have deployed sophisticated process controls to integrate batch data with manufacturing information systems to meet customers’ traceability requirements. Source: Citect.
Hope for the best, prepare for the worst: disaster-relief groups have lived by the maxim for years, and food companies have adopted the philosophy as their own in preparing for a possible recall. As 2004 entered the holiday season, the recall landscape presented some cause for optimism. USDA's Food Safety and Inspection Service (FSIS) had tracked 35 recall events, with 1,204 lbs. of frozen chicken products with the undeclared allergen whey from Tyson Foods Inc. and 154 lbs. of ineligible-for-import German canned meats from Brooklyn's Stark Foods sandwiching the Thanksgiving holiday.

The Food and Drug Administration had a relatively calm year, with 174 food-related recalls, warnings and advisories recorded by December 6, down from 2003's total of 186. More importantly, no BSE in livestock, hepatitis in green onions or lead contamination in candy figured in any of the health warnings.

Company size is no defense against a recall: voluntary recalls involve the best-known and most-obscure names in the industry. The possibility of issuing a recall alert lurks in the back of every food professional's mind. In periods of calm, there's always an element of waiting for the other shoe to drop and hoping it doesn't fall on the plant where your product is made. The odds are sufficiently short and the dangers are ominously high that most food and beverage processors have developed an action plan for the time when, not if, they must recall product.

Dry runs to gauge emergency preparedness are useful exercises, but response to an actual crisis is the benchmark for industry improvement. Washington state's Mad Cow incident 13 months ago suggests much work remains. "The Mad Cow incident was an example of handling a crisis the wrong way," declares Jonathan Bernstein, founder of a Los Angeles crisis management consultancy and author of a training manual on dealing with the media during crisis. "Everyone knew for years that a case like that was coming, but nobody could answer the most important question when it did: ‘Is it safe to eat my hamburger?' The first reaction of the public is fear, and if you're waiting for the FDA or USDA to quell fear emphatically and effectively, you're out of luck."

Bernstein's clients include food companies and tire manufacturers. The latter group still is dealing with the fallout of August 2000's Firestone recall of 14.4 million tires implicated in 119 highway deaths. Poor manufacturing practices may have been the root cause of the Firestone debacle, but "vulnerabilities that can create or exacerbate a crisis are not limited to product," Bernstein says. Organizations who limit crises audits to recall drills expose themselves to "real vulnerabilities and vulnerabilities of perception," he says. An effective program gauges customer perceptions of a processor's weaknesses, attempts to reverse engineer a crisis and defines the roles of sales, legal and PR personnel in detecting and communicating potential problems.

While denials of defects and perceived stonewalling preceded Firestone's recall, the record suggests food companies choose to err on the side of caution. Indeed, Tyson's November 24 recall was an expansion of an earlier action and was not motivated by any reports of allergic reactions associated with the products. Manufacturers have learned the bitter lessons of events such as the 35-million lb. Sara Lee Corp. recall in December 1998, when a listeriosis epidemic implicated in 21 deaths was linked to hot dogs and luncheon meats from the company's Bil Mar plant in Borculo, MI. "Half of those deaths could have been prevented if they had gotten the product out of the market faster," suggests Bob Strong, a quality assurance expert with Steritech Group's food safety division. "It's tragic to consider you could have saved 10 or more lives if your systems were more proactive."



Lessons learned

Sara Lee instituted sweeping changes in the wake of the Bil Mar recall, including $25 million in plant renovations, institution of an innovative Listeria monocytogenes testing program and installation of $3 million worth of post-pasteurization equipment. The corporation also overhauled recall-planning practices at all of its plants. To assist in the effort, Sara Lee hired Ann Marie McNamara, former director of microbiology at FSIS and currently vice president of food safety and scientific affairs at Silliker Inc. in Homewood, IL.

Effective crisis management begins with a clear definition of the duties and responsibilities of key personnel, including the plant manager, quality-assurance specialists, plant engineers and sales and marketing personnel. "The crisis management plan should fully delineate the responsibilities of everyone, from the president down to the plant manager, salespeople, public relations people and quality assurance personnel," McNamara emphasizes. "It sounds humongous, but only a handful are involved in the actual investigation and identification of the source and scope."

Recall plans and crisis management are core elements of the due diligence all food companies must practice to demonstrate they have taken all reasonable precautions to assure product safety. Mock recalls are one component, but programs must be more comprehensive and address issues such as customer communication and guarantees of store credit for any recalled product.

