Food Safety Practices Guidance for Ready-to-Eat Fresh-Cut Vegetable Manufacturers
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Table of Contents
- Hazard Summary for Ready-to-Eat Fresh-Cut Vegetables
- Using the Guidance Document
Chapter 1: Control of Operation
- 1.1 Product Formulation and Composition
- 1.2 Labelling and Net Quantity
- 1.3 Process Design
- 1.4 Incoming Material Control (Receiving)
- 1.5 Raw Material Preparation
- 1.6 Process Control
- 1.7 Packaging Control
- 1.8 Labelling Control
- 1.9 Product Coding Control
- 1.10 Deviations and Corrective Action
- 1.11 Verification of Product Safety
- Chapter 2: Equipment
- Chapter 3: Premises
- Chapter 4: Sanitation and Pest Control
- Chapter 5: Personnel
- Chapter 6: Transportation and Storage
- Chapter 7: Records
- Chapter 8: Complaint Handling and Recalls
- Appendix A: Good Agricultural Practices for the Primary Production and Harvesting of Fresh Vegetables
- Appendix B: Hazard Analysis and Critical Control Point (HACCP) Summary
Consumer awareness of the health benefits associated with eating fresh vegetables, combined with the increasing demand for convenient, easy-to-prepare foods, has resulted in a significant rise in the volume of Ready-to-Eat (RTE) fresh-cut vegetables being consumed. RTE fresh-cut vegetables were initially developed for the restaurant, hotel and institutional market and are now a common and very popular retail product, sold directly to the consumer for home consumption. While in the past, fresh vegetable dishes (e.g., salads) were prepared and washed at home shortly before meals, these products can now be eaten directly from the package, in some instances a week or more after being processed.
Most pathogens are not native to fresh-cut produce. Poor agricultural and manufacturing practices could introduce pathogens to fresh-cut products and thereby pose a potential hazard to consumers. Some of the microbial pathogens associated with RTE fresh-cut vegetables include Salmonella spp., Escherichia col O157:H7, Listeria monocytogenes, Shigella spp., Norovirus (Norwalk-like viruses), hepatitis A virus and protozoan parasites such as Cryptosporidium (WHO/FAO 2007). The possible sources of contamination in these products include the raw vegetables inbound for processing, the plant workers and the processing environment. When vegetables are chopped or shredded, the release of plant cellular fluids provides a nutrient-rich medium in which microorganisms can grow. The high moisture content of fresh vegetables, the lack of a thermal process to eliminate or reduce microbial pathogens and the potential for temperature-related abuse during preparation, distribution and handling further increase the risk of food-borne illness. In fact, RTE fresh-cut vegetables have been implicated in numerous outbreaks of food-borne illness.
Preventing the contamination of fresh vegetables with microbial pathogens, harmful chemical residues and/or physical contaminants is the most effective way to ensure the safety of these Ready-to-Eat products. This can be accomplished through key preventive approaches such as Good Agricultural Practices (GAP) on the farm, Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Point (HACCP) principles being applied at the processing facility.
HACCP is a systematic approach that assesses each step in a food manufacturing process for potential hazards and identifies controls to prevent their occurrence. HACCP is recognized by regulators, industry and academia as an important food safety approach available to the food industry. Prior to the application of HACCP, an establishment should be operating in accordance with GMPs and food safety legislation. The establishment should also have the guidance of a person trained in HACCP. The GMPs (prerequisite programs) serve as the building blocks upon which a HACCP plan is built.
A HACCP system is developed following a careful review and analysis of the unique processing facility characteristics in which it is to be implemented. Chapter 1 of this document provides guidance related to hazard analysis and control of the manufacturing process, while Chapters 2 to 8 are focused on generic HACCP prerequisite programs. Operators wishing to develop their own HACCP program can use this guidance document to build a customized plan for their operation.
This document was developed as a food safety resource by the Canadian Food Inspection Agency (CFIA) in consultation with the Canadian RTE fresh-cut vegetable industry, Health Canada and provincial government representatives. It is hoped that this document will complement existing references and the initiatives of other agencies, to make it easier for RTE fresh-cut vegetable manufacturers to adopt a HACCP approach and ultimately produce the safest possible products.
This guidance document applies to RTE fresh-cut vegetables which have been washed and then peeled, sliced, chopped or shredded prior to being pre-packaged for sale in Canada. Examples of these products include shredded bagged lettuce, peeled baby carrots, shredded cabbage, mixed vegetable salads (including coleslaw), salad kits, cauliflower, broccoli florets, etc. With the possible exception of the addition of dressing or croutons by the end user, the products do not require further preparation (e.g., cooking, washing, etc.) before consumption. This document could be used to develop HACCP systems for other products, such as vegetables, for further processing (e.g., sliced fresh potatoes for French fries) and fresh-cut fruits.
Hazard Summary for Ready-to-Eat Fresh-Cut Vegetables
Potential hazards associated with the production of Ready-to-Eat fresh-cut vegetables are summarized in the table that follows. Possible control measures are suggested in the table. The manufacturer is responsible for identifying hazards specific to its operations and for determining how each hazard can be controlled. For additional information, please refer to the specific sections of this document as outlined in the Reference column.
|Process Step||Potential Hazards||Control Measures||Reference|
|Incoming Materials / Receiving (fresh vegetables, packaging materials, and chemicals)||Pathogenic microorganisms on fresh vegetables and/or packaging materials (e.g., E. coli O157:H7 and Shigella spp.).||
Obtain a guarantee from suppliers that the fresh vegetables, packaging materials and chemicals provided meet the operator's purchase specifications (e.g., the supplier provides a Letter of Guarantee). Alternatively, suppliers may provide a certificate of analysis (COA) for each shipment.
Ensure that temperature requirements for ingredients have been maintained throughout their transportation to prevent pathogen growth.
Inspect the condition of all incoming materials and containers upon receipt and confirm that purchase specifications are met. Do not accept damaged containers.
Do not use materials that do not meet specifications.
|Incoming Materials / Receiving (fresh vegetables, packaging materials, and chemicals)||Pesticide residues on fresh vegetables.||
Obtain a guarantee from suppliers that the fresh vegetables provided meet the operator's purchase specifications (e.g., the supplier provides a Letter of Guarantee). Alternatively, suppliers may provide a certificate of analysis (COA) for each shipment.
Check incoming materials against predetermined screening criteria when received (e.g., GAP).
Do not use materials that do not meet specifications.
|Incoming Materials / Receiving (fresh vegetables, packaging materials, and chemicals)||Foreign materials (extraneous material), e.g., stones, glass, metal, plant debris, animals, etc.||
Check incoming materials against predetermined screening criteria when received (e.g., GAP). Inspect for the presence of foreign material, excessive filth, soil, etc.
Do not use materials that do not meet specifications.
|Storage of Incoming Materials||Growth of pathogenic microorganisms due to inadequate cooling.||
Unload and store fresh vegetables in a timely manner.
Control temperature and storage practices to minimize bacterial growth.
Implement procedures for ingredient rotation and use (i.e., first in, first out protocol).
|Storage of Incoming Materials||Contamination due to improperly stored chemicals (e.g., cleaning product(s), antimicrobials).||Store chemicals in a separate location from fresh vegetables and packaging material.||6.2|
|Inspection/Sorting and Trimming||Contamination with pathogenic microorganisms from field soil and/or contact with contaminated vegetables or other material.||Identify and remove vegetables with visible contamination, decay and/or damage.||1.5|
|Inspection / Sorting and Trimming||Contamination with foreign material.||Remove foreign material.||1.5|
|First Wash||Contamination due to pathogenic microorganisms and/or chemicals in the water.||Monitor and/or test water to ensure that it is acceptable (potable).||3.4|
|First Wash||Inadequate washing fails to lower the bacterial count.||Monitor and/or test that washing is done correctly.||1.6.1|
|First Wash||Contamination with pathogenic microorganisms due to the improper change/addition/removal of wash water, improper washing and/or warm wash water.||
Change water at a frequency to ensure that its potability is maintained.
Monitor and/or control wash water clarity (i.e., organic matter) and temperature to ensure the efficacy of chlorination or other antimicrobial treatment.
|Cutting/ Slicing/ Shredding/ Grinding||Contamination by metal fragments due to equipment and utensil wear and tear.||
Monitor equipment set-up and wear through an effective preventive maintenance program.
Inspect equipment and utensils regularly.
|Cutting/ Slicing/ Shredding/ Grinding||Growth of pathogenic microorganisms due to an excessive delay between cutting/ slicing/ shredding/ grinding operation and antimicrobial treatment.||Conduct cutting/ slicing/ shredding/ grinding step just prior to an antimicrobial treatment. Control ambient temperature during processing. Minimize the amount of time the product is sitting at elevated temperatures. Implement procedures for corrective action to be taken when delays occur.||1.6.1|
|Antimicrobial Treatment||Contamination due to pathogenic microorganisms and/or chemicals in the water.||Monitor and/or test water to ensure that it is acceptable (i.e., potable).||3.4|
|Antimicrobial Treatment||Inadequate reduction of pathogenic microorganisms due to inadequate treatment.||Use antimicrobial products at appropriate levels and monitor the levels during production.
Ensure that the amount of contact time of the antimicrobial product is appropriate.
|Antimicrobial Treatment||Chemical residue due to improper chemical application rates.||Use a validated antimicrobial treatment, and/or validate the process for the operator's specific facility, equipment and product.||1.6.1|
|Antimicrobial Treatment||Hazardous chemical residue on final product due to the use of unapproved antimicrobial treatment.||Use only antimicrobial treatment products that are approved for use on food.||1.6.1|
|Rinse After Antimicrobial Treatment||Contamination due to pathogenic microorganisms and/or chemicals in the water.||Monitor rinse water to ensure that it is acceptable (i.e., potable).||3.4|
|Rinse After Antimicrobial Treatment||Contamination with pathogenic microorganisms due to the improper change/addition/removal of rinse water.||Implement an effective rinsing procedure to ensure the adequate removal/change of rinse water and/or addition of potable water as appropriate.||1.6.1|
|Rinse After Antimicrobial Treatment||Excessive antimicrobial residue on final product.||Implement an effective rinsing procedure to ensure the adequate removal/change of rinse water and/or addition of potable water as appropriate.||1.6.1|
|Rinse After Antimicrobial Treatment||Growth of pathogenic microorganisms due to the use of warm rinse water.||Monitor and/or control rinse water clarity (i.e., the presence of organic matter) and temperature.||3.4|
|Drying||Growth of pathogenic microorganisms due to inadequate drying.||Control and monitor the effectiveness of drying.||1.6.1, 2.1|
|Blending / Mixing||Contamination with pathogenic microorganisms and/or chemicals due to the improper cleaning and sanitizing of equipment and utensils.||Monitor sanitation procedures and verify the effectiveness of the sanitation program.||4.1, 7.5.1|
|Blending / Mixing||Unlabelled allergens due to the addition of incorrect ingredients to the package (i.e., croutons, dressing packets, seeds, nuts, etc.)||Develop and implement an allergen control program to ensure the correct ingredients are added to the correct package and all allergens are labelled.||1.6.2|
|Packaging / Labelling / Coding||Growth of pathogenic microorganisms due to improper label instructions related to product storage and shelf life.||
Monitor label on product (e.g., correct label applied to product, all information provided is complete, accurate and legible).
