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Keeping Food Safe with a Food Safety Plan

If you are a domestic or foreign facility covered under the preventive controls rule, you must implement a food safety plan.  The rule on Preventive Controls for Human Food is mandated by the 2011 FDA Food Safety Modernization Act.  The food safety plans will help identify food safety hazards the require a preventative control and implement preventive controls to minimize or prevent hazards. Here are some helpful tips to provide a cleaner workflow for your staff and a cleaner environment for your consumers.

What is a food safety plan?A food safety plan consists of documents that provide an approach to identify hazards that need to be controlled to prevent the possibility of illness. The documents show proactive measures, which are enacted to minimize the risk of illness related to contamination. This continues ongoing evaluation of the policies, Standard Operating Procedures (SOPs), and records.   

The food safety plan must include:The Product Description, Incoming Materials, and Process Flow, Risk Evaluation, Hazard Analysis, Critical Control Points (CCPs), Monitoring Procedures, Corrective Actions, Supplier Evaluation, Recall Plan, Verification Procedures, Supply Chain Control Program, and Preventive Controls. 

Why is it beneficial to have all these documents within a food safety plan?Having a product description can identify some food safety hazards in how to control them. It is important to understand the process flow of the facility because it shows from the receiving of ingredients to the distribution of your product to help identify cross contamination points. A Hazard Analysis is used to identify any known or potential biological chemical and physical hazards and determine if any of those hazards require a preventive control. If the hazard analysis identifies a hazard that requires a preventive control, you are required to develop and implement a control to significantly minimize or prevent the hazard. The preventive controls must be written in the food safety plan and include as appropriate procedures, monitoring, corrective actions, verification, records, and in some cases, validation. 

A food safety plan can outline preventive controls and associated requirements that could include process controls, food allergen controls, sanitation controls and supplier controls. It is important to remember that a hazard to your consumer is a hazard to your business.  

If you fail to prevent to eliminate the hazard at a critical control point, you will not be able to prevent or potential illness. In other words, having a food safety plan that states control points are critical to keep your food product and the consumers safe. Careful monitoring procedures help ensure that your process facility is operating safely and within critical limits at each critical control point. Implementing monitoring procedures from a food safety plan can assist your company in a practical and realistic way by identifying unsafe food quickly and record keeping. Knowing who, what, how, and when to check when monitoring is conducted, will keep your company be in an organized manner. 

If there happens to be a non-conformance that occurs, it is a must to be prepared by following within a food safety plan to take Corrective Action. By taking Corrective Actions, you can investigate the cause, put products on hold, continue the process until it is safe, and recording any non-conformance taken to prevent reoccurrence. 

It is important that your facility is following food safety fundamentals. HACCP Prerequisite programs are fundamental and to see if verification procedures are being applied. It also vital that your facility is structured by keeping records. Obtaining records demonstrates how well your food safety plan and that your product is being made safely. Overall, food safety plans are valuable to have because they create a clean environment and good manufacturing practices for your establishment to make sure everything is running smoothly.  

Are there resources?There are resources available to help facilities develop a food safety plan. ConnectFood is a great resource!  ConnectFood uses a software program that has food safety professionals that can help you develop a customized food safety plan for your facility. It is in compliance with the USDA, FDA, and local regulatory bodies. ConnectFood’s plans are up to date with the latest information and has a variety of plan templates already available from dairy, beverages, seafood, and protein products. Following a food safety plan is very essential towards a company to avoid outbreaks and to ensure regulatory compliance. 

A Note From ConnectFood CEO Matthew Botos: 

We manufacture food every day both globally and locally. Food safety plans are different for every facility. You can make the same product in two different locations and have two slightly different plans.  Each facility is responsible for bringing a team together, as discussed above, to identify potential hazards and put measures in place to protect consumers and the supply chain.  It is important to analyze not only the physical characteristics of your product but also who in your facility is responsible and are the employees trained. Companies must also look at their facilities and equipment for areas of potential contamination.  Management commitment along with good manufacturing practices and proper sanitation are foundations of strong impactful food safety plans.

About the Author:

Daniela Jugueta received a B.S. degree from SUNY Buffalo State College. She is currently pursuing a M.A.S. degree in Food Safety and Technology in the Food Science and Nutrition department, Illinois Institute of Technology. She is also an intern for ConnectFood as a Food Safety Specialist.

