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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Recall: Lessons Learned – Part 2

In a previous ConnectFood blog, Recalls: Lessons Learned, I wrote about some personal experience working with industry during recalls. I discussed:

  • Are you sure you must initiate a recall?
  • Get yourself a good lawyer.
  • Don’t move that product!

There are two important reasons to have a written recall plan. First, the rule requires it, and, second, the written recall plan will get you organized in the case of an actual recall.

There is a requirement for a written recall plan in the rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. In Subpart C of the rule, any facility that manufactures, processes, packs, or holds food must complete a written hazard analysis. There are facilities which are exempt from a hazard analysis. Farms are exempt. Facilities earning an average of less than $1,000,000 in revenue are exempt. Food service operations like grocery stores and restaurants are exempt. If a food facility does not perform a hazard analysis, the facility must provide evidence of oversight by a non-federal entity, like a state department of agriculture or a local health department.

It is in the hazard analysis that hazards requiring a preventive control are identified. Right up front in Subpart C we see the Contents of a food safety plan

, and (4) The written recall plan as required by § 117.139(a).

Turning to 21 CFR 117.139(a), we see Recall plan.
For food with a hazard requiring a preventive control:
Does your product potentially have a hazard? Have you identified a hazard requiring a preventive control in the hazard analysis? If you have a ready-to-eat product, you have a hazard, namely an environmental pathogen. If your product has an allergen, you have a hazard. Does your process have metal-on-metal or other physical hazards?

If you have identified a hazard requiring a preventive control in the hazard analysis, you must have a written recall plan as part of your food safety plan.

The recall plan must include written procedures which the company will follow in the event of a recall. Most recalls are announced on Fridays, and then it is all hands-on-deck. The recall plan must name the position of who will do each procedure. You can include names and contact numbers in the recall plan; just remember to keep it updated. Here are some examples. Who is the:

  1. Single person to initiate the recall. Who has the responsibility to pull the trigger on a recall?
  2. Internal recall coordinator. This person may not be a Preventive Controls Qualified Individual.
  3. FDA recall coordinator
  4. State recall coordinator
  5. Accountant. A recall is going to be costly.
  6. Attorney or firm for the recall. Find an attorney who has recall experience.
  7. Contact for communication to the public and press. The public must be notified of the hazard.
  8. Sales personnel who must notify each customer, communicate if the product is to be returned or disposed, and calculate the daily effectiveness check which accounts for how much product has been recovered.

A team of experts must decide the fate of the recalled food. The company will work with the state and/or FDA recall coordinator, attorney, quality assurance personnel, and contract lab. The company may hire a consultant to investigate the cause of the hazard and advise through the recall. If a plan is developed for the food to be reconditioned, reprocessed including relabeling, reworked, diverted, or destroyed, the company will present the plan to the FDA for acceptance.

A mock recall is not required, but highly encouraged.

A mock recall is when the recall team tests and updates the information in the written recall plan. I was reviewing a food safety plan with a client, and we came to the recall plan section. The quality manager informed me that she had just emailed with the FDA recall coordinator during the previous week, when I asked about mock recalls and the testing of the plan. The contact information was on the email signature for the FDA recall coordinator. On a whim, I said let’s call the number. The recorded message told us that the person could no longer be reached!

Since the mock recall is not required, the company will determine the frequency of the mock recall and if the date is announced or surprise. There are advantages and disadvantages both ways. The important concept in a mock recall is to go one step back to the source of an ingredient and one step forward to your customers. For every mock recall you do, take the practice seriously, and you will learn more about your systems and become more organized in your company.

Unfortunately, food recalls are an every-day occurrence in the food industry. Not only is a written plan required by law, but the written recall plan will help your company be organized in the case of an actual recall.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. 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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Recalls: Lessons Learned

In the last year, I have worked side-by-side with industry folks as they navigate the aftermath of a recall. Every recall is unique and presents its own unique challenges, but here are some lessons I learned and can share with you. That is, most of this experience remains confidential.

