Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:
Food Defense Monitoring Procedures
Food Defense Corrective Action Procedures
Food Defense Verification Procedures
The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.
The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.
FDA, as part of FSMA, released its rule titled “Protecting Food Against Intentional Adulteration” on May 27, 2016. This rule was proposed in 2013. FDA received and responded to 200+ comments prior to its final release.
FDA states that this rule “is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, [and] economic disruption of the food supply absent mitigation strategies.”1
The rule requires a documented “Food Defense Plan” that at a minimum includes the following:
Procedures for food defense monitoring
Food defense corrective action procedures
Food defense verification procedures
Records confirming implementation, maintenance and conformance to the defined requirements
Evidence of effective training
As a food safety professional with more than 30 years in the industry, reviewing this rule brought back many memories. These memories combined with information gained from a recently completed Food Defense/ Crisis Management workshop presented by Rod Wheeler really set my brain into motion.2
Years ago, industry focused on crisis management and product recall. Requirements included having a crisis management team that was led by associates representing both upper and middle management. In addition, most programs included the following:
Posted identification of the crisis management team (i.e., pictures, phone numbers, etc.)
Specific training for receptionist and guards
Mock crisis exercises (i.e., fire drills)
Planned crisis calls to the operation’s direct incoming phone numbers (i.e., receptionist and guards)
Mock recalls (from supplier through finished product and distribution)
Security inspections which may now be considered the pre-cursor to today’s “Vulnerability Assessment”
With the introduction of the GFSI approved schemes (FSSC 22000, BRC, SQF, GlobalG.A.P., Primus, etc.), requirements for crisis management, emergency preparedness, security programs, food defense training and continuity planning gained an increase focus. Do any or all of these programs meet the requirement for a “vulnerability assessment”?
In the 2013 publication, Food Safety Management Programs, this subject-matter chapter was titled “Security, Food Defense, Biovigilance, and Bioterrorism (chapter 14)”.3 An organization must identify the focus/requirements that are necessary for its operation. This decision may relate to many different parameters, including the organization’s size, design, location, food sectors represented, basic GMPs, contractor and visitor communication/access, traceability, receiving, and any other PRP programs related to ensuring the safety of your product and your facility. Requirements must be defined and associates educated to ensure that everyone has a strong and effective understanding of the requirements and what to do if a situation or event happens.
Confirming the security of a facility has always been a critical operational requirement. Many audits have been performed that included the following management statement: “Yes, of course, all the doors are locked. Security is achieved through key cards or limited distribution of door keys, thus no unwanted intruder can access our building.” This statement reminds me of a preliminary assessment that I did not too long after the shootings at a Pennsylvania manufacturer in September of 2010. The organization’s representor and myself were walking the external parameter of a food manufacturer at approximately 7:30 PM (still daylight). We found two doors (one in shipping and one accessing the main office), with the inside door latch taped so that the doors were not secure. The tape was not readily evident. The doorknob itself was locked, but a simple pull on knob opened the door. Our investigation found that a shipping office associate was waiting for his significant other to bring his dinner and was afraid that he would not be at his desk when she arrived. An office associate admitted that that door had been fixed to pull open without requiring a key several months earlier because associates frequently forgot their keys and could not gain access to start work.
Debby Newslow will present ” Sanitary Transportation for Human & Animal Food – Meeting the new FDA Requirements” at the Food Safety Supply Chain Conference | June 5–6, 2017 | Attend in Rockville, MD or via webcast | LEARN MORE
We also observed a large overhead door adjacent to the boiler room along the street side of the facility open, allowing direct access to the processing area by passing through the boiler room and then the maintenance shop. It was stated that the door had been opened earlier in the day waiting for the delivery of new equipment. No one at the time knew the status of the shipment or why the door was still open.
Finding open access to facilities is becoming more and more common. A formal vulnerability assessment is not necessary to identify unsecured doors (24/7) in our facilities. Education and due diligence are excellent tools for this purpose.
Another frequently identified weakness is with organization’s visitor and contractor sign-in prerequisite programs. What type of “vulnerability” are we creating for ourselves (false confidence) with these programs? Frequently these programs provide more questions than answers:
Does everyone really sign in?
What does signing the visitor log mean?
Are visitors required to show identification?
Are the IDs actually reviewed and if so, what does this review include?
Who is monitoring visitors and contractors and are they trained?
Do all contractors have to sign the log or are they allowed to access the building at different locations?
