Prevent the devastating effects that recalls can have on your business.
Recalls are an inevitable reality of working in the food industry. Indeed, hardly a day goes by without one food company or another announcing a recall. According to the USDA, 150 food products were recalled in 2015. From large national brands like Tyson Foods and McCormick to smaller local manufacturers, no food company is immune from recalls.
Recovering from the sometimes devastatingly expensive recall process can be difficult, so it’s obviously best to avoid problems whenever possible. Understanding the top three reasons for food recalls is the first step toward greatly reducing how frequently they affect your food company.
1. Cross Contamination
Many food manufacturers process multiple products in a single factory. This can lead to cross-contamination issues involving foods to which people are commonly allergic, namely milk, wheat, soy and peanuts. Because cross contamination is sometimes unavoidable, manufacturers are permitted to sell cross-contaminated food, provided the potential contaminants are declared as allergens on the label. According to the USDA’s report, undeclared allergens accounted for 58 of the 150 food recalls in 2015, and milk has been identified as the number one offender.
How to Prevent Cross Contamination. Food is often contaminated because machinery isn’t properly cleaned between uses. Therefore, the most effective way to prevent it is to thoroughly clean equipment after processing food that contains common allergens. Visually inspecting the equipment following cleaning is important, but unseen residue can linger.
To overcome this, in-plant allergen testing of equipment, post cleaning, is recommended. Some tests utilize quick, non-allergen-specific colorimetric tests to identify sugars, proteins and other indicators that an allergen is present. More expensive enzyme-linked immunosorbent assay (ELISA) kits are more sophisticated and may be a better choice if cross contamination plagues your food manufacturing plant.
Other tips to prevent a recall caused by allergen contamination include:
Establishing spill-cleanup protocols
Training personnel on allergen management
Designing equipment with sanitary principles in mind, including self-draining equipment, smooth edges and rounded corners
Carefully inspecting product labels for accuracy
2. Pathogens
Recalls from pathogen-contaminated products are highly damaging because they affect all consumers, not just those with specific allergies. Listeria, E. coli and Salmonella are the most common—resulting in a combined 17 food recalls in 2015, according to the USDA’s report. Several foods have been identified as being most at risk for carrying these pathogens:
Deli meats, soft cheeses and other foods that usually aren’t cooked
Poultry, eggs, undercooked beef, and unpasteurized milk or juice
Raw fruits and vegetables
Raw or undercooked shellfish
Home-canned foods with low-acid content — including asparagus, corn, green beans and beets
How to Prevent Pathogens. As with avoiding cross contamination, the best way to prevent a pathogen outbreak is to implement hygienic manufacturing practices. Four specific techniques apply here:
Separate raw products from cooked/ready-to-eat products. Your efforts should even go as far as separating employees who work in each area. They should use divided washing facilities, locker rooms and cafeterias.
Control the temperature and moisture level to reduce bacteria and mold growth. Anywhere condensation forms or moisture is left to pool, micro-organisms can potentially grow and create a contamination issue. Ventilation and air conditioning can help tremendously with this, as can air dryers used to sap moisture from steamy air.
Implement pest-control techniques. Rats, flies and cockroaches are significant carriers of Listeria, Salmonella, Vibrio cholera and other bacteria. Effective pest-control techniques include disposing of garbage properly, sealing pest entry points, and using air curtains and screens to keep flies out.
Choose durable, easily cleanable equipment for your manufacturing plant and wash all surfaces regularly. Mold and bacteria can start growing within a matter of hours, so keeping surfaces clean is essential. Proper hygiene among plant personnel is critical as well.
3. Physical Contamination
When non-food items are found in food products, a recall is inevitable. Metal, plastic, wood and even insect body parts are examples of physical contaminants. Food is also considered physically contaminated if it’s chemically or biologically tainted. According to a Food Standards Agency report, of the 107 physical contamination incidents in 2012, the most common malefactors were metal (37), pests (23) and plastic/glass (10 each).