If the shelf life is printed on the label, it should be validated for quality and food safety.
|Packaging/ Labelling/ Coding||Growth of pathogenic microorganisms due to the improper application of gases for modified atmosphere packaging.||Where the finished product is packaged in a modified atmosphere, monitor gas mixtures.||1.7.1|
|Metal Detection||Contamination with metal fragments due to ineffective detection by the metal detector and/or failure of the metal detector to function properly when metal is detected.||Regularly calibrate metal detector to ensure that it is functioning as intended.
Monitor and control the function of the metal detector.
|Storage of Finished Product||Growth of pathogenic microorganisms due to inadequate cooling.||Control temperature and storage practices in the cooler to minimize the growth of pathogenic microorganisms.||6.2.3|
|Shipping / Distribution||Contamination from pathogenic microorganisms, extraneous material and/or chemicals due to unsanitary carriers, improper distribution temperatures and/or damaged packaging.||Inspect carriers before loading to ensure transportation conditions meet the requirements of the manufacturer for the product being shipped.||6.1|
|Shipping / Distribution||Growth of pathogenic microorganisms due to time and/or temperature abuse during transport.||Transport product in a timely manner at a temperature that will minimize the growth of pathogenic microorganisms.||6.1|
|All Process Steps||Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to employee error as a result of a lack of training and/or a failure to understand the importance of following written standard operating procedures (SOP) and/or Good Manufacturing Practices (GMP).||Provide employees with training in standard operating procedures (SOP) and/or Good Manufacturing Practices (GMP) appropriate to their position and the work being performed.||5.2|
|All Process Steps||Growth of pathogenic microorganisms due to time-temperature abuse.||Control the temperature during processing to minimize bacterial growth.||1.6.1|
|All Process Steps||Contamination with pathogenic microorganisms, chemicals and/or extraneous material due to employee handling practices.||Provide employee training in proper hygiene and correct handling procedures. Monitor employee practices.||5.1, 5.2|
|All Process Steps||Contamination with pathogenic microorganisms and/or chemicals due to the improper cleaning and sanitizing of equipment and facilities.||
Monitor sanitation procedures and verify the effectiveness of the sanitation program
Develop and implement an Environmental Sampling Plan for Listeria spp. as recommended in Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).
|All Process Steps||Contamination from pathogenic microorganisms, extraneous material, and/or chemicals (including lubricants) due to improper equipment design, installation and/or maintenance.||
Use equipment that has been properly designed and installed for use in a food establishment. Maintain equipment appropriately to ensure that it is functioning effectively.
Ensure that food contact surfaces are food grade and that equipment is designed and positioned to prevent contamination of product.
|All Process Steps||Contamination from pathogenic microorganisms carried in the air and/or as the result of condensation.||Control and monitor airflow and the ventilation system in order to minimize the risk of product contamination.||3.2|
|All Process Steps||Cross-contamination from pathogenic microorganisms due to improper plant layout (e.g., inadequate separation of operations).||Separate non-compatible operations through building and process design.||3.2|
|All Process Steps||Cross-contamination from pathogenic microorganisms due to the improper movement of employees or visitors between processing steps.||Control employee and visitor movement within the plant.||5.1|
|All Process Steps||Contamination with pathogenic microorganisms due to the presence of rodents, birds or insects.||Monitor the effectiveness of the pest control program.||4.2|
|All Process Steps||Contamination of finished product with Listeria monocytogenes.||Categorize and sample finished products in accordance with Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).||1.3|
Using the Guidance Document
Principle statements are outcome-based generic statements of objectives similar to those found in the Recommended International Code of Practice - General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex). They are intended to capture the intent of the guideline, while allowing flexibility in addressing specific products or processes.
Rationales are included only when required to explain the principle statement. They are included in several chapters of this guidance document (Control of Operation, Equipment, Records and Complaint Handling and Recalls) to explain the nature of the concern or potential hazard(s) and the need for control.
Anticipated Outcomes are intended to guide the industry by describing the factors influencing the objective underpinning the principle statement. The CFIA recognizes that there may be alternative means of meeting the intent of the principle statement other than those described in this guidance document. For example, these alternative means may include a specific process step that will be used to control an associated food safety risk or meet a regulatory requirement.
Chapter 1: Control of Operation
1.1 Product Formulation and Composition
1.1.1 Availability and Accuracy of Product Formulae
Current written formulae are available for each product.
Formulae provide information to employees to ensure the production of a consistent product and to avoid potential hazards (e.g., adding unlisted ingredients that could cause allergic reactions).
- Current written formulae for each multi-component product are available for production employees.
- The formulae contain all details of the formulation as follows:
- identification of all ingredients, food additives and/or processing aids (e.g., brand/supplier, concentration, type, common name);
- amounts of all ingredients (when a blend of different types of vegetables is used).
- Products are formulated to ensure that accurate nutrition declarations are present where required (see 1.1.3 Compositional Requirements for further details).
1.1.2 Identification of Critical Processing Factors in Product Formulation
Any factors in the product formulation that are critical to a safe process and to the delivery of a product with a uniform composition are identified.
The inadequate identification of either critical ingredients and their specifications, or critical preparation/process steps, could affect product safety or lead to inaccurate nutrient composition.
- Ingredients critical to the product's composition and its nutritional profile are identified with their specifications and limits.
- Ingredients susceptible to property changes and nutrient losses are identified.
- Control factors that are critical to the product's safety and integrity are identified (this includes microbiological, chemical or physical concerns, as well as concerns related to allergens, extraneous material, etc.). Their specifications and limits are identified.
1.1.3 Compositional Requirements
The nutrient content of the food is controlled to meet declared label values (when presentFootnote 1) as well as the applicable requirements found in the Food and Drugs Act and Food and Drug Regulations. Foods, for which nutrient content claims and health claims are made, must meet the compositional requirements of the Food and Drug Regulations [Division 24, B.01.503 and B.01.600].
Inaccurate nutrition information, nutrient content claims and health claims may pose a health risk for those who are making food choices based on the nutrient content of the food.
- The manufacturer has control over the formulation or blending to ensure that all nutrient content declarations are met.
Note: The following CFIA documents provide further guidance on food composition and labelling:
- The Evaluation Standard for Nutrition Labelling (Section J of the Nutrition Labelling Toolkit).
- The Guide to Food Labelling and Advertising (GFLA), which provides detailed guidance on the requirements for nutrient content and diet-related health claims.
- The Nutritional Labelling Compliance Test, which constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims (see 6.11 of the GFLA).
1.1.4 Food Additives and Processing Aids
Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations.
Chemicals can be considered food additives, processing aids or food contaminants depending on their nature, their use (e.g., pH adjusters for water and antimicrobial agents) and/or the amount of residual chemical in the final product. The inadequate control of food additives and/or processing aids 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 and any other applicable legislation.
- The manufacturer has chemical specifications (e.g., composition and concentration) for all food additives and/or processing aids and ensures that all specifications are met. Where there are no specifications in the Food and Drugs Act and Regulations, the manufacturer ensures that all food additives and/or processing aids meet Food Chemical Codex (FCC) specifications or their equivalent.
- The manufacturer ensures that processing aids are used at levels in accordance with GMPs.
1.2 Labelling and Net Quantity
1.2.1 Labelling / 1.2.2 Net Quantity
The manufacturer has controls in place to ensure that the labels are complete and accurate, and meet the requirements of the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations, the Fresh Fruit and Vegetable Regulations of the Canada Agricultural Products Act and the Weights and Measures Act and Weights and Measures Regulations, where applicable.
Food labels provide basic information, a Nutrition Facts table (where applicable), the net quantity as well as instructions for the product's safe storage, handling or preparation.
- The manufacturer ensures that all labelling requirements are met.
- All label claims are accurate and not misleading.
- If products are labelled with a best before date, it is printed in the specified format as per section B.01.007 of the Food and Drug Regulations. The best before date is permanent, visible and legible, and easily understood by the end user. The shelf life indicated by the best before date should be validated with a shelf life study.
- Allergens in the product are declared in the list of ingredients.
- The manufacturer has controls in place to ensure that the product's net quantity, as stated on the label, is in compliance with Section 39 of the Consumer Packaging and Labelling Regulations and Section 52 of the Weights and Measures Regulations.
1.3 Process Design
1.3.1 Process Design
The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) throughout the product's processing, packaging and distribution.
Written verification is necessary to demonstrate that each process adequately ensures a safe product. Poor process design could result in unintentional incorporation of ingredients, such as undeclared allergens, or in lack of control of pathogenic microorganisms, toxins, chemicals and other hazards.
- A written description of the process(es), including procedures, is available upon request.
- All Critical Control Points (CCPs) for each product, including the critical limits for each CCP, are identified, tested, evaluated and validated in the development of the process. See the Process Flow Diagram below for a generic process flow and potential CCPs. For further information regarding the CCP rationale, see the CFIA's HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables.
- Each product has been evaluated and categorized according to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011). The validation data to support the categorization of products as 2A or 2B has been reviewed by regulatory authorities, if required.
- Any changes to the product formulation or the process are assessed to ensure there is no impact on the product's safety or composition.
1.3.2 Shelf Life Validation
The manufacturer demonstrates that quality and food safety are maintained throughout the product's anticipated shelf life.
The cutting of fresh vegetables can create conditions for microbial growth. Some packaging and storage techniques (e.g., modified atmosphere packaging, vacuum packaging or refrigerated storage) may slow the rate of physical deterioration (quality) without inhibiting pathogen growth. This could result in a product that appears to be edible but is unsafe.
- The manufacturer has determined the shelf life of each product.
- The manufacturer has a validated shelf life study for each product which includes all information necessary to demonstrate the product's quality and safety up to its best before date.
- Ready-to-Eat minimally processed vegetables with a shelf life of five (5) days or less would fall into Category 2A according to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011) (unless they meet the physico-chemical requirements for Category 2B).
- For products with a shelf life greater than five (5) days, a shelf life validation study is required to demonstrate that the product can be categorized as Category 2A or 2B, according to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011). In the absence of a shelf life validation study, a product is considered as a being of Category 1.
- For more information on shelf life validation studies, refer to Health Canada.
See Section 7.2.1 for expected Process Design Records.
A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food safety system designed to prevent, reduce to acceptable levels, or eliminate the biological, chemical, and physical hazards associated with food production. One strength of HACCP is its proactive approach to food safety that consists in preventing food contamination rather than trying to identify and control contamination after it has occurred. Fresh alimentary paste manufacturers may control food hazards through a system based on Hazard Analysis and Critical Control Point (HACCP) principles. They may:
- identify hazards potentially associated with RTE fresh-cut vegetables and the RTE fresh-cut vegetable process;
- identify any steps in their operations that are critical for controlling the safety of RTE fresh-cut vegetables;
- implement effective control procedures at those steps by establishing critical limits;
- monitor control procedures to ensure their continuing effectiveness;
- have procedures in place for dealing with deviations from critical limits;
- verify control procedures periodically and whenever the operations change; and,
- maintain records as specified in Chapter 7 of this guidance document.
A HACCP type program will reduce the risk of unsafe food by taking preventive measures to assure the safety and suitability of food at an appropriate stage in the operation by controlling food hazards.
The HACCP team at each establishment is responsible for the validation of the HACCP system; that is, by first validating the hazards that exist in the facility and then validating that the standards for the prerequisite programs (GMPs) and the standards for the critical limits of the Critical Control Point(s) can control the hazards. A validation is also to be conducted whenever new procedures, policies or control measures are introduced. If scientific studies and/or government regulations exist in relation to the standard or critical limit, the facility may quote this information as the validation. If said studies or regulations do not exist, the facility must conduct a validation study of its own to validate the control measure through testing. Once the initial validation is completed during development of the HACCP system, the facility should conduct a validation of the control measures at least once per year. This yearly validation reviews all of the standards of the prerequisite programs (GMPs), as well as the critical limits of the control points, to ensure that these control measures continue to be effective in controlling the identified hazards.
