In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.
With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.
What Is the Preventive Controls (PC) for Human Food Rule?
In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.
Let’s break the term preventive control apart:
What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
Intentional adulteration for economic gain
What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.
A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.
Are All Control Measure or PRPs Considered Preventive Controls?
The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).
The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.
Are Corrective Actions Always Required?
Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:
There is a potential pathogen threat in RTE products
There is a potential pathogen threat from the environmental monitoring program
A preventive control is not properly implemented and a corrective action procedure has not been established
A preventive control(s) or the food safety plan as a whole is not effective
Records are not completed after review
Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.
The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.
Implementation of FSMA has prompted many organizations to take a closer look at sanitation practices, documentation of food safety plans and the traceability of materials and ingredients used to create food products.
Meanwhile, shifts in technology, such as cloud migration as well as the rise of big data and analytics platforms, present both opportunities and challenges in food manufacturing.
In many cases, digital transformation, including the adoption of a multi-cloud strategy, occurs as part of a roadmap set forth by a food company’s software vendors. Tech giants, including Microsoft, Oracle and SAP, are driving digital transformation through the modernization of ERP systems and dictating how food companies should utilize applications, data and software.
In those situations, digital transformation is not a choice, it’s a requirement. CIOs and IT professionals are seeking help. They are looking to understand the dynamics and characteristics of these new environments because they are compelled to change.
Yet, there are also organizations that would rather do more than simply follow the lead of their software vendors. Instead, they choose their own destiny in terms of IT modernization. They’re looking for opportunities by leveraging data to make better business decisions.
Before a food manufacturer can get to that point, however, there must be a strategy for gathering, storing, connecting and presenting different types of data across an organization as well as to external customers and business partners.
Managing the data required for FSMA compliance is an ideal example of the importance of pursuing digital transformation.
Food Safety Data and FSMA Compliance
A major component of FSMA involves having detailed documentation of a food safety plan and the ability to produce data proving adherence to that plan when the FDA shows up for a plant inspection. Food manufacturers need to show best practices are being followed, and that corrections are being made when concerns emerge. Otherwise, the FDA may impose fines or temporarily shut down production, which cuts into the bottom line.
Because of FSMA mandates such as the Sanitary Transportation Rule, your documented food safety plan needs to be communicated to key participants throughout the supply chain as responsibility for food safety problems typically falls back to the manufacturer.
For that reason, food processors need solutions allowing them to track and trace their product from the farm field to store shelves, or to any other final customer.
Imagine being a food manufacturer trying to document sanitation in a basic spreadsheet or even on paper. The extra work involved with specifying food safety tests, collecting and archiving results, and validating sanitation procedures would be overwhelming. Yet, just as perplexing of an issue is being a digitized food manufacturer with poor visibility and management of all the information that various IT systems and platforms provide.
Most companies acknowledge that the cloud is a necessity in today’s world. Organizations often need multiple cloud solutions to accomplish business objectives, from regulatory compliance to finances, inventory control and distribution.
CIOs, technology professionals and food safety/sanitation leaders should work with existing IT solutions partners or find consultants and experts who can ensure the following questions can be answered:
1. Is the location of your data known?
Data visibility in the cloud is the first step in the process, and it is a challenge for many organizations. You need to know where your data lives, that the right people have access to it and that it is secure. When you know where your data lives, you’ll better understand how to use and protect it.
2. Is your data in a location that allows for integration?
Can the different applications your company uses talk with each other, or is all the information siloed across different cloud providers and departments in the organization? Is it integrated? Can certain information, such as food safety plans, be communicated with partners including suppliers, distributors and your carrier network?
3. Can your data be put into a framework allowing it to be extracted, visualized and leveraged?
Data doesn’t help anyone if you’re unable to take that information and use it to make better business decisions. Whether it’s food safety, operational efficiency, forecasting needs or developing new ideas, the most successful food manufacturers will leverage integrated data to move the organization forward.
The Advantages of Pursuing Digital Transformation
If you were to go back about a decade and observed a small- to mid-sized food manufacturer using Microsoft as its data platform, that manufacturer would likely have been running applications for the business that created data while receiving little guidance pertaining to how the information should be interpreted and used. Fortunately, that has changed.