How to Prevent Physical Contamination. Foreign objects often enter food products when malfunctioning equipment or human error breaks down the production process. Safeguards such as X-ray scanning, metal detection and filtration/sieving processes help catch foreign objects before they’re shipped, but these aren’t foolproof methods. You should also only work with trustworthy suppliers and take the time to examine raw materials before using them.
The general public expects food manufacturers to produce safe, untainted food. By following these tips, you help uphold your brand and avoid the expensive, reputation-damaging effects of food recalls.
Hampton Inn & Suites Napa, 945 Hartle Court, Napa, CA 94559
Registration
1-4 Attendees - $850.00 (USD)
Registration is for 1 attendee, addtional guests/attendess can be added during the registration process.
5+ Attendees - Save $60 per attendee – $790.00 (USD)
Early Bird discount for 5+ only available for attendees from same company.
The FSPCA training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations Part 117.155 for the Preventive Controls “Qualified Individual” who conducts Food Safety Plan activities such as developing and reviewing a food safety plan, validating preventive controls, verifying and validating process controls among others. Attending an FSPCA course will provide assurances that the course content and resulting knowledge is consistent with regulatory expectations. Each facility registered with the FDA is required to have a Preventive Control Qualified Individual PCQI.
A preventive controls qualified individual is a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum from FSPCA.
The FSPCA program is based on collaboration among federal and state regulatory officials (FDA), academic food safety researchers and educators, and U.S. food industry representatives. This program is delivered by a FSPCA Lead Instructor.
This course meets the Preventive Controls Qualified Individual Training requirements. The participants will receive FSPCA Preventive Controls Qualified Individual certificate issued by AFDO.
Includes: Morning and afternoon snack breaks, Lunch, Course Materials and Certificate of Attendance.
Parking – Free parking
Hotel Booking - Hampton Inn & Suites 707-690-3075
REGISTRATION CLOSES ON December 6, no refunds will be given after October 30. Registrations may be transferred to another person from the same organization for the scheduled class.
Enjoy free horse drawn carriage rides through downtown Napa. It's one of the best ways to enjoy the Holiday lights on all the buildings and check out the Christmas windows, while snuggling with family. Carriages depart every fifteen minutes from the Napa River Inn at the Hatt Building on Main Street. Spend the time between rides shopping and dining in beautiful downtown Napa. Thanks to the 20/30 Club for their support with the rides.
Lots of holiday events are being celebrated! See all of them here!
It doesn’t take a great deal of reading or research to see that there has been a marked rise in Department of Justice (DOJ) activity in the food industry over the last few years. In fact, the DOJ’s Principal Deputy Assistant Attorney General Benjamin Mizer spoke at a food policy conference in April on that very topic, discussing DOJ’s role in ensuring the safety of the food supply, and the enforcement tools it has to fulfill that role.
As Mizer stated, “One of the government’s highest obligations is to protect citizens when they cannot protect themselves.” Because consumers have to rely on the companies who manufacture and distribute food to ensure that the food they buy is safe, the government sees food safety as an area in which consumers cannot always protect themselves, so it has an obligation to assist in providing that protection.
Such protection is also the very foundation of the Food Safety Modernization Act (FSMA) and its risk-based preventive controls, and DOJ, FDA, and USDA have been acting on that obligation not only in increasing frequency, but in increasingly severe ways, i.e., the 20+-year prison sentences of the PCA executives. And, as I wrote in a recent newsletter (How Serious is the Department of Justice?) which I will recap a bit in this article, my view is that this is very serious business, and it is a trend that I don’t expect to slow down any time soon.
“Back up a minute,” you may be thinking. “What about all the work we’ve done for FSMA compliance? Won’t that get us off the DOJ hook?”
WILL FSMA PROTECT YOU? Yes. And no. If you are truly and completely following FSMA, including its inference to build a food safety culture into your organization which is followed from the top down, you will have gone a long way in the prevention of the contamination or adulteration of your product which will, as a result, go a long way in the prevention of an investigation by FDA or DOJ. (Former FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor specifically discussed the relationship between FSMA and a food safety culture in FDA: Culture Is a Preventive Control, QA May/June 2015.)