Are you sure you must initiate a recall?
As a food microbiologist with expertise in lab methods, you need someone on board who understands the testing methods. You can find this expertise with your contract lab or with a consultant, if you don’t have it in-house. If you are initiating a recall due to a pathogen, you need to understand that these tests are comprised of many steps, and therefore days, before a positive pathogen test is confirmed. If that concept is foreign to you, find your person who is going to ask what method was performed and what was the result at every step. Where was the test performed and by whom? Labs make mistakes! Be absolutely certain that the positive pathogen result is true before initiating a recall. I have a story about this that is so bad, I can’t even put it in writing. Warning: be very certain.

Get yourself a good lawyer.
My cousin Vinny is not qualified to be your recall lawyer. Most companies use an outside lawyer or firm for business dealings on a routine basis. Your company attorney may be a relative or friend. This is not the person to work with you in a recall. The lawyer must have experience communicating with FDA. I have heard stories of lawyers thinking they are going to strong arm the FDA, they tell off the FDA, and the food facility just gets greater scrutiny and ends up doing even more work for the FDA. There are lawyers and firms who specialize entirely in working with the food industry and its government agencies. Hire a great recall lawyer. It is going to cost you a lot of money. Recalls cost a lot of money. If you want to fix the problem and resume operations, hire a great food recall lawyer.

Don’t move that product!
After a recall has been initiated with the codes of the recalled product, you probably will have product on site. It will be in the way. You will want to move it out of the way and into long-term storage. Don’t move that product, unless you have written permission from your state or federal recall coordinator. From my experience with product contaminated with a pathogen, that product is now considered hazardous material and must be handled as hazardous material. First, that means you must protect your workers, so that they do not become contaminated. The recall coordinator will want to know how much product was produced, where it went, and how much is under your control on-site or in company-owned warehousing. Once you have that information, you may present a plan for storage and moving the product into storage. To move the product during a recall looks nefarious, and you do not need any extra headaches during the recall.

Unfortunately, food recalls are an every-day occurrence and no company is exempt from the possibility. As much as possible, be prepared. If you are in a recall, be smart. I hope you can learn from these lessons.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. The folks at ConnectFood are here to help! Contact us.

For more about recall plans, read part two of this blog.

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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What is a Food Process Authority?

Your FDA inspector will ask to see your validation study in your food safety plan. We have been talking to many companies who need a validation study of their kill step. In a previous post in this blog, Validation of Thermal Processes, I wrote about the need for validation of kill steps in processing. These steps are process preventive controls and part of your food safety plan.

There are options for getting the data you need for a validation of your process preventive control. You can use technical, published data; we recommend a Google Scholar search. You can partner with a local expert found at your contract lab, university, extension office, or consulting firm. While only required for manufacturers of acidified and low-acid canned foods, we like the idea of using a food process authority. A food process authority is someone who will work with you to validate your process with your equipment and with your product.

A food process authority can do many things for you. They will partner with you to evaluate the worst-case parameters of your processing equipment. Where are the cold spots? Where is the product exposed to the shortest time of processing? Does the temperature drift over the duration of a long shift? Have you scientifically determined the longest run time for your equipment? There are so many variables to assess, and a food process authority will make sure you are addressing all the variables.

A food process authority is often a food engineer or chemical engineer. You want to hire someone who has been in a lot of food facilities with a variety of processing equipment. With experience like that, they will have applied their knowledge in many operations and may have seen a set up like yours or worked with the same equipment at a different facility.

Where will you find a food process authority? At the same places listed above. Every state has a land-grant university. Every land-grant university employs university extension personnel, and it is among the extension personnel that you can expect to find a process authority. I found a listing of food process authorities by state on the website of the Association of Food & Drug Officials:
http://www.afdo.org/foodprocessing,

ConnectFood has a marketplace to access process authorities for acidified foods. If you are looking for process authority services, you may create a free account to access the Expert Marketplace and find one that fits your needs.

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.