Dairy Establishment Inspection Manual – Chapter 10 Prerequisite Programs
1.10.05 - Sanitation Program

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Every dairy establishment and importer has an effective sanitation program in place to prevent contamination of food. This task assesses the sanitation of all structures, equipment and utensils.

This documented program as well as its effective implementation will help control operational conditions within an establishment allowing for environmental conditions that are favourable to the production of safe food. It serves as a prerequisite program or universal-type CCP for a HACPP based program.

1.10.05.01 General

Each plant must have a documented cleaning and sanitation program which specifies:

  • the cleaning policy (what is done),
  • procedures used (how it is done),
  • responsible personnel (who does it),
  • type and frequency of cleaning (how often or when it is done),
  • records to be kept
  • parameters of acceptability/unacceptability (tolerances),
  • results of monitoring,
  • cleaning verification procedures (both on-site and record review),
  • action taken for deviant situations.

The monitoring and verification procedures clearly define the preventative measures taken to prevent the re-occurrence of deviations. The person responsible for verifying the program must be different from the person performing the task. This program must also be updated as required when changes occur. Special sanitation and housekeeping procedures required during production must be specified, e.g. removal of product residues during breaks. Sanitation training is addressed under task 1.10.04.01 General.

Cleaning can be carried out by the separate or the combined use of physical methods, such as heat, scrubbing, turbulent flow, vacuum cleaning and chemical methods using detergents, alkalis or acids. Cleaning procedures generally involve removing gross debris from surfaces; applying a detergent solution to loosen soil and bacterial film and hold them in solution or suspension; rinsing with water to remove loosened soil and residues of detergent; and where necessary disinfection with subsequent rinsing unless manufacturers' instructions indicate otherwise.

Clean Out Of Place (COP) or hand cleaned refers to equipment that is disassembled for cleaning and inspection at a specified frequency, either after use or daily. Clean In Place (CIP) refers to equipment cleaned by an accepted CIP system and is disassembled for inspection at the frequency prescribed in the CIP. Chemicals are used in accordance with the manufacturer's instructions and are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents published by CFIA or the manufacturer has a letter of no objection from Health Canada. Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.

The cleaning policy should minimize cross contamination risks. For example, pipelines used for both pasteurized and unpasteurized cheese must be completely cleaned if pasteurized cheese is processed after unpasteurized cheese, pipelines used for both milk and non milk products must be completely cleaned if non milk products are processed after milk products.

Plant management must ensure that equipment and/or pipelines are not installed in a manner that will jeopardize the integrity of the CIP systems, resulting in cross-connections or processing problems. The concepts of Appendix 19 - 10 apply to CIP supply lines and return line circuits used for CIP cleaning and mini-washes.

Operations must not begin until after sanitation requirements have been met.

When individual tasks are being assessed (e.g. storage tanks) and poor sanitation is observed and rated unsatisfactory, this task must be referenced to determine if the sanitation program requires updating.

1.10.05.02 Plant Clean In Place (CIP) System

This technique is used for permanent installations with many pipes and tanks, which are practically impossible to clean by other means. It utilizes a combination of physical and chemical means to remove soil from product contact surfaces. Re-contamination potential is also reduced by this cleaning technique because it is a closed system.

For establishments that use their plant CIP system for both the raw and pasteurized product sides, the CIP system should be assessed under this task, not 1.10.05.03. Ideally, the plant should have independent CIP systems for raw and pasteurized product lines and equipment. If only one system is used, the pasteurized product lines and equipment must be cleaned first, followed by the raw product lines and equipment. When one CIP system is being used for both raw and pasteurized product lines and equipment the establishment should validate their procedure and chemical usage with their cleaning supplier to ensure the adequacy of the CIP Records of the validation should be kept and available to the inspector upon request. Establishments should be encouraged to have two separate CIP systems, one for the raw product side and one for the pasteurized product side.

Cleaning conditions vary widely from one installation to another and therefore each system must be dealt with according to its specific requirements.

