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What Happens at Receiving Does Not Stay at Receiving

Receiving is a critical operation within your company with great responsibilities.

  1. Receiving of raw materials potentially contaminated with pathogens
  2. Receiving of ingredients with known allergens
  3. Receiving of ingredients or packaging with a supply chain preventive control
  4. Prevention of intentional adulteration

Receiving personnel need access to records at Receiving. Do Receiving personnel have a tablet or computer to look up approved suppliers, specifications and other information? Stickers and placards should be readily available to label totes or pallets with QA hold, allergen, or other warnings. Receiving personnel must be properly trained in the receipt, labeling and handling of raw materials potentially contaminated with pathogens, ingredients with allergens, and ingredients or packaging with a supply chain preventive control.

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

The Preventive Controls for Human Food rule Subpart G details the requirements for supply chain preventive controls. With every receipt of an ingredient with a supply chain preventive control, bill of lading should be checked, along with the receipt of documentation of the absence of the hazard. The latter is needed, regardless of the same lot being repeated.

Receiving should have written SOPs for the inspection of vehicles for sanitary transport and receipt of materials in intact totes or on intact pallets. Not only are you concerned about determining if pests have accessed the ingredient, you are also preventing cross-contamination of pathogens and cross-contact of allergens. Within the written SOP, address the refusal of goods where the truck is unsanitary or when the packaging is compromised.

The Intentional Adulteration rule is effective in 2019, and Receiving plays a more direct role. Many of the steps taken now, like sealing of gaskets, will be documented to comply with the rule. The focus of the rule is on liquid ingredients and ingredients with the potential to cause widespread harm to public health. As you are implementing your food safety plans, consider incorporating measures designed to prevent intentional adulteration at Receiving.

Once an ingredient is accepted and properly labeled, Receiving may be responsible for notifying QA of a QA hold or for proper moving of ingredients to storage. Proper handling does not compromise the ingredient through cross-contamination or cross-contact. Another part of the Intentional Adulteration rule addresses the disgruntled employee. Start at Receiving and walk through the potential for an employee to have access to an ingredient or process, with the intent of widespread harm.

Receiving personnel play a key role in the safety of food. By providing the training and resources necessary for them to do their job well, you create a culture of food safety from the beginning.

Paperwork! Paperwork! And more paperwork! 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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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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2017 Illinois Food Safety Symposium: A Review

On August 8th and 9th, 2017, the ConnectFood team hosted the 2017 Illinois Food Safety Symposium in Bloomington-Normal, Illinois. There were nearly 250 food industry professionals that attended the two day event. ConnectFood organized and led the Symposium in order to continue the tradition, previously established by the Illinois Department of Public Health of bringing together regulators, academia, and industry professionals in order to work towards continuous improvement of the food safety environment in Illinois.

If you were unable to join us at the Symposium, we hope you enjoy this short overview of what you missed, and that you’ll be interested in attending next year!

The Symposium was started the Keynote address from Mike O’Grady, Vice President of the Bloomington-Normal Economic Development Council, and Molly Lamb, Deputy Director at Illinois Department of Public Health. Both touched on the fact that the food safety industry in Illinois is incredibly strong, but that there are many areas that are being expanded and strengthened. Matthew Botos, CEO of ConnectFood, introduced two of our exhibitors: Cheryl Hodges from Miller & Stryker, and Renee Hoggay from the National Restaurant Association, and encouraged them to speak about their products and businesses.

Matthew Botos, CEO, ConnectFood, welcoming the crowd to the 2017 Illinois Food Safety Symposium.

As participants refilled their coffee mugs and grabbed morning snacks, Dr. Robert Brackett, Director of Institute for Food Safety and Health set up for his discussion of Food Safety Modernization Act (FSMA) & Compliance. He began by introducing the foundation of FSMA – why is it necessary? In the shortest summary possible: FSMA is necessary because food supply is more complex, and an increased percentage of the population is at risk for foodborne illnesses. Dr. Brackett also covered the seven rules of FSMA: Preventive Controls for Human Foods and Animal Foods, Produce Safety, Foreign Supplier Verification Program, Accredited Third Party Certification, Sanitary Transport, and Intentional Adulteration. The first FSMA Compliance dates are right around the corner (this month, in fact): September 17-19th, 2017, so if you need help making sure you’re compliant, now is the time to act.

Dr. Bob Brackett at the 2017 Illinois Food Safety Symposium.

After lunch, Dave Park, Principal, Food Defense, LLC spoke on the topic of Food Defense. He touched base on the history of food defense, food fraud, the intentional adulteration rule, and the comparison of new regulations to HACCP. Mr. Park highlighted food defense audit failures, threats and risks, imports and refusals, and food fraud incidents. “The general Hazard Analysis and Vulnerability Assessment procedure is the same, but the perspectives and expert knowledge bases used are different.” We are told to “Remember: Food Safety + Food Defense = Food Protection.”