For additional information on how to build a HACCP system see, Appendix A (Hazard Analysis And Critical Control Point (HACCP) Summary) of this guidance document, the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables and the CFIA's Food Safety Enhancement Program (FSEP) Manual.
1.4 Incoming Material Control (Receiving)
1.4.1 Incoming Raw Vegetables and Other Non-Packaging Inputs
The manufacturer controls incoming produce, ingredients, chemicals and gases so that foods are not exposed to safety hazards (biological, physical and chemical) and remain both safe and correctly labelled.
The prevention of health hazards begins with the receiving of raw vegetables and other materials. Inadequate incoming product controls, such as a lack of appropriate product testing and sorting or a failure to verify labels, could result in the sale of contaminated product or misrepresented product. Specifications related to quality and safety provide standards against which the manufacturer can assess the acceptability of the components necessary for the production of the finished product.
- The manufacturer has written quality and safety specifications for all raw vegetables and other ingredients that are necessary for the production of the finished product.
- The manufacturer has documentation showing that vegetables were produced under Good Agricultural Practices (GAP) and that the product was grown according to the specifications. Refer to Appendix A – Good Agricultural Practices for the primary production and harvesting of fresh vegetables.
- The manufacturer has written specifications to avoid the presence of undeclared allergens.
- The manufacturer has written specifications for chemicals and gases that identify criteria essential for the manufacturing process and product safety (e.g., grade of gases and antimicrobial agents approved for food contact use).
- The manufacturer secures a Letter of Guarantee from each supplier that indicates that specifications are being met. Alternatively, a Certificate of Analysis (COA) can be provided by the manufacturer for each shipment.
- The manufacturer receives raw vegetables at the appropriate temperature, as indicated in the specifications.
- Each lot of incoming produce is visually examined for damaged containers (e.g., holes from rodents), product quality and for signs of contamination (e.g., stains, pests, insects, rodent and bird droppings, mould, foreign material, lubricants or other industrial chemicals from field equipment). Lots that do not meet established quality and safety specifications should not be accepted.
- Information about all incoming ingredients, such as the identity of the grower or supplier, date of harvest, field, etc., is retained and linked to the operation's production records (e.g., the date and shift when processed) for the finished product.
See Section 7.2.2 for expected Incoming Material Control Records.
1.4.2 Packaging Materials
The manufacturer controls incoming packaging materials to meet the requirements of Division 23 of the Food and Drug Regulations, such that there are no biological, physical or chemical hazards present in the food.
Controls are necessary to ensure that packaging materials meet the manufacturer's specifications. Inadequate controls could result in the use of containers that may contaminate or may permit the physical, chemical or biological contamination of the product.
- The manufacturer has written specifications for packaging materials that identify criteria essential for the manufacturing process and product safety (e.g., permeability of packaging materials, oxygen scavengers and other forms of active packaging).
- The packaging material is appropriate for the intended use and is used in accordance with the packaging manufacturer's instructions.
- Each lot of packaging material is visually examined for physical damage, signs of contamination (e.g., stains, bird droppings, rodent activity [e.g., faeces, urine], insects and foreign material [e.g., wood, metal, glass]) at the manufacturer's receiving facilities. The manufacturer does not use contaminated or potentially contaminated packaging material.
See Section 7.2.2 for expected Incoming Material Control Records.
1.5 Raw Material Preparation
1.5.1 Cleaning/Sorting - Contamination Control
Raw vegetables are inspected, sorted, trimmed, washed and disinfected in such a manner as to reduce biological, physical and chemical contamination and to prevent contamination of the finished product.
The adequate cleaning, sorting and antimicrobial treatment of raw material is necessary to prevent, reduce or remove contamination with biological, chemical and/or physical hazards.
The manufacturer may utilize the following procedures to control hazards:
- Sorting controls – visual inspection and removal of damaged or decomposed product from incoming raw ingredients.
- First wash – removal of dirt and reduction of the microbial load on intact vegetables. This may occur in the field or at the processing facility. The water must be potable. Washing raw vegetables may reduce, but not eliminate, pathogens that may be present on the produce.
- Depending on the nature of the produce, some items may be brush washed for the physical removal of soil and microorganisms (e.g., melons, mushrooms). This is often done in conjunction with a detergent followed by a rinse with potable water. Washing efficiency varies with the commodity, type of washing system, type of soil, contact time, detergent and water temperature.
- Antimicrobial treatment of whole vegetables – to minimize or reduce contamination of the raw material.
- Sorting controls – visual inspection to prevent use of produce that is noticeably damaged, contaminated by fuels (e.g., diesel, gasoline), machine grease, oil, lubricants, etc.
- Rinsing to remove excess antimicrobial agents from the produce after the antimicrobial treatment (if required).
- Extraneous material controls – visual inspection, sorting/cleaning by gravity, air or water, e.g., removal of stones, pebbles, wood, metal, and glass. Controls would include the application of metal detection using magnets or metal detectors.
1.6 Process Control
1.6.1 Processing Controls: Cutting/Slicing/Shredding/Grinding, Washing, Antimicrobial Treatment, Rinse after Antimicrobial Treatment, Drying After Rinsing, Product Temperature during Processing
All processing factors are controlled to ensure the safety of the product.
The inadequate control of processing steps could result in biological, chemical or physical hazards.
- The manufacturer evaluates the process and identifies all factors that have an impact on the safety of the final product.
- The manufacturer ensures that all appropriate processing factors are controlled within acceptable limits.
- The manufacturer monitors factors significant to food safety at a scheduled frequency.
Typical processing steps include:
Cutting, Slicing, Shredding and Grinding
Procedures are in place to minimize contamination with physical (metal) and biological (microbial) contaminants during cutting, slicing, shredding or grinding processes. This may include inspection of knives/blades, belts and other processing equipment for signs of wear or damage as well as product residue build-up. Knives and blades should be sharpened regularly. Knives and blades should be replaced if damaged or if they cannot be maintained in a sanitary condition.
The washing of cut produce with clean potable water reduces microbial contamination. Moreover, washing removes some of the cellular fluids released during the cutting process, thereby reducing the level of available nutrients for microbial growth.
- Cut vegetables are washed in potable water that meets the requirements of the Guidelines for Canadian Drinking Water Quality, published by Health Canada.
- Water is replaced at a sufficient frequency to prevent the build-up of organic material and prevent cross-contamination.
Antimicrobial treatments are used to minimize or reduce contamination of finished products and, where appropriate, to meet the criteria outlined in the validated shelf life study of the products.
Chlorinated Wash Water
Chlorine may be added to wash water to reduce microbial contamination on produce. After the antimicrobial treatment, excess chlorine is removed.
- Suggested concentrations for chlorinated wash water are between 100 and 150 parts per million (ppm) of total chlorine or between 2 and 7 ppm of free residual chlorine after contact. The pH of the water is between 6.0 and 7.0. The contact time is dependent upon the product and the chlorine concentration but ideally does 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 are consistently met.
Warning: Chemical disinfectants can be hazardous. People handling chemicals must follow the label directions and take appropriate precautions. Protective equipment should be worn, such as: waterproof gloves; chemical-resistant footwear and socks; protective clothing, such as coveralls over long sleeve shirt and long pants; protective eye wear; and, chemical-resistant headgear for overhead use.
Other Antimicrobial Treatments
Other antimicrobial treatments, such as organic acids or peracetic acid, may be used to inhibit microbial growth or reduce contamination. Antimicrobial treatments other than chlorination must be evaluated by the Food Directorate, Health Products and Food Branch, Health Canada.
- The antimicrobial treatments must comply with the Food and Drugs Act and Regulations.
- The manufacturer monitors and controls 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 consistently uses the antimicrobials as prescribed in the study.
Rinse After Antimicrobial Treatment
Excess antimicrobial chemicals (e.g., chlorine) are removed from the produce after the antimicrobial treatment by rinsing with potable water. Rinsing with potable water is repeated sufficiently to reduce the level of antimicrobial treatment to meet GMP levels. The GMP level is the amount of antimicrobial treatment required to achieve the intended purpose. See the Guidelines for Canadian Drinking Water Quality, published by Health Canada, for details.
Note: Excess chlorinated wash water may also be removed using drying methods (e.g., by centrifugal drier). All hazards are evaluated by the manufacturer when using this method.
Drying After Rinsing
Where appropriate for the product, as much excess water as possible from processed produce is removed through draining methods such as centrifugation.
Blending/mixing is controlled to ensure that no additional hazards are introduced into the product. For example: employees practice proper hygiene and product handling procedures; equipment, containers and utensils are clean and in good condition; etc.
- All products pass through a functioning metal detector. The metal detector functions as intended when metal is detected (e.g., the line stops, an alarm sounds or the product is ejected from the line).
- Proper function is monitored by passing test wands (ferrous, non-ferrous and stainless steel) through the detector at an established frequency.
Product Temperature during Processing
- Product temperature is controlled during processing to minimize the growth of pathogenic microorganisms.
Numerous factors may affect product temperature during processing including
- variations in incoming produce temperature;
- fluctuations in ambient air temperature and wash and rinse water temperatures;
- drying air temperature; and,
- cooling rate.
The higher the temperature of the finished product at time of packaging, the longer it will take to reach refrigeration temperature (4°C or less) and the greater the opportunity for microbial pathogens to grow. The shelf life of the product will also be reduced.
- The process is controlled to ensure that product temperature is reduced to refrigeration temperature (4°C or less) in as short a time as possible, without affecting product quality.
- The manufacturer demonstrates the control of product temperature through one of the following programs or equivalent:
1. Cold Chain Concept
- Cooling is initiated at the farm level by harvesting at cooler temperatures (e.g., at night or early morning), shading product during harvest, and reducing the time between harvest and arrival at the cooling or processing facility.
- Produce temperature is maintained at, or reduced to, 4°C or less prior to the start of processing. (However, some commodities have been shown to internalize pathogens when cooled too quickly. For example, tomatoes are washed in water at least 10°F warmer than the internal pulp temperature to prevent internalization of pathogens.)
- The air temperature in the rooms where fresh produce is processed does not exceed 4°C. Wash solutions are maintained at 4°C or less. Any other treatments that are part of the process do not cause the temperature of the produce to increase above 4°C.
- At all times, the finished product temperature is maintained at 4°C or less.
2. Validated Temperature Control Process
- The manufacturer has 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.
- The manufacturer demonstrates that the actual process does not exceed the maximum parameters of temperature and time set out in the validated study.
3. Time/Temperature Parameters
- The manufacturer follows the cooling guideline as outlined in the following table (Table 1).
Table 1 reads as follows: product temperature does not exceed the temperature stated in the left column for more than the corresponding total time stated in the right column. For example, the product temperature does not exceed 15°C for more than 4 hours from the start of processing and does not exceed 25°C for more than 0.5 hour within that 4-hour time period. If the processing of a vegetable starts at 20°C, the time does not exceed 1.5 hours at this temperature. If the processing room is set at less than 5°C, the processing time does not exceed 30 hours.
|Product Temperature||Total Time from the Start of Processing|
|Less than 5°C||30 h|
Note: The Cooling Guideline was developed by the Bureau of Microbial Hazards, Food Directorate, Health Canada.
See Section 7.2.4 for expected Process Control Records.
1.6.2 Control of Preparation and Composition
Preparation and blending of ingredients are controlled to minimize physical, chemical and biological hazards as well as to ensure the accuracy of composition.
