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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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Logs & Record Keeping

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

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

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

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

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

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

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

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

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

About the Author

Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

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Records Management: Storing Your Records

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

What records must my company have?

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

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

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

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

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

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

“How do I store all these records?”

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

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

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

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

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

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

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

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

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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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Adult Education and the Responsibility of Lead Instructors

Give a man a fish, and you feed him for a day. Teach a man to fish, and you feed him for a lifetime. -Anne Isabella Thackeray Ritchie http://quoteinvestigator.com/2015/08/28/fish/

How do we learn?

I found the diagram below in an interesting blog at http://www.willatworklearning.com/2006/05/people_remember.html.

I started college in 1979 from the top portion of my high school class, good in math, science and Latin; an excellent reader; and a quick learner. After ten years of college, my first job was teaching at a technical college. I learned that most instructors teach and evaluate students in the way they are most comfortable. After ten years of college, I was most comfortable with lecture and exams. That doesn’t fly for most technical college students. Next I learned about learning styles as shown above in the four colors. Many of my students were kinesthetic, meaning that they would literally not learn until they did the hands-on work. Think of students studying auto mechanics. How do they learn? Not by reading the book! Other students didn’t learn until they had a chance to talk about the material; they were social. Some students were equal in all four areas of learning.

Next I learned about retention of learning. As shown in the diagram, it is generally regarded that we retain 10% of what we read and 90% if we immediately use the information we just learned. Of course every person varies with their personal percentage, but the numbers represent the population averages. Now I understand why reading assignments of material before a learning activity do very little on their own toward actually learning and retaining the information. The exception is people with photographic memories; my statement does not apply to them.

A third piece in learning is not pictured here. That is, we must be exposed to new information at least 21 times to learn. When a child learns their ABCs, they sing the song over and over and over. The bedroom has the letters as art. There are books. There are videos. There are CDs. Children are quick learners, so we need to give our adult selves a break on expecting to learn information. For example and in the PCQI workshop, PCQIs learn the definition and application of “corrections” compared to corrective actions. The PCQI participant reads the definition and term within the book, sees the term on the projection of the slides, hears the Lead Instructor say the term many times, and uses the term in discussion with their team. Will the participant retain the definition of the term? Maybe. There may not be enough exposures to the term for it to stick.

The design of the curriculum maximizes learning for a wide range of learners in the population given the time we have in the workshop. This is just a start.

Another really cool thing that is happening in our brain is myelination. We used to think our brain did not grow in adulthood. That is absolutely not true. As we learn new material, new cells are making connections to other cells. As that cell is used over and over with the new information, layers of myelin are added to stabilize and cement the new cell. Those of you in my generation, do you ever wonder why you can still sing, “876-5309?” Myelin! If you play an instrument and it has been years, you can sit down and it just happens. Riding a bike. Reciting lines in a play or football play call. Myelin!

I think it is pretty freaky awesome that there are hard-core researchers out there discovering how we learn and giving us cool diagrams like the one above. I distinctly remember when I learned about PowerPoint. It was about 1995, and PowerPoint was slowly added as a tool in adult education. Just think, all my learning before 2000 happened without PowerPoint.

Learning changed quickly due to electronics. Young adult brains are literally wired differently due to exposure to devices, compared to older adults. I attended a K-12 teacher conference around 2010. There were about 500 teachers in the room. The speaker showed a video in which a group of about six teenagers bounced a ball back-and-forth from person to person. We were instructed to follow the movement of the ball. Of course, I thought it was a lesson in team-building. At the end of the video, the speaker asked us to raise our hand if we saw the gorilla walk through the scene. Gorilla, what gorilla?!! How could I not see a gorilla? Looking around the room, all the teachers, fresh out of college, i.e. young, had their hands raised. What? The speaker played the video again, and yes, there was a large person in a gorilla suit casually walking through the scene. All the young brains wired on computers and electronics had seen all the action. In 2010, that was less than 10% of the audience. I would expect that number to increase annually.

As Lead Instructors, we have an obligation to not only present the material in the curriculum, but to facilitate adult learning. The workshop has been designed to teach the material with multiple exposures of information, to address different learning styles, and to maximize retention. Adult education goes beyond making sure our participants are comfortable in the room and enjoy snacks and beverages, which in my opinion are very important! It is critical to try to meet the needs of each learner. Following the design of the curriculum is a good start.

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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I am a Preventive Controls Qualified Individual – what now?

I am a Preventive Controls Qualified Individual (PCQI). What have I gotten myself into?

First, congratulations! You have taken a big step in preventing hazards and providing a safe food for your customers. When teaching the PCQI course, we emphasize four major responsibilities of the PCQI:

  1. Create and implement the food safety plan
  2. Validate preventive controls in processing and potentially for allergens and sanitation
  3. Review records
  4. Reanalyze the food safety plan

As you can see these are large areas filled with details. Much of the work of a PCQI is focused on getting the food safety plan written, including the recall plan. You are going to do this in a team. It works better in a team. You can delegate. Reach out to personnel who you do not routinely work with, like human resources, sales, purchasing and transportation. I encourage my workshop participants to let go and let others do the work. As PCQI, you have to oversee the writing, but you do not have to do the writing. Find that super-organized person in your company, and have them do the organizing of materials and reminding others of deadlines set by the team. We all have that person who loves to tell others what to do. Put the full authority of the PCQI behind that person and unleash him or her.

Your day-to-day and week-to-week operations may not change much from what you do now. You will find steps where there is control of a hazard and document that. Much of this is done and already being done. In your hazards analysis, you identify process, sanitation, allergen and/or supply chain preventive controls, their corrective actions or corrections, and record keeping. You may identify hazards that were not previously identified and documented, but that work will just become part of your food safety system and part of your daily and weekly work along with what you have been doing.

Each PCQI works in a different food factory with different ingredients, equipment and products. Some factories have been operating the same way for decades and foresee no changes. Some factories are brand new. Some factories are expanding and bringing in new lines and their equipment. The food safety plan must be reanalyzed every three years, if there is no reason to do so earlier. Earlier reanalysis is at least discussed at the identification of a new hazard, new supplier, new equipment, new product… You get the picture. Any time there is a change in the food safety system, you as PCQI will document that you addressed the hazard potential and either changed the food safety plan or decided the current food safety plan controlled the hazard. The key to your success is documentation, but you already knew that!

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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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:

https://www.ifsh.iit.edu/fspca/fspca-preventive-controls-human-food

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.

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