Good manufacturing practices: Dairy processors

On this page

• Introduction
• Record keeping
• Premises
  • Facility blueprints and process flow diagrams
  • Facility exterior
  • Facility interior
  • Waste disposal
  • Sanitary facilities
  • Essential signs
  • Non processing areas
  • Water and steam safety and supply
  • Heating, ventilation and air conditioning (HVAC) system unit
  • Glass breakage policy
• Transportation and storage (including receiving)
  • Transportation
  • Incoming material (ingredients and packaging)
  • Raw product acceptability
  • Raw product and mix storage, aging, cooling, returns and rework
  • Finished product storage
  • Temperature and humidity control
  • Non-food chemicals
• Equipment
  • Air quality
  • Compressed air equipment
  • Metal detector
  • Critical process test procedures
• Personnel
  • Flow and practices
  • Hygiene and health
  • Handling of materials
• Sanitation
  • Clean-in-place (CIP) systems
  • Pest control
• Recall
• Process control
  • Manufacturing and allergen controls
  • Microbiological controls
  • Composition control
  • In-house laboratory facilities and practices

Introduction

The following good manufacturing practices (GMPs) are intended to help dairy processors control the operational conditions within their facility, allowing for environmental conditions that are favourable to the production of safe and suitable dairy products.

Record keeping

In a Preventive control plan (PCP), it is important to maintain and keep records of activities which demonstrate that the PCP is implemented and working effectively. Records can be in either a hard copy or electronic format. Refer to Record keeping for your preventive control plan for additional information.

Premises

The premises include all elements in the building and building surroundings: building design and construction, product flow, sanitary facilities, water quality, drainage, the outside property, roadways and waste disposal.

• Ensure the building and surroundings are designed, constructed and maintained in a manner to prevent conditions which may result in contamination of food

Facility blueprints and process flow diagrams

Blueprints and/or process flow diagrams provide a documentation of the structures in a facility as well as product flow.

• Keep on file up-to-date blue prints of the facility

Blueprints

Blueprint examples:

• have a floor plan of each level of the facility showing the dimensions and function of each room or area
• locate walls, partitions, windows and doors, stairs and drains
• list the materials used in the construction of all the equipment, floors, walls, ceilings and openings
• locate lighting, refrigeration, ventilation and plumbing systems
• show product flow patterns throughout the facility

Information to include in a blueprint:

• identify equipment types and location
• identify product piping (raw and finished), clean-in-place (CIP) systems, water and other lines that may affect the safety of the product, an up-to-date schematic of floor drains and traps
• outline product flow (for example, raw materials, packaging, finished product, raw cheese production versus pasteurized cheese production)

Process flow diagrams

• Use the flow diagram to verify that there are no cross-connections or contamination risks
• Assess major modifications to ensure the modification does not present a risk of contamination to the food, such as:
  • building additions
  • changes to the product flow and/or employee traffic flow
  • changes to the air flow
  • changes to the critical process equipment
  • changes to the activities and/or products being produced in the facility

Process flow separation

Adequate segregation of incompatible products and activities is necessary otherwise cross contamination may result. Examples of incompatible products and activities include raw materials and pasteurized or sterilized food products, cleaning products and food products, and waste materials or utility materials and food products.

• Use separate rooms for incompatible products
• If both pasteurized products and unpasteurized products are produced at the same facility (such as heat treated or raw milk cheeses), process pasteurized products first followed by the raw product or process them on different days
• Avoid contact between raw product and any product undergoing or having completed maturation or ripening
• Completely separate living quarters or areas where animals are kept from food handling, processing and packaging areas
  • no common hallway or entrance way
• Do not install equipment and/or pipelines in a manner that will jeopardize the integrity of the processing or CIP systems which could result in cross-connections or processing problems
  • thoroughly review all proposed installations, including minor changes such as pumps or pipelines
  • refer to the model system: Preventing cross-contamination and Appendix G: Preventing cross connections for more information

Facility exterior

The exterior of the facility is designed, constructed and maintained to prevent entry of contaminants and pests.

• Ensure the facility is not located in close proximity to any environmental contaminants and industrial activities that are likely to contaminate the dairy products within facility
• Maintain roadways to minimize environmental hazards, for example:
  • surface access roads with dust free material
• Ensure the surrounding property is adequately drained and there is no uncontrolled vegetation and stored items in close proximity to the facility
  • drain spouts at ground level are directed away from the facility
• Ensure the roof surfaces are:
  • sloped, with no accumulation of water
  • free of leaks, cracks or openings
  • clean (free of trash and vegetation)
• For powder facilities, if the air intake supply originates on the roof and the dryer exhaust stack exits on the roof, ensure the roof is cleanable to minimize powder build-up
• Verify that the exterior walls are sound and do not have openings or cracks
• Ensure eaves troughs and trim do not permit pest or bird harbourages

Facility interior

This section covers all floors, walls, ceilings, stairs and elevators, utility lines and electrical boxes in the facility. It also covers all windows, doors and openings (plastic curtains, hose ports, can inlet and outlet), loading facilities, lighting and ventilation.

• Design the interior of the facility to minimize contamination of food, to facilitate sanitary operation and to provide for easy and effective cleaning
• Ensure that the facility is adequate for the production volume

The interior structures are unlikely to have direct contact with the food produced in the facility. However, accumulations of dust and dirt and condensation may become sources of contamination.

