Food > Fresh Fruits and Vegetables
Code of Practice for Minimally Processed Ready-to-Eat
Vegetables
Table of contents
Part I Introduction
Part II Good
Agricultural Practices
Part III Pre-Requisites
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Processing Establishment
1.1 Location
1.2 Premises and Rooms
1.3 Sanitation Facilities
1.4 Quality and Supply of Water and Ice
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Transportation and Storage
2.1 Temperature Control
2.2 Conveyances and Containers
2.3 Incoming Materials and finished products
2.4 Non-Food Chemicals
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Equipment
3.1 Design and Installation
32 Equipment Maintenance and Calibration
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Personnel
4.1 Training
4.2 Hygiene and Health Requirements
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Sanitation and Pest Control
5.1 Sanitation Program
5.2 Pest Control Program
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Trace-Backs and Recalls
6.1 Trace-Back and Recall Systems
6.2 Recall Capability
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Documentation and Records
Part IV Manufacturing Controls
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Process Design
1.1 Shelf Life Validation
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Product Formulation
2.1 Specifications
2.2 Product Formula
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Incoming Material Control
3.1 Incoming Materials
3.2 Incoming Material Control Records
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Preprocessing and Processing
4.1 Inspection, Sorting, Trimming and First Wash
4.2 Cutting, Slicing, Shredding and Grinding
4.3 Washing
4.4 Antimicrobial Treatment
4.5 Adherence to Product Formulation
4.6 Product Temperature during Processing
4.7 Product Processing Records
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Packaging
5.1 Packaging and Containers
5.2 Critical Packaging Factors
5.3 Packaging Records
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Container Coding and Labelling
6.1 Product Identification
6.2 Label Accuracy
6.3 Coding - "Use-By" Date
6.4 Labelling - Storage Temperature
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Deviations and Corrective Action
7.1 Deviation Control
7.2 Corrective Action
7.3 Deviation and Corrective Action Records
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Verification of Product Safety
8.1 Verification Procedures
8.2 Verification Records
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Complaint Handling
9.1 Product Complaints
9.2 Complaint Records
Background
The health benefits associated with fresh produce combined
with the on-going consumer trend toward eating out and
consuming ready-to-eat foods have contributed to a
substantial increase in the popularity of minimally processed
ready-to-eat vegetables. Lettuce and other salad
vegetables which are minimally processed (washed, trimmed and
bagged) by food manufacturers provide convenient products to
the consumer.
The minimally processed ready-to-eat vegetable industry was
initially developed to supply restaurants, hotels and other
institutions and, more recently, was expanded to include food
retailers for home consumption. Although no detailed
statistical information is available on the volume of
domestic production or importation, these products appear to
be gaining an increased market share.
Whereas most salads and other vegetables are still prepared
at home, the inclusion of minimally processed ready-to-eat
vegetables has moved the preparation of these products from
the consumer. The increased time and distance between
processing and consumption may contribute to higher risks of
food-borne illness. Although chemical and physical hazards
are of concern; such as the presence of agricultural
chemicals and food additives above the maximum residue limits
or the presence of metals and other injurious particles; the
hazards specific to minimally processed ready-to-eat
vegetables reside mainly with microbial contaminants.
Some of the microbial pathogens associated with fresh
vegetables include Listeria
monocytogenes, Salmonella spp., Shigella spp., enteropathogenic strains of Escherichia coli, hepatitis A
virus, etc. The possible
sources of contamination in these products involve the
incoming raw vegetables, the plant workers, and the
processing environment. When vegetables are chopped or
shredded, the release of plant cellular fluids provides a
nutritive medium in which microorganisms can grow. The high
moisture content of fresh vegetables, the lack of lethal
process to eliminate microbial pathogens, and the potential
for temperature abuse during preparation, distribution and
handling further intensify the risk of food-borne illness.
In response to the increased consumption of minimally
processed ready-to-eat vegetables and the risks of food-borne
illness associated with these products, governments and
industry have initiated work in the development of a code of
practice for the manufacturing of minimally processed
ready-to-eat vegetables.
Scope
This code of practice has been developed for the
manufacturing of minimally processed ready-to-eat vegetables
consisting of raw vegetables that have been peeled, sliced,
chopped or shredded prior to being packaged for sale in
Canada. Applicable products include shredded lettuce,
shredded cabbage, mixed vegetable salads, ground broccoli and
peeled baby carrots. Packaging includes single serving
containers (e.g., sealed
pouches or plastic trays), larger consumer or institutional
size packages and bulk containers. With the possible
exception of the addition of dressing or croutons by the
end-user, the products do not require further preparation
before consumption.
Products for which this code does not apply include fresh
vegetables that have been trimmed only and sliced potatoes or
other vegetables that are destined for cooking (e.g., french fries). Manufacturers of
products that are prepared and consumed on the premises the
same day (e.g., restaurants
and delicatessens) are exempted from this standard.
Although there is no specific regulation for minimally
processed ready-to-eat vegetables under the Canadian
Agricultural Products Act, these products must conform
with sections 4 and 7 of the Food and Drugs Act.
Section 4 states that: No person shall sell an article of
food that has in or on it any poisonous or harmful substance;
is unfit for human consumption; consists in whole or in part
of any filthy, putrid, disgusting, rotten, decomposed or
diseased animal or vegetable substance; is adulterated; or
was manufactured, prepared, preserved, packaged or stored
under unsanitary conditions. Section 7 states that: No person
shall manufacture, prepare, preserve, package or store for
sale any food under unsanitary conditions.
Use of the Code
This code is intended to provide guidance for the safe
manufacturing of minimally processed ready-to-eat vegetables.
As there are several processes available to manufacture these
products, a general approach has been taken in developing
this code. It is not intended to cover all possible means of
implementing preventative measures. Alternative approaches
may apply if they adequately minimize food safety hazards.
Manufacturers are encouraged to use the general
recommendations of this code to tailor food safety practices
appropriate to their particular operations.
Part II of this code outlines Good
Agricultural Practices for the primary production and
harvesting of fresh vegetables. Although manufacturers may
not be involved in the primary production of vegetables, this
section was included in the code to raise the awareness of
its role in the safe manufacturing of minimally processed
ready-to-eat vegetables. A code of practice for the primary
production and harvesting of fresh produce is currently in
development. This code will provide farmers with guidance for
the hygienic production of fresh produce.
Part III and IV of this code are composed of general safety
objectives followed by specific recommendations on how to
achieve them. It is important to assess recommendations
individually and, when necessary, consider alternative
approaches that may be more appropriate to particular
operations in the achievement of general safety objectives.
