Tag Archive for: food safety experts

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FDA Listeria Draft Guidance for Ready-to-Eat Foods: Part 2

I first learned that Listeria monocytogenes is a foodborne pathogen in 1985 during the Jalisco cheese outbreak in Los Angeles and Orange Counties in California. There were 29 deaths from 86 documented cases. The veterinary world was very familiar with Listeria in cattle, long before food microbiologists. Industry and the federal Food and Drug Administration (FDA) took this emerging pathogen seriously. Since 1985, there has been active research and investigations at universities and food companies. We know that Listeria is ubiquitous, and current lab methods improve our chances of finding Listeria.

FDA Listeria Draft Guidance for Ready-to-Eat Foods: Part 1, published previously at connectfood.com, discussed Listeria testing on food contact surfaces (FCS) and non-food contact surfaces (NFCS) and from finished product. We encourage you to study FDA’s draft guidance, Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry. Here, I present three concepts needed to understand the information in the guidance.

A positive Listeria test from a FCS assumes the presence of Listeria in your product.

The guidance for ready-to-eat food recommends FCS be sampled after three hours of production and five FCS samples be collected per week per line. First consider these sample sites. The FCS sites should be after the final kill step. It does no good to sample FCS sites before the final kill step. If the test is positive, the assumption is that the final kill step killed the pathogen. The FCS sites are before the final product is sealed in packaging. Think about the distance where your product travels after the final kill step to where the package is sealed. In that distance, think about where the product is open to the environment. Listeria is an environmental pathogen. What I mean is if the product is in tubing, the product is not exposed to the environment, and these would not be FCS sites for Listeria. I am thinking about an ice cream plant. The mix travels through tubing until carton filling. The distance the product travels from the end of the tube to the carton is small, and the distance the open carton travels until sealed is small. Compare that to a large bakery. After leaving the oven on conveyor belts, the baked goods travel open to the environment for cooling and the addition of toppings. I have seen distance as long as 50 yards with the transfer onto multiple conveyor belts.

Once you have your FCS sites identified and if a FCS test is positive, it is assumed the product is positive, even without direct sampling and testing of the product. This makes sense. If a FCS is positive, the product touched the FCS. At that point it’s a chicken-and-the-egg discussion of whether the product contaminated the surface or the surface contaminated the product. It doesn’t matter until you do your root cause analysis. What you do know is that you have contaminated product.

A positive Listeria test from an environmental sample has an isolate identified as Listeria innocua or another Listeria species; consider Listeria monocytogenes as present.

Listeria monocytogenes is one of 17 species of Listeria. Only the species Listeria monocytogenes is considered a foodborne pathogen. When your contract lab tests for Listeria genus or spp., a positive test does not tell you the species. Further testing can identify the species, if needed. It is very common for the lab to report negative for Listeria monocytogenes and report the presence of Listeria innocua instead. In no way can you rest easy with a positive Listeria test and negative Listeria monocytogenes test. When the lab reports a positive Listeria test, consider Listeria monocytogenes present.

Consider the sampling site and technique. Let’s use the example of a drain swabbed with a sterile sponge. Assume Listeria monocytogenes is there. Perhaps the sponge did not swab the location of the pathogen. Perhaps the sponge did not get through the layers of goo where the pathogen is harbored. There are many reasons for missing the pathogen in the procedure for swabbing. If the test is positive for a different Listeria species, the conditions at that site are conducive for the presence of Listeria monocytogenes. Corrective action must be done in the same way as if the test were positive for Listeria monocytogenes.

Consider the variety of microflora at the site. The site was not sterile and does contain diverse types of bacteria at different numbers and proportions to each other. Listeria monocytogenes is the wimpy kid on the playground. Listeria innocua outcompetes Listeria monocytogenes not just 10-to-1, but as much as 20:1 or 50:1! The mere chance of finding Listeria innocua instead of Listeria monocytogenes is simply greater. Listeria monocytogenes may have been present in the sample, in the testing, and simply not detected.

