Tag Archives: food safety plan

ASI Food Safety
FST Soapbox

The Costs Of Food Safety: Correction vs. Prevention

By Matt Regusci
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ASI Food Safety

Every company that grows, produces, packs, processes, distributes and serves food has a food safety culture. In the food industry, when looking at food safety culture there are essentially two groups: The correction and the prevention groups. Basically, the prevention group is constantly improving their food safety practices to minimize foodborne illness while the correction group waits until there is an outbreak to make changes.

The correction group isn’t proactive and has a number of excuses that keep them from implementing a food safety program. Oftentimes owners or managers think, “The chances of my company being involved in a food safety outbreak are so rare, I just won’t worry about it.” Or they think, “The cost of having a food safety program is so prohibitive that I’d rather handle the consequences of an outbreak if it were to arise.” Also, sometimes there’s a lack of knowledge and some producers don’t even know about food safety programs and don’t have or want to take the time to learn about them.

If your food company is in the corrective group, you are not alone. Three years ago a private study was done to see how many food facilities could pass a basic Good Agriculture Practice (GAP) and/or Good Manufacturing Practice (GMP) audit. It was discovered that less than 20% of these companies would be able to pass the most basic food safety audit. This number is staggering and unfortunately the correction group is much larger than anyone thinks—it equals a majority of the facilities at around 80% of the food industry. This statistic is frightening and needs to be addressed to help reduce outbreaks.

What does the preventative group look like? Well it is more of an investment up front, but in the end helps reduce risk and costs. Companies that take on this responsibility go through an audit and implement procedures that prevent outbreaks. That is level one. The next level of protection involves applying and gaining a certification. All of these procedures help to give your organization a barrier against costs such as crisis management with a PR firm, a recall that leads to lost product and sales, and a thorough clean-up process.

Food safety prevention is an ongoing journey of understanding your many risks and implementing procedures and processes to minimize these risks. Prevention is not a one person job, but rather the whole company needs to join the common cause of protecting the brand and more importantly customers lives.

The cost though is always a huge consideration and can become a deterrent to implementation. Oftentimes owners or managers of facilities will say, “The cost of food safety prevention is so prohibitive that we can’t implement a program.” Yes, there is a cost to building, implementing, and maintaining a preventative food safety program. However, this cost pales in comparison to a corrective program.

Overall Cost of Correction: FDA – Lives – Individual Companies (Restaurants and Farms)

Just recently CDC posted that the economic impact of pathogenic food safety outbreaks is $17.6 billion which is $2 billion higher than 2013. The CDC calculates this based on medical expenses, productive decreases in wages, and ultimately loss of American lives. This large number and massive increase in economic cost has made headlines recently as a huge problem, but few in the media understand this number is small compared to the true cost of foodborne illness.

So what is the true cost annually of the collective in the corrective group to the food industry and America as a whole? To come up with that number we need to look at all the costs of an outbreak: Legal costs, fines, bankruptcies, decrease of overall commodity market share, decrease in public trust, and jail time. And let’s not forget, the real cost is that lives were lost due to lack of prevention.

To understand the cost, let’s look at a few examples, starting with Chipotle. Last year the company agreed to pay the largest fine in history of $25 million for its part in multiple outbreaks from 2015–1018 sickening more than 1,000 people. This fine is tiny in comparison to the stock market loss. In 2015 the stock went from $740 a share to a low of $250, and in fact Chipotle’s stock did not get back to $740 until July of 2019. That is billions of market opportunities lost.

Johns Hopkins Bloomberg School of Public Health did a study and concluded that foodborne illness costs the American food service industry $55.5 billion annually. On average each food safety outbreak costs the establishment between $6,330 to $2.1 million, depending on size of the operation and how widespread the outbreak is. Chipotle has a lot of resources to manage and recover from a crisis; many small and/or over-extended companies go bankrupt and are forced to close down.

There are plenty of examples on the supply chain side. The first example is the Salmonella outbreak of Peanut Corporation of America. The largest part of this tragedy is that 714 people got sick, about half of whom were kids, and nine people lost their lives. Due to this, three executives went to jail, not for a few months for decades. The economic cost is astounding; Peanut Corp of America had an annual revenue of around $25 million, but the cost of the outbreak was over $1 billion. This may seem like a very large number, but don’t forget peanuts are an ingredient in many other products. Kellogg’s estimates they lost $65–70 million in products they needed to recall from this one outbreak, and Kellogg’s is just one of many Peanut Corp of America customers.