Microbial and chemical contamination may occur during the
primary production and harvesting of fresh produce. The
safety of minimally processed ready-to-eat vegetables is
highly influenced by the degree of preventative measures used
on farm to prevent contamination. Growers should be aware of
good agricultural practices which minimize risks of
microbial, chemical and physical contamination during the
primary production and harvesting of fresh produce.
Manufacturers should prescribe growers to adopt good
agricultural practices and provide evidence that the product
was grown according to specifications.
The general aspects of the good agricultural practices to
promote safety of fresh produce include:
Land Usage
Previous and present usage of the growing field and adjoining
sites should be evaluated (crop grown, feed lot, toxic waste
site, etc.) to identify
potential sources of produce contamination such as
agricultural chemicals, fecal contamination or other toxic
compounds. Steps should be taken to prevent the access of
farm and wild animals to the sites to avoid potential fecal
contamination of the soil and the risk of contaminating crop.
Natural Fertilizer
The use of natural fertilizers (e.g., manure, organic materials,
slaughter wastes, sewage sludge, etc.) in the production of produce should
be managed to limit the potential for microbial and chemical
contamination of produce. Natural fertilizers should be
properly treated (composting, pasteurization, heat drying,
(UV irradiation, alkali
digestion or combinations of these) to minimize the potential
for microbial pathogens.
Agricultural Water
Water used for irrigation and fumigation is a potential
source of contamination as it may contain microbial
pathogens, heavy metals and other chemicals. Growers should
evaluate the source of water used on the farm (well, open
canal, reservoir, re-used irrigation water, municipality,
rivers, lakes, etc.), monitor
its safety and control potential sources of contamination.
Agricultural Chemicals
Growers should only use agricultural chemicals which are
acceptable for the cultivation of the specific produce and
should use them according to manufacturers instructions
for the intended purpose. Growers should keep records on
agricultural chemical applications (agricultural chemical
used, rate and date of application, etc.).
Worker Hygiene
Hygiene and health requirements should ensure that personnel
who come directly or indirectly into contact with produce are
not likely to contaminate produce. People known or suspected
to be carriers of a disease or illness likely to be
transmitted through produce should not be allowed access to
areas of the fields or indoor premises where there is a
likelihood of contaminating produce. To ensure good personal
hygiene, growers should provide toilets and hand washing
facilities easily accessible to farm workers.
Harvesting
Diseased, damaged or overripe vegetables which could be
susceptible to microbial contamination should be destroyed.
Only sound fresh vegetables should be harvested and shipped.
Physical contaminants such as stones, pieces of wood, metals
or glass and foreign material such as insects or insects
parts should be removed.
Transportation and Storage
Vehicles for transporting produce and storage facilities
should be suitable for produce and adequately refrigerated.
Containers, vehicles, and storage facilities should be
cleaned and sanitized regularly and secured from rodents and
insects to minimize risks of contamination.
1. Processing
Establishment
1.1 Location
Establishments should not be located in areas where the
presence of potentially harmful substances would lead
to unsafe finished product.
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Potential sources of contamination need to be considered when
deciding where to locate processing establishments as well as
the effectiveness of any reasonable measures that might be
taken to protect food. In particular, establishments should
be located away or protected from:
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environmentally polluted areas and industrial activities
which could pose a threat of contaminating produce;
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areas subject to flooding unless sufficient safeguards are
provided;
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areas prone to infestations of pests or areas where wastes
cannot be removed effectively.
1.2 Premises and Rooms
1.2.1 Design and Layout
Building interiors and structures should permit good
hygienic practices, including protection against
cross-contamination between and during operations.
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1.2.2 Internal Structures and Fittings
Structures within processing establishments should be
soundly built of durable materials and be easy to
maintain, clean and where appropriate, and disinfect.
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In particular the following specific conditions should be
satisfied, where necessary, to protect the safety and
suitability of food:
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The surfaces of walls, partitions and floors should be
made of impervious materials with no toxic effect in the
intended use;
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Walls and partitions should have a smooth surface up to a
height appropriate to the operation;
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Floors should be constructed to allow adequate drainage
and cleaning; Ceilings and overhead fixtures should be
constructed and finished to minimize the build up of dirt
and condensation, and the shedding of particles;
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Windows should be easy to clean, be constructed to
minimize the build up of dirt and where necessary, be
fitted with removable and cleanable insect-proof screens.
Where necessary, windows should be fixed;
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Doors should have smooth, non-absorbent surfaces, and be
easy to clean and, where necessary, disinfect.
1.2.3 Food Contact Surfaces
Food contact surfaces should be constructed of
appropriate materials and be maintained in a manner to
prevent contamination of food. Food contact surfaces
should be constructed of appropriate materials and be
maintained in a manner to prevent contamination of
food.
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Equipment and containers coming into contact with food
should be made of materials with no toxic effect, and
where appropriate, designed and constructed to ensure that
they can be adequately cleaned, sanitized and maintained.
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Coatings, paints and materials used for food contact
surfaces or equipment where there is a possibility of
contact with food should be listed in the "Reference
Listing of Accepted Construction, Packaging Materials and
Non-Food Chemical Agents", published by the Canadian
Food Inspection Agency (CFIA) unless
the manufacturer has a "letter of no objection"
from Health Canada.
1.2.4 Lighting
Adequate natural or artificial lighting should be
provided to operate in an hygienic manner.
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The intensity should be adequate to the nature of the
operation and should not be such that the resulting colour
of produce is misleading.
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Where appropriate, lighting fixtures should be protected
to minimize the risk of produce contamination by breakage.
1.2.5 Air quality and Ventilation
Adequate ventilation should be provided to prevent
excessive heat, condensation, dust, and to remove
contaminated air.
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Ventilation should provide sufficient air exchange to
prevent unacceptable accumulations of condensation or
dust.
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Ventilation openings should be equipped with close fitting
screens or filters to prevent the intake of contaminated
air. Filters should be cleaned or replaced as appropriate.
1.2.6 Drainage and Waste Disposal
Adequate drainage and waste disposal systems and
facilities should be provided.
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Drainage and waste disposal systems should be designed and
constructed so that the risk of contaminating produce or the
potable water supply is avoided. Suitable provision must be
made for the storage and removal of waste.
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To avoid pest and microbial contamination, waste should
not be allowed to accumulate in produce handling and
produce storage areas or the adjoining environment.
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Storage areas for waste should be kept clean.
