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Training Basics for Preventive Controls Qualified Individual

Training of Preventive Controls Qualified Individual (PCQI): the Basics

Who trains PCQIs? Lead Instructors (LIs). LIs come from industry, academia, government, professional and trade associations, or are independent consultants like me. All LIs are PCQIs and attended a workshop using the FDA-recognized curriculum. There are hundreds of us. In the same way PCQIs are being tracked by the International Food Protection Training Institute (IFPTI), there is a list of LIs. My guess is that half of LIs are in industry, teaching privately within their company. Think of very large companies and the need for internal training of PCQIs. Corporate LIs are getting people at each of their plants trained as PCQIs.

Professional and trade associations offer either private or public workshops. If you are in a specific field like produce (pun intended), dairy, bakery, or others, it may be beneficial for you to attend a PCQI workshop with an association serving your industry. You can go to the association website to look for training offerings. The other option when seeking a workshop is the list on the Food Safety Preventive Controls Alliance (FSPCA) website. In order for PCQIs to receive a certificate from IFPTI and FSPCA, the workshop is registered with IFPTI. You can search by course, course start date or location, with a link to registration. Go to the following page and click on FSPCA Preventive Controls for Human Food Courses under RESOURCES:


or directly here might work: https://fspca.force.com/FSPCA/s/course_registration/Course_Registration__c/00B36000007edjpEAA

I just spent some time navigating the list, and it is frustrating. Hang in there! FSPCA updated their website, and it is not for the better on the course listing page. At this point, there is a PCQI workshop every business day somewhere in the world. As consultants, Matt Botos, ConnectFood CEO, and I teach both private and public workshops and are willing to travel almost anywhere in the world. Matt was sent to Kingston, Jamaica when other LIs refused to go. That’s our Matt!

Over 18,000 PCQIs have been trained using the FDA-recognized curriculum. Some are the sole PCQI at their facility. Other companies have sent waves of personnel to get trained and stacked their departments with multiple PCQIs. Even expert food safety consultants have gone through the training to receive the title of PCQI. No matter where they come from, all PCQIs have been trained with the same curriculum.

Every PCQI receives the same book and training from the same deck of PowerPoint slides. I have been trained to write curriculum at the high school and college level. The curriculum is practically perfect in presenting information in 16 chapters, each starting with objectives, then material, chapter summary and additional reading resources. The book is packed with information and used by PCQIs as the bible of food safety. PowerPoint slides, worksheets and model food safety plans are all provided. As a LI, I add my personal stories and can supplement my own slides or handouts into the presentation.

There is only one recognized curriculum. It involves 20 hours of training. A typical public workshop is two-and-one-half days. Private workshops can be designed any way you want. If you want to do ten weeks of two-hour training sessions, that works! Five, four-hour sessions work. The requirement is to cover all the material, and participants must be present at all times. There are training companies offering workshops with their own curriculum and materials which are not recognized by FDA. If a workshop is not registered with IFPTI, the participants will not receive a certificate from IFPTI and FSPCA. Receiving a certificate from a different organization does not meet the requirement in the Preventive Controls for Human Food rule and will not be recognized by FDA. There are no on-line workshops at this time recognized by FDA. Buyer beware!

Matthew Botos and I welcome your questions about training.

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.


The Language of the Preventive Controls for Human Food Rule

Recently, I sat in a room with 20-some food safety experts eager to learn about the curriculum for the Preventive Controls for Human Food rule. The FDA-recognized curriculum is used as the primary means to call oneself a Preventive Controls Qualified Individual. At the start and at hearing the use of “preventive,” my colleagues and I whipped out our cell phones to look up the existence and meaning of the word. Well, I will tell you it is a word, is chosen for use by FDA, and means the same as “preventative.” Out loud, say to yourself, “preventive measures.” Sounds good, doesn’t it?

Preventive is not the only new word to the rule. The terms of HARPC, still in its infant stage, and its older siblings of HACCP, CCPs, and critical limits are fading into the sunset. If you are a food safety expert who has grown up on the use of HACCP and CCPs, don’t worry. FDA is not making you use the new language. There is still room for use of HACCP and CCPs when identifying process preventive controls. After all, processing is where much of the highest risk in food safety is controlled. Water is removed to prevent growth of mold and production of harmful toxins. Heat is used in pasteurization, canning and baking to kill pathogens. We use metal detectors. The youth in our business will label these process preventive controls, not CCPs. The youth will be studying the rule and the language of the rule.

There are three additional labels of preventive controls-allergen, sanitation, and supply chain. We do not apply the terms of HACCP, CCPs or critical limits to preventive controls in these three areas. Your hazard analysis will identify if you need a preventive control in any of these areas. We identify preventive controls for known or reasonably foreseeable hazards, and set parameters and values. Parameters are just the name of the measurement like temperature, time, belt speed or bed depth. Values are the number and corresponding unit which must be achieved for safety like 185oF, 25 minutes, 1 foot per second, or 2 cm.