Do those contractors who make frequent or regular trips have their own badges and/or keys (keycards) so they don’t have to take the time to sign-in (i.e., pest control, uniform supplier vending services)?
How are contractor badges controlled?
Are visitors required to be accompanied during the visit or does it depend on the visitor and whom they are visiting?
Are visitors and contractors trained in company requirements?
Do visitors and contractors have an identifying item to alert your associates of their status (i.e., visitor badge, visitor name badge, specifically colored bump cap, colored smock, etc.)?
How are truck drivers monitored? Do they have a secured room for them or do they have complete access to the facility to access the restrooms and breakroom?
How are terminated associates or associates that have voluntarily left the company controlled?
Can these associates continue to access the facility with keys, access cards, or just through other associates (i.e., friends or associates that did not know that they were no longer an employee)?
Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.
Complying with the Preventive Controls Rule
The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.
Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.
The following areas are all included under the FSMA Preventive Controls Rule:
Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
Monitoring. Preventive controls must be monitored for effectiveness.
Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
Recordkeeping. Records must be kept for two years.
Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.
Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.
Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.
Companies must have their training, planning and development underway to comply, or face possible violations, fines, and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.
Being audit-ready at any moment can be a daunting task, but pest management is one aspect of your audit that you can ace if you’re doing the right things. Pest control can account for up to 20% of your score, so taking it seriously can give you a huge boost the next time an auditor comes to your facility.
There are two components needed to help ease the stress of a third-party audit: An Integrated Pest Management (IPM) program and proper documentation.
IPM programs focus on incorporating green prevention and exclusion tactics into your facility’s ongoing sanitation and facility maintenance strategies, only using chemical solutions as a last resort. FSMA established that these tactics should be used when dealing with food safety issues and that thorough records should be kept to document the risk-based prevention efforts. This gives food manufacturing facilities even more of a reason to employ an IPM program.
A strong IPM program already has documentation built into it, as tracking pest activity and monitoring results over time are crucial steps to implementing the most effective pest prevention techniques for your business. Every IPM plan is tailored to your facility’s needs, so it needs to be dynamic and adaptable over time as new technologies emerge and your business needs change. Having the ability to show documentation of these changes and their positive effects will get you off to a great start on your next audit in showing your risk-based prevention food safety plan. If you do not already have an IPM program in place, speak with your pest management provider about establishing one.
Auditors like to see IPM programs in place because it means your business is taking a proactive approach and keeping detailed records.
Think about it like this: If the auditor is the judge and there’s no jury, would you ever walk into a court case without any evidence to prove your innocence? Of course not! So you wouldn’t want to walk into an audit without any documentation either.
In other words, document everything. Facilities must prepare and implement written food safety plans that identify potential risks to food safety, enumerate the steps and processes that will be executed to minimize or prevent those dangers, identify and implement monitoring procedures, keep detailed records of the food safety program, and list actions that will be taken to correct problems that do arise. If you’re doing all of this, you’ll make an auditor’s life that much simpler and improve the chances of receiving a high score.
When working to get audit-ready, you’ll want to have the following forms of documentation ready to go:
Proof of Training and Certification
Even though you know that your pest management professional is properly trained and certified, your auditor does not. Keep documentation on hand at your facility, as auditors may want to see one or more of the following documents:
A copy of the valid registration or certification document
hysical, written evidence that your pest management provider has been properly trained to use the materials necessary for your IPM program
Evidence of training on IPM and Good Manufacturing Practices (GMPs)
Proof of Service and Material Changes
A strong IPM program changes as new technologies emerge and your business’s needs shift over time, so be sure to have detailed documentation of these changes as they occur. It’s also important to note the reasons for making changes. Auditors will be looking for written documentation for even the smallest of changes to your IPM program, so take careful notes as your program adapts along with your business.
It can also help to assign specific roles to your employees. This not only will give employees clear direction on how they can contribute to your IPM program, but it can also help your case with an auditor by showing that your facility is maintained by an entire team rather than just a few people. Teamwork is a key part of any IPM program, so be prepared to show how your team runs effectively.
Pest Sighting Reports That Correspond with Corrective and Preventive Actions
When there is a pest sighting in your facility, record it immediately. Keeping records of sightings will help ensure that steps are taken to improve and show accountability to an auditor. Once action is taken, record exactly what was done and the results of the counteractive efforts. That way, you’ll have a paper trail that shows an auditor that for every pest problem, your pest management provider came up with a proactive pest solution that resolved—or is working to resolve—the issue.
