Chapter 19 Appendices

Appendix 20 Prerequisite Programs Cross-Reference with FSEP Prerequisite Program Bullets

• To meet regulatory and CFIA program requirements
• So its access is secure
• So the roof, air intakes, foundation, walls, doors and windows prevent leakage and entry of contaminants and pests
• To effectively separate incompatible operations*
• To provide hygienic operations by means of a regulated flow from point of entry to the premises to the final product*
• To effectively prevent cross-contamination due to employee traffic pattern, food product flow and equipment*
• So living quarters and areas where animals are kept are separated from and do not open directly into food processing or packaging areas
• So incoming materials (food, non-food, packaging) are received in an area separate from food processing areas
• So washrooms, lunchrooms and change rooms are separated from and do not open directly into food processing areas
• So separate and adequate facilities are provided for:
  • The storage of waste and inedible products*
  • The cleaning and sanitizing of waste/inedible equipment*
  • The cleaning of equipment*
• To prevent cross-connection between:
  • the effluent of human wastes and production drainage wastes in the establishments
  • potable water lines and non-potable water supply systems
    • Non-potable re-circulated/reused/recycled water has a separate distribution system which is readily identifiable in the facility
• So the sewage and the waste effluent system do not pass directly over or through production unless they are controlled to prevent contamination
• So drainage and sewage systems are equipped with functional traps and vents
• So floors permit liquids to drain to trapped outlets
• So floors, walls, doors, windows, ceilings, overheads and other structures in rooms or areas where food is manufactured, stored, packaged, received or shipped are cleanable, prevent contamination, prohibit deterioration, are suitable for the activities in each area and are free of any noxious constituents**

* If the building is not designed to effectively separate incompatible operations and/or to prevent cross-contamination, operational procedures to control cross-contamination must be defined in the General Food Hygiene Program D.2.1.1. and/or the Sanitation Program E.1.1.1.

**Reference Listing of Accepted Construction Materials can be found at:
http://www.inspection.gc.ca/english/fssa/reference/refere.shtml. See B.2.1.1 for purchasing control of construction material.

• The roof, air intakes, foundation, walls, doors and windows prevent leakage and entry of contaminants and pests
• The drainage and sewage systems prevent backflow and pooling liquids on floors
• Floors, walls, ceilings, overheads, doors, windows, stairs, elevators and other structures exhibit no evidence of degradation that would cause contamination and are cleanable

• An identification system for utensils and containers used for collection and holding of waste and inedible/food waste materials
• The frequency of removal of waste during operations
• If applicable, the frequency of removal of inedible/food waste products during operations
• If applicable, procedures for storage of waste and inedible/food waste products
• If applicable (see regulatory requirement for the commodity), a denaturing protocol, including methods and chemical(s) used for denaturing
• The frequency of removal of waste from the establishment
• If applicable, the frequency of removal of inedible/food waste product from the establishment
• Procedures for maintenance of waste/inedible/food waste equipment (Equipment must be leak proof and where appropriate, covered)

• Sanitizing installations for hands
• Sanitizing installations for boots
• Sanitizer for operational equipment

• Name or title of personnel responsible for the implementation of the water safety procedures
• Identification of the source of water supply (municipality, private well(s), storage tank(s), etc)
• Water sampling and testing schedule(s)
• Identification of the sampling site(s)
• Water and ice sampling procedures
• Description of testing activities to be performed
• Water potability criteria
• Documentation requirements (records should include the water source(s), sampling site(s), analytical results, analyst and date of sample(s)
• Deviation procedures when water testing results indicate water potability criteria have not been met
• Deviation procedures to be applied at the establishment in instances where the municipality identifies a failure with the water system 
• Record(s)to be kept

• Boiler feed water treatment or any chemically treated water (e.g., corrosion inhibitors, water conditioning and chlorination) that has direct product impact or is used on product contact surfaces meets the appropriate regulatory requirement and is potable
• Water mixed with chemical and applied on product to reduce the microbial load meets the acceptable chemical concentration for the intended purpose
• Re-circulated water for reuse meets the appropriate regulatory requirement

• Name or title of personnel responsible for the implementation of the water treatment procedures
• Identification of water treatment activities to be performed
• Water treatment method/frequency
• Chemicals used
• Proper handling and application of water treatment chemicals
• Acceptable chemical concentrations
• If applicable, description of any automatic warning control
• Testing procedure, including testing frequency, to ensure proper concentration is consistently met
• Documentation requirements (records should include method of treatment, sample site, analytical result, analyst and date)
• Deviation procedure when the criteria have not been met
• Record(s) to be kept.