The inadequate control of product preparation and blending could result in food safety hazards, such as excessive levels of food additives or the presence of undeclared allergens. The product's ingredient list, nutrition facts table and/or label claims may be inaccurate.
- The manufacturer controls conditions (e.g., time, temperature) during preparation, blending and holding of in-process materials to prevent undesirable microbial growth or the production of metabolic by-products of microbial growth.
- The manufacturer maintains proportion control of the ingredients during blending (e.g., weighing and metering) to ensure accuracy of the ingredient list, nutrition facts and/or label claims.
- The manufacturer has controls in place to ensure that each product contains only the ingredients listed in the formula and on the product label.
- The manufacturer has 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 has controls in place to prevent the presence of undeclared allergens. Potential areas that may require stricter controls include:
- cross-contamination or carry over;
- inappropriate use of rework;
- ingredient changes, substitutions or additions;
- incorrect labels;
- incorrect or incomplete list of ingredients;
- unknown ingredients.
Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens, guidance on the Labelling of Foods Causing Allergens and Sensitivities and a Tool for Managing Allergen Risk in Food Products.
See Section 7.2.3 for expected Product Preparation Records
1.7 Packaging Control
1.7.1 Handling and Use of Packaging
Handling and use of packaging is controlled to prevent product contamination.
The inadequate control of packaging may result in the use of damaged, defective or contaminated packaging materials which may in turn lead to the contamination of the product. Deviation from the packaging criteria could result in contamination or growth of microbial pathogens prior to the end of the shelf life.
- The manufacturer has an effective system in place to prevent the use of contaminated, damaged or defective containers. The controls in place are verified through periodic audits.
- Packaging material is handled and transferred in such manner as to minimize damage and contamination. There are controls in place for receiving, storage and conveying.
- Packaging material is examined for damage and contamination before use.
- Containers are used only for their intended purpose.
- Where containers are re-used, the manufacturer has in place a cleaning system whereby the containers are effectively cleaned prior to use.
- Container filling and sealing are controlled to meet the criteria outlined in the process design and/or shelf life study. See Section 1.3 – Process Design for additional information on shelf life studies.
- The manufacturer identifies and controls all critical packaging factors, when appropriate, such as bag or container composition, gas mixture, flushing time, and sealing of container. The manufacturer maintains appropriate records.
- The manufacturer has a program in place to identify and correct situations where container damage could or do occur.
1.8 Labelling Control
1.8.1 Prevention of Mislabelling
The manufacturer has controls in place to prevent mislabelling.
The control of labelling is important to ensure that the correct label is applied to each product. The use of incorrect labels could mislead the consumer and could pose a potential health hazard to segments of the population with allergies.
The manufacturer has procedures in place to ensure that labels accurately reflect product formulation and composition. Typical controls are as follows:
- Product types are effectively separated during changeovers (e.g., appropriate breaks between products and visual inspection to ensure products are not mixed prior to labelling).
- Different product labels or pre-labelled packaging are effectively separated and the number of product label types is kept to a minimum.
- During storage, care is taken to prevent mixing of individual labels or bundles of labels (e.g., labels are stored in separate boxes, no labels are loose and unused labels are returned to the correct boxes).
- Procedures are in place to ensure the product being supplied or added to the labelling operation corresponds to the labels in use (e.g., on-line checks to ensure that products are correctly labelled).
1.9 Product Coding Control
1.9.1 Product Coding
Each pre-packaged food product is identified with code marks or lot numbers on the label or container to allow the identification of the product in the event of a recall.
Coding permits products to be traced through the distribution chain and may provide information on product shelf life.
Note: Coding is not a mandatory labelling requirement for RTE fresh-cut vegetables. However, the practice is recommended under Section 8.2.1 (Procedure) to enhance the effectiveness of a recall.
- The manufacturer ensures that pre-packaged RTE fresh-cut vegetables are permanently marked with a legible code or lot identification on the label, the package or container.
- The coding system identifies where the product was manufactured (facility, line, etc.) and when (shift, day, month, year, etc.)
- The exact meaning of all code marks used is available from the manufacturer.
- Where used, case codes are legible and correspond to the identifying marks on the product within.
1.10 Deviations and Corrective Action
1.10.1 Deviation Control
When critical limits or limits of acceptability are exceeded or defects occur that could affect product safety or composition, procedures are in place to identify, isolate and evaluate products.
Deviations from critical limits, limits of acceptability and procedures, or the occurrence of defects, may affect the safety of the product. Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe product or misrepresented product.
Note: Deviation procedures apply to all sections of this guidance document, where appropriate.
The manufacturer has pre-determined and documented deviation procedures to:
- identify deviations in the incoming materials and ingredients, finished products and/or the procedures;
- isolate defective products; and,
- take appropriate corrective actions.
The manufacturer adheres to the requirements of Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011) in the event that a finished product or environmental sample is positive for Listeria monocytogenes.
Identification of Deviation
- The manufacturer has a system in place to identify and record deviations when they occur.
Isolation of Affected Product
- The manufacturer has effective procedures in place to isolate, clearly mark and control all product received and/or processed during the deviation period.
- All unsatisfactory product is isolated back to the point where the process was last in control. This could be back beyond the last satisfactory record.
- The isolated product is clearly marked (e.g., firmly attached tags contain the following information: hold number; product name; the amount; the date held; the reason for the hold; and, the name of the person holding the product).
- The manufacturer maintains control of the product from the hold date to the date of final disposition or until other actions are required following product evaluation.
Evaluation of Affected Product
- The product evaluation is conducted by a qualified person.
- Action on affected product (e.g., returning unused ingredients/materials to the supplier, sorting of suspect lots, re-processing, disposal) is conducted by adequately trained personnel in an appropriate manner to avoid the introduction of food safety hazards.
- The evaluation is adequate to detect potential health hazards or to identify misrepresentation. For example:
- sampling is adequate to identify the extent of the problem;
- tests are appropriate;
- the decision is based on sound science; and,
- the product is not released until the evaluation has determined that no health hazard exists and the product is in compliance with appropriate legislation.
See the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables for suggested deviation procedures and corrective actions.
1.10.2 Corrective Action
Corrective action taken following any deviation is effective to rectify and to prevent recurrence of the deviation.
Corrective action procedures are necessary to determine the cause of the problem and to take action to prevent recurrence. It is essential to follow up any corrective action with monitoring and reassessment to ensure that the correction has been effective.
- As part of the deviation procedure, the manufacturer has a set of documented corrective actions that include:
- an investigation to determine the cause of the deviation;
- preventive measures taken to prevent recurrence of the deviation; and,
- verification by the manufacturer of the effectiveness of the corrective action and preventive measures taken.
- The manufacturer's corrective actions in response to a positive Listeria monocytogenes result for either a finished product or environmental sample meet the requirements of Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).
See Section 7.2.5 for details on Deviations and Corrective Action Records.
See the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables for suggested deviation procedures and corrective actions.
1.11 Verification of Product Safety
1.11.1 Verification Procedures
The manufacturer uses supplementary methods of evaluation to verify the effectiveness of controls affecting product safety.
The purpose of verification is to assess the conformance and effectiveness of existing controls in preventing health hazards and to identify areas where improvements are required.
Note: Verification applies to all sections of this guidance document, where appropriate.
- The manufacturer verifies the conformance and effectiveness of controls affecting product safety.
- Individuals or organizations responsible for verification are identified. These individuals or organizations are suitably qualified.
- The verification frequency and methods are appropriate to the hazards associated with the product and process.
- Methods of verification may include the following:
- review of all specifications for incoming ingredients and materials as well as Letters of Guarantee at an adequate frequency or whenever any changes are made;
- an environmental sampling plan for Listeria spp. (food contact and non-food contact surfaces) as recommended by Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods;
- sampling and analyses of in-process and finished product for the appropriate chemical or biological hazards (e.g., Listeria monocytogenes, Salmonella spp.)
- refer to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011) and Compendium of Analytical Methods;
- on-site assessment of the monitoring procedure (e.g., GMPs and Critical Control Points);
- verification of the concentration of the antimicrobial agent (e.g., chlorine), pH and/or temperature of wash water;
- review of records for completeness;
- review of deviation records to ensure that appropriate corrective actions and preventive measures are taken and recorded in the event of a deficiency;
- challenge tests;
- independent external and/or internal audits;
- analysis of consumer complaint trends; and,
- retail audits (e.g., to determine if storage temperatures and shelf life limits are followed).
See Section 7.2.6 for expected Verification Records.
Chapter 2: Equipment
2.1 General Equipment
2.1.1 Design, Construction and Installation
All equipment and utensils are designed, constructed and installed to function as intended, to permit effective cleaning and sanitation and to prevent contamination of RTE fresh-cut vegetables.
- Equipment is designed, constructed and installed to ensure that:
- the process is capable of delivering the results which are required (e.g., rapid cooling, temperature control, sufficient drying, effective package sealing and control of gas flush composition and time for modified atmospheric packaging [MAP]);
- established temperatures can be achieved and maintained as rapidly as necessary. Cooling equipment is designed to control and monitor temperatures;
- it can be adequately and easily cleaned, sanitized, maintained and inspected to prevent contamination of the product during operations;
- it is installed a sufficient distance from floor drains to make them accessible for cleaning and to prevent contamination of the equipment;
- food contact surfaces are elevated sufficiently above the floor to prevent contamination from floor splashes;
- contamination of the product during operation is prevented (e.g., appropriate location of lubricant reservoirs, locating catwalks and conveyors such that they do not pass over exposed product or food contact surfaces); and,
- proper drainage is permitted and, where appropriate, equipment is connected directly to drains. Where applicable, drains are fitted with backflow preventers.
2.1.2 Food Contact Surfaces
Food contact surfaces are constructed of appropriate materials and are maintained in such a manner as to prevent food contamination.
- Food contact surfaces of equipment, containers and utensils are smooth, non-corrosive, non-absorbent, non-toxic, free from pitting, cracks or crevices, open seams, and able to withstand repeated cleaning and sanitation. Food contact surfaces include items such as knives, conveyors, belts, chutes, product totes, gloves, tools (including shovels and racks), cutting boards, tables, dryers and spinner baskets as well as packing scales.
- When coatings, paints, chemicals, lubricants and other materials are used for food contact surfaces or utilized on equipment where there is a possibility of contact with food, the substances are appropriate for the intended use and are used in accordance with the manufacturer's instructions.
- Equipment and utensils used to handle inedible material are not used to handle edible material.
2.1.3 Equipment Maintenance and Calibration Program
An effective maintenance and calibration program is in place to ensure that equipment performs consistently as intended and prevents contamination of the product.
Establishing a preventive maintenance and calibration program helps to ensure that all equipment functions as intended. Equipment failure requiring maintenance activities during production may increase the risk of biological, chemical and physical contamination.
- The manufacturer has an effective written preventive maintenance and calibration program to ensure that equipment that may have an impact on food safety functions as intended. This includes:
- a list of equipment requiring regular maintenance (e.g., refrigeration equipment, disinfectant delivery system, valves, gaskets, o-rings, pumps, screens, filters and heat exchanger plates, knives, cutting blades and belts); and,
- the maintenance procedures and frequencies (e.g., equipment inspection instructions, a schedule of adjustments and part replacements based on the equipment manufacturer's manual or equivalent, or based on operating conditions that could affect the condition of the equipment).
- The manufacturer establishes written protocols, including calibration methods and frequencies, for equipment monitoring and/or controlling devices that may have an impact on food safety.
