Food Safety Practices Guidance for Sprout 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 sprout product.
Formulae provide information aimed at ensuring the production of a consistent product and to avoid potential hazards (e.g. adding unlisted ingredients which could cause allergic reactions).
- Current written formulae are available for each multi-component product.
- 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); and
- amounts of all ingredients (when a mix of different types of sprouts are used).
- Products are formulated to ensure accurate nutrition declarations where required (see 1.1.3 Compositional Requirements for further details).
1.1.2 Identification of Critical Processing Factors in Product Formulation
This section does not apply to sprouts.
1.1.3 Compositional Requirements
The nutrient content of the food is controlled to meet declared label values (when present*) and applicable requirements found in the Food and Drugs Act and Regulations. Foods for which nutrient content claims and health claims are made meet the compositional requirements of the Food and Drug Regulations [Division 24, B.01.503, and B.01.600].
* Fruits and vegetables, including sprouts, are exempt from nutrition labelling requirements, unless the package bears a claim. Manufacturers may provide a Nutrition Facts table voluntarily, but if they do so, they must then meet all the nutrition labelling requirements.
Inaccurate nutrition information, nutrient content claims and health claims may pose a health risk for people making food choices based on the nutrient content of the food.
The manufacturer has control over the formulation to ensure that all nutrient content declarations are met.
Note: The following CFIA documents provide further guidance on composition and labelling issues:
- The Evaluation Standard for Nutrition Labelling addresses, in detail, the requirements of the Nutrition Facts table and the factors involved in determining nutrient content and producing a product with a consistent nutrient profile. This document may be found within the Nutrition Labelling Toolkit.
- The Guide to Food Labelling and Advertising provides detailed guidance on the requirements for nutrient content and diet-related health claims.
- The Nutritional Labelling Compliance Test constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims.
1.1.4 Food Additives
Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations.
Inadequate control of food additives and/or processing aids could result in chemical or biological hazards.
- Chemicals can be considered food additives, processing aids or food contaminants depending on their nature and/or their use (e.g. growth regulators, plant nutrients, fertilizers, pH adjusters for water and/or antimicrobial agents) and the amount of residual chemical in the final product.
- 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 [Division 16] and other applicable regulations.
- 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 requires that all food additives and/or processing aids meet Food Chemical Codex (FCC) grade specifications or equivalent (e.g. specification sheets, clear identification of the grade on the additive package or blanket guarantees).
- The manufacturer ensures that processing aids are used at levels in accordance with Good Manufacturing Practices (as per label instructions) and can demonstrate through calculations that food additives are permitted within the maximum level specified in the Food and Drug Regulations.
Note: Processing aids are substances 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 and non-functional levels. Note that food additives are not processing aids.
For additional information, see Health Canada's Policy for Differentiating Food Additives and Processing Aids.
Also see the Guide to Food Labelling and Advertising, Chapter 2, Section 2.8.3, for further information relating to processing aids.
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 Regulations and the Weights and Measures Act and Regulations, where applicable.
Mandatory information (where applicable) on food labels allows consumers to make informed choices by providing:
- Basic product information (i.e. common name, list of ingredients in the case of mixed varieties of sprouts, net quantity, durable life date, and name and address of the manufacturer);
- Nutrition Facts table (where applicable); and
- Other product information (e.g. instructions for safe storage, handling or safe use of the product).
Note: Mandatory information is determined, in part, by the regulatory requirements specific to the commodity in question.
Note: Pre-packaged sprouts are labelled with clear instructions to enable the next person in the food chain to handle, display, store or use the product safely.
Refer to Chapter 2 (Basic Labelling Requirements) and Chapters 5 to 8 (Nutrition Labelling and Claims) of the Guide to Food Labelling and Advertising for further details.
- The manufacturer has procedures in place to ensure that all mandatory information is properly declared on food labels in accordance with Canadian food labelling legislation, and that all label claims are accurate and not misleading.
- Each container of sprouts is labelled with a best before date.
