With GMPs, You Lay the Foundation for HACCP & Food Safety

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 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 Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through, 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

What I Learned from an FDA Seafood Guidance

I was on a flight to Boston, and in my hand was the FDA draft guidance, Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry. HACCP is hazard analysis and critical control points, and the Seafood HACCP rule was published in 1995. I had received the FDA guidance document at the previous Preventive Controls for Human Food (PCHF) workshop that I taught in Seattle. In Seattle, I had several workshop participants who worked in the seafood industry. I had dined on delicious salmon in Seattle and was dreaming of eating fresh seafood in Boston.

A substantial difference between the Seattle workshop and the Boston workshop was that the Boston workshop was comprised of people from the milling and baking industry, not seafood. Darn. Seafood HACCP has a life of its own in regulation, and I was looking forward to learning more about seafood from the workshop participants. Reading the guidance would not further my expertise as a Lead Instructor for the Boston workshop, but nevertheless I was in the mood to read this compact document. As I skimmed the introductory material, I came to a nice question and answer (Q & A) format. The FDA always does a nice job of communicating important information through the format of Q & A. Sometimes it is just nice to see plain English from the FDA, and that’s what a Q & A provides.

I did learn some information specific to the seafood industry from the guidance document, but it was the general information from the Food Safety Modernization Act (FSMA) that piqued my interest. Do you know the following three facts?

    1. Training and training records are now required.
    FDA is making a big deal out of training. Every person employed in the manufacturing, processing, packing or holding of food must be trained in food safety. There must be training records kept for each individual showing the individual is a “qualified individual” to perform his or her job. Supervisors must have additional training to demonstrate they are qualified to do their job.

    Who organizes the training records at your facility? The inspector will ask to see training records of employees. The more organized your company is, the easier it will be to show these records to the inspector. Training records can be paper, electronic, or a combination. FDA is focusing on training, so be prepared.

    2. Written sanitation procedures are not required for GMPs.
    Subpart B of the PCHF rule is Good Manufacturing Practices (GMPs) and replaces GMPs found in 21 CFR 110. Subpart B does not require written sanitation procedures. This means that the chemical concentrations, equipment, times and temperatures for a cleaning or sanitizing procedure are not required to be written, but you should. See my previous blog post on Sanitation Standard Operating Procedures (SSOPs).

    The sanitation crew at most facilities has a lot of turnover and little supervision for an extremely important job. Writing the procedures will facilitate training, consistency and effectiveness of cleaning and sanitizing. Written monitoring procedures and corrective action records are required.

    3. Written sanitation procedures are required for sanitation preventive controls.
    In Subpart C of the PCHF rule, this is how the logic flows in the rule:

    1. A written food safety plan is required 21 CFR 117.126(a)(1).
    2. A food safety plan includes preventive controls 21 CFR 117.126(b)(2).
    3. Preventive controls must be written 21 CFR 117.135(b).
    4. Sanitation preventive controls are procedures, practices and processes 21 CFR 117.135(3).

Therefore, if a facility identifies a sanitation preventive control in the hazard analysis, written sanitation procedures are required.

If a facility has an allergen in one product, but not in another product from the same line, the facility will have a sanitation preventive control for the allergen clean procedure. If a facility produces a ready-to-eat product, the facility will have a sanitation preventive control for the cleaning and sanitizing procedure to control pathogens. Like Subpart B, written monitoring procedures and corrective action records are required.

Even with plain English, information can be confusing. When I am teaching the PCHF course, I warn the participants that the answer to a question may be, “You have to take that to legal.” I encourage you to visit the FSMA website and review FDA guidance documents. Boston was my 17th PCHF workshop, and I am still learning.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at

2017 Illinois Food Safety Symposium: A Review

On August 8th and 9th, 2017, the ConnectFood team hosted the 2017 Illinois Food Safety Symposium in Bloomington-Normal, Illinois. There were nearly 250 food industry professionals that attended the two day event. ConnectFood organized and led the Symposium in order to continue the tradition, previously established by the Illinois Department of Public Health of bringing together regulators, academia, and industry professionals in order to work towards continuous improvement of the food safety environment in Illinois.

If you were unable to join us at the Symposium, we hope you enjoy this short overview of what you missed, and that you’ll be interested in attending next year!

