Tag Archives: hazards

Dairy

Q3 Hazard Beat: Milk & Dairy Products

By Food Safety Tech Staff
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Dairy

The following infographic is a snapshot of the hazard trends in milk and dairy from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. For the past several weeks, Food Safety Tech has provided readers with hazard trends from various food categories included in this report. Next week will conclude this series.

Mailk dairy hazards, HorizonScan
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in fruits and vegetables.

Seafood

Q3 Hazard Beat: Seafood

By Food Safety Tech Staff
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Seafood

The following infographic is a snapshot of the hazard trends in seafood from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the past and next few weeks, Food Safety Tech is providing readers with hazard trends from various food categories included in this report.

hazards, seafood, HorizonScan
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in herbs and spices.

Spices, Paprika, Curry

Q3 Hazard Beat: Herbs and Spices

By Food Safety Tech Staff
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Spices, Paprika, Curry

The following infographic is a snapshot of the hazard trends in herbs and spices from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the next several weeks, Food Safety Tech will provide readers with hazard trends from various food categories included in this report.

Hazards, Herbs, Spices
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in meat and meat products.

Alert

Q3 Hazard Beat: Meat and Meat Products Trends

By Food Safety Tech Staff
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Alert

The following infographic is a snapshot of the hazard trends in meat and meat products from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the next several weeks, Food Safety Tech will provide readers with hazard trends from various food categories included in this report.

HorizonScan, Meat hazards
2019 Data from HorizonScan by FeraScience, Ltd.

View last week’s hazards in poultry.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part I)

By Frank Pisciotta, Spence Lane
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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series is intended to assist facilities that have not yet conducted vulnerability assessments or wish to review those already conducted, by leveraging lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 1: VA outcomes are greatly enhanced if a physical security professional is consulted. In support of this contention, there are several physical security mitigation strategies, which can be employed to support a food defense program, that are frequently under-utilized and are not optimally managed by non-security staff. Also, the FDA seems to promote the use of cameras even though this equipment is unlikely to prevent an incident of intentional adulteration. For organizations that choose to use video surveillance, a competent security professional can help organizations engineer and operate video surveillance for maximum benefits and to meet challenging record-keeping requirements when this mitigation strategy is included in a food defense plan.

Lesson 2: Given the focus by the FDA on the insider, a formal insider threat detection program is highly recommended. Trying to promote the common, “See Something, Say Something” strategy may not be enough. For example, if employees are not clearly told what to look for in terms of uniform requirements, how to identify persons who do not belong or changes to a coworker’s baseline behavior, which may indicate moving toward a path to violence or sabotage, then “See Something, Say Something” may end up being no more than a catchy slogan.

A key element of an insider threat detection program is the completion of effective background checks for all persons who will be allowed in the facility unescorted. This includes temporary employees and contractors. A common theme in many of the recent, serious intentional adulteration incidents was that the person responsible was involved in some sort of grievance observable to coworkers and supervisors. In all insider threat detection programs, the grievance becomes an important trip wire. The Carnegie Mellon University Software Engineering Institute has published a document titled, “Common Sense Guide to Mitigating Insider Threats, Sixth Edition”. In this document is some particularly helpful guidance that can be used to stand up an insider threat detection program, but this is an effort that can take some time to fully implement.

Lesson 3: The FDA has made it abundantly clear that they believe the focus for the food and beverage industry should be the radicalized insider. A closer look at all the recently publicized contamination events suggests that there are other profiles that need to be considered. A good foundational model for building profiles of potential offenders can be found in the OSHA definitions for workplace violence offenders, which has been expanded to address ideologically based attacks. Table I applies those descriptions to the food and beverage industry, with an asterisk placed by those offender profiles that exist in recent incidents and discussed later in the text.