Another example is the Jensen Farms Listeria outbreak that sickened 147 people and of those 33 died. The brothers, of this multiple generation farm, Eric and Ryan Jenson, went bankrupt and were sentenced to five years probation and six months of home detention; each had to pay a $150,000 fine. Again, this small family’s operations outbreak had massive ramifications for the cantaloupe industry, which suffered significant damage as a result. Walmart reached a settlement for an undisclosed amount in 23 lawsuits involving the Listeria outbreak linked to the cantaloupes

Overall Cost of Prevention: Internal Programs, Supplier Programs, Testing and Audits

The FDA has conducted a few studies on the industry cost of the many leafy greens outbreaks. One study showed the spinach industry alone lost more than $200 million just in retail sales and many more millions in opportunity sales from the 2006 E. coli outbreak. And a recent leafy green outbreak in 2018 cost the industry an estimated $350 million. With staggering numbers like these, the LGMA was created in 2007 to help raise the bar for food safety prevention in this high-risk product. The LGMA study found that their members, which are large leafy green marketers, including Dole, Taylor Farms and Ready Pack, increased their spending three times for true prevention measures.

What does it look like to go from the corrective group to the preventative group? First you have to make the decision of implementation and get buy-in from your entire team. If you are starting from zero, asking your clients and competitors what standards they are utilizing and being audited to, or should be audited to, is a good starting point. This will help in developing a plan of action.

Once you have the checklist, audit human resources. Do you have a Food Safety and/or QA person or team? Are they capable of guiding the executives on this journey? If not, hire a consultant to help you get started.

Once they are on the journey of prevention, people see their entire operation in a different way. They see risks where they never previously saw them—risks with people, equipment, products, building, and the surrounding area. This can get super overwhelming, but if they don’t panic they will be excited about the future. The paradigm will change and they can build, implement and maintain practices to minimize risks one by one, starting with the biggest risks.

In accounting for the physical costs of prevention, the largest will come from the human resources component. Hiring people to build, implement and manage your food safety program will be your largest expense. Another human resources cost is the continued training for the entire staff on food safety expectations. After that cost drops significantly, annual audits and microbiological testing come into play, and the cost will vary on the size of your operation and the risk of your products. For instance the LGMA study showed on average the cost of their members went from $200,000 to about $600,000 annually for prevention, but these are very large multiregional organizations with a very high risk product.

The most important things in life come with hard work and at a price. Every person who has climbed Mount Everest did so one step at a time. Food safety prevention is no different. Is there a cost in money, time, and stress? Yes. Is that cost less than sitting on the beach with your head in the sand of the correction camp? No doubt. But the choice of leaving the majority that are wrong to the minority that are right is yours. Hopefully, you make the right decision.

Megan Coy-Moran, AIB

Be Confident in Your PCQI’s Training

By Megan Coy Moran
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Megan Coy-Moran, AIB

With allergens being the leading cause of recalls in the U.S., accounting for approximately 47 percent of recalls as of the most recent FDA reportable food registry annual report, FDA has placed “an emphasis on preventing allergen contamination, protecting consumers, and reducing the need for food recalls.” So, when FDA makes allergen control a priority, how can you be confident that it is a priority for your team and in your facility? By providing your designated Preventive Controls Qualified Individual (PCQI) with the right PCQI training.

Introduced in the Preventative Controls for Human Food Regulation final rule that exists within the FDA’s Food Safety Modernization Act (FSMA), a PCQI is required to be on staff in all food and beverage facilities registered under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act. In this role, the PCQI oversees development of the Food Safety Plan, hazard analysis, preventive controls, verification activities, and validation of process preventive controls. Further, FSMA mandates that all food manufacturing facilities conduct Hazard analysis and risk-based preventive controls (HARPC), while also implementing science-based preventive control measures to reduce the potential risk of food product adulteration. Each of these are managed by the PCQI and critical to achieving food safety.

With the goal of preventing foodborne illness and maintaining compliance with the FDA, the PCQI also needs to possess an in-depth knowledge of the facility’s Environmental Monitoring Program, food allergen controls, sanitation controls, supply chain controls, and recall plan. The importance of the PCQI’s many responsibilities means they need to have the necessary training and skills for the creation, application, and verification of these and other measures as applicable to their facility.