After taking corrective action, continue monitoring the issue over time and note any developments in order to help prevent the issue from reoccurring. Creating a trend report that keeps track of which pests your facility is dealing with over time can help, too, as it will help you determine which pests are the most problematic. Your provider can help build such a report.
Records of Pest Monitoring Devices and Traps with Corrective Actions
Pest monitoring devices and traps are great for giving insight into areas around your facilities that are most susceptible to pests. Along with these devices, however, you’ll need to show the following information to an auditor:
When and how often the monitoring devices and traps were checked
The type and quantity of each pest found
Corrective actions taken to reduce pest activity and prevent further issues
Work with your pest management provider to gather all of this information, as it is usually the technician who works on these devices regularly. Being able to give an auditor the full picture can certainly help you on your inspection as it demonstrates attention to detail throughout your entire facility.
Annual Pest Management Assessments and Resulting Actions Taken
With most IPM programs, your pest management provider will thoroughly inspect your facility annually to identify areas that can be improved. Many auditors require these annual check-ups, and they will be looking for proof that these facility assessments occurred and that action was taken as a result that led to positive changes. Year-over-year improvement is important, so measure your success against the areas of improvement specified in these annual inspection reports. That way, you can meet the objectives prior to an audit.
These annual inspections give you a chance to look back and see the progression over the years. If there are any pest issues that pop up year after year, make them a priority in order to show that your program is trending in the right direction.
This proactive approach to pest management will help protect your business from pests and the inherent risks, as well as help give you a better chance of receiving an excellent score on your next audit.
So don’t be afraid of an audit the next time one comes around. With a strong IPM program in place and detailed documentation over the course of the year, there won’t be an exorbitant amount of preparation needed. Stay organized and keep all of the above-mentioned documents together and on-site to keep things simple for both you and your auditor. All of these elements will help your facility receive a strong score and be audit-ready at a moment’s notice.
In recent years, several food products typically considered safe by consumers have fallen victim to recalls as a result of Listeria monocytogenes (Lm). Caramel apples, ice cream, packaged salads and frozen vegetables were responsible for sickening dozens of people and killing more than 10. These products are part of an alarming group of common foods that have caused outbreaks, including milk, spinach, sprouts, peanut butter, cheese, cantaloupes and raw cookie dough. And the broad range of pathogens causing these outbreaks is just as diverse, and they continue to find creep into food processing facilities, finished food products and consumer homes.
At the 2016 Food Safety Consortium, Shawn Stevens will moderate the workshop session, Bringing the final FMSA pieces together: You have a basic preventative control program, what’s left? | Friday, December 9 | LEARN MORERegardless of sophistication or expertise in pathogen control, there isn’t a single company out there that is immune to the risk of contamination. Why? Well much of the foods (or ingredients) that we consume are grown and harvested in environments that are susceptible to contamination. Fruits, vegetables and other products, such as spices, can easily become contaminated with Lm, Salmonella or E. coli in the fields where they are grown, in transit or in the processing facilities.
Once pathogens are introduced into the processing environment, they can quickly spread and contaminate food products. Recent studies reveal that Listeria is a significant concern in these environments. For example, out of 5,000 samples from the food preparation areas of 30 retail grocery establishments, approximately 10% tested positive for Lm. These are scary numbers considering almost 16% of those who become infected with Lm will die.
In today’s new environment, FDA will be seeking justification to bring criminal charges whenever a contaminated product causes human illness. You should be nervous about this: If your company sells finished goods into commerce, those products may be selected for sampling and testing, and your company runs the risk that the results will come back positive for a pathogen of concern. And what’s more troubling is the fact that many companies do not conduct environmental testing in their food processing facilities, and so they have no idea whether pathogens (whether transient or resident) are lurking within their facilities. Thus, a microbiological profiling study conducted under the veil of the attorney-client privilege should be conducted to determine the presence of any microbiological persistence issues within a facility. Upon completion of the study, a company should invest in pathogen-reduction technologies to decrease the chances that FDA will uncover pathogens in the environment during an inspection. Finally perform a criminal protection audit to help strengthen company programs and develop protocols that will further protect against criminal exposure.
The bottom line is that if food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products.