Dave Park speaking at the 2017 Illinois Food Safety Symposium.

Next, Matthew Botos moderated a panel regarding Distribution and Transportation of Products, featuring the expertise of Tanesia Cole, Manager of Food Regulatory Compliance at US Foods, and Jeff Newey, Manager of Deseret Transportation. Both members of the panel highlighted their individual company’s background; explaining what they ship, how their shipment process works, and the procedures that are in place to ensure safety in the distribution step. Both touched on the transportation rule of FSMA, urging folks to shift their way of thinking to match the safety regulations of the new rule.

Tanesia Cole & Jeff Newey at the 2017 Illinois Food Safety Symposium.

To close out day one, Matthew Botos, CEO of ConnectFood, and Chris Metz, CTO of ConnectFood, hosted a demonstration of the connectfood.com software. I won’t dive too much into detail here, but if you’re interested in a software demonstration, please contact us & we would be pleased to show you around our website. We wrapped up the day with a short reception, and set our focus on day two.

Matt Botos, CEO, and Chris Metz, CTO, ConnectFood, at the 2017 Illinois Food Safety Symposium.

Day two opened with William Weissinger, District Director at FDA Chicago District, speaking about FDA Inspections & Enforcement Then and Now: Changes Over 5 Years. Ultimately, Weissinger said that the current goal of FDA inspections is to educate while regulating, meaning that the industry shouldn’t attempt to know exactly what to expect during an inspection, as inspections are by special assignment. In addition, it was stressed that all food manufacturers (regardless of size) must be registered with the FDA. (If you need help with that, contact us.)

William Weissinger speaking at the 2017 Illinois Food Safety Symposium.

Jessica McAnelly, Chief, Division of Food, Drugs, and Dairies at Illinois Department of Public Health (IDPH), took over the podium next. She spoke on the state of public health in Illinois, which ended up being a major talking point for a lot of attendees. She spoke about new legislation and updates to the existing legislation. Allergen awareness training is included in these updates – a main change included was that the certified food protection manager must get allergen training within 30 days of employment at a high-risk restaurant. Another major announcement of this presentation was that IDPH will no longer validate hours for Food Service Sanitation Manager Certification (FSSMC) – the Certified Food Protection Manager is a required, national certification.

Jessica McAnelly speaking at the 2017 Illinois Food Safety Symposium.

After lunch, it was Eric Greenberg, Principal Attorney, Eric F. Greenberg, P.C.’s turn to chat with participants about Labeling & Nutrition. The finalized changes for the FDA for Nutrition Facts Label are as follows: calories presented more prominently, an altered format, and added sugars included. Unfortunately, these changes have been postponed indefinitely. In Mr. Greenberg’s words: “One thing’s for sure in the future: Label compliance will always be primarily the responsibility of food companies, and this is especially so given the FDA’s enforcement patterns.”

Eric Greenberg at the 2017 Illinois Food Safety Symposium,

ConnectFood team member Dr. Kathy Knutson moderated our second day panel. (You’ve probably read her outstanding blogs for ConnectFood – if not, check them out here.) This panel included members Joseph Cooper, Emergency Response Coordinator, Chicago District Office, Mancia Walker, Supervisor, Indianapolis Resident Post OHAFO 6E, and Christinae Hudson, Consumer Complaint Coordinator, Chicago District Office. They discussed Recalls & Outbreaks – what they’d seen, effective ways to handle them, and how important recall plans are for the safety of a company. A crowd pleaser that was discussed was the Blue Bell ice cream recall that was enforced across the state of Texas after the delicious ice cream was contaminated with Listeria.

Dr. Kathy Knutson and Matt Botos moderate the Recalls and Outbreaks panel.

The final speaker at the Symposium was Laurie Jahn, Senior Environmental Health Program Specialist of Lake County Health Department, talking about juice production & safety. The objectives of this presentation were to understand the methods of fresh juice processing, determine the code regulations, and present labeling requirements for bottling fresh juice. The main concerns with fresh juice are the possibilities of cross contamination and that there is no kill step, which leaves the juice untreated.

Laurie Jahn speaking at the 2017 Illinois Food Safety Symposium.

Matthew Botos wrapped up the Symposium with a final “thank you!” to everyone that joined us. If you attended the Symposium and have some feedback or need to obtain your certificate of completion, please complete this survey. As always, the ConnectFood team is always available to help you understand food safety. All you need to do is contact us.

Johanna Seidel has been a team member with ConnectFood since July 2016. She holds a B.F.A. from West Texas A&M University. She helped organize and run the 2017 Illinois Food Safety Symposium. https://www.linkedin.com/in/johanna-seidel-3a98b6130/

Johanna Seidel, ConnectFood, celebrating the completion of the 2017 Illinois Food Safety Symposium.

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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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