A CIP system can be an independent system or a partial system as in the case of the HTST circulated through the Constant Level Tank. In both cases, the effectiveness of CIP procedures is largely determined by:

  1. time
  2. temperature
  3. concentration
  4. velocity

In smaller establishments or in some instances, special demands have resulted in the establishment using equipment separate from the main CIP system to circulate cleaning and sanitizing solutions. These systems are often used to clean fluid fillers or product vessels and as such are normally smaller and may be mounted on wheels to facilitate relocation close to the equipment being washed after production. For example, the system may be as simple as a pump rolled up to a tank for the circulation of cleaning and sanitizing solutions. Baskets may be hung in the solution tank to wash filler parts at the same time as the circulation of cleaning and sanitizing solutions. In all cases the system must facilitate the monitoring of temperature, time and chemical concentrations to ensure these parameters are maintained until the end of the wash. If the system does not incorporate a recording chart, additional records must be kept to document that the temperature, time and chemical concentrations meet the minimum requirements. Although the velocity of the circulated solutions are not normally monitored per wash on these smaller systems, inadequate flows can have a detrimental effect on the quality of the wash and can be measured or calculated to meet the recommendations of the manufacturer of the cleaning compounds.

In order for the CIP technique to be effective, the materials used on devices must be resistant to corrosion and the surfaces in contact with the product must be smooth, free of cracks and capable of withstanding the effects of cleaning solutions. Each element in the manufacturing line or CIP circuit must be free of dead zones and easy to inspect. All return lines to CIP tanks must break to the atmosphere in order to prevent back siphonage. Swing elbows would be acceptable. The following are frequently encountered deficiencies in CIP cleaning systems:

  1. Conventional fittings used rather than CIP fittings or welded joints.
  2. Failure to provide slope or drainage.
  3. Inadequate pipeline supports.
  4. Supports should not allow electrolytic action between support and pipeline (supports to be made of stainless steel, or should have rubber or plastic contact points with the pipeline).
  5. No automatic temperature control for solutions.
  6. No recording thermometer.
  7. Poor condition gaskets and dirty exterior surfaces.
  8. Inadequate solution velocity.
  9. Recording charts show variations from the established cleaning regimen.
  10. Failure to monitor cleaning effectiveness.

To achieve satisfactory cleaning and to prevent pipeline corrosion, the recommendations of the cleaning compound manufacturer should be followed with respect to time, temperature and concentration of cleaning and sanitizing. These instructions should be posted or easily accessible for use.

1.10.05.03 Truck / Raw Product CIP System

For establishments that use their truck CIP system for raw product, the CIP system should be assessed under this task. If it is also to clean other pieces of equipment it should be rated under task 1.10.05.02 Plant CIP system.

CIP cleaning utilizes a combination of physical and chemical means to remove soil from product contact surfaces. Re-contamination potential is also reduced by this cleaning technique because it is a closed system.

In order for the CIP technique to be effective, the materials used on devices must be resistant to corrosion and the surfaces in contact with the product must be smooth, free of cracks and capable of withstanding the effects of cleaning solutions. Each element in the manufacturing line or CIP circuit must be free of dead zones and easy to inspect.

The effectiveness of CIP procedures is largely determined by:

  1. time
  2. temperature
  3. concentration
  4. velocity

The following are frequently encountered deficiencies in CIP cleaning systems:

  1. Conventional fittings used rather than CIP fittings or welded joints.
  2. Failure to provide slope or drainage.
  3. Inadequate pipeline supports.
  4. Supports should not allow electrolytic action between support and pipeline (supports to be made of stainless steel, or should have rubber or plastic contact points with the pipeline).
  5. No automatic temperature control for solutions.
  6. No recording thermometer.
  7. Poor condition gaskets and dirty exterior surfaces.
  8. Inadequate solution velocity.
  9. Recording charts show variations from the established cleaning regimen.
  10. Failure to monitor cleaning effectiveness.

To achieve satisfactory cleaning and to prevent pipeline corrosion, the recommendations of the cleaning compound manufacturer should be followed with respect to time, temperature and concentration of cleaning and sanitizing. These instructions should be posted or easily accessible for use.

1.10.05.04 Pest Control

Every dairy establishment and importer must have an effective pest control program in place to prevent contamination of food. This task assesses the control of the entry of pests, elimination of harbourages and extermination of pests.

This documented program as well as its effective implementation, will help control operational conditions within an establishment allowing for environmental conditions that are favourable to the production of safe food. It serves as a prerequisite program or universal-type CCP for a HACPP based program.

Three different activities are involved in a pest control program. They are:

  1. Prevention of entry of pests into the establishment,
  2. Elimination of potential sites for harbourage of pests, and
  3. Extermination of pests that do enter premises.