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Food Defense: A Shield for Businesses and Consumers

In an era of globalization, the world has become a smaller space. It has become easier to travel and transport things from one corner of the world to another. Likewise, the complexity, diversity and dependency on intertwined domestic and global processes continue to grow in the food system. At the same time, there are increasingly possible causes of deliberate adulteration that continue to develop, become more complex, and will simultaneously have a direct effect on public health. So: to prevent, plan, respond to, and recover from acts of deliberate adulteration of the distribution of food, Food Defensebecame an important part for shielding food businesses and consumers from any potential threats. 

Food Safety and Food Defense

To protect and prevent food from any adulteration – whether it is intended or not, regulatory requirements have been put into place, which are based on food safety and food defense procedures. In other words, food defense and food safety contribute to the prevention of adulteration. The key difference between these two types of training is that food safety prevents food from unintentional adulteration. Food defense is responsible for protecting and preventing the public from intentional adulteration, which in turn may cause harm to consumers. 

What is Food Defense?

The Food & Drug Administration (FDA) states “Food defense is the effort to protect food from acts of intentional adulteration.” So, more basically stated, it prevents consumers’ health from any physical, chemical, and biological impurities deliberately added to food that could harm the consumers’ health. Due to increasing need for food defense, FDA issued a rule in May 2016 under the Food Safety Modernization Act (FSMA). The main objective of the rule is to prohibit deliberate adulteration of actions designed to cause systemic damage to public health, including acts of terrorism targeted at food sources. Although these actions are unlikely to occur, they could potentially cause disease, death, and economic destruction to the food chain if there are no prevention strategies in place. Additionally, FDA has developed a range of instruments and tools to help food facilities prevent, plan, respond to, and recover from acts of deliberate adulteration of food facilities. 

Food Defense Plan

In accordance with FDA, it is required for both domestic and foreign companies that are registered with FDA as food facility to formulate and execute food defense plan. A food defense plan must include a vulnerability assessment, mitigation strategies, food defense monitoring of the implementation of mitigation strategies, corrective actions, verification procedures, and logs or records. Every three years or where conditions have failed (such as mitigation techniques that are found to be poorly applied) a reanalysis is required. A detailed overview of what needs to be included in a food defense plan is outlined in 21CFR121. This plan will help the facility to find out what precautions one must take to reduce the risk of food items in the facility being tampered with or deliberately poisoned. A food defense plan will strengthen the preparedness of a food processor. These protocols will also enhance the ability to respond efficiently during a crisis, where stress levels are elevated and reaction time is minimal. As it is a very new concept for the industry, FDA has published a number of tools and assistance on their website (https://www.fda.gov/food/food-defense).

Future and Present Situation

With intentional food adulteration and food fraud on the rise, it is crucial for food facilities to keep their food defense plan updated. Manufacturers should make sure to revisit and review their food defense plans for any improvements to facility designs or techniques, product changes, and protection upgrades. Facilities should also track their workers on a daily basis, both in terms of satisfaction and understanding. This will benefit the facility, the health of consumers, and eventually the economy of the country. 

A Note from ConnectFood CEO Matthew Botos:

Food Defense is the protection of food products from contamination or adulteration intended to cause public health harm or economic disruption. The mission of the Food Defense Programs is to protect the U.S. food supply from dynamic and evolving threats. ConnectFood and the Institute for Food Safety and Health conducted a two-day workshop on Food Defense last week. The workshop focused on how Food Defense is developed and the fundamental building blocks of our existing food safety plans. We taught with the understanding that we are facing trying times locally and globally. The class was interactive across abroad range of companies and allow for discussion and training allowing companies to supplement their existing best practices. Food is a vector that has long been used to disrupt supply chains and cause unfavorable conditions for consumers. ConnectFood.com strives to keep the food supply safe and secure by providing documentation that meets requirements for Food Defense.

About the Author

Saloni Shah 

Saloni Shah received a Bachelor’s degree in Biotechnology from India. She is currently pursuing an M.S. in Food Safety and Technology from the Illinois Institute of Technology. She is also a research assistant working on a thesis focusing on food packaging materials and additives under a FDA scientist and is currently working as part of the Food Safety Specialist internship at ConnectFood.com.