Microbiological Profiling Studies
Lesson number one from the Blue Bell Lm outbreak is that pathogens can be extremely elusive and, as a result, a simple environmental monitoring program will never save your company from being involved in an outbreak or being the focus of criminal sanctions. All food companies should be aggressively testing for Lm (or other pathogens, depending upon the product risk profile) in their facilities and must take strong action against sporadic or intermittent positive findings. Although many food companies view a single operational failure as the culprit of an outbreak, the reality is that in most cases, the cause is something far more subtle, far more persistent, and far more dangerous. In recent years, a large number of outbreaks have involved Lm and antibiotic-resistant Salmonella that was linked to products that had been processed over multiple months.
Food companies should conduct a comprehensive one-time microbiological profile for pathogens in their processing facilities. Be sure to coordinate your profiling study with a lawyer experienced in food safety to make sure that the study is designed correctly and that the results will be protected under the attorney-client privilege. Once the results are reported, the company can take care of any positive findings, identify the contamination source, implement technologies to reduce and control the contamination, and develop a microbiological control and monitoring program to ensure that the pathogen remains controlled moving forward.
Pathogen Reduction Technologies
The second lesson learned from the Blue Bell case is that, when Lm or any resistant pathogen is found sporadically in the environment, what was once regarded as effective corrective actions (i.e., re-cleaning, re-sanitizing and re-testing) are no longer enough. In addition to existing cleaning and sanitizing procedures, companies should use new pathogen reduction technologies to help control the environment.
Inexpensive air and surface treatment technology that sanitizes the food processing environment is now available. The treatment is approved for use in occupied spaces and provides 24-hour treatment of the environment. By using active air and surface treatment, food processing companies can gain a level of control and decrease the possibility that any pathogen, if introduced, will persist or establish a niche.
Puradigm, LLC, for instance, utilizes a multi- patented, NASA-based active air and surface sterilization approach to control pathogens in the food processing environment. In studies performed by Kansas State University, the company obtained a 2.9 Log reduction on environmental food contact surfaces in the food processing environment. Similar reductions for other pathogens are displayed in Table I.1
I make this observation because, given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in their food processing environments. Once these preventative technologies are put into place, companies can perform periodic microbiological monitoring to validate that the controls are effective and working as designed. If such solutions are employed, there is a greater likelihood that when FDA arrives to perform microbiological profiling, the agency will be less likely to find positive test results from the food processing environment, better protecting food companies from additional regulatory or criminal exposure.
Criminal Protection Audits
In addition to commissioning microbiological profiling studies in facilities and employing active air and surface sterilization technologies, food companies should also perform internal criminal protection audits. These audits should be designed to identify gaps in existing company protocols and develop written programs designed to help navigate the challenges posed by any food safety issues uncovered.
If developed correctly, the written program should provide the company with a decision-tree to follow in the event of a positive environmental finding, a series of customer complaints relating to the safety of a product, or a notification from a governmental entity of a potential food safety problem. These protocols and programs, if followed in the event of a food safety issue, can help ensure that the conduct of the company in response to any such issues will in all cases be appropriate, and that there will not be any basis upon which FDA or DOJ could support criminal charges.
The FDA (in cooperation with DOJ) has launched a war on pathogens. The agency is targeting food products at retail and engaging in microbiological profiling of all food companies. Unless companies act now to better quantify and control pathogens in the food processing environment, they are exposing themselves to incredible food safety risk, including significant brand damage (in the event of a recall) and criminal sanctions (if their product is linked to human illness). Companies must carefully consider the emerging risks facing them and take measures to decrease and eliminate their exposure.
GC/MS Evaluation of Compounds in Air Samples in a Controlled Environmental Chamber Equipped with a Puradigm Advanced Technology Cell, November 5, 2013, Dr. James Marsden, Kansas State University Food Science Institute.
When you choose a new vendor to partner with you, the decision is always important. Every vendor plays a role in your business and bottom line.
Some vendors, like pest control providers, can protect your brand and even help boost your reputation in the industry. When you factor in everything your pest control program can affect, it’s clear that picking the right pest management provider is one of the most important vendor decisions you’ll have to make.
Consider how pest management can impact your audit scores, especially when you’re expected to be audit-ready at any time. The success of your third-party audit hinges on documentation, and the pest management portion can make all the difference in your score, accounting for up to 20%. FSMA requires food processing facilities to execute proactive pest control programs and documentation efforts that not only follow and but also implement a risk-based prevention program to protect their product and consumer base. Just one low score can cause your customers to lose trust in your business—and if they pull their support, you could see a major impact on your balance sheet.
The safety of your products and even the health of your employees are also at stake. Cockroaches and ants can pick up and transfer harmful bacteria. Flies can spread disease-causing organisms when they land—and they land frequently, it can lead to them leaving their traces in an abundance of places.
Then there are rodents, which can also cause serious health problems. According to the Centers for Disease Control and Prevention, rats and mice are known to spread bacteria like Salmonella and E. coli, as well as more than 35 diseases worldwide, such as Hantavirus.
A Blueprint for Success
From its impact on audit scores to its role in abating health concerns to brand protection, pest control should be a priority for any food processing facility. There are several best practices to follow, most of them falling under the umbrella of Integrated Pest Management (IPM). IPM is the preferred proactive pest management practice in the food processing business, and it can help meet and exceed the requirements of industry auditors.
IPM programs are ongoing, comprehensive and well-documented, focusing on risk-based preventive strategies like sanitation and facility maintenance to help prevent pest activity. They’re also customizable based on your property and the pests you face.
It’s essential to find the right, licensed and experienced pest management professional who will partner with you and your staff to implement a customized IPM program for your facility and help keep pest problems away. When starting your search for a pest management partner, be sure to ask about IPM. One-size-fits-all pest management solutions are simply not effective, so look for a provider who can tailor an IPM program specifically to your needs.
When searching for a pest management partner, look for one that stands out with the following guidelines.
Talk to your peers. If you’re looking for pest management recommendations, start by talking to your industry colleagues about the successes—or challenges—they’ve had with their vendors. If you’re a member of a larger network or GPO, you may have a preferred provider in which to start your search.
Start with an inspection. Once you have a list of options to check out, it’s time to put them to the test. As IPM programs are customizable, insist that your prospects inspect your facility to determine the challenges you face and the services you need.
Get the details in writing. Remember, FSMA requires written risk-based preventive food safety plans that detail likely hazards, corrective actions and results. With this in mind, your pest management professional should thoroughly document any service visits and corrective actions.
Documenting your pest management plan does more than fulfill the FSMA requirement. The best pest management providers will document their every move, using the information to determine pest trends, which can aid in decisions about how to best manage pest activity going forward. These records should be kept on-site for any surprise audits.
Ask for audit help. In addition to documentation, your pest management professional should work with you to ensure all documents are in proper order and audit-ready at any time. Look for a provider that can help you prepare for the third-party auditor and food safety standards with which your facility is required to comply, and even provide on-site support the day of your audit.
Think about your entire staff. One of the most overlooked variables when choosing a pest management provider isn’t how the company works in your facility, it’s how it works with your staff. For your new pest management program to be effective, your staff has to buy in—and your new provider can help.
Your employees play an important role in reporting pest sightings and keeping your facility clean. With this in mind, make sure to ask about resources that your pest management professional can offer your staff. Many offer staff training and educational resources like tip sheets and checklists, and often at no extra cost.
Add accountability, establish thresholds. You may pick an outstanding pest management partner, but ideal results won’t happen overnight. Depending on your facility, creating a pest-free environment can be difficult, even with the best of help.
Progress is achievable and quantifiable when you have pest thresholds. Thresholds dictate how much and what kind of pest activity is acceptable before corrective actions need to be taken, and they are best set by working with your pest control professional because several factors can come into play.
Older facilities or buildings in environments more conducive to pest activity, such as areas near water, locales in warm environments or heavily wooded spaces, may face more pest pressures than newer establishments. Your pest management professional may want to counter these challenges with exclusion recommendations that can include extensive building maintenance and repairs.
If you’re in a newer building and don’t currently battle any present pest issues, it may be perfectly reasonable to move forward with a “one pest is one too many” threshold. To make sure your program stays this effective, your provider may need to adjust tactics of your IPM program over time.
Even with a sound IPM plan, however, if you are currently battling pests like cockroaches, flies or ants, reaching your threshold goals will take time. Work with your pest management provider to create a timeline for steady and reasonable improvement.
Once you choose a pest management partner, keep the lines of communication open and establish roles for everyone involved. Set benchmarks for your pest management program and specific times throughout the year to evaluate the program’s success and areas of improvement with your provider.
Keep all of this in mind, and you can help build a solid, long-lasting partnership. As a result, pest sightings can fall as your audit scores rise.
High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.
Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?
FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.
Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:
Inspection and compliance
Imported food safety
I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.
Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.
Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.
Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.
Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.
Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.
The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.
Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.
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You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.