Most food manufacturers do not have a supply chain preventive control and will not have supplier verification in their written food safety plan. A separate blog post of mine, Supply Chain Preventive Controls, discusses identification of a supply chain preventive control.

    1. Supply chain preventive controls are required for ingredients where YOUR suppliers control the hazards.
    2. A supply chain preventive control is required for imported packaging when a hazard is identified.

The safety of imported ingredients and imported packaging is enforced under the Foreign Supplier Verification Program (FSVP) rule. See the Preventive Controls for Human Food rule for supplier verification.

I get a Certificate of Analysis (COA) with my ingredient. I’m good, right?

Good, but you are not done. The way I approach supplier verification is as an attorney collecting evidence to build a case that a jury will decide. You are the attorney, and FDA is the jury. The burden of proof is on you to demonstrate the ingredient is safe. Yes, it is all about verification. Your FDA inspector will review your supplier verification.

Before we go on to the requirements and just checking in, have you identified a hazard requiring a supply chain preventive control? If the answer is yes, read on!

Requirements for Supplier Verification

    1. Supplier approval
    2. COA or similar document with receipt of every shipment
    3. Sampling and testing for hazard
    4. On-site supplier audit

      a. Use of a qualified auditor
      b. Proof of corrective action implementation

This is an extensive list and a lot of work to prove the hazard was controlled by the supplier. Let’s look at an example with peanut butter as an ingredient in a candy bar. The peanut butter is not further processed to control hazards, and supplier verification for the peanut butter is required for the control of hazards like pathogens Salmonella and Listeria monocytogenes, aflatoxin, and physical hazards. The United States had two major outbreaks from Salmonella in peanut butter, and other nut butters are under heavy scrutiny by the FDA.

Supplier approval. The approval process is not mandated, so you have flexibility on how you determine the supplier is approved. Include the written Standard Operating Procedure (SOP) for supplier approval in your food safety plan. You are required to document the supplier is approved. You are encouraged to complete this process before using the ingredient from this supplier. If not approved before you’re your Preventive Controls Qualified Individual (PCQI) must document in the food safety plan the timeline and justification for later approval.

In both peanut butter outbreaks, part of the blame lies with the customers not doing enough for supplier approval and verification. If you are purchasing an ingredient in which the pathogens are killed, the supplier is required to use a validated process preventive control. Ask for the results of the validation study and documents proving the process is validated, monitored and verified. Some suppliers are not willing to share this information. If a supplier is not willing to share food safety data, you may want to start searching for another supplier. Will you share with your customers?

Written procedures are required for Receiving for ingredients with a supply chain preventive control.

Specifications and COAs. Once the supplier is approved, you will set specifications for the absence of the hazard; that would be the absence of Salmonella and Listeria in the ingredient of peanut butter in our example. When the peanut butter is received, the Receiving personnel should inspect the vehicle for sanitary conditions and the containers to ensure they are intact. The bill of lading is checked against the goods received upon arrival. Every shipment of peanut butter must include a document stating the hazard is absent. With every shipment received, you get a COA, a Certificate of Conformance (COC), or letter of guarantee regardless of repeating a lot code. The ingredient container or pallets should be clearly labeled at Receiving, then moved and stored in a manner to prevent cross-contamination and cross-contact.

You cannot continue to just file away COAs for ingredients where a hazard is controlled by a supplier.

Sampling and testing. FDA requires verification of COAs at some frequency determined by you. Are you still with me that this is for ingredients where the hazard is controlled by the supplier? Develop a sampling plan for each ingredient to include:

    • who is responsible for sampling and how they are qualified,
    • the location where samples are taken,
    • the methods for sampling and shipping,
    • the number and size of samples,
    • the coding of samples,
    • the exact location of the laboratory, and
    • the method of the test.

Often the customer drives the sampling plan and orders too many samples and too many tests. Please do not order tests where you do not use the data. Don’t get me started on this! As the customer, you must be confident in samples being taken and shipped properly. You must trust the results of the laboratory. Work with experts to develop your sampling plan.

