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Prerequisite Programs

Prerequisite programs are steps or procedures, including GMPs and SSOPs, which control the operational conditions within a food establishment and promote environmental conditions that are favorable for the production of safe food. Prerequisite programs are the foundation of a Food Safety/HACCP system. According to Appendix K of the PMO, prior to the implementation of a Food Safety/HACCP plan, plants must develop, document, and implement written prerequisite programs. 

Safety of Water, Steam, and Ice

Water, steam, and ice are used in every part of food processing from transport to cleaning and sanitizing to ingredient use. It is essential that potable water, cooling water, steam, and ice must be available in sufficient quantities, at suitable pressures and temperatures, to meet the needs of the operation. Factors that must be considered include:

  • Water Source
    • Both the water and the plumbing system that transport to the facility must provide a safe supply for all water needs.
    • When using a municipal water source, the water treatment authority is responsible for the safety of the source as well as the means of conveyance to the facility.
      • The processor/facility should have documentation to identify the source of the water and annual water quality test results.
      • The processor/facility should independently test for microbiological activity.
      • The municipality should immediately notify the facility when any tests is out of specification.
    • When using private water systems (wells, etc.), a facility is directly responsible for the monitoring and documentation of the safety of their water source.
      • Tests should be routinely performed to test for chlorine levels and microbiological activity.
  • Protection
    • Care must be taken to prevent contamination from potential cross-connections and backflow.
      • Backflow prevention devices should be inspected and tested routinely.
      • Connections without backflow prevention devices must also be routinely inspected and tested.
  • Control Measures
    • Monitoring
      • Water quality test results
      • Review of plumbing system records
    • Corrective Actions
      • Operations must cease production until a safe source and plumbing are assured.

Condition and Cleanliness of Food-Contact Surfaces

All food contact surfaces, including but not limited to equipment, piping, and utensils, used in a food processing facility must be designed, fabricated, maintained in such a way that they are easy to clean and can withstand regular usage. Equipment should have smooth seams and be made of impervious materials such as stainless steel or plastic. Corroded or worn parts should be replaced.

  • Cleaning and Sanitizing
    • Procedures
      • Cleaning and sanitizing procedures for all food contact surfaces must be established and maintained. Cleaning should be done with appropriate detergents at the proper concentration and water at the appropriate temperature. Sanitizing is accomplished utilizing approved sanitizing agents at appropriate concentrations. Written documentation of cleaning, sanitizing, and maintenance procedures is necessary.
    • Frequency
      • Suggested frequencies for cleaning and sanitizing include:
        • Before use
        • After processing interruptions
        • At product changeover
        • After use
        • As necessary
  • Monitoring
    • What
      • Condition and construction of contact surfaces
      • Condition of gloves, outer garments, and utensils
      • Preventative maintenance programs and all repairs
      • Cleanliness and sanitation of food contact surfaces
      • Type and concentration of cleaning chemicals and sanitizers
      • Employee training and hygiene practices
      • CIP and COP systems
    • When
      • Many procedures must be monitored daily, while others may be monitored less frequently (such as preventative maintenance and training)
    • How
      • Pre-operation visual inspection
      • Recording instruments
      • Chemical testing
        • Sanitizer concentrations
        • Alkalinity/acidity of cleaning solutions
      • Verification Check
        • Microbial Test on surface
        • ATP Hygiene monitoring
        • Rinse water testing
        • Visual inspection

Prevention of Cross Contamination

Contaminants such as bacteria are unable to move from one place to another on their own. Cross contamination occurs when food, water, air, people, or equipment carry these contaminants from one location to another. Many factors can contribute to cross contamination, but the most common causes include:

  • Poor hygiene
  • Employee mistakes
    • Non-compliance with GMPs
    • Employee traffic patterns
  • Poor food handling practices
  • Failure to separate raw and cooked/RTE products
    • Product flow
    • Common equipment and utensils
  • Inadequate cleaning and sanitizing
    • Utilizing color-coded brushes and cleaning equipment
  • Poor plant design
    • Especially important when dealing with allergens
    • No cross connections between raw and pasteurized product  in piping or flow

Maintenance of Hand-Washing, Hand-Sanitizing, and Toilet Facilities

It is imperative that in addition to clean food processing equipment, the facilities associated with production must be cleaned, stocked, and properly maintained.

