Using Simulations to Identify and Characterize Food Safety Enterprise Risks

This is the second article in a series explaining the benefits of applying enterprise risk management (ERM) strategies to identify, assess, and manage food safety risks. The first article1 offered a primer on ERM and the ways to leverage these strategies in a food safety and quality management program and may be helpful to read to put this second article in greater context.

Simulations are an essential component of any comprehensive crisis management strategy. However, understanding what a robust simulation entails and ensuring it is structured to challenge all aspects of the crisis plan under the microscope for evaluation will increase your company’s chances of not just surviving, but also thriving through, a recall or other crisis.

This article will outline what a simulation entails as compared with mock trace exercises and detail the benefits of conducting simulations to identify and characterize material risks to your company that will require mitigation strategies to reduce or eliminate those risks. Consequently, proper application of simulations is essential to identifying food safety enterprise risks.

What Are Crisis Simulations?

Simulations are a comprehensive challenge of all aspects of a company’s written policies and procedures. Whether a crisis response plan, food recall, a fire, or a cybersecurity attack, simulations are the most effective way of testing a company’s level of preparedness to identify and mitigate material risks short of having to practice the plan in an actual crisis. Best practice is to take the opportunity to pressure-test your recall/crisis management plans in a time of calm rather than a time of potential chaos.

What Is the Difference Between a Simulation and a Mock Trace—Aren’t They the Same Thing?

Many companies will answer with an emphatic yes when asked whether they conduct recall or food safety simulations. In reality, they are conducting mock-trace exercises. What’s the difference?

Briefly, a mock trace typically involves taking a given lot number of an ingredient or finished product and identifying immediately preceding and immediately subsequent supply chain steps. For example, a finished product mock trace would involve identifying the current location or distribution of all products representing the identified lot number, including any products that may have been manufactured using this given finished product lot (e.g., as an ingredient or a component of a meal) to determine the scope of affected product that may necessitate a market action (such as market withdrawal for a quality issue or a product recall for a food safety issue). In addition, this would involve traceback of all ingredients that were used to produce the finished product lot in question (and in our blockchain dreams, it would take only 2.2 seconds).

In contrast, a simulation typically involves staging a realistic scenario that could actually happen to one or more products produced or distributed by the company. Examples may include detection of a pathogen by a regulatory agency, identification of foreign material in your product by a customer, or a consumer alleging an allergic reaction to your product that isn’t supposed to contain the allergen that causes them to react. Other examples include a natural disaster that destroys the flagship production facility or an IT disaster that cripples a company’s production and distribution software platforms, impacting the ability to make and trace production. Any of these incidents could lead to a full-blown crisis requiring an all-hands-on-deck approach to identifying, escalating, assessing, mitigating, and communicating the associated risks in a way that protects the brand, stakeholder reputation, bottom line, and, most importantly, public health and safety.

In short, a mock trace primarily tests your systems, and a simulation is an end-to-end test of your people, process, and systems.

What Are Other Benefits of Simulations?

One of the key benefits of conducting a crisis simulation is that it provides your crisis management team an opportunity to “practice” the plan and identify any gaps that need closing under conditions of calm rather than crisis. It serves as an opportunity to put theory into practice, tug on loose threads, and see if anything unravels. Having the chance to sew up loose ends proactively rather than reactively in an actual crisis is a key ERM strategy.

Benefits reach even more broadly throughout the company. Challenging your recall or other crisis plans in a controlled setting also allows your company to become more operationally efficient, to develop strategies to maintain key relationships, even in challenging circumstances, with regulators, customers, suppliers, shareholders, boards, and consumers, thereby protecting the company’s reputation.

While the list of benefits could continue for pages, the last benefit we will point out is this: Simulations are excellent tools to demonstrate the value of food safety and quality as a brand and bottom-line protector, not a cost center. How, you may ask? By capturing and quantifying the potential economic impact of the simulated scenario and demonstrating how it could be even worse but for effective food safety and quality people, processes, and systems working together (e.g., to reduce the recall scope). Food safety and quality leaders have an opportunity to use that information as grounds for additional resources to ensure the risk of loss is mitigated to a level that doesn’t generate economic losses that could cripple the company.

For example, maybe your simulation reveals a persistent Listeria monocytogenes issue in your facility. The most recent positive was identified by the U.S. Food and Drug Administration (FDA) in a routine inspection where it performed extensive swabbing. The positive was analyzed using whole-genome sequencing. The result matches two positives of the same strain found in your environment 2 years ago in the same area and matches a finished product positive that was shipped to your largest customer. FDA determines that your product is adulterated and highly encourages your company to recall it. Further, your company has no idea why or from where this pathogen has taken up residency, so it decides to shut down for 3 days for a deep cleaning and sanitizing of the facility and equipment.

During the simulation, capturing the cost associated with the length of the shutdown and potential loss of your largest customer may show a material balance sheet risk—the definition of an enterprise risk. These numbers may be the business case food safety professionals need to support requests for resources, more testing, capital expenditure approvals for equipment of sanitary design, etc.

The Anatomy of a Simulation

High-level examples of simulation topics are helpful; however, more comprehensive case studies can serve as valuable road maps to help structure your own simulation to test your programs. We offer two examples below to provide a more comprehensive perspective on the anatomy of a simulation and how it can help pressure-test your program and serve as a vehicle to identify potential enterprise risk and for continuous improvement.