But we all know that no one and nothing is perfect; no one expects that FSMA will eliminate all contamination and foodborne illness. But what you may not know or fully appreciate is that Congress made it a prohibited act to introduce adulterated food into interstate commerce; and it is a strict liability offense, meaning that a company or individual who violates the law can face misdemeanor charges – whether or not it intended to distribute adulterated food.
Additionally, in FDA’s Regulatory Inspection Manual under section 6.5 “Prosecutions,” FDA made it very clear that it sees prosecutions as beneficial to food safety as having a deterrent effect. Specifically, the document states: “Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities.” It’s essentially the same tactic that is taken by parents around the world. Threats are only as good as their corresponding action: if a rule is broken and the guilty child faces no repercussions, every other sibling will see the rule as nonbinding. But if punishment is meted out to a degree that befits each violation, it not only impacts the reprimanded child, but also each sibling who sees that the parent is serious.
Though the prosecution meted out by FDA is, of course, much more serious, it follows the same philosophy: Let the corporate executives see that we are serious; let them see that we will prosecute; and it will put the fear into them. As I heard one father say many times, “My children will either respect me or fear me.” If the only way a child/some food corporations will follow the rules is the fear of punishment/prosecution, then so be it.
The analogy can be taken even a step further: Recall a time that you were with a younger child (whether it was a sibling; a niece, nephew, a child you were babysitting, etc.) whose actions caused harm – broke an item, hurt another child, etc. Wasn’t the first question, “Why weren’t you watching him/her better?” or “You should have known, you were in charge!” or simply “Who’s older?” (i.e., “Who’s the boss?”) In the same way, any process that takes place in the food facility; any harm that is caused by a person or action; any contamination that began anywhere along the food chain will be considered to be the responsibility of the corporate executives, because as executives, it is their job to know, to ensure practices are in place and are being followed. They are “in charge.”
AN INCREASED FOCUS. And FDA is checking. With the advanced detection of whole genome sequencing; its “long memory” (ability to match a bacteria found in a facility today with one found four years ago – or longer); its linkage in CDC’s national database; and the FDA inspectors’ current propensity to undertake a “swabathon” in food manufacturing facilities – we are beginning to see more and more situations where a case or two of listeriosis is being linked back to a food production facility. What all this means is that it is much easier today to link a sick human with a suspect food and food plant. Thus, the odds that you will be found to have put adulterated food into commerce – even if totally without intent – continue to rise.
Further, if FDA then finds that you have had positive hits with Listeria but not taken appropriate corrective actions and root cause analysis, you can end up with the DOJ coming to visit. So, not only is FDA conducting microbiological profiling during facility inspections and testing food at retail, it is acting on its right to initiate criminal investigations against food companies and their executives who distribute food products that have the potential to cause human illness – even when the executives had no direct knowledge of the potential.
Although there is certainly an increase in criminal investigations and DOJ prosecutions, it is not a new tool for the agency. Rather, it dates back to a 1975 Supreme Court decision from which the Park Doctrine established that a responsible corporate official can be held liable for a first-time misdemeanor (and possible subsequent felony) under the FD&C Act without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.
You, obviously, will have noticed by now that I have repeatedly stated that one can be prosecuted and held liable even without knowledge or intent. In fact, it has been stated so often, you may be wondering if I actually reread my own columns before submitting them. But understand that my repetition is quite purposeful. There is an ancient legal principle that states, “Ignorance of the law is no excuse.” That is, even if you do not know that something is against the law, you can still be punished for doing it. The same holds true here – even if you don’t know that something occurred, or could occur, you can still be punished for it.
To see that this is true, simply consider Jensen Farms – which contended that it had relied on a Superior audit rating and didn’t know their operation was flawed, yet they were sentenced to probation, home detention, and a fine. You may also want to keep an eye on the current criminal investigations of Bluebell, Dole, and others for 2015 outbreaks.