An environmental sample tests positive for Listeria genus or Listeria species (spp.); react as if the sample were positive for Listeria monocytogenes.

You will direct the lab in what method to use and at what point to stop the testing. Work with the contract lab in making this determination. After a positive test for Listeria genus or spp., you have the option to continue testing to identify the isolate of Listeria. This costs more money and time. Will you do something different with that information? No! It is not necessary to confirm the presence of Listeria monocytogenes from a positive Listeria genus or spp. test, when your corrective action is the same. Think this through before testing. Know the action the plant will take when a Listeria genus or spp. test is positive. Expect to get positives from zones 3 and 4. FDA inspectors should not have a problem with seeing occasional positive tests. Since Listeria is ubiquitous, you are expected to find it. The important part is what you do as corrective action. Follow-up testing should be negative to prove Listeria is eliminated from the site and the area adjacent to the site.

As you work through the FDA Listeria guidance, 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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“Rotten” – An Unlikely Source of Information

A common conversation my husband and I have with friends and family is, “What are you watching?” We will find a show on Showtime or Netflix and binge-watch to get caught up to the current season. Somewhere along the way, I discovered Rotten on Netflix. The first season from 2018 had six episodes. As someone working in food safety, I was reticent to watch. My preconceived notion was that they would be anti-food industry, showing the likes of Food, Inc. Many Americans have turned against my food industry because of these types of shows featuring the worst of the worst practices by the few. Before I watched, I searched for reviews like the one on Paste, “Netflix’s Rotten Is Mandatory Viewing for People Who Buy Food in the U.S.”

The food industry is comprised of people, so it is not perfect. My experience with the food industry concludes that almost all people are working their butts off to do their best with the materials and equipment given. There have been a few bad characters, and the justice system has dealt with them. As a consultant, I talk with people when they are in trouble-either for food spoilage or pathogens. I go to their website to research the company. I have discovered there is no correlation between the quality of the website and the safety of the product. No shock there. I have been to dairy, fresh vegetable, freezing and drying operations. Never does the image in my head of the facility match what I see in operation. I have been surrounded by new, gleaming stainless steel equipment, and I have been in cold, damp and dark caves. I know that what I see on the screen in a movie or documentary is simply one perspective of clips spliced together to create a show.

The season of Rotten was simply fantastic, for me. Yes, they show scenes that will creep you out, like the prisoners forced to process garlic. Ugh. It is not the food that is bad; the situations of the people showcased are rotten. There is the beekeeper whose hives were stolen. There is the chicken farmer who works day and night to care for his flock like they are his children. As people working in the food industry, I believe it is important for us to learn how other companies operate and not remain isolated, so we can instill best practices. Watching shows like Rotten can help us to think outside our factory walls. You can check out the official Netflix trailer here.

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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4 Signs of a Food Safety Culture

All of us have our personal culture in which we live. How we spend our time at home and on the weekend creates our culture. The time we spend with our neighbors, friends, family and church defines us. Think of the clothes we wear, the food we eat and our traditions. Now think of the culture at your work. Think of the clothes we wear, the rituals in our procedures, and the food we make for customers. What is the status of your food safety culture?

When the FDA inspector visits your facility, the inspector will be looking for evidence of a good food safety culture. If you work in food safety or quality management, you work hard. You wear many hats. When the FDA inspector comes, your records will be inspected, and your employees will be observed. You prepare for that. You have good, organized records. You have good training programs for your employees. Most companies are confident in addressing records and training and making the evidence appear for the inspector. While the inspector is reviewing records and observing employees, the inspector is looking for evidence of a food safety culture. This is touchy-feely and sometimes hard to document. The culture is who you are and how you work together.