Today, companies like Microsoft, Oracle and SAP actively focus on the use of data rather than only data collection. The right IT solution, coupled with expert partners, allows you to eliminate the guesswork and leverage data to your advantage.
FSMA mandates are complicated, and compliance is crucial, but the pursuit of digital transformation supports the efforts of food manufacturers who are prepared to improve transparency and responsibility surrounding food safety.
Digital transformation represents change, which is never easy, but it will be worth the effort. Start by evaluating your organization’s technology needs as they relate to FSMA compliance as well as additional business objectives. Then, identify areas of internal strength and areas where improvements are needed.
Some food manufacturers partner with an IT solutions provider for support developing a cloud migration plan and a subsequent strategy for operating in multi-cloud environments. Others need managed services, helping them handle day-to-day IT needs through outsourcing so in-house resources can develop high-value solutions. Still, others are looking for consultative guidance to help them understand what changes in technology truly mean to their organization.
You want your people to focus on what they do best. Many food manufacturers are in locations where there’s a lack of technical resources for hire. That’s why they turn to IT consultants and service providers who understand their business, can provide expertise that fills the talent gap and are able to interpret business needs into technology solutions.
Digital transformation isn’t one big project, it’s an ongoing journey, a series of waves of new technologies and new ways to use applications and data. Make sure you find trustworthy allies to give you the guidance and solutions you need, not only for regulatory compliance but for growth and continued success.
The FSMA Intentional Adulteration rule (Mitigation Strategies To Protect Food Against Intentional Adulteration) requires companies that fall under the rule to implement a written food defense plan, identity vulnerabilities and establish mitigation strategies based on those vulnerabilities. This is new territory for FDA as well as for many companies in the industry—and for this reason, the agency has established a longer compliance timeline. However, that doesn’t mean companies should wait—the time to prepare is now.
Christopher Snabes, senior manager, food safety at the The Acheson Group (TAG) and Jennifer van de Ligt, Ph.D., associate director at the Food Protection & Defense Institute (FPDI) sat down with Food Safety Tech to discuss some of the challenges they see industry facing related to intentional adulteration and food defense.
In addition, TAG and FPDI are interested in gauging the industry’s level of readiness in this area and have put together the survey, Intentional Adulteration & Food Defense Industry Preparedness. We encourage you to take the survey. And don’t miss subject matter experts from TAG and FPDI at this year’s Food Safety Consortium as they discuss Food Defense: Lessons Learned from Recent Incidents + Key Steps to Mitigating Risks.
Food Safety Tech: Given the subject matter of the survey, what do you feel is the current preparedness level regarding compliance with the FSMA Intentional Adulteration rule?
Christopher Snabes: I see this from a variety of fronts. Some companies established food defense solely on the events of 9/11, putting initial food defense plans in place [that involved] fences, installing security guards and gates, and locking the outside doors. Some companies we’ve worked with feel this is sufficient enough to meet the IA rule, and that’s not correct.
TAG has assessed several companies that are in the process of conducting food defense assessments, and they’re doing them based on best industry practices, and preparing for the inside attacker and/or a terrorist getting into key production areas.
TAG has worked with some companies that are fully waiting for the second and third guidance documents from FDA to come out before they do the full food defense plan. We’ve worked with some companies doing a mix of the above—they’re not waiting for the guidance but are actively testing their plans and having an outsider test their vulnerability, and then they’re rewriting plans based on the findings. They’ll also update their food defense plans, once the second and third FDA guidances are released to the public.
We feel these are the most prepared facilities; there are not a lot of companies at this point, but they’re starting to pick up steam. At this point, I would say most companies are actively pursuing a food defense plan as well as beginning to test their vulnerability.
Jennifer van de Ligt: I agree with Chris and would add that in the past two years or so, there’s also been a shift in how the industry is viewing the Intentional Adulteration rule. Many companies currently have food defense plans based on the events of 9/11 and, for the first couple of years, as the new Intentional Adulteration rule was being written, there was still a heavy emphasis on “that should be enough.” I very rarely hear that now when discussing the Intentional Adulteration rule with our industry partners. I think companies are more prepared from an understanding perspective to move beyond perimeter security and guards to really think about the risks in the facilities that would come from people with legitimate access— what the rule defines as “insider attackers”. Although understanding is increasing, Chris is correct that different parts of industry are on different paths. Some just now understand that they have to do more, while others are well on the way on to looking at how they need to structure themselves internally and are already moving towards vulnerability assessments.