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The Complexities of FSMA

The Food Safety Modernization Act (FSMA), which was signed into law in January of 2011, was created with the intent to regulate the way foods are grown, harvested, and processed. This rule allows the Food and Drug Administration (FDA) to step into the food safety chain to protect the public by assessing, regulating, and ultimately strengthening the food safety system. FSMA focuses on five main topics according to the FDA’s fact sheet, each of which has subtopics that relate to your food safety depending on the classification, facility size and employee count, and the purpose of your food company:

    1. Prevention
    2. Inspection and Compliance
    3. Response
    4. Imports
    5. Enhanced Partnerships

Back in November of 2016, we released a blog entitled “What is the Food Safety Modernization Act?”, which began our continuous discussion of FSMA. For the past few months, ConnectFood has been releasing blogs that touch upon the topics most relating specifically to the safe production and hazards around human food. For example, we discussed every aspect of record management regarding safe production, documentation, logs and records, and food safety plans. (Part 1, Part 2, Part 3, Part 4, Part 5, Part 6) We also discussed the importance of practicing mock recalls and the more specific and intimate details of recall planning and writing your food company’s recall plan.

Whether you are a food manufacturer, a distribution plant, a restaurant, small food producer, or anything in between, your facility or kitchen must be compliant with FMSA regulations. You should assume that an FDA Inspector will arrive to perform an audit on your facility at any time, on any day of the week. Sometimes, these visits are scheduled, but often, you should be ready for a surprise. Get ready to hand over your required documentation, explain your processes, justify your Good Manufacturing Practices (GMPs), and most of all, get ready to be expected to implement some changes.

Over the next few weeks, ConnectFood’s goal is to continue to educate you on the segments of FSMA and the regulations surrounding food safety policies. We will be having food safety experts write on the following topics:

1. Sanitary Transportation of Human & Animal Food
Sanitary transportation is an element of FSMA that has a rule finalized by the FDA. According to their online documentation, “The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation… The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.”

2. Foreign Supplier Verification
The final rule on foreign supplier verification began implementation on May 30th, 2017. The online documentation states: “The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders.”

3. Preventive Controls for Animal Food
As you know, ConnectFood talks about human food constantly, but there is equal importance in making sure our pets are fed safely. Let’s not forget our furry friends in our safety planning. Check out the FDA’s final rule fact sheet here until we release our blog on the subject.

4. Strategies to Protect Food from Intentional Adulteration
Intentional Adulteration is not a topic to skim through – we will be having our own Kathy Knutson, Ph.D., PCQI, (who is trained in the prevention of Intentional Adulteration) write a post focusing solely on the topic. Until you get to read her writing on the subject, take a read through of the FDA’s webpage here.

All of this information may be overwhelming no matter if it is old news or fresh news. As always, if you have any questions regarding FSMA and how it relates to your food company, the team at ConnectFood is always here to help. Don’t hesitate to reach out for help if you need it. The time for compliance is the present – don’t be caught without a FSMA-compliant food safety plan in place. Contact us.

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. Johanna received her Preventive Controls Qualified Individual (PCQI) certification in November of 2017. She received a Bachelor of Fine Arts Degree upon graduation from West Texas A&M University in May of 2016. When she is not working with food safety experts, Johanna also works as a dance instructor for The Chicago School of Ballet, as well as a professional contemporary dancer in the city of Chicago.

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Recalls

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.

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Mock Recalls: Highly Encouraged

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.

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Dry Operations & Recalls

Dry operations are tricky. They are called dry operations not only because the finished product may indeed be dry, but also because water is the enemy of the products. Water creates a greater risk for the pathogen Salmonella in the environment. When I think of dry operations, I think of dry ingredients: powders, spices, gums, thickeners, vitamin and mineral blends, flour, salt, and sugar. All food companies have dry storage for these dry ingredients; I am not addressing storage here, but processing and manufacturing of these ingredients. For every dry ingredient purchased by a food facility, there is a food company making that dry ingredient.

Being from America’s Dairyland (Wisconsin), I have been in five different spray-dry facilities in the past two and a half years that were producing spray-dried milk or whey – or both. Dry. Nut roasting is dry. Peanut butter operations are dry. Chocolate – as an ingredient and chocolate manufacturing – are dry. Water is the enemy and creates an environment where the risk of Salmonella is greater.