The Symposium was started the Keynote address from Mike O’Grady, Vice President of the Bloomington-Normal Economic Development Council, and Molly Lamb, Deputy Director at Illinois Department of Public Health. Both touched on the fact that the food safety industry in Illinois is incredibly strong, but that there are many areas that are being expanded and strengthened. Matthew Botos, CEO of ConnectFood, introduced two of our exhibitors: Cheryl Hodges from Miller & Stryker, and Renee Hoggay from the National Restaurant Association, and encouraged them to speak about their products and businesses.

Matthew Botos, CEO, ConnectFood, welcoming the crowd to the 2017 Illinois Food Safety Symposium.

As participants refilled their coffee mugs and grabbed morning snacks, Dr. Robert Brackett, Director of Institute for Food Safety and Health set up for his discussion of Food Safety Modernization Act (FSMA) & Compliance. He began by introducing the foundation of FSMA – why is it necessary? In the shortest summary possible: FSMA is necessary because food supply is more complex, and an increased percentage of the population is at risk for foodborne illnesses. Dr. Brackett also covered the seven rules of FSMA: Preventive Controls for Human Foods and Animal Foods, Produce Safety, Foreign Supplier Verification Program, Accredited Third Party Certification, Sanitary Transport, and Intentional Adulteration. The first FSMA Compliance dates are right around the corner (this month, in fact): September 17-19th, 2017, so if you need help making sure you’re compliant, now is the time to act.

Dr. Bob Brackett at the 2017 Illinois Food Safety Symposium.

After lunch, Dave Park, Principal, Food Defense, LLC spoke on the topic of Food Defense. He touched base on the history of food defense, food fraud, the intentional adulteration rule, and the comparison of new regulations to HACCP. Mr. Park highlighted food defense audit failures, threats and risks, imports and refusals, and food fraud incidents. “The general Hazard Analysis and Vulnerability Assessment procedure is the same, but the perspectives and expert knowledge bases used are different.” We are told to “Remember: Food Safety + Food Defense = Food Protection.”

Dave Park speaking at the 2017 Illinois Food Safety Symposium.

Next, Matthew Botos moderated a panel regarding Distribution and Transportation of Products, featuring the expertise of Tanesia Cole, Manager of Food Regulatory Compliance at US Foods, and Jeff Newey, Manager of Deseret Transportation. Both members of the panel highlighted their individual company’s background; explaining what they ship, how their shipment process works, and the procedures that are in place to ensure safety in the distribution step. Both touched on the transportation rule of FSMA, urging folks to shift their way of thinking to match the safety regulations of the new rule.

Tanesia Cole & Jeff Newey at the 2017 Illinois Food Safety Symposium.

To close out day one, Matthew Botos, CEO of ConnectFood, and Chris Metz, CTO of ConnectFood, hosted a demonstration of the software. I won’t dive too much into detail here, but if you’re interested in a software demonstration, please contact us & we would be pleased to show you around our website. We wrapped up the day with a short reception, and set our focus on day two.

Matt Botos, CEO, and Chris Metz, CTO, ConnectFood, at the 2017 Illinois Food Safety Symposium.

Day two opened with William Weissinger, District Director at FDA Chicago District, speaking about FDA Inspections & Enforcement Then and Now: Changes Over 5 Years. Ultimately, Weissinger said that the current goal of FDA inspections is to educate while regulating, meaning that the industry shouldn’t attempt to know exactly what to expect during an inspection, as inspections are by special assignment. In addition, it was stressed that all food manufacturers (regardless of size) must be registered with the FDA. (If you need help with that, contact us.)

William Weissinger speaking at the 2017 Illinois Food Safety Symposium.

Jessica McAnelly, Chief, Division of Food, Drugs, and Dairies at Illinois Department of Public Health (IDPH), took over the podium next. She spoke on the state of public health in Illinois, which ended up being a major talking point for a lot of attendees. She spoke about new legislation and updates to the existing legislation. Allergen awareness training is included in these updates – a main change included was that the certified food protection manager must get allergen training within 30 days of employment at a high-risk restaurant. Another major announcement of this presentation was that IDPH will no longer validate hours for Food Service Sanitation Manager Certification (FSSMC) – the Certified Food Protection Manager is a required, national certification.

Jessica McAnelly speaking at the 2017 Illinois Food Safety Symposium.

