As of late, the problems for Chipotle have been endless. 2015 was a year of several Salmonella, norovirus and E. coli outbreaks for the restaurant chain. With the first full week of the new year wrapped up, 2016 is off to perhaps an even rockier start, with news of the company being hit with both a class action lawsuit and a federal grand jury subpoena.
Company stockholder Susie Ong filed a civil complaint against Chipotle on January 8, stating that the company made false or misleading statements and failed to disclose that its “quality controls were inadequate to safeguard consumer and employee health.” Filed in the U.S. District Court for the Southern District of New York, the complaint calls out a norovirus outbreak that occurred in August in Simi Valley, California; a Salmonella outbreak in Minnesota that sickened 64 people; the closure of all company restaurants in Portland, Oregon and Seattle, Washington in November following an E.coli outbreak; and the highly-publicized norovirus outbreak that sickened more than 140 students from Boston College in Brighton, Massachusetts last month.
Ong’s complaint also mentions the federal grand jury subpoena, which Chipotle made public two days prior (January 6) in an SEC filing. Served in December, the subpoena is part of a criminal investigation by FDA and the U.S. Attorney’s Office for the Central District of California into the Simi Valley norovirus outbreak, which sickened about 100 patrons and employees (some reports state that more than 200 people fell ill). Ong’s lawsuit states that health inspectors found “dirty and inoperative equipment, equipment directly linked to the sewer, and other sanitary and health violations” at the Simi Valley restaurant.
With December’s norovirus outbreak in Brighton and the CDC’s announcement that it was further investigating five new cases of E. coli that were reported the month prior, restaurant sales were down 30% for the month, according to the SEC filing. Ong adds up all of these unfortunate events in the lawsuit, stating, “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.”
Chipotle has not yet publicly commented on the lawsuit.
Earlier in December, Chipotle called attention to improvements it was making to its food safety program by bringing in IEH Laboratories and Consulting Group to reevaluate its processes in an effort to prevent future outbreaks. Clearly that was not enough.
Food companies take heed. 2016 is off with a bang, and not in a good way. Last week industry was also buzzing about the DOJ’s investigation into Blue Bell Creameries over the deadly Listeria outbreak. FDA and the other federal powers-that-be are making it very clear that negligence will no longer be tolerated (Or should I say, alleged negligence, in this case). Compliance, accountability, and above all, ethical behavior are at the heart of the matter.
Will it all come tumbling down for Chipotle? It remains to be seen whether the company will be able to recover from these issues. And maybe an even bigger question is, who will be next?
It’s safe to say that 2015 has been one of the worst years in recent history when it comes to food contamination. Everyone from global food manufacturers to major restaurant chains and grocery stores perpetuated or experienced outbreaks of foodborne illnesses like E. coli, Listeria, Salmonella and Norovirus. From farm to fork, the food industry needs to evalutate and improve its processes to deliver the utmost health and safety to consumers.
With FSMA and tougher industry standards in place, there will be much more emphasis on preventative measures—especially for food manufacturers. FSMA establishes a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.
Not surprisingly, most food manufacturers say they are being impacted by FSMA
Even though most of the regulations affiliated with the FSMA have just gone into effect, or will go into effect in 2016, food manufacturers are already feeling the heat. A recent survey found that the majority (81%) of food manufacturers are experiencing some level of impact from current and impending regulations. Processes pertaining to traceability, supplier and facility audits, HACCP and product recalls are causing the most concern. While most food manufacturers support FSMA’s mission to put prevention at the forefront, the reality is that many aren’t equipped to handle growing compliance demands.
There are still a sizeable number of food manufacturers that manually record their processes for identifying, evaluating and controlling food safety hazards. In fact, more than 30% of food manufacturers document their HACCP plan in this manner.