Floors, walls, ceilings, stairs and elevators

• Construct floors, walls and ceilings using materials that are suitable for the production conditions and that will not result in the contamination of the environment or food
  • use hard finishes that are suitable for cleaning, smooth and impervious to moisture (except dry storage areas)
  • avoid ceilings with exposed steel joints and H-beams in areas where the product is exposed to the atmosphere
    • where such ceilings are unavoidable, regularly clean and inspect them to ensure they remain in a clean condition
• Ensure corners are well joined or coved and that surfaces are free from pitting, indentations, cracks, crevices and ledges
• Slope floors in processing and receiving areas by at least 2% and provide drainage using trapped outlets

Utility lines (such as lines for water, steam, electricity, coolants, air and vacuum)

• Identify utility lines, such as through labelling or colour coding them
• Keep utility lines clean and ensure they are free of flaking material
• Suspend utility lines away from work areas and insulate them where necessary to prevent condensation

Doors and windows

• Where there is a likelihood of breakage of glass windows that could result in the contamination of food, construct windows of alternative materials or protect them
• Keep doors closed and windows well sealed or screened to minimize contamination risks

Loading areas

• Protect products in the loading area from exposure to extreme temperatures that could have an adverse effect on product safety
  • use air curtains, strips of plastic or similar set-ups to protect products

Lighting

• Ensure lighting in the facility is bright enough for safe food handling and thorough cleaning. For more guidance, refer to Lighting in an establishment.
  • provide supplementary lighting (for example, flashlights) for the inspection of the interiors of bulk tankers or storage tanks
  • protect bulbs and fixtures to prevent contamination should breakage occur in areas where dairy products and incoming materials are located
  • keep bulbs and fixtures clean

Ventilation

It may be necessary to install heating, ventilation and air conditioning (HVAC) systems or exhaust fans if air quality is inferior or to provide specialized treatment of air. Inadequate ventilation may lead to the presence of odours, condensation or mould growth.

• Design and construct ventilation systems so that air does not flow from contaminated areas to clean areas
• Provide adequate ventilation to prevent the accumulation of steam, condensation or dust and to remove contaminated air
  • monitor and clean filters regularly
  • avoid direct air movement onto product, product contact surfaces or filling and packaging areas
  • airborne pathogens can contaminate the product
  • in rooms such as those used for starter manufacture, it may be necessary to maintain the room under positive pressure to eliminate the possibility of airborne contamination

Drains

• Use trapped floor drains help to prevent possible off odours and contamination of air in the facility
• Install drains that are of adequate size, number and location to prevent the pooling of milk, water or other processing wastes
• Trap each drain individually
  • do not use central trapping systems without individual traps because contamination and odours could originate from sewer pipes located between untrapped drains
  • bell type traps which are well maintained and in good condition can be used
  • other suitable types of traps include U or P types
• Because of the potential to harbour microorganisms, locate floor drains so that they are readily accessible for cleaning, sanitizing, and inspection
  • do not locate floor drains under or near filling and packaging equipment
  • maintain floors and drains to ensure proper drainage
    • do not use brushes for cleaning floor drains for any other purpose
    • frequently clean floor drains and periodically flush them with a sanitizing solution
    • clean and sanitize floor drain covers and baskets after each production run
    • never use high pressure hoses to clean drains
• Design the sewage system so that it does not present a risk of contamination to the processing environment and the product. For example:
  • no cross-connection between the sewage system and any other waste effluent system in the facility
  • drainage and sewage systems are equipped with traps and vents to prevent backflow
• Ensure that effluent or sewage lines do not pass directly over or through production areas unless they are not a contamination risk (for example, properly protected)
• Have an action plan ready to mitigate the risk of contamination of the product if a problem with the drainage system occurs, including that production will not re-start until the drainage system is fixed

Waste disposal

Ensure dairy products are not exposed to contamination risks from waste disposal methods.

Sewage disposal

• Dispose of sewage in a sanitary manner so that it does not become a source of contamination to the facility environment. For example, there is no open sewage near the facility.

Garbage disposal

• Dispose of waste in a manner that prevents it from becoming an attraction to pests or contributing to airborne bacterial contamination
• Within the facility, provide a sufficient number of garbage containers so that they are accessible to all employees
• Use waste containers that are leak proof, and clearly identify them
• Empty, clean and sanitize waste containers regularly
  • where contamination is a greater risk, cover the waste containers
• If there is a garbage storage room in the facility, empty it daily
  • if odours are a problem, install a ventilation system
  • ensure the surface of the walls and floors are cleanable
  • to facilitate cleaning, locate the room near a spray hose and a drain
• Cover and keep closed waste disposal facilities that are located outside of the facility and maintain them in good condition
  • if compactors and bulk garbage units are used, locate them on a concrete, curbed and drained ramp to facilitate the clean-up
  • locate washing facilities nearby
• Do not incinerate combustible wastes in the vicinity of the facility in order to avoid airborne contamination by ash and odours
• Ensure the disposal of waste whey is by a method approved by the appropriate government authority and does not pollute the environment nor implicate the sanitary conditions within and outside the facility

Sanitary facilities

Careful and frequent hand washing in food handling situations reduces contamination. The location, number and the condition of hand cleaning and sanitizing stations are extremely important to the maintenance of good hygienic practices

Hand cleaning and sanitizing stations

• Ensure there is an adequate number of convenient and accessible hand cleaning and sanitizing stations close to product handling areas
  • Equip them with:
    • remote-control type (foot, knee activated or timed) stations in production areas
    • hot and cold potable water
    • germicidal soap
    • sanitary hand drying equipment or supplies
    • cleanable waste receptacles
• Keep hand cleaning and sanitizing stations clean and in good repair
• Trap waste pipes to drains in areas where the product is handled directly
  • do not use portable facilities and facilities with drainage piping unless they are connected to a drain

Employee facilities

• Equip washrooms with adequate hand washing facilities (see “Hand cleaning and sanitizing stations” above)
• Ensure employee facilities (washrooms, lunchrooms, change rooms):
  • provide floor drainage and good ventilation
  • are maintained in a manner to prevent contamination of food (ensure that pest harbourage, dirt and dust accumulations do not occur)
  • use self-closing double doors to separate employee facilities from processing areas

Essential signs

Signage helps reinforce essential management policies.

• Post authorized personnel signs at outside and inside entrances to the facility and all receiving, processing and storage areas
• Post hand washing signs in washrooms and in all product handling areas
• Post hazardous material signs in areas where materials such as cleaners and pesticides are kept

Non processing areas

Non processing areas include equipment cleaning and sanitizing facilities (for example, Clean-out-of-place (COP) areas) as well as boiler and compressor rooms, retail operations and mechanical shops. Because there is no exposed product in these areas it is not essential to meet the same sanitary conditions as the food processing areas of the facility.

