About 48 million Americans, roughly 1 in 6, get sick from foodborne disease each year. CDC
The average direct cost of a food recall has been estimated at $10 million, before lost sales and brand damage. GMA & FMI
“Cease dependence on inspection to achieve quality.”
W. Edwards Deming
FDA and USDA announce hundreds of food recalls every year. FDA & USDA
If it isn’t documented, it didn’t happen. Auditors examine your records as closely as your plant.
Unlike most foodborne bacteria, Listeria monocytogenes can grow at refrigerator temperatures. FDA
Listeria is the third leading cause of death from food poisoning in the U.S. CDC
“A bad system will beat a good person every time.”
W. Edwards Deming
Undeclared allergens are one of the leading causes of U.S. food recalls. FDA
Most food recalls are voluntary, started by the company rather than ordered by a regulator. FDA
A corrective action without a root cause analysis usually fixes the symptom, not the problem.
FDA classifies recalls as Class I, II or III, with Class I posing the most serious health risk. FDA
“Quality is free. It’s not a gift, but it is free.”
Philip B. Crosby
The Food Safety Modernization Act gave FDA mandatory recall authority over food for the first time in 2011. FDA
HACCP dates to the 1960s, when Pillsbury, NASA and U.S. Army laboratories developed it to keep astronaut food safe. FDA
A mock recall is the best time to find out your traceability records have gaps.
Salmonella causes an estimated 1.35 million infections and 26,500 hospitalizations in the U.S. each year. CDC
“Quality comes not from inspection, but from improvement of the production process.”
W. Edwards Deming
Salmonella can survive for long periods in low-moisture foods such as peanut butter, flour and spices. FDA
Raw flour has been linked to E. coli outbreaks, which is why it shouldn’t be eaten uncooked. CDC
Shiga toxin-producing E. coli (STEC) cause an estimated 265,000 U.S. infections each year. CDC
Environmental monitoring is meant to find problems. A program that never finds a positive may not be looking in the right places.
Campylobacter causes an estimated 1.5 million U.S. illnesses each year, most often linked to raw or undercooked poultry. CDC
“Food safety equals behavior.”
Frank Yiannas
Norovirus is the leading cause of foodborne illness in the U.S. CDC
Infected food workers cause about 70% of reported norovirus outbreaks from contaminated food. CDC
Foodborne illness sends about 128,000 Americans to the hospital and causes about 3,000 deaths each year. CDC
“Quality is conformance to requirements.”
Philip B. Crosby
USDA estimates that 15 leading foodborne pathogens cost the U.S. more than $17 billion a year. USDA ERS
Worldwide, an estimated 600 million people, almost 1 in 10, fall ill from contaminated food each year. WHO
Any change to ingredients, equipment or process is a reason to revisit your hazard analysis.
The Food Safety Modernization Act, signed in 2011, shifted U.S. food safety from responding to contamination to preventing it. FDA
“An ounce of prevention is worth a pound of cure.”
Benjamin Franklin
Under FSMA, covered food facilities need a written food safety plan prepared or overseen by a Preventive Controls Qualified Individual (PCQI). FDA
Under FSMA, facilities must verify their suppliers when a hazard is controlled before an ingredient arrives. FDA
FDA regulates about 80% of the U.S. food supply. USDA oversees meat, poultry and processed egg products. FDA
“Quality control begins with education and ends with education.”
Kaoru Ishikawa
USDA requires HACCP for meat and poultry plants, and FDA requires it for seafood and juice processors. USDA & FDA
Facilities that make, process, pack or hold food for U.S. consumption must register with FDA and renew every two years. FDA
Training sticks when people understand the why behind a requirement, not just the rule.
The Reportable Food Registry requires facilities to report within 24 hours when a food may cause serious harm. FDA
“Where there is no standard, there can be no kaizen.”
Taiichi Ohno
Bacteria multiply fastest between 40°F and 140°F, the range known as the Danger Zone. USDA
The FDA Food Code calls for cooling cooked food from 135°F to 70°F within 2 hours, and to 41°F within 6 hours total. FDA
Poultry is safe when cooked to an internal temperature of 165°F; ground beef, 160°F. USDA
“Quality is fitness for use.”
Joseph M. Juran
Ready-to-eat foods get extra Listeria scrutiny because there’s no cooking step left to kill bacteria before eating. FDA
Biofilms let bacteria cling to equipment in a protective layer that can resist routine cleaning.
Sanitizers work best on clean surfaces. Leftover soil and residue can shield bacteria from them.
A gap assessment before a certification audit turns surprises into a planned to-do list.
“The measurement of quality is the price of nonconformance.”
Philip B. Crosby
Sesame became the ninth major food allergen in the U.S. on January 1, 2023. FDA
The nine major U.S. food allergens are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans and sesame. FDA
About 33 million Americans have food allergies. FARE
“Quality is a customer determination, not an engineer’s determination, not a marketing determination, nor a general management determination.”
Armand V. Feigenbaum
The Global Food Safety Initiative launched in 2000 to align food safety standards around the world. GFSI
GFSI-benchmarked certification schemes now assess food safety culture, not just written procedures. GFSI
FDA’s Food Traceability Rule requires extra traceability records for foods on its Food Traceability List. FDA
Supplier approval is part of your food safety program, not just a purchasing decision.
“Improve constantly and forever the system of production and service.”
W. Edwards Deming
Coliforms and generic E. coli are widely used indicators of sanitation and possible fecal contamination.
Aerobic plate counts measure overall microbial load, a useful gauge of hygiene and shelf life.
Yeasts and molds can spoil acidic, sugary and refrigerated foods where many bacteria struggle to grow.
“Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for.”
Peter F. Drucker
Water used in food processing can spread contamination if it isn’t monitored and maintained.
FDA’s Produce Safety Rule includes requirements for agricultural water used to grow produce. FDA
A negative result describes the sample tested. Your sampling plan decides how much confidence it gives about the whole lot.
“Drive out fear, so that everyone may work effectively for the company.”
W. Edwards Deming
Leftovers should be refrigerated within 2 hours, or within 1 hour when it’s above 90°F. USDA