- Sprouts are labelled with the statement "Keep Refrigerated". Refrigeration means exposure to a temperature of 4°C or less, but does not mean frozen.
1.3 Process Design
1.3.1 Process Design
The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) as a result of process design.
Written scientific evidence is necessary to demonstrate that each process adequately ensures the safety of the product. An inadequate process could result in unintentional incorporation of ingredients, such as undeclared allergens like soy, sesame and/or wheat, or in lack of control of pathogenic organisms, toxins and other hazards.
- A written description of the process(es), including procedures, is available upon request.
- Each process is established using accepted scientific methods. Details of actual experimental methods are available.
- 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 following Process Flow Diagram for a generic process flow and potential CCPs. For further information regarding CCP rationale see the CFIA's HACCP Generic Model for Sprouts Grown in Water.
- Any changes to the product formulation or the process are assessed to ensure there is no impact on the safety or composition of the product.
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. Sprout 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 sprouts and the sprouting process;
- identify any steps in their operations that are critical for controlling the safety of sprouts;
- 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 the 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 validation of the HACCP system, that is, 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) are able to control the hazards. A validation should 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 not, the facility conducts a validation study to validate the control measure through testing. Once the initial validation is completed during development of the HACCP system, the facility conducts a validation of control measures at least once yearly. This yearly validation reviews all of the standards of the prerequisite programs (GMPs), as well as the critical limits of the Critical 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 C (Hazard Analysis And Critical Control Point (HACCP) Summary) of this guidance document, the HACCP Generic Model for Sprouts Grown in Water and the CFIA's Food Safety Enhancement Program (FSEP) Manual.
Note: While the generic model identifies antimicrobial treatment as a CCP for addressing the risk of pathogen contamination, seed purchase specifications (requiring pathogen-free seed, seed produced under Good Agricultural Practices, etc.) and/or the testing of seed at receiving play a significant role in reducing the risk related to contamination of finished product. The testing of sprout irrigation water at 48 hours is also considered important.
1.4 Incoming Material Control
Note: Control of incoming materials (Receiving) could be included in Chapter 6 – Transportation and Storage, provided that all of the anticipated outcomes for sections 1.4.1 and 1.4.2 are achieved.
1.4.1 Incoming Seeds and Other Non-Packaging Inputs
The manufacturer controls incoming seeds and other non-packaging inputs so that foods are not exposed to safety hazards (biological, physical and chemical), and so they remain both safe and correctly labelled.
Prevention of health hazards begins with control of incoming seed and other non-packaging inputs. 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 provide standards against which the manufacturer can assess the acceptability of the components necessary for the production of the finished product.
Note: The degree of control exercised is appropriate to the level of risk posed by the ingredient to the safety of the food.
Note:: As the variety of seeds used in the edible sprout industry expands, manufacturers need to ensure that all types chosen are acceptable for human consumption (i.e. have a history of safe use as food and do not contain naturally occurring or added toxic compounds).
- Sprout manufacturer has specifications that seeds were produced under Good Agricultural Practices (GAP) (e.g. provide evidence that the product was grown according to Appendix B Seed Production – Good Agricultural Practices) and seeds are free of microbial pathogens (i.e. salmonella spp. and E. coli O157:H7). Seed producers should provide certificates of analysis.
- Sprout manufacturer has specifications to avoid the presence of undeclared allergens (e.g. soy, sesame, wheat) and acquires a Letter of Agreement from each supplier to indicate that all specifications are met.
- Sprout manufacturer has certificates of analysis for microbial pathogens of concern (i.e. salmonella spp. and E. coli O157:H7) from seed producers or distributors for each incoming lot. If certificates of analysis are not provided by seed producers or distributors or if sampling and analyses have not been done according to Section 3.10 of Appendix B Seed Production – Good Agricultural Practices, sprout manufacturers analyse the seed lots for the presence of microbial pathogens of concern according to Section 3.10 of the Appendix B.
