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From: Food Quality & Safety magazine, April/May 2005

What the Future Holds

Consistency and calibration should be hallmarks of the audit process.

by Mark Jarvis

Over the last few decades, public focus on food safety has increased due to better detection and traceback techniques, greater media attention, emerging pathogens and increased liability for food processors and retailers. Serious questions exist around the quality and safety of fresh produce. BSE in cattle has, on several occasions, rocked the beef industry. The risk of a deliberate attack on the food supply is described by the World Health Organization and others as a “real and current threat.” Animal welfare, allergens and ingredient traceability can be added to the more conventional areas of risk such as food safety, worker safety and public liability.

In this changing landscape of food safety, retailers, processors and distributors are increasingly looking outside their own quality control departments for help in ensuring the safety of their food. This need for outside inspections is particularly acute in the face of projected budget cuts to FDA’s inspection programs, including checks on imported foods. If Congress approves the budget, the number of domestic food safety inspections in FY 2006 would fall by five percent. As the federal government decreases the number of inspections it conducts, third-party auditing companies will be the best choice to provide reassurance.

A major goal for any food safety program is to reduce risk behaviors that can cause food-borne illnesses. Independent, third-party food safety audits and inspections can show levels of compliance with a company’s food safety program and can point out specific risk factors. These, in turn, help shape intervention strategies and drives decision-making on issues such as employee training, equipment purchases and facility design.

A recent study 1 tracing the results of independent food safety audits found some compelling data to support this. A year’s worth of independent audit data from 2,400 restaurant locations in North America (1,500 full service and 900 quick service) show restaurants that implement formal food safety management systems are able to significantly reduce restaurant-level food safety violations, including risk behaviors the CDC most commonly associates with food-borne illness outbreaks. Those same restaurants typically experience ongoing improvement in overall food safety.

Since food safety and quality significantly affect customer satisfaction, restaurants and other retail-level food providers are taking the idea of independent food safety audits outside their facility’s walls. They are finding that food safety and quality assurance audits of their suppliers are a powerful and cost-effective way to ensure that their suppliers and distributors have the prerequisite good manufacturing practices (GMPs) and quality systems in place to provide safe food.

From Fork Back to the Farm

While improper holding temperature and poor personal hygiene top the list of factors that lead to food-borne illness, “food from unsafe sources” is another key factor. These are linked to about five percent of food-borne illness outbreaks, according to the CDC. Even with a perfect HACCP system in place, a food company can fall victim to a supply chain problem, such as the contaminated green onions distributed to a Mexican restaurant chain that resulted in a massive Hepatitis A outbreak. Had the restaurant chain known more about the quality systems of its green onion suppliers, the company might have avoided this crippling incident.

In the summer of 2004, Roma tomatoes contaminated with salmonella were distributed to convenience stores in Pennsylvania for use in deli subs and sandwiches. The contaminated tomatoes sickened nearly 600 people in a multi-state area. While the CDC cleared the convenience store of any fault, the source of the contamination has still not been determined. The supplier to the convenience store chain, however, was forced to shut its doors due to losses incurred by the outbreak.

The issue of unsafe food sources has grown in recent years, concurrent with the significant increase in foods being imported from other countries (see Table 1 for a listing of some recent food-borne illness outbreaks associated with imported foods).

According to news reports, since the U.S. Homeland Security Department took over responsibility for inspecting imported agricultural products from the U.S. Department of Agriculture, fewer inspections are being conducted. In fact, the Center for Science in the Public Interest notes that only about two percent of imported produce and seafood gets inspected. Most border inspections are visual; food is rarely tested in a lab for contamination. Trace back of food products to sources can take weeks or months. The fresh-cut produce industry is particularly vulnerable because of the complex chain of custody from packing houses through distribution to the retailer or restaurant.

As the global marketplace continues to evolve, buyers, regulators and suppliers will increasingly depend on standards and conformity assessment to ensure that products and services fulfill specified requirements. This is where independent GMP audits come into play. Many food retailers (grocers and restaurants) have asked for such audits of their suppliers for the past few years. And now, food processors and distributors have begun to request and conduct GMP audits on their own as they seek to implement voluntary standardization and conformity assessment programs.

Emerging Pathogens

In the first half of the 20th century, the primary food-borne illnesses of concern to humans were botulism, salmonellosis and staphylococcal food poisoning. By the last quarter of the century, new foodborne pathogens had emerged, including campylobacter jenjuni, shiga toxin-producing E. coli, Listeria monocytogenes and cyclospora cayetanensis. Some of these emerging microorganisms are resistant to an ever wider spectrum of antibiotics - perhaps as a result of the overuse of antibiotics.