After lunch, it was Eric Greenberg, Principal Attorney, Eric F. Greenberg, P.C.’s turn to chat with participants about Labeling & Nutrition. The finalized changes for the FDA for Nutrition Facts Label are as follows: calories presented more prominently, an altered format, and added sugars included. Unfortunately, these changes have been postponed indefinitely. In Mr. Greenberg’s words: “One thing’s for sure in the future: Label compliance will always be primarily the responsibility of food companies, and this is especially so given the FDA’s enforcement patterns.”

Eric Greenberg at the 2017 Illinois Food Safety Symposium,

ConnectFood team member Dr. Kathy Knutson moderated our second day panel. (You’ve probably read her outstanding blogs for ConnectFood – if not, check them out here.) This panel included members Joseph Cooper, Emergency Response Coordinator, Chicago District Office, Mancia Walker, Supervisor, Indianapolis Resident Post OHAFO 6E, and Christinae Hudson, Consumer Complaint Coordinator, Chicago District Office. They discussed Recalls & Outbreaks – what they’d seen, effective ways to handle them, and how important recall plans are for the safety of a company. A crowd pleaser that was discussed was the Blue Bell ice cream recall that was enforced across the state of Texas after the delicious ice cream was contaminated with Listeria.

Dr. Kathy Knutson and Matt Botos moderate the Recalls and Outbreaks panel.

The final speaker at the Symposium was Laurie Jahn, Senior Environmental Health Program Specialist of Lake County Health Department, talking about juice production & safety. The objectives of this presentation were to understand the methods of fresh juice processing, determine the code regulations, and present labeling requirements for bottling fresh juice. The main concerns with fresh juice are the possibilities of cross contamination and that there is no kill step, which leaves the juice untreated.

Laurie Jahn speaking at the 2017 Illinois Food Safety Symposium.

Matthew Botos wrapped up the Symposium with a final “thank you!” to everyone that joined us. If you attended the Symposium and have some feedback or need to obtain your certificate of completion, please complete this survey. As always, the ConnectFood team is always available to help you understand food safety. All you need to do is contact us.

Johanna Seidel has been a team member with ConnectFood since July 2016. She holds a B.F.A. from West Texas A&M University. She helped organize and run the 2017 Illinois Food Safety Symposium.

Johanna Seidel, ConnectFood, celebrating the completion of the 2017 Illinois Food Safety Symposium.


The Language of the Preventive Controls for Human Food Rule

Recently, I sat in a room with 20-some food safety experts eager to learn about the curriculum for the Preventive Controls for Human Food rule. The FDA-recognized curriculum is used as the primary means to call oneself a Preventive Controls Qualified Individual. At the start and at hearing the use of “preventive,” my colleagues and I whipped out our cell phones to look up the existence and meaning of the word. Well, I will tell you it is a word, is chosen for use by FDA, and means the same as “preventative.” Out loud, say to yourself, “preventive measures.” Sounds good, doesn’t it?

Preventive is not the only new word to the rule. The terms of HARPC, still in its infant stage, and its older siblings of HACCP, CCPs, and critical limits are fading into the sunset. If you are a food safety expert who has grown up on the use of HACCP and CCPs, don’t worry. FDA is not making you use the new language. There is still room for use of HACCP and CCPs when identifying process preventive controls. After all, processing is where much of the highest risk in food safety is controlled. Water is removed to prevent growth of mold and production of harmful toxins. Heat is used in pasteurization, canning and baking to kill pathogens. We use metal detectors. The youth in our business will label these process preventive controls, not CCPs. The youth will be studying the rule and the language of the rule.

There are three additional labels of preventive controls-allergen, sanitation, and supply chain. We do not apply the terms of HACCP, CCPs or critical limits to preventive controls in these three areas. Your hazard analysis will identify if you need a preventive control in any of these areas. We identify preventive controls for known or reasonably foreseeable hazards, and set parameters and values. Parameters are just the name of the measurement like temperature, time, belt speed or bed depth. Values are the number and corresponding unit which must be achieved for safety like 185oF, 25 minutes, 1 foot per second, or 2 cm.

Another new kid on the block is the term “correction.” We will still issue corrective action when a food safety issue affects finished product. What about when product has not been affected? The wrong label is moved from storage to the packaging line. Get the right label. A post-sanitation inspection observes areas not cleaned properly. Reclean. A correction allows the righting of a wrong at a preventive control step and before any product is affected.

It takes practice to adopt the new language of the rule. As an educator, I encourage you to say the terms out loud. After some time and in our future, we will hear a colleague say, “What’s HACCP?”

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