1.3 Sanitation Facilities
1.3.1 Employee Facilities
Personnel hygiene facilities and toilets should be
available to maintain an appropriate degree of hygiene
and to avoid contaminating produce.
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Adequate and conveniently located changing facilities and
toilets should be provided in close proximity to the
processing operation areas.
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Facilities should provide adequate means of hygienically
washing and drying hands, including wash basins, soap,
disposable towels and a supply of hot and cold (or
suitably temperature controlled) water adjacent to
toilets.
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Toilet facilities should be designed to allow hygienic
removal of waste and be located to avoid contamination of
produce or premises.
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Toilet facilities should be maintained under sanitary
conditions and good repair at all times.
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Hand washing notices should be posted in appropriate
areas.
1.3.2 Equipment Cleaning and Sanitizing Facilities
Cleaning and sanitizing facilities and equipment should
be adequately designed, constructed and maintained to
prevent contamination.
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Facilities should be constructed of corrosion resistant
materials easily cleanable and should be provided with
potable water at temperatures appropriate for the cleaning
chemicals used.
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Cleaning and sanitizing facilities and equipment should be
designed for their intended use and be properly
maintained. They should be adequately separated from food
storage, processing and packaging areas to prevent
contamination.
1.4 Quality and supply of Water and
Ice
An adequate supply of potable water with appropriate
facilities for its storage, distribution and
temperature control should be available where
appropriate.
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Water should meet the requirements of Health Canada's
"Guidelines for Canadian Drinking Water
Quality". Water from sources other than municipal
supplies must be treated as necessary by the manufacturer.
Water should be analyzed by the manufacturer or
municipality at a frequency adequate to confirm its
potability.
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There should not be cross-connections between potable and
non-potable water supplies. All hoses, taps, or other
similar sources of possible contamination should be
designed to prevent back-flow or back siphonage.
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Where it is necessary to store water, storage facilities
should be adequately designed, constructed and maintained
to prevent contamination.
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The volume, temperature and pressure of the potable water
should be adequate for all operational and cleanup
demands.
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Water treatment chemicals, where used, should be listed in
the "Reference Listing of Accepted Construction
Materials, Packaging Materials and Non-Food Chemical
Products" published by the CFIA unless
the manufacturer has a "letter of no objection"
from Health Canada. The chemical treatment should be
monitored and controlled to deliver the desired
concentration and to prevent contamination.
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Recirculated water should be treated, monitored, and
maintained as appropriate to the intended purpose.
Recirculated water should have a separate distribution
system which is clearly identified.
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Ice used as an ingredient or in direct contact with food
should be made from potable water and protected from
contamination.
2. Transportation and
Storage
2.1 Temperature Control
Incoming vegetables and finished products should be
refrigerated during transportation and storage to
minimize the growth of pathogenic microorganisms.
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Subsequent to the control of incoming product temperature
during processing, refrigeration of the finished product
throughout its expected shelf life is required to minimize
the growth of pathogenic microorganisms.
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Temperature during transportation and storage should be
controlled to maintain optimum storage conditions for
fresh vegetables.
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Other incoming ingredients requiring refrigeration should
be maintained at 4°C or
less.
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Finished products should be maintained at 4°C during transportation and
storage.
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Refrigeration facilities (transportation vehicles, storage
rooms) should be equipped with temperature measuring
devices, preferably recording thermometers. If recording
thermometers are not used, maximum/minimum thermometers
should be used.
2.2 Conveyances and containers
Conveyances and containers used by the manufacturer
should be designed, constructed, maintained, cleaned
and utilized in a manner to prevent food contamination.
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Transportation and storage of food products should
preferably take place in conveyances and containers
dedicated to food use only. When used for food and
non-food loads, procedures should be in place to restrict
the type of non-food loads to those that do not pose a
risk to foods in the same shipment or to subsequent food
loads after an acceptable clean-up.
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Conveyances and containers should be constructed,
maintained and cleaned in a manner to prevent
contamination of food.
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Conveyances and containers should be inspected prior to
loading to ensure that they are free from contamination
and are suitable for the transportation of food.
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Conveyances and containers should be loaded, arranged and
unloaded in manner that prevents damage and contamination.
2.3 Incoming Materials and Finished
Products
Incoming ingredients, packaging materials and finished
products should be stored and handled in a manner to
minimize spoilage and deterioration and to prevent
damage and contamination.
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Temperature of the storage rooms should be controlled to
maintain optimum storage conditions (refer to section
2.1.: Temperature Control).
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First-in-first-out" stock rotation should be
practiced.
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Ingredients, packaging materials and finished products
should be handled and stored in a manner that will prevent
damage and contamination (e.g., control of stacking heights and
forklift damage).
2.4 Non-Food Chemicals
Non-food chemicals should be received and stored in a
manner to prevent contamination of food, packaging
materials and food contact surfaces.
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Chemicals should be received, stored and handled in dry,
well ventilated areas.
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Chemicals should be stored in designated areas such that
there is no possibility for contamination of food or food
contact surfaces.
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Chemicals should be stored and mixed in clean, correctly
labelled containers.
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Chemicals required for ongoing use in food handling areas
(e.g., conveyor
lubricants) should be operationally separated from food
and located to prevent contamination of food, food contact
surfaces or packaging materials.
3. Equipment
3.1 Design and Installation
All equipment and utensils should be designed and
constructed to permit effective cleaning and
sanitation, and to prevent contamination.
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Equipment should be designed, constructed and installed to
ensure that it is capable of delivering the requirements
of the process (e.g.,
refrigeration equipment).
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Equipment should be located so that it permits adequate
maintenance, cleaning, sanitizing, and inspection to
prevent contamination of the product during operations.
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Equipment should be designed, constructed and installed to
permit proper drainage and, where appropriate, should be
connected directly to drains.
Refrigeration Equipment
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Equipment used to cool product should be designed to
achieve and maintain the required temperatures as rapidly
as necessary. Such equipment should be designed to control
and monitor temperatures.
Temperature Measuring Devices
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Temperature measuring/recording devices should be
installed, calibrated and maintained as necessary to
ensure accuracy.
Magnets
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Magnets should be installed in manner to effectively
remove metal before or after certain operations (e.g., dicing, slicing or
filling).
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The strength of magnets should be appropriate to the need
and should be tested as necessary.
Metal Detectors
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Metal detection equipment should be installed, calibrated,
maintained and operated in accordance with the
manufacturer's manual to ensure effective removal of
metals. This may include adjustment for the nature of the
product, selection of target metal and size and timing of
the reject mechanism.