58% of manufacturers surveyed are using an in-house system for recording issues as part of their HACCP plan
With FSMA, there isn’t any room for human error. Although technology with track and trace capabilities has been available long before FSMA came into play, obstacles such as complicated interfaces, lack of interoperability and resources deterred wide-spread adoption among food manufacturers. The tide is changing here. Advanced enterprise resource planning (ERP) solutions have built in track and trace functionality that is more intuitive and integrates seamlessly with vital manufacturing execution systems (MES).
Manufacturing execution solutions play a key in helping companies achieve traceability. All figures courtesy of Aptean. View full infographic
Although the FDA does not have the legal authority to require companies to use computerized traceability solutions, implementing track and trace technology is one of the most effective measures a food manufacturer can take when it comes to FSMA compliance. It can help create a more systematic and reliable account throughout the lifecycle of a food product, and also establish preventative measures, including automated product checkpoints and quality tests throughout the supply chain. Ultimately, this gives food manufacturers the opportunity to identify and prevent issues before they become epidemics.
In addition to taking strong measures to prevent contamination, under FSMA the FDA now has authority to initiate mandatory recalls. Although mandatory recalls are anticipated to be rare, food manufacturers should use track and trace technology to make recall preparation routine. When used properly, these tools can pinpoint specifics about a product in real time, streamline quality reporting, and launch mock recalls.
Of course, technology is not only the vessel for improvement—to actually see change, food manufacturers need to take a critical look at their processes and make adjustments. Automating poor processes will only accelerate poor results, therefore approaching FSMA compliance and implementing track and trace technology requires time and strategy.
Ultimately, your company’s reputation is on the line as well as the safety of consumers. Dedicating necessary resources toward compliance planning and technology implementation is always well worth the investment. Many of the companies and suppliers that were in this year’s spotlight for contamination will look back on 2015 with regret because safety wasn’t at the forefront. Let’s learn from the hard lessons they provided and make 2016 the year that food manufacturers win back consumer trust and focus on quality.
November 17 was an inspiring evening at the Food Safety Consortium! Thanks to the generosity of Food Safety Tech and Chemstar, a number of friends were able to join STOP Foodborne Illness in celebrating two of its Food Safety Heroes.
We honored Nancy Donley, former STOP spokesperson with the Legacy Tribute award. Since the death of her son Alex, in 1993, Nancy has selflessly advocated for stronger food safety policies and practices. Our other esteemed guest was Frank Yiannas, vice president of food safety for Walmart, a man known for passionately escalating the notion of a “food safety culture.” Frank received STOP’s Industry Advocate Hero award.
Another highly regarded guest, FDA Deputy Commissioner Michael Taylor, shared his reflections on the magnitude of the evening. Please take a moment to read Taylor’s eloquent and thoughtful words regarding this milestone celebration.
Days are now shorter, and temperatures are slowly dropping in most parts of the country. It is the time of year when individuals look to spend a little more time indoors and a little less time outdoors. However, did you know we aren’t the only ones looking for relief from the cold?
Similarly to us, this is the time of year when certain pests look for a nice, warm home to spend the winter months. The downside for food facilities is that they offer everything pests need for survival—food, water and harborage.
In fact, food facilities can face numerous pest challenges during the colder months, including ants, cockroaches, stored product pests and flies. Additionally, the most common and challenging winter pests are rodents. Due to their ability to squeeze through small spaces and adapt to many different environments, they can be a facility’s worst nightmare.
Don’t let rats and mice threaten food safety audit scores. All images courtesy of Orkin
The presence of rats and mice can lead to food contamination and can threaten your food safety audit scores, reputation and bottom line. Rodents are known carriers of deadly neurological and respiratory diseases like lymphocytic choriomeningitis virus (LCMV) and Hantavirus Pulmonary Syndrome. Ticks, mites and fleas can feed on infected rodents and transmit diseases like pox, plague and typhus indirectly to humans—putting not only employees in your facility at risk, but also customers.
Rodents can be tough to control and are very adaptable at living indoors. Some mice that take shelter inside due to weather can survive indefinitely as indoor mice. In fact, there is a possibility rodents may have already taken shelter by now, so it’s important to talk with your pest management professional about common areas where rodents may be hiding.