Activities (a) and (b) are evaluated with respect to individual inspected tasks, e.g. grates on sewer drains that prevent rodents from gaining entry to the plant are evaluated with task 1.10.01.05 Waste Disposal. Accumulation of dust and debris that provides a harbourage for pests is also evaluated under specific tasks, e.g. task 1.10.01.04 Building Interior, would evaluate dust accumulations on high exposed beams in the ceiling that provide insect harbourage spots.

The plant should consider the following items when developing their effective written pest control program for the premises and equipment:

  • The name of the person at the establishment responsible for pest control (who is doing it).
  • Where applicable, the name of the pest control company or the name of the person contracted for the pest control program.
  • The list of chemicals used, the concentration, the location where applied, method and frequency of application (when and what is being done and how often it is done).
  • A map of trap locations.
  • The type and frequency of inspection to verify the effectiveness of the program (on-site and record review). The person responsible for verifying the program must be different from the person performing the task.
  • parameters of acceptability/unacceptability (tolerances)
  • records and results of monitoring and action taken for deviant situations.
  • the monitoring and verification procedures define the preventative measures taken to prevent the re-occurrence of deviations.

This program must also be updated as required when changes occur.

Proper understanding of the techniques used to exterminate pests is required so that only acceptable chemicals and devices are used in the proper areas, and that application methods do not contaminate products, equipment or packaging material. The plant may have an in-house pest control program or contract out this activity to professionals. Pesticides used are registered under the Pest Control Products Act and Regulations (PMRA) and are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non Food Chemical Agents published by CFIA. Pesticides are used in accordance with the label instructions and are regularly inspected and maintained by the contractor, the plant or both. Properly located and well maintained electric insect killers are acceptable. Knock down type sprays or prolonged insect strips must not be used in product handling areas. Bait stations with exposed poison are also not acceptable. Air curtains with properly maintained air pressure may be used as a method to prevent pest entry. Treatment of equipment, premises or ingredients to control pests must be used in accordance with label instructions. Birds and animals are excluded from establishments.

The effectiveness of the program is evaluated by observing if live pests are present, monitoring the records and making observations with regards to the population of exterminated pests.

Sanitation Program Summary Table
Table description

This table shows the tasks, ratings and inspection criteria for Sanitation Program general, plant CIP system, truck/raw product CIP system, truck/raw product CIP System, pest control.

Task Inspection Criteria
1.10.05.01 General (HS=3) (A) Documented Program
  • Covers all areas and equipment
    • structure
    • equipment
    • utensils
    • any others impacting on food safety
  • Designates responsible personnel
    • qualified
  • Specifies cleaning procedure
    • chemicals used and concentration; acceptable types
    • temperature requirements
    • procedures used; steps and methods (COP, CIP)
    • equipment used
  • Specifies frequency of cleaning and sanitizing
  • Cleaning policy
    • minimizes cross contamination risk
  • Verifies cleaning effectiveness
  • Specifies parameters of acceptability/tolerances
  • Specifies preventative measures to prevent re-occurrence of deviations
  • Updated as required
    • new/modified equipment or processing techniques
    • ineffective cleaning
    • adherence and effectiveness to sanitation program is monitored/verified (e.g. swabs, sensory inspection, direct observation)

(B) Operation

  • Instructions available and used
  • Cleaning/sanitizing equipment properly maintained
  • No processing until sanitation requirements met

(C) Records

A representative sampling of the plant's historical records must be assessed.

  1. Records must be:
    • Accessible and complete
    • Clear, legible and permanent
  2. Information must indicate:
    • Date and person responsible
    • All equipment, structure and utensils' cleaning records (temperature, time, concentration, etc.)
    • Frequency and results of monitoring and verification
    • Microbiological tests where appropriate
    • Satisfactory follow-up when deviations found and documentation of actions taken

Note: This task evaluates the presence and usage of a Sanitation Program. Individual task evaluations for cleanliness will determine if the program is used and effective.