This brings us to cleaning and sanitizing. For most of dry operations, production does not stop. (Everyone working in a wet-clean operation just gasped!) It’s true. If the equipment can keep running, it does. There may be short shutdowns for minor repairs or adjustments, but the equipment keeps running. Most of these dry-ingredient manufacturers do business on a small profit margin and can’t afford to shut down. When the equipment does go down for cleaning, it is a big deal and may take days or a week to clear the lines, make repairs, clean, sanitize, completely dry, and start back up. Most companies discard a substantial portion of the first product out in case a pathogen in the lines was cleared at start up. The cost to the company is significant.

Then there is the equipment that is never cleaned. In some operations, it is just not possible during a normal shutdown to take apart and open certain pieces of equipment for cleaning. In the event of a recall, it means that there never was truly a clean break. FDA looks to companies to inform them on when the last clean break occurred. With a clean break, a company has evidence to shorten the span of a recall back to that last clean break. This reminds me of a company I was in that had four large tanks of melted chocolates, and the different chocolates were drizzled on the top of the product. It was heaven for this chocoholic, until I learned that the large tanks were never emptied. Never. This is standard practice throughout industry. The company had a clever way of cleaning the equipment that dispensed the chocolate, but not the mother tanks. The question becomes: in the event of a recall, would the company recall all product in market with that particular chocolate?

Without a clean break, how does a company determine how far back to go for a recall? One way to determine the cut-off date is to stop production, call in a consultant to investigate, and collect hundreds of swabs for the determination of root cause. This takes time, and the company has an obligation to inform customers of the recall and may not have enough time.

My suggestion to owners of dry operations is to schedule an annual shutdown for repairs and complete cleaning and sanitizing. I know this is a huge cost. Your CFO can calculate the ultimate cost for this shutdown of production. Then calculate the cost of a recall. In addition to the cost of recalling all product from the market, what is the cost of loss of customers? This Cheesehead is going to continue to learn from clients of dry operations and formulate best practices for cleaning and sanitizing of dry operations. Please share your thoughts with me. Food safety is not competitive.

Matthew Botos, CEO of connectfood.com agrees, saying: “Dr. Knutson makes excellent points in this post. When dealing with any good manufacturing operation you must understand the hazards. This is why FSMA plans require a hazard analysis. Dry plants, as pointed out, have moisture as a concern for potential human health issues.”

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! The online service allows you to complete a facility hazard analysis. Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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Truisms About Food & Documentation

Eric F. Greenberg, a private attorney with a practice concentrated in representing FDA-regulated food companies and others.
Informational only, not legal advice

There are several truisms about food companies and documentation:

MORE DOCUMENTS THAN EVER
First, companies producing FDA-regulated foods these days are required to make and keep more documentation than ever, mostly due to the Food Safety Modernization Act of 2011. Companies are required to generate, for example, food safety plans with a hazard analysis and preventive controls, a supply chain program and a recall plan. Then, after setting up these systems, companies need to generate and keep documentation proving they are following the programs they established.
Also, companies who recall food should remember that they might have reporting obligations, within 24 hours of discovery, about food that might be a danger to health, via the Reportable Food Registry portal.

DOCUMENTS ARE NOT ENOUGH: ALSO TRAIN
Second, once you have set up those documented programs, don’t neglect to train your employees on what they require. This goes for recall plans as surely as any other aspect of your program. FDA inspectors think perty documents are fine, but they would rather see confirmation that your people have a thorough knowledge of what’s in them and operate under them all the time. Which leads to the third point…

DOCUMENTS ARE NOT ENOUGH: ALSO DO WHAT THE DOCUMENTS SAY
Third, for gosh sakes, be sure to follow your own procedures. It’s the easiest thing in the world for an FDA inspector to cite your company (that is, make an inspectional observation) for your failure to follow your own written procedures. There are a lot of interesting policy debates one could have about the wisdom or necessity of any particular detail of a company’s safety plan or preventive controls, but those debates really don’t matter if you said in your own SOP that you would check the temperature of your cake mix after baking, but didn’t do so.

DOCUMENTS AND RECALLS
Finally, documentation is relevant to recalls in at least two important senses. One is that the company will have in place the requisite recall plan, having thought through in advance the necessary steps to undertake or consider when problems arise. The value of preparing in advance cannot be underestimated, particularly because circumstances in which safety concerns arise or are suspected can be high-pressure, fluid, and even emotionally charged.
Second, of course, documentation of production can help a company identify causes or potential causes and define a limited scope for the affected product, and then identify the consignees who received the product within that scope. Without such documentation, the prospect exists that a company might decide its only reasonable option is to recall everything it’s made that is still out in commerce, which is often a very expensive and burdensome option.

