Archived - Dairy Establishment Inspection Manual – Chapter 10 Prerequisite Programs

1.10.01 - Premises Program

Building and surroundings are designed, constructed and maintained in a manner to prevent conditions which may result in contamination of food.

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 Critical Control Point (CCP) for a Hazard Analysis Critical Control Point (HACCP) based program.

1.10.01.01 General

Dairy establishments and importers must have a documented program in place to monitor and control all elements in this section, and maintain the appropriate records.

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.

Adherence to the criteria is verified by examining the establishment's written program that outlines the procedures that will be undertaken to ensure satisfactory conditions are maintained. The program must specify:

• areas to be inspected (what is done),
• tasks to be performed (how it is done),
• person responsible (who does it),
• inspection frequencies (how often or when it is done),
• records to be kept,
• parameters of acceptability/unacceptability (tolerances),
• results of monitoring,
• verification procedures (both on-site and record review) and
• action to be 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.

The actual monitoring of the adequacy of this program will be done by inspecting and assessing tasks 1.10.01.02 to 1.10.01.11.

1.10.01.02 Plant Blueprints and Process Flow

Up-to-date blueprints are a requirement for the registration and licensing of a dairy establishment. The operator must notify the Canadian Food Inspection Agency (CFIA) and responsible provincial authority of any proposed major modification to the registered establishment and submit detailed plans and specifications of the modification. Major modifications that would require the submission of plans and specifications include changes to the boundaries of the registered premises, building additions, changes to the product flow and/or employee traffic flow in the establishment, changes to the air flow, changes to the critical process equipment, changes to the activities and/or products being produced in the establishment.

Blueprints and/or process flow diagrams provide a documentation of the structures in a plant as well as product flow. Refer to Chapter 3.0 Registration (Section 3.5) for list of blueprints required. Blueprints or plant schematics should cover:

1. Equipment types and location,
2. Product piping (raw and finished), Clean In Place (CIP), water and other lines that may affect the safety of the product, an up-to-date schematic of floor drains and traps. If the original schematics are not available, new schematics must be created; and
3. Product flow, i.e. raw materials, packaging, finished product, raw cheese production versus pasteurized cheese production, etc.

Cross connections and cross contamination have been factors in the outbreak of milkborne illnesses in the past. Adequate segregation of incompatible products and activities must be provided by physical means (e.g. separate areas/rooms) or other effective means where cross contamination may result. Examples of incompatible products and activities would include raw milk/pasteurized milk products, raw milk cheese production/pasteurized cheese production. If an establishment produces both pasteurized products and unpasteurized products such as heat treated or raw milk cheeses, pasteurized products must be processed first followed by the raw product or these could be processed on different days. It is also critical that the establishment is designed to avoid contamination between raw product and any product undergoing or having completed maturation or ripening.

All new registrations must have separate rooms for incompatible products. Existing registered establishments must make every effort to separate incompatible products. If a plant is undergoing renovations in the facility then segregation by physical means should also be considered at this time. The type of product being produced would also have to be considered, for example, open cheese vats versus fluid milk plants where product is contained mostly within pipelines. Measures to control cross-contamination risks may include personnel practices (changing clothes, use of foot baths), operational segregation and/or making construction modifications to the plant, with the corrective action dependent upon the type of products and processing equipment used in the plant.

Buildings and facilities must be designed to facilitate hygienic operations by means of a regulated flow in the process from the arrival of the raw material at the premises to the finished product. Living quarters/areas where animals are kept must be separated (complete segregation/separation with no common hallway or entrance way) and not open directly into food handling, processing and packaging areas.

Plant management must ensure that equipment and/or pipelines are not installed in a manner that will jeopardize the integrity of the processing or CIP systems, resulting in cross-connections or processing problems. Plant management must thoroughly review and approve all proposed installations. Minor changes such as pumps or pipelines must also be reviewed and approved. Colour coding of the pipelines on the schematic and use of the envelope method may help to identify cross-connections.

A cross-connection is a direct connection allowing one material to contaminate another. There needs to be a complete segregation of incompatible products such as raw materials and pasteurized or sterilized food products, cleaning products and food products and waste materials or utility materials and food products.

Segregation of incompatible products must be accomplished by the use of separate pipelines and vessels and establishing effective physical breaks at connection points by at least one of the following arrangements: physical disconnecting of pipelines, double block and bleed valve arrangements, double seat valves, aseptic barriers, or other equally effective systems. The installation of segregating valves does not constitute a physical break and is not acceptable, except that a properly designed block and bleed valve arrangement or properly designed aseptic barrier may be used to separate cleaning solutions from food products during CIP or mini-washes.

Plant management and the inspector must follow-up on areas where there appears to be a potential cross-connection. Even if the plant does not have a schematic piping diagram for the plant, an assessment for cross-connections must be made.

Schematics for processing systems will be evaluated under the appropriate task, e.g. for High Temperature Short Time (HTST), 1.11.01, Aseptic Packaging and Processing System (APPS), 1.14.01 and Higher Heat Shorter Time/ Extended Shelf Life (HHST/ESL), 1.17.01.

1.10.01.03 Building Exterior

The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. Prevention of pest entry and harbourages is an important factor for the exterior structure. The building must not be built in close proximity to any environmental contaminants and industrial activities that are likely to contaminate dairy products within the establishment. Roadways must be maintained to minimize environmental hazards. The surrounding property must be adequately drained.

When evaluating the roof and exterior structure, the elements within this task may contribute to contamination of the plant environment in 3 ways:

1. provide entry points for pests,
2. contribute to air borne contamination,
3. permit leakage of water into plant.

Airborne contamination and leakage of water are the two most important factors with regards to the inspection of the establishment roof. Flat roofs are permissible; however, there must be no accumulation of water. For powder plants, if the air intake supply originates on the roof, and the dryer exhaust stack exits on the roof, powder build-up must be minimized; the roof must be washable.

An establishment with driveway, parking lots and surroundings that are clean and well maintained can give a first impression of good sanitation. When evaluating this task, consider the potential for contamination of the plant interior from:

1. Dust and soil migrating to the plant interior.
2. Pests gaining entry to the plant; surrounding trees and shrubs provide food and harbourage for pests.
3. Storage of equipment, supplies, etc.

1.10.01.04 Building Interior

This task covers all floors, walls, ceilings, stairs and elevators, utility lines and electrical boxes in the establishment. As well, all windows, doors and openings (plastic curtains, hoseport, can inlet and outlet), loading facilities, lighting and ventilation are included.

The building interior is assessed separately for every room in the establishment (exception is item (D) Loading Facilities which is only assessed once). For example, the floors, walls, ceilings, lighting, ventilation, drainage will be rated together for each room in the establishment.

The interior of the plant must be designed to minimize contamination of food, to facilitate sanitary operation and to provide for easy and effective cleaning. To achieve these objectives, attention must be paid to the structural design of the establishment. Facilities must be adequate for maximum production volume.

The interior structures are unlikely to have direct contact with the food produced in the plant. However, accumulations of dust and dirt and condensation may become sources of contamination. It is necessary then to design, construct, finish and maintain these structures in a manner that prevents such conditions. Floors, walls and ceilings are to be constructed of materials that are suitable for the production conditions in the area and are listed in the Reference Listing of Accepted Construction Materials, Packaging Materials, and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada and will not result in the contamination of the environment or food. The reference listing can be consulted for further information.

Older establishments with floors, walls and ceilings which are well maintained and meet the regulatory requirement of a hard finish that is suitable for cleaning, smooth and impervious are not required to renovate or upgrade construction materials to those listed in the Reference Listing of Accepted Constructed Materials, Packaging Materials and Non-Food Chemical Products. As renovations and repairs to the facility are made it is expected that all new construction materials and coatings will be on the list.

Interior structures that do not meet the design criteria outlined on the facing page may be assessed as satisfactory provided that management has an effective program to monitor and clean them. For example ceilings with exposed steel joints and H-beams are not satisfactory in areas where the product is exposed to the atmosphere, except if a program is in place that affirms their good condition through regular cleaning, dusting and inspecting. If no program is in place then modifications or renovations may be required. Another exception to the design criteria outlined on the facing page would be for dry storage areas where less stringent requirements would be acceptable. Existing walls in dry storage areas which exhibit signs of deterioration due to moisture indicate that the construction materials may not be acceptable for that area, and/or ventilation may be inadequate. In these cases even if there is no contamination risk, the materials must be replaced with an approved material that is smooth, hard, and impervious to moisture in order to better facilitate cleaning and withstand working conditions.

A) Floors in processing and receiving areas must be sufficiently sloped to drain to trapped outlets (i.e. ¼ inch per foot or 2%) to enable rapid drainage of liquids. Pooling of liquids must be avoided because they provide a good medium for microbiological growth.

B) Utility lines include all lines for water, steam, electricity, coolants, air and vacuum. The contamination potential of utility lines must be carefully assessed. Colour coding of these lines is recommended to aid in their identification.

C) Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows must be constructed of alternative materials or be adequately protected. Where applicable, doors are kept closed and are well sealed to minimize contamination risks (e.g. receiving rooms, boiler rooms, etc.).

D) In the evaluation of the loading area, 2 aspects are important: product integrity and pest control. It is important that the products be protected from exposure to extreme temperature that would have an adverse effect on product integrity. Products can be protected by the use of air curtains, strips of plastic or similar set-ups.

E) The lighting in an establishment must be bright enough for safe food handling and thorough cleaning. Lighting must be appropriate such that the intended production or inspection activity can be effectively conducted; lighting should not alter the food colour. Inspection areas are defined as any point where the food product or container is visually inspected, e.g. Empty container evaluation, product sorting and grading, product evaluation areas in the lab. An establishment must have adequate supplementary lighting (e.g. flashlights) for the inspection of the interiors of bulk tankers or storage tanks. Bulbs and fixtures must be protected to prevent contamination should breakage occur in areas where dairy products and incoming materials are located. All bulbs and fixtures must be clean. Light intensity is to be measured with a light meter at a distance of 75 cm from the floor.

F) This task will also assess if there is a need for ventilation and if the ventilation is adequate. Ventilation assessed in this sub-item is for individual ventilation and heating units within a specific room. The heating, ventilation and air conditioning (HVAC) system will be evaluated under task 1.10.01.10.

The air quality within the room must be examined. Three conditions may apply:

1. The room may receive air from a central HVAC system,
2. The room may have its own independent HVAC system,
3. The ambient air may be the air supply for the room.

In situations (i) & (ii), the installation of an HVAC system or exhaust fans may be required if inferior air quality is evident or there is exposed product. Some rooms require specialized treatment of air. In rooms used for starter manufacture, it may be necessary to maintain the room under positive pressure to eliminate the possibility of airborne contamination.

Ventilation systems are designed and constructed so that air does not flow from contaminated areas to clean areas. Adequate ventilation must be provided to prevent unacceptable accumulations of steam, condensation or dust and to remove contaminated air. Inadequate ventilation may lead to the presence of odours, condensation or mould growth. Direct air movement onto product, product contact surfaces or filling and packaging areas must be avoided (airborne contamination has been suspected as a vehicle allowing pathogens to enter the product).

G) Drains must be trapped and be of adequate size, number and location to prevent the pooling of milk, water or other processing wastes and not pose a contamination risk to dairy products.

