Tag Archive for: product recall

Last week we talked about the importance of mock recalls. It was inferred that companies find mock recalls painful, but maybe some companies love them. That being said, mock recalls are crucial to the survival of a company if a full recall is necessary. “The Preventive Controls for Human Food regulation requires the development of a written Recall Plan when a hazard analysis identifies a hazard requiring a preventive control.” The rule discusses “reviews definitions of recall classes, required elements of a Recall Plan, who to notify when a recall is necessary, how to conduct effectiveness checks and methods that can be used to dispose of affected product.”

Recently I received a call and a company had an adulterated product from a source overseas. The call started with an attorney and ended with company management over a series of conversations in just days. The outcome was a Class III recall, and it was not a danger to human health – just an ingredient that was not for use in the United States. The company took all of the right actions and, even though a tremendous amount of work was put in over a short period of time, the proper actions were followed. This is why mock recalls are so important for the viability of a company. Knowing what to do and having an internal team and external advisors can and will save time, money, and possibly a brand if handled correctly.

“Recalls are actions taken by an establishment to remove an adulterated, misbranded or violative product from the market. In other words, a product for which FDA or a state could take legal action against the company would be subject to recall. If a company withdraws a product that does not violate food law or the product has not entered the marketplace, these situations dealing with quality issues are not usually considered recalls but may be considered a stock recovery or market withdrawal. Three classes of recalls are defined based on the potential health effects.

    • A Class I recall is the most serious and involves product that has a reasonable probability of causing serious injury, illness or death.
    • Class II recalls may cause temporary illness that typically resolves in full recovery. For Class II recalls, death and other serious consequences are not likely.
    • Class III recalls are not likely to cause illness but are still in violation of the law. Typically, a company voluntarily conducts a product recall, either on their own accord or at the request of FDA or a state.

FDA has the authority to require a company to conduct a recall in Class I situations.” (Preventive Controls for Human Food Curriculum)

The largest factor in determining a recall is understanding your hazard analysis. If you do not understand where a person is reasonably likely to become injured or ill then your company cannot fully implement a product’s recall. There are many factors that work in conjunction with one another to establish when a recall should be implemented. You must understand your process and what products are coming in as ingredients and what products are leaving your facility. A Class I, II, or III recall may not even be your company’s fault from the beginning. For example, a company could receive an adulterated ingredient or could have been shipped the wrong labels. However, a company could also be at fault because they did not properly check their labels or they could not have followed another preventive control that allowed for a product to be potentially harmful to the consumer.

I have been involved in a Class I recall where the manufacturer had data that led the regulatory authority to believe that a raw material came from a supplier that had a pathogen in the raw material. At this point, the game changes because a company must find and isolate any potentially adulterated product. They must then work with the recall team to make sure that specific product has not been sent to the consumer until such time as proper testing and evaluation of the product has been conducted. These recalls are time consuming and are tough decisions that must be made – but ultimately the safety and the security of the food supply in the most important factor.

Recall teams are critical to the process of deciding when a recall is necessary and what is to be done in case a recall is, in fact, initiated. “The owner, operator or agent in charge of a facility is accountable for the safety of the food and must ensure that a Recall Plan is written. A recall coordinator and recall team are typically identified ahead of time. The recall team should include all functions necessary to collect accurate and complete information. For example, production, shipping, quality assurance, sales and administrative personnel should be considered as members of the recall team. If the firm has multiple locations, the team may include corporate team members from different departments (e.g., safety, quality assurance, distribution, etc.). Each recall team member should have clearly defined roles.”

A recall plan must have a hazard analysis and dedicated team to make sure that an effective recall, if necessary, can be completed with maximum efficiency. There are many ways to have your written documentation to prepare for a recall and there is an abundance of work that must be completed before, during and after a recall. If you have a recall you must be prepared for one and understand the impact, you must be ready to act and you have to have programs in place to implement documented corrective actions. connectfood.com has recall planning tools available for companies, so if you need help we are here for you to contact at connectfood.com.