DOJ “TOOLS.” Back in the first paragraph of this article I noted that Mizer’s statement included the fact that DOJ is not only focused on ensuring the safety of the food supply, it also has the enforcement tools to do so. What exactly are these “tools”? What sorts of punishment might a corporate executive (or others) face?
First, it is important to understand that DOJ relies on FDA, USDA, and CDC for “their technical expertise, their investigative support and their deep knowledge of the industries they regulate as keys to building cases,” and that the FD&C provides DOJ with both criminal and civil authorities, with that decision based on the evidence and applicability. Following is some of the detail Mizer provided about these tools:
Civil Authority. The civil authority is primarily designed to prevent the distribution of adulterated food, such as asking a court to order the seizure of potentially unsafe products or to temporarily prevent a facility from operating until sanitary conditions are established. In these cases, which are often resolved through negotiated agreement, the goal is to require that the company institute new health and safety procedures and that it not be able to distribute food until the government can verify that it has taken all steps necessary to prevent a recurrence. Civil enforcement is often used in cases of unsanitary conditions and has also been used for those involving the administration of drugs/antibiotics to animals intended for human consumption.
Civil cases make up the majority of the food safety actions brought by DOJ. “But,” Mizer said, “sometimes it’s important that we hold criminally accountable those individuals and entities that place consumers at risk by putting unsafe food on our table and in our lunchboxes. That way we make clear to people in the industry that they have a responsibility to protect the safety of the public.”
Criminal Prosecution. When DOJ decides that criminal prosecution is warranted, based on such things as the nature and seriousness of the offense, the deterrent effect of the prosecution, and the culpability of the individuals or entities involved, it must then decide whether to bring misdemeanor or felony charges. Even if DOJ elects to charge a violation as a misdemeanor, it can still bring serious penalties, such as the misdemeanor sentences of the Iowa egg farm owner and CEO of three months in prison, one year of supervised release, and a $100,000 fine. Felony charges will be brought when the facts become egregious enough to warrant that, such as when DOJ can show an intent to defraud or to mislead consumers or the FDA.
What makes these prosecutions of further consequence is that, under the Park Doctrine, once a person has been convicted of a misdemeanor under FD&C, any subsequent violation is an automatic felony, even, again, without proof that the defendant acted with the intent to defraud or mislead.
So, to jump back to the question: Will FSMA get you off the DOJ’s hook? Yes and no. But full implementation of FSMA and the involvement of everyone in the organization will certainly help in prevention, and in providing at least some defense if a contamination does occur. FSMA is serious stuff for sure, but this new trend from DOJ and FDA should be taken very seriously, and every executive in a company involved with food should be aware of the trend and act accordingly.
David Acheson is Founder and CEO, The Acheson Group.
Superior Food Safety training is offered at top facilities in beautiful downtown Napa in the heart of California wine country. While receiving the best in food safety training, our clients also enjoy exceptional weather, stunning nearby countryside vistas and access to some of the world’s best restaurants and wineries. We also provide customized, on-site training for our clients worldwide. All classes are offered in English and in Spanish.
Our highly praised training services cover all prerequisite programs for Food Safety Management Systems, HACCP and FSMA. We are developing more detailed training in areas such as Food Defense, Preventative Controls and HARPC, Integrated Pest Management Systems, Environmental Monitoring, Crisis Management, Food Safety and Quality Continuous Improvement, among other offerings.
At these more detailed training sessions, Superior Food Safety welcomes experts who enrich our course offerings with their deep experiences in various food safety fields. If your concern is food defense, for example, we would offer an expert who teaches the steps needed to guard against bioterrorism and outside threats to your company’s food safety.
Whatever your needs, Superior Food Safety can gather the necessary resources to present you with the training and expertise that will set you on the path for success.
It seems there isn’t a day that goes by without a food recall being announced. National brands like General Mills, Kellogg’s and Kraft alone have all experienced major recalls over products contaminated with such hazards as E. coli or undeclared allergens in the last few months. Food recalls are incredibly costly to a company, but can be handled effectively and efficiently with good planning, proper execution and the right technology to back it up.