On-site audit. At first glance, the requirement for an on-site audit of the supplier seems daunting. However, you do not personally have to do the audit. You may use the audit of another body for your documentation. That means you can use the audit report from a state inspector, federal inspector, broker, consultant, or auditing firm. There is a requirement for a qualified auditor, not a certified auditor. You are required to prove to an inspector how an auditor was qualified to inspect your supplier. After the initial inspection, an annual audit is required, unless there is justification for a less frequent audit that is based on evidence. Work with a qualified auditor to put together your auditing plan. After you have agreed upon the scope of the audit and how the audit will address the hazard, you must obtain all corrective action and implementation documents to address problems.

Your job is to collect evidence to prove your case for safety. Confidence will climb for your case before an FDA inspector, when you have an approved supplier, documentation of receipt of the ingredient, verification of COAs for the hazard, and results of on-site audits.

If you want to read the requirements for supplier verification, find Subpart G in the Preventive Controls for Human Food rule. However, I recommend starting with the FDA At-a-glance document which provides a neat summary of the rule. Still not sure if you are meeting the requirements for supplier verification? 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

May 2, 2018 Update
Both the FDA and CDC published updates on the pathogenic E. coli outbreak today. Sadly, one death was reported. This blog post was published earlier in the day and has been updated below the original post.

Romaine Recall: What You Should Know

There is an outbreak of pathogenic E. coli in the US. The Centers for Disease Control and Prevention (CDC) through PulseNet, a national database, recognized the outbreak in March 2018 with the initial CDC announcement on April 10, 2018. With the initial announcement, there were 17 cases across seven states with the largest number identified by the New Jersey Department of Health.

What do we know about the outbreak?

    • The pathogen is Shiga toxin-producing Escherichia coli O157:H7.
    • The likely source is Romaine lettuce.
    • The Romaine lettuce is from the Yuma, AZ growing region.
    • Illnesses started March 13th, 2018.
    • 22 states.
    • 98 cases ranging in age 1-88.
    • 46 hospitalizations, including.
    • 10 patients with hemolytic uremic syndrome, a form of kidney failure.
    • 0 deaths reported.
    • 65% of cases are females.
    • Dozens of farms in the Yuma, AZ region are being investigated.

How do we know what we know?

    • When a clinical isolate from a patient is identified as E. coli O157:H7, the result is reported to the state department of health. The state reports the result to the CDC. The isolate is tested by pulsed field gel electrophoresis (PFGE) and the data are entered in the national PulseNet database. The CDC monitors the database and sees the matches across multiple states. There are differences in strains of E. coli O157:H7, and PFGE is used to show matches of the same strain. The outbreaks isolates are also tested by whole genome sequencing (WGS), a method to fingerprint the strains.
    • Health departments conduct food surveys of patients to learn foods eaten. For this outbreak, 64 of 67 patients interviewed reported eating Romaine the week before the illness started.
    • The Yuma, AZ growing region provides Romaine to the US during the winter growing months.
    • The CDC epi curve shows the first case had an illness start date of March 13th.
    • The CDC Case Count Map shows the number of cases per state.
    E. coli O157:H7 was traced back and found from one farm in Yuma, AZ, after cases developed at a correctional facility in Alaska where whole-head Romaine was shipped. This one farm has not been called the sole source of the outbreak, and the investigation continues in the Yuma, AZ growing region

What do we expect?

    • Illnesses started after April 7th may not be reported yet, so the number of cases will increase. The timeline for the illness and outbreak is:

      1. Onset time is 1-8 days.
      2. Duration of the illness is 5-10 days.
      3. Medical diagnosis can be 2-3 weeks.
      4. PFGE and WGS conducted.

    • Watch for another CDC update on the number of cases and hospitalizations.
    • The investigators will locate the source of E. coli O157:H7. The isolates will be tested by PFGE and WGS. The results from the source will be compared to the patient isolates to detect matches.
    • The number of cases will taper off and the outbreak will be over, due to the end of the Romaine growing season in Yuma, AZ.

What can you as a consumer do?

    • Do not eat Romaine from Yuma, AZ or if the growing location is unknown.
    • Do not eat salad blends containing Romaine, if the growing location is unknown.
    • Do not eat salads, if you do not know if the salad contains Romaine.
    • As we start the summer season, follow the rules of clean, chill, cook and combat cross-contamination.
    • Finally, my favorite rule is, “When in doubt, throw it out.”

