Tag Archives: recalls

Recall

FDA Food Recalls Up Nearly 93% Since 2012

By Food Safety Tech Staff
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Recall

Over the past five years, the food and beverage industry has seen a big increase in the units recalled—a 92.7% spike in FDA recalls and an 83.4% increase in recalled pounds by USDA since 2012, according to Stericycle’s quarterly recall index. The firm cites technological advances in food testing, factory farming and more automation in food production as the main contributors to the high numbers.

During Q4 2017, bacterial contamination and undeclared allergens led the pack in food recall causes. According to Stericycle, back in 2012, about 28% of FDA food recalls were a result of bacterial contamination, while undeclared allergens accounted for 35% of pounds of food recalled by USDA. During Q4 2017, 44% of food recalls (based on units) were from bacterial contamination, followed by undeclared allergens (31%), mislabeling (13%), and quality (10%). Among the top categories for recalls were prepared foods (20%, nuts and seeds (16%), produce (15%) and baked goods (12%). In addition, nearly 50% of the USDA recalled pounds were a result of lack of inspection.

Lance Roberie, D.L. Newslow
FST Soapbox

Can You Defend Your Food Safety Plan?

By Lance Roberie
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Lance Roberie, D.L. Newslow

As a food safety plan manager, do you ever get asked these questions regarding your food safety plan: What was your thought process for making this decision? Why do you do it this way? How do you answer this?

And, do you ever answer with one of the following statements:

  • I’m not sure? What do you mean?
  • That’s the way it has always been.
  • Our customer asked us to do it that way.
  • That’s what our last auditor recommended.
  • We make a low-risk product.

If this is one of your answers, defending your food safety plan may be a challenge. There is a major shift taking place in the world of food safety. With the implementation of FSMA Preventive Controls, the widespread adoption of GFSI audits, along with advanced technologies such as rapid pathogen and allergen detection, whole genome sequencing, and transparency efforts such as Blockchain, as well as with the increasing use of social media and access of information via the internet, food industry professionals are more educated and informed than ever before and ready to challenge your every move. As a food safety plan manager, you and your team must be ready! Being prepared to defend your food safety plan can be the difference between a recall and a routine audit. If you cannot fully explain the reasoning behind your decision-making, then how will you be able to prove that you are in complete control and are being proactive against food safety hazards? It will not be easy.

You must be ready to defend each and every part of your food safety plan. You must be able to defend questions and challenges with certainty and facts. Every decision made in your hazard analysis should be written down and backed with factual evidence whenever possible. Even the “none identified” areas should be backed by strong reasoning if no other factual evidence is available. You can use the data that you collect daily to help justify your decisions. Data collected from your prerequisite programs (ATP swab results, allergen cleaning validations, GMP audit findings, pest control trends, etc.) and food safety plan (CCP’s, validations, verifications) is all support for your decisions. Have this on file and ready to review when necessary.

If something looks out of the ordinary in your plan, make sure you can fully explain it and can back it with solid justification. If not, auditors, regulators, customers, etc. may start to become suspicious, which can lead to unwanted questions. You will then oftentimes start to get suggestions for change based on others’ individual expertise. Regulators may make “strong suggestions” for changes, for instance, and some people will just go along with it to avoid the pushback or because they simply don’t have a better solution. If this happens, soon your plan is no longer yours—it’s everyone’s. Some of these suggestions may be good, but is it really the right change for your plan? If not, it will often make the plan less rational and often difficult to defend.

The following are tips to help you avoid this situation.

