Tag Archive for: preventive controls

HACCP vs. Preventive Controls

The world of HACCP (Hazard Analysis and Critical Control Points) versus Preventive Controls is an interesting conversation we are seeing at connectfood.com and across the entire food industry. FDA has trained hundreds of inspectors in Preventive Controls for Human Food and there are thousands of Preventive Controls Qualified Individuals (PCQI’s) across the country and the world. There are tens of thousands of HACCP trained individuals. I have used the analogy that food safety best practices are like a sport; the more you train and the more you focus on “basics done well,” the better your plan will be on a day-to-day basis. The focus is making the food supply safer. This does not mean that HACCP is not valid, as a matter of fact HACCP and Good Manufacturing Practices (GMP’s) should be looked at as the foundation of Preventive Controls for Human Food. Local departments of public health still rely on HACCP as their main line of defense for the food safety industry. We have seen so many small processors and restaurants that have inspections at which HACCP is still the focus, even though Preventive Controls has some more advanced techniques for protection.

Both HACCP and Preventive Controls focus on making sure you have good sanitation practices, employee training and have done a hazard analysis for biological, chemical and physical hazards. I feel like the lines are blurring a bit as companies, academics, and regulators don’t often understand the differences between the two and – to be honest, the differences are not that great from a fundamental level. Here is where I come in with some definitions for you…

    “HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.

    HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

    HACCP System: The result of the implementation of the HACCP Plan.

    HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system.

    Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

    Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.” FDA.gov

The fundamental principles of HACCP come through in Preventive Controls with some additional areas to focus on as we enhance our food safety plans.

    “In general, you are a covered facility if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Covered facilities are required to have and implement a written food safety plan that includes:

Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).

If the hazard analysis reveals one or more hazards that require a preventive control, the facility must have and implement written preventive controls for the identified hazards.

Preventive controls: Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls:

Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.

Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products.
Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards.

Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.

Oversight and management of preventive controls: Once a facility has identified a preventive control for a hazard, the facility must make sure that the controls are being met.

Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented.

Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.

Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records.

Verification: These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented.

Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.

Supply chain program: Manufacturers must have and implement a risk-based supply chain program if the hazard analysis identifies a hazard that

    (1) requires a preventive control and
    (2) the control will be applied in the facility’s supply chain.

Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements.

Manufacturers are responsible for ensuring that raw materials and other ingredients requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. (Suppliers are approved by the facility after the facility considers several factors, such as a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)

Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.

Recall plan: 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.” FDA.gov

In conclusion, HACCP and Preventive Controls are both food safety risk management systems. connectfood.com provides the ability for all facilities that handle or process food to create a plan depending on what the regulatory authority or a clients needs. Contact us and let us assist you in your food safety planning.

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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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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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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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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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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Supply Chain Preventive Controls

You have a supply chain program. The supply chain program is a prerequisite programfor the safe manufacture of your product. For your ingredients, packaging and other materials, you are sourcing the best materials at the price you are willing to pay. For each ingredient, you have agreed upon specifications with your supplier. Some of those specs are sensory-related, like color, and affect quality. Some of those specs are chemical, like pH or moisture content. Some of those specs are microbiological, like Aerobic Plate Count or absence of Salmonella.

  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 second requirement above is enforced under the Foreign Supplier Verification Program (FSVP) rule. Do you have imported ingredients? These must meet the same food safety standards as domestic ingredients, under the FSVP rule.

Only for those ingredients where you have identified a hazard requiring a preventive control AND the preventive control is a supply chain preventive control, are you REQUIRED to have a supply chain preventive control in your written food safety plan.

Most food manufacturers do not have a supply chain preventive control.

Why would you not have a supply chain preventive control?

  1. You have not identified a hazard in an ingredient or packaging.
  2. You identified a hazard and are controlling the hazard under your own roof.
  3. Your customer will control the hazard.

The good news is there is no validation of a supply chain preventive control! The Preventive Controls for Human Food rule only requires validation of process preventive controls. If you want to read the requirements for supply chain preventive controls in the FDA rule, follow the previous link and find Subpart G at the end of the rule. However, I recommend starting with the FDA At-a-glance document which provides a neat summary of the rule.