What does food safety culture look like? Start with your employees. Are the uniforms clean? Is their footwear of good quality and cleanable? How is their personal hygiene? Do all employees practice good handwashing? These observations plus good recordkeeping lay the foundation of a favorable food safety culture. These parts of a food safety culture are obvious to most and will be discussed more in this blog. In a second blog, I discuss 5 Signs You Don’t Have a Food Safety Culture.

Training records are complete for each employee.
Under the Food Safety Modernization Act (FSMA)’s PCHF rule, training records are required for every employee. The FDA inspector will review your training records as part of a FSMA inspection. Companies earning more than $1,000,000 annually must have a PCQI, and most PCQI will provide a certificate from their training. Going beyond the PCQI, all other employees are qualified individuals, i.e. qualified to do their job. Ensure that your training records are complete, up-to-date, and show how an employee is qualified to do their job.

Your company uses signage.
Show me the sign! We have all seen the sign in the public bathroom stating employees must wash hands before returning to work. I think we get a little numb to the handwashing command. In fact, you cannot invest enough time and resources for proper handwashing. Besides handwashing, we use signs to direct employees to do many things. Signs are great! I am a huge proponent of signs. First, a picture says a thousand words; use pictures on your signs. Make the signs language appropriate for your employees. Use universal symbols as much as possible. Use color. If your employees are getting numb to the signs, move the signs. Change it up. Change the color. Change the shape.

As I travel to different food factories and am escorted into operations, I am always impressed by well-used and maintained handwashing stations, perfectly placed in a transition area and before entering operations. I like to see reminder signs. I love to see posted directions on the proper method for washing hands. My biggest pet peeve with handwashing is people not rinsing and wetting their hands before applying soap. Rinse first! Also, how many of us lather the full length of two “Happy Birthday” songs? That is the minimum time for just the lathering step.

Your company has obvious means for employees to report problems and offer suggestions.
Do you have a suggestion box in the lunchroom? As you observe employees in operations, do they freely discuss concerns with each other and supervisors? There should be an obvious and free exchange of information at all times. A red flag is when an employee is asked a question they should know and states they do not know. Does your company have team meetings with operators? Team meetings should include all shifts and facilitate communication among operators.

I worked with a company where the President sat at the conference table with his Vice Presidents and Managers. Over and over, I witnessed the President shutting down the excuses for food safety shortcomings. He was preaching food safety culture. Sanitation doesn’t have enough thermometers. Buy more. It’s not practical to record data in real time. Find a technology that works in real time. Occasionally a foot foamer is not working. Have a back-up ready to go.

Matthew Botos, CEO of connectfood.com, tells us, “Food Safety is ‘Basics Done Well’. As described, risk management best practices start at the top and filter all the way down to every employee and vendor. Food Safety is everyone’s responsibility. There are many tools out there to help companies.”

It is difficult to present a favorable food safety culture and sometimes more difficult to measure. The topic of a food safety culture is new and will develop over time in the food industry. As we continue to talk to each other about food safety culture, we will know it when we see it, and we will be able to measure it.

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

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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What are Preventive Controls in the Food Industry?

Preventive controls are actions your company takes to ensure the product is safe. The FDA recognizes five types of preventive controls in the Preventive Controls for Human Food rule. They are process, allergen, sanitation, supply chain, and other preventive controls.

Food companies with more than $1 million in annual revenue are required under FSMA’s Preventive Controls for Human Food rule to conduct a hazard analysis and identify preventive controls. The company will consider biological, chemical, physical, and radiological hazards. The hazard analysis drives the discussion and decisions on preventive controls. For every hazard, there are actions the company takes to control the hazard.

Most food companies have a process preventive control and monitor time and temperature. The time and temperature are combined to control a biological hazard. Most companies have a metal detector, inspection of packaging to match the product and label allergens for an allergen preventive control, and monitoring of sanitation preventive controls for the control of environmental pathogens. FDA’s current thinking on environmental monitoring is detailed in the draft Listeria guidance. Process preventive controls and sanitation preventive controls may be designed to prevent foodborne illness, but did you know most recalls are due to the hazard of allergens? The food may be perfectly made, but if the packaging is wrong, the company will have a recall. Follow this link for just one example.