As you winterize your facility, it’s important to keep rodents and other pests in mind. A proactive approach to facility maintenance, as well as an effective Integrated Pest Management (IPM) program, can help keep pests out and your food product and business secure.
The following tips will help keep your facility off pests’ radars this winter.
Stay Vigilant in Monitoring for Pest Activity
Vigilant, ongoing monitoring is a cornerstone of an effective IPM program. With this strategy in place, there are many tactics you and your staff can use.
Identify “hot spots”. Work closely with your pest management professional to identify the most common places pests reside in around your property. These can include loading docks, utility rooms, employee break rooms, dumpsters and trash cans, storage rooms and behind any heavy, immobile pieces of equipment. By identifying these hot spots, you’ll be able to prevent pests from entering your facility.
Involve your employees. Educate your staff on the pests themselves, as well as the conditions that attract them, and encourage your employees to report any signs of problems. Utilize a reputable pest management company to provide your employees with this training—many providers offer training at no extra cost.
Look for gaps and fill them to keep those pesky critters out!
Strengthen Your Facility’s Perimeter
While certain pests can hitch a ride into your facility via shipments and even on people, the biggest pest threats start on the outside. With this in mind, you can take fight pests outside by strengthening your perimeter.
Look for and fill cracks and crevices. Crawling pests like to creep inside through small openings. Additionally, rodents can squeeze through holes the size of a quarter, mice through dime-sized openings that create gaps barely noticeable to the human eye. Regularly inspect the exterior of your facility for any cracks that may develop and pay close attention to openings that can form around pipes and utility penetrations. Don’t forget to seal any holes in exterior walls with water-resistant sealant and steel or metal mesh.
Eliminate clutter and attractants. Rodents may burrow or live up to 100 yards away from your structure, and flies, ants and cockroaches are also on the hunt for easy meals that can often be found on the property. Keep trash handling areas free of clutter, and clean up any uncovered garbage or standing water outside. Also, work with your waste management company to ensure they clean and switch out dumpsters regularly.
Keep landscaping off your building. Pests will often use vegetation as staging and feeding sites. Keep trees trimmed and plants at least 12 inches from your building, and remove leaves quickly so pests cannot use them for cover. As an extra step, consider installing a two-foot wide gravel strip around the perimeter of the building. Think of these exclusion techniques as digging a moat around your castle.
For rodents, bait stations can be set outside. Work with your pest management provider to place tamper-resistant bait stations around the exterior of the facility. However, do not place the stations near doors or entryways, as they can attract pests into the facility. Be sure to maintain an up-to-date map of bait stations and record activity at each station to determine the source of rodent pressure and target future treatments accordingly.
Prevent fruit flies by keeping employee break rooms clear of food remnants and tightly sealing garbage cans.
Reinforce Clean Conditions Inside
Once you set up an outside defense against pests, you can double down on your pest management efforts by taking a few proactive measures inside as well. The key to keeping pests from infesting your facility is removing incentives for them to go inside in the first place.
Inspect incoming shipments. When you are not receiving materials, keep loading bay doors closed—make sure the doors close securely so that pests cannot sneak under them. Inspect incoming raw materials, packaging and truck trailers for signs of infestation.
Reduce potential food sources inside your facility. Employee break rooms should be clear of any food remnants, and garbage cans with food and other waste need to be kept tightly sealed.
Monitor the plant floor. Sanitize drains and equipment with an organic cleaner to eliminate the residue that pests can feed on. With colder temperatures, pipes can break or crack, so ensure plumbing is also maintained properly to prevent leakage and property damage. Monitor for spills and clean them immediately, as pests only need a small amount of moisture to survive.
By putting proactive defenses into place, your facility can enjoy the winter seasons with a decreased likelihood of the appearance of unwanted visitors like rodents, ants, cockroaches, stored product pests and flies. Talk with your pest management professional about these steps and other tactics you can put in place to keep your facility safe against overwintering pests and relegate them to the cold.