Class OSHA Workplace Violence Offender Description Motivation Translated to the Food and Beverage Industry
1 The offender has no legitimate relationship to the business or its employee(s). Rather, the violence is incidental to another crime, such as robbery, shoplifting, trespassing or seeking social media fame. Behavioral Health Patient *
Social Media Fame Seeker *
Copycat *
Extortion *
Economic motivation *
2 The violent person has a legitimate relationship with the business—for example, the person is a customer, client, patient, student, or inmate—and becomes violent while being served by the business, violence falls into this category. My load isn’t ready, you are costing me money
3 The offender of this type of violence could be a current employee or past employee of the organization who attacks or threatens other employee(s) in the workplace. I am upset with a coworker and adulterate to create problems for that person *
I am upset with the company and adulterate as retribution and to harm the brand *
Youthful stupidity
I am not paid enough *
4 The offender may or may not have a relationship with the business but has a personal (or perceived personal) relationship with the victim. I am upset with an intimate partner/ coworker and adulterate to create problems for that person
5 Ideological workplace violence is directed at an organization, its people, and/or property for ideological, religious or political reasons. The violence is perpetrated by extremists and value-driven groups justified by their beliefs. Radicalized Insider
Table I. A description of OSHA workplace violence offenders and how it can be applied to the F&B industry.

A supermarket in Michigan recalled 1,700 lbs. of ground beef after 111 people fell ill with nicotine poisoning. The offender, an employee, mixed insecticide into the meat to get his supervisor in trouble. In Australia, the entire strawberry industry was brought to its knees after a disgruntled supervisor “spiked” strawberries with needles. There were more than 230 copycat incidents impacting many companies. A contract employee in Japan, apparently disgruntled over his low pay, sprayed pesticide on a frozen food processing line resulting in illnesses to more than 2,000 people. A contract worker upset with a union dispute with the company at a food manufacturing plant videoed himself urinating on the production line, then uploaded the video to the Internet. Be cognizant of any grievances in the workplace and increase monitoring or take other proactive steps to reduce the risk of intentional adulteration.

Lesson 4: The IA Rule requires that every point, step and procedure be analyzed to determine if it is an actionable process step (APS). The Hazard Analysis Critical Control Point flow charts are a good starting point to comply with this element of the law but cannot be counted on completely to achieve the standard of analyzing every point, step or procedure. Critical thinking and persons familiar with the production process need to be involved to ensure that no steps are missed. Oftentimes companies modify the HACCP flow diagrams after a VA.

Lesson 5: The FDA states in the second installment of guidance (here’s the full copy) to the industry that, “There are many possible approaches to conducting a VA. You may choose an approach based on considerations such as the time and resources available and the level of specificity desired. You have the flexibility to choose any VA approach, as long as your VA contains each required component (21 CFR 121.130).”

The FDA further states that the Key Activity Type, or KAT method, is an appropriate method for conducting a VA because it reflects consideration of the three required elements and the inside attacker. Using this methodology alone, however, can result in substantially more APS’s, which might otherwise be ruled out for practical purposes such as a lack of accessibility or a lack of feasibility to contaminate the product at a point, step or procedure. We have experienced up to a 90% decline in APS’s by utilizing another FDA recommended assessment approach, the hybrid approach, which assesses each point, step or procedure as first whether it is a KAT. Then to qualify as an APS, it must also trigger positively for public health impact, accessibility and feasibility to contaminate the product.

Organizations who have yet to execute vulnerability assessments (due July 26, 2020) or who may wish to reflect back on their existing VA’s in an effort to eliminate unnecessary APS’s should find these strategies helpful to focus limited resources to the areas where they can have the greatest effect. The next two articles in this series will cover more information on electronic access, the value of site tours, comparisons to drinking water security strategies, dealing with multi-site assessments and more.

Poultry

Q3 Hazard Beat: Poultry and Poultry Products Trends

By Food Safety Tech Staff
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Poultry

The following infographic is a snapshot of the hazard trends in poultry and poultry products from Q3 2019. The information has been pulled from the HorizonScan quarterly report, which summarizes recent global adulteration trends using data gathered from more than 120 reliable sources worldwide. Over the next several weeks, Food Safety Tech will provide readers with hazard trends from various food categories included in this report.

Hazard Trend Report, Poultry & Poultry Products
2019 Data from HorizonScan by FeraScience, Ltd.
Jill Ellsworth, Willow Industries
FST Soapbox

Modeling Cannabis Safety from Food and Beverage Quality Regulations

By Jill Ellsworth
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Jill Ellsworth, Willow Industries

There’s a reason you can eat or drink pretty much anything you want from American grocery stores and not get sick. Food manufacturing is highly regulated and subject to rigorous quality control.