Though Silliker does not conduct mock recalls, it conducts more than 24,000 audits of food-safety programs each year. The good news is that only nine percent of companies audited in 2003 failed to conduct at least one annual mock recall. The bad news is that recall scenarios usually do not consider contaminated ingredients "that can be dispersed over many products on multiple production days," McNamara points out. "Companies get very good at recalling final product, but those are the easiest mock recalls to do."

Raw materials often get short shrift in recall drills, agrees Stephanie Lopez, HACCP coordinator with AIB International. Processors also should consider scenarios involving a skipped clean-up after an allergen changeover, a faulty piece of equipment, the handling of unpackaged product by an employee diagnosed with Hepatitis and other situations not defined by a lot or date code.

The greatest recall vulnerability in most plants is "where you have the most human intervention," points out John Cavalenes, an electrical engineer and systems specialist with Citect, a supplier of process control software. "People are the biggest wild card in the process." Cavalenes works with food manufacturers in implementing industrial information management systems to enhance food safety and traceability programs.

The ability to demonstrate a good-faith effort to account for all variables of production is as much a part of effective recalls as identifying the product itself. Cumbersome record and retrieval systems run counter to those efforts, and major customers increasingly are demanding that processors have systems in place to quickly and efficiently track all elements of production. Otherwise, those customers will find someone who can.

Citect's clients include Farlo, a Swedish processor who produces one million hamburger patties a day for McDonald's. Traceability ranks with cleanliness and consistency in how the fast-food chain evaluates suppliers. Automating functions to eliminate potential human errors, then relaying process data to a manufacturing information database for both traceability and improved production performance help Farlo protect the McDonald's brand.

The Farlo experience gave Citect the inside track on a recent project involving a Portland, OR, processor that began supplying a fast-food chain. The contract was contingent on "traceability back to the animal where the beef came from," says Cavalenes. "People who rely on paper and pencil (reports) don't have the infrastructure to do that. The real benefit with electronic systems is speed."

To limit the scope of a recall, more than speedy reporting of traceability data is necessary. Altering processing practices could hold the key, though there always is resistance to process change. Making sure operators understand the importance of adhering to established procedures is another fundamental step, a difficult challenge when incentives are geared to meeting production goals. Maintaining compliance with data capture procedures also is a recall imperative. The BSE case dramatizes what can happen when this rule is violated. Because the farmer could not account for the movement of the affected cow's calf, a herd had to be destroyed instead of a few handfuls of cattle, Cavalenes maintains. "They couldn't find the needle in the haystack, so they ended up burning the haystack," he says.



Training partners

Most recall drills are handled in house, without involving anyone from outside the organization. That can promote a false sense of security and even a degree of smugness, cautions David Theno, vice president of food safety, quality and logistics at San Diego-based Jack In the Box (JIB) Inc. "It's not twice as tough to stage a mock recall with a customer. It's exponentially more difficult," he says.

Lot codes, production dates and other product information on packages and shipping cartons may make perfect sense to a manufacturer's staff, Theno points out, but when it reaches the customer, the information becomes part of a Tower of Babel of supplier codes. Confusion increases with distribution complexity. A foodservice customer presents a much more direct recall route than a retailer who relies on direct-store shipments or warehouse distribution.

JIB was at the center of one of the most notorious food poisoning and recall storms in the nation's history. Three children under the age of three died as a consequence of E. coli 0157:H7 linked to the chain's hamburgers in 1993. JIB's initial response became a textbook example of how not to handle a recall: initial explanations of the source of the illness were unclear, the meat supplier was used as a scapegoat and communication with news media was nonexistent. JIB also is hailed for the corrective steps it took to rehabilitate its reputation, including payment of E. coli patients' medical bills, the introduction of food-safety innovations and the hiring of Theno, a prominent food-safety consultant, to design a new food-handling system. No supplier recalls have occurred since, and the JIB recall plan is regarded as an industry model that the firm offers to share with other food companies.

Theno advocates letting senior management devise the recall scenario and issue the execution order when key plant personnel may be gone. "If the staff experts are on the golf course and you can't do the recall with the players on hand, it's not adequate, and you want to find that out before a crisis," he says.

Good advice for the nine out of ten processes who conduct mock recalls. But drills are only one element in an effective risk management effort. When an event occurs, the steps in place to detect potential problems will determine the impact on public confidence in the firm.

For more information:

Stephanie Lopez, AIB International,
253-217-7430,
slopez@aibonline.org

Jonathan Bernstein, Bernstein Crisis Management,
626-825-3838

John Cavalenes, Citect,
630-865-6872,
johncavalenes@citect.com

Dave Theno, Jack in the Box,
858-571-2322,
david.theno@jackinthebox.com

Ann Marie McNamara, Silliker Laboratories,
708-957-7878

Bob Strong, Steritech Group,
858-254-5963

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