Fortunately, the food industry is moving in the right direction to encourage better recall management by way of regulations under FSMA. Underscored by these federal mandates, the industry as a whole is moving away from a reactive approach to quality and safety issues within the supply chain, instead adopting a preventative plan of action.
Recalls are inevitable in the food industry, and in reality every company has, or will, experience one at some point. What sets a company apart essentially boils down to how they prepare for and react to a recall situation. If a company has done its due diligence to prepare for the inevitable (i.e. putting a recall team in place and implementing the right traceability technology), dealing with a quality or contamination issue can be less painful. Additionally, taking the right preventative steps can ensure a recall situation is proactively handled, rather than leading to a brand’s nightmarish public meltdown.
Getting Beyond “One-up and One-Back”
The industry has relied on a more linear approach to supply chain transparency—the “one-up and one-back” method (OUOB). Knowing where a product has come from one step back in the chain and where it is being sent or sold one step forward is no longer enough. To properly prepare for a recall, and manage product quality, it is imperative that a company employ whole chain traceability software, rather than relying solely on the movement of product within its own four walls.
The OUOB traceability approach is especially dangerous when handling high-risk, perishable foods, like produce or meat—which are often the culprit for recalls. According to a recent study in the Journal of Business Logistics titled, “Tracing Bad Products in Supply Chains” by Kaitlin Wowak, assistant professor of management at Notre Dame, “perishable products, like fresh produce and meats, flow through the supply chain very quickly. And while federal regulations mandate that firms have traceability one step up and down the chain, this may not be sufficient for these perishable products. In those situations, there is often a gap in the information received about the product, say a positive Listeria test, and where that product went in the supply chain.”
Root Cause Analysis is Key
When faced with a recall situation, time is of the essence. The time it takes for the recall team to identify the root cause of an issue and remove it from the supply chain could be the difference between sick consumers and serious brand implications. Being fully cognizant of the entire supply chain via a whole-chain traceability solution allows you to visualize a contaminant’s exact location; this information ultimately helps a brand streamline and manage the issue quickly and effectively.
Wowak’s research profiles a series of recall scenarios. One that was studied found that 50% of the food removed from the supply chain during that recall was actually affected—the other half was perfectly fine. Take the example of a batch of tainted tomatoes in your supply chain. Without being able to identify the root cause at the lot level, a company might be forced to remove all of the tomatoes from its supply chain.
Rather, by utilizing end-to-end traceability software, they can identify the specific farm, pack date and lot from which the produce originated. Tracing that information through each step in the supply chain—hether the tomatoes ended up on a pizza, in a can of salsa, or in a farmer’s market—allows the brand to manage the bad products without disrupting their entire chain or wasting perfectly good produce.
Unfortunately, without the visibility of whole-chain traceability, companies do not have the option to cherry pick tainted vs. untainted food from their chain. This is especially relevant as up to 40% of food in the United States goes to waste, according to the NRDC.1
Centralized Recordkeeping
When faced with a safety or quality issue, communicating information to relevant parties is necessary throughout the process. Especially with FSMA coming into play, if a company experiences a quality issue, they must promptly notify regulatory establishments and be sure to submit documentation and data in an immediate manner for investigative purposes. This can be hindered if a brand does not have a good handle on their supply chain data and must spend hours sorting through file cabinets, emails, or Excel sheets for proper documentation, or coordinating with suppliers for records. The longer it takes to comply with federal regulations and submit data around a recall, the more likely consumers, and the brand, are at risk.
The industry’s shift towards a preventative approach to safety is hitting a milestone as FSMA compliance periods have already taken effect. With this change, the FDA will no longer tolerate poor handling of contamination or quality issues. A company cannot get away with blaming a partner’s lack of transparency, or a supplier’s inconsistent records— the brand is now always accountable. In the coming months, we can anticipate added scrutiny from auditors, more mandatory recalls, even the shutting down of facilities due to noncompliance or negligence around safety concerns.
