A common conversation my husband and I have with friends and family is, “What are you watching?” We will find a show on Showtime or Netflix and binge-watch to get caught up to the current season. Somewhere along the way, I discovered Rotten on Netflix. The first season from 2018 had six episodes. As someone working in food safety, I was reticent to watch. My preconceived notion was that they would be anti-food industry, showing the likes of Food, Inc. Many Americans have turned against my food industry because of these types of shows featuring the worst of the worst practices by the few. Before I watched, I searched for reviews like the one on Paste, “Netflix’s Rotten Is Mandatory Viewing for People Who Buy Food in the U.S.”

The food industry is comprised of people, so it is not perfect. My experience with the food industry concludes that almost all people are working their butts off to do their best with the materials and equipment given. There have been a few bad characters, and the justice system has dealt with them. As a consultant, I talk with people when they are in trouble-either for food spoilage or pathogens. I go to their website to research the company. I have discovered there is no correlation between the quality of the website and the safety of the product. No shock there. I have been to dairy, fresh vegetable, freezing and drying operations. Never does the image in my head of the facility match what I see in operation. I have been surrounded by new, gleaming stainless steel equipment, and I have been in cold, damp and dark caves. I know that what I see on the screen in a movie or documentary is simply one perspective of clips spliced together to create a show.

The season of Rotten was simply fantastic, for me. Yes, they show scenes that will creep you out, like the prisoners forced to process garlic. Ugh. It is not the food that is bad; the situations of the people showcased are rotten. There is the beekeeper whose hives were stolen. There is the chicken farmer who works day and night to care for his flock like they are his children. As people working in the food industry, I believe it is important for us to learn how other companies operate and not remain isolated, so we can instill best practices. Watching shows like Rotten can help us to think outside our factory walls. You can check out the official Netflix trailer here.

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

FDA Listeria Draft Guidance for Ready-to-Eat Foods: Part 1 is an outline of essential information on the Listeria draft guidance, answering who, what, when, where, why and how questions. The guidance is written for companies manufacturing ready-to-eat (RTE) food and ingredients. As a guidance document the language is different from a rule where companies are required to comply. In general, an FDA guidance document does not require compliance, is written to help industry interpret rules, and explains FDA’s current thinking on a topic. The FDA Listeria Draft Guidance is different. In this author’s opinion, the guidance carries the full weight of a rule and will be enforced as such by FDA. If your company manufactures a RTE food, your President or company owner must be fully informed on the contents of the guidance. This paragraph answers why.

Who must test for Listeria?
All food companies making RTE foods under the jurisdiction of the federal Food and Drug Administration (FDA).

What must be tested for Listeria?
The company will identify food contact surfaces (FCS) and non-food contact surfaces (NFCS) as appropriate to the design of individual facilities. Finished product testing is discussed in the guidance and is recommended.

    We recommend that you establish and implement a written procedure for the periodic collection of samples of your RTE food product, and for testing those samples for the presence of L. monocytogenes. See page 52.

What sterile supplies are needed?
The best method to sample a surface uses a premoistened, sterile sponge on a stick. My personal favorite comes from World Bioproducts. In addition to sponges, companies can use any sterile tool including Q-tip type swabs, tongue depressors to collect solids, scoops, dippers, pipets, bottles or bags. If you are concerned about contamination during sampling, have sterile gloves available for your technicians and intensify training. Finished product may be shipped in final packaging, or, if the finished product is large, a trained technician can obtain a portion aseptically to ship.

What lab method for Listeria is used?
When samples are sent to your contract lab, you specify for the testing of Listeria genus or Listeria monocytogenes. You can specify a one- or two-step enrichment. There are pros and cons for every method and its application, but you are expected to use a standard method which has been validated when testing for Listeria. Indicator tests which do not directly test for Listeria are useful for zone 1 and 2 samples; my favorite is an indicator test called HQA.

When are FCS sampled?
Warning! Warning! You are not going to like the answer. FDA wants food companies to sample FCS after three hours into production. The reasoning here is that microbial niches will have shook free and the conditions are representative of normal operations. Be very careful if following this FDA recommendation.

When are NFCS sampled?
NFCS can be sampled at any time provided food is not affected in the process of sampling and a positive Listeria test would not be associated with the product. When NFCS are tested as part of pre-op, this is a verification activity for a sanitation program.

Where are samples taken?
FCS and NFCS samples must be taken from every production line and from any area in the facility beyond production lines.

How many samples are taken?
A minimum of five samples from FCS (Zone 1) must be taken from every line every week. A minimum of five samples from NFCS must be taken. Imagine you have four lines in each room. You will take a minimum of five FCS samples from every line, for a total of 20 samples. Know that FDA is very conservative on their definition of FCS. For example, a control panel can be a FCS, if the technician who touches the panel in turn touches the production line or product. The same is true of overhead structures like pipes where condensate or powder could fall on to the product. How you interpret the minimum of five NFCS samples is up to you and dependent on the variables in that room. In general, FDA wants to see more samples from Zones 1 and 2 than from Zones 3 and 4.