The PCQI’s oversight and familiarity with the Food Safety Plan also suggests they are likely the primary contact when FDA arrives at your facility for an inspection. Their ability to answer the inspector’s questions and successfully manage this process helps ensure that those visits are as concise and positive as possible. Having this single point of contact is also beneficial for the inspector, as they know they can count on the PCQI as a resource to provide them with necessary information without having to chase down multiple sources. Too, having a PCQI on site makes it easier to then implement regulatory requirements and any necessary preventive controls within the designated time, as they are already familiar with the facility and team.

The best PCQI training will prompt participants to think through real-world scenarios, preparing them to identify best practices to achieve food safety. By then putting this theory into practice in their facilities, they will help ensure compliance. Further, it is important that any course they take features consistently updated information, so you can be assured that what they are being trained on is current and accurate. For instance, when the U.S. Congress passed and President Biden signed the FASTER Act into law in April 2021, including sesame as an allergen of concern, this was an important update. As new information becomes available, their training should remain timely and accurate, ensuring that the experience is relevant and responsive to changing regulations.

Because production right now is priority and many teams are short-staffed, it can be difficult for some to find the time to travel to participate in an in-person training course. This makes online training appealing, as it can be completed when time becomes available, while also saving on travel costs.

With the right training, your PCQI will be an invaluable member of your team. By aligning priorities with regulators and prioritizing food safety throughout their responsibilities, they will improve your facility’s ability to produce safe food.

With our PCQI Online training, your PCQI will be an invaluable member of your team. By aligning priorities with regulators and prioritizing food safety throughout their responsibilities, they will improve your facility’s ability to produce safe food.

Earl Arnold, AIB International
FST Soapbox

HACCP is the Past, Present and a Building Block for the Future

By Earl Arnold
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Earl Arnold, AIB International

“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.

One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.

  1. Assemble a HACCP team
  2. Describe the finished product
  3. Define intended use and consumer
  4. Create process and flow diagram
  5. Verify process and flow diagrams

This is followed by the seven principles of HACCP.

  1. Conduct the hazard analysis
  2. Identify critical control points
  3. Establish critical limits
  4. Establish monitoring requirements
  5. Establish corrective actions for deviations
  6. Procedures for verification of the HACCP plan
  7. Record keeping documenting the HACCP system

HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.

When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.

HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.

Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.

For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.

Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:

  1. Assemble a food safety team
  2. Describe the product and its distribution
  3. Describe the intended use and consumers of the food
  4. Develop a flow diagram and describe the process
  5. Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

  1. A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
  2. Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
  3. A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
  4. A written recall plan if a facility identified a Preventive Control.
  5. Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
  6. Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
  7. Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.

While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.

Manuel Orozco, AIB International
FST Soapbox

Detecting Foreign Material Will Protect Your Customers and Brand

By Manuel Orozco
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Manuel Orozco, AIB International

During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.

As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.

The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.

The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.

To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.

But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.

Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.

It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.

Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.

The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.

The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.

Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.

There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.

Alert

Flooding and Food Safety: A Two-Part Plan for Extreme Weather Season

By Paula Herald
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Alert

The spring of 2019 saw record rain fall across North America, causing historic, severe flooding in the Great Plains, parts of the Midwest, and the Southern United States. That above-normal precipitation doesn’t look to be ending, either. The National Oceanic and Atmospheric Administration’s Climate Prediction Center predicts that wide swaths of the United States could face above normal precipitation for the remainder of 2019.

In addition to disrupting power to critical equipment and damaging property, when food businesses flood, food safety is put at risk. Flood waters can be contaminated with debris, sewage, chemicals, pests and more. In a restaurant or foodservice operation, any product, object or surface that flood waters touch becomes contaminated.

Pre-Flood Preparation

Having a documented flood emergency plan in place can give location staff a step-by-step course of action to follow in times of increased stress and panic. It can also help minimize losses for a business.

For national chains in particular, it can be harder to ensure that all locations have the resources and tools available in their area. Corporate operations can assist by identifying vendors and resources ahead of time.