Have more questions about documentation or would like to get in touch with the author? Contact ConnectFood.

About the Author:


Eric F. Greenberg is Principal Attorney of the law firm Eric F. Greenberg, P.C., with a practice concentrated in food and drug law, packaging law, and commercial litigation.

His food and drug work has included regulatory counseling, label and claims review, new product development, GRAS and food contact materials evaluations and clearances, negotiations with the U.S. Food and Drug Administration and state agencies, handling recalls, and defending enforcement actions.

In addition to his law practice, Eric is a member of the Adjunct Faculty of the Chicago-Kent College of Law, where he teaches Food and Drug Law and Administrative Law, and graduate and undergraduate Packaging Law and Regulation at California Polytechnic State University (CalPoly).

Eric wrote the book, Guide to Packaging Law, the Second Edition of which was published in October 2007. He serves as Legal Editor and monthly legal columnist for Packaging World Magazine. Eric has served as General Counsel of the Contract Packaging Association for over 15 years. His firm is based in Chicago and represents clients based all over the world.

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Logs & Record Keeping

In this blog we are going to talk about logs and record keeping. If you seem to continue seeing this topic as a constant theme within the food safety industry, it is because it is the way that all companies have to keep “score” in the food safety world. Documentation is what allows us to benchmark our progress. Records and logs exist so that an organization can tell their food safety story to both regulators and to their customers. Logs are a necessity for your food safety chain, and you can find example forms for logs and record keeping on connectfood.com.

An example of where records are important is if you have a deviation in the food production process. An instance of this would be that your chart recorder ceases to work during a thermal process, say batch heating a product with a pH below 4.1, and at the end of the run you realize that you do not have the chart-recorded log. In this case, other measurements such as handheld temperature monitoring or visual readouts of a redundant thermocouple could be used to showcase that you still have a safe product for the target consumer. You will then use these records and logs to show that you did, in fact, follow your process and that with adequate testing and record review the product would be safe to ship.

    “Implementation records document the actual implementation of the Food Safety Plan. In other words, implementation records demonstrate that you did what you were supposed to do. Examples of implementation records include, where applicable, records that document the actual monitoring of preventive controls, corrective actions taken, different verification activities performed, validation activities performed (if needed), the supply‐chain program checks and applicable training records.” –FSPCA Preventive Controls for Human Food course curriculum.

Records and logs tell a story: from the time a supplier provides an ingredient until the time the product is delivered to the consumer, there is documentation. This story can include a manufacturer asking for the records and logs of how an ingredient was processed to how it was shipped and stored before arriving. This story could follow the documentation of a low moisture ingredient that is shipped at ambient temperature but needs certain humidity controls. Or, it could be an example of fresh fish where the records must show temperature control and amount of time the product has been in transit. These records are all things that an FDA regulator will ask for and that a facility must be able to provide within the 24-hour restriction set by the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

Another area that companies wonder about in regards to record keeping is: how long do I need to keep records, and what if I want to use electronic records?

“Electronic or computerized records are acceptable in a preventive controls system as long as they are equivalent to paper records and electronic signatures are equivalent to traditional handwritten signatures. Controls are necessary to ensure that records are authentic, accurate and protected from unauthorized changes.” – FSPCA Preventive Controls for Human Food course curriculum. ConnectFood talked about the move towards electronic records in a recent online interview with Food Safety News.

When it comes to how long records need to be kept, the answer is a minimum of two years from the date the log or the record was created. The records that relate directly to the food safety plan and the product’s completed food safety plan must be kept on site. Collecting proper records and logs and having them readily available is how companies demonstrate that the food safety plan is working. You can find many of these best practices in the FSPCA manual.

Most important to remember when it comes to records and logs are that, 1. you know what you are monitoring and, 2. you have trained personnel in your facility. All the logs and records in the world will not make a difference if the person tracking and monitoring the records do not know why they are taking these records and how they impact the food safety plan. Having A Preventive Controls Qualified Individual on site that can review and sign off on logs is a critical part of your food safety process. The worst-case scenario is to have a complete plan and a detailed hazard analysis but then have records and logs that do not reflect the accuracy of your production. This can lead to recalls and other issues that jeopardize the company and the consumer.