Paperwork! Paperwork! Yes, it is all about verification. Include verification of your supply chain preventive control in your food safety plan. Your FDA inspector will ask to see it. Supplier verification is discussed in a separate blog post.

Still not sure if you have a supply chain preventive control? 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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Recall: Lessons Learned – Part 2

In a previous ConnectFood blog, Recalls: Lessons Learned, I wrote about some personal experience working with industry during recalls. I discussed:

  • Are you sure you must initiate a recall?
  • Get yourself a good lawyer.
  • Don’t move that product!

There are two important reasons to have a written recall plan. First, the rule requires it, and, second, the written recall plan will get you organized in the case of an actual recall.

There is a requirement for a written recall plan in the rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. In Subpart C of the rule, any facility that manufactures, processes, packs, or holds food must complete a written hazard analysis. There are facilities which are exempt from a hazard analysis. Farms are exempt. Facilities earning an average of less than $1,000,000 in revenue are exempt. Food service operations like grocery stores and restaurants are exempt. If a food facility does not perform a hazard analysis, the facility must provide evidence of oversight by a non-federal entity, like a state department of agriculture or a local health department.

It is in the hazard analysis that hazards requiring a preventive control are identified. Right up front in Subpart C we see the Contents of a food safety plan

, and (4) The written recall plan as required by § 117.139(a).

Turning to 21 CFR 117.139(a), we see Recall plan.
For food with a hazard requiring a preventive control:
Does your product potentially have a hazard? Have you identified a hazard requiring a preventive control in the hazard analysis? If you have a ready-to-eat product, you have a hazard, namely an environmental pathogen. If your product has an allergen, you have a hazard. Does your process have metal-on-metal or other physical hazards?

If you have identified a hazard requiring a preventive control in the hazard analysis, you must have a written recall plan as part of your food safety plan.

The recall plan must include written procedures which the company will follow in the event of a recall. Most recalls are announced on Fridays, and then it is all hands-on-deck. The recall plan must name the position of who will do each procedure. You can include names and contact numbers in the recall plan; just remember to keep it updated. Here are some examples. Who is the:

  1. Single person to initiate the recall. Who has the responsibility to pull the trigger on a recall?
  2. Internal recall coordinator. This person may not be a Preventive Controls Qualified Individual.
  3. FDA recall coordinator
  4. State recall coordinator
  5. Accountant. A recall is going to be costly.
  6. Attorney or firm for the recall. Find an attorney who has recall experience.
  7. Contact for communication to the public and press. The public must be notified of the hazard.
  8. Sales personnel who must notify each customer, communicate if the product is to be returned or disposed, and calculate the daily effectiveness check which accounts for how much product has been recovered.

A team of experts must decide the fate of the recalled food. The company will work with the state and/or FDA recall coordinator, attorney, quality assurance personnel, and contract lab. The company may hire a consultant to investigate the cause of the hazard and advise through the recall. If a plan is developed for the food to be reconditioned, reprocessed including relabeling, reworked, diverted, or destroyed, the company will present the plan to the FDA for acceptance.

A mock recall is not required, but highly encouraged.

A mock recall is when the recall team tests and updates the information in the written recall plan. I was reviewing a food safety plan with a client, and we came to the recall plan section. The quality manager informed me that she had just emailed with the FDA recall coordinator during the previous week, when I asked about mock recalls and the testing of the plan. The contact information was on the email signature for the FDA recall coordinator. On a whim, I said let’s call the number. The recorded message told us that the person could no longer be reached!

Since the mock recall is not required, the company will determine the frequency of the mock recall and if the date is announced or surprise. There are advantages and disadvantages both ways. The important concept in a mock recall is to go one step back to the source of an ingredient and one step forward to your customers. For every mock recall you do, take the practice seriously, and you will learn more about your systems and become more organized in your company.