Metres
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Flow metres (e.g.:
chlorine feed rate metres, gas pressure metres, etc.) should be verified to
ensure accuracy at the time of installation and annually
thereafter.
Other Instrumentation
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Other specialized instrumentation necessary for the
control of critical factors should be in place and
calibrated as necessary (e.g., chlorine injectors, chlorine
concentration test equipment, pH metres).
3.2 Equipment Maintenance and
Calibration
Maintenance and calibration programs should be in place
to ensure that equipment performs consistently as
intended and prevents contamination of product.
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The manufacturer should follow effective written
preventative maintenance program to ensure that equipment,
which may impact on food safety, functions as intended.
This includes: a list of equipment requiring regular
maintenance; maintenance procedures and frequencies.
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The maintenance procedures and frequencies should be based
on the equipment manufacturer's manuals or equivalent,
or on operating conditions that could affect the
performance of the equipment.
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The manufacturer should follow a written calibration
program, including calibration methods and frequencies.
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Maintenance and calibration of equipment should be
performed by appropriately trained personnel.
4. Personnel
4.1 Training
Food handlers should be trained in personal hygiene and
hygienic handling of food such that they understand the
precautions necessary to prevent the contamination of
food.
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The manufacturer should have a written training program.
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Appropriate training in personal hygiene and hygienic
handling of food should be provided to all food handlers
at the beginning of their employment.
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The food hygiene training should be reinforced and updated
at appropriate frequency.
4.1.2 Technical Training
Personnel should be trained to have the adequate
technical knowledge and understanding of the operations
or processes for which they are responsible.
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Training should be appropriate to the complexity of the
manufacturing process and the tasks assigned.
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Personnel should be trained to understand the importance
of the critical control points for which they are
responsible, the critical limits, the procedures for
monitoring, the actions to be taken if the limits are not
met, and the records to be kept.
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Personnel responsible for maintenance of equipment
impacting on food safety should be appropriately trained
to identify deficiencies that could affect product safety
and take the appropriate corrective action (i.e., in house repairs, contract
repairs). Individuals performing maintenance on specific
equipment should be appropriately trained.
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Personnel and supervisors responsible for the sanitation
program should be appropriately trained to understand the
principles and methods required for effective cleaning and
sanitation.
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Additional training should be provided as necessary to
ensure current knowledge of equipment and process
technology.
4.2 Hygiene and Health Requirements
Hygiene and health requirements should be followed to ensure
that personnel who come directly or indirectly into contact
with produce are not likely to contaminate produce. Visitors
should, where appropriate, wear protective clothing and
adhere to the personal hygiene provisions in this section.
4.2.1 Cleanliness and Conduct
All persons entering food handling areas should
maintain an appropriate degree of personal cleanliness
and take the appropriate precautions to prevent the
contamination of food.
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All persons should wash their hands upon entering food
handling areas, before starting work, after handling
contaminated materials, after breaks, and after using
toilet facilities. Where necessary, to minimize
microbiological contamination, employees should use
disinfectant hand dips.
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Protective clothing, hair covering, footwear and/or
gloves, appropriate to the operation in which the employee
is engaged, should be worn and maintained in a sanitary
manner.
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Persons should not adopt behaviours which could result in
the contamination of food, such as eating, using tobacco,
chewing gum, or unhygienic practices such as spitting in
food handling areas.
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Persons entering food handling areas should not wear
jewellery or other objects which could fall into or
otherwise contaminate food. Jewellery which cannot be
removed, including wedding bands or medical alerts, should
be covered.
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Personal effects and street clothing should not be kept in
food handling areas.
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The traffic pattern of employees should prevent
cross-contamination of the product. Access of personnel
and visitors should be controlled to prevent
contamination.
4.2.2 Communicable Diseases/Injuries
Preventative measures should be in place to minimize
the risks of directly or indirectly contaminating food
by persons with communicable diseases or injuries.
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Persons known to be infected with diseases likely to be
transmitted through food, or with open cuts or wounds, should
not work in food handling areas where there is a likelihood
of directly or indirectly contaminating food.
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The manufacturer should establish and enforce a policy to
prevent employees known to be carriers of a disease
transmissible through food from working in food handling
areas.
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The manufacturer should require that employees advise
management when they are suffering from a communicable
disease likely to be transmitted through food.
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Employees having open cuts or wounds should not handle
food or food contact surfaces unless the injury is
completely protected by a secure waterproof covering
(e.g., rubber gloves).
5. Sanitation and Pest
Control
5.1 Sanitation Program
An effective sanitation program for equipment and
premises should be in place to prevent contamination of
food.
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Cleaning and sanitation programs should ensure that equipment
and all parts of the establishment are appropriately clean.
Cleaning and sanitation programs should be reviewed and
modified as needed.
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The manufacturer should follow a written cleaning and
sanitation program for all equipment and premises
(production and storage areas) which includes: the name of
the responsible person; the frequency of the activity; the
procedures for cleaning and sanitizing; the chemicals and
concentrations used; the temperature requirements; and the
type and frequency of inspection to verify the
effectiveness of the program.
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Procedures for cleaning and sanitizing should be as
follows: identify lines, equipment and utensils; follow
disassembly/reassembly instructions as required for
cleaning and inspection; identify areas on equipment
requiring special attention; and follow method of
cleaning, sanitizing and rinsing.
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Chemicals must be used in accordance with the
manufacturer's instructions and be listed in the
"Reference Listing of Accepted Construction,
Packaging Materials and Non-Food Chemical Agents"
published by CFIA unless the
manufacturer has a "letter of no objection" from
Health Canada.
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The sanitation program should be carried out in a manner
that does not contaminate food or packaging materials
during or following cleaning and sanitizing (e.g., aerosols, chemical residues).
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The effectiveness of the sanitation program should be
monitored and verified by an audit or pre-operational
inspections of premises and equipment or, where
appropriate, by microbiological sampling. The sanitation
program should be adjusted accordingly.
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Operations should begin only after sanitation requirements
are met.
5.2 Pest Control Program
Effective pest control programs should be in place to
prevent entry, detect and eliminate pests, and to
prevent the contamination of food.
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The manufacturer should follow a written pest control
program for the premises and equipment which includes: the
name of the responsible person; where applicable, the name
of the pest control company or the person contracted for
the pest control program; the list of chemicals used and
the concentrations; the location where applied; the method
and frequency of application; a map of trap locations; and
the type and frequency of inspection to verify the
effectiveness of the program.