Before food and beverages hit store shelves, the manufacturer must have a Hazard Analysis Critical Control Point (HACCP) system in place. The HACCP system requires that potential hazards—biological, chemical and physical— be identified and controlled at specific points in the manufacturing process. In addition, fresh foods undergo a kill-step. This is the point in the manufacturing or packaging process where food is treated to minimize and remove deadly pathogens like bacteria, mold, fungus and E. coli.

Generally speaking, when cannabis hits dispensary shelves, a less stringent set of rules apply, despite the fact that cannabis is ingested, inhaled and used as medicine. Cultivators are required to test every batch, but each state differs in what is required for mandated testing. Compared to the way food is regulated, the cannabis industry still has a long way to go when it comes to consumer safety—and that poses a considerable public health risk. In the early stages of legalization, the handful of legal states did not have rigid cannabis testing measures in place, which led to inconsistent safety standards across the country. State governments have had a reactionary approach to updating testing guidelines, by and large implementing stricter standards in response to product recalls and customer safety complaints. While local regulators have had the best intentions in prioritizing consumer safety, it is still difficult to align uniform cannabis testing standards with existing food safety standards while cannabis is a Schedule I substance.

The stark differences in safety measures and quality controls were first obvious to me when I moved from the food and beverage industry into the cannabis industry. For five years, I operated an organic, cold-pressed juice company and a natural beverage distribution company and had to adhere to very strict HACCP guidelines. When a friend asked me for advice on how to get rid of mold on cannabis flower, a light bulb went off: Why was there no kill step in cannabis? And what other food safety procedures were not being followed?

What to know more about all things quality, regulatory and compliance in the cannabis industry? Check out Cannabis Industry Journal and sign up for the weekly newsletterThe current patchwork of regulations and lack of food safety standards could have dire effects. It not only puts consumer health in jeopardy, but without healthy crops, growers, dispensaries and the entire cannabis supply chain can suffer. When a batch of cannabis fails microbial testing, it cannot be sold as raw flower unless it goes through an approved process to eliminate the contamination. This has severe impacts on everyone, starting with the cultivator. There are delays in harvesting and delivery, and sometimes producers are forced to extract their flower into concentrates, which really cuts into profits. And in the worst cases, entire crop harvests may have to be destroyed.

So, what do cannabis cultivators and manufacturers have to fear the most? Mold. Out of all the pathogens, mold is the most problematic for cannabis crops, perhaps because it is so resilient. Mold can withstand extreme heat, leaving many decontamination treatments ineffective. And most importantly, mold can proliferate and continue to grow. This is commonplace when the cannabis is stored for any length of time. Inhaling mold spores can have serious adverse health effects, including respiratory illness, and can even be deadly for immunocompromised consumers using it for medical reasons.

What the industry needs is a true kill step. It’s the only way to kill mold spores and other pathogens to ensure that they will not continue to grow while being stored. States that mandate microbial testing will benefit from the kill step because more cultivators will be in compliance earlier in the process. In states that don’t require comprehensive microbial testing, like Washington and Oregon, the kill step is a critical way to provide consumers with a preemptive layer of protection. Microbial testing and preventative decontamination measures encourage customer brand loyalty and prevents negative press coverage.

Adopting a HACCP system would also build additional safeguards into the system. These procedures provide businesses with a step-by-step system that controls food safety, from ingredients right through to production, storage and distribution, to sale of the product and service for the final consumer. The process of creating HACCP-based procedures provides a roadmap for food safety management that ultimately aligns your staff around the goal of keeping consumers safe.

It’s high time for the cannabis industry to adopt FDA-like standards and proactively promote safety measures. Cannabis growers must implement these quality controls to ensure that their products are as safe to consume as any other food or drink on the market. Let’s be proactive and show our consumers that we are serious about their safety.

Brett Madden, Aviaway
Bug Bytes

Bird Problems and Control Methods for Food Production Facilities

By R. Brett Madden
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Brett Madden, Aviaway

Various types of pest birds can impact food plant structures and facility surroundings. Even a single bird that finds its way into a food plant can trigger a host of concerns such as, failed audits, product contamination, plant closure, production stoppage, lost revenues, fines, structural damage, health hazards to occupants and fire hazards.

