Tag Archive for: sanitation

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Don’t Fear the New FDA Sanitary Transport Rule

By Dave Seddon, MBA RD LD (PEAKCORE, a ConnectFood Partner)

For many, change can be daunting. This includes the new FDA Sanitary Transportation of Human and Animal Food Rule. With increasing regulations, such as with the implementation of Electronic Logging Device (ELD), transportation companies are wondering what impact will this new rule have on the bottom line and operations. Fortunately, the changes that have come about since the 2005 Sanitary Transportation of Food Act, provide more flexibility and a preventative scope on top of the existing industry’s best practices.

The FDA’s Food Safety Modernization Act (FSMA) final rule on Sanitary Transportation of Human and Animal Food’s foundation is a “risk-based” model for food safety, clearly defines who is covered by the rule, and highlights certain preventative operational areas that help to ensure product food safety, such as temperature, is being maintained throughout the course of transport. The final compliance date for most businesses, barring any waivers, are upon us. We have provided a few bullet points of those requirements that are now being monitored to help you implement an improved food safe environment.

    ● The final rule establishes clear definitions of the transport role you play in transport. Those identified are Shippers, Carriers, Loaders, and Receivers. Some of the operational guidelines also will enhance and impact cGMPs (Current Good Manufacturing Practices) and SOPs (Standard Operating Procedures). Since, businesses can play multiple roles, a food safety plan should state each of these.
    ● FDA states “any movement of food in commerce by motor vehicle or rail vehicle,” all Transport Operations, Vehicles, and Transport Equipment are subject to the requirement.
    ● Temperature monitoring operations for foods are now required for temperature control safety. Thus businesses need to be able to provide temperature maintenance documents upon request. Clearly, these requests are becoming more prevalent and you should be prepared to show evidence for your clients.
    ● Training certificate and internal training programs are a few ways that businesses can illustrate compliance for training employees on food safe handling practices.
    ● The final rule requires maintenance and retention of records of written procedures, agreements, and trainings have been completed. Procedures should include ways to address pre-cooling, prior cargo handling (post), and vehicle/transport vehicle cleaning records. Cleaning, sanitizing, and inspecting of vehicles and transport equipment procedures must be written and maintained. Retention length depends upon the type of record and when the activity occurs.

Raising the bar for food transport adds to the increasing awareness that improved food safety transport systems strengths the diverse and complicated food procurement system. Creating a Sanitary Food Safety plan is a great way and first step for some to help your company meet many of these new requirements and ease the burden of compliance. Tools, such as ConnectFood, provide a resource for templates, models, and a framework to develop your own plan in short period of time. Best of all, all records can be maintained for ease of access for your client and the regulatory bodies. If you need further assistance, experts are available as well.

As always, ConnectFood is ready to help. A transportation plan guidance is available on the ConnectFood website, and a template with information is available to be loaded for your company upon request. Contact us.

About the Author
Dave Seddon, MBA RD LD (PEAKCORE, a ConnectFood Partner) is a food safety consultant with 25+ years of financial, operational, and managerial experiences in for-profit and non-profit organizations. He is well versed in food safety, SQF, HACCP, operational control, business development, entrepreneurship, M/A, risk analysis, and ERP/system implementation. Dave is a ConnectFood partner as part of the Expert Services.

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5 Signs You Don’t Have a Food Safety Culture

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

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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 https://www.linkedin.com/in/kathyknutsonphd.

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Sanitation Standard Operating Procedures (SSOPs)

In the blog post, The Basics of Sanitation in the Food Industry, I laid the foundation for a successful sanitation program. I discussed:

  • What is soil?
  • The sanitation crew members are your most valuable employees.
  • There are four crucial factors for successful cleaning and sanitizing.
  • What are clean-in-place (CIP) and clean-out-of-place (COP) procedures?

Sanitation crews work hard. Sanitation crews have a lot of turnover and require extensive training and monitoring. The crew must be supplied with the resources they need to do the job right. Crew members must be trained to handle chemicals safely and wear appropriate personal protective equipment. The crew is supplied with EPA-registered cleaning and sanitizing chemicals and follow the manufacturer’s directions. After training and when an employee’s performance is good, please pay them well.

On this foundation, companies will build a sanitation program with training records, Sanitation Standard Operating Procedures (SSOPs), and monitoring of sanitation preventive controls.

Document training.

Every sanitation crew member is a qualified individual as defined by the Food Safety Modernization Act (FSMA) final rule for Preventive Controls for Human Food. FSMA requires documented training records. Most companies fulfill this function through human resources, but owners of small companies may be doing this record-keeping. Because training records are required, you must be ready for a federal or state inspector to review the training records. During the on-boarding process of a new sanitation crew member, document the training. Document a follow-up observation to confirm the work is being done correctly. Document additional training as the employee takes on more responsibilities.

Document cleaning and sanitizing procedures.

SSOPs are detailed step-by-step procedures and can be written with your chemical supply company. The chemical supply company should have resources to answer all your questions. The SSOPs will be tailored to your manufacturing equipment, your product, and your cleaning and sanitizing procedures. Beyond your chemical supply company, there is a wealth of information to sift through on-line. ConnectFood provides resources on their site and will match you up with experts in the design of cleaning and sanitizing programs.