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Pesticides must be used in accordance with the
manufacturer's instructions, be registered under the
Pest Management Regulatory Agency, Pest Control
Products Act and Regulations and be listed in the
"Reference Listing of Accepted Construction,
Packaging Materials and Non-Food Chemical Agents"
published by CFIA.
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Treatment of equipment, premises or ingredients to control
pests must be conducted in a manner to ensure that the
maximum residue limit as listed in the Food and Drugs
Act and Regulations is not exceeded (e.g., limiting the number of
fumigation treatments).
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Birds and animals should be excluded from establishments.
6. Trace-Backs and
Recalls
6.1 Trace-Back and Recall Systems
Manufacturers should ensure that effective trace-back
and recall procedures are in place to respond to food
safety hazards.
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A written procedure should be in place to enable the recall
of any lot of product and provide detailed information to
assist in the investigation of any identified produce
contamination.
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The written procedure should include: the persons
responsible (e.g., recall
coordinators); the roles and responsibilities for the
coordination of a recall; the methods to identify, locate
and control recalled products; the requirements to
investigate other possibly affected products which could
consequently be included in the recall; and procedure for
monitoring the effectiveness of the recall (section 6.2).
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The regulatory agency having jurisdiction should be
immediately notified in the region where the manufacturer
is located (e.g., The
Chief of Food Inspection of CFIA). This
notification should include: the reason for the recall;
the amount of implicated products manufactured, in
inventory, and distributed; the name, size, code and/or
lot numbers of implicated products; and the area of
distribution (e.g.,
local, national, international).
6.2 Recall Capability
Recall procedures should be tested periodically to
verify the capability of rapidly identify and remove
products from the market.
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The manufacturer should be capable of producing accurate
information on a timely basis to verify that all affected
products can be rapidly identified and removed from the
market.
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Periodic mock recalls should be conducted and records
should be kept to determine the capability of the
manufacturer to reconcile the amount of product produced,
in inventory and in distribution. Any deficiencies in the
recall procedure should be identified and corrected.
7. Documentation and
Records
Written records that adequately reflect product
information, program and operational control should be
available to demonstrate the adequacy of the
manufacturing activities.
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Water Quality and Supply Records
-
The manufacturer should have records available to
demonstrate the adequacy of the microbial and chemical
safety of the water including: the source of potable
water, method of water treatment, sample sites, analytical
results, analyst and date.
Temperature Control Records
-
Daily records of temperatures in all refrigeration
facilities should be maintained. These could consist of
recorder charts or a daily log of maximum/minimum
temperatures. This should include the date and location
where the temperature was recorded.
Equipment Maintenance Records
-
The information required for critical equipment includes:
identification of equipment; maintenance activity; reason
for activity; person in charge; and date.
Calibration Records
-
The information required in calibration records includes:
identification of equipment; date, person in charge;
calibration results; and corrective actions.
Sanitation Records
-
The records of sanitation activities should include the
date, person responsible, the findings, corrective action
taken, and microbiological test results where appropriate.
Pest Control Records
-
Pest control records should include: results of the
inspection programs and the corrective action taken (e.g., findings in traps,
location of insect infestation); record of pest control
activities (e.g.,
pesticide used, method and location of application, dates
of fumigation; and date and person responsible.
Distribution Records
-
Distribution records should contain sufficient information
to permit traceability to a particular code or lot number.
The minimum information required includes: product
identification and size; lot number or code; quantity;
customers names, addresses, and phone numbers to the
initial level of product distribution.
1. Process Design
1.1 Shelf Life Validation
The prescribed shelf life for finished products should
not exceed 10 days at refrigeration temperature unless
an appropriate shelf life study demonstrates the safety
of the product over its prescribed shelf life.
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Vegetables may be contaminated with a wide variety of
microorganisms, including some pathogens such as Listeria monocytogenes, Clostridium
botulinum, Shigellaspp., Salmonella spp, and enteropathogenic Escherichia coli. There is no step in
the processing of minimally processed ready-to-eat vegetables
that will ensure the total elimination of microorganisms.
Minimal processing of vegetables can create conditions for
microbial growth. Some packaging and storage techniques
(e.g., controlled or
modified atmosphere packaging, refrigerated storage, etc.) may slow the rate of physical
deterioration without preventing microbial pathogens to
develop to levels which would render the product unsafe while
still edible.
-
The manufacturer must have a validated shelf life study
for each product which includes all information necessary
to demonstrate the safety of the product over its
prescribed shelf life.
-
In the absence of a shelf-life validation, the shelf life
must not exceed 10 days at refrigeration temperature for
the control of Listeria
monocytogenes.
The following is required for shelf-life validation:
-
The person responsible for developing the shelf life of
each product should have sufficient knowledge, training
and experience to conduct these studies.
-
All critical factors should be identified and evaluated
such as: disinfectant strength and contact time on
produce; use of additives as antimicrobials; packaging
material; gas mixture; storage temperature; sanitation
criteria; etc.
-
The most extreme conditions should be included in the
shelf life validation (e.g., temperature abuse during
distribution, storage and display for sale).
-
Challenge tests should be conducted using microorganisms
of concern or equivalent non-pathogenic organisms.
-
A sufficient number of trials should be performed to
confirm that the critical limits established for each
factor are adequate.
-
The shelf life study should be documented and available
for review.
-
Alternate methods for determining shelf life must be
evaluated by the Food Directorate of the Health Protection
Branch, Health Canada.
2. Product
formulation
2.1 Specifications
The manufacturer should have written specifications for
all components, including raw vegetables, packaging
materials and gases, that are necessary for the
production of the finished product.
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Specifications provide standards against which the
manufacturer can assess the acceptability of the components
necessary for the production of the finished product.
Manufacturers should prescribe growers to adopt good
agricultural practices and provide evidence that the product
was grown according to specifications. Refer to Part II Good Agricultural Practices.
The manufacturer should have written specifications for
ingredients and components that identify criteria essential
for the manufacturing process and product safety (e.g., permeability of packaging
materials, grade of gases consistent with food contact use).
Purchasing specifications must include a provision for
compliance with the Food and Drugs Act and
Regulations, specifically: food additives, if present,
must meet the requirements; and packaging materials must be
intended for direct food contact.
2.2 Product Formula
Current written formulae should be available for each
multi-component product processed.
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Formulae provide information to employees to produce a
consistent product and to avoid potential hazards (e.g., adding unlisted ingredients
which could cause allergic reactions).
-
Current, written formulae for multi-component products
should be available for production employees.
-
The formulae should contain all details of the formulation
such as the identification and amount of ingredients,
including food additives if present.