In most cases, a food plant operation has a bulletproof pest control plan; however, in most cases, birds are always an afterthought in most pest management plans. After inspecting and consulting numerous food plants, I hear the same story over and over: “I have a person in the warehouse that can chase them out” or, “are birds really a big deal?” or, “why do I have to be concerned about birds?” and on and on. Despite what you may think, birds are a big deal, and you should take them seriously!

Pest management, pigeon droppings HVAC
Larger birds, such as pigeons, can cause more problems around the exterior of a facility on HVAC units as seen here. (Image courtesy of Aviaway Bird Control Services & Consulting)

Since food processing plants contain areas that have very sensitive environments, birds can introduce various adulterants and harmful contaminants. Birds can cause potential harm to humans due to foodborne illness.

Pest Bird Species

There are four main pest birds: Pigeon, Starling, Sparrow and Seagull. Each one of these birds can cause a host of concerns and issues for food processing facilities. Just one bird can cause catastrophic damage. In most cases, small pest birds such as Sparrows and Starlings can gain access into a facility through a variety of ways:

  • Damaged bumpers around truck bay loading dock doors.
  • Open doors (seems obvious, but I always find doors wide open during audits).
  • General building deficiencies.

Larger birds, such as Pigeons and Seagulls, typically cause more problems around the exterior of a facility on ledges, rooftops, HVAC units, loading docks and related areas.

In either case, these various types of pest birds can cause significant problems on the interior and exterior of food plants.

Conducive Conditions

In most cases, facilities want to reduce as many conducive conditions as they can around and within the facility in a timely fashion. A conducive condition is one whereby due to a building condition, structural design, equipment operation, food or water source, or surrounding conditions (i.e., near a public landfill, raw materials mill or body of water) can attract pest birds to a facility. With each of these conditions, great care must be taken to reduce as many conducive conditions as possible.

Examples of Conducive Conditions

Structural Conditions

  • Loading docks/canopies with open beams and rafters
  • HVAC equipment
  • Pooling water (roof and landscaping)
  • Structural overhangs and ledges
  • Open access points
  • Landscaping (types of plantings)
  • Damaged truck bay bumpers
  • Gaps and opening around the structure
  • Doors with improper sealing

Human Conditions

  • Open dumpsters
  • Overflowing dumpsters
  • Dirty dumpsters
  • Product spillage
  • Employees feeding birds
  • Doors left open

All these conducive conditions, if left unresolved, can lead to significant bird problems. Reducing as many conducive conditions as possible will be the first step of any bird management program.

Bird Control Methods

From the start, your facility should have a bird management plan of action. For the most part, bird problems should not be left to be handled internally, unless your staff has been properly trained and has a bird management plan in place.
Most birds are protected by the Federal Migratory Bird Treaty Act of 1918. However, Pigeons, Sparrows, and Starlings are considered non-migratory birds and are not protected under this Act. Even though these three bird species are not protected, control methods still need to be humane. More specifically, your bird control program must also comply with is the American Veterinary Medical Association (“AVMA”) Guidelines for the Euthanasia of Animals if this is the control method selected. The AVMA considers the House Sparrows, Feral Pigeon, and the Common Starling “Free-Ranging Wildlife.” And Free-Ranging Wildlife may only be humanely euthanized by specifically proscribed methodology.

In addition to the above-mentioned regulations, various regulations regarding the relocation of birds/nests may also apply. I also always recommend checking with local and state agencies to ensure that there are no local regulations that may apply. Bottom line: Don’t rely on untrained internal practices; one misstep could result in heavy financial fines and penalties.

Bird Management Strategies

First Line Defense

  • Stop any bird feeding around the facility immediately
    • Any bird management plan should have a clear policy prohibiting employees from feeding birds. Once birds have been accustomed to routine feeding, the birds will continue to return.
  • Eliminate Standing Water Sources
    • All standing or pooled water needs to be eliminated. Thus, routine roof inspections need to be conducted to ensure drains are working properly.
    • Landscape irrigation needs to be calibrated to ensure no puddling of water in areas of low sun exposure.
  • Proper Sanitation Practices
    • Ensure that dumpster lids are closed when not in use.
    • Trash removal frequency adequate.
    • Routine cleaning of trash receptacles.
    • Immediate removal of spilled food.
  • Eliminate Entry Points
  • Survey the facility to ensure that all holes are properly sealed.
    • Around truck bay bumpers and doors
  • Exhaust vents are properly screened.
  • Windows are closed and have screens when in use.