- The equipment is maintained in a manner that ensures that there is no potential for the development of physical or chemical hazards (e.g., hazards resulting from inappropriate repairs, flaking paint and rust, excessive lubrication, leaking fluids).
- The maintenance and calibration of equipment is done by appropriately trained personnel.
- The preventive maintenance and calibration programs and written protocol are adhered to.
See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.
2.1.4 Instrumentation Maintenance and Calibration Program
Instrumentation is designed, constructed, installed, calibrated and maintained such that the equipment is capable of delivering the required process, thereby ensuring product safety.
The improper design, installation, calibration or maintenance of instruments can lead to inadequate processing of the product or to misuse of food additives and antimicrobial treatments.
- The manufacturer has an effective written preventive maintenance and calibration program to ensure that instrumentation which may have an impact on food safety functions as intended. This includes
- a list of instrumentation requiring regular maintenance and calibration; and,
- the maintenance and calibration procedures and frequencies.
- The instruments that control factors that may have an impact on food safety are designed, installed, constructed, calibrated and maintained as necessary to ensure that they function as intended.
- The maintenance and calibration of instruments is done by appropriately trained personnel.
- The preventive maintenance and calibration programs and written protocol are adhered to.
The following are some examples of instrumentation that may be required to control factors significant to the process:
Temperature measuring devices
- Temperature measuring/recording devices are installed, calibrated and maintained as necessary to ensure accuracy.
- Timing devices are verified upon installation and annually thereafter (or more frequently as necessary to ensure accuracy).
- Any official timing device is located so that it can be easily and accurately read by the operators.
- Metal detection equipment is 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, timing of the reject mechanism and suitability for environmental conditions.
- Magnets are installed to effectively remove metal before or after certain operations (e.g., dicing, slicing or filling).
- The strength and type of magnets are appropriate to the need.
- The strength of magnets is confirmed using probes or other effective devices as necessary.
- Magnets are monitored as necessary to ensure effective operation and surface exposure (e.g., adequately cleaned and metal particles removed).
- Flow meters (e.g., chlorine feed rate meters, gas pressure meters, etc.) are verified to ensure accuracy at the time of installation and annually thereafter.
- Other specialized instrumentation necessary for the control of factors significant to food safety is in place and calibrated as necessary (e.g., chlorine injectors, chlorine concentration test equipment, pH meters).
Note: The manufacturer initiates corrective action as per Section 1.10 - Deviations and Corrective Action when critical limits or limits of acceptability are exceeded, or whenever products could have been affected and found not to meet specifications.
See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.
Chapter 3: Premises
3.1 Building Exterior
3.1.1 Outside Property and Buildings
Buildings and surrounding areas are designed, constructed and maintained in a manner that prevents conditions that may result in the contamination of food.
Grounds, Roadways and Drainage
- The surrounding land is maintained to control sources of contamination such as debris and pest harbourage areas.
- The building is not located in close proximity to any environmental contaminants.
- Roadways are properly graded, compacted, dust proofed and drained.
- The surrounding property is adequately drained.
Exterior Building Structure
- The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. For example: the exterior has no unprotected openings; air intakes are appropriately located; and, the roof, walls and foundation are maintained to prevent leakage.
3.2 Building Interior
3.2.1 Design, Construction and Maintenance
Building interiors and structures are designed, constructed and maintained to prevent conditions that may result in the contamination of food.
Floors, Walls and Ceilings
- Floors, walls and ceilings are constructed of materials that are durable, impervious, smooth, cleanable and suitable for the production conditions in the area (i.e., materials will not result in the contamination of the environment or food).
- Where appropriate, wall, floor and ceiling joints are sealed and angles are coved to prevent contamination and facilitate cleaning.
- Floors, walls and ceilings are composed of materials that will not result in the contamination of the environment or food.
- Floors are sufficiently sloped to permit liquids to drain to trapped outlets.
- Ceilings, overhead structures, stairs and elevators are designed, constructed and maintained to prevent contamination.
Windows and Doors
- Windows are sealed or equipped with close-fitting screens.
- Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected.
- Doors have smooth, non-absorbent surfaces and are close-fitting and self-closing where appropriate.
Process Flow Separation
Building interiors and structures permit good hygienic practices, including protection against cross-contamination between and during operations. For example:
- Raw incoming vegetables, in-process vegetables and finished product areas are maintained separate from each other to prevent the potential for microbial cross-contamination.
- The internal design and layout are designed to facilitate good hygienic practices during production, including protection against cross-contamination between operations and during cleaning and sanitation of utensils and equipment. There is regulated flow in the process, from the arrival of the raw material at the premises to the finished, RTE fresh-cut vegetable products.
- Where mobile equipment (such as hand trucks or forklifts) moves between incompatible areas, measures are taken to sanitize the wheels (floor foamers, sanitizer sprays, etc.) to minimize cross-contamination.
- Foot dips/hand dips are to be used between clean/sanitary areas and areas presenting a potential for pathogen cross-contamination.
- Where food processing operations other than RTE fresh-cut vegetables exist at the same facility, there is adequate separation to prevent potential hazards associated with cross-contamination (i.e., biological, chemical, allergens).
Lighting is adequate for the activity being conducted. Where appropriate, light bulbs and fixtures are protected to prevent contamination of food or packaging material.
- The lighting is appropriate, such that the intended production or inspection activity can be effectively conducted. The lighting does not alter food colour and is not less than the following:
- 540 lux (50 foot candles) in inspection areasFootnote 2
- 220 lux (20 foot candles) in work areas
- 110 lux (10 foot candles) in other areas
- In case of their breakage, light bulbs and fixtures located in areas where exposed food and packaging material are located, are of a safety type or are protected so as to prevent contamination of food and packaging material.
Adequate ventilation is provided to prevent excessive condensation and dust and to minimize the entry of contaminated air.
- Ventilation provides sufficient air exchange to prevent unacceptable accumulations of condensation or dust and to minimize the entry of contaminated air.
- Ventilation systems are constructed such as to avoid airflow from the least clean areas (e.g., the receiving area) to cleanest areas (e.g., packaging and finished product storage) and are designed to be adequately maintained and cleaned.
- Ventilation openings are equipped with close-fitting screens or filters, as appropriate, to prevent the intake of contaminated air. Filters (for intake air, compressed air, etc.) are cleaned or replaced at least as often as the manufacturer specifies or more frequently if a problem is indicated, such as evidence of filter fouling or perforation.
- Air used as a processing technique (e.g., pneumatic conveying, air agitation, air blowers, air dryers, etc.) is appropriately sourced and treated (e.g., air intakes, filters, compressors) to reduce any source of contamination.
3.2.4 Waste disposal
Sewage, effluent and waste storage and disposal systems are designed, constructed and maintained in such a manner as to prevent contamination.
- Drainage and sewage systems are equipped with appropriate traps and vents.
- Establishments are 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 do not pass directly over or through production areas unless they are controlled to prevent contamination.
- Adequate facilities and equipment are provided and maintained for the storage of waste and inedible material prior to their removal from the establishment. These facilities are designed to prevent contamination.
- Containers used for waste are clearly identified, leak-proof and, where appropriate, are covered.
- Waste is removed and containers are cleaned and sanitized at an appropriate frequency to minimize the potential of contamination. Waste is not allowed to accumulate in produce handling and storage areas or the adjoining environment.
3.3 Sanitary Facilities
3.3.1 Employee Facilities
Employee facilities are designed, constructed and maintained to permit effective employee hygiene and in such a manner as to prevent contamination.
- The processing areas are provided with an adequate number of conveniently located hand-washing stations (preferably hands-free) with trapped waste pipes to drains.
- The washrooms, lunchrooms and change rooms are adequately ventilated and maintained. They are separate from and do not lead directly into food processing areas.
- The facilities provide adequate means for the hygienic washing and drying hands and include wash basins, soap, hands sanitizer, disposable towels or sanitary hand-drying supplies or devices and a supply of hot and cold water (or suitably controlled temperature) adjacent to toilets.
- The toilet facilities are designed to allow for the hygienic removal of waste and be located to avoid contamination of produce or premises.
- The toilet facilities are maintained under sanitary conditions and in good repair at all times.
- The washrooms, lunchrooms and change rooms are maintained in a clean condition.
- Hand-washing notices are posted in appropriate areas.
3.3.2 Equipment Cleaning and Sanitizing Facilities
Facilities for cleaning and sanitizing equipment are adequately designed, constructed and maintained in such a manner as to prevent contamination.
- The facilities are constructed of corrosion-resistant materials that are capable of being easily cleaned. They are supplied with potable water at temperatures appropriate for the cleaning chemicals used.
- The equipment cleaning and sanitizing facilities are adequately separated from food storage, processing and packaging areas, such as to prevent contamination.
3.4 Water/Ice/Steam Quality
3.4.1 Water and Ice
The potability of hot and cold water is controlled to prevent contamination.
- The potable water meets the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality and any applicable provincial and municipal requirements.
- The water from sources other than municipal supplies is treated as necessary by the manufacturer.
- The water is analysed by the manufacturer at a frequency adequate to confirm its potability. For microbial analysis, municipal water is analysed on an annual basis or results can be obtained from municipal or provincial government testing. Water from other sources is analysed semi-annually. For chemical analysis, water from non-municipal sources is analysed at least at the initial start-up of the well.
- The manufacturers have contingency plans in place to deal with provincial/municipal orders to boil water and unsatisfactory water analysis results.
- There are no cross-connections between potable and non-potable water supplies and all hoses, taps and other similar sources of potential contamination are designed to prevent back-flow or back-siphonage.
- Where it is necessary to store water, storage facilities are adequately designed, constructed and maintained to prevent contamination (e.g., the storage is covered).
- The volume, temperature and pressure of the potable water are adequate for all operational and clean-up demands.
- Water treatment chemicals, where used, are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
- The chemical treatment is monitored and controlled to deliver the desired concentration and to prevent contamination.
- Recirculated water is treated, monitored and maintained as appropriate to the intended purpose. Recirculated water has a separate distribution system which is clearly identified. Recirculated water flow should be counter to the movement of product, such that as vegetables are further processed they are exposed to the cleanest water.
- Ice used as an ingredient or in direct contact with food is made from potable water and is protected from contamination. Ice purchased by the manufacturer is treated as an incoming ingredient and is assessed under Section 1.4.1 Incoming Raw Vegetables and Other Non-Packaging Inputs.
For more information, manufacturers can refer to the CFIA Fresh Fruit and Vegetable Program's Record of Decision on Registered Produce Warehouse Registration/Renewal Requirements for Water Analysis.
See Section 7.4.1 for expected Water/Ice/Steam Quality Records.
The potability of steam which is in direct contact with food or food contact surfaces is controlled to prevent product contamination. The steam supply is adequate to meet operational requirements.
Note: Where steam is not in direct contact with food or food contact surfaces, this section is considered to be not applicable.
- The boiler treatment chemicals used are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
- The boiler feed water is tested regularly and the chemical treatment is controlled to prevent contamination.
- The steam supply is generated from potable water and is adequate to meet operational requirements.
- Traps are provided as necessary to ensure the adequate removal of condensate and the elimination of foreign materials.
See Section 7.4.1 for expected Water/Ice/Steam Quality Records.
Chapter 4: Sanitation and Pest Control
4.1.1 Sanitation Program
An effective sanitation program for equipment and premises is in place to prevent contamination of food.
- The manufacturer has a written cleaning and sanitation program for all equipment which includes:
- the name or title of the person in the position of responsibility;
- the frequency of the activity;
- the chemicals and concentrations used;
- the temperature requirements;
- the procedures for cleaning and sanitizing that:
- identify lines, equipment and utensils;
- outline disassembly/reassembly instructions as required for cleaning and inspection;
- identify areas on equipment requiring special attention;
- outline the method of cleaning, sanitizing and rinsing.