-
If food additives are used, levels must conform to the
provisions of the Food and Drugs Act and
Regulations.
3. Incoming Material
Control
3.1 Incoming Materials
The manufacturer should control incoming produce,
ingredients, packaging materials and gases to minimize
microbial, physical and chemical hazards and to prevent
labelling inaccuracies.
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The manufacturer should have a program in place to control
incoming ingredients (Refer to sub item 2.1 for
specifications of incoming materials). For incoming
ingredients that are likely to impact on the safety of
finished products, manufacturers should implement one of the
following programs:
Periodic Evaluation of Incoming Materials:
-
The manufacturer should obtain a certificate of analysis
for each incoming lot.
-
Representative samples should be taken to verify the
accuracy of the certificates of analysis at scheduled
frequency appropriate to the risk (e.g., monthly).
-
The manufacturer should maintain a documented history of
adherence to specifications for each ingredient and
supplier (e.g.,
analytical results).
100% Lot Inspection
-
Each incoming lot should be sampled according to a
pre-determined sampling plan and evaluated for adherence
to specifications.
Supplier Certification
-
The manufacturer should have documentation to demonstrate
adequate knowledge of the supplier's process (e.g., good agricultural
practices on farm, process flow charts, etc.)
-
The manufacturer should have data to demonstrate the
capability of the supplier's process to consistently
manufacture within specifications. Statistical process
control charts for each critical control point should be
available upon request from each supplier.
-
The manufacturer should conduct periodic monitoring to
verify adherence to specifications (e.g., annually).
-
The manufacturer should conduct supplier audits to
validate the status of the supplier certification program.
3.2 Incoming Material Control Records
The manufacturer should have records available that
demonstrate the adequacy of incoming material controls.
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Adequate records will allow verification of the
manufacturer's control over microbial, physical and
chemical hazards associated with incoming materials.
-
Appropriate records should be kept depending upon the
incoming ingredient control program that is established
(e.g., analytical
results, history of adherence to specification, audit
reports etc).
4. Preprocessing and
Processing
All critical processing factors should be controlled to
minimize risks associated with the product. Raw
vegetables should be inspected, sorted, trimmed, washed
and disinfected, as appropriate, to prevent
contamination of the finished product.
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4.1 Inspection, Sorting, Trimming and First
Wash
During preparation of vegetables for processing, field
contaminants which were not identified during the incoming
material inspection may be revealed and can be removed. The
manufacturer should prevent and remove microbial, chemical
and physical hazards by:
-
visual inspection and removal of decomposed product,
extraneous matter, produce contaminated by fuels, (e.g., diesel, gasoline) and
machine grease and oil.
-
removal of dirt and reduction of the microbial
contaminants by washing.
-
metal detection using magnets or metal detectors
-
sorting/cleaning by gravity, air or water.
4.2 Cutting, Slicing, Shredding and
Grinding
-
Procedures should be in place to minimize contamination
with physical (metal) and microbial contaminants during
cutting, slicing, shredding or grinding process.
4.3 Washing
Washing cut produce with clean potable water reduces
microbial contamination. In addition, it removes some of the
cellular fluids that were released during the cutting process
thereby reducing the level of available nutrients for
microbial growth.
-
Cut vegetables should be washed in potable water that
meets Canadian drinking water guidelines.
-
Water should be replaced at a sufficient frequency to
prevent the build-up of organic material and prevent
spreading microbial contaminants over produce.
4.4 Antimicrobial Treatment
Antimicrobial treatments should be used to minimize or reduce
contamination of finished products and, where appropriate, to
meet the criteria outlined in the shelf life study.
4.4.1 Chlorinated Wash Water
Chlorine may be added to wash water to reduce microbial
contamination on produce. After the chlorination treatment,
excess chlorine must be removed from the produce.
-
The manufacturer should monitor and control the chlorine
concentration, pH,
temperature of the wash water and contact time on the
vegetables.
-
Suggested concentrations for chlorinated wash water are
between 100 and 150ppmof total chlorine or between
2 to 7ppmof
free residual chlorine after contact. The pH of the water should be
between 6.0 and 7.0. The contact time is dependent upon
the product and the chlorine concentration but ideally
should not exceed 5 minutes.
-
Where the manufacturer has a validated shelf life study,
and the use of chlorine is part of the process, the
chlorine concentration and contact time prescribed in the
study should be consistently met.
-
Excess chlorinated wash water should be removed from the
produce (e.g., by rinsing
with potable water, with centrifugal drier, etc.)
4.4.2 Other Antimicrobial Treatments
Other antimicrobial treatments, such as acidification or use
of food additives, may be used to inhibit microbial growth or
reduce contamination. Antimicrobial treatments other than
chlorination must be evaluated by the Food Directorate of the
Health Protection Branch, Health Canada.
-
The antimicrobial treatments must comply with the Food
and Drugs Act and Regulations.
-
The manufacturer should monitor and control the use of
antimicrobial treatments.
-
Where the manufacturer has a validated shelf life study,
and the use of antimicrobial treatments is part of the
process, the manufacturer should consistently use the
antimicrobials as prescribed in the study.
4.5 Adherence to Product Formulation
The manufacturing process should be controlled to
ensure that each multi-component product is produced in
accordance with its formula.
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Adherence to product formulae ensures that products are
consistent, precludes the addition of ingredients not listed
on the label that may elicit an adverse food reaction in
sensitive individuals and ensures that ingredients essential
to product safety are added.
-
The manufacturer should have controls in place to ensure
that each product contains only the ingredients listed in
the formula and on the product label.
-
The manufacturer should have controls in place to ensure
that food additives, if present, are used within allowable
levels including accurate measurement and adequate
blending for homogeneity.
-
The manufacturer should have controls in place to prevent
the presence of undeclared ingredients that may elicit an
adverse food reaction in sensitive individuals. Potential
areas that may require stricter controls include:
-
misdirected ingredients;
-
use of rework;
-
carryover from equipment after product changeovers;
-
substitution of ingredients.
4.6 Product Temperature During
Processing
Product temperature should be controlled during
processing to minimize the growth of pathogenic
microorganisms.
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Numerous factors may affect product temperature during
processing including: variations in the temperature of
incoming produce; fluctuations in ambient temperature; and
changes in wash water temperature. If the product is packaged
at elevated temperature, there may be an unacceptable time
lag before the product reaches refrigeration temperature.
This could result in growth of microbial pathogens to
unacceptable levels. The processing must be controlled to
ensure that product temperature is reduced to refrigeration
temperature (4°C or less) within an acceptable time
frame.