Updated information from the CDC and FDA, May 2, 2018

    • The last reported illness started on April 21, 2018.
    • The number of states has increased to 25.
    • The number of cases has increased to 121.
    • The number of hospitalizations has increased to 52.
    • The number of patients with hemolytic uremic syndrome is 14, up from 10.
    • California reported one death.
    • CDC investigations are ongoing.
    • As expected, the growing season is over for the Yuma growing region as reported by the Arizona Leafy Greens Marketing Agreement on April 27, however, Romaine has a 21-day shelf life which puts Romaine with consumers until mid-May or longer.

Because of the timeline for illness and outbreak detailed above, additional cases are expected. I want to note that growers who participate in the Arizona Leafy Greens Marketing Agreement implement strict procedures for food safety. The grower who sourced to Alaska is an active participant in the Agreement and highly regarded for compliance in food safety. Participants must have a food safety plan, employee training in food safety, pass an audit and pass inspections. I hope that the source of the contamination is discovered, and the growers will come back even better than they already were. Food safety is not competitive, and we are all in this together.

Correction: The original blog stated that E. coli O157:H7 was found from one farm in Yuma, AZ. That is not correct as the FDA continues to investigate the source of the pathogen along the supply chain. FDA traced the source of the Romaine shipped to Alaska back to one farm in Yuma, AZ.

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

I heard that inspections are looking more like audits than the historical walk-through and observation of employees working. Why is that? Documentation is required by law and tells the story of food safety. The success of your company inspection lies in your records. Today I am writing some good, general concepts and requirements on records management under the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

What is the purpose of records management?
This is the way I look at it: your company (and most of the food manufacturers in the United States) are making and selling a safe product. The bad ones who intentionally sell harmful products go to jail – these are rare. Then there are the companies who think they are doing the right thing, and they simply do not know their product is potentially harmful. For example, there is the national recall of Romaine lettuce contaminated with E. coli O157:H7. Something is wrong with the Romaine system, and hopefully the problem will be found and fixed.

For everyone else, you are making a safe product. You are the expert for your ingredients, personnel, equipment, and customer base. However, when the inspector shows up at your door, what records do you have as proof that you are making a safe product? You have a written food safety plan, written procedures, and supporting documentation. Through good record management, you can show the inspector records from receiving to shipping. Have you ever sat on a jury panel? Like the lawyer presenting evidence for the case, your company compiles evidence of food safety and, in turn, presents that evidence to an inspector.

What counts as a record?
Any and every written document can build your case. Records can be handwritten, hard copy documents, or you can create them with an electronic record. A true copy of the record is made with a photocopy or scan of the original in case of an accident that destroys the bench sheet. In addition, handwritten records must be recorded in permanent ink, preferably blue or black, and at the time of the observation be neat enough to read and provide enough detail to prove safety.

What information is required on the record?
Information must be complete to document the safety of the product. As you think through the possibility of a product recall, what information would you need and what information does the FDA and state recall coordinator need? Every document created at your company must include the name and location of the company. Location is critical if there is more than one facility, such that the document shows where the record was made and reflects the safety of the product made at that location. On the record sheet, include the name of the record, date of record, initials of employee recording data, and signature or initials of the company’s Preventive Controls Qualified Individual (PCQI) for record review, along with the date of the record review. Note the time the observation was recorded too, if time is important. Record the name of the product and lot code for the batch. Again, think through what information you would need in the event of a recall.

Complete information discussed above is required in electronic records just like in a bench sheet. The same is true for a temperature chart or any record automatically generated. Don’t forget record review as a verification step by a PCQI.

What do I do with all these records?
It is completely up to you to choose paper or electronic records – or a combination of both! By law, you must store records related to food safety for two years. However, the food safety plan must be reviewed within three years, and if records are related to the food safety plan, those records may need to be stored longer. The easy part is electronic records – no matter where the data are stored electronically, if the record can be viewed on site, the record is considered stored on site. The hard part is paper records – if your company runs out of room to store boxes of records, they can be stored off site, provided that upon request of an inspector, the records can be retrieved within 24 hours. There are companies that provide off-site storage and retrieval as a service.