Some companies have so many redundant steps that it is difficult to name the step which is a preventive control. In this case, the food safety team should talk through their process and imagine taking away a step. I talked with a company that had multiple filters for their stream of product. To name every filter as a preventive control creates a lot of work and is unnecessary. Failure of the first filters was not a food safety issue because later filters work. The company visualized which filters were the most important for food safety by visualizing the removal of each individually. Where failure could result in a food safety hazard, the step was named as a preventive control.

If the hazard is controlled by the supplier, the receiving company must verify the hazard was controlled. An example is ice cream inclusions, like nuts. Imagine how the receiving company could verify the safety. COAs of course. Will the supplier share their food safety plan? An audit is required. Does the supplier have a validated process? Supply chain preventive controls are all about verification.

In addition to the four types of preventive controls mentioned above, the FDA also gives industry the option of other preventive control. I look at this type in two ways. First, your food safety team may disagree on naming the type of preventive control. For example, is an allergen clean a sanitation or allergen preventive control? It doesn’t matter! It only matters that it gets done. The second way that other can be used is if new scientific information emerges and does not fit into one of the four types of preventive controls. Current scientific understanding (below) means that we are always learning, and new information on hazards is always emerging. With the latest information, a company may need to reanalyze their food safety plan.

Here is the definition of preventive controls from the rule:

“Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”

The knowledgeable person ultimately is a Preventive Controls Qualified Individual (PCQI) in cooperation with engineers, microbiologists, and other food safety experts. The PCQI works with his or her food safety team to write the hazard analysis and identify preventive controls. The food industry has trained over 40,000 PCQIs in less than two years. PCQIs are your go-to people for food safety. If you are a small company in need of food safety expertise, the folks at ConnectFood are here to help.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources; click here to Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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September 18, 2017: Enforcement Date for Food Safety Plans

I am writing this on September 18th, 2017. For over a year I have trained people in workshops that this date is the FDA enforcement date for all food companies as regulated under the Food Safety Modernization Act (FSMA)’s Preventive Controls for Human Food rule. The small companies had more time for compliance, but this is it. Time is up.

Going forward from this day, all food companies in the United States earning more than $1 million in annual revenue must have a written food safety plan. The written food safety plan starts with a written hazard analysis and ends with a written recall plan. The food safety plan must meet the requirements in Subpart C of the Preventive Controls for Human Food rule. Today changes the way I teach, the way FDA enforces, and the way food companies prove food safety.

Even though today is the day, word on the street is that the FDA is a little behind on FSMA inspections. The FDA has done a great job training inspectors, providing guidance, and giving inspectors the tools they need. I hear that FSMA inspections will be more like audits: with the emphasis on review of the food safety plan and employee training records. There will be less time walking the line and more time reviewing monitoring and verification records. That being said, most FDA inspections are still for Good Manufacturing Practices, found in Subpart B of the Preventive Controls for Human Food rule. If your company manufactures a product that has been recalled by a competitor or is known to be under high scrutiny by the FDA, then you should be prepared for an inspection in the near future. If not, you may have more time to prepare.

Are you feeling overwhelmed? Did you find this blog post because your food safety plan is not finished or you feel it is lacking? I do not want you to feel alone or isolated from the resources and help you need. There are plenty of food companies still writing their food safety plans, so you are in good company if yours is not yet complete. You have landed in the right place – let ConnectFood help you get it done!