Trapped floor drains are essential to prevent possible off odours and contamination of plant air. Drains must be individually trapped; central trapping systems without individual traps are unacceptable because contamination and odours could originate from sewer pipes located between untrapped drains. Bell type traps which are well maintained and in good condition are acceptable. Other acceptable types of traps include U or P types. All new drain construction must have U or P type traps.

Because of the potential to harbour microorganisms, floor drains should be located so that they are readily accessible for cleaning, sanitizing, and inspection. Ideally, floor drains should not be located under or near filling and packaging equipment.

Floors and drains should be constructed and maintained to ensure proper drainage. Brushes used for cleaning floor drains must not be used for any other purpose. Floor drains must be frequently cleaned and periodically flushed with a sanitizing solution. Floor drain covers and baskets should be cleaned and sanitized after each production run. Under no circumstances should high pressure hoses be used to clean drains.

Establishments must be designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment. Effluent or sewage lines must not pass directly over or through production areas unless they do not pose a contamination risk (e.g. properly protected).

In the event that there are cross connections between plant waste and human waste, within the facility, this task must be scored as non-satisfactory. Establishments must have an action plan in place to mitigate the risk of contamination of the product if a problem with the drainage system occurs. The action plan must also include the provision that if an actual problem does occur, that production will not re-start until the drainage system is fixed. Establishments are to be reminded that meeting regulatory requirements is a condition of registration. Establishments operating with drainage problems can be denied registration renewal. It is expected that all new registrations meet the regulatory requirements prior to registration.

The above statements also apply to establishments seeking Food Safety Enhancement Program - Hazard Analysis Critical Control Point (FSEP-HACPP) recognition. Requirements for FSEP-HACPP recognition should be no stricter than what we require in non-FSEP-HACPP establishments. Establishments can be FSEP-HACPP recognized as long as acceptable short and long term action plans are in place.

1.10.01.05 Waste Disposal

Other agencies (e.g. environmental agencies) usually have jurisdiction over sewage disposal. Our concern is that the dairy products are not exposed to contamination risks from the sewage disposal methods.

A) Sewage must be disposed of in a sanitary manner. It is imperative that it not become a source of contamination to the plant environment. Of particular importance is the prevention of odours and pests. For example, open sewage near the plant must not be allowed.

B) Garbage disposal evaluates the handling of wastes from within the plant during operations and the waste collection facilities outside the plant.

It is important that waste be properly disposed of to prevent it from becoming:

1. an attraction to pests, and
2. a contribution to air borne bacterial contamination.

Within the plant there must be a sufficient number of garbage containers so that they are accessible to all employees. Plastic bag are permissible but if contamination is a great risk then covered containers are required. These containers must be clearly identified, leak proof, emptied regularly, and cleaned and sanitized prior to use.

If there is a garbage storage room in the plant it must be emptied daily. If odours are a problem then a ventilation system must be installed. The surface of the walls and floors must be cleanable. To facilitate cleaning, the room should be located near a spray hose and also have a nearby drain.

Waste disposal facilities that are located outside of the plant must not attract pests. They must have covers and be kept closed and in good condition. If compactors and bulk garbage units are used, they should be located on a concrete, curbed and drained ramp to facilitate the clean-up of spills. Washing facilities must be nearby.

Combustible wastes should not be burned in the plant vicinity in order to avoid airborne contamination by ash and odours.

C) Whey, if used as a food, can be further processed into products such as lactose, whey powder, whey protein concentrate, etc. and the handling of it as a food will be evaluated under the appropriate processing equipment. This task covers whey when considered as a waste product. Disposal should be by an approved method and must not pollute the environment nor implicate on the sanitary conditions within and outside the establishment.

1.10.01.06 Sanitary Facilities

Careful and frequent hand washing is required in food handling situations to reduce contamination. If a hand washing facility is difficult to find or operate it will not be used. Hand washing facilities in production areas must be of the remote-control type (foot, knee activated or timed). The location, number and the condition of the hand washing facilities is extremely important to the maintenance of good hygienic practices. Evaluations of adequate number and accessibility of handwash stations will be made by the inspector observing the work habits if the employees. These facilities must be provided with liquid or other type of soap dispensers, paper towels in suitable dispensers, and properly constructed and easily maintained receptacles for used towels. In areas where the product is handled directly, hand washing and sanitizing facilities must be provided in a convenient location with trapped waste pipes to drains. It is not acceptable to use equipment and sanitizing facilities as hand dip stations.

Portable facilities and facilities with drainage piping not connected to a drain are not acceptable.

Washrooms must have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a cleanable waste receptacle. Washrooms, lunchrooms and change rooms must be provided with appropriate floor drainage, good ventilation and be well maintained in a manner to prevent contamination. Specific attention is required to ensure that pest harbourage and dirt/dust accumulations do not occur. Double doors must separate employee facilities from the processing rooms; these doors are to be self-closing.

1.10.01.07 Essential Signs

Essential signs are required to enforce management policies. No smoking and unauthorized personnel signs are to be posted at outside and inside entrances to the plant and all receiving, processing and storage areas. Hand washing signs are to be posted in washrooms and in all product handling areas. Hazardous material signs are required in areas where cleaners, pesticides, etc. are kept.

The adherence to these management policies is assessed under task 1.10.04.02 - Flow and Practices and task 1.10.04.03 - Hygiene & Health.

1.10.01.08 Non-Processing Areas

This task includes equipment cleaning and sanitizing facilities (e.g. Clean Out of Place - COP) as well as boiler and compressor rooms, retail operations, mechanical shops, etc.

Because there is no exposed product in these areas it is not essential to meet the same sanitary requirements as the food processing areas of the plant. The location of the non-processing area must not pose a risk of contamination to food processing and handling areas. Proper maintenance is required to ensure a sanitary environment.

1.10.01.09 Water/Steam Quality & Supply

This task assesses the quality of the water and steam emanating from the plant's lines and hoses for use in various processing applications. There must be a safe, sanitary and adequate supply of water for use in a dairy establishment at all times. The water supply source must meet the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality. A summary of Canadian Drinking Water Guidelines can be found on Health Canada's website. These guidelines cover microbiological, chemical (e.g. agricultural, heavy metals), physical and radiological contaminants.

The document titled, Canadian Guidelines for Food Processing during Adverse Water Events is also available on Health Canada's website. These guidelines pertain to the safe use of water in the processing of foods during adverse water events. The document is a good reference to assist the industry in minimizing economic impacts of adverse water events.

Typical contaminants that industry should be fully aware of include:

• Bacterial pathogens - Salmonella, Shigella, Campylobacter, Yersinia, Aeromonas and various strains of Escherichia coli (E. coli).
• Viral pathogens - Norwalk virus, hepatitis virus and other human enteric viruses.
• Protozoan parasites - Entamoeba histolytica, Giardia lambia, Cryptosporidium parvum and Cyclospora.
• Chemical contaminants that could result from environmental contamination or from a chemical spill, incorrect use of pesticides or cross contamination of the water supply with sewage or industrial waste.
• Cyanobacteria or blue-green algae or pond scum which form in shallow, warm, slow-moving or still water that produce and release cyanobacterial toxins.

A) General

i. Documented Program:

Dairy establishments must have a complete written and fully documented program in place to ensure they are continuously using safe/potable water in the preparation and processing of food. It must monitor for microbiological, chemical (e.g. agricultural) and physical (e.g. heavy metals) contaminants. This program covers all aspects related to water (e.g. water source, in-plant water, reuse water, steam) used in the establishment.

ii. Boil Water Advisory or Water Safety Alert/Drinking Water Avoidance Advisories:

A boil water advisory or a water safety alert may be issued by the local public health unit or other responsible authority, as a result of unacceptable microbiological quality, significant deterioration in the microbiological quality of the source water, significant increase in turbidity (cloudiness) of the source water, chemical contamination, inadequate filtration and/or disinfection during treatment, re-contamination during distribution or as a precautionary measure when there is a concern that microbiological contamination may exist.

Drinking water avoidance advisories may be issued when there is concern about water safety that is not related to microbiological contamination. Examples may include chemical spill into a water source, the inability of existing treatment processes to treat a particular contaminant, cross connection or back flow of a contaminant into the distribution system. Drinking water avoidance advisories are issued when contaminants (e.g. nitrate, copper, cyanobacterial toxins, ethylene glycol) are present at levels considered sufficient to cause acute health effects. These are issued only when there is convincing evidence of a significant public health risk.

Dairy establishments must have an action plan in the event of a boil water advisory/water safety alert/drinking water avoidance advisories. The action plan may include, but is not limited to disinfection, pasteurization of plant water, alternate water source, plant closure. Plant management must also include in the action plan an investigation into the safety of the product produced prior to the advisory.

iii. Communication Strategy:

It is recommended that dairy establishments, where possible, establish a communication strategy with the appropriate municipal, provincial or territorial water authorities for the timely exchange of information in the event of a boil water/water safety alert. It is recognized that there are differences in how this information is communicated, depending on the jurisdiction in which an establishment is located and as such will affect the degree to which an establishment can develop this strategy. Nevertheless it is the responsibility of the plant management to ensure they are continuously using safe/potable water.

B) Water Testing

1) Microbiological Testing:

The microbiological quality of water is determined by testing for the presence of indicator bacteria, such as coliform bacteria. Water must meet Provincial requirements, if these differ and are more stringent than Health Canada's Guidelines for Canadian Drinking Water Quality amended December 2010.

A 100 mL water sample is required for each test, and acceptable test methodology must be used. In Canada three methods are currently used to detect coliform organisms in water (presence-absence (P-A), membrane filter (MF) and multiple tube fermentation (MTF). The methods are described in detail in the most current version of the Standard Methods for the Examination of Water and Wastewater. Refer to Appendix 19 – 12D of Chapter 19 for more information on methods of analysis and procedures for sampling. The water can be analyzed at provincial or municipal public health laboratories, provincially recognized private laboratories or at the establishment's in-house laboratory, but it is critical for accurate results that the water sample size, sampling procedures and acceptable test methodology are followed.

Water is considered microbiologically safe if the maximum acceptable concentration (MAC) for total coliform and E. coli is non-detectable per 100 mL water sample. When using MF or MTF methods results reported as <1 CFU/100mL (for MF method) and <1.8 CFU/100 mL (for MTF method) are considered as meeting these standards,

E. coli is the only coliform bacteria that is considered faecal-specific. Therefore, the presence of E. coli indicates faecal contamination of the water and the possible presence of enteric pathogens, and a boil water advisory should be issued by the local public health unit or responsible agency.

The presence of total coliforms, in the absence of E. coli does not necessarily require the issuance of a boil water advisory but corrective actions need to be taken. The operator must re-sample and test any sites that are positive for coliforms.

If E. coli is confirmed, immediate re-sampling of the positive site is required, the appropriate agencies should be notified, and if applicable, a boil water advisory should be issued by the local public health unit or responsible agency and corrective actions taken. An evaluation of any product will also have to occur

Refer to Appendix 19 - 12D for more information on corrective action and follow-up procedures for unsatisfactory results. The corrective action and follow-up will vary depending on whether the contamination was found in the source water sample or the in-plant water samples or if the source water is municipal water or private well water.

i. Source Water:

The water entering the establishment meets the requirements of the official government body having jurisdiction. The quality of the water supply must be analyzed at least once per year to confirm its microbiological quality. If the source of the water is a private well then the manufacturer is responsible to have the water analyzed. If the source of the water is from the municipality and the analysis is carried out by the municipality, then the manufacturer can obtain the analysis from the municipal agency. In either case the record of the analyses must be on file at the establishment.

ii. In Plant Water:

The quality of product contact water must be tested once per month. Such analyses will determine if the plant's water lines and filters are sanitary and effective. Product contact water is defined as ingredient water, water used for flushing product, and water used for washing and sanitizing purposes. A record of the analyses must be maintained by the plant. Suitable sites for sampling include a drinking water tap and a point of use, such as a hose. Sampling sites should be representative of different areas throughout the plant, although not necessarily the same points at each occasion. Over time, the sample sites should cover all applicable areas of the plant.