About the Author
Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

Let’s spend some time addressing a topic that not one single food manufacturer or distributor enjoys discussing: product recalls. Let’s face it, a product recall could be one of the largest headaches your company has to face, but if completing a smoothly operated and well-organized recall means no consumer gets ill or passes away, it is worth the preparation and action.

Mock recalls are a vital part of your company’s food safety chain. The way you plan for an event, such as a recall, will determine how the event will go in the case of a time-sensitive emergency. To begin, “what is a mock recall, and why do we need to do one?” Jumping right in, a mock recall is a test run at carrying out a product recall and a way of finding the insufficiencies in your written recall plan. During a mock recall, a consultant or simply your facility manager will oversee the process of what a specific product recall would look like. The overseer will take a good look at your recall team -who you have assigned to each task, they will double check the phone numbers and contact information for your U.S. Food & Drug Administration (FDA) representative, the statement you would release to the public, etc. Ultimately, they will make sure that your facility would be able to smoothly execute what your documentation outlines without straying from your written food safety and recall plan.

According to the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food: “If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product. The recall plan must include procedures to notify consignees, to notify the public when necessary, to conduct effectiveness checks and to appropriately dispose of recalled product.”

A mock recall can be conducted as a scheduled event or as a surprise to the facility employees. Of course, there are advantages to both. Scheduling your mock recall will ensure that you’ve organized your documentation to the best of your ability, and can run the mock recall with absolutely no surprises or hiccups. This will be your “best case scenario” situation. However, springing a surprise test of your emergency preparedness system will give you a more accurate representation of how equipped your facility is for an emergency recall. Think of this as your stress test – you’ll find the holes your recall team’s plans that may not have caught in a controlled, scheduled test. It is entirely up to you which plan of action you’d like to take.

Document everything! We at connectfood.com cannot shout this statement loudly enough from the highest rooftops! As you’ve read in prior posts from us, CEO Matthew Botos frequently says, “If you didn’t document it, you didn’t do it.” This includes your mock recall testing. Record it all – what went well, what did not go so smoothly, the original plan, and the newly edited documentation. Being able to provide documents describing your emergency planning to an FDA inspector during an audit will keep your company compliant with the requirements of your written food safety plan. The FDA released an updated set of requirements in May 2018 regarding recalls, which can be found here. This regulatory procedures manual outlines exactly what your facility needs to have prepared as part of your written recall plan. This manual may be 87 pages long, but it is necessary information for your food safety manager and recall team to be familiar with. Review and get comfortable with what is required as a part of your recall plan – this is what you will assess during your mock recall.

Though FSMA does not require a mock recall as part of your written food safety plan, take a moment to think of the chaos your facility could avoid by choosing to get ahead of the issue. Brian Honigbaum of Quality Assurance Magazine says “practice makes perfect” in his article on mock recalls, and he is absolutely correct. The more effort and seriousness you put into your mock recall, the more prepared and confident your facility will be in the case of initiating and carrying out a product recall. Recalls are high-pressure situations, but you can be prepared to handle the stresses and surprises with a bit of preparation.

Want more information on recalls? Dr. Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), wrote a series of “Recalls: Lessons Learned” blogs for connectfood.com last summer just for you! Check them out here: Part 1 & Part 2.

connectfood.com can help you get your recall team, hazard analysis, and recall documents organized and in place. If you need assistance with any of these items or would like to schedule a consultant to conduct a mock recall for your facility, contact us. We are here to help you achieve the utmost food safety status.

About the Author
Johanna Seidel, PCQI
Johanna Seidel is an administrative member of the ConnectFood team, where she works as manager of operations and manager of social content. She is a certified Preventive Controls for Human Food Qualified Individual (PCQI). She received a Bachelor of Fine Arts Degree from West Texas A&M University in 2016. When she is not working food safety, Johanna also works as an instructor for The Chicago School of Ballet.