The most appropriate bird control strategy will be determined based on the severity of the bird pressure. For example, if the bird pressure is high (birds have nested), then in most cases, you will only be able to use bird exclusion methods. Whereas, if the bird pressure is light to moderate (birds have not nested), bird deterrent methods can be used. This is an important distinction. Bird exclusion is physically changing the area to permanently exclude said pest birds. Whereas, bird deterrent devices inhibit birds from landing on treated areas.

Bird Deterrent Methods

After the previously mentioned first-line strategies have been implemented, the next step would be to install bird deterrent products (birds have not nested).

  • Bird Spikes
  • Bird Wire
  • Electrified Shock Track
  • Bird Gel
  • Sonic & Ultra Sonic Devices
  • Lasers and Optical Deterrents
  • Hazing & Misting Devices
  • Pyrotechnics
  • Live Capture

Bird Exclusion Methods

If the birds have nested in or around the facility, the next step would be to install bird exclusion products (birds have nested).

  • Bird Netting
  • Ledge Exclusion (AviAngle)
  • Architectural modifying structural
  • Aggressive Harvesting (Targeting)

Prevention Strategies

The best prevention strategy is planning and knowledge. Conduct a bird audit and develop a bird management plan before birds get near or inside the facility. The key is to act quickly, as soon as an incident occurs. I find countless times when I am called in to consult or service a food plant, that the birds got into the facility and no one knew what to do, and as a result, the birds remained within the facility for an extended period, thus increasing the risk of exposure. It is always much easier to remove a bird when they are unfamiliar with their surroundings. Whereas, it is much more difficult to remove birds from a facility that has had a long-standing bird problem.

Once you have a plan, who oversees the bird management plan? Are thresholds determined and set for various areas of the facility? For example, a zero threshold in production areas? Threshold levels will be set based upon by location and sensitivity of the said location. What steps are going to be taken to remove the bird? For how long is each step conducted? These questions need to be answered and developed to stay ahead of bird problems.

Reduce as many conducive conditions as possible. The longer a conducive condition stays active, the more likely birds, as well as other wildlife or rodents, will be attracted to the site and find a way into the facility.

Pathogen Contamination & Hazards

Birds present a host of problems, whether they are inside or outside of a facility. Birds can roost by air vents, and the accumulation of bird feces can enter the facility air system. Bird droppings on walkways and related areas allow for the possibility of vectoring of said dropping when employees step on droppings. Thus, spreading fecal matter/spores and other contaminants to areas throughout the facility.

If birds are within the facility, droppings can spread on product lines, raw materials, stored products, equipment and more, thus, causing contamination. Because of a bird’s ability to fly, they are perfect creatures to spread various diseases, pathogens, ectoparasites and fungal materials. Diseases such as Histoplasmosis, Salmonella, Encephalitis, E-coli, Listeria, and more. Birds have been known to transmit more than 60 infectious diseases!

Besides the spread of potentially harmful contaminants throughout the facility, bird droppings and nesting materials can also create a host of additional problems:

  • The acidity in bird droppings can damage building finishes, façade signs, lighting and more.
  • Wet bird droppings can create a slip and fall hazard.
  • Bird nesting materials can create a fire hazard around façade signs, exit signs and light fixtures.
  • Bird nesting and debris can clog roof drains and cause roof leaks from standing water.
  • Introduction of ectoparasites into the facility such as bird mites, lice, fleas, ticks and more.

Conclusion

In summary, taking a proactive approach to bird control is the best practice. Reduce food, water and shelter sources (aka conducive conditions) promptly. Pest management programs need to implement a more in-depth section of the program for bird control. Like integrated pest management, bird control should be based upon an integrated method. Each facility will have its unique challenges. As such, each bird management plan needs to be tailored to the specific site. A well designed and balanced, integrated bird management program will provide long-term and cost-efficient bird control.

The next article in this series takes a closer look at how to prepare an integrated bird management audit program.