• Locate non processing area where they will not pose a risk of contamination to food processing, handling and storing areas
• Maintain these areas to ensure a sanitary environment

Water/steam safety and supply

This section covers the quality of the water and steam emanating from the facility's lines and hoses for use in various processing applications.

Water safety

• Ensure that there is a safe, sanitary and adequate supply of water for use in the various processing applications at all times
• Use potable water for cooling in heat exchangers
• Only use non potable water in evaporators for condensing when there are no restrictions (such as pumps) on the condensation line
  • label or colour code non potable water lines

Refer to Water for use in the preparation of food, Ice used in the preparation of food and Culinary steam for more guidance on control measures that can prevent water, ice and culinary steam from being a source of contamination to dairy products.

There are areas and processes in dairy facilities that may pose a backflow risk, including:

• CIP and COP systems
• water used for flushing product or chemical
• raw receiving, rinsing tankers, silos
• reclaimed water (cow water) from evaporators or membrane filters
• boiler rooms and boiler water feed
• cooling towers, plate heat exchangers using potable water, chilled water tanks and glycol supply systems
• process water used for reconstitution or water for brining
• fire protection water systems
• other equipment using potable water such as fillers, homogenizers, separators

Design and install equipment and/or pipelines in a manner that will not jeopardize the safety of potable water.

Refer to Preventing water backflow for guidance on the use of appropriate backflow prevention devices.

Water treatment

If the source of the water poses a contamination risk it may be necessary to treat the water. The water treatment method used will depend on the reason for treating the water, for example, microbiological, protozoan, viruses, or chemical.

• Ensure water treatment chemicals are safe and suitable for use in dairy processing

Chlorine may be used as a disinfectant for well water supply. The dose is dependent on the water flow rate, pH, temperature and chemical composition. Automatic dosing can be done by the use of a metering device.

When automatic chlorinators are used:

• establish procedures to ensure water potability
• ensure the device is capable of adding chlorine in the correct concentration relative to the water flow rate, and that it is designed to readily indicate a malfunction
• monitor chlorine addition twice daily
  • conduct tests to determine the available chlorine level at a specific point, remotely located from the chlorine application site, but before distribution to the facility system, or
  • use an automatic analyzer equipped with a recorder and an alarm

Where water is in direct contact with finished product (for example, when washing cheese curds) or when water is added unintentionally when flushing product post-pasteurization:

• install an in-facility disinfection system for food application for those areas of the facility
• manage water disinfection systems like a critical control point
  • establish measurable tolerances for acceptability and unacceptability
  • monitor and verify procedures
  • establish an action plan in the event of a failure to the system

Water reuse

Reuse water is water that has been recirculated or reclaimed from a processing step, including from the food components, and that after subsequent reconditioning treatment(s), is reused in the same, prior, or subsequent food processing operations.

• Ensure that reuse water does not jeopardize the safety or suitability of the product
  • refer to Water for use in the preparation of food for additional guidance

Steam supply

• Use culinary type steam if steam comes in direct contact with the product and product contact surfaces
  • For example, use culinary steam:
    • to manufacture ricotta and cottage type cheeses
    • to preheat milk for the production of evaporated milk, sweetened condensed milk and non-fat dry milk
    • for steam injection into a "vacreator" to pasteurize milk and cream
    • to heat water used in the production of, for example, butter oil and mozzarella cheese
    • to cook processed cheese
    • for Aseptic Processing and Packaging System (APPS) processing

Refer to Culinary steam for additional guidance.

Water and steam hose equipment

Poorly maintained hoses may contribute to the contamination of the water supply.

• Periodically inspect the condition of hose equipment (nozzles, ends and exterior) to ensure it is maintained in a sanitary manner and in good repair
• Store hoses off the floor

Records

Records demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply.

• Keep records of:
  • municipal and/or in-house water potability testing
  • water treatment records
  • water reuse records (for re-circulated and reclaimed water)
• Follow-up on out of specification findings

Heating, ventilation and air conditioning (HVAC) system units

Since air from the HVAC system unit is supplied to various parts of the facility by ducts, it is important that this air supply not be a source of contamination. Pathogenic organisms can enter the product via a contaminated air source.

• Use HVAC systems that are cleanable and maintain them in clean condition
  • pay special attention to condensate drip pans and drain lines to help minimize potential growth of pathogens
  • locate air intakes away from incompatible activities, such as feed mills and livestock operations
  • use screens or self-closing louvres on fans

Glass breakage policy

• Avoid using glass in processing areas
  • where glass is used, use shatterproof type
• If there is glass in processing areas, have a documented glass breakage policy

Transportation and storage (including receiving)

Ingredients, packaging materials and other incoming materials are transported, received, inspected and stored in a manner which prevents conditions which may result in the contamination of food.

Transportation

External food carriers

• Use carriers that are designed, constructed, maintained, cleaned and used in a manner to prevent food contamination, and that:
  • permit the effective separation of different foods or foods from non-food items where necessary
  • provide effective protection from contamination, including dust and fumes.
  • drain adequately (for example, bulk tanks)
• Visually inspect carriers upon receipt and prior to loading to ensure they are free from contamination and are suitable for the transportation of food
• Have a program in place or assurances to demonstrate the adequacy of cleaning and sanitizing. For example:
  • keep records demonstrating that the carrier is properly cleaned and sanitized
• Do not use re-useable plastic totes to transport pasteurized product
• If the same carrier is used for a variety of different foods (for example, egg albumen) or for raw and pasteurized dairy products, ensure that there is no contamination risk to subsequent loads. For example:
  • ask the transport owner to provide a cleaning certificate and a record of the previous material transported prior to loading or unloading dual use tankers
  • verify the adequacy of cleaning, such as by tanker inspections, sensory evaluation of ingredients and/or analysis as appropriate
• Where pasteurized dairy products are transported in bulk multi-use containers, re-pasteurize the dairy products as there is no guarantee that equipment is adequately cleaned
• If the dairy product is not going to be re-pasteurized, use carriers, tanks, transport lines and transfer pumps that are dedicated to transporting pasteurized products
  • only consider this practice for certain products such as whey or condensed milk destined for drying, ice cream mix or cream cheese mix, but not for fluid milk and cream
  • keep records that demonstrate that the pasteurized product integrity is maintained

