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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I was on a flight to Boston, and in my hand was the FDA draft guidance, Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry.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.

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.