Your recordkeeping is your product’s story: make sure you’re telling a good one. ConnectFood can help you get your documentation in order and provide you with example sheets for logging. Send us a message.

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.

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Records Management: Storing Your Records

Your company is generating a record right now. Somewhere in the facility there is monitoring, a new employee is being trained, or ingredients are being shipped to you. I have written in previous posts here on connectfood.com about required and recommended records. Below is an outline of topics which generate records in need of management.

What records must my company have?

    • Good Manufacturing Practices (GMPS). Every food facility is required to follow GMPs.* You will feel confident in an inspection or audit if you have good documentation for GMPs.
    • Standard Operating Procedures (SOPs)

      • Sanitation Standard Operating Procedures (SSOPs) are required when a sanitation preventive control is identified in the hazard analysis and for some allergen preventive controls.*

    • Training records*
    • Hazard Analysis*
    • Validation study for each process preventive control or critical control point*
    • Shelf-life study, recommended
    • Supply chain program

      • Supply chain preventive controls are required for ingredients for which the supplier controls the hazard.*

    • Receiving records for ingredients with a supply chain preventive control*
    • Monitoring and Verification*
    • Calibration of monitoring devices*
    • Equipment maintenance, recommended
    • Corrective action*
    • Recall plan*

*Required by the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule.

“How do I store all these records?”

This is a question I always get in a training workshop. It usually starts with, “I have a HACCP plan” or “I have records for auditing” and proceeds to the concern of getting rid of everything that has been done up to now and starting over. The answer is an emphatic “No!” to starting over. Your company is not going to rid itself of the old systems and start with the new kid on the block. Everything you have done for record keeping is still valuable and fits into the new food safety or HACCP plan. The next question is harder. “How do I organize my food safety plan and my required records for audits?” Unfortunately, I can’t answer that question, because it is completely up to you.

Matthew Botos, CEO of ConnectFood, did have a response to the above question:

“Records are of the utmost importance in the food safety risk management system. As I have said probably thousands of times (as have my peers): “If you haven’t documented it, you have not done it.” Records have traditionally been paper records, but over the decades with advancements in technology we are now ready to “trust” electronic records. As always, they are only as good as the information we put into them. What I can tell you is that there are companies like ConnectFood which will facilitate the storage and retrieval of records. In the electronic world that we live in, electronic storage of records is no longer just the future, it is the present.”

When the FDA inspector requests review of an electronic record, there is no requirement to supply a paper copy or printout. Records can be stored in the “cloud” if they can be retrieved. Imagine being on the floor in operations with an inspector and you are asked for the pH meter calibration record from a year ago. You can pull up the record on your phone or tablet and move on to the next question.

For your ease of mind, it is important that you understand how electronic records are stored and retrieved at your company so that you can efficiently display the record for review. What I tell my workshop participants and clients is to find the person at your company who loves office supplies. This is the tell that they love to sort, store, and organize things. Do they have every color of highlighter? I do. Do they have a label maker? I do. While my desk is often messy, my office supplies are organized and labeled. If you need a pad of paper, this person knows exactly where to get one for you. This is the person you want to task with organizing records electronically, too. As quality manager or Preventive Controls Qualified Individual (PCQI) you have too much on your plate, and I want you to delegate when possible.

Once a system for records management is created, all food safety team members should be required to follow the system. There should be no stray records being held outside of the system and unavailable to the entire team. Never rely on one single person having access to part of the records. Store electronic records in a common location for two or more years.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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Importance of Records Management: Supplier Verification

Most food manufacturers do not have a supply chain preventive control and will not have supplier verification in their written food safety plan. A separate blog post of mine, Supply Chain Preventive Controls, discusses identification of a supply chain preventive control.

    1. Supply chain preventive controls are required for ingredients where YOUR suppliers control the hazards.
    2. A supply chain preventive control is required for imported packaging when a hazard is identified.

The safety of imported ingredients and imported packaging is enforced under the Foreign Supplier Verification Program (FSVP) rule. See the Preventive Controls for Human Food rule for supplier verification.

I get a Certificate of Analysis (COA) with my ingredient. I’m good, right?

Good, but you are not done. The way I approach supplier verification is as an attorney collecting evidence to build a case that a jury will decide. You are the attorney, and FDA is the jury. The burden of proof is on you to demonstrate the ingredient is safe. Yes, it is all about verification. Your FDA inspector will review your supplier verification.