Temperature control

• Ensure ingredients and finished products requiring temperature controls are transported in a manner to prevent temperature abuse that could result in deterioration affecting product safety
• During transport:
  • keep ingredients and dairy products that require refrigeration at a temperature of 4°C or less
  • keep frozen ingredients at a temperature that does not permit thawing
• Monitor and record transportation temperatures to ensure proper temperatures for refrigerated and frozen ingredients
• Transport finished products under conditions to prevent microbiological, physical and chemical deterioration

Internal transportation equipment

Carts used for transportation of ingredients and finished products within the processing operation, as well as forklifts used in the warehouse, are subject to abuse. Careful maintenance is needed to upkeep these pieces of equipment.

• Maintain painted surfaces on forklifts and carts so that the exterior of these items are free of flaking material that could contaminate product
• Frequently wash transportation equipment
  • carts should have sanitary drain cocks to prevent accumulation of water in the carts.
• Clearly label carts used for waste and scrap to avoid contamination of ingredients or product
• Use electric forklifts in food processing areas
  • propane may contaminate some stored food

Incoming material (ingredients and packaging)

This section covers all incoming material (except raw milk or cream) and packaging. Milk and cream are covered under Raw product acceptability, and non-food materials are covered under Non-food chemicals.

• Control the receipt, storage and handling of incoming ingredients (such as freeze dried cultures, flavours, fruits and powders, protein concentrates) and packaging materials (including pre-formed containers such as ice cream barrels and milk jugs) to ensure they do not pose any biological, chemical or physical hazards to the dairy products

Procurement and receiving

• Ensure that food additives are permitted for use in the particular food and meet all the requirements of the Food and Drug Regulations (FDR)
• Ensure packaging materials are non-toxic and do not pose a threat to the safety and suitability of food under specified conditions of storage and use
• Procure materials according to buying specifications
  • for dairy powders, include in the specification the receipt of certification papers that the product is either pasteurized, is alkaline phosphatase negative or is labelled for further processing
• Accept only sound, suitable incoming materials
• Cover re-usable containers to be used for milk ingredients or other ingredients
• Monitor the acceptability of incoming materials
  • the degree of monitoring will depend on whether buying specifications are used and the supplier's record of performance
  • a control program is especially important in the case of glass containers which may contain fragments of glass or glass defects which are difficult to see

For additional guidance on specifications and supplier approval, refer to the Supplier food safety assurance program.

Storing

• Once the materials are received in the facility, label and store them in a manner that protects their integrity and minimizes the risk of contamination
  • store incoming materials according to the supplier's instructions
• Store ingredients that require refrigeration at 4°C or less
• Store frozen ingredients at a temperature that does not permit thawing
• Monitor storage room temperatures
• Store humidity sensitive materials under appropriate conditions
• Store ingredients and packaging materials off the floor
• Rotate inventory to prevent deterioration and spoilage

Raw product acceptability

This section covers the acceptance, receiving, sampling and monitoring of raw milk, cream and other dairy products treated as raw ingredients and applies to these products from all species (for example, sheep, goat). Other incoming food ingredients are addressed in Incoming material.

The receiving of raw milk and cream needs to be well controlled to minimize growth of microorganisms and toxins that could affect food safety.

Acceptance

• Establish acceptance criteria for incoming raw milk/cream
  • check each load to ensure it meets the criteria before unloading it into storage tanks. For example:
    • check that receiving temperature is 6°C or less
    • test for antibiotic residues
    • grade for appearance and odour
• Keep records of the checks performed and segregate any loads that do not meet the acceptance criteria
• If raw milk or cream receiving temperature is greater than 6°C, have a deviation procedure in place. For example:
  • cool the product to 6°C or less
  • pasteurize or process the raw milk product within a specified time frame (for example, within 2 hours of receipt)
  • conduct microbiological/toxin testing (for example, for S. aureus)
  • reject the shipment

Receiving

• Use a filter on receiving equipment to exclude any hazardous extraneous materials (greater than 2 mm)
• If water is used to reclaim any milk adhering to food contact surfaces after milk delivery trucks, milk silos and pipelines are emptied, ensure that product integrity is maintained. For example:
  • consider the sanitary quality of hoses, proper sanitation procedures, the potential for chemical contamination from the CIP system, water potability, storage and end use of the product
  • keep records of this practice to demonstrate that the safety and composition of the product is not affected
• Obtain a sample of raw milk or cream from each tanker in case of further testing
• Store these samples in clean and sanitary containers at the appropriate temperature prior to testing
  • most provincial governments have regulations stating the length of time and temperature that milk and cream samples must be held prior to testing and under what conditions they must be held

Raw product monitoring

• Check at an appropriate frequency that incoming raw milk/cream meets the quality standards of the relevant provincial or federal authority, such as for antibiotics, microbiological content, sediment and titratable acidity
  • exclude (or segregate) milk which is suspected to be contaminated until subsequent tests show correction of the problem

Raw product and mix storage, aging, cooling, returns and rework

The storage time and temperature of raw milk and cream need to be well controlled to minimize growth of microorganisms. Microbial growth could produce heat stable toxins and potentially pose a hazard that would not be controlled by the pasteurization step.