The manufacturer should demonstrate the control of product
temperature through one of the following programs or
equivalent:
Cold Chain Concept
-
Produce temperature should be maintained at, or reduced
to, 4°C or less prior to
the start of processing.
-
The air temperature in the rooms where fresh produce is
processed should not exceed 4°C. Wash solutions should be maintained at
4°C or less. Any other
treatments that are part of the process should not cause
the temperature of the produce to increase above
4°C.
-
At all times, finished product temperature must be at
4°C or less.
Validated Temperature Control Process
-
The manufacturer should have a validated study to show
that any variation in product temperature other than those
listed in the following table (table 1) during the process
will not adversely affect the safety of the product.
(Refer to sub item 1.1.: validated shelf-life)
-
The manufacturer should demonstrate that the actual
process does not exceed the maximum parameters of
temperature and time set out in their validated study.
-
At all times, finished product temperature must be at
4°C or less.
Time/Temperature Parameters
-
The manufacturer should follow the cooling guideline as
outlined in the following table (table 1).
Table 1 reads as follows: Product temperature must not be
above the temperature stated in the left column for more than
the corresponding total time stated in the right column. For
example: product temperature must not be at or above
15°C for more than 4 hours
from the start of processing and must not be at or above
25°C for more than 0.5 hours
within the 4 hour time period.
Table 1. Cooling Guideline for Minimally Processed
Vegetables
Product Temperature
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Total Time from the Start of Processing
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25°C
20°C
15°C
10°C
<5°C
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0.5 h
1.5 h
4.0 h
10 h
30 h
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Note: The Cooling Guideline was developed by the Bureau of
Microbial Hazards, Food Directorate, Health Canada.
4.7 Product Processing Records
Written records that adequately reflect the control of
critical processing factors should be available upon
request.
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Adequate records will allow verification of the process and
product composition. Records should be available to
demonstrate:
-
Adequate control of critical process and composition such
as: chlorine concentration, pH and contact time (as
required); and use of other antimicrobial treatments.
-
Control of product temperature during processing.
-
Deviations as noted by the operator during the process.
5. Packaging
5.1 Packaging and Containers
Quality of packaging and handling should be controlled
to prevent product contamination.
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The manufacturer should have an effective system in place to
prevent the use of contaminated, damaged or defective
containers and prevent the contamination of the product. The
controls in place should be verified through periodic audits.
-
Containers should be used only for their intended purpose.
-
Packaging should be handled and transferred in a manner to
minimize damage and contamination. There should be
controls for receiving, storage and conveying.
-
Packaging should be examined for damage and contamination
before use.
-
Where containers are re-used, the manufacturer should have
in place an effective cleaning system, immediately before
use.
5.2 Critical Packaging Factors
Container filling and sealing should be controlled to
meet the criteria outlined in the process design
and/or shelf life study.
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Deviation from the packaging criteria could result in
contamination or growth of microbial pathogens above safe
levels prior to the end of the shelf life.
-
The manufacturer should identify and control all critical
packaging factors, when appropriate, such as: bag or
container composition; gas mixture; flushing time; and
sealing of container.
-
The manufacturer should have a program in place to
identify and correct situations where container damage
could occur.
5.3 Packaging Records
Packaging records should be available to demonstrate
that the manufacturer has adequate control of critical
packaging factors.
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-
The manufacturer should have records to demonstrate
adequate control of any critical packaging factors
identified in the process design or shelf life study.
6. Container Coding and
Labelling
6.1 Product Identification
Each packaged food product must be marked to allow the
identification of product in the event of a recall.
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-
Each prepackaged food product, as defined under the
Food and Drug Regulations, must be permanently
and legibly marked on the label, the package or container
with the brand, type of product, the establishment
responsible for the production or marketing of the product
and a code from which the production date can be
determined. The "use-by" date may form part of
this code.
-
Code marks used and their exact meaning should be
available from the manufacturer.
-
Where used, case codes should be legible and should
correspond to the identifying marks on the product within.
6.2 Label Accuracy
The manufacturer should ensure that label information
is complete and accurately represents the product. The
label must meet the requirements of the Food and
Drugs Act and Regulations and the Consumer and
Packaging and Labelling Act and Regulations.
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The manufacturer should have controls in place to prevent
mislabelling. Accurate labels inform and protect individuals
allergic or sensitive to certain foods or with specific
dietary needs.
-
Procedures should be in place to ensure that labels
accurately reflect product formulation and composition.
These controls should include:
-
Effective separation of product types during changeovers.
-
Separation of product labels or pre-labelled packaging
during processing activities and storage.
-
On-line checks to ensure that products are correctly
labelled.
6.3 Coding - "Use-By" Date
All finished products must be coded with a
"use-by" date.
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The "use-by" date is the date by which the product
should be consumed. After this date, the risk of
microbiological hazards (e.g., high level of Listeria monocytogenes) could be
unacceptable, especially if the product has not been handled
properly (e.g., inadequate
refrigeration).
-
All products must be coded with a "use-by" date.
The "use-by" date should be permanent, visible
and legible, and easily understood by the end-user.
-
The "use-by" date corresponds to the shelf life
determined in the shelf life study, or, in the absence of
such study, must not exceed 10 days.
6.4 Labelling - Storage Temperature
All finished products must be labelled with the
statement: "Keep Refrigerated"
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Products must be kept at refrigeration temperature during
storage, transportation and display for sale to minimize the
potential for growth of microbial pathogens. Proper labelling
is required to ensure that all persons handling the product
are aware of the storage temperature requirement. "Keep
Refrigerated" by the Food and Drug Regulations
means 4°C.
7. Deviations and Corrective
Action
7.1 Deviation Control
Procedures should be in place to identify, isolate and
evaluate products when critical limits are exceeded or
when other defects occur which could affect product
safety.
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Identification of Deviation
-
The manufacturer should have a system in place to identify
deviations when they occur.
Isolation of Affected Product
-
The manufacturer should have effective procedures in place
to isolate, clearly mark and control all product produced
during the deviation period.
-
All unsatisfactory product should be isolated from the
point where the process was last in control and be clearly
marked (e.g., tags firmly
attached with information such as: reason for hold; hold
number; amount of product; person in charge; date; etc.).
-
The manufacturer should maintain control of the product
until its final disposition or until other actions are
required following product evaluation.
Evaluation of Affected Product:
-
Product evaluation should be conducted by a qualified
person and be adequate to assess potential health hazards
such as: adequate sampling to identify the extent of the
problem; appropriate tests; etc.