With the signing of FSMA in 2011, wholesaler and retailer executives are now legally responsible for the safety of their supply chains. In addition, FSMA’s focus on prevention and its seven new rules requires retailers and wholesalers to collect, manage and store multiple documents from each vendor for compliance. These documents must be accessible upon FDA request within 24 hours and extend two years back. And here’s the kicker: Senior executives are now responsible for the compliance of their supply chain with FSMA.
At the Food Safety Consortium, Affiliated Foods Midwest (AFM) will talk about their preparation for FSMA compliance and decision to move away from their “home-built” and “highly manual” compliance system, which stored both soft and hard copies of vendor documents. With FSMA rules focused heavily on documenting preventive measures, AFM executive leadership assessed the company’s gaps and determined they needed to be more proactive. John Grimes, director of safety for AFM, estimated that at the start of the company’s journey, about 30% of vendors were non-compliant with the three records they required: Certificates of Liability with specified limits, Hold Harmless forms and W-9s.
“We knew compliance built on trust was not enough and wanted more business documents and regulatory records collected. We also needed to increase compliance, be more proactive, and so we were looking to automate our systems,” explains Grimes.
AFM decided to adopt the cloud-based Compliance Management System to proactively manage both business-related documents and FSMA-related records. Once implemented, the wholesaler’s non-compliance among vendors was reduced by 60% in the first 90 days through proactive alerts, automated exception reporting and focused, personal follow up.
On Thursday, November 19, Randy Fields and John Grimes will discuss “FSMA Compliance Really Starts With Knowing Your Supply Chain” at the Food Safety Consortium. LEARN MORE“With our prior system I could find a requested document within 24 hours, but with the cloud-based compliance management system, I can pull it up and instantly share it with an FDA agent even before they have a chance to leave my office,” says Grimes.
Document management at AFM is now much more proactive vs. reactive. The Compliance Management System automatically sends alerts to Grimes and the vendor when documents are missing, when insurance limits are too low, or when a document is due to expire. The system enables AFM to proactively manage more documents by vendor than ever before.
The active approach that our staff enables its customers to take in managing compliance is really its differentiator. Each customer is provided with a dedicated team to reach out to their vendors to speed enrollment and quickly address their compliance issues.
According to Grimes, as more retailers and wholesalers adopt this type of system, the vendor community will move more quickly to embrace solutions that will help them comply with FSMA.
Economically motivated adulteration (EMA) of food, or food fraud, has been estimated to cost the food industry $30–40 billion per year. The 2008 incident of melamine adulteration of milk powder has cost billions of dollars to companies and invaluable loss of consumer confidence. Even more significant than the economic cost or loss of confidence, the impact on public health was enormous. An estimated 290,000 consumers were affected with more than 50,000 hospitalizations including at least six deaths. There is also collateral damage caused by incidences of EMA, including the loss of confidence in government regulatory systems around food safety. Although major incidents like the melamine scandal happen infrequently, food fraud commonly occurs under the radar. According to a 2014 report by the Congressional Research Service, it is estimated that up to 10% of the food supply could be affected by food fraud Thus, the costs of fraud food are borne by industry, regulators and, ultimately, consumers.
Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREFood fraud is not a new phenomenon. During the time of the Roman Empire, Pliny the Elder wrote in Natural History about the adulteration of wine, bread and pepper, and tracked the fluctuation of their prices with the appearance of adulteration. In Medieval Germany, the adulteration of saffron was such a problem that the Safranschou Code was enacted, which described standards for saffron and allowed convicted adulterators to be executed.1 When there is an opportunity for economic gain, adulterators tend to come out of the woodwork.
As recently as the 1980s, food fraud was mostly an event confined to local markets. In 1981 the adulteration of olive oil with an industrial lubricant injured thousands and killed hundreds, but because the oil was not widely distributed, the primary effects were limited to Spain. Similarly, when apple juice adulteration occurred in the United States in the 1980s, the consequences were basically confined to the United States.