- the type and frequency of inspection to verify the effectiveness of the program.
- The manufacturer has a written cleaning and sanitation program for premises (production and storage areas) which specifies areas to be cleaned, the method of cleaning, the person responsible and the frequency of the activity. The special sanitation and housekeeping procedures required during production are specified within the document (e.g., removal of product residues during breaks).
- Chemicals are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
- The cleaning and sanitizing equipment is designed for its intended use and is properly maintained.
- The sanitation program is carried out in a manner that does not contaminate food or packaging materials during, or subsequent to, cleaning and sanitizing (e.g., no contamination from aerosols or chemical residues).
- The effectiveness of the sanitation program is monitored and verified (e.g., by a pre-operational inspection of premises and equipment or, where appropriate, by microbiological sampling) and, where/when necessary the program is adjusted accordingly. Establishments processing RTE foods should design, implement and maintain an environmental sampling program for testing food contact surfaces and non-food contact surfaces for the presence of Listeria spp. as recommended by Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).
- The sanitation program is adjusted, as necessary, to incorporate new cleaning procedures (new equipment, new chemicals, etc.).
- The sanitation program may be used to provide control over cross-contamination issues associated with the production of non-allergenic and allergenic products.
- Operations begin only after sanitation requirements have been met.
See Section 7.5.1 for expected Sanitation Records.
Example of cleaning and sanitizing steps within processing areas
Cleaning and sanitizing steps
- Remove heavy debris from floors with brooms or shovels and dry clean processing equipment, if needed.
- Pre-rinse the equipment with potable water.
- Clean remaining debris from floor.
- Rinse floor and drains with potable water using a low pressure hose.
- Use dedicated brushes to scrub floor and drains with an effective cleaner, applying potable water as needed.Footnote 3
- Foam and scrub the equipment with an effective cleaner and scrub using dedicated brushes.
- Thoroughly rinse the equipment, floors and drains with potable water using a low pressure hose.
- Remove excess water from floors.
- Sanitize (according to manufacturer's directions) the equipment and floors.Footnote 4
4.2 Pest Control
4.2.1 Pest Control Program
Effective pest control programs are in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.
- There is an effective written pest control program for the premises and equipment that includes:
- the name or title of the person in the position of responsibility;
- 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 they were applied as well as the method and frequency of application;
- a map of trap locations;
- the type and frequency of inspection to verify the effectiveness of the program.
- The pesticides used are registered with the Pest Management Regulatory Agency under the Pest Control Products Act and Pest Control Products Regulations and have been issued a PCP Registration Number. Pesticides are used in accordance with the label instructions.
- The chemical treatment of equipment, premises or ingredients to control pests is conducted in a such manner as to ensure that the maximum residue limit of the Food and Drugs Act and Regulations is not exceeded (e.g., the number of fumigation treatments per lot is limited).
- Poisonous rodenticides are not used in food processing or storage areas.
- Birds and animals are excluded from establishments.
See Section 7.5.2 for expected Pest Control Records.
Chapter 5: Personnel
5.1 Hygiene and Health Requirements
5.1.1 Cleanliness and Conduct
All persons entering food handling areas maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food.
- All persons wash and sanitize their hands upon entering food handling areas, before starting work, after handling contaminated materials (e.g., picking objects off the floor, handling garbage, cleaning chemicals or raw incoming materials), after breaks, and after using toilet facilities or blowing their nose. Where necessary to minimize microbiological contamination, employees use disinfectant hand dips.
- Disposable gloves are changed whenever contamination is a possibility.
- Protective clothing, hair covering, footwear and/or gloves, appropriate to the operation in which the employee is engaged, are worn and maintained in a sanitary manner.
- Behaviour which could result in contamination of food (e.g., eating, use of tobacco or chewing gum, unhygienic practices like spitting) is not conducted in food handling areas.
- All persons entering food handling areas remove jewellery and other objects which may fall into or otherwise contaminate food. Jewellery which cannot be removed (wedding bands, medical alerts bracelets, etc.) is secured and covered.
- Personal effects and street clothing are not kept in food handling areas and are stored in such a manner as to prevent contamination.
- The access of personnel and visitors is controlled to prevent contamination. The traffic pattern of employees prevents cross-contamination of the product (e.g., the employees avoid going back and forth to various stages of production. The employees do not go from a potentially contaminated area to the packaging area unless they have washed their hands and changed to clean, protective clothing).
- The responsibility for ensuring that all employees comply with the requirement of this section is specifically allocated to competent supervisory personnel.
5.1.2 Communicable Diseases and Injuries
No person who is known to be infected with a disease likely to be transmitted through food, or who has open cuts or wounds, is permitted to work in food handling areas where there is a likelihood of the person directly or indirectly contaminating the food.
- The manufacturer has and enforces a policy to prevent personnel from working in food handling areas if they are known to be suffering from a disease or are known to be carriers of a disease transmissible through food.
- The manufacturer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food. Conditions which are to be reported include:
- sore throat with fever; and,
- discharges from the ear, eye or nose.
- Employees having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g., rubber gloves).
5.2.1 General Food Hygiene Training
Food handlers are trained in personal hygiene and the hygienic handling of food. They understand the precautions necessary to prevent the contamination of RTE fresh-cut vegetables.
- The manufacturer has a written training program for employees and maintains appropriate records.
- Appropriate training in personal hygiene and the hygienic handling of food is provided to all food handlers at the beginning of their employment.
- Food hygiene training is reinforced and updated at appropriate intervals and each time a food handler changes duties.
5.2.2 Technical Training
To ensure food safety, personnel are trained such that they have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible.
The training is appropriate to the complexity of the manufacturing process and the tasks assigned. The manufacturer has a written training program for employees and maintains appropriate records. Examples are listed below.
- Personnel are trained to understand: the importance of the critical factors for which they are responsible; the critical limits and/or company standards; the procedures for monitoring; the action to be taken if the limits or standards are not met; and, the records to be kept.
- Personnel and supervisors are trained to have adequate technical knowledge and understanding of the operations or processes for which they are responsible.
- The managers and supervisors for RTE fresh-cut vegetable manufacturing have the necessary knowledge of food hygiene principles and practices to be able to judge potential risks and take the necessary action to remedy deficiencies.
- All employees, including those in maintenance and customer service, are trained to implement allergen controls.
- Personnel responsible for the maintenance of equipment that may have an impact on food safety have been appropriately trained to identify deficiencies that could affect product safety and to take the appropriate corrective action (e.g., in house repairs, contract repairs). Individuals performing maintenance on specific equipment are appropriately trained.
- Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing.
- Personnel and supervisors responsible for water treatment and water safety monitoring are appropriately trained to understand the principles and methods and are competent in applying procedures designed to protect the safety of food.
- Personnel who handle potentially hazardous chemicals are instructed in safe handling and disposal techniques.
- Additional training is provided to personnel, as necessary, to keep their knowledge of equipment and processing technology current.
- Periodic assessments of the effectiveness of training and instruction programs are made as well as routine supervision and checks to ensure that procedures are being carried out effectively.
Chapter 6: Transportation and Storage
6.1.1 Food Carriers
Conveyances and containers used by the manufacturer are designed, constructed, maintained, cleaned and utilized in a manner that prevents food contamination and minimizes microbial growth.
- The transportation of food products preferably takes place in conveyances and containers dedicated to food use only. When used for food and non-food loads, procedures are 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-out.
- Conveyances and containers are inspected by the manufacturer upon receipt of incoming ingredients and prior to loading of final products to ensure that they are free from contamination and suitable for the transportation of food.
- Conveyances and containers are constructed, maintained and cleaned in a manner that prevents the contamination of food. The manufacturer can demonstrate that the carrier has an adequate cleaning and sanitizing program in place.
- Conveyances and containers are loaded, arranged and unloaded in a manner that prevents damage and contamination.
6.1.2 Temperature Controls
Incoming vegetables and finished products are refrigerated during transportation to minimize the growth of pathogenic microorganisms.
- The temperature during transportation is controlled to maintain optimum storage conditions for fresh vegetables.
- Other incoming ingredients requiring refrigeration are maintained at 4°C or less.
- Finished products are maintained at 4°C or less during transportation.
- Transportation vehicles are equipped with temperature measuring devices, preferably recording thermometers. If recording thermometers are not used, maximum/minimum thermometers are used.
6.2.1 Incoming Materials Storage
Incoming ingredients and packaging materials are stored and handled in a manner designed to minimize spoilage and deterioration and to prevent damage and contamination. Incoming vegetables are refrigerated during storage to minimize the growth of pathogenic microorganisms.
- The temperature of the storage rooms is controlled to maintain optimum storage conditions for fresh vegetables (refer to Section 1.8.1 Processing Control: Temperature Control). Incoming vegetables are refrigerated during storage to minimize the growth of pathogenic microorganisms.
- Other incoming ingredients requiring refrigeration are maintained at 4°C or less.
- The refrigeration facilities (storage rooms) are equipped with temperature measuring devices, preferably recording thermometers. If recording thermometers are not used, maximum/minimum thermometers are used.
- Stock rotation (of ingredients and, where appropriate, of packaging materials) is controlled to prevent deterioration and spoilage. First-in, first-out stock rotation is practiced.
- Incoming ingredients and packaging materials are stored and handled in a manner that prevents damage (e.g., control of stacking heights and forklift damage) and/or contamination (including cross-contamination with allergens).
- Humidity sensitive ingredients and packaging materials are stored under appropriate conditions to prevent deterioration.
6.2.2 Non-Food Chemicals – Receiving and Storage
Non-food chemicals are received and stored in a manner that prevents contamination of food, packaging materials and food contact surfaces.
- Non-food chemicals are received and stored in a dry, well ventilated area.
- Non-food chemicals are stored in designated areas such that there is no possibility for cross-contamination of food or food contact surfaces.
- Where required for ongoing use in food handling areas (e.g., conveyor lubricants), these chemicals are stored separate from food and located in a manner that prevents contamination of food, food contact surfaces and packaging materials.
- Non-food chemicals are stored and mixed in clean, correctly labelled containers.
- Non-food chemicals are dispensed and handled only by authorized and properly trained personnel.
6.2.3 Finished Product Storage
Finished products are stored and handled in a manner designed to minimize spoilage and deterioration and to prevent damage and contamination. Finished products are refrigerated during storage to minimize the growth of pathogenic microorganisms.
The refrigeration of the finished product throughout its expected shelf life is required to minimize the growth of pathogenic microorganisms.
- The temperature of the storage rooms is controlled to maintain optimum storage conditions. Finished products are maintained at 4°C or less during storage.
- The refrigeration facilities (storage rooms) are equipped with temperature measuring devices, preferably recording thermometers. If recording thermometers are not used, maximum/minimum thermometers are used.
- Stock rotation is controlled to prevent deterioration and spoilage that could present a health hazard (e.g., products exceeding their shelf life). First-in, first-out stock rotation is practiced.
- Finished products are stored and handled in a manner that prevents damage, (e.g., control of stacking heights and forklift damage) and/or contamination (including cross-contamination with allergens).
- Product returned as defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.
Chapter 7: Records
7.1 General Records
7.1.1 General Record Requirements
Information is recorded in a manner that represents an accurate history of the product or process. Records are retained for the required period of time.
- The records are legible, permanent and accurately reflect the actual events, conditions or activities.
- Errors or changes are identified so that the original record remains clear (e.g., strike out with a single stroke and initial the correction/change).