Your company may already be doing all the right steps for cleaning and sanitizing, and that is great! Attaining clean and sanitary equipment as well as manufacturing environments supersedes all other sanitation team goals. However, written SSOPs will help to ensure that all sanitation crew members are following the same steps in the way the procedures were designed. Written SSOPs are critical to training. Remember, there is usually great turnover in sanitation crews, and new employees are frequently being on-boarded. If crew members are unsure about a step or disagree about a step, the written SSOP will explain the procedure to follow. If there are deviations, the written SSOP will get the process back on track.

I highly encourage clients to write SSOPs with pictures of the chemical labels, tools being used on equipment, clean-in-place control panels and tanks, and the finished job of clean surfaces. A picture is worth ten thousand words, said Fred R. Barnard. Click here to see a splendid example of an SSOP with pictures that I found on-line.

Effective SSOPs are key in our complex world of allergen control. Does your product contain one or more allergens? The big eight regulated by the FDA are wheat, soy, egg, milk, peanut, tree nuts, fish and shellfish. If you make a product which contains an allergen and then use the same line to make another product without the allergen, you must have a complete allergen clean step. The clean step is designed to remove residue of the allergen, so that cross-contact into the next product does not occur. In this case you would have a preventive control for the allergen.

Monitor cleaning and sanitizing.

If you have an allergen clean step or an environmental monitoring program as required by the FSMA Preventive Controls for Human Food rule, you will have a preventive control in your cleaning and sanitizing program. With a preventive control comes the requirement to monitor and document the step. Record-keeping proves you did what you say you are doing in your SSOPs. Keep this simple! Here are examples of what you can record:

  • Visual check after cleaning with a simple pass/fail
  • ATP test result
  • Amount of cleaner added to what amount of water
  • pH of cleaning solution
  • Concentration of sanitizer with a dip test strip
  • CIP tank temperature
  • CIP run time on a recording chart
  • Sanitation supervisor checks that an allergen clean was done after production with an allergen

Use this list as a menu of choices and add your own options. If this information creates more questions, seek out resources. The science of cleaning and sanitizing is vast, in which some people have devoted their entire careers. The concept is that you must prove that you did what you say you are doing in your SSOPs. If critical parameters for successful cleaning and sanitizing are time, temperature, and concentration, then how are you going to document the data?

The search for forms and checklists can be overwhelming, and the ConnectFood website has free resources. The partners at ConnectFood are here to help! Contact us.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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Sanitation Basics in the Food Industry

Today I am writing an introduction to cleaning and sanitizing procedures. Twenty years ago, I believed most spoilage issues and contamination of food were due to poor cleaning and sanitizing. The food manufacturing environment is much more complex now with the concern of allergen cross-contact and the hunt for Listeria in growth niches. Here is a foundation on which to build your cleaning and sanitizing program.

What is soil?

Soil is very simply matter out of place. A lubricant on a gear is in the right place. If you get the lubricant on a food contact surface, like a conveyor belt, the lubricant has soiled the surface. When production shuts down, every particle of food on the equipment and floor is soil, and it is the job of the sanitation crew to remove the food, including any surface film from fat, protein, carbohydrate or mineral build-up. When soil is removed, the process is cleaning.

It is not possible or desirable to remove everything on a surface, down to the smallest bacterium or virus. If the surface is free of every living cell, the surface would be sterile. This is not a realistic goal in the food industry. At the microscopic level, cells adhere to the surface of the equipment and remain after cleaning. THIS IS NORMAL. The purpose of sanitizing is to kill cells which remain after cleaning. In this way, you see that it is not possible to clean and sanitize at the same time. Neither the work of cleaning nor the work of sanitizing would be efficient. It is a waste of resources to clean and sanitize in one step.

The sanitation crew members are your most valuable employees.

The work of sanitation starts your day. Production follows sanitation. Production does not start until sanitation has done their job correctly and completely. Some companies run sanitation during business hours, to emphasize that the work of sanitation parallels the work of upper management. Sanitation crews have a lot of turnover and require extensive training and monitoring. The crew must be supplied with the resources they need to do the job right. Sanitation crew members should earn some of the highest wages among a company’s workers.

There are four crucial factors for successful cleaning and sanitizing.

For successful cleaning and sanitizing, the factors are time, temperature, concentration, and energy. In general, the more, the better. However, you will use EPA-registered cleaning or sanitizing chemicals and follow the directions from the chemical supply company. It makes sense that cleaning at a higher temperature is better, but running the equipment at a higher temperature may cause damage, and workers cannot be exposed to excessive temperatures. With concentration, more is not better after a certain point. Using 5% bleach is not recommended due to its corrosive property. Energy can be supplied by manual scrubbing or by turbulence within equipment.

What are clean-in-place (CIP) and clean-out-of-place (COP) procedures?

CIP systems for cleaning are installed when a continuous loop of equipment, pumps, and pipes can be developed. CIP systems are designed with your chemical supply company to run at much higher temperatures, concentrations, and turbulence than can be achieved in a tank. COP cleaning can be done in an open tank with recirculating solution in which the disassembled parts sit, or COP cleaning can be done with manual scrubbing of parts in a bucket or tank.

With the concepts described here, I hope you can build a successful cleaning and sanitizing program. Other blog posts here at ConnectFood elaborate on the topic of cleaning and sanitizing.

The search for forms and checklists can be overwhelming, and the ConnectFood website has free resources. The folks at ConnectFood are here to help! Contact us.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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