ConnectFood is a great tool to write your food safety plan. You can choose the free option, which is a good place to start, or you can subscribe for a low, reasonable cost. By subscribing, you will have access to the ConnectFood experts, like ConnectFood CEO Matthew Botos, myself, and other ConnectFood experts. If we don’t have the answer, we have a vast network of food safety experts to get you the answers you need.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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Software Update – Expert Services and SOP Template Library

Access Food Safety Experts and Standard Operating Procedure Templates

Announcing the major release of ConnectFood version 2.0! The release contains two major features:

  1. The Food Safety Expert Marketplace with On-Demand Services
  2. Standard Operating Procedure (SOP) templates

In our continuing pursuit to best serve you, these two features help make writing Food Safety Plans even easier!

1. Food Safety Expert Services On Demand!

You now have the ability to hire highly-vetted food safety experts from
our national partner network at a fraction of the cost and at a faster response of traditional consulting services. Average experience of food safety experts is over 10 years in the food industry. You can request a FREE quote on any of the readily available services listed below:

  • Expert Help to Write Food Safety Plans
  • Expert Reviews of Existing Food Safety Plans
  • Process Authority Letters
  • Expert Help to Write Recall Plans
  • Standard Operating Procedures Development or Review
  • Audit Preparation
  • Laboratory Verification Tests
  • Laboratory Validation Tests
  • Good Manufacturing Practices Review
  • Implementation Record Review

ConnectFood Expert Services

Our Food Safety Expert network is composed of food engineers, chemical engineers, food scientists, and others involved in various aspects of food safety. They will partner with you to help you write your food safety plans and perform your hazard analysis. They can help ensure that your facility’s Good Manufacturing Practices (Code of Federal Regulations 117) are compliant. ConnectFood Expert Partners such as Process Authorities can help evaluate the worst-case parameters of your processing equipment. There are so many risk based variables to assess, and a food safety expert help will make sure you are addressing all of them to keep your food product manufacturing process safe and compliant with Food and Drug Administration and United States Department of Agriculture regulations.

For a more detailed description of each service, be sure to login with your account and navigate to “Expert Services”.

If you are a Food Safety Expert and would like to join ConnectFood’s partner network, please contact us here.

2. Standard Operating Procedure (SOP) Template Library

Also included in this major release is a Sanitation SOP and SOP library. These are templates that you can import into your own list of SOPs to modify in order to save you time and start you off with some guidelines.

ConnectFood Expert Services

Well written Sanitation SOPs are the foundation of a good sanitation program. A sanitation program will include training records, Sanitation SOPs, and monitoring of sanitation preventive controls.

The ConnectFood SOP library is consistently growing the the number of templates available is a part of our Premium level subscription plan. Sign up today to gain access to this valuable feature!

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If I Am Compliant with a Third-Party Audit, Am I FSMA-Compliant?

One of the biggest challenges for a company and its Preventive Controls Qualified Individual (PCQI) is organizing both the food safety plan and materials for an audit. The food safety plan will be reviewed by the local, state, or FDA inspector. Some companies are under USDA inspection as well. In my experience, most food companies have a third-party audit for BRC, SQF, or ISO 22000 certification or with an auditing firm specializing in food manufacturing. How do you prepare for both?

There are different requirements for a government inspection and a third-party audit. The inspection is driven by public health and regulations. Food facilities will be inspected against the requirements for Good Manufacturing Practices, hazard analysis, preventive controls, and recall plan found in the Preventive Controls for Human Food rule. Quite frankly, the government is not concerned at all with your audit criteria. The focus will be on public health and FSMA rules. Going forward, FDA inspections will evolve in to more audit-like activities with the emphasis on record review. The PCQI is required to organize or oversee the organization of records. The goal is to be inspection-ready at all times.

Much of the material that is required for an audit is the same for an inspection. Each certification or auditing body has their own requirements, and often the PCQI has the responsibility of organizing these materials also. Do you need help with organization? I encourage PCQIs whom I train to find that one person at work who loves office supplies. Put them in charge of labeling and storing materials. Trust me, they will love it! Also, find the person who is exceptionally good at organizing electronic documents. Put them in charge of developing the system of storage and retrieval. The PCQI just needs to know where paper and electronic files are and how to access them.