  • Designate roles and responsibilities. Having a clearly outlined plan with designated roles and responsibilities can prevent confusion and extra work during the crisis. Have an updated phone contact list of key contacts available for those with designated roles and responsibilities.
  • Sandbags. Placing sandbags in front of doors or other openings may help limit flood damage.
  • Vital records. Both paper and digital/electronic records can be at risk. Businesses using electronic records should ensure that files are automatically backed up regularly. Businesses using paper records should ensure that vital records are secured in such a way that they can be quickly removed to a safe place or elevated to prevent damage.
  • Equipment. Flood waters can damage or destroy expensive equipment. Have a plan in place to remove equipment to a safe place.
  • Food storage. If flood waters contact food supplies, many may need to be destroyed. Arranging for food storage in a secure place away from flood waters can help minimize losses. This may require refrigeration storage.
  • Turn off electric and gas. Turning off natural gas lines can prevent devastating damage and contamination from occurring. Turning off and unplugging equipment that uses electricity can help protect the safety of rescue workers or staff returning for cleanup.
  • Refrigeration. If it is not possible to remove food, be certain that all refrigerated units are equipped with accurate thermometers. If possible, monitor the temperature in the units during the disaster situation.

Post-Flood Recovery

Even with a rock-solid pre-storm plan in place, Mother Nature’s extreme weather events can wreak havoc on facilities. In the wake of a storm, sorting out what needs to be done to restore order to operations can be a hefty task.

Post-storm recovery can be an extensive task, especially if flooding is involved. It may require work of many staff members or outside vendors, such as remediation specialists. Safety should be absolutely paramount. No one should enter a space that has been flooded without confirmation that there are no electrical shock hazards, gas leaks or debris that could harm people. Structural damage that could lead to collapse or other injury is possible. Mold is also a risk following floods. All personnel involved in flood clean-up must wear personal protective equipment—eye protection, gloves, disposable aprons, rubber boots, and masks or respirators, etc.

The following guidelines can help prioritize steps to ensure food safety won’t be a factor holding back a location from re-opening.

  • Safe water. Facilities cannot prepare food without a clean, potable water supply. If the water system was affected by flood or the local water supply was unsafe, the local health department should be involved in clearing re-opening.
  • Disinfection of equipment. Any food equipment that was exposed to flood water or other non-potable water must be disinfected prior to use, including ice machines, which are often overlooked. Discard any ice already present in a machine. Thoroughly clean and sanitize the machine before turning it on. Once the machine is running again, discard the first two cycles of ice.
  • Disinfection of surfaces. Any surface (countertops, walls, ceilings, floors, equipment surface, etc.) that was contacted by floodwaters must be disinfected before reopening.
    • Use a commercial disinfectant with effectiveness against norovirus or make a chlorine bleach solution to disinfect affected areas.
    • Use unscented bleach and wear gloves.
    • Make fresh bleach solutions daily.
    • Food contact surfaces that are disinfected must be rinsed with clean, potable water, and sanitized before use.
    • Discard any mop heads or absorbent materials used to clean flooded areas.
  • What to discard. Inevitably, there will be items that cannot be salvaged following a flood event. The following items should be discarded if they have come into contact with floodwater or non-potable water or were subjected to temperature abuse due to power outages. If there is any doubt, throw it out.
    • Unpackaged food (examples: fruits, vegetables)
    • Food in permeable packaging (examples: flour in bags, produce in cardboard boxes)
    • Food packaging materials
    • Refrigerated food in a refrigerated unit where the temperature rose above 41°F for more than four hours
    • Any refrigerated product that was not temperature-controlled for more than four hours
    • Frozen food product that has thawed to a temperature of above 41°F for more than four hours
    • Canned items with damaged seams, swelling or dents
    • Items with screw tops, twist-off caps, or other semi-permeable packaging
    • Single service/use items
    • Any linens that contacted floodwaters that cannot be laundered with bleach and dried in a mechanical dryer
  • What can be safely kept. Not everything will need to be discarded.
    • Canned foods free of dents or rust can be kept after labels are removed, they are disinfected, washed, rinsed in clean water, and sanitized; cans with any signs of bulging or leaking must be discarded; canned foods should be also be relabeled with the name of the food product, as well as the expiration date
    • Linens that can be safely laundered with bleach and dried in a mechanical dryer
    • Dishes, utensils, pots and pans, and other service items that are free of rust and can be disinfected, washed, and sanitized

As climate change continues to advance, the threat of extreme weather and flooding situations may soon be a reality for areas of the United States that have never experienced them before. In the Congress-mandated Fourth National Climate Assessment, compiled by the U.S. Global Change Research Program, the authors warn of the future of severe weather events.