Unfortunately, food recalls are an every-day occurrence in the food industry. Not only is a written plan required by law, but the written recall plan will help your company be organized in the case of an actual recall.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. The folks at ConnectFood are here to help! Contact us.

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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FDA and the State of Wisconsin Agree to Recognize Each Other’s Inspections

At the Food Safety Summit 2017 I heard an announcement that piqued my interest. The FDA and my home state of Wisconsin have an agreement for recognizing the other’s inspections. There will not be duplicate inspections! That is great news. Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) and the FDA Minneapolis District Office (MN‐ DO) have developed a process for sharing inspection reports, work plans and establishment inventories; read more about that agreement here.

First, I want to state the obvious. That’s the way it should be. I feel for the food companies that have more audits and inspections than there are months in the year. Inspections are time-consuming and costly to business. Food prices include the cost of audits and inspections.

This was a big announcement at one of the keynote presentations in front of a packed room. It was big, because that is not what is normally done. Even though the state and FDA inspectors use the same federal rules and have the same goals, they rarely coordinate inspections, resulting in duplicity.

The other reason this agreement makes sense is that both FDA inspectors and state inspectors are going through the same training on the FSMA rules. Matt Botos, ConnectFood CEO, and I know, because we trained them. For the last year I have had state of Wisconsin inspectors in my Wisconsin workshops and FDA inspectors in workshops across the nation. Everyone feels better knowing that FDA inspectors, state inspectors and industry are all in the room for training together. I have only had good experiences with exchange of information. I did not get a sense in the classroom that industry was shy about asking questions, which one might fear. Inspectors were honest about where they were in the process of learning and enforcing the Preventive Controls for Human Food (PCHF) rule. As I have attended training, listened and read about the roll out of other FSMA rules, I have heard over and over that FDA plans to train inspectors with industry, following the training model of the PCHF training. That is more good news.

At Food Safety Summit 2017 I confirmed that FDA is conducting 300 PCHF inspections for fiscal year 2016-2017, the year ending in September. These will be at businesses with more than 500 employees. Other inspections beyond the 300 will be GMP inspections and are designed to educate on PCHF. The food industry can relax (a bit) in the knowledge that the FDA is getting trained alongside industry and will use inspections as an opportunity to educate on FSMA.

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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Risk-based Preventive Controls

If you are new to the food manufacturing industry or at least new to food safety, you may not know that the food industry heavily relied on finished product testing to determine safety. It wasn’t until the US manned space program was developed in the 1960s that industry looked at building safety in to the process. Now we look more at farm-to-fork and identify preventive controls outside of processing, as well as within processing. Because of this all-inclusive trip down the food highway, some managers have a difficult time choosing the controls most important to food safety.

One analogy I use is my frightening drive from Green Bay to Chicago one January. I worked until 6:30 pm and left Green Bay in the dark. As I drove out of Green Bay and into the darker countryside, it started to rain. The rain mixed with buckets of snow that alternated between rain and snow for the first hour of my drive. I was in a hurry, driving fast, and actually hydroplaned at least once. As fast as I was going, I was still being passed by semis and other trucks. By the time I reached Milwaukee, the rubber of the driver’s side wiper was flapping around and giving me a marginal view.

In this scenario, what were the most important controls for a safe drive? I stopped in Milwaukee to install a new wiper. My tire tread kept me on the road. The lights were working, as was the engine. I used my seatbelt. The air bags were assumed to be in working condition. The brakes worked. The gasoline is analogous to utilities. My cell phone was charged, if needed as a communication tool.

It was not important how much trunk space I had for my bags. It was not important that the radio worked. Optional features like automatic windows or adjustable mirrors were not important.

Similarly, much of your process is not related to safety. In the hazard analysis for our food safety plans, we are asked to identify hazards and their preventive controls. When you are deciding if a preventive control is needed, imagine taking it away. In my driving scenario, my safety would be compromised without working wipers, lights, tires, engine, seatbelt, air bags, and brakes. These parts of driving received my utmost focus that night. What, if taken away, will compromise safety?