2) Chemical Testing:

Chemical analysis of the source water must be provided by the operator prior to establishment registration. The range of chemical analysis will depend on local conditions, such as geological formation, seepage from soil treated with fertilizers, pesticides or local exposure to industrial pollution. To establish the range of tests and when to test, Provincial Environmental authorities should be consulted. The guidelines for chemical parameters can be found on the Health Canada website. Health Canada recommends chemical testing the source twice a year.

If the source of the water is a private well the analysis must be undertaken by the manufacturer. Subsequent testing, once an establishment is registered may be required if there is any change to the well or piping system of a private well. If the source of the water is the municipality and the chemical analysis is carried out by the municipality, the manufacturer can obtain a copy of the analysis from the municipal agency. In either case the record of analyses must be on file at the establishment.

C) Operation

i. Water Filtration

Water used as a food ingredient or for flushing product must be filtered to remove hazardous extraneous material to a particle size of 2mm. Water used for CIP purposes must be free of rust, excessive scale and other foreign material. This may be done by filtering it.

Water could be filtered at the supply end or it could be filtered by a central filtration system. Wherever the location of the filter, it is important that all pipelines downstream from the filter are made of a material that does not contribute the addition of extraneous material to the water e.g. corrosion free (not rusting, not flaking).

ii. Design

Water that is used solely for fire protection, boilers or auxiliary services (e.g. cooling of compressor heads) does not have to meet the same criteria for potability. However, it is mandatory that there be no possibility of cross connections between the potable and non-potable systems, i.e. must be a closed system. A cross-connection, in the context of potable water, means any actual or potential connection between a potable water system and any source of pollution or contamination (Note: Bypass arrangements, jumper connections, removable sections, swivel or changeover devices, or any other temporary or permanent connecting arrangements through which backflow can occur are considered cross-connections.)

When water is used for cooling in the heat exchanger it must be potable.

Non-potable water may be used in an evaporator for condensing providing there are no restrictions (such as pumps) on the condensation line. Colour coding of non potable water lines is recommended.

Plant management must ensure that equipment and/or pipelines are designed and installed in a manner that will not jeopardize the safety of potable water used in dairy establishments. Therefore, plant management must ensure adherence to the requirements outlined under Appendix 19 - 12C with regard to the potential and actual risks associated with backflow as well as the use of appropriate backflow prevention devices.

Throughout the course of the in-depth inspection, particular attention must be paid to areas and processes in the establishment that have the potential to pose risks of backflow. These areas and processes include, but are not limited to:

• 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, etc.
• Fire protection water systems
• Other equipment using potable water such as fillers, homogenizers, separators

Devices used for prevention of backflow as per Section 6.0, Appendix 19 - 12C, require periodic testing at an appropriate frequency determined by the establishment or as per manufacturer's recommendations to verify that they are operational.

Where it is necessary to store water, storage facilities are designed, constructed and maintained to prevent contamination, e.g. covered, properly constructed of material(s) that will not contaminate the water and should allow for periodic cleaning and sanitizing. For example, these could be approved materials from the Canadian Water and Wastewater Association (CWWA) or materials for such use as per manufacturer's guidelines. Without proper design, operation, and maintenance of these facilities, stored water may easily become stagnant and subject to loss of chlorine residual, as well as bacterial re-growth, contaminant entry, and a host of other water quality problems.

iii. 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, e.g. microbiological, protozoan, viruses, chemical. Some water treatment devices are described in Appendix 19 - 12A.

Water treatment chemicals, where used, are listed in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada.

The method of disinfection chosen by the operator must result in water that does not present a microbiological or chemical risk. Chlorine may be used as a disinfectant for well water supplies. The dose is dependant on the water flow rate, pH, temperature and chemical composition. Automatic dosing can be done by the use of a metering device. Where automatic chlorinators are used, it is essential that the establishment establish procedures to ensure water potability. Two controls which are fundamental when using automatic chlorinators are as follows:

1. A metering device for adding chlorine in the correct concentration, relative to the water flow rate, designed to readily indicate malfunction and
2. Such systems must be monitored and controlled twice daily. Tests shall be made to determine available chlorine level at a specific point, remotely located from the chlorine application site, but before distribution to the plant system. The establishment should have the appropriate test kit on hand (titration method) to determine available chlorine.

An automatic analyzer equipped with a recorder and an alarm, to ensure water potability, desired concentration and to prevent contamination may be utilized as an alternative to the above testing.

Where water is in direct contact with finished product, as is the case with washing cheese curds or when water is added unintentionally when flushing product post-pasteurization it is recommended that the operator considers installing an in-plant disinfection system for food application for those areas of the establishment. This water disinfection system should be handled like a critical control point including measurable tolerances for acceptability/unacceptability, monitoring and verification procedures and an action plan in the event of a failure to the system.

D) Water Reuse

Reuse water is water that has been recovered from a processing step, including from the food components, and that after subsequent reconditioning treatment(s), as necessary, is intended to be re(used) in the same, prior, or subsequent food processing operation.

The type of reconditioning to reduce or eliminate microbiological, chemical and physical contaminants will depend on the intended use of the water. Reuse water should not jeopardize the safety or suitability of the product. The source of the water and/or the prior collection and the intended reuse of the water dictate the degree of reconditioning and frequency of monitoring that is necessary. Reuse water intended for incorporation into a food product, used for flushing product or for washing and sanitizing purposes must meet the microbiological and chemical specifications for potable water.

The two types of reuse water identified for use in a dairy establishment are as follows:

i. Re-circulated water:

Re-circulated water is defined as water re-used in a closed loop for the same processing operation. Re-circulated water must be treated, monitored and maintained as appropriate for the intended purpose. Re-circulated water must have a separate distribution system which is clearly identified.

ii. Reclaimed water:

Reclaimed water is defined as water that was originally a constituent of a food, has been removed from a food by a process step, and that is intended to be subsequently re-used in a food processing operation. Condensed water from milk evaporators and water reclaimed from milk and milk products, also referred to as cow water, may be re-used within the establishment, thereby conserving water resources. Where water is reclaimed it is important to ensure the water is safe and suitable for its intended purpose. This water may be treated and must be monitored and maintained as appropriate for the intended use within the establishment. Refer to Appendix 19 - 12B for specific requirements on this task.

E) Steam Supply

The operation of the boiler and the quality of the steam it produces are evaluated here. Within an establishment steam is used for cleaning, sanitizing and as part of the manufacturing processes. If it has direct contact with the product and product contact surfaces it must be culinary type steam.

i. Water/Steam:

The water from which the steam is generated may be a food ingredient and thus must meet all the regulatory requirements for potable water. Of particular risk are the corrosion inhibitors and water conditioning compounds that are used in the boiler.

Control of boiler operations, in particular the boiler feed water treatment, must be under the supervision of trained personnel or a firm specializing in industrial water conditioning. Boiler feed water must be tested regularly and the chemical treatment controlled to prevent contamination.

If the steam/hot water is in direct contact with product and/or the steam/hot water is used to sanitize product contact surfaces and is not followed by a potable water rinse then boiler treatment chemicals used must be listed in the Reference Listing of Accepted Construction Materials, Packaging Materials, and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada. In this case it is important that the operator of a dairy plant read the label of all water additives and consult with the manufacturer to assure that the water additives do not contain the following chemicals:

• 2-Amino-2-methyl-1-propanol
• Cyclohexylamine
• Diethylaminoethanol
• Morpholine
• Octadecylamine
• N,N-Bis (2-hydroxyethyl) Alkyl (C 12-C 18) amine derived from coconut oil
• Trisodium nitrilotriacetate

The prohibition of boiler water additives that contain amines is to eliminate the risk of forming nitrosamines in the dairy products.

ii. Culinary Steam

Culinary steam must meet certain standards because it is used in direct contact with milk and dairy products. Refer to Appendix 19 - 1 for further information on this task.

Direct steam injection that requires culinary steam is used in the following processes and products:

• Manufacture of ricotta and cottage type cheeses.
• Preheating of milk for production of evaporated milk, sweetened condensed milk and non-fat dry milk.
• Vacreation and pasteurization of milk and creams.
• Heating of water used in production of for example, butter oil and mozzarella cheese.
• Process cheese cooking.
• APPS processing.

It is recommended to periodically analyze steam condensate samples. Carry over of boiler water additives can result in the production of off flavours. Samples should be secured from the line between the final steam-separating equipment and the point of the introduction of steam into the product.

F) Water and Steam Hose Equipment

Poorly maintained hoses may contribute to the contamination of the water supply. Inspecting the condition of the hose equipment (nozzles, ends and exterior) is done to determine if it is maintained in a sanitary manner and is in good repair. Hoses are stored off the floor.

G) Records

The manufacturer has written records available to demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply. The records include municipal and/or establishment's own water testing records for microbiological and chemical testing; water potability testing (water source, sample sites (including date and time sample taken), analytical results, analyst, date); water treatment records (method of treatment, sample site (including date and time sample taken), analytical results, analyst, date); water reuse records (for re-circulated and reclaimed water). The records specify the person who is responsible, analyses and results, parameters of acceptability/unacceptability (tolerances), frequency and results of monitoring and verification, satisfactory follow-up for out of specification findings and is updated as required.

1.10.01.010 HVAC (heating, ventilation, air conditioning) System Unit

This task assesses the HVAC system unit only. Individual ventilation units are evaluated separately under task 1.10.01.04 - Building Interior, in specific rooms.

Since air from the HVAC system unit is supplied to various parts of the establishment 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.

This unit is usually located on the roof or in a special room. Temperature is controlled by placing heating and/or cooling elements within the ducts. Filters are used to remove extraneous matter.

HVAC systems must be cleanable and maintained clean. Special attention to the condensate drip pans and drain line is required to minimize potential growth of pathogens. Air intakes should not be located near unfavourable activities (e.g. feed mills, livestock operations).

1.10.01.011 Glass Breakage Policy

This task will cover the policy required if an establishment handles glass containers or has glass or glass substitutes (e.g. plexi-glass) present in manufacturing areas, e.g. glass windows, UV lights, glass doors, in-line pH meters etc. The use of glass in processing areas should be discouraged. Where glass does exist it is recommended to be of the shatterproof type, where applicable. The receipt, acceptance and storage of glass is rated under task 1.10.02.03 Incoming Material.

The plant must have a documented glass breakage policy if it meets the above mentioned conditions, to assess if it will control the risk of glass contamination should breakage occur. Some guidelines that could be included in this policy are:

1. The line or processing area must immediately shut down.
2. Broken glass containers and/or loose glass fragments must be removed from the area.
3. Clean-up procedures are to be outlined (they must not spread the contamination).
4. The line (filler, capper) and/or area must be inspected to ensure that clean-up was adequate.
5. The breakage and the type (thermal shock, impact etc.) must be recorded.
6. Excessive breakage is to be investigated.