Going beyond the discussion of generalities, there are required records for hazard analysis; preventive controls and their monitoring, verification, and corrective action; validation; recall plan; training records and records in support of Good Manufacturing Practices. The folks at ConnectFood will design Record Management with you and 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

With formidable GMPs, you lay the foundation for HACCP and Food Safety.

When the FDA or state inspector steps inside your facility, they may not want to immediately go to a conference room and review your written Hazard Analysis and Critical Control Points (HACCP) or food safety plan. The written plan is important, but the inspector will potentially want to walk the facility for a current Good Manufacturing Practices (GMPs) inspection. There will be inspection checklists and notes of observations. Shortcomings could result in a Form FDA-483 to the facility from the inspector. Companies should continue to work hard on their risk management programs and that starts with the food safety fundamentals of GMPs.

In the same way that you can’t run a business without funds, people, equipment and supplies, you can’t have a functioning HACCP or food safety plan without a foundation of good current GMPs.

Lynn Knipe of Ohio State University said it well,

    GMPs can support a processors’ HACCP programs, however, they cannot be used to directly control a hazard.

As I work with clients on HACCP or food safety plans, I have been reminded several times this week of the importance of GMPs in my work, which brings me to write about GMPs again. In a previous post, I wrote a review of GMPs on ConnectFood.com. When I reviewed the weekly post of FDA Warning Letters for food issues, I found mostly GMP issues, not HACCP or preventive controls issues. In most cases, a food facility receives an Warning Letter as a follow up to an inspection and Form 483, when the FDA is not satisfied with the actions taken to address the issues. Sometimes it is a matter of timeliness in that the facility has not responded by a deadline or is lacking documentation to prove corrective action. Warning Letters can be juicy reading for those of us that live food safety and for customers and clients because they are very specific in naming the issue.

Let’s play a game of “Name the GMP that was not followed.”

Case study: Cakes and Biscotti Bakery

    [a] live rodent was observed running across the east end of the production area, into the laundry room and into a hole in the wall at the northeast corner of the room.

Name the GMP that was not followed: Pest Management & Plant and Grounds

    [d]ough residues were observed on the edge of the (b)(4) north prep station and on the (b)(4) south prep station after (b)(4) sanitation was conducted.

Name the GMP that was not followed: Sanitary Operations

    [t]he interior of the stove hood was observed with a build-up of dust and debris directly above the stove and prep table where uncovered in-process foods are prepared. Employees were observed melting chocolate and gelatin, heating cream, and preparing blueberry topping on the stove directly below the hood.

Name the GMP that was not followed: Plants and Grounds

    [i]n the men’s restroom, the floor was observed soiled in front of both toilets, the urinal, and both sinks. One of the toilets was observed soiled. A toilet brush was observed on the hand wash sink. No hot water was available at the hand wash sinks and no paper towels or hand drying device were observed. The trash can was observed with overflowing toilet paper tubes, used paper towels, and other waste.

Name the GMP that was not followed: Sanitary Facilities and Controls

    [a]n employee was observed handling biscotti with a bare hand that was bandaged. She was observed removing the bandage and continuing to package biscotti without washing her hands.

Name the GMP that was not followed: Personnel

In the latter example, there are so many problems to address. Because of the bandaged hand, the employee should be removed from the packaging station. Without the need for a bandage, the employee should be following hand washing procedures and the glove use policy. This observation shows a lack of food safety culture and the need to train the entire workforce at packaging.

This food safety culture is key. Being part of the team in the position of writing a HACCP or food safety plan, please take time for an internal audit of GMPs. Without good GMPs, food safety cannot be realized. The search for GMP forms and checklists can be overwhelming, and the ConnectFood website has free resources. Sign in and find information under cGMPs. Do you have questions about GMPs? 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

I subscribe to alerts for Class I recalls from the Food and Drug Administration (FDA). The message goes to my email with a link to the press release. It’s a great automated system, and the number of alerts is small enough to manage daily in email. The FDA recalls more than just food – their recalls include biologics (medical products), animal health products (pet food), medical devices, drugs, cosmetics and tobacco. I didn’t sign up for everything, and the subject of the emails I receive helps me decide which ones I can delete without opening… efficient.