I cannot take credit for the following analogy to define risk vs. severity, but it is a good one. When we are out walking in the world, there is a risk of getting hit and hurt by a car. It is a hazard we all experience. When I leave a building and walk through the parking lot to my car, the probability or severity of getting hit and hurt is small. It hasn’t happened yet! If I do get bumped by car, my injuries might not even be treatable. Now let’s say I walk across an LA highway-six lanes going each way. The risk of getting hit is high, and the injuries will be severe. Think about it; it is the same hazard!

Since I scored high in Harmony on the StrengthsFinder survey, I like my team to be happy and get along. If you have food safety teammates who want to list every hazard in the world in your hazard analysis, keep the peace, and go ahead and list them! Then, your team will debate the risk vs. the severity. By the way, at the end of Chapter 1 in the book for Preventive Controls for Human Food, there is a nice definition for your team of both risk and severity. If loss of control results in a class I recall due to an allergen or pathogen, then the hazard is automatically severe and must have a preventive control. Other hazards, while theoretically possible, may be concluded to be of low risk and low severity. These hazards to not require a preventive control.

As a team:

  • Identify hazards.
  • Define risk vs. severity.
  • Debate and assign risk and severity to each hazard.
  • Identify hazards requiring a preventive control.

The folks at ConnectFood are here to walk across the farm-to-fork path together, hand-in-hand.

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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Regulators for Human Food – What are They Good For?

Regulators, what are they good for?

When I think about regulators, I think about the wonderful people I met this year while teaching the Preventive Controls for Human Food workshop. I had participants who were state inspectors, and I had FDA inspectors. Some were very knowledgeable and could have taught the workshop. Some were new to their jobs and were learning from the beginning just like many of the industry participants. We all have the same goal of safe food.

When I think about regulators, I think of the ones I have not met, but I know their stories. I know about the state inspector who bullied a company on a Friday afternoon to initiate a recall based on presumptive lab results. I know about the inspector who labeled a control panel swab as a zone 1 sample, and when it came back positive the company had to recall the product. I know about the inspector who chatted up the quality manager about personal matters and wasted a day’s work. There are stories after stories about the demanding, unknowledgeable inspectors who are unreasonable. Just like the news of the world, these are the stories we hear, and we start to believe they represent the whole. They do not.

I am encouraged to know that the inspectors are being trained using the same curriculum as that used to train industry. I am encouraged that FDA inspectors are in the same room with industry participants for the discussion and debate on the material. We are all in this together.

FDA rules and guidance documents are available for free on-line. The much-anticipated Hazards and Controls guidance was published in draft form at the end of August. See the link below. The document is in a six-month comment period. Individuals and organizations can submit comments. After the comment period, the FDA must address every comment, and publish the final guidance document. After working with the FDA, I expect this document to be published around the end of 2017. The Hazards and Controls guidance is critical to inspections. Some inspectors will use it as the bible for inspections. If the guidance identifies a hazard in the food you produce, you better have a preventive control for that hazard or have written justification as to why you do not have a preventive control for that hazard.

So, what do you do in the meantime? You can check the FDA Hazards and Controls draft guidance, or you can go to Canada! The Canadian Food Inspection Agency (CFIA; remember chapter 7 in the PCHF workshop?) has a searchable database; see the link below. This is a technical resource you can cite in your hazard analysis. Check it out!

I know there are many other resources for inspectors, including more training programs. The International Food Protection Training Institute (IFPTI) coordinates training of inspectors with the Association of Food and Drug Officials (AFDO). The IFPTI website provides a link to online courses available free for FDA, State, Local, Territorial & Tribal (SLTT) regulators at:
http://www.fda.gov/Training/ForStateLocalTribalRegulators/default.htm
This summer I asked about these courses being available to industry and the reply was yes, for a fee. Contact the Director of IFPTI, if you are interested in this training for your company.

FDA Hazards and Controls draft guidance
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517412.htm
See Download the Draft Guidance.

CFIA searchable database
http://active.inspection.gc.ca/rdhi-bdrid/english/rdhi-bdrid/searece.aspx?i=11

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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