Note: It is important for sprout manufacturers to be aware that negative results do not guarantee pathogen free seeds because of analytical and sampling limitations.
- Statistically valid sampling methods are used.
Note: It is important to use random sampling techniques, sufficient sample sizes and sub-sample numbers to represent the lot as best as possible.
- Where seed lots are analysed for the presence of microbial pathogens of concern, the seed lots are not be used until the analytical results are available. Seed lots for which positive results are obtained are not used for sprout production.
- The sprout manufacturer maintains a documented history of seed suppliers' adherence to specifications (e.g. analytical results, GAP records, etc.).
- Each bag of seeds is labelled with the name of the seed producer or distributor, the lot number and the country of origin. The same information should be available for all components of seed blends.
- Each bag or container of seeds and incoming material is examined for physical damage (e.g. holes made by rodents), signs of contamination (e.g. stains, bird droppings and rodent activity including faeces and urine), insects, mould, lubricants from field equipment) and foreign material (e.g. stones, wood, metal, glass) upon arrival. Contaminated or potentially contaminated seeds are not to be used for sprout manufacture.
Note: Section 1.1.4 of this document provides guidance for assessing specifications for food additives and/or processing aids.
See Section 7.2.2 for expected incoming material control records.
When ingredients fail to meet specifications that impact food safety, the manufacturer investigates and identifies the root cause. The manufacturer initiates corrective action by determining whether food safety is compromised and by taking the necessary actions. See Section 1.10 - Deviations and Corrective Action and Section 7.2.5 -Deviations and Corrective Action Records.
1.4.2 Packaging Materials
The manufacturer controls incoming packaging materials to meet the requirements of Division 23 of the Food and Drugs Regulations, such that no biological, physical or chemical hazards result 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 the product, or may permit physical, chemical or biological contamination of the product.
- Packaging design and materials provide adequate protection for sprouts to minimize contamination, prevent damage, and accommodate proper labelling.
- Packaging materials are new, clean and non toxic and pose no threat to the safety and suitability of sprouts under the specified conditions of storage and use.
- 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 examined for physical damage, signs of contamination (e.g. stains, bird droppings, rodent activity [e.g. faeces, urine], and insects) and foreign material (e.g. wood, metal, glass) at receiving. Contaminated or potentially contaminated packaging material is not to be used for sprout manufacture.
See Section 7.2.2 for expected Incoming Material Control Records.
1.5 Packaging Control
Handling and use of packaging is controlled to prevent product contamination.
Inadequate control of packaging steps may result in the use of damaged, defective or contaminated packaging, which may lead to contamination of the product.
- The manufacturer has an effective system in place to prevent the use of contaminated, damaged or defective containers (e.g. receiving and storage controls, visual examination prior to use).
- Only packaging materials required for immediate use are kept in the packaging or filling area.
- Packing is done under hygienic conditions that preclude the introduction of contamination into the product.
- Containers are used only for their intended purpose.
1.6 Product Preparation
1.6.1 Control of Preparation and Composition
Factors significant to food safety are controlled during preparation to minimize physical, chemical and biological hazards, and to ensure accuracy of composition.
Inadequate control of factors associated with product preparation could result in inadequate processing or the presence of undeclared allergens (e.g. soy, sesame, wheat). The product may violate permissible levels of food additives.
The manufacturer has controls in place to prevent hazards associated with the preparation of the product. Areas significant to food safety are outlined below:
The manufacturer has controls in place to prevent the presence of undeclared allergens. Allergens are ingredients that can elicit an allergic response in sensitive individuals. Areas that may require control include:
- cross-contamination or carry-over;
- inappropriate use of rework;
- ingredient changes, substitutions or additions;
- incorrect labels;
- incorrect or incomplete list of ingredients; and
- unknown ingredients (e.g. seeds purchased from a new supplier and without specifications).
Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens and a Tool for Managing Allergen Risk in Food Products.
The manufacturer has controls in place to ensure that the food additives that are used are permitted, and are used within allowable levels. Specifically, controls ensure
- clear identification of additives;
- accurate measurement;
- adequate blending for homogeneity; and
- checks against unauthorized substitution.