“More frequent and intense extreme weather and climate-related events, as well as changes in average climate conditions, are expected to continue to damage infrastructure, ecosystems, and social systems that provide essential benefits to communities.” – Fourth National Climate Assessment

Even for businesses that have not had to consider flooding before, it may be time to sit down and develop a flooding and food safety plan of action. The time invested in training and educating staff members may help to protect investments and keep food safe in the event of flooding and weather emergencies.

Doug White, PSSI
FST Soapbox

The Real-Time Value of Technology in Food Safety

By Doug White
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Doug White, PSSI

We live in a world where information on any subject is at our fingertips and can be accessed instantly. These real-time notifications keep us up to date on whatever topics we choose. This information helps guide our daily decisions and communicate more effectively with each other.

The same is true in business. We can be more efficient and make more informed decisions based on the information we have at various points throughout our day. However, for many companies and industries, the key is figuring out what information is needed and how it can be transmitted in real-time to increase the efficiency or effectiveness of the work.

In an industry not known for being on the leading edge of new technology, it is still not uncommon to have data captured using the good old pad and pencil method. This, unfortunately, limits visibility and the timely application of that information. This is especially critical when it comes to sanitation and food safety data. It is a complex, high-risk industry with tight timelines and lots of moving parts (figuratively and literally), and various teams working together 24/7.

The 2019 Food Safety Consortium Conference & Expo features a dedicated track on Cleaning & Sanitation | Attend the event October 1–3 | Schaumburg, ILAdditionally, new rules and regulations around FSMA require processors to have more detailed documentation of a food safety plan and produce data proving adherence to that plan during plant inspections. Processors must show that best practices are being followed and address any instances where concerns may arise with immediate corrective actions, or face potential fines or temporary shutdown of production.

The bottom line is, technology is no longer a “nice to have”, it is a must have. Data is our friend and, if used appropriately, can significantly help mitigate risk and improve food safety.

Innovation in Sanitation

Specifically in the sanitization process, there is a distinct science-based, data-driven approach that can be used to document and report on the consistency and effectiveness of each cleaning process. However, without the right experience or specific microbiological training, it is hard for a processor to know what to document, how to document it and why it matters.

For instance, as part of standard operating procedures, our team always monitors and documents four key factors that can influence a successful cleaning process: Time, temperature, concentration of cleaning agents and mechanical force (i.e., water pressure). If any one variable as part of the sanitization process is off, it can impact the overall effectiveness of the cleaning.

This is the type of risk-based data that can be applied as part of FSMA reporting and compliance.

However, the real opportunity for improving food safety is about the visibility of that data and how it can be used to adjust the sanitization processes in real-time.

I was fortunate to be part of a team that developed and implemented a new real-time performance metrics platform over the last year. It is a digital system that helps sanitation teams proactively track and respond to critical data that can impact the effectiveness of the sanitation process.

Replacing the pen-and-paper method is a system in which data is logged digitally into an application on a tablet or mobile device in real-time during the sanitation process.

Site managers closely monitor data, which can be shared or accessed by other stakeholders to perform analytics and make real-time adjustments to the sanitation process. The system sends alerts and notifications regarding changes or updates that must be made as well.

From internal communications to coordination with USDA and FDA inspectors, it supports a much more seamless communication structure as well. Employees feel more confident and empowered to manage the sanitation process and partners feel armed with the right information and data to focus on managing the needs of their business.

As an industry, I believe we have a great opportunity ahead of us to continue advancing food safety. The technology and tools are there to support us. It is a matter of taking small steps to innovate and improve efficiencies in our own businesses every day that will have a drastic impact on the industry as a whole.

Question mark

The Results Are In: FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Question mark

Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.

We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.

If you haven’t taken Part II yet, take the Supply Chain IQ Test now.

And now for the results!

  1. Control limits must be included within the hazard analysis and preventive controls for HACCP.
    • FALSE. More clarification is needed here, as 96% of respondents said this is true.
  2. CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
    • TRUE. 91% got this right.
  3. Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
    • FALSE. 87% answered correctly.
  4. You must document justification of records not required by a food safety plan in a food operation under FSMA.
    • TRUE. Just 44% responded “true”.
  5. You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
    • TRUE. Congratulations, 100% got this one right!
  6. Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
    • FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
  7. Under FSMA supply chain requirements, you must document approved suppliers.
    • TRUE. Once again, great job—100% answered correctly!
  8. A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
    • TRUE. 91% knew this one.
  9. A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
    • FALSE. 91% answered correctly.
  10. Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
    • TRUE. 74% answered correctly.
  11. Only the personnel of the carriers transporting food product require training and training records.
    • FALSE. 96% got this one right.
  12. Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
    • TRUE. 91% answered correctly.