Storage of raw milk and cream

• Store raw milk and cream at a maximum temperature of 6°C, ideally 4°C or lower
  • establish a maximum limit for storage time to minimize excessive microbial growth during storage
  • monitor and record storage time and temperature
• If raw milk or cream is stored at a temperature greater than 6°C and/or for a prolonged length of time, have a deviation procedure in place to control the microbiological growth in the product. For example:
  • cool the product down to at least 6°C
  • pasteurize or process the raw milk product within a specified time frame
  • perform an odour evaluation
  • perform a microbiological or toxin test (for example, S. aureus)

Thermisation is a mild form of heat treatment which can be used to extend the keeping quality of raw milk before pasteurization. Milk subjected to thermisation is still considered to be raw.

• Ensure thermisation does not affect raw product integrity
  • keep records to demonstrate that raw product integrity is maintained

Storage of frozen dairy product mix

Pasteurized product intended for further processing could be re-contaminated due to improper handling or poor sanitation of storage tanks

• Rapidly cool these products after mixing (within one hour)
• Control the storage time and temperature (for example, at or below 4°C) to minimize growth of microorganisms

Product aging

Certain dairy products are kept at temperatures that exceed 4°C as part of their manufacturing process; for example, during tempering, drying, curing and aging.

• When product is tempered from a frozen state, have a protocol for how the product will be handled so as to minimize the growth of microorganisms, including routine documented temperature/time checks and microbiological testing
• When these manufacturing processes are completed, keep the dairy products at 4°C or less

Product cooling

• Cool all pasteurized milk and milk products to 4°C or less immediately prior to filling or packaging
  • this is not necessary if the products are to be cultured or if drying commences immediately after condensing

Handling of returns

Dairy products that are returned to the facility may be a source of contamination to the facility environment, equipment and other dairy products. Contamination can be prevented by not accepting returns, or by proper control of such products as they arrive at the facility from external sources such as retail outlets.

• Where returned products are accepted, have a return policy that defines what products are accepted and how they are to be handled. For example:
  • segregate products that have left the control of the dairy processor (for example, collect fluid milk returns in a separate, well identified tank; identify and store other by-products separately while they await disposal and/or re-work)

Reruns or rework

• Ensure that reruns or rework do not contain ingredients that may be allergenic to sensitive individuals unless they are clearly identified on the label of the finished product
• Store reruns (for example, ice cream, chocolate milk) in covered and clearly labelled containers

Finished product storage

Finished product needs to be stored and handled under conditions to prevent deterioration (for example, spoilage) and damage (for example, control of stacking heights and forklift damage).

• Protect products that are stored at ambient temperatures against external agents and contamination, such as direct sun, excessive heating, moisture, external contaminants, and rapid temperature changes which could adversely affect the integrity of the product container or the safety or suitability of the product
• Store finished products that require refrigeration at 4°C or less
• Store frozen products at a temperature that does not permit thawing
• Monitor storage room temperatures
• Store humidity sensitive materials under appropriate conditions
• Rotate stock to prevent deterioration that could present a health hazard

If there is no capacity on site to cool the finished product to 4°C or less, the product may be transported to a public refrigerated warehouse in order to get the temperature down to an acceptable level (provided this practice does not contravene provincial regulatory requirements).

• When cooling is done off-site, have written procedures and records to demonstrate full control over the product
  • keep records of temperature/time during transportation on refrigerated trucks, temperature/time records at the public warehouse, and final control of product release to distribution
• Identify containers and store them in a manner to prevent them from falling over
• Store items a suitable distance from the walls and off the floor, such as on pallets or shelves, to permit effective cleaning and pest control
• Ensure that equipment and other food products which are stored in a finished product storage room do not pose a contamination risk to the dairy products or ingredients
  • for example, eggs may be a source of microbial hazards and fish products may transmit odours

Wood shelves, 640s and pallets

• Regularly inspect, clean, maintain and replace wooden pallets and 640's (cheese boxes) so that they do not become a source of contamination
  • keep records of these activities
• Clean and maintain wood shelves used for the curing of bacterial surface ripened cheeses
• In processing and packaging rooms, use non-wooden type pallets
  • wooden pallets pose a risk of wood fragments and insects, rodents and other contaminants that may be carried into the facility on the pallet

Refer to Appendix H: Use of wood in dairy facilities for additional guidance on the use of wood 640's and wood shelving for curing bacterial surface ripened cheese.

Temperature and humidity control

Proper control of temperature and humidity is essential in various areas of the facility. In refrigerated storage areas it is necessary to maintain humidity conditions that prevent the formation of condensation and subsequent mould growth. Control of the conditions in the salting and curing stages of the manufacturing process will ensure even distribution of salt and optimal microbial and enzymatic activity in the ripening process.

• Use thermometers, hygrometers and other automatic devices that do not pose a contamination risk, such as non-breakable thermometers
  • have replacement measuring devices available
• Monitor and record temperature and humidity conditions to ensure that the product is being appropriately held
  • these could be manual records or automated charts
• Keep refrigeration units free of excessive frost build up and maintain them in a clean and sanitary condition
• Connect the refrigeration unit to a drain system so that condensate is removed

Non-food chemicals

• Keep a list of all non-food chemicals used in the facility
• Ensure they are safe and suitable for use in dairy facilities
  • Refer to the Guidance for food establishments concerning construction materials and packaging materials and non-food chemicals
• Receive, store and handle non-food chemicals in a manner that prevents contamination of food, food contact surfaces or packaging materials. For example:
  • store them separately from any food ingredients or products, such as in a special room or caged in area that is dry and well ventilated
  • label or colour code the containers for ease of identification
  • keep containers closed between uses
• Allow only trained personnel to dispense and handle non-food chemicals
• Use non-food chemicals in accordance with the manufacturer's instructions

Equipment

This section covers equipment and components which may affect the safety of the product.