See Section 7.2.3 for expected Product Preparation Records.
1.6.2 Cleaning/Sorting Contamination Control
Seeds are cleaned, receive antimicrobial treatment and are rinsed in such a manner as to reduce biological, physical and chemical contamination and to prevent contamination of the finished product.
Adequate cleaning and antimicrobial treatment of seeds is necessary to prevent, reduce or remove contamination with biological, chemical and/or physical hazards. Initial rinsing before the antimicrobial treatment removes dirt and increases the efficiency of the antimicrobial treatment. Seeds should undergo an antimicrobial treatment to reduce the potential for contamination by pathogenic microorganisms.
The manufacturer controls the following hazards (where applicable):
- Sorting controls - visual inspection to prevent use of noticeably damaged seeds.
- Control by initial rinse - increase efficiency of antimicrobial treatment.
- Antimicrobial treatment of seeds, i.e. minimum 3 log reduction of the microbial pathogens of concern (Salmonella spp. and E. coli O157:H7).
- Sorting controls – visual inspection to prevent use of noticeably damaged seeds (e.g. staining or discolouration on seeds from lubricants or industrial chemicals).
- Control by rinsing – initial rinse to remove chemical contaminant from seeds.
- Extraneous material controls – visual inspection, sifting, sorting/cleaning by water, e.g. removal of stones, pebbles, wood, metal, glass.
Refer to the CFIA's Reference Database for Hazard Identification for more hazard information.
Refer to Section 1.8.1 (Processing Controls) for details on initial Rinse, antimicrobial treatment and rinse after antimicrobial treatment.
1.7 Product Coding Control
1.7.1 Product Coding
Pre-packaged sprouts are identified with code marks or lot numbers on the label or container to allow the identification of product in the event of a recall.
Coding control permits products to be traced through the distribution chain and could provide manufacturing details.
Note: Coding is not a mandatory labelling requirement (for sprouts); however, this practice is recommended under Section 8.2.1 (Recall Procedure) to enhance the effectiveness of a recall.
- The manufacturer ensures that pre-packaged sprout products are permanently marked with a legible code or lot identification on the label, the package or the 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.
1.8 Process Control
1.8.1 Processing Controls (Cleaning and sorting process: Initial rinse, Antimicrobial treatment for seeds, Rinse after antimicrobial treatment and Germination and harvesting process: Pre-germination soak and rinse, Germination, Harvesting, Final rinse and cooling/dehulling and Bulk cooling).
All processing factors are controlled to ensure the safety of the product.
Inadequate control of processing factors 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 all appropriate processing factors are controlled within acceptable limits.
- The manufacturer monitors factors significant to food safety at a scheduled frequency.
The typical cleaning and sorting process involves the following:
- Seeds are rinsed and agitated in large volumes of potable water. The process is repeated with potable water until most of the dirt is removed and the rinse water remains clear.
- The rinsing process is carried out in such a way to maximize surface contact with water (e.g. use large buckets of water and sieves).
Antimicrobial treatment for seeds
Note: If seeds for sprouting have been grown under GAP and stored and transported in closed containers, the likelihood of the seeds being contaminated with pathogenic bacteria is minimized but not eliminated. Seeds should undergo an antimicrobial treatment to reduce the presence of viable of pathogenic microorganisms. There is currently no treatment available that can guarantee pathogen-free seeds. An antimicrobial treatment for seeds that can achieve a minimum 3-log reduction of the microbial pathogens of concern should be considered. Examples of such treatments are the use of 2,000 ppm of calcium hypochlorite or sodium hypochlorite for 15–20 minutes or 6–10% hydrogen peroxide for 10 minutes. Other antimicrobial treatments for seeds may be evaluated by the Food Directorate, Health Products and Food Branch, Health Canada, if enough data is provided.
Note: What does Log mean?
"Log" = Logarithm = "power of ten"
1 Log = 101 = 10 = ten times
2 Log = 102 = 100 = 100 times
3 Log = 103 = 1000 = 1000 times
4 Log = 104 = 10,000 = 10,000 times
When expressed as Log Reduction with respect to microbial counts or population numbers:
Given an initial bacterial count of 1,000 bacteria per gram in a product:
- One Log (1 Log) Reduction would decrease the bacteria population to 100 per gram (a reduction of 90%).
- Two Log (2 Log) Reduction would decrease the bacteria population to 10 per gram (a reduction of 99%).
- Three Log (3 Log) Reduction would decrease the bacteria population to 1 per gram (a reduction of 99.9%).
When a 3-Log Reduction is required, it is anticipated that immediately before the treatment, the initial (starting) count of the organism of concern (i.e. salmonella), if present, will be well below 1,000 per gram, resulting in a final theoretical count well below 1 per gram.
Depending on the food commodity and the microorganism of concern, government or industry standards may require different hazard reduction levels, i.e. a 3 Log Reduction in certain cases (i.e. sprouts) or a 12 Log Reduction in others ( i.e. low acid canned food).
During the antimicrobial treatment, sprout manufacturers adhere to the following practices:
- A fresh solution of antimicrobial treatment is used for each sprout lot.
- Seeds are well agitated in large volumes of antimicrobial treatment solution to maximize surface contact. At least five times the volume of antimicrobial treatment solution for the amount of seeds is used (e.g. for each 5 kg of seeds, at least 25 litres of antimicrobial treatment solution is used).
- Antimicrobial treatment products are appropriate for use on foods.
- The duration of the treatment and the concentration of the antimicrobial treatment solution used are accurately measured and recorded.
- Strict measures are in place to prevent re-contamination of seeds after the antimicrobial treatment.
Warning: Chemical treatments 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.
Rinse after antimicrobial treatment
- The seeds are thoroughly rinsed with potable water after the antimicrobial treatment. Rinsing with potable water is repeated an adequate number of times to reduce the level of the antimicrobial treatment solution in order to meet GMP levels. The GMP level is the amount of the antimicrobial treatment solution required to achieve the intended purpose.
Note: Antimicrobial treatment residues are to be removed in the Final Rinse step.
The typical germination and harvesting process involves:
Pre-germination soak and rinse
When a pre-germination soak is used, the sprout manufacturer performs the following:
- All containers used for soaking are sanitized prior to use.
- Seeds are soaked in water for a short period to minimize microbial growth.
- This step may also include an additional antimicrobial treatment.
- After soaking, seeds are rinsed thoroughly with potable water.
During germination, it is critical to keep the environment and the equipment clean to avoid potential contamination. All equipment should be cleaned and sanitized before each new batch.
- Only potable water is used.
Note: If recirculated water is used, proper water treatments are in place to maintain the potability of the water. Monitoring systems are in place to ensure the adequacy of the treatment.
- The spent irrigation water is collected after 48 hours of germination and analysed for the presence of microbial pathogens.
See Section 1.11.1, Verification Procedures, for further information.
Note: When growth regulators, plant nutrients, fertilizers and pH adjusters for water are added at this step, they must be mixed and added to the seeds as per the label directions to ensure appropriate use.
All equipment is cleaned and sanitized before each new batch.
- Harvesting is done with cleaned and sanitized tools dedicated for this use.
- There are no unnecessary delays between harvesting and final rinse and/or cooling.
Final rinse and cooling/dehulling
Note: A final water rinse will remove hulls and may reduce microbial contamination on sprouts. Cold water will lower sprout temperature and slow down potential microbial growth. In addition, the final rinse will reduce the antimicrobial treatment level to safe levels (e.g. for chlorine - Guidelines for Canadian Drinking Water Quality).
Refer to the Guidelines for Canadian Drinking Water Quality, published by Health Canada.
When the final rinse is carried out, the following procedures are followed:
- Sprouts are rinsed in cold potable water.
