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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

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