  1. Meet with your food safety team regularly. Go through each part of your food safety plan and figure out how to answer the “why’s”. Why are things done this way? Why did we decide if this hazard was significant or not? Have annual reviews to make sure your plan is still functioning as originally intended and review new industry trends to be proactive regarding new potential hazards.
  2. Write a process narrative. Writing a process narrative documenting what happens at each step of your process and explaining your “thought process” for making decisions is a great support tool. It gives your team a chance to elaborate on the “justification” column in the hazard analysis, providing more decision-making details without crowding the hazard analysis form.
  3. Gather supporting documents. Scientific studies, guidance documents, expert opinions, etc. are vital pieces to have in your supporting documents library. Make sure it is appropriate for your individual products and the documents are from reputable sources, such as FDA, USDA, universities, process authorities, etc. Oh, and don’t forget about history! A reputable supplier with a long track record of safe product, a low history of recalls for the products you produce, etc. can help justify your decision-making.
  4. Conduct Internal Audits. Having an internal audit schedule and well-trained internal auditors help with finding inconsistencies within your program and allow you to make corrections before outside parties find these issues.
  5. Prepare. Have a “mock audit” and prepare for questions that are commonly asked during audits. Practice your answers and make sure you have supporting evidence when needed. Stay up-to-date with industry trends, especially common audit non-conformances.
  6. Be organized. It’s great to have all the supporting documents that you need, but if you cannot find them, then you just as well have nothing.
  7. Be confident. People, especially experienced auditors and inspectors, can quickly sense fear and lack of confidence. This often prompts more questions. Knowledge is power, and knowledge also builds confidence. Simply put, the more knowledgeable you are about your food safety plan, the more confident you will be when someone is trying to test you.
  8. Continuously Improve. It’s understandable that mistakes will be made. However, the next logical question you will be asked is: What did you do about it? Remember, for every nonconformance you find in your system, there should be a correction or corrective and preventive action to address it. It must not simply restate the problem, but legitimately correct the issue. This will give regulators, auditors, customers and anyone else looking at your system confidence that you are in control and can provide a consistently safe product.
Scott Gottlieb, M.D., FDA

FDA’s Gottlieb Says Some Food Recall Practices Raise Significant Concerns

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

Following the Office of Inspector General’s (OIG) final issuance of its report on FDA food recall practices, FDA Commissioner Scott Gottlieb, M.D., is voicing concern. The OIG report looked at FDA food recall practices from October 1, 2012 to May 4, 2015. Its findings are obvious in the report’s title: The Food And Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply.

“Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always (1) evaluate health hazards in a timely manner, (2) issue audit check assignments at the appropriate level, (3) complete audit checks in accordance with its procedures, (4) collect timely and complete status reports from firms that have issued recalls, (5) track key recall data in the RES [Recall Enterprise System], and (6) maintain accurate recall data in the RES,” according to the OIG report.

Food Safety Tech first reported on the draft findings in June 2016 when the OIG said the FDA recall initiation process was not efficient or effective. Although Gottlieb noted that the agency took action after the draft was released, “we still have more work to do,” he said in an FDA statement.

One of the action steps for 2018 is that FDA will issue guidance on recall communications in the first half of the year. The agency is also looking at situations in which it can assist consumers in getting information about the stores and food service locations that may have sold or distributed recalled food, as well as the company that supplied the product.

“Much work remains to be done if we’re going to provide the highest assurance of safety.” – Scott Gottlieb, FDA

Gottlieb stated that the agency will be revealing more early this year about policy steps it will be taking to improve food safety oversight and how the recall process is implemented. FDA is also examining how it can expedite the timeliness and scope of information provided to consumers about food recalls.

Julie McGill

Make Your Food Chain Recall Ready At The 2017 Food Safety Consortium

By Julie McGill
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Julie McGill

As we reflect back on 2017, food recalls continued to dominate our headlines even after the implementation of FSMA. Our industry has taken corrective actions to limit risk. We want to protect consumers as well as our brands, limiting the financial and reputational damage that a recall can inflict on a company. We, along with consumers, are also more aware and in tune with the news due to social media and the 24-hour news cycle. It may appear that there are more recalls, but I would argue that the industry is more proactive and more accountable by submitting itself to voluntary recalls. Without a doubt, the food industry is under increased pressure.

Looking forward to 2018, we are reminded that it was 25 years since the E. coli outbreak at Jack in the Box. It was a monumental turning point in food safety that sparked the industry to modernize and examine processes. Since then, the food industry as a whole has come a long way. During my 16 years at GS1 US, working on programs such as the Foodservice GS1 US Standards Initiative, I saw food companies embrace global standards to increase efficiencies and build a foundation for traceability and supply chain visibility. Now adding Blockchain, Smart Labels, and IoT data to the technology mix will continue to advance the modernization of the food industry.

The good news for our industry is that consumers are patronizing companies that are embracing transparency as a strategic business strategy and these are the companies who are winning the market share as a result.

As stewards of our industry, we will always review our processes, continue to train and educate our employees and adopt better ways of guarding the supply chain. One way to become better at protecting the food chain and the public is exchanging ideas with our peers. We are stronger together.