The records must be examined to determine if breakage did occur and if it was well handled and documented. The date, time and location of glass breakage, the type of breakage (e.g. thermal shock/impact), the extent of potential contamination (filler bowl, capper, hopper) and the results of the investigation must be recorded.

1.10.02 - Transportation & Storage Program (including receiving)

Dairy establishments transport, receive, inspect and store ingredients/packaging materials and incoming materials in a manner which prevents conditions which may result in the contamination of food.

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.

1.10.02.01 General

Dairy establishments and importers must have an adequate documented program in place which controls all the elements in this section, and maintain the appropriate records.

To ensure the production of safe food, it is necessary to know and control the type of incoming materials brought into the establishment. These materials include all raw products, ingredients, packaging materials, non-food chemicals and returned products. It is important that the carriers (vehicles) of these products be suitable and well maintained for the type of product they carry. The same requirements apply for carriers of finished product leaving the establishment. These requirements may be the direct or indirect responsibility of the processor; in either case the processor must outline a system to ensure the requirements are met.

Appropriate specifications for the incoming materials need to be defined to ensure that the materials supplied will minimize any biological, chemical, or physical hazards and be food grade. As these products are received into the establishment, they need to be screened for their acceptability according to the specifications. This may involve verifying if certification papers are present, performing product analysis through a regular monitoring program or a combination of these activities. Once these products are accepted into the establishment, they need to be stored and handled appropriately to minimize the contamination risk.

Adherence to the criteria is verified by examining the establishment's written program which specifies the requirements for food carriers; defines the specifications for all food grade ingredients, packaging materials and non-food chemicals; outlines the receiving requirements; and specifies storage and handling requirements for all incoming materials. The program must specify:

• areas to be inspected (what is done),
• tasks to be performed (how it is done),
• person responsible (who does it),
• inspection frequencies (how often or when it is done),
• records to be kept,
• parameters of acceptability/unacceptability (tolerances),
• results of monitoring,
• verification procedures (both on-site and record review),
• action to be 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 be regularly reviewed and updated to assess its effectiveness under changing conditions.

The actual monitoring of the adequacy of this program will be done by monitoring and assessing tasks 1.10.02.02 to 1.10.02.08.

1.10.02.02 Transportation

A) Carriers used by the establishment must be designed, constructed, maintained, cleaned and utilized in a manner to prevent food contamination. Carriers must be suitable for the transportation of food. This can be verified by visual inspection upon receipt by the manufacturer and prior to loading to ensure they are free from contamination and suitable for the transportation of food. Carriers permit effective separation of different foods or foods from non-food items where necessary during transport. Carriers provide effective protection from contamination, including dust and fumes. The manufacturer has a program in place or assurances to demonstrate the adequacy of cleaning and sanitizing. For example, the plant should have records that the carrier is properly cleaned and sanitized. Special attention should be given to carriers used to transport goat and sheep milk from the farm to the establishment to ensure that these meet the appropriate requirements.

In the event that the same carriers are used for a variety of different foods (e.g. egg albumen) or for raw and pasteurized dairy products, procedures must be in place to ensure that there is not a contamination risk to subsequent loads. For example, the manufacturer receives a cleaning certificate and a record of the previous material transported prior to loading or unloading dual use tankers. The manufacturer has a program in place to verify the adequacy of cleaning, e.g. tanker inspections, sensory evaluation of ingredients and/or analysis as appropriate.

The transportation of pasteurized dairy products in bulk multi-use containers without re-pasteurization is strongly discouraged as there is no guarantee that equipment is adequately cleaned. Re-useable plastic totes are not acceptable for the transporting of pasteurized product. For establishments who do not wish to re-pasteurize already pasteurized product, food carriers, tanks, transport lines and transfer pumps must be dedicated to pasteurized product only. This practice must be limited to certain products such as whey or condensed milk destined for drying, ice cream mix or cream cheese mix but would not be acceptable for fluid milk and cream. As well, documented protocol and written records for this practice are required to maintain the pasteurized product integrity. This practice will have to be assessed on a case by case basis.

Ingredients and finished product requiring temperature controls must be transported in a manner to prevent temperature abuse that could result in deterioration affecting product safety. Dairy products which require refrigeration are transported at a transport temperature of 4°C or less; refrigerated ingredients at a transport temperature of 4°C or less; frozen ingredients at a transport temperature that does not permit thawing. Transportation temperatures must be monitored and recorded to ensure proper temperatures for refrigerated and frozen ingredients. Finished product must be transported under conditions to prevent microbiological, physical and chemical deterioration.

To adequately assess this task, the written program must be examined to verify that the requirements for food carriers as outlined in the program are being followed, records are kept and acceptable deviation procedures occur when conditions are not met. It is important that dairy products are not transported in carriers that do not meet the requirements of the program, thereby posing a contamination risk to the product. This can be verified with visual and organoleptic inspections of the carriers by the inspector and visual observations of personnel responsible for loading and unloading carriers.

B) 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 so careful attention is required to the maintenance of these pieces of equipment. Forklifts and carts tend to have painted surfaces so it is important that the exterior of these items be free of flaking material that may contaminate the products. Transportation equipment must be frequently washed; carts should have sanitary drain cocks to prevent accumulation of water in the carts.

It is imperative that waste and scrap carts be clearly labelled to avoid adulteration of ingredients or product. Also the type of forklift dictates the area where it may be used. Propane may contaminate some stored food so electric forklifts should be used in food processing areas.

1.10.02.03 Incoming Material (ingredients & packaging)

This task assesses all incoming material except raw milk or cream. Milk and cream are assessed under task 1.10.02.04 - Raw Product Quality and non-food materials are assessed under task 1.10.02.08 - Non-Food Chemicals.

The receipt, storage and handling of incoming ingredients (e.g. freeze dried cultures, flavours, fruits and powders, protein concentrates, etc.) and packaging materials (includes preformed containers such as ice cream barrels, milk jugs, etc.) must be well controlled to ensure they do not pose any biological, chemical or physical hazards to the dairy products. Only sound, suitable raw materials are used.

The manufacturer must ensure that all food additives used are permitted for use in the particular food and meet all the requirements of the Food & Drug Regulations (assessed under task 1.10.07.02 - Manufacturing/Allergen Controls).

Plants should procure all material according to specifications. Their compliance with these specifications is verified at a frequency determined by the establishment (assessed under task 1.10.07.03 - Microbiological controls and Records and 1.10.07.04 - Composition Control and Records). Establishments receiving dairy powders define specification requirements for incoming dairy powders and specify receipt of certification papers that product is either pasteurized, is alkaline phosphatase negative or is labelled for further processing. A program (which is assessed under task 1.10.02.01- General) must be in place to monitor the acceptability of incoming materials received in the plant; 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.

Packaging design and materials provide adequate protection for products to minimize contamination and prevent damage. Packaging materials must be non-toxic and not pose a threat to the safety and suitability of food under specified conditions of storage and use. Packaging materials purchased are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Products published by the CFIA or the manufacturer has a letter of no objection from Health Canada. The reference list can be consulted for further information.

Once the materials are received in the plant, they must be labelled and stored in a manner that protects their integrity and minimizes the risk of contamination. Ingredients requiring refrigeration must be stored at proper temperatures (4°C or less) and frozen ingredients must be stored at temperatures that do not permit thawing; storage room temperatures must be monitored. Humidity sensitive materials must be stored under proper conditions. Rotation of ingredients and packaging material where appropriate is controlled to prevent deterioration and spoilage.

1.10.02.04 Raw Product Acceptability

This task assesses 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 (e.g. sheep, goat, etc.). Other incoming food ingredients are assessed under task - 1.10.02.03 Incoming Material.

There are many biological, chemical and physical hazards in raw milk products that must be identified and controlled to ensure production of safe dairy products.

Raw milk products must meet the quality standards established by the appropriate provincial or federal authority. Specifically, it is critical that raw products are only accepted if they meet specifications related to odour, acidity levels, temperature, antibiotics and filtering. If not, the raw product may not be further controlled in the manufacturing process and therefore may pose a contamination risk.

The receiving of raw milk/cream must be well controlled to minimize growth of microorganisms/toxins that could affect food safety. Raw milk/cream must be received at a maximum temperature of 6°C but preferably 4°C or lower. Plant specific limits need to be set for raw milk/cream receiving temperature that establish the maximum conditions that will be allowed before product is received. These limits should have a scientific basis and must be monitored by a designated, trained person at a set frequency and recorded and actioned appropriately.

If raw milk/cream is received at a temperature greater than 6°C the establishment must have deviation procedures in place to control the microbiological growth in the product. Deviation procedures might include cooling the product down to at least 6°C ; pasteurizing or processing the raw milk product within a specified time frame (e.g. 2 hours of receipt); odour evaluation; microbiological/toxin testing (e.g. S. aureus); notifying the provincial milk board or provincial government; rejecting the load.

If during an in-depth inspection the inspector noted that the establishment had on occasion received shipments of raw milk/cream with a temperature above 6°C and deviation procedures were implemented and effective, records indicated that each load had been monitored for compliance to specifications and the temperature history of raw milk/cream illustrated for the majority of the shipments that receiving temperatures did not exceed 6°C this criteria can be rated as satisfactory.

It must be a regular practice to make appearance and odour checks of each tanker load of bulk milk before unloading into storage tanks to allow segregation of milk with quality defects. This provides a check on the grading of the milk done at the farm before pumping into the bulk truck. It is important that such tests be performed and recorded before unloading each tanker of milk received.

Raw milk or cream samples should be obtained from each tanker for further testing. These samples must be stored in clean and sanitary containers placed on suitable racks and stored 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 milk or cream received at the plant must be subjected to grading and relevant laboratory tests, e.g. antibiotics, microbiological, sediment, titratable acidity, etc. The plant should have an effective follow-up program to exclude (or segregate) milk which is suspected to be contaminated until subsequent tests show correction of the problem.

It is a practice in some dairy establishments to rinse milk delivery trucks, milk silos and pipelines once emptied with water and reclaim this milk in their production. The purpose for doing this is to reduce the loss of milk due to adherence to the walls of the containers and ineffectual flow of pumps. The establishment must have a documented protocol and written records for this practice in order to maintain the product integrity. The protocol should include procedures to ensure the safety and compositional standards of the product. Some items to be considered in the procedures would be the sanitary quality of hoses, proper sanitation procedures, possible risk of chemical contamination, water potability, storage and end use of this product.

1.10.02.05 Raw Product/Mix Storage/Aging/Cooling/Returns and Rework

A) The storage time and temperature of raw milk/cream must 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. Raw milk/cream must be stored at a maximum temperature of 6°C but preferably 4°C or lower. Manufacturers must have time controls in place to minimize excessive microbial growth (e.g. an established maximum storage time prior to processing which was determined to be safe). If raw milk/cream is stored at a temperature greater than 6°C and/or for a prolonged length of time, the establishment must have deviation procedures in place to control the microbiological growth in the product. Deviation procedures might include cooling the product down to at least 6°C ; pasteurizing or processing the raw milk product within a specified time frame; odour evaluation; microbiological/toxin testing (e.g. S. aureus). Plant specific limits need to be set for raw product storage time and temperature that establish the maximum conditions that will be allowed before product is held before further processing. These limits must be monitored by a designated, trained person at a set frequency and recorded and actioned appropriately.