Another new kid on the block is the term “correction.” We will still issue corrective action when a food safety issue affects finished product. What about when product has not been affected? The wrong label is moved from storage to the packaging line. Get the right label. A post-sanitation inspection observes areas not cleaned properly. Reclean. A correction allows the righting of a wrong at a preventive control step and before any product is affected.

It takes practice to adopt the new language of the rule. As an educator, I encourage you to say the terms out loud. After some time and in our future, we will hear a colleague say, “What’s HACCP?”

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.

What I want all my students to know about Listeria

The FDA guidance on Listeria is now out in draft form. I have known about Listeria since I was in grad school at the University of Wisconsin-Madison in 1985. That is when I learned about Listeria, but farmers and vets had known much longer. I now know that many of the miscarriages in friends, aunts and grandmothers were caused by the presence of Listeria in raw milk and from exposure in the Wisconsin farm environment. When I teach the workshop on Preventive Controls for Human Food or in other work, this is what I tell my students.

Listeriosis is an infection by Listeria monocytogenes. There is a primary and potential secondary infection. We have all consumed Listeria. Most Listeria passes through us without causing an infection. When the primary infection develops, most of us experience flu-like symptoms and recover easily. You may have had listeriosis and not even known it.

Some of us cannot fight the primary infection, because the immune system is already weakened or compromised. This includes adults who are highly stressed, undergoing chemotherapy to fight cancer, with suppressed immune systems for bone marrow or organ transplant, or who have immune-suppressing conditions like HIV, auto-immune diseases, and pregnancy.

After Listeria colonizes the intestine, cells will transfer through the lining of the intestine and into the bloodstream. This is sepsis, and a healthy body may still fight off the infection. Once in the bloodstream, Listeria has access to all parts of the body. Listeria has the unique ability to cross membranes that other bacteria do not. Listeria can cross the barrier of the brain, the meninges. The infection is called meningitis and known as circling disease in cattle. Listeria can infect the eye and cause conjunctivitis. Listeria can cross the heart lining and cause endocarditis. Listeria can set up shop in the vagina, such that when an infant is born, the infant is exposed to the pathogen. Post-partum infant deaths may be caused by Listeria.

The most impressive feat of Listeria is its ability to cross the placental barrier. I am not aware of any other bacterium capable of this. Let me know, if you know of one. Depending on the age of the fetus, Listeria infection causes a miscarriage or death shortly after birth. This is heart-breaking, and most of us know a woman who has suffered a miscarriage. Not all miscarriages are due to Listeria.

When the CDC tracks a Listeria outbreak, the number of fetal deaths are counted along with the infant, child and adult deaths. The number of deaths from Listeria is staggering and can be as high as 40% in an outbreak. The average is 20% mortality rate from listeriosis. While the sheer number of Listeria cases, i.e. individuals, is nowhere near the annual one million cases of Salmonella, it is the number of deaths that makes Listeria a pathogen of concern.

If you need help understanding the FDA Listeria guidance or the requirements for your food safety plan, please contact the friendly folks at ConnectFood.

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.

Software Update – Process Flow

It’s all about Flow!

Announcing the major release of the process flow drawing capabilities to help make Food Safety Plans even easier! In the continuous pursuit to make the complex task of developing Food Safety Plans simpler, the ConnectFood team has developed an easy to use, drag and drop visual designer. A process flow allows a facility to design the ‘story’ to tell regulators and inspectors how a food product is made. The process flow has visual indicators on process steps that signify which process steps have hazards, critical limits, and ingredients. Users can navigate to each of these entities from the process flow.

Product Flow Screen Shot

Why is a process flow diagram important?

When developing a process flow diagram, it is important to include all the process steps within the facility’s control, from receiving through final product storage, including rework and diverted by‐product, if applicable. Each process
step should be considered in detail and the information expanded to include all relevant process information. Information may include:

  • All ingredients and packaging used
  • Where raw materials, ingredients and intermediate products enter the flow
  • The sequence and interaction of all steps in the operation
  • Where product reworking and recycling take place in the process
  • Where product is diverted to waste, if applicable.

Since the accuracy of the process flow is critical to conduct a hazard analysis, the steps outlined in the chart must be verified at the plant. If a step is missed, a food safety hazard requiring a preventive control may be missed. Include every handling, processing and holding step for the product, as well as ingredients and packaging. The food safety team should walk through the facility and make any changes required in the flow diagram. At the same time, the team should make observations related to sanitation, potential for cross‐contamination or allergen cross‐contact, and potential harborages or introduction points for environmental pathogens. The walk‐through allows each team member to gain an overall picture of how the product is made. It may be helpful to invite additional plant personnel to review the diagram during the walk‐ through. Many times operators can identify issues that may be overlooked by management or the food safety team. The complete, verified flow diagram should be retained and periodically evaluated as a food safety record and part of the Food Safety Plan.
Food Safety Plans are dynamic and must be updated to reflect any changes in process or food safety considerations. Therefore, any significant changes to the process must be accurately reflected in the product flow diagram, and the Food Safety Team must evaluate if these changes have an impact on the hazard analysis and preventive controls in place.