However, with the increasing globalization of the food supply chain and freer movement of foods and ingredients among countries, the opportunities for food fraud not only increased, but the consequences also now more easily have a global impact. By the late 1990s, the global consequences of food fraud became more evident with the contamination of fats intended for animal feed with industrial oils containing PCBs and dioxins. This scandal, which started with an oil recycler in Belgium, led to massive recalls of products throughout Europe and concerns about contaminated products reaching the United States. The impact of this episode arguably changed the food safety environment in Europe and led to the formation of the European Food Safety Authority. Likewise, the fallout from the adulteration of wheat gluten with melamine in 2008 likely contributed to the passage of new food safety legislation in the United States, including FSMA.
FDA has always acted against food fraud whenever there was an indication of public health hazards. With the passage of FSMA and the Preventive Controls for Human Food rule (published in September 2015), the agency has come full circle to its roots with Harvey W. Wiley, M.D. and his famous Poison Squad. Dr. Wiley formed his famous group to go after adulterators of foods. The Poison Squad was famously known for their willingness to consume suspect foods to test for adulteration. FDA’s history of Dr. Wiley states that “In the 1880s, when Wiley began his 50-year crusade for pure foods, America’s marketplace was flooded with poor, often harmful products. With almost no government controls, unscrupulous manufacturers tampered with products, substituting cheap ingredients for those represented on labels: Honey was diluted with glucose syrup; olive oil was made with cottonseed; and “soothing syrups” given to babies were laced with morphine. The country was ready for reform…” While the opportunities for fraud have not changed, luckily we no longer have to rely on human volunteers to detect adulterated food.
The new Preventive Controls rule published in September addresses EMA when there is a reasonable possibility that adulteration could result in a public health hazard. Companies are required to conduct a written hazard analysis, which should include hazards identification and evaluation. Companies are expected to identify “…known or reasonably foreseeable hazards that may be present in the food…The hazard may be intentionally introduced for the purposes of economic gain.”[i] While companies were previously expected to be knowledgeable about microbiological hazards in their products, it appears that they now also have the responsibility to be knowledgeable about known or reasonably foreseeable hazards from EMA.
How can organizations identify potential EMA threats as part of hazards analysis? One way is via the Food Fraud Database, which is designed to help answer this question by taking a look into the past. Launched in 2012, the database provides the information necessary to identify ingredients with a past pattern or history of adulteration and the adulterants used—a perfect fit for the EMA requirement in FSMA. The database has more than 140,000 users from 194 countries documented.
After identifying an ingredient with a pattern/history of EMA, companies need to determine whether the ingredient may introduce potential food safety hazards and how to develop a control plan in response. To address those issues, USP undertook a project in 2013 to take a more holistic approach to identifying EMA vulnerable ingredients by looking at factors beyond history. It assembled a group of leading food adulteration experts to develop a first-of-its-kind guidance document that offers a framework for the food industry to help develop and implement preventive management systems to deal specifically with EMA.
The Food Fraud Mitigation Guidance became official in the Food Chemicals Codex (FCC) in September 2015, just as FSMA’s Preventive Rule for Human Food was published. The aim of the guidance is to assist manufacturers and regulators with identifying the ingredients most vulnerable to fraud in their supply chains and how to choose effective mitigation tools to combat EMA. This is a significant leap forward in the battle against food fraud—and a way to get ahead of criminals engaging in EMA. The guidance provides not only a solution to deal with FSMA’s EMA provision, but goes beyond FSMA to help organizations fulfill GFSI requirements to conduct a food fraud vulnerability assessment and control plan.
Thenadier (The innkeeper), in Les Miserables said in the lyrics of Master of the House:
“…
watering the wine and making up the weight
…
Food beyond compare. Food beyond belief
Mix it in a mincer and pretend it’s beef
Kidney of a horse, liver of a cat
Filling up the sausages with this and that”
While deceiving the unwary can seem humorous in fiction, in real-life food fraud can have extremely serious consequences to consumers and everyone involved with the production of safe food. There are multiple large-scale efforts in many regions and countries to address food fraud. The attention that is now focused on food fraud and the development of new tools such as Food Fraud Database cast a bright light that will hopefully make it more difficult for food fraudsters to operate.