Don Groover, DEKRA OSR
FST Soapbox

Why Changing Workplace Safety Culture Must Start From the Top

By Don Groover
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Don Groover, DEKRA OSR

Workplace safety in the food industry can be challenging. The precision required of workers in slaughter, meat packing or wholesale processing facilities can lead to serious harm or worse. The Bureau of Labor Statistics reports that the potential hazards in this industry are many: Knife cuts to the hands and the torso, falls, back injuries, exposure to toxic substances, carpal tunnel syndrome, and even infectious diseases.

This industry may have more challenges in safety than any other industry. Yet, there are companies that excel in safety performance, even given these challenges.

Organizations that are serious about protecting their workers must do far more than react after an injury or rely on awareness-based safety efforts. Typically this approach only delays the next injury. Safety is not just about responding to injuries, but is about the ongoing identification of exposure, the implementation of control systems, and assuring these controls are used to neutralize the exposure.

The challenge is that the root of why an exposure exists or can even thrive in an organization maybe due to culture, organizational urgency, operational instability or a lack of understanding about the concept of exposure, to mention a few. Because the issue is bigger than safety programs, safety excellence requires all levels of an organization, from the C-Suite to the frontline worker, committing to a process that focuses on exposure. This needs to be done in a way that creates trust that safety is a value and if there is a values conflict, that safety has top priority.

Ultimately, it’s about shifting culture by making a safety excellence a priority.

Oftentimes leaders articulate that they want a safe culture, but they may not fully understand their role in creating the culture they desire and how they sustain the change. Senior leaders must go beyond a catch phrase approach to safety and actually articulate what are the cultural attributes they want to see firmly embedded in their organization.

These may be:

  • Workers watching out for each other and a willingness to step in if somebody is at risk.
  • Excellent housekeeping.
  • Workers stepping up to address physical hazards without being asked.
  • A willingness to report safety concerns and incidents.

Once the attributes are defined, then the organization is ready to understand what it takes to support that culture.
However, senior leadership needs to drive that change. Once upper management understands that accountability starts with them and not with the worker, they can move forward and create a culture that reinforces practices that identify potential exposure before incidents take place and not after. Doing so not only has the potential to lower incident rates, but it also:

  • Boosts morale. Workers believe the company has their backs and will commit to safety principles.
  • Strengthens trust between workers and management. Workers believe that safety excellence is a shared responsibility.
  • Increases commitment to all organizational objectives. Social theory research has shown that if you do something for someone else, they experience a pull to reciprocate. The more we do, the stronger the pull. When management shows that they can be trusted with employee safety, employees are free to reciprocate in other areas.

Our strongest and deepest relationships are built on a foundation of safety—not just physical safety but also psychological safety. If we come to believe that another person is interested in our physical or mental wellbeing, the foundation strengthens.

When leadership uses the power of safety they will see employee engagement increase. And the safety implications of worker engagement are profound: Disengaged workers are focused on their own safety. Involved workers are concerned with their own safety but are likely also concerned with the safety of their workmates and perhaps certain other people they interact with. Fully engaged workers are concerned with the safety of everyone around them and without prompting take proactive actions to help others.

Engaged workers are more likely to follow rules and procedures, be more receptive to change, and give discretionary effort. It seems like all companies are doing some type of engagement survey, yet the actions they develop to try and raise their scores are often lacking. Organizations that are serious about having an engaged workforce must fully understand how safety is foundational to engagement. More importantly, safety involvement activities need to be designed and implemented in a way that moves employees beyond mere involvement to full on engagement.

When a company demonstrates it values safety, workers will volunteer to get involved. Leadership must carefully consider what safety involvement activity is right for the culture. When employees participate in a successful and rewarding involvement activity, their personal level of engagement will move upward. Leadership must then figure out how to expand safety involvement. This isn’t done by demanding involvement. It requires purposeful planning and patience.

Melody Ge, Corvium
FST Soapbox

Compliance with the Intentional Adulteration Rule: Using FMEA for Your Vulnerability Assessment

By Melody Ge
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Melody Ge, Corvium

What is FMEA? What is a vulnerability assessment (VA)? How can these two be linked? Despite what you may think, there are similarities between these two methods. FMEA (Failure Modes and Effects Analysis) methods can be utilized to help objectively assess the vulnerable steps within your process.