Having a robust supplier management system in place enables a company to be prepared for a recall situation. With all of your product and supplier data in one place, companies can quickly gather and allocate necessary data like audits and assessments to the appropriate officials, complying with the new required recordkeeping rules. By streamlining the availability of key information, and supporting seamless communication, a brand can be empowered to navigate a quality or safety issue.
As testing across the supply chain increases and the demand for fresh food rises, recalls are not going away. Fortunately, the move to a preventative approach to safety comes at a time where traceability technology is more comprehensive than ever. Food companies have the opportunity to invest in themselves with end-to-end traceability, arming the brand for the inevitable occurrence of a safety or quality issue. By enhancing visibility of the supply chain via an all-encompassing whole-chain platform, it is possible to track a product through each stopover to the consumer, from farm to fork. At the same time, housing all data in one efficient platform can ease the pressure of liaising with supply chain partners and regulatory bodies and streamline communications when faced with a safety situation.
While recalls are an inescapable part of the food industry, what sets a brand apart is how well they prepare and arm themselves with the technology to stay ahead. Implementing supplier management and whole-chain traceability software can help a company stay one step ahead of a recall, which makes all the difference when consumer wellness and brand reputation are on the line.
Hampton Inn & Suites Napa, 945 Hartle Court, Napa, CA 94559
Registration
1-4 Attendees - $850.00 (USD)
Registration is for 1 attendee, addtional guests/attendess can be added during the registration process.
5+ Attendees - Save $60 per attendee – $790.00 (USD)
Early Bird discount for 5+ only available for attendees from same company.
The FSPCA training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations Part 117.155 for the Preventive Controls “Qualified Individual” who conducts Food Safety Plan activities such as developing and reviewing a food safety plan, validating preventive controls, verifying and validating process controls among others. Attending an FSPCA course will provide assurances that the course content and resulting knowledge is consistent with regulatory expectations. Each facility registered with the FDA is required to have a Preventive Control Qualified Individual PCQI.
A preventive controls qualified individual is a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum from FSPCA.
The FSPCA program is based on collaboration among federal and state regulatory officials (FDA), academic food safety researchers and educators, and U.S. food industry representatives. This program is delivered by a FSPCA Lead Instructor.
This course meets the Preventive Controls Qualified Individual Training requirements. The participants will receive FSPCA Preventive Controls Qualified Individual certificate issued by AFDO.
Includes: Morning and afternoon snack breaks, Lunch, Course Materials and Certificate of Attendance.
Parking – Free parking
Hotel Booking - Hampton Inn & Suites 707-690-3075
REGISTRATION CLOSES ON December 6, no refunds will be given after October 30. Registrations may be transferred to another person from the same organization for the scheduled class.
The first major compliance dates have arrived for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). Some members of the food industry have expressed concern and uncertainty about enforcement measures that may accompany September 19, 2016. That’s the date when larger businesses must comply with certain new standards. Human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs); animal food facilities must meet CGMPs. (The larger animal food businesses have an additional year to meet the preventive controls standards.)
Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addresses questions that have been raised about what the next few months will look like for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.
What happens next in terms of FDA enforcement of these new standards? We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.
A top priority for FDA is providing the framework for industry’s implementation of preventive controls and CGMP requirements. We recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidances to come, about two dozen planned over the next few years. We intend to continue this dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.
This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)
Does the focus on education mean that companies won’t really be held to these standards yet? No. The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.
What is the best thing covered food facilities can be doing now? The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.
In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place.
If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?
Where can companies go wrong? A company’s approach should not be: “The government was here and did our inspection. We’re safe for X amount of time.” Rather we want facilities to be confident that if FDA or the state walks in tomorrow, they’ll be able to demonstrate what they’re doing to meet the new food safety requirements.
And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.
What is the ultimate goal? The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law.
The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with CGMPs, will help protect consumers into the future.
We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.
This article has been republished with permission from FDA. The original version can be viewed on FDA’s website.