What is the frequency of testing for Listeria?
Designing the sampling plan for Listeria testing is an art and a science and determines the cost to the company. Here are examples provided in the FDA Listeria Draft Guidance. See pp. 37-38. Pay attention to the wording on frequency:

    An example of how to specify the frequency of sample collection in a written environmental monitoring plan for FCSs in an establishment producing an RTE food that supports growth of L. monocytogenes is as follows:
    • Collect environmental samples from specific FCSs on the production lines at least once every week when the plant is in operation; and
    • Test each FCS in the plant at least once each month.

    An example of how to specify the frequency of sample collection in a written environmental monitoring plan for non-FCSs in an establishment producing an RTE food that supports growth of L. monocytogenes is as follows:
    • Collect environmental samples from representative sets of non-FCSs at least once weekly for zone 2 sites, every two weeks for zone 3 sites, and monthly for zone 4 sites when the plant is in operation; and
    • Test all non-FCS sites identified in the monitoring plan at least once each quarter.

Table 4 in the guidance, pp. 34-35, is the only published FDA guidance on zone designation of which this author is aware. Please share FDA publications on zone designation with me. I would love to talk through the design of your Listeria sampling plan with you. You can reach me by signing up for Expert Services on ConnectFood.com.

Of course you still have questions! 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

As I travel across the nation helping food companies with food safety issues, I get to be in a lot of food companies and observe many employees going about their jobs. Most of what I see is good. When I dig deeper into a company, I see what is missing in the food safety culture.

There is no publicly-available training program (so far) for a food safety culture. If you know of one, I want to know. What do you think about when you first think of food safety culture? I think of employees wearing clean uniforms and footwear. I think of good handwashing procedures. As I have been in food plants, I have compiled evidence of a food safety culture. As you get deeper into the culture of your company, you will see or not see these five signs of food safety culture.

You need a Vice President of Food Safety.
A food safety culture starts at the top with the President of the company. Period. If that is true, your company will have a direct report for food safety to the president, CEO or owner of the company. The title of the job may be Director or Manager, but the role of that person is to oversee food safety. It doesn’t matter how big or small your company is and what the actual titles are. What matters is that food safety has a seat at the table, i.e. the conference table where the President is at the head of the table. The Vice President of Food Safety must be equal in importance with Operations and Sales and Marketing. Why? Because you make food! Your company is legally obligated to make safe food.

You need a preventive maintenance program.
There are companies and management styles which are described as “putting out fires.” If your management goes from one crisis to the next, you do not have a food safety culture. One symptom is the absence of a preventive maintenance program. Gears must be lubed; filters need changing. In a preventive maintenance program, these activities are scheduled. Factory shutdowns for cleaning are scheduled.

Your work orders need to be completed in a timely manner.
In a food safety culture, there is a work order form. Employees know where to find the form, anyone can fill out the form, and everyone knows who receives the form. After the form is completed and turned in, the work order is logged and goes through triage to determine its timeline to completion. Critical problems are reported and fixed immediately. Less serious problems are fixed as soon as possible, e.g. within a week. Problems requiring additional labor or capital expense are put in the budget to get done within a year. As work is completed, the keeper-of-the-log records valuable information for planning purposes and marks the work order as complete. Typically, the manager of maintenance is responsible for employees following the company’s procedures for work orders, including paperwork, and reports the status of work orders to upper management. In a company without food safety culture, this simply does not happen. According to Matthew Botos, CEO of ConnectFood.com, “Food Safety is all about communication and documentation! Communicating what is being manufactured, what is arriving and what is leaving are just some of the fundamentals of food safety. Communicating when equipment needs to fixed and documenting the actions is critical. Consumers consume safe products because all throughout the supply chain, from top to bottom, we are communicating and documenting our procedures.”

Speaking of critical problems being fixed immediately, it is Murphy’s Law that critical problems will occur at night on a weekend or when key personnel are on vacation. It does not matter what day or time of day the problem occurs; the appropriate maintenance personnel must return to work and fix the problem. In a food safety culture there is a record of maintenance on equipment. This history is valuable in times of trouble and when planning for capital expense. It is wrong to rely on people’s memory of the history of repair.

Your company’s food safety team needs to meet.
A food safety team is required of small and larger companies and documented in a written food safety plan. If I were an inspector, I would ask to show me the list of names on the food safety team. I want to see the name, title, email address and telephone number. You get extra credit for personal cell numbers. Is everyone on the team still employed at the company? Are their titles current? Second, show me the food safety team meeting minutes. There are many opportunities for the team to meet. I am not a fan of scheduled meetings for the food safety team, so I do not want to see consistent dates, like a monthly meeting. I am a fan of the team meeting when corrective action forms are initiated that affect food safety. I want to see a copy of the corrective action form to show the root cause. The team discusses the situation and determines if there is a threat to food safety; document the discussion and conclusion.

Duct tape has been used.
First, never use duct tape in the production area. Second, never use duct tape beyond the production area where wet cleaning is done. Duct tape does not provide a smooth, complete seal. Product and moisture get under the tape, creating the perfect growth niche for your pathogen of choice.

As I returned to write this blog over several days, I thought of more and more examples. It is easier to determine where you lack in a food safety culture and focus on making improvements. That is good quality assurance, but don’t forget to recognize and celebrate good food safety culture when you see it. You can read my blog, 4 Signs of a Food Safety Culture here at ConnectFood.com.

Still have questions? 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

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