Example #1: A customer detects Listeria monocytogenes in a finished product

Fact #1

Your company manufacturers aged, soft and semisoft, and hard cheeses.
- Your largest customer performs periodic sampling and testing to verify your finished product meets specifications and to verify testing your company performs and reports in a certificate of analysis for each lot.
- This test reveals a presumptive positive for Listeria monocytogenes in your feta cheese lot number 1122.
- Your customer calls its account manager in your company to alert them to the matter.
- The customer has asked for a root-cause investigation and information on the extent of the problem. The customer wants this information in 4 hours as it believes it will need to alert the FDA.

What do you do? Does your account manager know to whom he or she should escalate this issue? How much time elapses before the person notifies the right people in your company? Do you recall the entire lot number 1122 of feta upon receiving this notification? If not, what additional information do you need to determine the appropriate response?

These are just a few of several questions that need answering, and fast. Your recall/incident management team needs to make these decisions quickly, understand their roles, regulatory reporting responsibilities, and more to beat the 4-hour clock given by your customer.

Now what?

Fact #2

Your recall coordinator requests a report from production to see what ingredients went into the feta and if other products were produced in the same line, requests sanitation to produce documents showing what cleaning and sanitation was performed before and after that production run, and asks a food safety/quality colleague for any evidence of environmental contamination of the product prior to packaging.
- Your trace report reveals that the feta lot in question was shipped to two other key customers.
- You have approximately 10 percent left in your inventory.
- The sanitation records document a full cleaning and sanitizing prior to the production run of the suspect product; however, the records for postproduction were incomplete and unsigned by the sanitation or line operator during pre-op inspections.
- Production records show that mozzarella was run after the subject feta production run.
- Your environmental monitoring records reveal two Listeria spp. positives, one on a zone 2 nonfood contact surface area and one on a zone 1 (food contact) site that is part of your feta production line. Your company did not speciate or confirm those results.

Is this information sufficient to make a decision whether to recall and to define the scope of a potential recall? If not, what more do you need to know?

Remember, it is a rare day that we can obtain 100 percent of the information we need to make these decisions. More often than not, the clock runs out before all the information is in—whether it’s the regulatory reporting clock of FDA’s Reportable Food Registry or the clock that tolls in the court of public opinion (it’s a tough story to tell that “we waited 2 weeks to issue a recall until we had all the facts”).

You see the flow and escalation of events? Simulations can go on, and on, with more facts sprinkling in, just as if this were real life. This example is meant to illustrate the importance of clearly defined incident identification, escalation, and decision-making procedures because time is of the essence. Clear decision trees and procedures are useful tools to support the rapidly changing dynamics involved in managing a recall.

An additional brief example follows.

Example #2: An environmental sample tested by FDA yields Salmonella

For this simulation, you may start the scenario with a call from someone playing the role of an FDA inspector who is contacting the facility to report that the agency found Salmonella in an environmental zone 3 sample that was collected 7 days ago and that they will visit the facility starting in 60 minutes. The person or team that will impersonate the FDA will then conduct an in-plant investigation that may not involve just a walk-through and record review but may also involve collection of additional environmental samples (that could even be tested by a contract lab provided associated risk mitigation guardrails are in place). During the plant visit, FDA can even introduce new information that the Salmonella isolates matched an isolate that was obtained from the same facility 6 years ago. Or they could introduce new evidence that two human cases match the environmental isolate by fewer than 7 single-nucleotide polymorphisms. A scenario like this could realistically pressure-test many aspects of both your food safety plans and your crisis-response procedures.

Additional examples could consist of one of your suppliers calling to let you know that the soy protein you purchased as an ingredient was found to contain dairy protein at 10 percent or that hard and sharp glass fragments were found in a lot of ingredient recently shipped to you. The food safety-related examples are practically endless.

But the benefits of simulations do not end with food safety scenarios.

Simulations are as easily applicable to nonfood safety incidents as they are to food safety incidents. IT, cybersecurity, natural disasters, and even the recent COVID-19 pandemic are all topics ripe for simulations that pressure-test the entirety of these programs.

Our experiences show that there are some key considerations that will help with performing effective and realistic simulations. First and foremost, keep the simulations as realistic as possible. For example, only two or three people in leadership roles should know when and where this simulation will be performed. Then hire an outside expert to show up at your facility and show their ID and a letter from the CEO or the vice president of food safety stating that they were hired to perform a food safety incident simulation and that everyone in the facility has to follow the same procedures they would if this were real. And then let things unravel from there: The plant manager will be out because she is at the dentist; the quality assurance manager will be a new hire without the benefit of time to read the recall plan; and that’s just the start. Another key consideration is that the CEO has to play his or her part: to demonstrate commitment from the top and especially if he/she is to be called at some point because the CEO heads the crisis response team or makes the final “go/no-go” decision. Also, involve your CFO and have her be responsible for estimating the costs associated with the incident. It will soon be clear how planning for, and investing in, food safety and crisis-related resources ahead of a crisis is justified.

Conclusions

While food safety risks may not always reach the top of the list of enterprise risks (defined as material balance sheet risks), this may often be because the C-suite underestimates the balance sheet risk associated with food safety issues. Well-designed and -executed simulations of food safety (and quality) risks represent an underutilized tool to test all aspects of your food safety program and your food safety crisis response plan and to quantify the potential business impact of a food safety incident. Start today—particularly since at the moment, COVID-19 mitigations need focus too, pulling most of your food safety resources in even more directions than usual!