Sanitary Operations (Section 110.35 of 21CFR)

Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary and functional condition to prevent food from becoming adulterated through the manufacturing and handling process.

Definition of Maintenance is to keep and preserve equipment and facility in a functional state for a specific purpose.

Reliability begins with following and understanding best practices. Good Manufacturing Practices (GMPs) are the foundation to build the operational and maintenance best practices. For the food industry, GMPs come from the FDA in 21CFR- Part 110.

This is the third article of an eight part series discussing why Maintenance must be aware and manage GMP's. GMP's are the foundation to build the operational and maintenance best practices to manage food safety hazards.

Sanitary Operations (Section 110.35 of 21CFR)

Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary and functional condition to prevent food from becoming adulterated through the manufacturing and handling process. Definition of Maintenance is to keep and preserve equipment and facility in a functional state. Any emergency work caused by equipment breakdown will increase the risk of food being adulterated. Maintenance and Reliability personnel must work with their operation partners to eliminate breakdowns. An interruption in production requires someone to intercede within the equipment or breaking the product line. This exposes product and product contact surfaces to potential microbiological contamination and will require care and sanitation practices to eliminate any potential contamination. This can be very costly to assure the food safety risk is at an acceptable level. These high costs are: scraped product, sanitation labor, lost production time and other elements. All of this is done to ensure that food-contact surfaces are proactively cleaned to protect against contamination of the food.

Maintenance is also responsible to maintain outside of the equipment, floors, walls and ceilings. Deferred maintenance in these areas will produce space (cracks in floor or wall, damage guarding dents, broken weld or support equipment) for food material and water to collect. The result of this material at room temperature is a microbiological stew. Microbes, fungi and yeast can grow in these areas. This is a problem when the material is disturbed because these organisms can be splattered on to food or food contact surfaces or become air borne to only settle out on surfaces or product at a later time.

The standard specifically deals with wet processing, when it states, "for wet processing when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated" Again, Maintenance and Operation must work to eliminate unplanned downtime due to equipment failures.

"Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food." This includes hand tools, operator jigs, operator work station, guard covers, etc... Keeping these surfaces clean and sanitized will help to minimize the risk of contaminating the product streams. If appropriate, maintenance job plans should include the cleaning and sanitation procedures and tools to ensure the job is completed properly.

Maintenance Storerooms are sometimes asked to manage some manufacturing supplies such as cleaning and sanitizing agents that are used within the cleaning and sanitizing procedures. These cleaners must be free of microorganisms and properly stored. Some of these chemicals may contain toxins or is toxic at some level of concentration. They must be properly stored and contained. These chemicals can only be used and stored in a food plant if they meet one or more of the following criteria:

(i) required to maintain clean and sanitary conditions;

(ii) necessary for use in laboratory testing procedures;

(iii) necessary for plant and equipment maintenance and operation; and

(iv) necessary for use in the plant's operations.

Portable equipment and utensil must be stored in a location and a manner that protects food-contact surfaces from contamination. This includes sampling tools, change parts, cleaning equipment and hand tools. Hand tools used in microbiologically "HOT" part of the plant (raw material, non-cooked product, outside the plant, etc.) MUST not be used in an area where product or product contact surfaces can be contaminated without following the approved sanitation procedure.

All chemicals in the facility, including the storeroom, must be properly labeled and stored in a manner to protect against contamination to food and food contact surfaces. Material Safety Data Sheets (MSDS) must be properly filed and displayed based on OSHA, Corporate and Plant standards.

Just like in the Dark ages pests can spread microorganisms. Insects, rodents, birds and other animals such as guard dogs shall be excluded from the processing area to protect against contamination of food and food contact surfaces. Many of these pests find their way into the plant through a poorly maintained facility. Doors, door seals, non filtered openings into the plant, unguarded ventilation discharges, dirt and filth which are an attractant to pest, etc .Any chemical treatment to control an infestation must be done under very detailed precautions and restrictions to protect against the contamination of food, and food-contact surfaces. Maintenance personnel are in all areas of the plant including remote areas. Maintenance job plan special notes should be to inspect for signs of pest when a job is performed in utility closet, utility room, elevated areas and other hard to reach area. Early detection prevents costly fumigations, plant shutdowns and possible product recall.

All maintenance technicians should have a basic knowledge of microbiology and product risks for the product streams on which they work. How do microbes grow? What kind of risk to the consumer? How is growth control? In what part of the process does the microorganism first appear? How can the equipment be changed to eliminate these growth points? How do the maintenance practices around Critical Control Point (CCP) equipment minimize these product risks?

There are many stories about consumer illness due to the microbiological contamination. Most of these stories end with a brand or company being destroyed. Sanitization is a key preventive maintenance practice which should be optimized by the Natural work teams (operators, mechanics, cleaners, etc.) under the guidance of a subject matter expert.

Tip provided by Kevin Lewton
Met Demand