- Each entry on a record is made by the person in the position of responsibility at the time that the specific event occurred. The completed records are signed and dated by the person in the position of responsibility.
- Critical Control Point records are signed by a qualified individual designated by management. All other records are reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
- The records are retained for at least one year after the best before date on the label or container.
- The records are maintained and are available upon request.
7.2 Records on Control of Operation
7.2.1 Process Design Records
Records are available to demonstrate the adequacy of procedures and methods used in process development.
Records are necessary to verify that factors significant to food safety including Critical Control Points are adequate to produce a safe product.
- The records are available upon request to verify that reliable procedures have been followed in designing the process.
7.2.2 Incoming Material Control Records
The manufacturer keeps records that demonstrate the adequacy of incoming materials control.
Adequate records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards associated with incoming materials.
- Appropriate records are kept to demonstrate that incoming lots of raw vegetables and other ingredients were inspected for signs of contamination and adherence to written specifications.
- Data on antimicrobial agents and food chemicals (e.g., food additives/processing aids) are kept on file.
Incoming Packaging Materials
- Appropriate records are kept to demonstrate adequate control of essential criteria identified in the process design or shelf life study.
Non-Conforming Incoming Materials (including ingredients and packaging material)
- The manufacturer has records to:
- identify the material;
- identify the deficiency; and,
- specify the preventive and corrective action taken.
7.2.3 Product Preparation Records
Records for factors significant to food safety are maintained and are available on request.
Records are necessary to verify that factors significant to food safety during preparation are controlled.
The manufacturer has records that demonstrate the control of product preparation through adherence to factors significant to food safety where applicable (e.g., allergens, food additives).
7.2.4 Process Control Records
Written records that adequately reflect the control of Critical Control Points and/or factors significant to food safety during processing are available upon request.
Records are necessary to verify the safety of the process.
- The manufacturer has records that demonstrate the control of Critical Control Points and/or factors significant to food safety during processing.
- Deviations are noted on the records by the operator during the process and not after the fact.
Inspection, Sorting, Trimming
- The manufacturer has records that demonstrate the control of biological, chemical and physical hazards (e.g., visual inspection, metal removal, sorting/cleaning by gravity, air and water).
- The manufacturer has records that demonstrate the control of the initial wash to ensure the effective removal of soil and the reduction of initial microbial load.
Cutting, Slicing, Shredding and Grinding
- The manufacturer has records that demonstrate the control of these steps to minimize contamination with biological and physical hazards such as pathogens and metal.
- The manufacturer has records that demonstrate efficient washing to remove cellular fluids, reducing the available nutrients for microbial growth.
- The manufacturer has records that demonstrate the control of the critical processing factors such as chlorine concentration, pH and contact time (as required) and use of other antimicrobial treatments.
Rinse After Antimicrobial Treatment
- The manufacturer has records that demonstrate the reduction of antimicrobial treatment residues to acceptable levels.
Drying After Rinsing
- When appropriate for the product, the manufacturer has records to demonstrate the effective removal of excess water.
- Where appropriate, the manufacturer has records to demonstrate that no additional hazards have been introduced into the product.
- The manufacturer has records that demonstrate the proper functioning of all metal detectors as determined by passing test wands through the devices at the established frequency.
Product Temperature During Processing
- The manufacturer has records that demonstrate the control of product temperature during processing.
Product Temperature During Storage
- The manufacturer has records that demonstrate the control of product temperature during storage. Daily records of temperatures in all refrigeration facilities are maintained. These could consist of recorder charts or a daily log of maximum/minimum temperatures. The records include the date and location where the temperature was recorded.
Note: Minimum information required on records may vary depending on the type of process.
7.2.5 Deviation and Corrective Action Records
Records are available to document deviations and demonstrate the effectiveness of corrective actions taken.
Records are required to verify that the manufacturer has documented deviations and that corrective actions have been effective.
Deviation records include information such as:
- the product and code;
- the date when the product was manufactured, held, released or destroyed;
- the description of deviation and reason for the hold;
- the amount of product held, e.g., back to the point where the process was last in control;
- the results of the evaluation/sort, e.g., amount analyzed, analysis report of the number and nature of defects;
- the disposition of the held product, e.g., amount sorted, destroyed or returned to the supplier, employee sales, distress or salvage, reconditioning and retail sales;
- the signature of personnel responsible for the hold and evaluation;
- the signed authorization for disposition.
Corrective action records include information such as:
- the cause of the deviation identified;
- the corrective action taken to correct the deficiency;
- the follow-up/assessment related to the effectiveness of the corrective action;
- the preventive measures taken to prevent a recurrence;
- the date corrective action was taken and verified; and,
- the signature of the person in the position of responsibility.
7.2.6 Verification Records
Records are available to demonstrate the adequacy of verification procedures.
Records show the results of verification and confirm the conformance and effectiveness of manufacturing controls.
- The records of verification include the methods utilized, the date, the individuals/organizations responsible, the results/findings and the action taken (corrective action when a deviation is found).
7.3 Records on Equipment
7.3.1 Equipment/Instrumentation Maintenance and Calibration Records
Records are available to demonstrate adherence to the maintenance and calibration program for equipment and instrumentation that may have an impact on food safety.
Records permit verification of the effectiveness of the equipment/instrumentation maintenance and calibration program.
- In Maintenance Records, the manufacturer typically includes an identification of the equipment/instrumentation, the maintenance activity, the date of maintenance, the name of the person in the position of responsibility and the reason for the activity.
- In Calibration Records, the manufacturer typically includes an identification of the equipment/instrumentation, the date of calibration, the name of the person in the position of responsibility, the calibration results and corrective actions.
7.4 Records on Premises
7.4.1 Water/Ice/Steam Quality Records
Written records that adequately reflect control of water, ice and steam quality and treatment are available upon request.
- The manufacturer has records available upon request to demonstrate the adequacy of the microbiological and chemical safety of the water, ice and steam supply.
- The records must indicate the water source, the sample site, the date and time sampled, the method of treatment, the analytical methods, the analytical results, the name of the analyst and the date completed.
- The manufacturer should refer to the CFIA Fresh Fruit and Vegetable Program's Record of Decision on Registered Produce Warehouse Registration/Renewal Requirements for Water Analysis for additional records required by registered establishments.
7.5 Records on Sanitation and Pest Control
7.5.1 Sanitation Records
Records are available to demonstrate the effectiveness of the sanitation program.
- The records of sanitation activities include the date, the name of the person in the position of responsibility, the findings, the corrective action taken and, where appropriate, the microbiological test results.
7.5.2 Pest Control Records
Records are available to demonstrate the effectiveness of the pest control program.
- Minimum pest control records include:
- the results of the inspection programs and the corrective action taken (e.g., the findings in traps, the location of insect infestations);
- a record of pest control activities (e.g., the pesticide used, the method and location of application, the dates of fumigation); and,
- the date and the name of the person in the position of responsibility.
7.6 Records on Complaint Handling and Recalls
7.6.1 Complaint Records
Records of product complaints, investigation findings and action taken are available upon request.
Records provide verification that the appropriate action was taken within a reasonable time frame.
- The establishment maintains detailed records of consumer complaints received and of the subsequent investigations, including the corrective actions taken. The complaint records include the information listed below.
The manufacturer's records contain, at a minimum:
- the name, address and telephone number of the complainant as well as the date the complaint was received;
- the details of the complaint and/or illness;
- the product's name, code and size; and,
- the retail outlet where the product was purchased.
The manufacturer's records contain, at a minimum:
- the name of person responsible for the investigation;
- the action taken (concerning the product and/or the process) as a result of the investigation;
- the corrective action taken to prevent a recurrence; and,
- a follow-up/assessment of the effectiveness of the corrective action.
7.6.2 Distribution Records
Product distribution records are available to enable the manufacturer to recall any lot of food in a timely fashion.
The distribution records contain sufficient information to permit traceability to a particular code or lot number. The following minimum information is required for distribution records:
- the product identification and size;
- the lot number or code;
- the quantity; and,
- the name and type of the account (e.g., manufacturer, distributor, retailer), addresses and phone numbers of recipients.
Chapter 8: Complaint Handling and Recalls
8.1 Complaint Handling
8.1.1 Product Complaints
The establishment has an effective system for handling and investigating complaints.
Product complaints are an important indicator of possible deficiencies in manufacturing controls and/or deficiencies in the distribution handling system. When the complaint handling system itself is deficient, it could result in the failure to identify and eliminate risks.
- The manufacturer has a system in place to handle and investigate product complaints which identifies the person or persons responsible for receiving, evaluating, categorizing and/or investigating complaints.
- The complaints are accurately categorized according to risks.
- Potentially serious complaints are forwarded immediately to appropriate personnel for action.
- Safety and contamination complaints are investigated by appropriately trained technical personnel.
- The examination of the complainant's specimen, the retail product or other product of the same code is conducted on complaints related to food safety.
- The depth of the investigation is appropriate to the risk and similar complaint trends.
- Appropriate corrective action is taken for deviations identified during the investigation.
See Section 7.6.1 for expected Complaint Records.
8.2.1 Recall Procedure
The manufacturer establishes a written procedure to permit the complete and rapid recall of any lot of food from the market.
- A written procedure is 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.
Note: In some instances, the establishment may be required to recall a product because of the use of a raw ingredient or packaging material which has been determined to be unsafe. By linking raw ingredient lot codes to the finished product code, the establishment will be able to identify which of its finished products need to be recalled.
- The written procedure identifies the person or persons in the position(s) of responsibility (e.g., recall coordinators) and the roles and responsibilities of those who coordinate and implement a recall.
- The procedure specifies methods to identify, locate and control recalled product and includes a requirement to investigate other products that may be affected by the hazard and that should be included in the recall.
- The procedure requires that the recall be monitored to assess its effectiveness (e.g., an effectiveness check is conducted to the appropriate level of distribution specified in the recall notice).
- The Canadian Food Inspection Agency is immediately notified in the region where the manufacturer is located. This notification includes the following:
- the amount of product produced, the amount in inventory and the amount distributed;
- the name, size, code or lot numbers of the food recalled;
- the area in which the product was distributed (e.g., local, national, international); and,
- the reason for the recall.
See Section 7.6.2 for expected Distribution Records.
Note: For additional information on developing a recall plan, please refer to the Food Recalls: Make a Plan and Action It! Manufacturers' Guide.
8.2.2 Recall Capability
Recall procedures are tested periodically to verify the manufacturer's capability to rapidly identify and remove product from the market.
- The manufacturer demonstrates the capability to provide accurate information on a timely basis, to verify that all affected product can be rapidly identified and removed from the marketplace. For example:
- the manufacturer conducts periodic testing (internal simulations or mock recalls) to verify the capability of the procedure to rapidly identify and control a code lot of potentially affected product and to reconcile the amount of product produced with the amount in inventory as well as the amount in distribution.
- the manufacturer identifies and corrects any deficiencies in the recall procedure.
For the purpose of this guidance document, the following expressions have the stated definitions:
- Any substance capable of producing an abnormal immune response in sensitive individuals.
- Challenge test
- Scientific study by which specific microorganisms of concern are added to a product to confirm the adequacy of a theoretical process.
- The introduction of foreign material, harmful substances or disease-causing microorganisms to product or packaging material by raw materials, hands, food-contact surfaces, equipment and utensils.
- Means that an operation performs consistently within pre-determined limits based on process capability, meets process requirements, provides a mechanism to maintain the stability of the process and consistently results in a safe product.
