“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.
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.
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.
Food Safety Tech recently spoke with Katy Jones, chief marketing officer at FoodLogiQ about consumer preferences and their expectations during a product recall, along with how food companies can manage better visibility further in their supply chain.
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.
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
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.
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
From countless recalls, to FSMA deadlines, to the rising demand for transparency, 2016 has been a monumental year in the food industry. With 2017 knocking, here are the top trends and predictions to watch out for in the food industry next year.
1. Moving Toward a Fully Digital, Connected Supply Chain
The food supply chain in many ways is still lagging behind in technology compared to other supply chains. In 2017, many companies will begin or continue on their journey to fully digitize their supply chain, whether that is simply getting their list of approved suppliers out of an Excel spreadsheet and into a supplier management software technology solution or fully capturing every step of their products along the journey from farm to fork.
The spectrum of digitization across the supply chain is quite broad. But bottom line, supply chain analytics will empower food companies to create useful KPIs, allow them to truly measure the ROI of their supply chain initiatives and give consumers the transparency that they demand. And systems that fully support the daily monitoring, sharing and interpretation of those analytics needed to help companies will experience tremendous growth in 2017.
Collaboration with your supply chain partners is an absolutely critical element, and we can expect to see more companies fully integrate throughout their network of suppliers and customers. Food companies that will succeed in 2017 will need a fully integrated supply chain network, with access to the same information, working towards a shared mission to deliver results and be ahead of their competitors. A connected supplier network will allow food companies to be agile when faced with an issue, responsive to recalls, as well as be flexible and efficient.
2. Recalls, Recalls, Recalls
We saw a high volume of recalls this year, and this trend is not going away anytime soon. As more and more advances in food testing are made, companies will have access to new technologies across their supply chain that will identify issues early. Consequently, more products will need to be pulled out of the supply chain because of that increased testing in order to maintain consumer sentiment.
The companies that are able to roll out these capabilities quickly and efficiently—armed with the data needed—will be well poised to manage their supply chain, potential recalls and the impact to their customers. With the knowledge that we can expect to see several recalls in the new year, food companies should be looking to mitigate risks and better manage their supply chain.
3. Full-force FSMA Is Here Whether You Like It or Not
FSMA focuses on amplifying preventive controls for food production in order to alleviate potential food contamination outbreaks, and the past two or more years have been focused on this preparation. This preparation will come to a pinnacle in 2017, the first full year of FSMA implementation worldwide, with the FDA starting audits for larger companies. This could lead to the FDA requesting required records, conducting audits and in the worst situation for food companies, shutting down operations if they feel it’s necessary.
FSMA will require detailed record keeping when a recall or outbreak occurs, with clearly defined corrective actions in place. Companies will see an increased need for technologies that help supply preventive processes such as food allergen and sanitation controls, as well a prepared recall and supply chain plan. Tracking and traceability will be the two key parameters that will offer manufacturers the ability to examine specific foods and trends to improve their overall process. In order to comply with these new FSMA regulations at every step of the process, food companies will increasingly look to utilize these technologies to account for full traceability of the supply chain.
4. Growth in Foodservice At the Consumer’s Doorstep
Brands like Starbucks and Panera have been testing the food home delivery waters, but more companies seem to be jumping onto the trend of bringing gourmet food directly to the consumer’s doorstep—Blue Apron, Plated, HelloFresh just to name a few.
The increasing complexity of the global food chain has also increased the complexity of traceability of ingredients. However, FSMA has made this task a critical part of the seed to fork process. More vigilance and awareness of the supply chain is an essential part of protecting consumers and the company brand, and plays in an important role in the event of a recall. In a Q&A with Food Safety Tech Dean Wiltse, CEO of FoodLogiQ, explains the issues the food industry is experience in this area and why transparency in the supply chain will become the new normal.
Food Safety Tech: What are the biggest supply chain challenges you see industry facing today?
Dean Wiltse: The biggest challenge we see in the food supply chain is getting beyond the “one-up and one-back” approach to supply chain management to achieve real transparency in the supply chain. Now I think more than ever consumers want to know more information about their food and 2017 is going to be the year of transparency. A year of getting beyond one-up and one-back, and beyond the four walls of the food manufacturing facility to really dig down and understand what is going on two, three, four, or five levels down the supply chain, from a safety and risk mitigation standpoint.
I also think food companies will continue to be challenged by the ripple effect of increased recalls: Sunflower seeds, flour, powdered milk. Many food companies were rocked with these recalls in 2016. We expect these recalls to continue in scale and frequency going into 2017.
Another challenge is in the area of quality incidents—and the monitoring of those quality incidents. Oftentimes these quality issues go unchecked and it’s damaging to the quality of your food—and of course your brand—as well as damaging to the bottom line.
FST: How should companies monitor and ensure that they are getting high quality product from suppliers?
Wiltse: It sounds simple, but it all starts with being aware of exactly where you are experiencing quality issues across your supply chain. At FoodLogiQ, we pull all of the quality and incident data together in our dashboard to enable food companies to know exactly which suppliers you are having quality issues with and which ones you aren’t.
FoodLogiQ dashboards enable users to monitor quality issues in the supply chain and document incidents. (Click above images to enlarge the dashboards)
Tracking and documenting these incidents—followed by the corrective actions—is critical. It is also important that all of the requirements and expectations are communicated openly; it makes the food supply chain safer by opening up transparency.
Customers can also use our technology to aggregate the quality and safety data into a star rating for their suppliers. Defining what is important to you from a quality and safety standpoint and aggregate that data in the software, and then assign a star rating for your suppliers. You can then use this star rating to formulate your preferred and approved supplier list.
FST: Where are the biggest disconnects in the supply chain? And how can companies rectify this?
Wiltse: Back to what the consumer is demanding: More information about their food, where it came from and what exactly is in it. Leading food brands want to provide this level of transparency to their consumers, but many are struggling with delivering this information in an authentic, real-time fashion.
Today there’s technology that can deliver it to them. In order to get more granular and provide more detailed information through the supply chain, there’s a cost associated with that, even down to the labeling at the grower for traceability. Many in the industry view this as an additional cost, but the leaders see this as a strategic investment and realize there is significant ROI in supply chain transparency.
FST: What are the most serious concerns surrounding FSMA and the supply chain?
Wiltse: Clearly the majority of the industry has been preparing for FSMA for several years now, getting their processes in place, if they weren’t already. Where we see a significant opportunity for companies to be proactive is in centralizing their required records, safety plans, and other essential processes into one platform for their entire supply chain.
We see many food companies who may have the required documentation and corrective actions in place, but they are scattered or siloed throughout the organization, and not centralized and easily accessible when the FDA calls on you to provide that information.
Another challenge is certainly top of mind is foreign supplier verification. The wave of required verification for foreign suppliers will be significant for many companies so they must be vigilant and start that process now or risk a significant disruption to their business.
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