Class I recalls are announced when there is a large possibility a consumer will become ill or be injured from a food they have ingested; think of glass shards or pathogens in food. This is where the food industry spends research dollars and companies take measures to prevent biological, chemical, and physical hazards. Class I recalls are the ones we see in social media, which are heavily communicated on the news and posted about on the FDA website. Class I recalls must be entered into the Reportable Food Registry. Do you know what hazard is the number one cause of Class I recalls? The answer is… allergens: a chemical hazard. You cannot put too many resources into allergen management if your product contains an allergen.

I was recently reminded by a colleague to keep up with the Class I notices (done!) and enforcement reports. Hmmm, enforcement reports? In FDA’s words:

    “All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.”

“Classified” does not mean the recall is top secret! There are three classes; Class I is discussed above as the most serious among the classes. A Class II recall is a situation where the probability of illness or injury is remote. Only the manufacturer can make the call on if the recall will be classified as Class I or II based upon the specifics of what went wrong. The situation has a possibility of illness or injury, but the chances are so small that the conditions for illness or injury are unusual or unlikely. A Class III recall is not likely to cause any illness or injury. Period. It absolutely will not happen. The fourth option in an enforcement report is “pending.” This means the FDA is still considering the class for the recall. You would think this is pretty straight forward, but recalls are one big bell curve. Class I and Class III extremes are easy to get right, but there is a huge bump in the middle for Class II. This leads me to the FDA website.

Enforcement reports are posted weekly. When you go to the previous link, click on the week of interest, then sort with the ‘Product Type’ dropdown menu for ‘Food’ or another category. Dietary supplements are posted under ‘Food,’ even though they are not food and are separately regulated. If you really want a scare, choose the category of ‘Drugs’ to see all the problems in that industry, or see pending recalls of drugs. In addition to the Class I recalls, the other classes are of interest as well.

We use enforcement reports to keep up with our industry. What problems do others in your commodity experience? When we read the Class II and Class III recalls, we see what problems are occurring in our industry. Are you in dairy, flour, nuts, or produce? Look for companies with similar commodities as both your ingredients and your products. As part of reviewing your written food safety plan, the food safety team is required to keep up with current science and potential hazards. One way to know what is going on in your commodity is to keep up with enforcement reports.

Have you heard all the recalls of pet food? These are not coming to my email, so I need to update my alerts. The ConnectFood website has free resources, including the ability to create a recall plan for your facility and products using the online software. 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 published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry on March 19, 2018. The comment period is through May 20, 2018. The purpose of the guidance is to raise awareness of exemptions for Part 117, the human food rule, and Part 507, the animal food rule. There is also a later compliance date for small businesses under the animal food rule of September 17, 2018, than originally set. I am addressing human food within this blog.

Why did FDA publish this draft guidance?
I’m having a difficult time understanding the publication of this Food Safety Modernization Act (FSMA) draft guidance at this time. It is helpful in defining subsidiary, affiliate, facility and full-time equivalent (FTE) employee. There are clear examples to showcase types of facilities and calculations of FTEs. The purpose of calculating FTEs is to determine if a facility is defined as a small business of less than 500 FTE employees. This is a concern when multiple facilities are related and if there are part-time or seasonal employees. This is a question I have tried my best to address in PCQI workshops for my participants. It’s nice to have the draft guidance. The reason I am having a difficult time is that it is a moot point for industry now. All small businesses came under enforcement in September 2017 for human food. Small businesses must meet the same requirements their larger competitors met in September 2016.

    I believe the reason for the publication of the draft guidance
    is not as much for industry as it is for the FDA.

Will my facility be inspected?*
FDA prioritizes their inspections, so FDA must know if a facility is a small business or larger. In fiscal year 2016-2017 when businesses with more than 500 employees came under enforcement, FDA’s goal was to complete 300 FSMA inspections. Facilities with more than 500 employees were under inspection first, because of the potential public health impact to a larger number of consumers. A total of 165 domestic and foreign FSMA inspections were completed. All other inspections-the majority-were Good Manufacturing Practices (GMP) inspections. That trend will continue with most inspections being GMP inspections. The FDA continues to train its inspectors on FSMA, and FDA inspectors are primarily in a FSMA educator mode with industry. In fiscal year 2017-2018 the goal is higher at 500 FSMA inspections; the pace is faster.