1.10.05.02 Plant CIP System (more to follow) (HS=2) (A) Circuit Diagram (for CIP)
  • Available; complete and up-to-date (includes all pipelines)
  • No cross connections
    • prevent mixing of CIP solutions with products and potable water for final rinse

(B) Components

  1. Pumps
    • Solution and return pumps
      • centrifugal type
    • Chemical feed pump
      • positive displacement type
  2. Tanks (solution and rinse
    • Stainless steel or corrosion resistant
    • Kept covered
    • Stainless steel or corrosion resistant baskets for parts washed in tank at same time (if applicable, for mobile CIP systems)
  3. Pipelines and valves
    • Rigid
    • Sloped to enable draining
    • Pipelines equipped with line screens or filters
    • Food grade hoses designed for CIP use or regularly disassembled for inspection/cleaning (if applicable, for mobile CIP systems)
  4. Thermostat
    • Indicating thermometer (optional)
      • located on return solution tank
      • may be located in return line or in baskets when parts being washed (if applicable, for mobile CIP systems)
    • Recording thermometer and charts
      • located in return solution line
      • located in return line or in baskets when parts being washed (if applicable, for mobile CIP systems)
  5. Temperature controller
    • Located on return solution tanks
    • If not present for mobile systems, manual records kept for time, temperature and concentrations; recorded at start and end of CIP

(C) Operation

  1. Independent raw, pasteurized systems or one system with appropriate cleaning protocol (pasteurized first)
  2. Cleaning instructions posted or easily accessible and followed
    • Connecting/disconnecting information for equipment
  3. Charts/Records
    • For each cleaning cycle
    • Record of temperature and time
    • Dated; operator's signature
    • Record of solution concentrations
  4. Program to verify system effectiveness
    • Equipment inspected
    • Charts checked
      • temperature; time; solution concentration
    • Compare with product quality records
    • Verify CIP system in operation
      • review of records, proper operation of the CIP programming
1.10.05.03 Truck/Raw Product CIP System (HS=3) (A) Circuit Diagram
  • Available; complete and up-to-date
  • No cross connections
    • prevent mixing of CIP solutions with raw milk and potable water for final rinse

(B) Components

  1. Pumps
    • Solution and return pumps
      • centrifugal type
    • Chemical feed pump
      • positive displacement type
  2. Tanks (solution and rinse)
    • Stainless steel or corrosion resistant
    • Kept covered
  3. Pipelines and valves
    • Rigid
    • Sloped to enable draining
    • Pipelines equipped with line screens or filters
  4. Thermometers
    • Indicating thermometer (optional)
      • located on return solution tank
    • Recording thermometer and charts
      • located in return solution line
  5. Temperature controller
    • Located on return solution tanks

(C) Operation

  1. Cleaning instructions posted or easily accessible and followed
    • Connecting/disconnecting information for truck equipment hook-up
  2. Charts/Records
    • For each cleaning cycle
    • Record of temperature and time
    • Dated; operator's signature
    • Record of solution concentrations
  3. Program to verify system effectiveness
    • Equipment inspected
    • Charts checked
      • temperature; time; solution concentration
    • Verify CIP system in operation
      • review of records, proper operation of the CIP programming
1.10.05.04 Pest Control (HS=3) (A) Documented Program
  1. Complete
    • Prevent entry
      • appropriate use of air curtains and insect electrocutors
      • area under loading sealed
    • Eliminate harbourages
    • Exterminate pests
  2. Designated responsibility
    • Plant contact person and extermination company (if applicable) names
      • familiar with insecticide applications and rodent control methods
    • Inspect and service traps and bait stations at specified frequency
    • Maintain appropriate records
  3. Specifies procedures
    • Chemicals and concentrations; acceptable types
    • Procedures used; steps and methods
      • location of where applied
      • frequency of application
    • Map of trap locations
  4. Monitored to evaluate effectiveness
    • Type and frequency of inspection
    • Specifies parameters of acceptability/tolerances
    • Specifies preventative measures to prevent re-occurrence of deviations
    • Updated as required

(B) Operation

  • No pests
  • Equipment /traps
    • acceptable type; well maintained; well located
  • Chemical use avoids contamination
    • not to exceed limits prescribed on the label

(C) Records

A representative sampling of the plant's historical records must be assessed.

  1. Records must be:
    • Accessible and complete
    • Clear, legible and permanent
  2. Information must indicate:
    • Date of service; date of fumigation
    • Number, type and location of stations
    • Type of chemical used and method
    • Person responsible
    • Survey of pest population observed and exterminated
    • Frequency and results of monitoring and verification
    • Satisfactory follow-up when deviations found and documentation of actions taken
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