That is why I am excited to bring together a diverse group of industry leaders for this year’s Food Safety Consortium to discuss this very topic. Titled, Is Your Food Chain Recall Ready?, I will be joined on Thursday, November 30th at 2:30pm CST by Jessica Jones, sr. specialist of Supplier Quality & Safety at Chick-Fil-A; Barbara Hullick, senior director of Food Safety at Produce Alliance and Bryan Cohn, vice president of Operations at Seal the Seasons.

During this panel session, we will discuss:

  • Best practices for FSMA compliance before, during and after a recall.
  • Best practices to execute precise, data-driven and timely recalls and stock withdrawals.
  • Establish and execute a process for escalation and post-recall audit reporting.
  • Work and communicate with suppliers and distributors on “what if” scenarios and what they can expect when quality issues arise.
  • Create a food safety culture which works in concert with legal, marketing and other internal teams.

I hope you will join us in person at the Renaissance Schaumburg Convention Center Hotel for the entire conference but if not, join us virtually! Registration details can be found on the Food Safety Consortium website.

Dollar

Trends and Real Cost of Product Recalls

By Food Safety Tech Staff
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Dollar

Last year, nearly 550 food products were recalled in the United States. Nearly half of those recalls were a result of biological contamination, a whopping 65% of which was due to Listeria monocytogenes, according to Rentokil. The company recently released an infographic about the cost of a product recall, pulling out some of the key trends in food product recalls in the United States and the United Kingdom. Next to biological contamination, mislabeling continues to be a large issue.

Rentokil Product Recalls 2016
The Cost of a Product Recall in the Food Industry. Infographic courtesy of Rentokil.
FoodLogiQ Recall Response, SaaS

New Technology Helps Companies Respond to Recalls Faster

By Food Safety Tech Staff
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FoodLogiQ Recall Response, SaaS

A recent survey found that many consumers expect a recall to be resolved within one to two days. Today one company released a product touted as the first real-time software as a service (SaaS) platform for managing recall and stock withdrawal with the goal of helping food companies respond to recalls faster.

Recall + Response, launched by FoodLogiQ, allows food companies to implement a targeted recall strategy across the supply chain and track the progress of the recall. An automated communications function (via phone, email and text) sends notifications that can accelerate the delivery of information throughout the supply chain during a recall. The platform can initiate stock withdrawals and recalls, as well as mock recalls. Its features include withdrawal templates that the user can define and create to prepare for recalls and stock withdrawals, and a mock recall feature to test the recall readiness of a user’s supply chain. It also has an automatic escalation function if no action is taken by a location or no contact is made in a specific timeframe.

Food Safety Tech

Recall Consequences: What Consumers Think

By Maria Fontanazza
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Food Safety Tech

Consumer preferences have clearly shifted to a more personal, hands-on experience that requires food companies to maintain trust by being completely forthright about what is in their products. And when a company is involved in a recall, consumers expect a fast response—within days, according to a recent survey. Half of the survey participants expect a company to address a recall within one to two days. In addition, if a brand or restaurant has a recall or contamination that leads to illness, 23% said they would never use the brand or visit the restaurant again and 35% said they would avoid it for a few months and “maybe” come back.

A company’s supply chain can be the weakest link in its food safety program. Learn how to mitigate these risks at the Food Safety Supply Chain conference | June 5-6, 2017

The survey, commissioned by FoodLogiQ and titled, “What Consumers Care About in the Age of Transparency”, polled more than 2000 people. It also found that the same consumers who expect a one- to two-day turnaround in addressing a recall also care a great deal about clarity in food labeling: 57% want to see as much information on a label as possible. This includes country of origin, allergen information and identification of genetically modified ingredients.

With the number of recalls occurring four times as often as they did five years ago, food companies are at an even higher risk of facing a negative financial impact and losing consumer confidence. Maintaining transparency throughout the supply chain is a crucial part of managing consumer expectations and executing effective risk mitigation.

“Open, constant and transparent communication with your suppliers is a must for addressing these issues. After all, you can’t offer consumers the information they crave about your product and processes if you aren’t getting that information from your suppliers and brokers,” state the survey authors. “You cannot expect a supplier to fulfill your requirements around safety and brand promise if you aren’t open about your expectations. It’s a two-way relationship that can make a huge difference in your business.”