In addition to the number of FTEs, there are other factors used by FDA to prioritize inspections.

    • Domestic and foreign facilities goals are 400 and 100 inspections, respectively.
    • Facilities with a current or previous Class I recall or warning letter
    • Facilities in the same market as a facility with a Class I recall
    • Facilities making a high-risk ingredient or product

      1. Ready-to-eat foods
      2. Foods identified in FDA’s Listeria risk assessment
      3. Foods otherwise with a history of risk

While it is not possible to know if your facility will be inspected until the FDA inspectors are at your door, you can determine the likelihood by using the same tools FDA has to prioritize inspections.

*The author participated in a Food Safety Preventive Controls Alliance quarterly webinar for Lead Instructors on February 8, 2018, in which FDA inspection data was shared.

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

I first learned that Listeria monocytogenes is a foodborne pathogen in 1985 during the Jalisco cheese outbreak in Los Angeles and Orange Counties in California. There were 29 deaths from 86 documented cases. The veterinary world was very familiar with Listeria in cattle, long before food microbiologists. Industry and the federal Food and Drug Administration (FDA) took this emerging pathogen seriously. Since 1985, there has been active research and investigations at universities and food companies. We know that Listeria is ubiquitous, and current lab methods improve our chances of finding Listeria.

FDA Listeria Draft Guidance for Ready-to-Eat Foods: Part 1, published previously at ConnectFood.com, discussed Listeria testing on food contact surfaces (FCS) and non-food contact surfaces (NFCS) and from finished product. We encourage you to study FDA’s draft guidance, Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry. Here, I present three concepts needed to understand the information in the guidance.

A positive Listeria test from a FCS assumes the presence of Listeria in your product.

The guidance for ready-to-eat food recommends FCS be sampled after three hours of production and five FCS samples be collected per week per line. First consider these sample sites. The FCS sites should be after the final kill step. It does no good to sample FCS sites before the final kill step. If the test is positive, the assumption is that the final kill step killed the pathogen. The FCS sites are before the final product is sealed in packaging. Think about the distance where your product travels after the final kill step to where the package is sealed. In that distance, think about where the product is open to the environment. Listeria is an environmental pathogen. What I mean is if the product is in tubing, the product is not exposed to the environment, and these would not be FCS sites for Listeria. I am thinking about an ice cream plant. The mix travels through tubing until carton filling. The distance the product travels from the end of the tube to the carton is small, and the distance the open carton travels until sealed is small. Compare that to a large bakery. After leaving the oven on conveyor belts, the baked goods travel open to the environment for cooling and the addition of toppings. I have seen distance as long as 50 yards with the transfer onto multiple conveyor belts.

Once you have your FCS sites identified and if a FCS test is positive, it is assumed the product is positive, even without direct sampling and testing of the product. This makes sense. If a FCS is positive, the product touched the FCS. At that point it’s a chicken-and-the-egg discussion of whether the product contaminated the surface or the surface contaminated the product. It doesn’t matter until you do your root cause analysis. What you do know is that you have contaminated product.

A positive Listeria test from an environmental sample has an isolate identified as Listeria innocua or another Listeria species; consider Listeria monocytogenes as present.

Listeria monocytogenes is one of 17 species of Listeria. Only the species Listeria monocytogenes is considered a foodborne pathogen. When your contract lab tests for Listeria genus or spp., a positive test does not tell you the species. Further testing can identify the species, if needed. It is very common for the lab to report negative for Listeria monocytogenes and report the presence of Listeria innocua instead. In no way can you rest easy with a positive Listeria test and negative Listeria monocytogenes test. When the lab reports a positive Listeria test, consider Listeria monocytogenes present.

Consider the sampling site and technique. Let’s use the example of a drain swabbed with a sterile sponge. Assume Listeria monocytogenes is there. Perhaps the sponge did not swab the location of the pathogen. Perhaps the sponge did not get through the layers of goo where the pathogen is harbored. There are many reasons for missing the pathogen in the procedure for swabbing. If the test is positive for a different Listeria species, the conditions at that site are conducive for the presence of Listeria monocytogenes. Corrective action must be done in the same way as if the test were positive for Listeria monocytogenes.