Do you remember Venn diagrams? List everything you need for an inspection in one circle. List everything you need for an audit in a second circle. What overlaps, and what is unique? One option is duplicating common records for both inspection and for auditing. Another option is to keep records unique to an inspection separate from records unique to an audit and have one record of common records. The inspector will not review records unique to an audit. As you are working through this organization, focus on the best location for individual records, in general. Records for an inspection can be paper or electronic, in a format of your choice. There is no mandate for use of forms. Focus on what makes sense for storage and then retrieval of records.

Let’s go back to the original question. If I am compliant with a third-party audit, am I FSMA-compliant? Maybe; it depends. The Preventive Controls for Human Food rule requires a written hazards analysis which identifies hazards requiring a preventive control. The preventive controls go beyond process preventive controls to include allergen, sanitation, and supply chain preventive controls. If all the preventive controls are addressed in the audit requirements, then you are covered for both an inspection and audit. Beyond the Human Food rule, are you compliant with the Sanitary Transportation rule? In 2019, compliance with the Intentional Adulteration rule takes effect. Are you required to comply with any of the other FSMA rules? The answer is complicated.

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

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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How Do I Write a Food Safety Plan?

Congratulations! You are looking for expert help in writing a food safety plan, and you found ConnectFood. ConnectFood developed software for an on-line food safety plan builder with you in mind, every step of the way. You are not alone. Behind the screen there is a cadre of food safety experts to help you. Through our knowledge, experience, and connections, we can help you write your food safety plan quickly. I have known Matthew Botos, CEO of ConnectFood, since 2000. I know Matthew to work tirelessly for the food industry, to travel worldwide for training and helping the food industry, and to network with government agencies from local to federal.

FDA recently published their on-line food safety plan builder for food manufacturers. Like usual, FDA is late to the party and behind industry. I have worked alongside some fine people at FDA. They work hard to steer a huge, government system. Like the Titanic, reaction time is slow and often too late.

ConnectFood has been working with the food industry to write food safety plans for over three years. My biggest concern for companies writing their food safety plans is getting their questions answered in a timely fashion. FDA has a Technical Assistance Network (TAN) which will answer questions on the rule only. Don’t expect an answer within 24 hours. At FDA pace, it would take months to write a single food safety plan. If the question is outside the realm of the rule, companies will be referred to the Food Safety Preventive Controls Alliance (FSPCA) TAN. Matthew, ConnectFood Experts, and I have access to members of the FSPCA TAN too.

Getting questions answered is one of the reasons that a Preventive Controls Qualified Individual (PCQI) is required to supervise the writing of a food safety plan. Do you know who is a PCQI? Matthew Botos, CEO of ConnectFood, and I are. Not only are we PCQIs, but we are also Lead Instructors of the workshop for PCQIs. Matt Botos also is a Trainer of Trainers. Collectively, we have delivered over 50 PCQI workshops since the end of 2015. It is pretty safe to say we know the rule. Matthew is a food engineer, and I am a food microbiologist. Along with our network of food safety experts, ConnectFood has you covered. The ConnectFood software is a cost-effective method to get your food safety plan written. ConnectFood continues to develop cutting-edge easy-to-use software for an on-line food safety plan builder that can be used to showcase food safety either on-line or printed out to be shared with clients or regulators.

ConnectFood is not just for food manufacturing. Restaurants are using the ConnectFood software to build their Hazard Analysis and Critical Control Points (HACCP) plan. While the application is a bit different, the process of building a HACCP plan is the same. ConnectFood is the perfect solution for chefs and our foodservice friends: restaurant food safety could look like HACCP, the important part is to know your product, ask yourself if you have any hazards, and have a good safety plan!.

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

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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Food Allergens: Eight Key Points

I have been teaching for over a year from the Preventive Controls for Human Food curriculum and feel quite comfortable with the topic of food allergens. I heard a talk by Dr. Steve Taylor, Co-Director and Founder of the Food Allergy Research and Resource Program. These are eight key points I learned.