Reference
Willard, P. (2002), Secrets of Saffron: The Vagabond Life of the World’s Most Seductive Spice, Beacon Press, ISBN 978-0-8070-5009-5
As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.
Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities. Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.
In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records. Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility. This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon. LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.
In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs. The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.
Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?
Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference. LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?
Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.
The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”. FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.
When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.
To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.
Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.
So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment. And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.
No experience in our lives prepares us for working in a food manufacturing plant. It’s noisy, cold, hot, dry, wet, dark, or extra bright. It has a variety of aromas that are beyond description. And it has more rules about how to dress, personal hygiene and traffic patterns than can be committed to memory. Every day, frontline food workers make individual decisions that impact food safety, workplace safety, product quality, and operations. So inspiring employees to learn, apply and retain knowledge requires multiple touch points.
At this month’s Food Safety Consortium conference, Holly Mockus will moderate the session, “Gathering Data to Gather Data: Don’t Learn the Hard Way!” LEARN MOREAt most plants, employee onboarding is usually done through formal classroom training. Group training is a great way to learn in a focused setting and interact with an instructor and co-workers. But ensuring that the training is clear and easy to understand can be a challenge. A recent survey of frontline food workers by the Center for Research and Public Policy, Mind of the Food Worker, reveals that 39% of employees say that training is sometimes too complicated or difficult to understand. Learning must be contextually accurate to resonate with the learner, and alignment with the diversity of today’s frontline worker requires new approaches.
Ensuring employees learn, apply and retain knowledge requires multiple touch points because attention spans are getting shorter. According to the National Center for Biotechnology Information, the average attention span is now just 8.3 seconds. Training content has to be presented through different channels in order to stick in the employee’s mind and drive the required behavior.
Companies are increasingly using digital signage to show relevant and eye-catching visuals to reinforce the formal training. The content is more impactful when played at strategic times throughout the production day—continuous or too infrequent may cause the retention level to wane. The content also needs to be changed periodically. Truly effective digital content display will be managed effectively to get the biggest bang for the effort.
The Mind of the Food Worker survey found that just 43.2% of food workers rarely or never receive coaching from manager/supervisor. Figure courtesy of Alchemy Systems
Leveraging the supervisor and employee interaction through shift change meetings is another important delivery channel for training reinforcement. According to the Mind of the Food Worker survey, only 56.8% of workers said they receive coaching from supervisors. By providing supervisors with scripted huddle guides, they can effectively and consistently reinforce key messages. In addition, supervisors and managers who observe and provide reinforcement or correction individually to employees have found a winning combination that will strengthen and drive culture so that everyone will know the right thing to do every day.
Supervisors are the hub of the wheel that keeps manufacturing on the road and pushes the industry forward every day. Anything that can make life easier for the frontline supervisor will have a high potential for return on investment. Tablets are increasingly being used by supervisors to complete tasks in real time, as it eliminates the need to spend hours deciphering and following up on notes after a shift ends. This in turn gives the supervisor more time to spend on the floor coaching and reinforcing employees. The bond between supervisor and employee is the absolute core of the culture of each manufacturing plant.
The survey, Mind of the Food Worker, was sponsored by Alchemy Systems.
If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.
An estimated 1 in 6 Americans fall victim to a foodborne illness annually.
While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.
We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.
In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.
In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.
Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.
Does your leadership recognize the importance of your FSMS? An effective FSMS should be established before a product incident or recall occurs.
Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.
Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.
The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.
At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.
For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.
Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.
The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.
A thorough auditor won’t look the other way and will find the problems. Call it as you see it–don’t be too soft when getting an assessment.
Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.
At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.
A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.
With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.
If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.
We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.
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