Consider the variety of microflora at the site. The site was not sterile and does contain diverse types of bacteria at different numbers and proportions to each other. Listeria monocytogenes is the wimpy kid on the playground. Listeria innocua outcompetes Listeria monocytogenes not just 10-to-1, but as much as 20:1 or 50:1! The mere chance of finding Listeria innocua instead of Listeria monocytogenes is simply greater. Listeria monocytogenes may have been present in the sample, in the testing, and simply not detected.

An environmental sample tests positive for Listeria genus or Listeria species (spp.); react as if the sample were positive for Listeria monocytogenes.

You will direct the lab in what method to use and at what point to stop the testing. Work with the contract lab in making this determination. After a positive test for Listeria genus or spp., you have the option to continue testing to identify the isolate of Listeria. This costs more money and time. Will you do something different with that information? No! It is not necessary to confirm the presence of Listeria monocytogenes from a positive Listeria genus or spp. test, when your corrective action is the same. Think this through before testing. Know the action the plant will take when a Listeria genus or spp. test is positive. Expect to get positives from zones 3 and 4. FDA inspectors should not have a problem with seeing occasional positive tests. Since Listeria is ubiquitous, you are expected to find it. The important part is what you do as corrective action. Follow-up testing should be negative to prove Listeria is eliminated from the site and the area adjacent to the site.

As you work through the FDA Listeria guidance, 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

If you are in a drought, just have me visit, because I seem to bring rain storms. At first, I was frustrated by rain and having to navigate to a facility new to me. But when touring food plants after or during a rain storm, it is a blessing. Now I pray for rain! Examine Your Facility During a Hard Rain was a slide title in a presentation by Kevin Lorcheim of ClorDiSys Solutions, Inc., during the workshop Key Elements of a Food Safety System. Hearing Kevin talk, plus there was an 80% chance of rain that afternoon, got me thinking about my visits to food plants.

The next time you get a hard rain, I encourage you to walk your entire facility and perimeter outside. When inside, you are going to look up at the ceilings. Search for any evidence of water getting in and dripping down. Are the ceiling tiles bowed and holding water? Do you see evidence of water from stained ceiling tiles or hanging light covers? Are tile tracks rusted? Pay particular attention to pipes and I-beams coming down from the ceiling and any water coming down.

The next level down is the dripping lines. In most facilities and when it rains, there will be excessive condensate dripping down from cold lines. Pay extra attention to areas over the open product, in packaging, in dry ingredient and packaging storage and in final product storage. While you are looking for condensate drips, look for leaking pipes. I am a professional leak detector. Product, steam or water. This is a point of high complacency in food plants, where employees get numb to leaks and don’t report them for repair. You do not need to pay a consultant to detect leaks. Repairing leaky pipes is critical for efficient operations.

I was in a plant one morning where liquid product was shooting from a pipe. The pinhole leak had been reported before midnight, and the split had grown. This was a 24/7 operation. Product was literally going down the drain. The QA Manager reported the leak; the pipe was repaired and reinstalled. Not long after, the pipe had split again and farther, so product was showering out. The QA Manager reported the leak again. Please train all employees on the importance of reporting leaks.

You are probably not standing at shipping or receiving as you read this, but when you get a hard rain, investigate those sites. When a driving rain hits the side of your building, does water ingress around bay doors and outside doors? As part of your facility walk, examine doors and outer walls as soon as possible after the rain to detect leaks. Look for rivers flowing from bay doors and wet floors under the doors. Many food plants have screened windows and other air intakes; check these too. Does the rain flow down an inside wall from an upper window?

As you walk your facility, has a new river of water formed on the floor? There may be a leak coming down along an I-beam or into an interior wall and then out. The good thing about water is that it follows the path of least resistance. When you start at the river on the floor, follow the path to the wall or interior structure, and trace back to the source.

Examine EVERY room from top to bottom in your facility: boiler room, maintenance, break room, dry storage, cooler, offices, shipping and receiving. Talk to your people and ask them where they see water. Do not skip any area. Be deliberative about seeing every room. It would be best to check the outside of the building during the rain storm. Walk the perimeter outside. Note standing water. Check the integrity of the building to keep water out. Check the that downspouts are functional.

By fixing your problems of water coming in, you will stop or prevent problems in your food plant. 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

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