Thermisation is the practice of heating up the raw milk for a specified time/temperature, e.g. 57- 65°C for 15 seconds, followed by refrigeration and storing it for an extended period of time prior to pasteurization. It is a mild form of heat treatment which can be used to extend the keeping quality of raw milk. The aim is to reduce the growth of psychrotrophic bacteria which may release heat-resistant protease and lipase enzymes into the milk. The milk that is treated this way is still considered to be raw but can be held for a longer period of time before pasteurization. A documented protocol and written records for this practice are required to maintain the raw product integrity. This practice will have to be assessed on a case by case basis.

B) The storage time and temperature of product requiring further processing (e.g. dairy product mix held at or below 4°C ) must be well controlled to minimize growth of microorganisms. This is pasteurized product which could be re-contaminated due to improper handling or poor sanitation of storage tanks and as such requires to be kept at refrigeration temperatures.

C) Certain dairy products require to be kept at temperatures that exceed 4°C as part of their manufacturing process. These processes can include but are not limited to tempering, drying, curing and aging of dairy products. However, when these manufacturing processes are completed, these dairy products must be kept at 4°C or less. If a plant is tempering product from a frozen state the preferred option would be a tempering room, however this is not always possible. An establishment that tempers product from a frozen state requires a written protocol of how the product will be handled so as to minimize the growth of microorganisms, including routine documented temperature/time checks and microbiological testing. This practice will have to be assessed on a case by case basis.

D) All pasteurized milk and milk products, except those to be cultured, must be cooled immediately prior to filling or packaging to 4°C or less, unless drying is commenced immediately after condensing.

E) Dairy products that are returned to the establishment may be a source of contamination to the plant environment, equipment and other dairy products. Contamination can be prevented by proper control of such products as they arrive at the plant from external sources, e.g. retail outlets.

To properly control the handling of returns, employees must adhere to the policy regarding returns that has been established by the management. A policy to not accept any returns is the best. A plant that has an evident no return policy that can be substantiated is evaluated as satisfactory.

The policy must define what products are acceptable. It is recommended that only products which the establishment has retained ownership (e.g. undelivered product that has remained on the truck) be accepted as returns. If product that has not remained as property of the establishment (i.e. store returns) is accepted at the plant, it must be segregated from other plant operations. Fluid milk returns may be collected in a separate well identified tank; other by-products must be separately stored and identified while awaiting disposal and/or re-work if applicable. The handling of returned product must not compromise the safety of fresh product in any way.

The situation of excessive amounts of product being habitually returned to the establishment needs to be addressed by the management.

It is recommended that only the cheese for which the establishment has retained ownership should be accepted for shredding or grating. Cheese returns that are going to be used for shredding or grating must be well controlled and the integrity of the product must be demonstrated.

F) The manufacturer has controls in place to ensure that reruns or reworks do not contain ingredients that may be allergenic to sensitive individuals unless clearly identified on the label of the finished product. Reruns (for example: ice cream, chocolate milk) must be stored in covered and clearly labelled containers.

1.10.02.06 Finished Product Storage

Finished product must be stored and handled under conditions to prevent deterioration (e.g. spoilage) and damage (e.g. control of stacking heights and forklift damage).

Finished products requiring refrigeration must be stored at proper temperatures (4°C or less) and frozen products must be stored at temperatures that do not permit thawing. As is always the case, if provincial requirements are more stringent, then those must be met. Storage room temperatures must be monitored. Humidity sensitive materials must be stored under proper conditions. Stock rotation must be controlled to prevent deterioration that could present a health hazard. Particular attention should be paid to periods of defrosting of refrigeration units, temperature abuse and overloading of the cold storage capacity.

If an establishment does not have the capacity to cool the finished product to 4°C or less on-site at the establishment, it is acceptable (provided this practice does not contravene Provincial regulatory requirements) to ship the product to a public refrigerated warehouse in order to get the temperature down to an acceptable level. There must be written procedures in place and records kept to show the establishment has full control over the product. The tracking documents must include temperature/time during transportation on refrigerated trucks, temperature/time records at the public warehouse, and final control of product release to distribution. These records must be available to the inspector for review.

Products that can be stored at ambient temperatures are protected against external agents and contamination, e.g. direct sun, excessive heating, moisture, external contaminants, from rapid temperature changes which could adversely affect the integrity of the product container or the safety or suitability of the product.

In order to maintain the integrity of the product from pests, moisture, excess weight, etc. The stacking of dairy products is important. Containers must be well identified and stored in a manner to prevent them from falling over. Adequate cleaning and effective pest control can be achieved in storage areas by storing items a suitable distance from the walls and off the floor. Products stored longer than one month must be on pallets approximately 46cm (18in.) from the wall.

Equipment and other food products which are stored in a finished product storage room must pose no contamination risk to the dairy products or ingredients.

The storage of eggs in finished product storage rooms is not to be encouraged. Fish or other products that may transmit odours or undesirable attributes must not be present. Other acceptable products must be stacked on pallets or shelves in a neat and orderly manner.

Wooden pallets and wood 640's (with appropriate liners and pallets) used throughout the plant must be maintained in a manner that prevents them from becoming a source of contamination. Potential risks include: fragments of wood and insects, rodents and other contaminants that may be carried into the plant on the pallets. Improperly reconditioned or reused 640's without washing could promote a cheese mite problem. Wood 640's not well maintained may have splintered wood, mouldy wood, imperfections and splints. Steel frames may exhibit rust. An intensive maintenance program for 640's will assure the containers are in good condition at all times. An effective written program is required for the inspection, cleaning, replacement, storage and handling of these materials. Records must be kept. Employees who are responsible for inspecting and making decisions on the acceptance and rejection of the 640's need to be properly trained. Ideally, in processing and packaging rooms, non-wooden type pallets (e.g. Teflon, plastic, etc.) should be used.

Wood used for cheese shelves to cure bacterial surface ripened cheeses must be smooth and either unsealed or sealed with an approved sealant. The supports for the shelves must be stainless steel or a non-corrosive non-absorbent material. The establishment must have a written program in place to clean and maintain the shelves which needs to specify the frequency and methods of washing, checking for physical condition (splinters, cracks, mite infestation) and if required environmental sample monitoring of the product contact surfaces and the room environment. Records must be kept. See Policy for the Use of Wood in Dairy Establishments (Appendix 19 - 11).

1.10.02.07 Temperature and Humidity Control

Proper control of temperature and humidity is essential in various areas of the establishment. In storage areas the temperature is dependent on the product that is held there. In refrigerated storage areas it is necessary to maintain humidity conditions that prevent the formation of condensation and subsequent mould growth. In cheese salting and curing rooms the temperature and humidity conditions are also dependent on the type of cheese being manufactured. 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. This task will be assessed twice for an establishment that manufactures cheese (once for the establishment and once for the salting and curing room).

Appropriate thermometers, hygrometers or automatic devices that do not pose a contamination risk (non-breakable thermometers) must be used. Replacement measuring devices should be available. Records that document temperature and humidity conditions are required to indicate that the product has been appropriately held. These may be manual records or automated charts.

The sanitary condition of the components of the refrigeration unit is important because improper maintenance may result in the formation of condensate and mould growth which may become a source of contamination. Pathogens have been found in drainage and condensate from cooling units; therefore, it is critical that condensate be well controlled.

1.10.02.08 Non-Food Chemicals

Chemicals purchased are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada. The plant must have a documented list of all non-food chemicals that are used to enable verification of the products' acceptability for use in dairy plants.

Chemicals must be received and stored in such a manner that prevents contamination of food, food contact surfaces or packaging materials.

The storage of non-food chemicals in food plants takes place in two areas:

1. Long term storage of unopened containers in a warehouse; and
2. Short term storage of opened containers in areas separated but in close proximity to the food processing area.

This task will assess both types of storage.

Because the packaging of many cleaners and sanitizers resembles that of food products or ingredients, there is a possibility that such compounds could adulterate a food product through careless handling. These products must be stored away from any food ingredients or products. A special room or caged in area that is dry and well ventilated is preferred. The use of a colour coding system will enable identification of non-food chemicals. Chemicals must be dispensed and handled only by authorized and properly trained personnel. Chemicals are to be used in accordance with the manufacturer's instructions.

1.10.03 - Equipment Program

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.

1.10.03.01 General

Dairy establishments and importers must have a documented program in place to monitor and control all the elements in this section, and maintain the appropriate records.

This task covers equipment and components which may affect the safety of the product. This task assesses:

1. The design and installation of equipment. For example, equipment is to be designed and installed to be accessible for cleaning, sanitizing, maintenance and inspection, to prevent contamination of product during operations, to prevent excessive condensation, permit proper drainage and has acceptable food contact surfaces. There must be a detailed plan showing the types and locations of equipment used in the establishment.
2. The maintenance of all equipment and its components. For example, the calibration of indicating thermometers, gasket and filter replacement program, testing for all critical processes (e.g. HTST, Batch pasteurizer, APPS), etc.
3. The establishment's control and use of equipment seals. There are many tasks within the critical processes (HTST, Batch pasteurizer, APPS) that require a particular device be sealed to maintain the safety of the product. There must be a program in place to monitor and control the use and replacement of these seals. Records must be kept by the establishment for the sealing of equipment, which identifies (e.g. sequential numbering system) and lists the seals used and their location, when the seals are broken, reason why the seal was broken, that the equipment is re-sealed and the person responsible. In order for an establishment to be able to identify which seal has been removed, replaced and recorded, i.e. identifiable, the seals themselves need to be coded. This is the only way for the establishment to exhibit control over the seals.
4. The documented program must specify:
   • protocols and methods of standardization (how it is done and what is done),
   • responsible personnel (qualified and trained) (who does it),
   • inspection frequencies (how often or when it is done)
   • records to be kept
   • parameters of acceptability/unacceptability (tolerances).
   • results of monitoring and verification (both on-site and record review),
   • action to be 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.

The equipment must be maintained to ensure that no physical or chemical hazard potentials result (e.g. inappropriate repairs, flaking paint and rust, excessive lubrication). Mechanical parts, lubricants, oils, etc. must not be stored in food containers. Metal detectors can be useful in detecting some physical hazards in foods. If the establishment does not have a metal detector, the inspector must assess if the establishment has control over metal hazards (e.g. inspector would look for high number of foreign object complaints that have been received, maintenance of screens/filters, employee training program to see if employees are trained to observe any equipment malfunctions, etc.).

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

This program must be regularly reviewed and updated as required when changes occur.

1.10.03.02 Air Quality

This task covers the air and inert gases that are added directly into the product or on the packaging; for example air used in drying, freezing, agitation (e.g. product storage tanks), and ice cream and fluid milk 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.

Processing systems which incorporate air directly into the product, such as freezers, air blows and air agitation systems must be designed to reduce potential contamination and should be easily cleanable. All air used for processing must be filtered. Sanitary check valves should be provided as necessary to prevent product backup into air lines. Air blow and agitation equipment must be routinely checked for proper assembly and cleanliness. Most sanitary check-valves, air blows and agitation equipment are not satisfactorily cleaned by usual CIP methods and should be dismantled and manually cleaned and sanitized routinely.

The design of the compressing equipment must preclude contamination of the air with lubricant vapours and fumes. Oil-free air may be produced by one of the following methods or their equivalent:

1. Use of a carbon ring piston compressor.
2. Use of oil-lubricated compressor with effective provision for removal of any oil vapour by cooling the compressed air.
3. Water-lubricated or non-lubricated blowers.