• Are designed, constructed, maintained and cleaned to prevent contamination, damage and deterioration of the food product
• Are equipped, where applicable, to maintain food products in a refrigerated or frozen state
• Are not being used for the transport of any material or substance that might adulterate the food product

• Prevents outside contaminants from entering the establishment
• Prevents damage and contamination of the finished product, raw materials, ingredients and incoming materials that come in contact with the product or are used in preparing the product

• Raw material and ingredients are ordered from suppliers/sources approved by the establishment
• The required information on raw materials and ingredients is maintained on file (e.g., specifications, letters of guarantee, certificate of analysis)
• Construction materials, packaging materials and non-food chemical products are listed in CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products*. Otherwise, the manufacturer has a letter of no objection from Health Canada

• It meets regulatory and CFIA program requirements
• It is capable of delivering the requirements of the process and the sanitation program
• It is accessible for cleaning, sanitizing, maintenance and inspection and is easily disassembled for those purposes
• Contamination of the product and food contact surfaces is prevented during operations
• It permits proper drainage and where appropriate, it is connected directly to drains
• It is smooth, non corrosive, non absorbent, non toxic, free from pitting, cracks and crevices where there are food contact surfaces
• It is, where necessary, exhausted to the outside to prevent condensation

• A list of equipment that may impact on food safety requiring regular maintenance
• A preventative maintenance schedule or frequency of preventative maintenance activities
• The maintenance procedures to perform for each preventative maintenance task
• Records to be kept to demonstrate that the preventative maintenance tasks have been completed

• A list of equipment monitoring and controlling devices that may impact on food safety requiring regular calibration
• A calibration schedule or frequency of calibration activities
• The calibration procedures to perform for each calibration task
• Records to be kept to demonstrate that the calibration tasks have been completed

• The establishment’s general food hygiene program (see D.2.1.1)
• A list of employee positions who must receive the training
  • All food handling employees and other employees that may work in food handling areas (e.g., maintenance staff, quality assurance (QA) staff, supervisors, etc.)
• The frequency of training
  • The training is delivered at the start of employment, whenever changes are made to the program and reinforced at appropriate intervals
• Records to be kept to prove completion of personnel training.

• The prerequisite programs
• The CCP(s), if applicable
• The process control(s), if applicable
• Any additional external technical training that is necessary to ensure current knowledge of equipment and process technology (e.g., licenses/certification required to operate equipment - HTST operator’s certification / retort operator certification)
• A list of employee positions who must receive the training
  • Designated employees involved in the delivery of procedures developed in response to the prerequisite programs requirements, CCPs, and process controls
• The frequency of training
  • The training is delivered before the beginning of assignment and reinforced whenever changes are made and at appropriate intervals
• A method to confirm that the training has been effectively understood
• Records to be kept to prove completion of personnel training

• Good Manufacturing and Personnel Hygiene Practices:
  • Methods for hand washing/sanitizing
  • Correct use of protective clothing, hair coverings, gloves, footwear
  • Prohibited practices at the establishment
  • Hygienic handling of food
  • Correct use of utensils and equipment
  • Storage of personal effects to prevent cross-contamination
  • Where required, restricted access to areas of the facilities by specific employees to prevent cross-contamination
  • When required, procedures to prevent contamination due to the process flow, employee flow, product flow, equipment or incompatible operations
  • When required, procedures to prevent cross-contamination during production. For example:
    • Glass control and breakage procedures
    • Procedures to follow when:
      • Product falls on the floor
      • Product is exposed to dripping condensation
• Procedures for visitors and contractors during production including:
  • Restricted Access
  • Hygienic Practices
• Personnel Health Status:
  • The program must clearly state that personnel must advise management when known to be suffering from a disease likely to be transmitted through food
  • No person is permitted to work in a food handling area when he or she is known to be suffering or a carrier of a disease likely to be transmitted through food
  • Employees having open cuts or wounds should not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering

• The sanitation schedule/frequency for all equipment, and for all rooms within the establishment including livestock holding facilities, utensils, waste and inedible/food waste equipment and facilities, work gear etc that, if not kept in a clean/sanitary condition, would have a negative effect on food safety
• Cleaning and sanitizing procedures including:
  • Details and specifics describing the method and procedures for equipment and room cleaning and sanitizing
  • The chemicals required
  • The chemical concentration level required
  • Proper handling and application of chemicals (duration of application, etc)
  • The chemical solution temperatures, where applicable
  • Equipment disassembly and assembly instructions
  • Methods to prevent cross-contamination, where necessary
• Housekeeping and sanitation procedures required during operations
• Pre-operational inspection procedures
• Environmental sampling procedures, if any
• Corrective actions to be taken for non-compliant situations observed during pre-operational inspection activities and unsatisfactory environmental testing results
• Records to be kept

• Where applicable, the name of the pest control company or the name of the person contracted for the pest control program
• The name of the person at the establishment assigned responsibility for pest control
• A schedule or frequency of pest control activities
• Pest control procedures for the exterior and interior of the establishment including:
  • The pest control activities to be performed
  • The chemicals required for the effective implementation of the pest control program
  • The methods for proper handling and application of pest control chemicals
  • The type and location of pest control devices
  • Corrective actions to be taken for non-compliant situations observed during pest control activities
  • Records to be kept

• Finished products are correctly and legibly coded
• The finished product label information accurately represents the product name and the composition of the product on which the label is affixed

• The names or title of personnel responsible for particular task
• Frequency of activity
• Description of the task to be performed
• Corrective actions to be taken when product is mislabelled or miscoded
• Operational records to be kept

• A product development and approval process flow including steps to be followed when modifications to existing product formulations are made
• Communication links among all the steps in the chain of production once a new formulation or changes in a formulation have been approved

• Identification of any allergens not allowed in an establishment if such a policy is in place
• A list of approved suppliers and ingredients
• Supplier specification for each ingredient or ingredient blend clearly listing each ingredient and, where applicable, components of ingredients
• Documentation indicating that the supplier will:
  • Meet the establishment’s specifications
  • Notify the establishment when a change is made to their ingredient blend formula which adds or eliminates an allergen or in the case of sulphites, increases or decreases the level of sulphites

• A label approval process including steps to be followed in case of re-approval of product labels resulting from modifications to existing product formulations 
• Communication links among all the steps in the chain of production once a new label, or changes to a new label, have been approved

• Only approved ingredients from approved suppliers/sources are received
• The labels of approved ingredients received match the establishment’s finished product list of ingredients and components of ingredients
• Externally printed labels meet the specifications

• The names or titles of personnel responsible for these particular tasks
• Methods or instructions for the task(s) to be performed
• Corrective actions to be taken when deviant situations occur during any of these steps
• Operational records to be kept

• The names or title of personnel responsible for particular tasks
• Frequency of activity
• Methods or instructions for the task(s) to be performed
• Corrective actions to be taken when product is mislabelled
• Operational records to be kept

• Labels (refers to any pre-printed packaging that bears a list of ingredients)
• Formula documents, and
• Ingredients and work in process

• Production scheduling if dedicated lines for allergens are not available
• Traffic patterns of employees who handle allergens and non allergens
• The traffic flow and handling of ingredients containing allergens during receiving, storage, processing and packaging
• Dedicated or segregated storage of ingredients containing allergens
• The identification and sanitation of bulk containers housing allergens or ingredients containing allergens
• Dedicated utensils, equipment and areas used to handle allergens
• The handling and storage of rework product(s) containing allergen ingredients
• Cleaning of equipment/food contact surfaces/areas during operations if dedicated lines/equipment/areas for allergens are not available