  • Hand washing facilities
    • Should be at each location where GMPs require their use
    • Condition and cleanliness of facilities must be monitored daily
    • Much be equipped with soap, water at the appropriate temperature, disposal towels/hand  dryers, and adequate waste disposal
    • Employees should be properly trained in appropriate hand wash technique
    • Should be used for hand washing only, not cleaning of parts/COP
  • Sewage disposal
    • A properly functioning sewage disposal system is required
  • Toilet facilities
    • Should be adequate and readily accessible with self-closing doors to protect from airborne contamination
    • Must be in good repair and maintained in a sanitary condition
    • Must be properly supplied with paper products, soap, and warm water

Protection from Adulteration

Section 402 of the Food, Drug, and Cosmetic Act defines adulterated food if “food bears or contains any poisonous or deleterious substance which may render it injurious to health and/or if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious health.”  Ingredients, packaging materials, food contact surfaces, and finished product must be protected from various microbiological, chemical, and physical contaminants including but not limited to:

  • Sources of Contamination
    • Water
      • Condensate
      • Splashing from floors, walls, and/or ceilings
      • Leaks
    • Chemical Hazards
      • Fuels
      • Non-food grad lubricants
      • Cleaning and/or sanitizing compounds
      • Pesticides
    • Physical Hazards
      • Glass
      • Metal
      • Plastic
      • Dirt/Rust
      • Pests
    • Additives
      • Vitamins
    • Allergens
  • Monitoring
    • Procedures must be set in place to monitor any possible contamination of food or food contact surfaces according to GMPs.

Proper Labeling, Storage, and Use of Toxic Compounds

Toxic compounds, such as cleaning and sanitizing chemical and pesticides, must be properly labeled, used, and stored in a way that protects food, food contact surfaces, and packaging materials from contamination. A secured area with limited access and removed from food storage, processing, and packaging areas is an essential condition in this prerequisite program.

  • Labeling
    • Original container label must remain intact, visible, and include:
      • Name of compound or solution in container
      • Name and address of manufacturer
      • Instructions for proper use
      • Potential hazards and cautions
    • Working container label must include:
      • Name of compound or solution in container
      • Instructions for proper use
      • Potential hazards and cautions
  • Storage
    • Room/area with limited access
    • Segregate food grade compounds from non-food grade
    • Segregated from food equipment, utensils, and other food contact surfaces
    • Working containers should be kept in a secure location that prevents misuse, spills, or product contamination
  • Use
    • Use according to the manufacturer’s instructions
    • Procedures should exist that will not result in the adulteration of products
    • Keep Material Safety Data Sheets (MSDS) for proper handling
  • Disposal
    • Dispose of unused compounds in an approved manner

Control of Employee Health Conditions

Food processors and handlers with an apparent illness, wound, or open lesion are a potential source of microbiological contamination of food, food packaging, and food contact surfaces.

  • Policies
    • Policies must be in place that exclude or restrict employees who show or who are diagnosed with systems of an illness or wounds that could be a source of microbial contamination.
  • Monitoring
    • Daily
      • All employees should adhere to the Illness and Injury Notification Policy.
      • Supervisors should observe employees for signs of illness and/or exposed wounds.
    • Annually
      • Employees should undergo documented GMP training upon initial hiring and on an annual basis.

Exclusion of Pests

Pests, such as rodents, birds, and insects, are excluded from relevant areas of the plant to the extent possible and should also confirm that approved procedures are followed to prevent and/or eliminate infestation without contaminating foods or food processing equipment. In the event that pest control is contracted to an outside company, it is up to the processor to ensure that the facility is free of pests.

Other Potential Prerequisite Programs

According to Appendix K of the Pasteurized Milk Ordinance, “in addition to the required prerequisite programs, any other prerequisites that are being relied upon in the Hazard Analysis to reduce the likelihood of hazards shall also be monitored and documented.”

Some potential programs may include:

  • Ingredient and Packaging Supplier Management
  • Facilities
  • Environment
  • Temperature Control
  • Receiving
  • Training
  • Traceability
  • Recall
  • Allergen Management
  • Labeling
  • Calibration
  • Cleaning and Sanitation
  • Personnel Processing Practices
  • Storage and Transport
  • High Risk Processes
  • Control of Foreign Matter
  • On-Site Laboratories
  • Waste Disposal
  • Exterior