FST: Are you seeing company size play a role in the readiness level?
Join the Food Protection and Defense Institute and The Acheson Group (TAG) at the 2018 Food Safety Consortium for an interactive discussion as they explore recent food defense events, highlighting key components of the incidents relative to government interactions, FSMA regulations, brand reputation, financial interests, and public health response. van de Ligt: The larger companies thinking about a multi-international approach seem to be further along in the process. I think they started thinking about the vulnerability assessment, how they’re going to structure it in their company, and how they’re going to come to compliance because of the breadth and the scope that impacts them. But we’re also seeing, at least in our training, some of the mid-sized companies beginning to take action. I think again, they realize that even though they’re smaller, they’re going to need additional resources, and they might not have those resources in house, so it might take them a bit longer.
Snabes: In general I would agree with Jennifer. I think a lot of it is because they have additional resources, and they can leverage them across many facilities as needed. I don’t see as much action being taken outside the United States on the facilities that are importing into the United States. I think that’s just starting to ramp up. I’m also seeing very small businesses that aren’t required to follow the IA rule implementing this because they want to protect their brand.
FST: What challenges are you seeing companies experience in understanding food defense, IA, and the appropriate preventive actions they should be taking?
FSMA Checklist: Intentional Adulteration ruleSnabes: Just understanding how the rules can apply to the business. For some companies, that’s still a challenge. Other companies, like the large ones, get it. Other small- and mid-sized companies are still trying to figure out how it applies to them. After that, the challenge is realizing there are expenses involved. For example, they have to install key fobs, cameras in critical areas, etc. They also have to realize they can meet the IA rule by not spending an exorbitant amount of money. For example, within a budget there are things companies can do without having to spend a lot of money, such as food defense awareness training.
Another challenge is educating all workers in food defense; enforcing the food safety culture within the facility and the idea that their job can be at risk. They have to realize that if they don’t recognize an individual inside the premises, or if something is out of place in a critical area, they need to inform their supervisor. If they see something, they need to say something—and ensure that the intentional adulteration is not taking place.
Educating employees is the least expensive way to invest in food defense, and it is the most effective. However, this can be a challenge for the companies that, for example, have a high turnover rate—if you have a lot of employees coming in and out, that means constant training, enforcement and re-educating. We see quite a bit of companies with a large turnover rate.
van de Ligt: I agree with those points. In our training, we also talk about food defense culture and how it needs to be supported across the business, similar to the way food safety culture is already in many of our businesses, and how to incorporate food defense awareness training, and on-boarding and refresher training.
The other challenges I see is that once you get to the understanding of what needs to be done and you get the buy in, there are some logistical issues at some of the companies—from big to small. Some companies are struggling with understanding which part of the business should be responsible for this (the food safety group, the security group, etc). Because we are talking about legitimate access and who is responsible for putting the plan together: How do these groups that may not have worked closely within the bigger companies now create that shared collaborative environment?
At the smaller companies, where they may not have that breadth or resources, now you’re asking a specialist in one area to pick up a completely different expertise and discipline. With a food safety and quality person, part of their job may be supply chain and sourcing, and now they also have to learn food defense. How are they managing and balancing all the different FSMA rules in their portfolio—because you have one person actually thinking about the breadth of them all. This presents a challenge to the logistics of implementation.
The other challenge I see is that FDA has done a really good job in providing input, guidance and listening sessions, and has been open and available to answer questions—more so for this rule than any of the other rules that I’ve watched go through industry. However, with the guidance being published so close to the compliance date it presents a challenge—companies that are waiting on the guidance will have to comply very quickly without the best understanding on what FDA’s thoughts are—because they’re waiting on the pending guidance.
FST:What steps should companies take to mitigate the IA risk?
van de Ligt: I have three action items for every company to take.
Read the IA rule, including the preamble if they haven’t. There’s a lot of information there that will help them understand the mindset and how the IA rule came about.
Read the guidance document when it comes out. The first guidance contains many clarifying examples that will help understanding and implementation.
Train the key people who are going to be responsible for writing the food defense plan and all employees on food defense awareness.
There are resources out there, whether it’s talking with FDA or coming to a sponsored training, for folks to get assistance in understanding and interpretation, and it would be great for them to take advantage of it.
Snabes: I agree with those three points. In general—do an FDA food defense assessment of your facility. Look for and concentrate on the key activity types that are critical. At least get a list of what areas are going to be the ones you have to mitigate. For example: The offloading of liquids, open vats, hand applied additives, etc. The most important thing I suggest doing right away is food defense awareness training for not just the supervisors, but all the employees—everyone from receiving to shipping to supply chain, etc. Everyone should be aware of the importance of food defense training and how their job depends on it.
In general, with food defense or IA—the rule is a brand new concept to FDA. It’s something they never tackled before. Because of that, there is going to be a longer time of educating before regulating. FDA is going to bend over backwards to work with companies so they understand how this rule is going to be implemented.
Any company out there can have a “strong employee” who wants to cause intentional adulteration, so the time to plan for that is now. Don’t wait for the rule to come into effect before you start planning.
We were asked if we think FSMA is driving strong food safety cultures. Our answer is: Yes, but there’s more to the story.
For the dozens of impacted families that advocated for years on behalf of the thousands of individuals who are sickened and die each year from foodborne illness, FSMA marked a sea change in accountability for preventing foodborne illness. And it demonstrated that the consumer voice can impact a Washington legislative process often perceived as impenetrable to the everyday citizen. It’s also true, however, that even before FSMA, leading companies had been implementing modern preventive measures in response to unacceptable illness outbreaks and consumer demands. And food safety thought leaders were writing about food safety culture and working to drive it. We thus see FSMA reinforcing the movement to strengthen food safety cultures rather than being the primary driver.
After all, a genuine food safety culture is as much about people and motivation as regulation. The people in food companies driving strong cultures are motivated at a personal level by knowing the severe harm deadly pathogens in food can inflict on illness victims and their families. And they are motivated at a business level by the realization that the success of a food company hinges on continuously meeting high consumer expectations for food safety. These personal and business motivations are the original and continuing drivers of strong food safety cultures.
The 2011 enactment of FSMA was made possible by the coming together of consumers, food safety experts, and industry leaders who agreed that application of the best available science to prevent problems is the responsibility of everyone. This agreement and the enactment of FSMA powerfully demonstrated how far our food safety culture had come since the uphill battles of 25 years ago over accountability for keeping E. coli O157H:7 out of ground beef and mandating HACCP for meat, poultry and seafood. There is now consensus that adoption of modern preventive controls is a basic responsibility of everyone producing food.
Food safety culture is about much more, however, than simply doing the basics of preventive controls. It’s about staying on top of change in the hazards that occur in our food system and in the means available to minimize them, and being committed to continuous improvement in response to these changes. FSMA took the breakthrough step of making continuous improvement a regulatory requirement by tying the definition of preventive controls to current expert knowledge about how to control hazards and requiring controls to be updated regularly as new knowledge emerges. In this way, FSMA reinforces the movement to strengthen food safety culture and makes it everyone’s responsibility.
But it all still comes back to motivation. Stop Foodborne Illness has long contributed to that motivation by sharing the stories of individuals and families who have experienced devastating loss and lasting harm from foodborne illness. Companies seeking to strengthen their cultures invite Stop constituents to tell their stories in employee training sessions and meetings with senior executives. In this new era of food safety, we see great opportunity to expand collaboration with food companies to help drive the widest possible implementation of best practices, continuous improvement and strong food safety cultures. In this effort, FSMA is our important ally.
Bush and Taylor co-chair the Board of Directors of Stop Foodborne Illness, a non-profit consumer organization that represents victim of foodborne illness and their families.
Last week FDA released a guidance document to help facilities understand whether they are subject to the “qualified facility” definition under the FSMA preventive controls rules for human and animal food. Titled “Determination of Status as a Qualified Facility”, the guidance offers frequently asked questions about the requirements for facilities that manufacture, process, pack or hold human as well as animal food (defined separately—Part 117 for human food and Part 507 for animal food).
“Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.” – FDA
Facilities that fall under the PC Human Food rule must submit the first required attestation forms by December 17, 2018, and those subject to the PC Animal Food role must submit the first required attestation forms by December 16, 2019.
In today’s global marketplace, it has become necessary for facility managers to implement more detailed inspection and documentation policies for incoming shipments as part of the larger food safety plan. But plan as you might, pests are adept at infiltrating food products and contaminating shipments. Their resilience and persistence will make you pay, literally, if you’re not paying close attention.
Pest management is a key component of any facility manager’s food safety plan, but understanding how best to prevent pests from compromising shipments—and by extension the supply chain—takes diligence.
Chelle Hartzer will be speaking during the complimentary webinar, Pest Management’s Role in Food Safety and FSMA Compliance, on September 26, 2018 An integrated pest management (IPM) program is the best way to ensure that insects and rodents are kept away from processing, packaging and storing food products. Again, this information shouldn’t be anything new if you’re a food processing facility manager, but it’s important to note that IPM focuses on proactive prevention of pests, to align with FSMA’s Hazard Analysis and Risk-Based Preventive Control (HARPC) regulations. These newer regulations shift the focus from reacting to potential contamination concerns to preventing as many issues as possible. Being proactive is a must.
Aside from the legal backlash a facility could face if found if violating these rules, pest issues can also have a major negative impact on a business’ bottom line. Imagine the cost of even one of your outgoing shipments being contaminated by cockroaches or stored product pests. Now, imagine the impact on your business from consumer backlash if the pest-ridden shipment travels further down the line. Simply put, it’s never good if the pest problems are traced back to your facility.
So, what’s the best way to protect your supply chain from potential pest issues and remain compliant under FSMA and HARPC?
All food safety plans should have considerations in place based on a review from a Preventive Controls Qualified Individual (PCQI). This individual is responsible for preparing the document, with the input of as many departments and people as possible, such as QA/QC, maintenance, production teams, and more. Since pests are a common potential hazard, a pest management program should be included in the plan.
That being said, it’s important to inspect all incoming shipments. Even if suppliers have implemented measures to help keep pests away from their sites and products, pests are tough to entirely prevent and it’s always a possibility some have slipped through the cracks (literally!). Pests are attracted by food, water and shelter, so a truck transporting products to your facility is going to be chock-full of attractants! Carefully inspecting incoming shipments will not only help ensure pests don’t enter your facility, but it will help you and your supply chain partners target exactly where problems may be occurring. Forming good relationships with your suppliers, and keeping communication open can help to manage any issues that may pop up.
The faster pest issues are detected, the better. It’s easier to address a pest problem and more accurately pinpoint where it originated if it can be caught early. Otherwise, pests can reproduce quickly and spread, making it harder to pin down the source of an infestation and to treat it. It’s tough to overstate the importance of open lines of communicated between supply chain partners!
To avoid allowing pests into your facility or sending them to a supply chain partner, implement the following processes:
Inspect shipments for pest activity, especially incoming shipments. Some common signs include live or dead insects, droppings and damage to the product and packaging.
Ensure packaged products are properly sealed and undamaged before transport, and then check the transportation vehicle before loading product for shipping.
If there is a pest sighting, remove any compromised product to avoid allowing pests to spread to other goods or find a way into the facility. If it can’t be removed from the facility, isolate it in a contained area and call your pest management provider immediately.
Empower employees to call out pest issues as well by implementing a “see something, say something” policy. Don’t forget to have a pest sighting log, and let the employees know where it is and what to record.
Use monitoring devices to detect pest activity levels. Devices like insect light traps, pheromone monitors, and glue boards can be easily placed in shipping and receiving areas as an early warning sign of pest activity.
With an untrained eye, pest issues can be difficult to notice. Ask your pest control professional about a free training session for employees. Most pest management companies offer this service free of charge, and it can be a big help. There’s no reason you shouldn’t take advantage.
The pest pressure a facility faces is dependent on a variety of factors including location, geography and the type of product being produced and stored. No two facilities are the same, which is why every pest management program should be customized to meet the needs of the business.
As a start, the following pests are the most common to find in the food processing industry.
Rodents: Rats and mice can carry disease-causing pathogens that can be deposited onto other surfaces by simply making contact with equipment or products. Both are capable of fitting through tiny gaps (mice can fit through a hole the size of a dime, while rats can fit through a hole the size of a quarter), meaning any openings on the exterior of a building serve as a welcome mat to a curious rodent. To spot the signs of rodent activity, look for droppings and yellowish-brown grease marks around corners and along baseboards, as these marks can be caused as a rodent rubs against these areas. In addition, look for gnaw marks around any gaps or openings in walls and on products.
Cockroaches: Able to squeeze their bodies through miniscule gaps, cockroaches will feed on just about anything. With a good food source, they can reproduce quickly. A couple cockroaches can become an infestation in a matter of months, especially with an abundant food supply. Cockroaches are most active at night, so if you see one during the day it’s a good sign that it’s time to act quickly!
Flies: While less likely to find their way into packaged products, flies can spread dangerous, potentially disease-spreading pathogens on everything they touch. They usually don’t travel too far from their larval food source, but their ability to reproduce quickly can make them a nightmare to get rid of if steps aren’t taken to remove them immediately.
Stored Product Pests: There are numerous kinds of stored product pests, but all are adept at thriving in and around products undetected. The Indian meal moth, for example, is a moth with small, cream colored larvae that will eat just about anything. Stored product pests are some of the most likely pests you’ll find on incoming shipments and in storage areas, as they’re right at home breaking into and surviving within product packaging.
Keep these pests on the radar, and make sure to take note of where pests are found and how many are spotted. The more information, the better, as it helps pest management professionals get to the root of pest problems.
Documentation is always a major key. It shows an auditor that careful planning and proactive prevention are points of emphasis, which will be important. Although there are numerous documents to keep on hand, add the following to your list in order to more easily demonstrate compliance with pest related FSMA regulations:
Supply chain program, including suppliers and ingredients.
Receiving procedures, including the pest management program that helps prevent pests from entering the facility on products or through loading areas.
Receiving records, or, in other words, documentation of shipments received from suppliers.
Monitoring records of any captured pests in or around the facility and any corrective actions.
Application records for treatments used in and around the facility.
If suppliers are located in another country, note the requirements differ from facilities located in the United States. The FDA breaks this down on their website, but importing products from another country means a facility must follow the Foreign Supplier Verification Program. This comes with a different set of compliance documents and means the importing facility must monitor foreign suppliers’ food safety plans.
Remember: Preventing pests needs to be a proactive process included in the food safety plan. If you want your supply chain to remain pest free, partner with a pest management company and talk to your supply partners to establish standards for documentation and communication. All will benefit, as you’ll be able to catch problems early and have a better chance of keeping pests from wrecking your supply chain.
The American National Standards Institute (ANSI) has accredited Perry Johnson Registrars Food Safety, Inc. under FDA’s Accredited Third-Party Certification Program. The firm is the first certification body (CB) to be accredited under the program for the scopes of Produce Safety, Preventive Controls for Human Food, Juice HACCP and Seafood HACCP. Under the voluntary program CBs can conduct food safety audits and issue certifications of foreign food facilities.
FSMA is in no longer in its infancy – but, still, documentation can be a challenge. With TraceGains, companies are able to keep up with compliance regulations and document requirements – and are always 365AuditReady. We’re here to help! Want to know what we can do for your FSMA needs?
Supply chain management is becoming more and more relevant to small and entrepreneurial food businesses, particularly related to FSMA requirements that are required to be fully implemented by this September. To meet these requirements, it is important for small businesses to understand:
Applicable FSMA requirements
How to develop a supplier approval program
What challenges companies may encounter and tips to overcome them
How to find an appropriate starting point to develop a supply chain management program
Supply Chain Management Program
1. Receiving facility: A facility that is subject to preventive controls and supply-chain program and that manufacturers/processes raw materials or ingredients that it receives from a supplier.
2. Supplier: The establishment that manufacturers/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.Food manufacturers need to develop and implement a supply chain management program, including supply chain preventive control, to control those potential hazards identified that shall be controlled by the suppliers when receiving all raw materials and ingredients. As defined in the actual FDA regulation, a supply management program will only be considered as a preventive control when it is linked to a potential food safety hazard in the raw materials and incoming ingredients. It is the supply-chain-applied control (21 CFR 117.3). As a receiving facility, you have the right to ask your suppliers for all related information associated with the food safety hazards that you identified from your own food safety plan.
What should be in your supply chain management program or supply-chain-applied control?
There needs to be a series of credentials for approval. This can be determined by you, depending on the hazards and product risks. For example, a third-party audit result or a certification from a reliable audit can serve this purpose.A few questions can be considered, including whether suppliers have a recall plan, whether suppliers have an existing food safety plan to control hazards, or whether suppliers have a non-conforming products control plan. Often these can be checked and verified when a third-party audit or third-party accredited audit is conducted. Once a supply chain management program becomes a preventive control, the raw materials can only be supplied by an approved supplier.