After July 26, 2019, businesses other than small and very small businesses (defined by FDA) must comply with the FSMA Intentional Adulteration (IA) Rule. The rule is intended to enforce industry regulation to conduct vulnerability assessments and address proper mitigation plans to prevent any potential fraud risks within the food defense plan. For small businesses, the compliance date is July 27, 2020; for very small businesses, the compliance date is July 26, 2021.

Although the IA rule does not specify a particular method that you must use to conduct your VA and address proper mitigation plans, the following elements must be considered during your evaluation and mitigation strategy and must be implemented at each actionable step afterwards:

  • The potential public health impact (e.g., severity and scale) if a contaminant were added (21 CFR 121.130(a)(1))
  • The degree of physical access to the product (21 CFR 121.130(a)(2))
  • The ability of an attacker to successfully contaminate the product (21 CFR 121.130(a)(3))

During the 2019 Food Safety Consortium, Melody Ge will present: How to prepare ourselves in this data-driven transitioning time for the smart food safety era? | October 2 @ 10 am FMEA is a Six Sigma method widely used in operations when implementing a new process. It is a structured approach to discover potential failures that may exist within the design of a product or process. Within FMEA, the RPN (Risk Priority Number) score is used to prioritize risks and is calculated by Severity × Occurrence × Detection. RPN is a quantified number that helps you prioritize risks when determining actions. If we employ the same mentality, FMEA is a useful method in helping to identify vulnerable steps based on the risk within your process. Take a close look at how the RPN is generated; the following three components are also important during the vulnerability assessment.

Severity or the potential public health impact (e.g., severity and scale) if a contaminant were added.
Severity is identified when considering the consequence of when a processing step goes out of control; or thinking about the severity of the health impact. We can consider those impacts or consequences using four common categories:

  • Biological contaminants
  • Chemical contaminants
  • Physical contaminants
  • Intentional adulteration for economic gain contaminants

Occurrence or the degree of physical access to the product.

Occurrence is identified when considering how frequently a process step is expected to go out of defined controls. Is it once a week or once a month? Depending on how often the step goes out of defined controls, this will trigger different action steps as well as mitigation plans.

Detection or the ability of an attacker to successfully contaminate the product.

Detection is considered by how easy it can be detected when the failure occurs. For example, within the food production operation, mixing steps is relatively easier than a CIP step to be detected. More references could be found in FDA’s definition of KAT (Key Activity Types, as discussed in the draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration”), such as:

  • Bulk and liquid receiving and storage
  • Liquid storage and handling
  • Secondary ingredient handling
  • Mixing and similar activities

Once the RPN is identified, then the vulnerable steps can be sorted based on the RPN. To utilize this approach, Table 1 provides a template to be considered using FMEA for the vulnerability assessment.

Process Step Description Is it KAT? (Y/N) RPN Action Process Step Mitigation Strategy Explanation
Sev Occ Det RPN
Table 1: Determine the vulnerable steps (for reference)

As IA rules regulate, a mitigation plan must be generated once a vulnerable step is identified. The intention of the plan shall ensure those risks identified are mitigated and controlled so that the final finished products are not impacted or contaminated. One tip to begin this process is to start with reviewing your current control plan for potential food safety risks. As FSMA Preventive Controls are fully implemented, all food plants shall have a food safety plan in place with validated control plans that are intended to reduce risks for potential physical, chemical, biological and adulteration for economic gain. Sometimes, these risks are highly associated with potential vulnerable steps for intentional adulteration, especially those processing steps associated with potential economic gain hazards. If those controls are not working properly, then we can seek out other mitigation plans. Nevertheless, regardless of what steps are taken, they have to be validated to show that the IA risks are effectively mitigated. Monitoring and verification shall be conducted as well once the mitigation plan is implemented.

Of course, like all food safety management systems, every food plant should have its own designated plans based on the products being produced, operations implemented and the nature of the production. Ultimately, it will be your choice to find an effective method that fits your production culture. However, the intention should always be in compliance with the IA rules: Identify the vulnerable steps within the process, and conduct mitigation plans to control the risks of intentional adulteration.