Oils and lubricants used 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.

The air supply must be taken from a clean space or from relatively clean outer air and pass through an air filter upstream from the compressing equipment. This filter is located and constructed so that it is easily accessible for examination. The filter should be protected from weather, drainage, water product spillage and physical damage. Filter size must be such that it is effective for the purpose it is designed. See Appendix 19 - 2 for various types of compressed air systems.

A process air system must contain appropriate filters to remove undesirable particulate matter. If this air is withdrawn from a room, the air supply to the room must be filtered. The air filters in the latter case are rated under task 1.10.01.04 Building Interior. A variety of air filters are available to the industry. Pressure differential prior and after the filter may be used as an indicator of the filter's effectiveness.

To ensure good air quality, the air filters must be cleaned appropriately. Coarse metal mesh filters are cleaned by boiling in an alcohol solution followed by a dip in special adhering oil. Oil coated, fiberglass filters are discarded after use. These filters are used in tandem; the second filter is moved up when the first becomes dirty. If a dirty second filter is observed, then the filters are not being cycled in a satisfactory manner. Common furnace type filters (usually one inch thick) are inefficient and are unsatisfactory.

1.10.03.03 Compressed Air Equipment

This task includes 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, evaluate this under task 1.10.03.02 Air Quality.

For most purposes, the compressed air must be dry. This is achieved by passing the air under pressure through an oil-free filter and moisture trap for removal of solids and liquids. The filter and trap are located in the air pipeline downstream from the compressing equipment and air tank, if one is used. Filter size must be such that it is effective for the purpose it is designed. Air pipeline filters and moisture traps downstream from compressing equipment are not needed where the compressing equipment is of the fan or blower type (See Appendix 19 - 2).

1.10.03.04 Metal Detector

Metal detectors must be suitable for the specific product, associated hazard and the environmental conditions that the unit will operate in. If metal detectors are used, they must be designed, constructed, installed, calibrated and maintained in accordance with the equipment manufacturer's manual to ensure effective removal of metals. This may include: adjustment for product effect, selection of target metal and size and timing of the reject mechanism.

1.10.03.05 Critical Process Test Procedures

Plant management must ensure that the critical processes (e.g. HTST, Batch Pasteurizer, APPS, HHST/ESL) are tested in accordance with the Critical Process Test Procedures (Chapter 18), the appropriate Dairy Establishment Inspection Manual (DEIM) chapters, and Appendix 19 - 5 and 19 - 6 of the DEIM manual. This testing can be done by trained plant personnel or a reliable third party. The results of the testing should be recorded on the CFIA test procedures form. It will also be acceptable for the establishment or third party to use a different form to record the results of testing as long as the inspector assessing this task feels that the results can be easily interpreted, that the form has all the information present and that the test procedures are completed according to the test procedures.

The establishment must have a written procedure outlining what tests are being performed, how often, who is responsible (plant contact and third party, if used), verification procedures (record and on-site review) to verify that the requirements are being met. If the requirements are not met, appropriate action is taken by the establishment to correct the non-compliant equipment. Depending on the non-compliance, an investigation into the safety of the product may have to be done. Records are being kept to show that testing was done and corrective action was taken. All test procedure results must be reviewed on a timely basis by a member of plant management.

To adequately assess this task, records for all critical processes in the establishment must be available for review. In addition, the inspector is to observe the testing of the equipment at an appropriate frequency to assure proper procedures are being followed. The inspector will be looking to see that the testing is done according to the procedures and frequencies outlined in Chapter 18. If the testing is contracted out a list of the contractors could be maintained and scheduling could be coordinated with the establishment in order for the inspector to observe the testing. A suggested frequency of observation could be once per contractor per area.

For the critical processes, the following tasks are associated with a specified frequency of testing: 1.11.04.03, 1.11.05.01, 1.11.06.02, 1.11.06.03, 1.11.07.01, 1.11.07.03, 1.11.08.04, 1.11.09.01, 1.11.09.05, 1.011.09.06, 1.11.10.04, 1.11.11.02, 1.11.11.06, 1.11.12.03, 1.11.15.04, 1.11.16.03, 1.11.18.02, 1.11.19.02, 1.12.03.03, 1.12.04.03, 1.12.05.05, 1.14.04.03, 1.14.05.01, 1.14.05.02, 1.14.06.02, 1.14.06.03, 1.14.07.01, 1.14.07.03, 1.14.08.03, 1.14.09.04, 1.14.09.05, 1.14.10.04, 1.14.11.01, 1.14.11.03, 1.14.11.04, 1.14.11.05, 1.14.12.01, 1.14.12.04, 1.14.14.01, 1.14.14.02, 1.14.17.02, 1.17.04.03, 1.17.05.01, 1.17.05.02, 1.17.06.02, 1.17.06.03, 1.17.07.01, 1.17.07.03, 1.17.08.03, 1.17.09.01, 1.17.09.04, 1.17.10.04, 1.17.11.04, 1.17.11.05, 1.17.12.01, 1.17.12.04, 1.17.14.01, 1.17.14.02 and 1.17.17.02. When assessing the frequency of testing, each individual task should be assessed as unsatisfactory if the frequency of testing is not adhered to according to those set out in the DEIM, not just once for the overall system. The overall written program for the Critical Process Test Procedures task 1.10.03.05 should also be reviewed to see if there is a concern with the written program and maintenance schedules being followed. In some cases, depending on the scheduling by the third party testing company the timeframes may not be exactly as stated in the DEIM so there should be some flexibility allowed as to the exact timeframe (Not exceeding one month).

1.10.04 - Personnel Program

The objective of the personnel program is to ensure safe food handling practices. The personnel program is to provide, on an ongoing basis, the necessary training to production personnel.

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.

1.10.04.01 General

Every dairy establishment and importer must have a written training program for employees, providing adequate training in personal hygiene and the hygienic handling of food to all food handlers at the beginning of their employment. This training is to be reinforced and updated at appropriate intervals. An adequate personnel program monitors and controls all elements in this section and maintains the appropriate records.

Adherence to the criteria is verified by examining the establishment's written program that outlines the procedures that will be undertaken to ensure adequate training is maintained. The program must specify:

• areas to be inspected (what is done),
• tasks to be performed (how it is done),
• person responsible (who does it),
• inspection frequencies (how often or when it is done),
• records to be kept
• parameters of acceptability/unacceptability (tolerances)
• results of monitoring,
• verification procedures (both on-site and record review)
• action to be 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.

Training must be adequate and suitable to the complexity of the manufacturing process and the tasks assigned. For example:

1. Personnel must be trained 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.
2. Personnel responsible for maintenance of equipment impacting on food safety, are to be properly trained to identify deficiencies that could affect product safety and to take the appropriate corrective action i.e., in house repairs, contract repairs. Individuals performing maintenance on specific equipment must also be appropriately trained, e.g. closing machines, recorders. Personnel responsible for critical process test procedures are properly trained.
3. Personnel and supervisors responsible for the sanitation program must understand the principles and methods required for effective cleaning and sanitizing. Employees handling hazardous chemicals should be instructed in safe handling techniques.
4. Additional training needs to be provided as necessary to ensure current knowledge of equipment and process technology, e.g. specific technical training, apprenticeship programs, etc.

In order to minimize the risk that dairy products could be subject to while under control of the establishment, it is recommended that management provide training in food security awareness to encourage all staff to be alert to any signs of tampering or other malicious or terrorist actions or areas that may be vulnerable to such actions. Employees should be encouraged to be alert to the presence of unidentified or unknown individuals that are in areas to which they do not have designated access and report them to management.

This task will assess the written program and the records kept. The assessment of other inspection tasks will provide on-site verification of the effectiveness of the plant's training program.

1.10.04.02 Flow and Practices

This task will assess the movement or flow of both people and equipment throughout the establishment as well as the processing practices (good manufacturing practices) utilized.

To reduce the risk of contamination in processing and packaging areas the movement of personnel and equipment between areas must be restricted and well controlled. This applies to lab personnel, delivery and maintenance personnel as well as staff performing various processing activities. Generally speaking, personnel (including maintenance staff) may move freely from microbiologically clean areas to less clean ones but their movement back to a cleaner area must be restricted or very well controlled. Personnel in raw receiving areas should not move into any other areas of the plant unless strict procedures are followed (e.g. foot baths, hand dips, etc.). Employees responsible for the receiving of raw milk must not move throughout the plant as their clothing and shoes may be a source of contamination in clean areas. This also applies to all visitors to the plant such as farmers, salespersons and field personnel. The colour coding of clothing facilitates the monitoring of personnel flow.

With respect to equipment layout, a process flow that is straight and simple is preferable from a sanitation point of view. The movement of portable equipment (e.g. pallets, carts, etc.) from one area to another must also be restricted and controlled to minimize the potential for cross contamination. The same principle applies to equipment as to personnel flow; equipment should not move to or back from cleaner areas after being in less clean areas without appropriate controls.

Special attention must be made to control frequent personnel and equipment flow between wet areas of the plant to minimize the risk of spreading contamination. The use of strategically located and well maintained foot baths or sprays may be one method to minimize the risk of spreading contamination.

To evaluate the flow aspect uniformly:

1. observe if personnel/equipment move between activity areas.
2. observe if controls are in place (required if movement occurs from less clean to cleaner areas).
3. if controls are not adequate, assess the task as not satisfactory.

The manufacturer ensures good personal hygiene and hygienic behaviour and work procedures are followed to prevent contamination of food products.

1.10.04.03 Hygiene & Health

This task assesses the employee's hygiene as well as their personal behaviour and habits in areas where food is processed. Practices related to food handling are evaluated under task 1.10.04.02 Flow and Practices.

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. Although no jewellery, including facial adornments is preferred, jewellery worn for religious, marital or health reasons must be properly secured and covered. These items have the potential to fall into or otherwise contaminate the dairy product and as such pose a food safety hazard. Clothing cleaned by a private service should be delivered clean and protected and stored separately from street clothes.

It is recommended that employee clothing should be white or light coloured or colour coded to distinguish work areas (e.g. red in raw receiving areas and white in the packaging room). It is recommended that hair nets that are used be obvious and shower type.

Poor hygiene and all unhygienic behaviours that would contaminate food must be prohibited. Personnel engaged in food handling activities should refrain from behaviour which could result in contamination of food, for example smoking, spitting, chewing or eating, and sneezing or coughing over unprotected food. Personal effects and street clothing must not be kept in food handling areas and must be stored in a manner to prevent contamination. In-plant footwear and clothing is to worn only within the plant. Wearing in-plant footwear and clothing outside the plant and then returning to the plant could result in a source of contamination to the product or processing area. The establishment would develop policies and procedures to mitigate this requirement.

It is important that employees with obvious health conditions are not in direct contact with food products. Plant management must have a policy to prevent personnel known to be suffering from, or known to be carriers of a disease transmissible through food, from working in food handling areas. This policy could be part of the company's written training program directed to all new employees. Proper training and education of employees in food safety, maintenance of hand washing facilities and sanitary waste handling are measures that can be included in the preventing the spread of foodborne disease.

The manufacturer must require that employees advise management when they are suffering from a communicable disease likely to be transmitted through food. Employees should be encouraged to report to their supervisors whenever they have diarrhoea, sore throat, fever, a cold, or open skin lesions, or are jaundiced. Employees with cuts or wounds must be assigned to non-product work areas or their cut or wound must be protected by a secure, waterproof covering. Latex gloves are not recommended for use in a food establishment. There is evidence to suggest that for some individuals there is a potential allergy concern with the transfer of latex to food products. This is not a mandatory requirement, but only a recommendation that when establishments use sanitary gloves they choose a non-latex type.