Design and installation

• Design and install equipment to:
  • be accessible for cleaning, sanitizing, maintenance and inspection
  • prevent contamination of product during operations
  • prevent excessive condensation (where necessary)
  • permit proper drainage and to connect directly to drains where needed
  • have food contact surfaces that are smooth, non-corrosive, non-toxic, free from pitting, cracks or crevices, and able to withstand repeated sanitation
  • have or use coatings, paints, chemicals and lubricants that will not affect the safety of the product
• Keep a detailed plan showing the types and locations of equipment used in the facility

Preventative maintenance

• Have a preventative maintenance program for the routine maintenance and calibration of equipment and any components. For example:
  • calibrate indicating thermometers, replace gaskets and filters, conduct routine testing of all critical processes (for example, high temperature short time (HTST), batch pasteurizer, APPS)
• Maintain the equipment to ensure that no physical or chemical hazard potentials result (for example, inappropriate repairs, flaking paint and rust, excessive lubrication)
  • keep records of maintenance activities
• Ensure that maintenance activities do not contaminate food
• When changes occur, review the preventative maintenance program and update it as required

Seals

• Monitor and control the use and replacement of seals on critical equipment
  • apply a unique code to each seal so that it is possible to identify which seal has been removed or replaced
  • keep records that identify and list the seals used and their location, when the seals are broken, the reason why the seal was broken, that the equipment is re-sealed and the person responsible

Air quality

This section covers the air and inert gases that are added directly into the product or on the packaging. It covers both ambient air and compressed air sources.

Air, when used for agitation, air blows, drying processes and incorporation into product (overrun), may be a vehicle that allows pathogenic organisms to enter the product. Poor quality air can also lead to product contaminated with particulate matter, condensate or oil.

• Use processing systems which incorporate air directly into the product that are designed to reduce potential contamination and that are easily cleanable
• Filter all air used for processing
• Provide sanitary check valves as necessary to prevent product backup into air lines
• Routinely check air blow and agitation equipment for proper assembly and cleanliness
  • dismantle and manually clean sanitary check-valves, air blows and agitation equipment, and sanitize routinely
• Use compressing equipment that is capable of producing oil-free air. For example:
  • carbon ring piston compressor
  • cool the compressed air to remove any oil vapour
  • water-lubricated or non-lubricated blowers
• Ensure oils and lubricants are safe and suitable for use in dairy processing
• Locate air intakes so that air is taken from a clean space or from clean outer air

Filters

• Pass air through an air filter upstream from the compressing equipment
  • locate this filter and construct it so that it is easily accessible for examination
  • protect the filter from weather, drainage, water, product spillage and physical damage
  • use a filter size that is effective for the purpose it is designed (see Appendix A: Compressed air - milk and milk product contact surfaces for various types of compressed air systems)
• Use appropriate filters in a process air system to remove undesirable particulate matter. If this air is withdrawn from a room, filter the air supply to the room.
• Clean air filters to ensure good air quality. For example:
  • clean coarse metal mesh filters by boiling them in an alcohol solution followed by a dip in a special adhering oil
  • when fiberglass filters are used in tandem, discard the first filter when it becomes dirty, move the second filter to the first position, and add a new filter in second position
    • if a dirty second filter is observed then the filters are not being cycled frequently enough
  • do not use common furnace type filters (usually one inch thick) as they are inefficient and not suitable for this purpose

Compressed air equipment

This section covers compressed air equipment that is used to operate valves and other equipment pneumatically. This air is not intended to be in direct contact with the product. If the air is in direct contact with the product or packaging, refer to Air quality.

• Use filters, traps and condensers to remove solids and liquids from the compressed air
  • locate the filter and trap in the air pipeline downstream from the compressing equipment and air tank, if one is used. Note: this is not necessary when the compressing equipment is of the fan or blower type (See Appendix A: Compressed air - milk and milk product contact surfaces)
  • use a filter size that is effective for the purpose it was designed

Metal detector

Metal detectors need to be suitable for the specific product, associated hazard and the environmental conditions that the unit will operate in to ensure the effective removal of metals.

• Install, maintain and use metal detectors in accordance with the equipment manufacturer's manual
  • adjust for product type, selection of target metal and size, and timing of the reject mechanism
• Test metal detectors regularly
• Keep records that demonstrate the equipment is capable of identifying the test material

Critical process test procedures

• Test the critical processes (for example, HTST, batch pasteurizer, APPS, higher heat shorter time (HHST), extended shelf life (ESL)) according to the frequencies and methods in the Critical process test procedures and Appendix D: Criteria for the evaluation of computerized food safety controls.
  • have testing conducted by trained facility personnel or a reliable third party
  • record the results of this testing and any corrective actions taken
    • use the forms provided in Appendix D: Criteria for the evaluation of computerized food safety controls

Personnel

The objective of training production employees is to ensure safe food handling practices.

• Provide training in personal hygiene and the hygienic handling of food to all food handlers at the beginning of their employment. Reinforce and update this training at appropriate intervals.
• Ensure the training is adequate and suitable to the complexity of the manufacturing process and the tasks assigned. For example:
  • train employees to understand the importance of the critical control points for which they are responsible, the critical limits, the procedures for monitoring, the action to be taken if the limits are not met, and the records to be kept
  • train employees responsible for maintenance of equipment impacting on food safety to identify deficiencies that could affect product safety and to take the appropriate corrective action
  • ensure employees and supervisors responsible for the sanitation program understand the principles and methods required for effective cleaning and sanitizing
  • train employees handling hazardous chemicals on safe handling techniques
• Provide additional training as necessary to ensure current knowledge of equipment and process technology (for example, specific technical training, apprenticeship programs)
• Keep records of training activities and monitor personnel to ensure adequate training is maintained

Flow and practices

This section covers the movement or flow of both people and equipment throughout the facility as well as the processing practices used.

People

• To reduce the risk of contamination in processing and packaging areas, restrict or control the movement of employees between areas
  • this includes lab employees, delivery and maintenance employees as well as employees performing various processing activities. For example:
    • employees in raw receiving areas do not move into any other areas of the facility unless strict procedures are followed (for example, foot baths or sprays, hand dips)
    • employees responsible for the receiving of raw milk do not move throughout the facility as their clothing and shoes may be a source of contamination in clean areas
    • the flow of employees and equipment between wet areas of the facility is controlled to minimize the risk of spreading contamination
• Control the access of all visitors to the facility, such as farmers, salespersons and field personnel
• Monitor the flow of people in the facility, for example, use colour-coded clothing

Equipment

To reduce the risk of contamination in processing and packaging areas, restrict or control the movement equipment between areas. With respect to equipment layout, a process flow that is straight and simple is recommended from a sanitation point of view.