Listeria is unique because it grows at refrigeration temperatures. It can cause flu-like symptoms and also serious illnesses such as meningitis and is especially dangerous for the very young and very old, and causes miscarriages in pregnant women.

E. coli is commonly transmitted through ground meats and can cause severe illness, and even death. Fortunately, cases of E. coli have declined 42 percent since 1998, according to a recently-issued CDC report, which noted that cases of E. coli 0157 infections are below the national “Healthy People 2010” health goal. Illnesses associated with Listeria and Campylobacter have also declined.

Instead of small, isolated cases of food-borne illness, these bacteria have been linked to large, multi-state outbreaks in recent years. The first of this is widely acknowledged to be the 1993 fast food chain outbreak in which E. Coli 0157:H7 found in hamburger was linked to 700 illnesses and four deaths across four states. Other incidents have included a 2000 outbreak of Norwalk-like virus found in pasta salad that sickened 333 people across 13 states and a 1999 Listeria outbreak associated with lunch meats that killed 21 people and sickened manyothers in at least 11 states.

A New Breed of Food Safety Audits

While there will always be a great need for food safety audits at the retail level, the globalization of our food supply chain, coupled with factors such as bioterrorism, the need to control feed, a herd strategy in the light of BSE, and the emergence of interest in genetically modified foods, has shifted the focus upstream in the farm-to-fork continuum.

In the early 1980s, processor audits tended to focus on facility sanitation issues. In the 1990s, the production process became a bigger focus, with the emergence of HACCP standards. Now, in the 21st century, processor audits have evolved into GMP and Total Quality Systems audits, where every process within a food processing facility is evaluated. GMP-level audits must also cover every opportunity for contamination - from delivery of ingredients and packaging materials at the processor location through trace back of outbound shipping to warehouse and retail locations.

At a minimum, a food safety/GMP audit should cover the following: Food safety programs and training, pest control, operational conditions, building and equipment conditions, building and equipment cleanliness, and food/plant security. The food/plant security portion should cover management of food security, raw materials and packaging, finished products, facility security, employee security, computer security, water and air security, laboratory security, and chemical security.

GMP audits and other food safety audits at the processor level are much more complex than those carried out at the retail level. While retail food products are generally purchased and consumed shortly after arrival at the retail location, products from processors can remain in the food chain for up to a year. Thus, the safety of those food items must be ensured for their entire shelf life.

While comprehensive retail-level food safety audits typically take a half day or less to complete, the complex nature of food processing means that GMP-level food safety audits may take as many as four to five days to complete. A large percentage of that time is spent reviewing the documentation for a plant’s HACCP and GMP programs and making sure that those programs are not only properly documented, but properly implemented as well. Microbiological testing, which remains rare at the retail level, is another important component of GMP-level food safety audits.

Concurrent with the changes in the type of food safety audits being conducted, auditing technology has evolved as well. Until recently, processor audits were decidedly low-tech affairs. Auditors used pen and paper to take notes during an audit session, and facilities generally needed to wait for days or even weeks to receive a written evaluation and report. Today, handheld computers, portable printers and the 24/7 nature of the Internet allow detailed information and final reports to be shared with the audited facility and/or its customers immediately, sometimes even before the auditor has left the premises.

In addition to expediency, technology affords the ability to slice and dice audit data in a variety of ways. C-suite denizens can view top-line and trend data, while plant and department managers can drill down for more details in order to target specific corrective actions.

Ultimately, the quality and value of an independent GMP or any food safety audit depends to a great degree on the quality, calibration/consistency and expertise of the individuals involved.

The best auditors have advanced degrees in microbiology, chemistry, environmental health, food science, dietetics or nutrition as well as food safety training and certification from an organization such as the National Environmental Health Association (NEHA).

For GMP audits, advanced GMP training, coupled with subject matter expertise/ experience and commodity certification (dairy, low-acid canning, USDA meat and poultry, etc.), help ensure that the auditor has the necessary technical expertise.

Consistency and calibration should be hallmarks of the audit process; standards must be interpreted consistently and should follow written audit protocols. For example, the auditor should have written instructions and clear explanations behind policies for each audit line item. The audit process also should be consultative and educational, with a strong emphasis on process improvement. Corrective actions should be recommended and those areas should be re-inspected at a subsequent audit.

In an April 18, 2005 USAToday article, USDA and FDA officials credited the recent decline in rates of food-borne illness to “strengthened scientific testing and safety plans, [as well as] increased training and oversight in factories that produce food.” Such oversight ¬– in the form of independent GMP and Quality Assurance audits – will continue to be a key factor in ensuring both a safe food supply and a sustained decrease in food-borne illnesses.


  1. Annual Food Safety Audit Trends report, or

Mark Jarvis is president and chief operating officer of the Food Safety Division at The Steritech Group, Inc. Reach him at 858-535-2040 or



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