The Health Surveillance and Management Procedures For Food-Handling Personnel Technical Report from the World Health Organization, dated 1989 is a good reference document on the hygienic approach to food handling. According to this document infections and intoxications potentially transmissible by food handlers include: Staphylococcus aureus infection, typhoid and paratyphoid fevers, non-typhi salmonellosis, Escherichia coli enteritis, Shigellosis, Cholera and Viral hepatitis A. Some other illnesses to be concerned with include those due to Campylobacter jejuni, Rotovirus, E. coli 0157:H7, Norwalk and Norwalk-type viruses, Streptococcus pyogenes, Yerisinia enterocolitica and Giardia lambia. Since health examinations of food-handling personnel are not effective in preventing the spread of foodborne diseases, alternative measures might include surveillance of outbreaks of foodborne diseases, the use of a HACPP system within the food establishment, education and training of managers and food handlers in food safety and provision and maintenance of hand-washing facilities and the sanitary collection and disposal of wastes.

1.10.04.04 Handling of Materials

This task assesses how personnel handle the ingredients (e.g. fruits, nuts, powders, starter cultures, etc.) and packaging materials (glass containers, foil and plastic wrap, powder bags, etc.) during processing. It also assesses the manual formation of packaging containers such as ice cream cartons.

The materials must not pose a contamination risk as they are received into the processing area and when they are in use. If these materials are not properly handled they can be contaminated by dust, foreign materials, moisture and personnel; subsequently they can affect the safety of the product. Prior to filling, containers should be cleaned by air, suction or water.

Task 1.10.02.03, Incoming Material, evaluates the initial receipt of incoming ingredients and packaging material.

1.10.05 - Sanitation Program

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.

1.10.06 - Recall Program

This task assesses a manufacturer's and importer's written recall procedure to ensure an effective recall of any lot of food from the market. This procedure helps to minimize the confusion that may result during a recall. The information in this document must be kept current. It should include details about the retrieval of information that is typically required during a recall. This includes:

• The person or persons responsible (who does it).
• The roles and responsibilities for coordination and implementation of a recall (what is done).
• Methods to identify, locate and control recalled product (how and when it is done).
• A requirement to investigate other products that may be affected by the hazard and that should be included in the recall.
• Procedure for monitoring the effectiveness of the recall, e.g. effectiveness check to the appropriate level of distribution specified in the recall notice.
• Immediate notification to the CFIA Area Recall Coordinator in the area or region where the manufacturer is located, or in the case of a provincially licensed establishment, the appropriate provincial authority. A list of CFIA Area Recall Coordinators is available on the CFIA website.

Flow charts are useful to summarize the steps involved in a recall.

Manufacturing records must be detailed enough to trace back a particular lot of product and even a specific ingredient or additive added to the product. Distribution records must be able to account for the total quantity of the lot produced. Parts of a lot that are on hand, on hold or reworked must also be referenced in the records. The distribution list should be product and lot code specific. If the distribution list is not specific, the manufacturer must be prepared to do a wider recall to bring back all implicated products.

The manufacturer must be capable of producing accurate information on a timely basis to verify that all affected product can be rapidly identified and removed from the marketplace. This can be demonstrated by complete manufacturing and distribution details for every lot.

The establishment must assess the effectiveness of their notification. This should include the number of accounts that were notified, the number of accounts that were contacted or checked to see if they had received the recall notification, method of confirming that the accounts were notified. A statement describing how they determined if the recall notification was effective, a statement of the recall notification effectiveness, i.e. satisfactory, not satisfactory, and a statement of corrective action to be taken where it is determined that the recall was not satisfactory.

Periodic testing (minimum of once per year) of the recall program must be done to verify the capability of the procedure to rapidly identify and control a code lot of potentially affected product and reconcile the amount of product produced, in inventory and in distribution. The establishment should be able to demonstrate the traceability of the affected product to the distribution centre level. Any deficiencies in the recall procedure must be identified and corrected.

An establishment must have a standard documented procedure which details the action taken when complaints are received on dairy products. The complaint should be taken by a designated individual. The complaint file should include recording of the initial complaint information, investigating the complaint and recording the findings and taking action based on the investigation findings. The investigation should be investigated by a trained person. When all the investigation findings are collected a decision of the action to be taken must be made. In some instances, a complaint investigation by the establishment may reveal that the product should be withdrawn from the market. This recall of product is undertaken when a product is considered to be a potential health hazard or in violation of government regulations. Should an establishment be unsure of the need for a recall or to ensure the action/decision is correct, they should contact the CFIA for consultation. The decision must include what to do with the affected product(s) and how to correct the problem.

Once the recall is complete and all the non-compliant product is removed from the marketplace, the manufacturer or importer must perform an assessment to determine the root cause of the recall. The establishment must develop and implement appropriate corrective measures to prevent the re-occurrence of the deficiencies or a similar violation which may result in future recall action. The establishment must review the current written procedures used in the manufacture/importation or sale of the non-compliant product and the appropriate changes must be made to prevent the re-occurrence. Detailed records must be kept by the establishment documenting that the assessment was completed and what corrective action was taken.

For further information on this task please refer to the Recall Plan - Manufacturers' Guide

Additional guidelines on food emergencies can be found in the Canadian Food Inspection Agency - Food Investigation Response Manual (CFIA).

1.10.07 - Process Control Program

The objective of this program is to ensure the production of safe food. By having controls in place throughout the manufacturing process to monitor product formulation, labelling and preparation, shelf life and finished product analysis, the likeliness of having to recall product after it has left the establishment could be reduced.

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.

1.10.07.01 General

Dairy establishments and importers (where applicable) must have a documented program in place to monitor and control all elements in this section, and maintain the appropriate records.

The process controls that must be covered in this program include product formulae, food additives, nutritional requirements, label accuracy, product preparation, shelf life studies, product and environmental monitoring (including Health Canada's (HC) Policy on Listeria monocytogenes in Ready-to-Eat Foods – HC Listeria monocytogenes (Lm) Policy) and laboratory facilities and practices.

Adherence to the criteria is verified by examining the establishment's written program that outlines the procedures that will be undertaken to ensure satisfactory conditions are maintained. The program must specify:

• assigned risk categories for ready-to-eat foods (HC Lm Policy),
• areas to be inspected (what is done),
• tasks to be performed (how it is done),
• person responsible (who does it),
• inspection frequencies (how often or when it is done),
• sampling procedures and lab methodologies,
• records to be kept,
• parameters of acceptability/unacceptability (tolerances),
• results of monitoring,
• verification procedures (both on-site and record review),
• action to be taken for deviant situations,
• trend analysis (HC Lm Policy)

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 be updated as required when changes occur.

The actual monitoring of this program will be done by assessing tasks 1.10.07.02 to 1.10.07.05.

1.10.07.02 Manufacturing /Allergen Controls and Records

This task assesses if the plant has good control over its product formulae, food additives, nutritional requirements and label accuracy. In order to rate this task as satisfactory the inspector must do an on-site observation to determine if product is being manufactured in accordance with written procedures for components listed in A - E.

A) Product Formulae: The manufacturer has written formulae available for each product processed that are current, permitted by the standard and provide a basis for assessment and control of food additives, nutritional requirements and food allergens (ingredients which may cause adverse reactions). The formulae contain all details of the formulation as follows:

• identification of specific ingredients and additives (e.g. concentration, type)
• amounts of additives and ingredients

The production worksheet identifies all ingredients (including re-runs and re-work) for each batch. Although it is not required, a double sign-off procedure is one way manufacturers can exhibit control over the ingredients being used. This is usually done at two separate stages of processing by two separate people, first when ingredients are measured out and secondly when added to the formulation or mix tank. The manufacturer has verified he has control over the ingredients and additives through calculations, ingredient inventory balance sheets and finished product testing.

B) Food Additives: Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations. Inadequate control of food additives could result in chemical or biological hazards. The manufacturer ensures that all food additives used are permitted for use in the particular food and meet the requirements of the Food and Drug Regulations. The specifications for all food additives are on file. As part of the product formulations, the manufacturer can show with calculations and has verified that food additives are used within the maximum level specified in the Food and Drug Regulations. Certificates of Analysis from the ingredient suppliers stating all food additives used in an ingredient meet the requirements of the Food and Drug Regulations would be satisfactory for the sub-ingredients within an ingredient.

C) Nutritional Requirements: The addition of nutrients (with respect to vitamin and mineral fortification) to food products is controlled to meet the requirements of the Food and Drugs Act and Regulations. The manufacturer has control over the formulation to ensure that all nutritional requirements and claims are met. 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 (example calorie-reduced, low sodium). Nutrients used are permitted in accordance with the Food and Drug Regulations. The nutrient content of the product is accurately reflected on the label. The manufacturer has specifications for nutrients. The manufacturer has received certification from the supplier as follows:

• a certificate of analysis accompanies each lot of nutrient
• for nutrients used in foods that are the sole source of nutrition, each certificate is verified through analysis

The manufacturer has verified and can demonstrate through calculations that nutrients are used within the limits specified in the Food and Drug Regulations.

D) Label Accuracy: The manufacturer ensures that the label information accurately represents the composition of the products packaged at the facility. Controls are necessary to prevent the presence of undeclared allergens in the product. Accurate labels inform and protect segments of the population which may be allergic to certain foods. Procedures are in place to ensure that labels accurately represent product formulation and composition. The following are such procedures:

• new label review
• incoming label review for accuracy/correctness
• formulation changes/substitutions
• procedures are in place to prevent the product mis-labelling at time of packaging, example, effective separation of product types during changeovers, labels are visually checked prior to use, proper storage of labels
• weighed out ingredients used during the formulation process are properly labelled and segregated (where required)

It is recognized that it is common industry practice that the development of the label is completed at corporate office but it is expected that the checks for label accuracy, incoming label review, formulation changes and controls to prevent mis-labelling are all responsibilities of the processing establishment and thus require procedures to ensure accuracy.

E) Product Preparation: In order to avoid contamination with ingredients which may cause adverse reactions, for all products packaged in the facility, the establishment must provide proper training to ensure:

• that during product preparation no ingredient substitution occurs;
• that internally processed ingredients (re-runs and re-work material) do not contain ingredients that may result in adverse reactions unless the finished product label clearly indicates the presence of these ingredients;
• that controls are in place to ensure that when different flavours of dairy products are processed successively common equipment (such as mix transport lines, freezing machines, molds, novelty lines and hoppers) is free of undeclared ingredients which may result in adverse reactions that could be carried over into the next production;
• controls are in place to ensure that when milk/non-milk products are processed in the same establishment, there is no carry-over into the next production (no dead ends/pockets/cross connections allowing for the introduction of milk between dairy and non-dairy production runs, CIP systems are adequate);
• controls are in place for establishments that process both pasteurized and heat treated or raw milk cheese to ensure that all pasteurized product is processed first followed by the raw product with a complete wash with sanitizing prior to the processing of pasteurized product.
• controls are in place to ensure that raw milk cheese is labelled with the manufacturing date to ensure the 60 day period of maturation (Food and Drug Regulations B.08.042 - B.08.048).
• controls are in place to avoid mixing different ingredients during storage and handling;

It is recommended that manufacturers package in containers with tamper evident seals that will ensure the security and integrity of their products once they are produced, until they are purchased by the consumer.