Before we go on to the requirements and just checking in, have you identified a hazard requiring a supply chain preventive control? If the answer is yes, read on!

Requirements for Supplier Verification

    1. Supplier approval
    2. COA or similar document with receipt of every shipment
    3. Sampling and testing for hazard
    4. On-site supplier audit

      a. Use of a qualified auditor
      b. Proof of corrective action implementation

This is an extensive list and a lot of work to prove the hazard was controlled by the supplier. Let’s look at an example with peanut butter as an ingredient in a candy bar. The peanut butter is not further processed to control hazards, and supplier verification for the peanut butter is required for the control of hazards like pathogens Salmonella and Listeria monocytogenes, aflatoxin, and physical hazards. The United States had two major outbreaks from Salmonella in peanut butter, and other nut butters are under heavy scrutiny by the FDA.

Supplier approval. The approval process is not mandated, so you have flexibility on how you determine the supplier is approved. Include the written Standard Operating Procedure (SOP) for supplier approval in your food safety plan. You are required to document the supplier is approved. You are encouraged to complete this process before using the ingredient from this supplier. If not approved before you’re your Preventive Controls Qualified Individual (PCQI) must document in the food safety plan the timeline and justification for later approval.

In both peanut butter outbreaks, part of the blame lies with the customers not doing enough for supplier approval and verification. If you are purchasing an ingredient in which the pathogens are killed, the supplier is required to use a validated process preventive control. Ask for the results of the validation study and documents proving the process is validated, monitored and verified. Some suppliers are not willing to share this information. If a supplier is not willing to share food safety data, you may want to start searching for another supplier. Will you share with your customers?

Written procedures are required for Receiving for ingredients with a supply chain preventive control.

Specifications and COAs. Once the supplier is approved, you will set specifications for the absence of the hazard; that would be the absence of Salmonella and Listeria in the ingredient of peanut butter in our example. When the peanut butter is received, the Receiving personnel should inspect the vehicle for sanitary conditions and the containers to ensure they are intact. The bill of lading is checked against the goods received upon arrival. Every shipment of peanut butter must include a document stating the hazard is absent. With every shipment received, you get a COA, a Certificate of Conformance (COC), or letter of guarantee regardless of repeating a lot code. The ingredient container or pallets should be clearly labeled at Receiving, then moved and stored in a manner to prevent cross-contamination and cross-contact.

You cannot continue to just file away COAs for ingredients where a hazard is controlled by a supplier.

Sampling and testing. FDA requires verification of COAs at some frequency determined by you. Are you still with me that this is for ingredients where the hazard is controlled by the supplier? Develop a sampling plan for each ingredient to include:

    • who is responsible for sampling and how they are qualified,
    • the location where samples are taken,
    • the methods for sampling and shipping,
    • the number and size of samples,
    • the coding of samples,
    • the exact location of the laboratory, and
    • the method of the test.

Often the customer drives the sampling plan and orders too many samples and too many tests. Please do not order tests where you do not use the data. Don’t get me started on this! As the customer, you must be confident in samples being taken and shipped properly. You must trust the results of the laboratory. Work with experts to develop your sampling plan.

On-site audit. At first glance, the requirement for an on-site audit of the supplier seems daunting. However, you do not personally have to do the audit. You may use the audit of another body for your documentation. That means you can use the audit report from a state inspector, federal inspector, broker, consultant, or auditing firm. There is a requirement for a qualified auditor, not a certified auditor. You are required to prove to an inspector how an auditor was qualified to inspect your supplier. After the initial inspection, an annual audit is required, unless there is justification for a less frequent audit that is based on evidence. Work with a qualified auditor to put together your auditing plan. After you have agreed upon the scope of the audit and how the audit will address the hazard, you must obtain all corrective action and implementation documents to address problems.

Your job is to collect evidence to prove your case for safety. Confidence will climb for your case before an FDA inspector, when you have an approved supplier, documentation of receipt of the ingredient, verification of COAs for the hazard, and results of on-site audits.

If you want to read the requirements for supplier verification, find Subpart G in the Preventive Controls for Human Food rule. However, I recommend starting with the FDA At-a-glance document which provides a neat summary of the rule. Still not sure if you are meeting the requirements for supplier verification? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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