  1. The science of food allergens is new. Food allergens were recognized in 1988. An article in the Journal of the American Medical Association from a physician at the Mayo Clinic reported eight deaths associated with the consumption of food and development of an allergic response. I don’t know the details, but I do know that 1988 was not a long time ago.
  2. Besides the United States, Canada, the EU, FAO and Codex Alimentarius recognize the Big 8 allergens. The Big 8 are dairy, egg, peanut, tree nuts, fish, shellfish, soybeans, and wheat. I wrote that list off the top of my head! Teaching the workshop helps. In the United States, the Big 8 are regulated under the Food Allergen Labeling and Consumer Protection Act of 2004. Other countries may recognize other allergens or include sulfites, which are technically not allergens.
  3. The Canadian Food Inspection Agency pulls food from the shelf and tests for undeclared allergens. Let that sink in.
  4. Very few universities teach the science of food allergens. With food allergens being the number one cause of recalls and food packaging being most responsible, students need to understand quality assurance in a food manufacturing facility and effective methods for cleaning to remove allergens.
  5. Fourteen different companies make test kits for allergens. Buyer beware. There are sensitivity and matrix differences that will get you significantly different results. You are not mandated, but are highly encouraged, to validate your allergen clean process.
  6. Food allergens cause up to 40% of eczema.
  7. Physicians were wrong to tell parents to not introduce peanut butter to infants. The American Academy of Pediatrics guideline for introducing peanut butter is at 4-6 months for infants at highest risk with other food allergies or severe eczema and earlier for infants at lower risk. It is best to blend the peanut butter in another food, to avoid its choking hazard. A peanut butter campaign for pediatricians is needed to reverse the thinking of physicians and well-meaning grandparents. Soon peanut patches will be available, like the technology of nicotine patches.
  8. A safe dose of each allergen does exist. While the US currently has a zero-tolerance policy for allergens, more research is needed to understand low thresholds for each allergen where an allergic response would not occur. In the future, we may move to defect action levels being allowed for each allergen, as the lowest amount allowed in food at a safe level for all.

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

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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What is a Food Process Authority?

Your FDA inspector will ask to see your validation study in your food safety plan. We have been talking to many companies who need a validation study of their kill step. In a previous post in this blog, Validation of Thermal Processes, I wrote about the need for validation of kill steps in processing. These steps are process preventive controls and part of your food safety plan.

There are options for getting the data you need for a validation of your process preventive control. You can use technical, published data; we recommend a Google Scholar search. You can partner with a local expert found at your contract lab, university, extension office, or consulting firm. While only required for manufacturers of acidified and low-acid canned foods, we like the idea of using a food process authority. A food process authority is someone who will work with you to validate your process with your equipment and with your product.

A food process authority can do many things for you. They will partner with you to evaluate the worst-case parameters of your processing equipment. Where are the cold spots? Where is the product exposed to the shortest time of processing? Does the temperature drift over the duration of a long shift? Have you scientifically determined the longest run time for your equipment? There are so many variables to assess, and a food process authority will make sure you are addressing all the variables.

A food process authority is often a food engineer or chemical engineer. You want to hire someone who has been in a lot of food facilities with a variety of processing equipment. With experience like that, they will have applied their knowledge in many operations and may have seen a set up like yours or worked with the same equipment at a different facility.

Where will you find a food process authority? At the same places listed above. Every state has a land-grant university. Every land-grant university employs university extension personnel, and it is among the extension personnel that you can expect to find a process authority. I found a listing of food process authorities by state on the website of the Association of Food & Drug Officials:
• http://www.afdo.org/foodprocessing,

ConnectFood has a marketplace to access process authorities for acidified foods. If you are looking for process authority services, you may create a free account to access the Expert Marketplace and find one that fits your needs.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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