1.10.07.03 Microbiological Control and Records

This task assesses if the plant has good microbiological control over its products and environment. Microbiological control programs are used to verify the production of safe food.

Product Shelf Life Studies:

Microbial growth is dependent upon many environmental conditions such as: ingredients, nutrients, water activity, pH, presence of preservatives (e.g. curing salts), competitive microorganisms, gas atmosphere, redox potential, storage temperature and time. Control of these conditions can therefore be used to limit microbial growth.

Product shelf life is an inherent control measure that, in many cases, is crucial for the safety and suitability of the product. There are a number of reasons for shelf life testing: to assure consumer acceptability, to test compliance with regulatory standards, to establish viability in the marketplace, to verify quality assurance procedures, to compare different processors' products and to determine effects of abuse on products.

Product shelf life is influenced by a number of factors, such as:

• Product formulation (might include decreased pH, decreased water activity)
• Scheduled heat or other preservation treatments,
• Applied hurdles (e.g. water activity, pH), including storage temperature,
• Cooling methods applied to product,
• Type of packaging (e.g. hermetically sealed or not, Modified Atmosphere Packaging),
• Level of post process contamination and type of contamination

Product shelf life studies must be determined and re-formulated for all products with a mandated best before date, for new products, when formulations change, when processing and equipment changes occur, when significant alterations have been made to the scheduled process and when the best before date is changed. If plant documentation and records show that changes made do not affect the already established shelf life study on a product there would be no need to conduct another shelf life study. For example, if a filling machine was replaced by another filling machine this would not necessarily constitute a shelf life study. However, if the type of packaging system changed for example to an extended shelf life system there would need to be a shelf life study done.

When establishing product shelf life, it is the responsibility of the manufacturer to assure and to demonstrate that the safety and suitability of the milk product can be retained throughout the maximum period specified, taking into consideration the potential for reasonably anticipated temperature abuse during manufacture, storage, distribution, sale and handling by the consumer. This means that any regulatory microbial limits must not be exceeded up to the last day of the product's shelf life.

Shelf life determination should be carried out at the establishment by testing products submitted to the storage conditions specified or by predicting microbial growth in the product under the specified storage conditions. Reasonable anticipated temperature abuse can be integrated into the study or be taken into account by applying an appropriate safety factor (e.g. by shortening the maximum durability specified in the labelling or by requiring lower storage temperatures). To determine shelf life potential, for example many establishments hold samples of processed milk in unopened consumer packages for seven, ten and/or fourteen days at 7.2°C (45°F) to the sell-by-date or beyond. This temperature is considered to simulate potential conditions under which milk is exposed during distribution and home storage prior to consumption. After a chosen holding period the milk is often evaluated for odour and taste. Bacterial tests may also be performed at this time. Ideally, coliform and Standard Plate Counts (SPC) should not increase significantly during storage when compared with fresh samples.

For longer shelf-life products, where shelf-life studies are commonly performed on unopened packages, it is recommended that the manufacturer applies a consume within … statement to the package to assist the consumer in making informed choices on the quality of the product once opened.

Product and Environmental Monitoring:

Food processing and environmental conditions are monitored to determine adherence to good manufacturing practices, conformance to standards, adherence to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods and for the detection of contaminants. It is the dairy establishment's responsibility to verify compliance to regulatory standards, to ensure the safety of the product and for verification that the HACPP based program is working.

The food establishment may perform analyses in house or use outside laboratory services. It is recommended that certified laboratories be used when possible. It is important when sampling to have a representative number of samples depending on the size of the lot and the type of analysis being conducted. Sample selection should be as random and representative as possible. When sampling for microbiological analysis aseptic sampling techniques (using sterile containers and equipment, clean clothing, sterilized gloves) need to be followed so as to not contaminate the samples. Procedures with respect to representative number of samples based on lot size, suitable sample size, random sampling, aseptic sampling procedures are outlined in the Dairy Sampling Procedures of the Dairy Product Inspection Procedures.

Acceptable test methodologies (methods which reliability, accuracy, reproducibility, lab variation have been statistically established) must be used when conducting the analysis so as to provide accurate and meaningful results, e.g., AOAC methods. The Standard Methods for the Examination of Dairy Products by the American Public Health can be consulted for methodologies. Preference should be given to methods which have been validated for the commodity concerned preferably in relation to reference methods elaborated by international organizations.

While methods should be the most sensitive and reproducible for the purpose, methods to be used for in-plant testing often sacrifice to some degree sensitivity and reproducibility in the interest of speed and simplicity. They should, however, have been proved to give a sufficiently reliable estimate of the information needed. The Health Canada website provides a reference of laboratory methods within the Compendium of Analytical Methods.

If an establishment is using a blend of both in-house indicator testing and validation/verification using the official testing procedures, this can be rated by the inspector as satisfactory. Whenever confirmation of a result is needed the official method of testing needs to be used as well as an acceptable method and lab.

For microbiological monitoring samples where the degree of non-compliance is minimal or non-existent it would be acceptable for the 5 sub-samples to be composited and still maintain the 3 class sampling plan. The document on how to evaluate composited results can be found in the Dairy Sampling Procedures of the Dairy Product Inspection Procedures. If results come back out of compliance on the composited sample, then the 5 sub-samples would have to be re-analyzed individually to ensure compliance to regulations.

It is most effective to test products in the condition the consumer purchases the product, for example after being packaged and cooled, not hot from the vat or churn. Products must be tested at a frequency sufficient to determine compliance to regulatory standards, adherence to good manufacturing practices, to ensure product safety (free from potential pathogens), as well as to meet the safety and suitability requirements at the end of the shelf life. It is up to the establishment to define the frequency of sampling and should be based on product history, risk of the product, type of process (batch vs. continuous), consumer complaints, volume of product produced, the intended use of the product, the category of consumers concerned. It will be up to the inspector to assess if the frequency is adequate based on the establishment's criteria. The Dairy Sampling Procedures of the Dairy Products Inspection Procedures can be used as a guide to determine what type of analysis could be performed on various types of products.

The following analyses should be considered:

I. Product testing:

1. As an indication of overall sanitation and shelf life:
   • total coliform and E. coli,
   • SPC,
   • yeast and mold
2. For compliance to regulatory standards and for product safety:
   • pathogens such as (but not limited to) Salmonella, Listeria, S. aureus or verotoxigenic strains of E. coli
3. To verify the suitability of incoming raw materials and ingredients and their compliance to supplier specifications.
4. Phosphatase Testing: For the manufacturers of dairy powders, where there is no HTST system, each lot is tested for alkaline phosphatase using a validated method such as Official Method (MFO)-3, Charm Paslite or Flurophos by in-house or accredited labs. Acceptable procedures are included in the manufacturer's product monitoring program. Product is labelled accordingly depending on the processing treatments received.

II. Environmental monitoring:

The establishment has a written program in place to monitor the environmental conditions and food contact surfaces within the establishment. Environmental monitoring is a tool to verify good manufacturing practices, effective sanitation and prerequisite programs within an establishment. Health Canada's policy on Listeria monocytogenes in Ready-to-Eat Foods (HC Lm Policy) clearly defines the roles of industry and government and can be found on Health Canada's website. Persistent contamination of product contact surfaces in the plant environment is an indication of inadequate good manufacturing practices and may lead to finished product contamination.

III. Application of Health Canada's Policy on Listeria monocytogenes Ready-to-Eat Foods

The HC Lm Policy describes Listeria verification activities for RTE foods in both the plant environment and in finished products. The verification activities assess the effectiveness of Good Manufacturing Practices (GMP) or the HACPP system to minimize potential sources of food contamination. Dairy processors producing RTE foods are responsible to test their environment for Listeria spp. and confirm whether any product is contaminated with Lm when environmental findings are unsatisfactory. With respect to this policy and the criteria listed under task 1.10.07.01, the establishment's written program specifically includes the following:

• assigned risk categories for RTE products,
• acceptable sampling procedures and methodologies of analysis,
• sampling sites, monitoring frequencies and rationale for these frequencies,
• trend analysis,
• notification to CFIA and submission of a corrective action plan for unsatisfactory situations

The establishment is responsible for determining the risk categories of their RTE foods and establishing sampling frequencies to monitor their environment and products throughout the year. Sampling frequency of environmental (Food Contact Surface (FCS) and non-FCS) and finished product should be based on an internal risk assessment that takes into consideration specific criteria such as product risk categories, volume produced, processing conditions, equipment design, history of compliance etc.

Environmental sampling (Listeria spp.) is to include FCS sites taken during production (including final packaging step) and non-FCS based on the complexity of the process as per the HC Lm Policy. The Dairy Sampling Procedures of the Dairy Product Inspection Procedures needs to consist of 5 sub-samples (at least 100 g each) and it is recommended these be taken at the same time as the FCS environmental sampling. Acceptable testing methods are to be used (see HC's Compendium of Analytical Methods)

It is also recommended for the establishment to hold product until results are received.

The establishment is to notify the CFIA of positive results for Lm or persistent L. spp. findings on a FCS (for all RTE foods). A corrective action plan is to be submitted by the establishment. Appropriate follow up actions (HC Lm Policy Figures 1, 2 and 3) are to be followed.

Industry is also responsible to perform trend analysis of environmental and product sampling results. This could include an on-going review and analysis of data for L. spp. from routine monitoring to detecting trends and improving controls before major issues develop. For example, the use of quality control methods and statistical methods, e.g. control charts, Pareto diagrams, etc. are recommended.

All records must indicate satisfactory frequency of monitoring and must be complete and available at the plant. Out of compliance results must trigger action that is documented in the records. Follow up investigations on any out-of-specification results must look for the root cause and be well documented.

1.10.07.04 Composition Control and Records

This task assesses if the plant adequately controls product composition.

Composition records must provide this assurance. Composition analyses can be performed in house or contracted out. It is important when sampling to have a representative number of samples depending on the size of the lot and the type of analysis being conducted. Sample selection should be as random and representative as possible. Procedures with respect to representative number of samples based on lot size, suitable sample size and random sampling procedures are outlined in the Dairy Sampling Procedures of the Dairy Products Inspection Procedures.

Acceptable test methodologies must be used when conducting the analysis so as to provide accurate and meaningful results. It is most effective to test products in the condition the consumer purchases the product, example after being packaged and cooled, not hot from the vat or churn.

It is the dairy establishment's responsibility to verify compliance to regulatory standards. Products must be tested at a frequency sufficient to determine compliance to regulatory standards. Records must be complete and available at the plant and indicate satisfactory frequency of monitoring and that appropriate action is taken for the products out of compliance. Follow up investigations on any out-of-specification results must be looking for the root cause and be well documented.

1.10.07.05 Laboratory Facilities and Practices

Lab facilities must not provide a contamination risk to food products. If the lab is conducting micro and pathogen testing the lab facilities must be well isolated from processing areas of the plant; if not isolated then the lab facilities must have negative pressure. Isolation and enumeration of pathogenic microorganisms must not pose a risk of contamination to the product or to the plant environment. Therefore, pathogenic testing should be done in a separate building.

Lab practices must be controlled to ensure that no contamination risk exists to food products. The techniques used to take samples in the processing line must not pose a contamination risk. Proper disposal of laboratory samples and materials is required.