Monitoring activities and verifications should be applied to those approved suppliers in your supply chain. This can be done throughout the business history and supplier performance. You need to demonstrate how you continue monitoring the supplier approval status, and suppliers must demonstrate how their products remain guaranteed. Public records (e.g., warning letters), sample testing incoming goods, and customer audits are commonly utilized in the industry. However, in FSMA, when an approved supplier is supplying a high-risk raw material, such as one with SAHCODHA (Serious Adverse Health Consequences or Death to Humans or Animal) risks, an onsite (your own audit or third-party (accredited) audit) is required to be conducted as the verification activity. This must be completed annually unless you can provide a risk-based justification of other types validated verification activities.
Afterwards, as a receiving facility, you need to consider and develop procedures for non-conforming suppliers:
How do you require your suppliers maintain their “approval” status in your supply chain management program throughout the business years?
When one approved supplier is unapproved or experiencing unexpected incidents, how do you manage back-up suppliers?
What criteria do back-up suppliers need to meet prior to supplying the product(s)/ingredient(s)?
Melody Ge will be presenting “What Have We Learned After FSMA Implementation?” at the 2018 Food Safety ConsortiumDifferent products will have different approaches based on facility business operations. However, one thing remains the same. The justification must ensure that potential hazards identified from the original approved supplier are controlled when a back up supplier is used.
4. Last but not least, just like all other programs and controls, records and documentation are important! Records must be kept for all parts of the supply chain management program, including plan, monitoring, verification and any corrective actions that have been conducted. These data are precious to your facility over time, as supplier performance and trending could be a strong reference to see whether adjustment or modifications should be applied to your supply chain management.
There may be challenges collecting information or approving suppliers, but never forget the intention of a supply chain management program—to control the food safety hazards of incoming goods. Your supply chain management program will allow you to demonstrate that you have made all efforts to control the hazards that could potentially arise from your supply chain.
Recorded September 26, 2018 – Pests are a major threat to food product integrity and any facility’s bottom line. FSMA mandates a proactive approach to food safety and, by extension, pest management. This webinar discusses preventive pest management controls that should be implemented to help ensure you and your staff are operating the safest food facility possible. Sponsored by Orkin.
“Recalls”. This topic got me thinking, what is the literal meaning of recall? So, I looked it up:
Bring (a fact, event or situation) back into one’s mind, especially so as to recount it to others, remember.
“I can still vaguely recall being taken to the hospital”
Officially order (someone) to return to a place
“the Panamanian ambassador was recalled from Peru”
An act or instance of officially recalling someone or something
“the recall of the ambassador”
The action or faculty of remembering something learned or experienced.
“their recall of dreams”
Many people think of FDA when hearing the word “recall”, and many consumers believe that the FDA often or even always orders recalls. In fact, the FDA relies on responsible parties to voluntarily recall food products when a threat exists, but FSMA’s mandatory recall authority allows FDA to mandate a recall only when the criteria under section 423 of the FD&C Act are met.
For most, the word “recall” is all too familiar. We hear it so often that I wonder if we are becoming desensitized to it. Almost daily we hear this item or that item has been recalled due to XXX, allergy, Salmonella, Listeria, foreign matter, and the list goes on. I counted 45 human and three pet food-related recalls just since May 1, 2018—that’s in just 84 days as I write this. So, for consumers (and we are all consumers), how do we hear the word recall and what is our visceral reaction when we hear the word? What actions if any do we take? Does it become too overwhelming? Are we becoming immune from the word? We are required to eat for survival sake and we don’t know if there is a problem with the food we are eating until after it has been recalled. At Stop Foodborne Illness, we send out recall notices every time there is a recall announced, which is typically a few times a week. Recently, a friend asked, “So, do I just quit eating to avoid contamination?”
I wonder if we can start a conversation about the term, how we use it and how to use the word and related action effectively. What does it mean for consumers? Is it only meaningful after the fact? The word and action of the word “prevention” is so much more powerful. Just “food” for thought.
You can adjust all of your cookie settings by navigating the tabs on the left hand side.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
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.