The risk of factory footpaths

Traffic. I lived for 15 years in a Chicago suburb, where traffic to anywhere was a normal part of life. I didn’t hate the line of cars at a stop light or the stop-and-go on the interstate at rush hour. The opening scene of the musical LaLaLand starts with a visually beautiful number on the stalled LA freeway, a normal part of life there. The last episode of Homeland that I watched showed Saul waiting to enter the West Bank in a sea of cars. Traffic is a part of life. We are directed when and where to go.

In a visit to a food factory, I stood at the nexus and observed the traffic where every employee and every forklift traveled. I could see the employee entrance and the stairs to the employee break room. The forklift moved product from packaging to the dock. The stairs to the lab. The path to the maintenance room. The hall to the front offices. It was all there-so much traffic. A production worker walked through processing, through packaging to the raw side and back. The forklift went everywhere, including outside.

It was an old building that had been added to over and over again. Yet, in that one spot I could see so much. What I could not see was the transfer of pathogen contamination, and I was there to do thousands of dollars in testing to find the contamination. There was no concern of allergen cross-contact, but there was the concern of pathogen cross-contamination. The pathogen had gotten in somewhere, and the test results would show it was all over.

Foot traffic. Yes, there were footbaths. Could the production worker call a different worker on the raw side and eliminate that trip? When the employees enter from outside, there must be an area to shed the outer world and don clean coverings after hand-washing. That is not negotiable. Any time an employee uses the restroom, goes on break, goes to the lab, or goes to the office, they must not carry a pathogen out or in. Are there maintained footbaths, foot sprays, or air curtains to keep pathogens out of areas where product is exposed? Where is the transition area for each path? Are the employees trained to understand not only the how and when, but the why? Does your smoking policy send workers outside to their vehicles multiple times a day to track dirt back in the building?

What to do? Work needed to be done, and product needed to be moved. It’s all about transition areas. Could one forklift move the product on pallets to the dock area and another forklift pick up the pallet from the other side and load? Yes, forklifts dedicated to a task or an area do exist. You say you can’t afford dedicated forklifts for different areas? Can you afford a recall? I just read the average recall has a direct cost of $10 million. That’s a lot of forklifts.

The FDA will be judging your company for evidence of a food safety culture. How you manage your employee and forklift traffic becomes that evidence. A stop-and-go light is a sign directing the flow of traffic. Signs make our lives safer, and signs are evidence of a food safety culture. Set up transition areas and dedicated hand wash stations with clear access and signage. Create a food safety culture where every employee holds every other employee accountable to transition area procedures.

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.

Validation of Thermal Processes

I listened to a webinar by Adam Borger of the University of Wisconsin-Madison’s Food Research Institute on calculating thermal lethality of microorganisms in foods. In one hour, he did an excellent job of reviewing what I learned in Food Engineering class at the UW (OK, I learned more than that) and applied the information to show how industry can do the math. Have you ever had a process fail, but want to know if the heat was enough to kill? There are spreadsheets publicly available to do the math.

At the end of the talk, Adam referred to validation studies. Is your company one where validation of the kill step has yet to be done? Maybe you do baking, roasting or frying. Under FSMA, companies must have validation of process preventive controls. Our own Matthew Botos here at ConnectFood is a process authority for acidified foods. A process authority is someone who will work with you to validate your process with your product. Legally, manufacturers of acidified and low-acid canned food must use a process authority to validate the thermal process. Process authorities can be found among extension professors, contract labs, and consultants. While writing this blog, I did a search and found listings of process authorities by AFDO by state:

and the Department of Health and Human Services lists four universities in this document:

Only if you are hermetically sealing your product are you required to work with a process authority, internally or externally. Otherwise, validation of your process can be done in many ways. If you can find processing time and temperatures in the scientific literature for your product, you may cite that source. For example, milk pasteurization times and temperatures are published by FDA in the Pasteurized Milk Ordinance. Similar published data may be available for your product. One way to do this search in on Google Scholar; ask a young person about that. After doing a search, you may still need to measure the temperature profile of your product through your process. BEWARE, Peanut Corporation of America, responsible for nine deaths from Salmonella-contaminated peanut butter, had a perfectly good roasting operation that WAS NOT VALIDATED. This is a great example for the need for validation of your process preventive controls.

Get that validation study in your food safety plan. Your FDA inspector will ask to see it.

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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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.

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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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.