• Restrict and control the movement of portable equipment (for example, pallets, carts) from one area to another
• Do not move equipment to or back from cleaner areas after being in less clean areas without appropriate controls

Hygiene and health

This section covers the employee's hygiene as well as their personal behaviour and habits in areas where food is processed.

Clean and appropriate clothing, good grooming and habits as well as employee health monitoring reduce the possibility of milk, milk products, containers and equipment from becoming contaminated.

Clothing

• Ensure clothing is clean. For example:
  • can be washed or disposed of
  • has no buttons or pockets above the waist
  • clean clothing on-site or by a third party
  • protect and store clean clothing separately from street clothes
• Ensure hair and beard coverings are worn properly and provide complete coverage
  • hair nets should be obvious and of the shower type
• Use sanitary, disposable gloves and dedicated footwear and clothing for certain areas, where necessary
  • latex is not recommended because of the potential allergy concern with the transfer of latex to food products
• Do not keep personal effects and street clothing in food handling areas
• Wear in-facility footwear and clothing only within the facility
  • wearing in-facility footwear and clothing outside the facility and then returning to the facility could result in a source of contamination to the product or processing area

Grooming and behaviours

• Secure and cover jewellery that is not removed (for example, medic alert bracelet)
• Prohibit poor hygiene and all unhygienic behaviours that could contaminate food
  • fingernails should be clean and without nail polish
• Instruct employees engaged in food handling activities to refrain from behaviour which could result in contamination of food, for example, smoking, spitting, chewing or eating, and sneezing or coughing over unprotected food
• Instruct employees to clean and sanitize their hands:
  • when starting and returning to work
  • after using toilet facilities
  • after hands become soiled or contaminated

Health

• Instruct employees to advise management when they are suffering from a disease or illness, symptoms of a disease or illness or an open wound
  • encourage employees to report to their supervisors whenever they have diarrhea, a sore throat, a fever, a cold, or an open skin lesions, or are jaundiced
• Assign employees with cuts or wounds to non-product work areas or protect their cut or wound with a secure, waterproof covering
• Prevent personnel known to be suffering from, or known to be carriers of a disease transmissible through food, from working in food handling areas

Handling of materials

This section covers how ingredients (for example, fruits, nuts, powders, starter cultures) and packaging materials (for example, glass containers, foil and plastic wrap, powder bags) are handled during processing. It also covers the manual formation of packaging containers such as ice cream cartons.

• Receive and use materials in the processing area in a manner that does not pose a contamination risk
  • clean or remove outer wrappings before moving them from storage
• Handle materials in a sanitary manner to protect them from contamination by dust, foreign materials, moisture and employees. For example:
  • protect materials from aerosols, moisture and contamination, such as by inverting formed containers and by using lids or protective coverings
  • prior to filling, clean containers using air, suction or water
  • reseal unused materials and return them to storage

Sanitation

This section covers the sanitation of all structures, equipment and utensils. For more guidance, refer to Cleaning and sanitation program.

Clean-in-place (CIP) systems

This cleaning technique is used for permanent installations which are difficult or impossible to clean by other techniques. It uses a combination of physical and chemical means to remove soil from food contact surfaces. Re-contamination potential is reduced by this technique because it is a closed system.

• Use 2 independent CIP systems, 1 for the raw product side and 1 for the pasteurized product side
• If this is not an option and only 1 CIP system is used, clean the pasteurized product lines and equipment first, followed by the raw product lines and equipment
  • ensure that the cleaning procedure is effective for the particular installation as cleaning conditions vary from 1 installation to another. For example:
    • validate the procedure through the manufacturer of the cleaning compounds
• Set up the CIP system so that it is capable of being monitored for the necessary cleaning parameters (for example, temperature, time, chemical concentration) to ensure these parameters are maintained until the end of the wash
  • if the system does not incorporate a recording chart, keep additional records to document that the cleaning parameters are achieved
• In order for the CIP technique to be effective, ensure that:
  • materials used on devices are resistant to corrosion
  • surfaces in contact with the product are smooth, free of cracks and capable of withstanding the effects of cleaning solutions
  • each element in the manufacturing line or CIP circuit is free of dead zones and is easy to inspect
  • all return lines to CIP tanks break to the atmosphere in order to prevent back siphonage
• Follow the recommendations of the cleaning compound manufacturer with respect to time, temperature and concentration to ensure effective cleaning and to prevent pipeline corrosion
  • post instructions or ensure they are easily accessible for use, including instructions for connecting and disconnecting equipment

The following are recommendations for various components of the CIP system:

1. Pumps
   • use centrifugal type solution and return pumps
   • use positive displacement type chemical feed pumps
2. Tanks (solution and rinse)
   • use tanks that are stainless steel or corrosion resistant
   • have stainless steel or corrosion resistant baskets for parts washed in tank at same time (if applicable, for mobile CIP systems)
   • keep covered
3. Pipelines and valves
   • ensure they are rigid
   • ensure they are sloped to enable draining
   • equip pipelines with line screens or filters
   • ensure food grade hoses are designed for CIP use or regularly disassemble for inspection and cleaning (if applicable, for mobile CIP systems)
4. Thermostat
   • indicating thermometer (optional)
     • locate on return solution tank
     • locate in return line or in baskets when parts being washed (if applicable, for mobile CIP systems)
5. Recording thermometer and charts
   • locate in return solution line
   • locate in return line or in baskets when parts being washed (if applicable, for mobile CIP systems)
6. Temperature controller
   • locate on return solution tanks
   • if not present for mobile systems, keep manual records for time, temperature and concentrations; record at start and end of CIP

Pest control

The presence of pests such as insects, rodents and birds in and around dairy establishments is unsanitary.