-
The product should not be released unless the evaluation
determines that no health hazard exists.
-
Actions on affected product (e.g., sorting, re-processing,
disposal) should be conducted in an appropriate manner by
adequately trained personnel.
7.2 Corrective Action
Effective corrective actions should be implemented to
prevent the recurrence of deviations.
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Corrective action procedures are necessary to determine the
cause of the problem, take action to prevent a recurrence and
verify with monitoring and reassessment to ensure the
efficiency of the actions. The corrective action procedures
should include:
-
An investigation to determine the cause of the deviation.
-
The establishment of effective measures to prevent
recurrence of the deviation.
-
Verification of the effectiveness of the corrective
actions taken.
7.3 Deviation and Corrective Action
Records
Records should be available to demonstrate controls of
deviations and the effectiveness of corrective actions.
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Complete records will allow verification of the adequacy of
the manufacturer's control of deviations and the
implementation of effective corrective action procedures.
Deviation/Hold
-
Deviation records should include information such as:
product and code; date when the product was manufactured,
held, released or destroyed; description of deviation and
reasons for the hold; amount of product held; results of
evaluation/sort (e.g.,
amount analyzed, number and nature of defects);
disposition of held product (e.g., amount sorted, destroyed,
employee sales, distress, salvage, reconditioning, retail
sales); signature of person responsible for hold and
evaluation; and signed authorization for disposition .
Corrective Action
-
Corrective action records should include information such
as: cause of deviation identified; corrective action taken
to correct the deviation; follow-up/assessment of
effectiveness of corrective action; date corrective action
was taken and verified; and signature of person
responsible.
8. Verification of Product
Safety
8.1 Verification Procedures
The manufacturer should use supplementary methods of
evaluation to verify the effectiveness of controls
affecting food safety.
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The purpose of verification is to determine the effectiveness
of manufacturing controls in preventing health hazards and to
indicate areas where improvements are required.
-
Individuals or organizations responsible for verification
should be identified. These individuals should be suitably
qualified.
-
The verification frequency and methods must be appropriate
to the hazards associated with the product and process.
-
Methods of verification include: sampling and analyses of
in-process and finished product for the appropriate
chemical or microbial hazard (e.g., Listeria
monocytogenes, Salmonella spp., etc.); verification of the
concentration of antimicrobial, p Hand/or temperature of
washwater; challenge tests; independent external or
internal audits; analyses of consumer complaint trends;
and retail audits (e.g.,
determine if storage temperatures and shelf life limits
are followed).
8.2 Verification Records
Records should be available to demonstrate the adequacy
of verification procedures.
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-
Records of verification should include methods, date,
individuals/ organizations responsible, results/findings
and action taken.
9. Complaint
Handling
9.1 Product Complaints
The establishment should have an effective system for
handling and investigating complaints.
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Product complaints are an important indicator of possible
deficiencies of manufacturing controls and the distribution
handling procedures.
-
The manufacturer should identify the person responsible
for receiving, evaluating, categorizing and/or
investigating complaints.
-
Complaints should be accurately categorized according to
the risks.
-
Potentially serious complaints should be forwarded
immediately to the appropriate personnel for action.
-
Safety-related complaints should be investigated by
appropriately trained technical personnel.
-
Examination of the complainant's specimen, retail
product or other product of the same code should be
conducted on safety-related complaints.
-
The depth of the investigation should be appropriate to
the risk and similar complaint trends.
-
Appropriate corrective action should be taken for
deviations identified during the investigation.
9.2 Complaint Records
Records of product complaints, investigation findings
and action taken should be available upon request.
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Consumer Information
-
Consumer information records should include information
such as: the name, address, telephone number, and date
received; the details of complaint and/or illness; the
product name, code and size; and the retail outlet.
Investigation
-
Investigation records should include information such as:
the name of the person responsible for the investigation;
the action taken on products as a result of the
investigation; and the corrective action taken.
Glossary
Adverse food reaction - a general term that can be
applied to a clinically abnormal response to an exposure to a
food or food component.
Certification - in this document, process to ensure
and verify the reliability and the capability of a supplier
to consistently manufacture within the manufacturers
specifications. This may include periodic monitoring to
verify adherence to specifications and audits to validate the
status of the supplier certification program.
Challenge test - scientific study by which specific
microorganisms of concern are added to a product to confirm
the adequacy of a theoretical process.
Control - measure to ensure that an operation:
performs consistently within predetermined limits based on
process capability; meets process requirements; and
consistently results in a safe product.
Corrective action - any action to bring the process
into control and manage any affected product when critical
limits or other criteria are not met. The action is to be
prompt and appropriate to the seriousness of the deficiency.
Critical control point - a point, step or procedure
at which control can be applied and food safety hazard can be
prevented, eliminated, or reduced to acceptable levels.
Critical factor - any property, characteristic,
condition, or other variable parameters which may affect the
validated process and compromise the safety of the product.
Critical limit - a value which delimits
acceptability from non-acceptability for which the safety of
the product may be compromised. Critical limits are different
from control limits or specification limits. Control limits
indicate what the process is capable of delivering and are
tighter than specification limits which are in turn tighter
than critical limits.
Deterioration - for produce, deterioration can be
used interchangeably with spoilage, When applicable to non
food products such as packaging materials, deterioration is a
physical or chemical change in the material that may
adversely affect the safety of the food.
Deviation - failure to meet the critical limits or
other specified requirements for a critical factor.
Hazard - the potential to cause harm. Specifically,
a microbial, chemical or physical property responsible for an
unacceptable food safety risk.
Lot - the amount of product of a specific container
size, product style and code produced by a food establishment
during a specified period of time.
Minimally processed ready-to-eat vegetables - raw
vegetables that have been peeled, sliced, chopped or shredded
prior to being packaged for sale. With the possible exception
of the addition of dressing or croutons by the end-user, the
product does not require further preparation before
consumption.
Monitoring - a planned sequence of observations or
measurements to assess whether a critical control point [or
other activity] is under control.
Periodic mock recall - internal activities conducted
on a periodic basis to verify the capability of the
manufacturer to rapidly identify and control a given lot of
product. These activities do not necessarily require the
manufacturer to contact customers.
Records - documented observations and measurements
to determine adherence to critical limits or other specified
requirements for critical factors.
Risk - an estimate of the likelihood of occurrence
of a hazard.
Spoilage - a process whereby food quality and/or
food safety is rendered unacceptable through microbiological
or chemical reaction.
Verification - confirmation of the accuracy,
correctness or effectiveness of process controls through
testing, investigation or comparison with a standard.
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