- Water is changed as needed (e.g. between lots or batches) to prevent cross-contamination.
- Rinsing is sufficient to remove antimicrobial treatment solution, plant nutrients, growth regulators and fertilizers on sprouts.
- Where applicable, sprouts are drained using a sanitized food-grade centrifugal dryer.
- Sprouts are placed in a cool room to further lower the temperature.
- Sprouts are placed in small, shallow containers to allow for rapid cooling and to minimize the potential growth of pathogens.
- There are no unnecessary delays prior to packaging.
See Section 7.2.4 for expected Process Control Records.
1.9 Labelling Control
1.9.1 Prevention of Mislabelling
The manufacturer has controls in place to prevent mislabelling.
Control of labelling is important to ensure that the correct label is applied to each product. Use of incorrect labels could mislead the consumer and could pose a potential health hazard to segments of the population with allergies (to wheat, soy, sulphites, etc.).
The manufacturer has procedures in place to ensure that the correct label is applied to the correct product. Typical controls are listed below:
- Product types are effectively separated during change-overs (e.g. appropriate breaks between products, 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); and
- 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).
Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens and A Tool for Managing Allergen Risk in Food Products.
1.10 Deviations and Corrective Action
1.10.1 Deviation Control
When critical limits or limits of acceptability are exceeded or defects occur which 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, where appropriate.
The manufacturer has a pre-determined and documented deviation procedure designed to identify deviations in either the product and/or the procedures, isolate defective products and take appropriate corrective actions.
Identification of Deviation
The manufacturer has a system in place to identify deviations when they occur.
Isolation of Affected Product
- The manufacturer has effective procedures in place to isolate, clearly mark and control all product manufactured during the deviation period.
- All unsatisfactory product is isolated back to the point where the process was last in control. This could be beyond the last satisfactory record.
- Isolated product is clearly marked (e.g. firmly attached tags contain the following information: hold number, product, 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
- 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 in an appropriate manner by adequately trained personnel.
- Evaluation is adequate to detect potential health hazards, or to identify misrepresentation. For example:
- sampling is adequate to identify the extent of the problem;
- the tests are appropriate:
- the judgement is based on sound science; and
- the product is not released until the evaluation has determined that no health hazard exists and that the product is in compliance with appropriate legislation.
See the HACCP Generic Model for Sprouts Grown in Water 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 taken.
See Section 7.2.5 for expected Deviations and Corrective Action Records.
See the HACCP Generic Model for Sprouts Grown in Water for suggested deviation procedures and corrective actions.
1.11 Verification of Product Safety
1.11.1 Verification Procedures (Including testing for spent irrigation water)
The manufacturer uses supplementary methods of evaluation to verify the conformance and 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 indicate areas where improvements are required.
Note: Verification applies to all sections of this guidance, 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 appropriated to the hazards associated with the product and process.
- Methods of verification may include the following:
- review all specifications for incoming ingredients and materials as well as Letters of Agreement at an adequate frequency and/or whenever any changes are made;
- develop a sampling plan to ensure the consistent collection of samples in an appropriate manner. Spent irrigation water is the water that has flowed over and through the sprouts and is a good indicator of the types of microorganisms in the sprouts themselves. It is analysed for microbial pathogens of concern by collecting a representative sample from each production lot or batch. Finished product samples may also be collected and analysed;
- ensure that employees are adhering to sampling programs if applicable;
- on-site assessment of the monitoring procedures (e.g. GMPs and Critical Control Points);
- review of records for completeness;
- review of deviation record to ensure that appropriate corrective actions are taken and recorded in the event of a deficiency;
- independent external or internal audits; and
- analysis of consumer complaint trends.
Note: The criteria set out in the Health Canada's Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water (December 2006) should be used by sprout manufacturers as a basis for establishing a sampling program. See Appendix A, Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water for details.
Refer to Health Canada's Compendium of Analytical Methods for microbiological guidelines and analysis for seeds, sprouts and irrigation water.
See Section 7.2.6 for expected Verification Records.
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