The key activities to control for pests are:

• prevent the entry of pests into the facility
• eliminate potential harbourage sites
• remove or exterminate pests that do enter the facility

For additional guidance on pest prevention and assessment, pest control measures and developing a pest control program, refer to Pest control.

Recall

A written recall procedure enables the effective recall of any lot of food from the market.

For additional guidance on how to develop an effective recall program, refer to Recall procedure: A guide for food businesses.

Process control

Implementing process controls throughout the manufacturing process help to ensure the production of safe food.

The following are recommended process controls for product formulae, food additives, nutritional requirements, label accuracy, product preparation, shelf life studies, product and environmental monitoring, and laboratory facilities and practices to ensure product is being manufactured as intended.

Manufacturing and allergen controls

This section covers controls for product formulae, food additives, nutritional requirements and label accuracy.

Product formulae

• Maintain a master formula for each product that identifies:
  • specific ingredients and additives (for example, concentration, type)
  • amounts of additives and ingredients
• Identify on the production worksheet all ingredients (including reruns and rework) for each batch
• Use methods such as calculations, ingredient inventory balance sheets and finished product testing to verify effective control of ingredients and additives

Food additives

Inadequate control of food additives could result in chemical or biological hazards.

• Ensure that all food additives are permitted for use in the particular food and meet the requirements of the FDR
  • certificates of analysis from the ingredient suppliers stating that all food additives used in an ingredient meet the requirements of the FDR can be used to demonstrate that the sub-ingredients within an ingredient are permitted
• Keep specifications for all food additives on file
• Verify using calculations that food additives are used within the levels specified in the FDR

Nutritional requirements

Formulation controls are necessary to prevent hazards which could result from excesses, inadequacies and omissions of nutrients, for example, infant formulae, fortified foods, foods for which there are nutritional claims (for example, calorie-reduced, low sodium).

• Control the addition of vitamins and minerals to ensure that all nutritional requirements and claims are met
• Use nutrients in accordance with the FDR
• Accurately reflect the nutrient content of the product on the label.
• Keep specifications for all nutrients on file
• Obtain a certificate of analysis from the supplier for each lot of nutrient
• For nutrients used in foods that are the sole source of nutrition, verify each certificate through analysis
• Verify using calculations that nutrients are used within the limits specified in the FDR

Label accuracy

Accurate labels inform and protect segments of the population which may be allergic to certain foods.

• Ensure that labels accurately represent product formulation and composition. For example:
  • review new labels and new label stocks for accuracy and errors
  • adjust labels when there are formulation changes/substitutions
  • prevent product mislabelling at the time of packaging by, for example, separating product types during changeovers, visually checking labels prior to use, and properly storing labels
  • label and segregate ingredients that are pre-weighed ahead of the product formulation process

Where the development of the label is completed at a corporate office, the processing facility should verify the accuracy of the label.

Product preparation

• Avoid contamination with ingredients which may cause adverse reactions:
  • do not substitute an ingredient during production
  • ensure internally processed ingredients (reruns and rework material) do not contain ingredients that may result in adverse reactions unless the finished product label clearly indicates the presence of these ingredients
  • when different flavours of dairy products are processed successively on common equipment (such as mix transport lines, freezing machines, molds, novelty lines and hoppers), ensure there is no carryover of flavours between products
  • prevent carryover between milk/non-milk products processed in the same facility (for example, no dead ends/pockets/cross connections allowing for the introduction of milk between dairy and non dairy production runs, CIP systems are adequate)
  • process pasteurized product first followed by raw product. Do a complete wash with sanitizing prior to processing pasteurized product.
  • label raw milk cheese with the manufacturing date to ensure the 60 day period of maturation [B.08.042 to B.08.048, FDR]
  • avoid mixing different ingredients during storage and handling

Tamper evident seals on packaging should be used to ensure the security and integrity of products once they are produced and until they are purchased by the consumer.

Microbiological controls

This section covers microbiological controls that are used to verify the production of safe food.

Product shelf life studies

Shelf life studies demonstrate that the safety and suitability of the milk product is retained throughout the shelf life of the product.

• Conduct shelf life studies for all products with a mandated best before date
• Conduct a new shelf life study if changes are made that could affect the already established shelf life, such as formulation changes, processing and equipment changes, significant alterations to the scheduled process and changes to the best before date
  • microbial growth is dependent upon many environmental conditions such as ingredients, nutrients, water activity, pH, presence of preservatives (for example, curing salts), competitive microorganisms, gas atmosphere, redox potential, storage temperature and time

Refer to Shelf life studies for additional guidance.

Product and environmental microbiological monitoring

The monitoring of finished products and environmental conditions demonstrates adherence to good manufacturing practices and compliance to regulatory standards.

• Refer to Sampling procedures for guidance on what, where, how, and how often to sample

The potential for the growth of L. monocytogenes (Lm) in dairy products depends on certain inherent characteristics. Health Canada's Policy on Listeria monocytogenes ready-to-eat foods provides guidance on a risk-based approach to controlling Lm in the processing environment and RTE foods.

• Refer to Control measures for Listeria monocytogenes in ready-to-eat foods for more information on Health Canada's Lm policy and how to apply it

Composition control

The Canadian standards of identity, Volume 1 contains the composition requirements for dairy products. Finished product testing demonstrates that dairy products meet the parameters set out in the applicable standard (for example, moisture level, protein content).

• Refer to Sampling procedures for guidance on what, where, how, and how often to sample

In-house laboratory facilities and practices

Where testing is conducted in house, lab facilities can pose a risk of contamination to food if they are not controlled.

• If micro and pathogen testing is being done in the lab, isolate the lab facilities away from processing areas, or use negative air pressure in the lab
• Control lab practices to ensure that no contamination risk exists to food products
• Take samples from the processing line in a manner that does contaminate the food
• Properly dispose of laboratory samples and materials. For example:
  • autoclave plates and materials used for the isolation and enumeration of pathogens
  • dispose of samples in a hygienic manner