The authors offer recommendations on how companies can keep a clear line of communication open with consumers, including:

  • Transparency throughout the supply chain, including from where food is sourced
  • List all product ingredients and include information about allergens and animal products
  • Have open communication concerning mislabeling, and contamination and recalls
product recall sheet

Effective Supplier/Retailer Communication Eases Pain of Food Recalls

By Holly Mockus
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product recall sheet

Food recalls are not 100% avoidable, and they are costly. The hit to an individual food company or retailer, on average, can run to tens of millions of dollars. Annually, millions of consumers become ill as a result of contaminated food products, and the dollar costs in terms of lost productivity, medical treatment and deaths run into the tens of billions.1 More than 20% of consumers have said that they would not purchase any brands from a company suffering a food recall.2 At best, damage to a company’s brand and reputation could take a long time to repair. Clearly, the need to prevent food contamination is obvious and should be the ultimate goal of all food safety professionals.

But despite the best industry efforts, recalls inevitably occur. And since they aren’t 100% avoidable, suppliers and retailers must continue to look for ways to minimize the safety and financial impact of the recall events that do occur. It’s good to begin that process by understanding some statistics surrounding the most common recalls. Globally, 46% of food recalls are for chemical hazards or the introduction of non-food-grade ingredients. 79% of these are due to undeclared allergens. 26% of recalls are for food-borne pathogens, and 8% are due to physical hazards (metal, glass, plastic, paper, wood, etc.). The remaining 20% are generally quality-based recalls and withdrawals.3

Head Off Recalls Before They Occur

Knowing the numbers helps suppliers and retailers home in on their most likely problem areas and get a leg up on potential product contamination problems. Since chemical hazards are the single biggest culprit, and because most of these instances are due to allergens, food companies should closely examine their cleaning and sanitation practices during production line changeovers. Keep in mind the potential role of contract service providers as sources of adulteration. Regarding pathogens, evaluate raw and ready-to-eat segregation procedures, staff access points, and  good manufacturing practices and employee traffic patterns.

Many companies focus their efforts on passing food safety certification audits, but faithful adherence to food safety measures just to pass an audit misses the point. Focus on the development and implementation of comprehensive food safety systems to guard against contamination and food safety incidents, and not just avoid non-conformances to certification codes. Preventing food safety incidents and recalls before they happen must be the priority.

Supplier Best Practice: The Mock Trace

Manufacturers, suppliers and certification bodies have evolved a set of best-practice recommendations that will go a long way toward reducing the number of food safety incidents and recalls. These include conducting regular internal audits of food safety plans and procedures, including approved supplier programs and environmental monitoring programs, both to re-evaluate their effectiveness and discover new or previously overlooked gaps.

Suppliers should consider taking things to the next level. SQFI’s LeAnn Chuboff suggests that suppliers “make their retailers happy” through the use of mock trace exercises.3 These “dry runs” are invaluable for reinforcing the close examination and evaluation of recall plans and to become intimately familiar with the necessary procedures in the event of an actual adulteration event. Mock trace exercises should be intensive: They are particularly effective in identifying gaps when they occur during off shifts. Making the exercise challenging rather than check-the-box easy helps companies reveal and close critical gaps. Conduct the mock trace in both directions, from raw materials to finished goods, and vice versa.

Include every department in the company. For mock trace exercises to be completely effective, review all documentation for errors or omissions. All employees should be interviewed to determine whether they fully understand food safety and documentation procedures. Review training modules and observe manufacturing procedures for evidence of knowledge or operational gaps. Examine bulk material receiving and storage, employee and material traffic patterns, packaging materials and procedures, and cleaning and maintenance chemicals.

Speed as well as accuracy and thoroughness are critical in the event of an actual recall event. Companies should practice rapid response. Take advantage of all the accumulated experiences from the mock exercise to improve every aspect of the company’s food contamination response tools and practices.

Recall

Persistent Strain of Salmonella Triggering Dozens of Recalls

By Food Safety Tech Staff
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Recall

The recalls involving powdered milk continue to pile up.

Since December, more than a dozen products containing powdered milk have been recalled due to the risk of Salmonella, including mini eclairs and cream puffs, mac & cheese products, chocolate-covered pretzels, potato chips, seasonings and white peppermint Hostess Twinkies.

Back in November, FDA seized more than 4 million pounds of dry nonfat milk powder and buttermilk powder produced by Valley Milk Products, LLC. The agency used whole genome sequencing to make the connection between the samples that were collected in the facility—Salmonella strains were found from samples taken in 2016 and back to 2010. FDA identified it as a persistent strain of the pathogen.

“FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized.” – FDA news release

To date, no illnesses have been reported.