- Any aircraft, carriage, motor vehicle, trailer, railway car, vessel, cargo, container or other contrivance used to move food or containers of food.
- Corrective action
- The actions to be taken when the results of any monitoring indicates a loss of control. In addition, this term refers to any action taken to bring the process into control and deal with any affected product when critical limits or other criteria are not met. The action should be prompt and appropriate to the seriousness of the deficiency.
- Critical Control Point (CCP)
- A point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels.
- Critical limit
- A value which separates acceptability from unacceptability (for a Critical Control Point).
- Contamination of Ready-to-Eat vegetables or packaging material by direct or indirect contact with material from an earlier stage of the process. A regulated process flow and good employee practices will minimize the risk of cross-contamination occurrences.
- For the purposes of this document, deterioration can be used interchangeably with spoilage. However, deterioration can also apply to non-food products such as packaging materials. For non-food items, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.
- Failure to meet the critical limits for a Critical Control Point or failure to meet the limits of acceptability for factors significant to food safety.
- Deviation procedure
- A pre-determined and documented set of corrective actions (immediate and preventive) that are implemented when a deviation occurs.
- For the purposes of this document, documents refer to written formulae, procedures or specifications used by or required of a manufacturer.
- Equipment that may have an impact on food safety
- Equipment that performs a function whose impact on the process is such that a food safety hazard could be prevented, eliminated or reduced to acceptable levels.
- Factors significant to food safety
- Means any property, characteristic, condition, aspect, or other parameter, where/when a variation of which may affect the safety of the product or the process.
- Finished product
- A product that will undergo no further processing or transformation by the establishment.
Note: A product that undergoes further processing or transformation by another establishment is a finished product, in the context of the first establishment and a raw material or an ingredient in the context of the second establishment.
- Food contact surface
- Any equipment or utensil that normally comes in contact with the food product or surfaces that are normally in contact with the product.
- Good Agricultural Practices (GAP)
- The general practices used in the planting, growing, harvesting, sorting, packing, storage and transportation of fresh vegetables that will reduce and minimize the risks of biological, chemical and physical contamination.
- The potential to cause harm. A biological, chemical or physical property that may cause an unacceptable consumer health risk.
- Hazard Analysis Critical Control Points (HACCP)
- A systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control.
- Inspection areas
- (definition with respect to lighting requirements) inspection areas are defined as any point where food products or containers are visually inspected or instruments are monitored.
- Means the amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
- Include yeasts, moulds, bacteria, viruses and parasites. When used as an adjective, the term microbial is used.
- A planned sequence of observations or measurements to assess whether a CCP (or other activity) is under control.
- Potable water
- Water that meets the requirements of the Guidelines for Canadian Drinking Water Quality published by Health Canada and any applicable provincial and municipal requirements.
- Pre-packaged product
- As per the Food and Drugs Act, any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person.
- Processing aids
- As per the Guide to Food Labelling and Advertising, processing aids are substances/ingredients that are added to a food for a technological effect during processing and that are not present in the finished food product or are present at insignificant or non-functional levels.
- Product formulation
- A written recipe for multi-ingredient products, including ingredients and food additives and their proportions. May also refer to either the process of product development (design) or the act of physically blending ingredients to produce the multi-ingredient product.
- Ready-to-Eat (RTE) fresh-cut vegetables
- Raw vegetables that have been washed and 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.
- Recall (noun)
- Denotes the process of retrieving the affected product from the marketplace and encompasses all tiers of the affected product's distribution system.
- Recall (verb)
- Means for an establishment to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by the CFIA.
- Recall, periodic testing
- 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.
- Observations and measurements recorded by a manufacturer to determine adherence to critical limits, limits of acceptability or other specified requirements (for a Critical Control Point or for factors significant to food safety).
- Means exposure to a temperature of 4°C or less, but does not mean frozen. Risk – an estimate of the likelihood of occurrence of a hazard.
- The application of heat or chemical treatments to destroy or substantially reduce the number of microorganisms present that have the potential to cause adverse health effects.
- A process whereby food is rendered unacceptable for consumption through microbiological or chemical reaction.
- The obtaining of evidence showing that control measures are capable of being consistently effective. Validation is performed when new control measures or a new food safety control system is designed, or when changes indicate the need for revalidation, in order to confirm that the control measures or food safety control systems, when implemented as intended, are capable of controlling the hazard to the appropriate level and that this level of control can be achieved consistently.
- Examination of the accuracy, correctness or effectiveness of validated processes or process controls through testing, investigation or comparison against a standard.
Code of Hygienic Practice for Fresh Fruits and Vegetables, Annex 1 for Ready-to-Eat Fresh Pre-Cut Fruits and Vegetables. WHO/FAO. 2007.
Acts and Regulations
- Consumer Packaging and Labelling Act
- Consumer Packaging and Labelling Regulations
- Food and Drugs Act
- Food and Drug Regulations
- Pest Control Products Act
- Pest Control Products Regulations
- Weights and Measures Act
- Weights and Measures Regulations
Canadian Food Inspection Agency
- Code of Practice for Minimally Processed Ready-to-Eat Vegetables
- Food Allergies and Allergen Labelling - Information for Consumers
- Food recalls: Make a plan and action it! Manufacturers' guide
- Food Safety Enhancement Program Manual
- General Principles of Food Hygiene, Composition and Labelling
- Guide to Food Labelling and Advertising
- HACCP Generic Model for Ready-to-Eat Fresh-Cut-Vegetables
- Nutritional Labelling Compliance Test
- Nutrition Labelling Evaluation Standard
- Reference Database for Hazard Identification. March 1, 2008. Ottawa, Canada.
- Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products
- Compendium of Analytical Methods
- Guidelines for Canadian Drinking Water Quality - Summary Table
- Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011)
- Codex Alimentarius Commission. WHO/FAO Food Standards Programme. 2003. Recommended International Code of Practice - General Principles of Food Hygiene - PDF (234 kb). CAC/RCP 1-1969, Rev. 4.
- Codex Alimentarius Commission. WHO/FAO Food Standards Programme. 2003. Code of Hygienic Practice for Fresh Fruits and Vegetables - PDF (212 kb) CAC/RCP
- U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition. 2008. Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables
- U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition. 2001. Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce PDF (1.56 mb)
Appendix A: Good Agricultural Practices for the Primary Production and Harvesting of Fresh Vegetables
Part II of the Code of Practice for Minimally Processed Ready-to-Eat Vegetables published by the Canadian Food Inspection Agency 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 Ready-to-Eat (RTE) fresh-cut 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.
Microbial and chemical contamination may occur during the primary production and harvesting of fresh produce. The safety of RTE fresh-cut vegetables is highly influenced by the degree of preventive measures used on the farm to prevent contamination. Growers should be aware of good agricultural practices that 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:
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 crops.
The use of natural fertilizers (e.g., manure, organic materials, slaughter wastes, sewage sludge) 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.
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.
Growers should only use agricultural chemicals that are acceptable for the cultivation of the specific produce and should use them according to manufacturer's instructions for the intended purpose. Growers should keep records on agricultural chemical applications (agricultural chemical used, rate and date of application, etc.)
Hygiene and health requirements should ensure that personnel who come directly or indirectly into contact with produce are not likely to contaminate the 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.
Diseased, damaged or overripe vegetables that 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 insect 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 as well as secured from rodents and insects to minimize risks of contamination.
Appendix B: Hazard Analysis and Critical Control Point (HACCP) Summary
This guidance document and the HACCP Generic Model for Ready-to-Eat Fresh-Cut Vegetables were developed by the Canadian Food Inspection Agency (CFIA) in an effort to reduce the health risk(s) posed by the consumption of higher risk foods.
Hazard Analysis Critical Control Point (HACCP) is recognized as the most respected food processing concept in the world for enhancing the production of safe food. The HACCP approach involves the review of each step of the food manufacturing process, from start to finish, in order to identify every possible hazard or source of contamination. Hazards can be biological (e.g., pathogenic microorganisms), chemical (e.g., pesticides, allergens) or physical (e.g., extraneous material). For each identified hazard or source of contamination a reliable control or procedure is put in place to ensure that contamination does not occur or is controlled to an acceptable level.
A HACCP system is built on an establishment's existing food safety control program. The standard operating procedures developed and written by the establishment can be Good Manufacturing Practices (GMP) or an adopted food safety code. In many HACCP guideline documents, these GMPs are referred to as prerequisite programs that represent the foundation of the HACCP Plan. The GMPs must be equivalent to the Recommended International Code of Practice - General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex) to ensure that adequate control exists over the environment in which the food processing is taking place.
It is generally recognized that in adopting the HACCP approach, a food processing establishment needs to carry out the following five preliminary tasks:
- Assemble a HACCP team with the expertise and knowledge to develop the HACCP Plan.
- Thoroughly describe the product and its intended use (e.g., common name, important product characteristic, shelf life, labelling instructions, etc.)
- List all product ingredients and incoming materials that come in contact with the product or are used in preparing the product.
- Develop an accurate and detailed Process Flow Diagram (from raw material receiving to finished product shipping) and Plant Schematic/Blueprint showing product and traffic flow.
- Verify the Process Flow Diagram and Plant Schematic on-site.
After completing the preliminary tasks, the HACCP team develops the HACCP Plan by applying the seven principles of HACCP to each food category processed.
Conduct a hazard analysis from the receiving of raw materials to the use of the finished product by the consumer.
Note: Information on food hazards (e.g., biological, chemical and physical hazards) can be obtained from scientific publications and industry associations.
Apply the HACCP decision tree to determine Critical Control Points (CCPs).
Establish critical limits, i.e., criteria that define acceptability and unacceptability of food products.
Establish monitoring procedures to ensure that the critical limits are being met.
Establish deviation procedures when monitoring at a CCP indicates a deviation from an established critical limit.
Establish procedures for verification to confirm the company's conformance to and the effectiveness of the HACCP Plan.
Establish documentation and records, including the HACCP Plan details, processing records, as well as HACCP-related monitoring and verification records.
The HACCP Generic Model, developed following the CFIA's Food Safety Enhancement Program (FSEP) approach, includes all of the seven principles outlined above. It provides information to be used by the establishment in developing a plant-specific HACCP Plan. The Generic Model includes an example of a process flow diagram and identifies possible food safety hazards associated with each step in the process. Using the Codex Alimentarius decision tree, the Generic Model determines the points in the process where Good Manufacturing Practices (GMP) in place at the facility do not control the potential hazard (Critical Control Points). For each of the Critical Control Points in the process, the Generic Model provides examples of:
- procedures to be implemented in order to ensure that the hazard is controlled (i.e., monitoring procedures);
- procedures to be implemented when monitoring determines that the hazard is no longer controlled and a possible food safety hazard could exist (i.e., deviation procedures); and,
- procedures to be implemented to ensure that both the monitoring procedures and the deviation procedures are being followed and are effective in controlling the identified hazards (i.e., verification procedures).
It is hoped the HACCP Generic Model will provide guidance and information to manufacturers in developing their own HACCP Plan. Each manufacturer must create its own process flow diagram according to its specific practices and procedures. Moreover, hazards and how they are controlled as described in the Generic Model will need to be changed where necessary to reflect a manufacturer's unique flow diagram and/or product characteristics.
Additional information on developing a HACCP Plan can be found in the FSEP Manual on the CFIA website.
This guidance document includes a proposed GMPs guide that could serve as a prerequisite program. As mentioned above, by implementing GMPs the manufacturer could control many of the hazards identified for each step in the process. This document also includes information on process controls. Both the Generic Model and this guidance document are intended to be tools for the food industry's voluntary use in creating a food safety control system.
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