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By Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in the prevention of Intentional Adulteration (IA)

Dry operations are tricky. They are called dry operations not only because the finished product may indeed be dry, but also because water is the enemy of the products. Water creates a greater risk for the pathogen Salmonella in the environment. When I think of dry operations, I think of dry ingredients: powders, spices, gums, thickeners, vitamin and mineral blends, flour, salt, and sugar. All food companies have dry storage for these dry ingredients; I am not addressing storage here, but processing and manufacturing of these ingredients. For every dry ingredient purchased by a food facility, there is a food company making that dry ingredient.

Being from America’s Dairyland (Wisconsin), I have been in five different spray-dry facilities in the past two and a half years that were producing spray-dried milk or whey – or both. Dry. Nut roasting is dry. Peanut butter operations are dry. Chocolate – as an ingredient and chocolate manufacturing – are dry. Water is the enemy and creates an environment where the risk of Salmonella is greater.

This brings us to cleaning and sanitizing. For most of dry operations, production does not stop. (Everyone working in a wet-clean operation just gasped!) It’s true. If the equipment can keep running, it does. There may be short shutdowns for minor repairs or adjustments, but the equipment keeps running. Most of these dry-ingredient manufacturers do business on a small profit margin and can’t afford to shut down. When the equipment does go down for cleaning, it is a big deal and may take days or a week to clear the lines, make repairs, clean, sanitize, completely dry, and start back up. Most companies discard a substantial portion of the first product out in case a pathogen in the lines was cleared at start up. The cost to the company is significant.

Then there is the equipment that is never cleaned. In some operations, it is just not possible during a normal shutdown to take apart and open certain pieces of equipment for cleaning. In the event of a recall, it means that there never was truly a clean break. FDA looks to companies to inform them on when the last clean break occurred. With a clean break, a company has evidence to shorten the span of a recall back to that last clean break. This reminds me of a company I was in that had four large tanks of melted chocolates, and the different chocolates were drizzled on the top of the product. It was heaven for this chocoholic, until I learned that the large tanks were never emptied. Never. This is standard practice throughout industry. The company had a clever way of cleaning the equipment that dispensed the chocolate, but not the mother tanks. The question becomes: in the event of a recall, would the company recall all product in market with that particular chocolate?

Without a clean break, how does a company determine how far back to go for a recall? One way to determine the cut-off date is to stop production, call in a consultant to investigate, and collect hundreds of swabs for the determination of root cause. This takes time, and the company has an obligation to inform customers of the recall and may not have enough time.

My suggestion to owners of dry operations is to schedule an annual shutdown for repairs and complete cleaning and sanitizing. I know this is a huge cost. Your CFO can calculate the ultimate cost for this shutdown of production. Then calculate the cost of a recall. In addition to the cost of recalling all product from the market, what is the cost of loss of customers? This Cheesehead is going to continue to learn from clients of dry operations and formulate best practices for cleaning and sanitizing of dry operations. Please share your thoughts with me. Food safety is not competitive.

Matthew Botos, CEO of ConnectFood.com agrees, saying: “Dr. Knutson makes excellent points in this post. When dealing with any good manufacturing operation you must understand the hazards. This is why FSMA plans require a hazard analysis. Dry plants, as pointed out, have moisture as a concern for potential human health issues.”

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! The online service allows you to complete a facility hazard analysis. 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

Eric F. Greenberg, a private attorney with a practice concentrated in representing FDA-regulated food companies and others.
Informational only, not legal advice

There are several truisms about food companies and documentation:

MORE DOCUMENTS THAN EVER
First, companies producing FDA-regulated foods these days are required to make and keep more documentation than ever, mostly due to the Food Safety Modernization Act of 2011. Companies are required to generate, for example, food safety plans with a hazard analysis and preventive controls, a supply chain program and a recall plan. Then, after setting up these systems, companies need to generate and keep documentation proving they are following the programs they established.
Also, companies who recall food should remember that they might have reporting obligations, within 24 hours of discovery, about food that might be a danger to health, via the Reportable Food Registry portal.

DOCUMENTS ARE NOT ENOUGH: ALSO TRAIN
Second, once you have set up those documented programs, don’t neglect to train your employees on what they require. This goes for recall plans as surely as any other aspect of your program. FDA inspectors think perty documents are fine, but they would rather see confirmation that your people have a thorough knowledge of what’s in them and operate under them all the time. Which leads to the third point…

DOCUMENTS ARE NOT ENOUGH: ALSO DO WHAT THE DOCUMENTS SAY
Third, for gosh sakes, be sure to follow your own procedures. It’s the easiest thing in the world for an FDA inspector to cite your company (that is, make an inspectional observation) for your failure to follow your own written procedures. There are a lot of interesting policy debates one could have about the wisdom or necessity of any particular detail of a company’s safety plan or preventive controls, but those debates really don’t matter if you said in your own SOP that you would check the temperature of your cake mix after baking, but didn’t do so.

DOCUMENTS AND RECALLS
Finally, documentation is relevant to recalls in at least two important senses. One is that the company will have in place the requisite recall plan, having thought through in advance the necessary steps to undertake or consider when problems arise. The value of preparing in advance cannot be underestimated, particularly because circumstances in which safety concerns arise or are suspected can be high-pressure, fluid, and even emotionally charged.
Second, of course, documentation of production can help a company identify causes or potential causes and define a limited scope for the affected product, and then identify the consignees who received the product within that scope. Without such documentation, the prospect exists that a company might decide its only reasonable option is to recall everything it’s made that is still out in commerce, which is often a very expensive and burdensome option.

Have more questions about documentation or would like to get in touch with the author? Contact ConnectFood.

About the Author:


Eric F. Greenberg is Principal Attorney of the law firm Eric F. Greenberg, P.C., with a practice concentrated in food and drug law, packaging law, and commercial litigation.

His food and drug work has included regulatory counseling, label and claims review, new product development, GRAS and food contact materials evaluations and clearances, negotiations with the U.S. Food and Drug Administration and state agencies, handling recalls, and defending enforcement actions.

In addition to his law practice, Eric is a member of the Adjunct Faculty of the Chicago-Kent College of Law, where he teaches Food and Drug Law and Administrative Law, and graduate and undergraduate Packaging Law and Regulation at California Polytechnic State University (CalPoly).

Eric wrote the book, Guide to Packaging Law, the Second Edition of which was published in October 2007. He serves as Legal Editor and monthly legal columnist for Packaging World Magazine. Eric has served as General Counsel of the Contract Packaging Association for over 15 years. His firm is based in Chicago and represents clients based all over the world.

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.

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.