How ERP Can Help Ensure Food Safety in the Cannabis Edibles Market

By Daniel Erickson
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The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.

This year the Cannabis Quality Conference & Expo is co-located with the Food Safety Consortium | October 1–3 | Schaumburg, ILCannabis Edibles Defined

Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.

Safety and Quality Concerns

An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.

How ERP Can Help

Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.

The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:

Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.

Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.

Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.

Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.

Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.

Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.

Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.

With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
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Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

What To Consider When Developing A Facility Food Safety Plan

By Adam Serfas
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No two facilities will have the same food safety plan, as each should address the specific needs of that facility. Before beginning your draft, there are several critical factors to consider. Use the guide below as a checklist to review before starting or revisiting your own food safety plan—the following tips can be applied to all food and beverage processors and manufacturers.

1. Review current legislation that applies to your industry

The food safety sector evolves rapidly. Keep your finger on the pulse of updates and changes, whether current or forthcoming, to ensure that your plan is current and up to code. You can quickly familiarize yourself with guidelines and regulatory bodies dealing with your industry with a handful of excellent resources. Generally, we recommend starting with the FDA website, and from there you can navigate to resources that are specific to your industry. We also recommend you make use of the FDA’s Food Safety Plan Builder to assist you in meeting requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

2. Identify current potential risks in your facility

Once familiar with your industry requirements and inspection standards, the next step is to identify any current potential food safety risks specific to your facility. Be sure to incorporate employees at all levels while detailing these potential hazards or concerns. Oftentimes, employees at the management level will make note of things different than employees working on the plant floor. And the delivery truck driver’s perspective will vary from those of your janitorial team. Aim to build a comprehensive list, noting everything from obvious high-risk areas, to what might be trivial or unlikely facility hazards. The more robust the list, the easier your food safety plan will be to form later on.

3. Consider your facility layout

Your facility’s physical layout often determines what type of food safety plan is necessary. Ask yourself:

  • Does your facility have natural zones?
  • Is it comprised of multiple buildings?
  • Are certain defined areas more high-risk than others?
    If you answered “yes” to any of these questions, you’ll most likely want to incorporate a zone-based color-coding plan as a part of your food safety plan to ensure that all of your tools remain in their proper location and are used correctly.

4. Review the quality of your current tools
Take stock of your current tools, that includes everything used to make or process your product and everything required to clean the facility itself. Consider the tool quality—are these presentable and acceptable for an inspector to see? Do your brushes have loose bristles? Has your mop seen better days? Tools that are made of low-quality materials or are not in top shape present potential risks for a food-safe environment. Note which tools need to be replaced and perhaps consider incorporating color-coded tools if you have not yet done so, as they are a great way to step up your food safety practices and safeguard against cross contamination.

5. Review and communicate the food safety plan and training procedures

Review your current employee training materials –in particular, your cleaning and sanitation measures and food handling procedures–and hold a meeting to go over current training protocols with your team. Consider the following questions:

  • Are the expectations made clear?
  • Are there references to procedures that are no longer up to date?
  • Is there appropriate signage that can be readily referenced?
  • Is information available for non-native speakers?
  • Are the appropriate channels in place for employees to voice concerns about these training procedures?

Be sure to take notes on each of these items that need to be addressed. One of the most important pieces of a food safety plan – and something inspectors pay close attention to – is that it is properly communicated to all employees. Taking detailed notes as you discuss these procedures will be helpful in documenting your training methodology for the food safety plan and, of course, will help you to ensure that the training procedures themselves are the best they can be.

6. Consider the documentation requirements for your industry.

Your industry might require certain specific documentation for your food safety plan, which can include facility policies, procedures, safety review records, maps and more. Additionally, some governing bodies require that the food safety plan is completed by a certified individual who doesn’t necessarily need to be an employee of the facility. Review all necessary requirements to ensure that you satisfy all of these standards for your next inspection.

Should you have any questions when getting ready to start on your plan, we suggest you reach out to a company that specializes in color-coding tools, as they have experience in creating plans to accommodate all kinds of identified risks and can be a great resource.