Food Safety Practices Guidance for Ready-to-Eat Fresh-Cut Vegetable Manufacturers
Chapter 1: Control of Operation
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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.
- Date modified: