HACCP Generic Model for Sprouts Grown In Water

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Table of Contents

Introduction

The Code of Practice for the Hygienic Production of Sprouted Seeds, developed with the sprout industry's input in 2001 and amended in February 2007, continues to be the current Canadian regulatory guideline for sprout manufacturers. The HACCP Generic Model for Sprouts Grown in Water and its companion document, Food Safety Practices Guidance for Sprout Manufacturers, were developed by a committee consisting of representatives from the Canadian Food Inspection Agency (CFIA) and Health Canada. These documents are intended to be food safety resources for the sprout industry.

The generic model was developed using the CFIA's Food Safety Enhancement Program (FSEP) approach and tools: Sections 1, 2 and 3 of the FSEP Manual, including the ten forms, as well as the Codex Alimentarius Decision Tree to determine the critical control points (CCPs). It provides a practical example for sprout manufacturers to follow in designing their own facility-specific HACCP Plan. The HACCP generic model was used by the committee during the development of the Food Safety Practices Guidance document. This guidance document incorporates Chapters 4 to 10 of the Code of Practice for the Hygienic Production of Sprouted Seeds as well as Chapters 1 to 8 of the General Principles of Food Hygiene, Composition and Labelling, in addition to other reference material. Using a HACCP approach, it provides guidance on controlling potential hazards. Chapter 1 provides information about developing operational controls for controlling hazards, while Chapters 2 to 8 provide information about developing Good Manufacturing Practices (GMPs) or prerequisite programs, as they are called in the FSEP approach. A hazard summary is provided after the Scope section in the companion guidance document.

Together, the generic model and its companion guidance document establish a practical system that sprout manufacturers can use to review all potential health and safety hazards in their operations, allowing the facility to focus on controlling the points that are critical to the safety of the finished product.

Limitations

The committee wishes to emphasize that the model described here is a GENERIC MODEL. It does not cover all sprout products and processes, nor does it list all possible associated hazards. This generic model is a template that can be adapted to most sprout operations. The process flow diagram in this generic model does not reflect the characteristics of the specific manufacturing line of any of the companies consulted by the committee; instead, it represents the basic processing steps of all the companies consulted. The model reflects the entire line from receipt of the seeds through to shipping/distribution of the sprouts to hospitals, restaurants, institutions and retail outlets. For products or processes that differ significantly from this generic model, the HACCP team must still follow the seven principles of HACCP as described in the FSEP Manual.

The HACCP team at each establishment is responsible for identifying and controlling all hazards specific to its operations and for determining how each hazard is controlled. In order to identify all possible hazards, the HACCP team should consult the Reference Database for Hazard Identification developed by the CFIA, along with reference texts and scientific publications, as well as industry associations. A review of the manufacturer's processes and procedures should then be conducted to determine whether each of these hazards actually exists in the facility. Where ingredients, procedures or processes differ from those in the generic model, the HACCP team should conduct a hazard analysis to determine whether any hazards should be added to or removed from the generic model and to determine how each of the additional hazards are controlled at the facility. Here are some examples:

  1. Seeds sprouted in soil or sprouted with the use of fertilizers could require the addition of one or more hazards due to the increased risk of pathogen presence on sprouts.
  2. If the facility does not use growth promotants or fertilizers at germination, it may be necessary to remove one or more hazards. Extra microbiological testing and validation may be necessary.

For additional information on the use of generic models in the development of facility-specific HACCP plans, manufacturers should consult the FSEP Manual.

The HACCP team at each establishment is also responsible for validation of the HACCP system; it should first validate the hazards that exist in the facility and then validate the standards for the prerequisite programs (GMPs) along with the standards for the critical limits of the Critical Control Points (CCPs). If the manufacturer is unable to find a scientific study or government regulation supporting the standard or critical limit identified in the HACCP Plan, facility personnel should conduct a validation study to validate the control measure through testing. This step is generally completed during the development of the HACCP system. Once the control measure has been established and validated, facility personnel should carry out a validation to show that its process is able to consistently meet the standard. A validation of all control measures should be conducted at least once a year. During the annual validation, all of the standards of the prerequisite programs (GMPs), as well as the critical limits for the CCPs, should be reviewed to ensure that the control measures continue to be effective in controlling the identified hazards. Manufacturers are reminded that a HACCP Plan is a dynamic document that requires updating whenever any changes are made to the establishment, its processes or its products. A validation should also be conducted whenever new procedures, policies or control measures are introduced. For additional information on validation of the HACCP system, the FSEP Manual should be consulted.

During the development of the model, while working through hazard identification and analysis, the committee discussed and dealt with several issues. The following decisions and/or assumptions were made and are reflected in the generic model:

  1. To minimize the likelihood of producing sprouts contaminated with pathogenic microorganisms, it is understood that seeds for sprouting should originate from producers that use Good Agricultural Practices (GAP). However, it is recognized that pathogenic microorganisms may be reduced but not eliminated through adherence to these procedures. Therefore, seeds should undergo an antimicrobial treatment at the manufacturing facility to reduce the potential for contamination by pathogenic microorganisms.
  2. Although the generic model was developed using the CFIA's FSEP approach, the committee endeavoured to adhere to the General Principles of Food Hygiene, Composition and Labelling (GPFHCL) wherever possible. For example, the GPFHCL covers the receiving of incoming materials and ingredients in Chapter 1, Operational Controls. The FSEP Manual covers receiving in the prerequisite program, Transportation, Purchasing/Receiving/Shipping and Storage (Section B2.1.3).

    During the development of the Generic Model and its companion guidance document, it was decided that, to be consistent with the FSEP approach, it would be assumed that facilities will identify Receiving as a prerequisite program. Therefore, when hazards associated with the receiving of incoming materials and ingredients are put through the Codex Alimentarius Decision Tree, they will be controlled under Transportation and Storage (Section 6.1) and under Section 1.4.1 and 1.4.2 (Incoming Material Control) of the GPFHCL and the guidance document. If a facility wants to maintain a CCP at Receiving, this will be considered acceptable.

    Where applicable, in the "Controlled at" column on Forms 5, 6 and 7, the FSEP prerequisite program is identified by the name it is given in the GPFHCL (i.e. Transportation and Storage and not Transportation, Purchasing/Receiving/Shipping and Storage). In addition, the section of the guidance document specific to this step and/or hazard is referenced on Forms 5, 6 and 7 to provide additional information for the manufacturer; however, the guidance document section is not identified on Form 8. Only the name of the prerequisite program and the specific bullet in Appendix II of the FSEP Manual that relates to the control of the hazard is identified on Form 8.

  3. While the generic model identifies the antimicrobial treatment step as a Critical Control Point (CCP) intended to address the risk of pathogen contamination on sprouts, seed purchase specifications (requiring pathogen-free seeds, seeds produced under (GAP), etc.) and/or the testing of seeds at Receiving are considered significant steps for reducing the risk of contamination of finished product. The testing of sprout irrigation water 48 hours after initial seed soaking is also important.
  4. The likelihood of biological hazards (e.g. E.coli O157:H7 and Salmonella) associated with incoming seeds is considered to be controlled by Step 8, the antimicrobial treatment step. However, following this step, the antimicrobial treatment solution is drained off, and the seeds are rinsed to remove the antimicrobial treatment and/or soaked during the pre-germination soak step. These steps are conducted at warm temperatures that could permit the growth of pathogenic microorganisms.
  5. The use of non-approved chemicals (e.g. regulators, fertilizers, growth promoters or antimicrobial treatments), as well as the improper use of these chemicals, were identified as a chemical hazard that is likely to occur.
  6. The rinsing and soaking of the seeds, as well as the irrigation and watering of the sprouts, serve to reduce the chemical hazard associated with the application of antimicrobial treatments.
  7. Control of hazardous extraneous material, especially pebbles and stones, was raised as a concern. When addressing this issue for most seeds, the committee determined that if the pebbles and stones are present in the seeds received from a farm, there are few control measures available to the manufacturer. For mung beans, a trough system at the rinsing/cooling step is considered to effectively remove this hazard. However, this does not apply to the other types of seeds. Although irrigation/watering of the sprouts may remove some of the pebbles and stones, most of these are similar in size and/or colour to the seeds and difficult to differentiate and therefore remove. For some sprouts, the seeds are germinated in the retail container. Therefore, the committee decided that this hazard is beyond the manufacturer's control (for all other seeds besides mung beans) and that the manufacturer could indicate on Form 9 how the hazard can be addressed at the farm level.
  8. Testing of the spent irrigation water after 48 hours of germination was determined to constitute verification of the effectiveness of irrigation (culminating with the final rinse) in reducing the biological hazards.
  9. The testing of the spent irrigation water was also determined to constitute verification of the effectiveness of the irrigation (culminating with the final rinse) in reducing the chemical hazards.

Definitions

Refrigerated Temperatures
Sprouts are labelled with the statement "Keep Refrigerated," meaning 4 °C or less but not frozen.
Pathogenic Microorganisms
In the document, the term "pathogenic microorganisms" may include Salmonella spp., Shigella spp., Escherichia coli O157:H7, viruses (Hepatitis A virus, Norovirus, and Rota virus), and parasites (Cyclospora spp. and Cryptosporidium spp.).

Example of Completed Form 1: Product Description Process

1. Product name

Water-grown sprouts

Note: The manufacturer should list each specific product name (mung bean sprouts, onion sprouts, alfalfa sprouts, etc.). Where the manufacturer produces numerous types of products in varying package sizes, a separate list may be attached to Form 1 or a reference to a current computerized list of products may be added here.

2. Important product characteristics (Aw, pH, preservatives, etc.)

No existing pathogen barriers

3. How the product will be used

Ready-to-eat

4. Packaging

  • plastic liners
  • reusable plastic totes
  • plastic bags
  • cardboard boxes (bulk)
  • plastic containers (clam shells)

5. Shelf life

X days, depending upon the product, at refrigerated temperature (4°C)

6. Where it will be sold

  • Retail
  • Restaurants
  • Institutions
  • Sold directly to the general public
  • For further processing (e.g. egg rolls, frozen dinners)

7. Labelling instructions

  • Keep refrigerated
  • Rinse prior to use
  • Best Before date

8. Special distribution control

Temperature control (X °C )

Example of Completed Form 2: List of Product Ingredients and Incoming Material

Legend: Explanation of Codes

(B) = Biological

(C) = Chemical

(P) = Physical

Fresh Commodity

seeds (BCP)

Water (well and/or municipal)

water (BCP)

Packaging Material

  • plastic bags (BCP)
  • plastic containers (BCP)
  • cardboard boxes (BCP)
  • plastic liners (BCP)
  • reusable plastic totes (BCP)

Regulators

growth regulators/plant nutrients/fertilizers (BCP)

Antimicrobial Treatment

  • calcium hypochlorite (CP)
  • sodium hypochlorite (CP)
  • hydrogen peroxide (CP)
  • peroxyacetic acid (CP)

Example of Completed Form 3: Process Flow Diagram

Diagram - Process Flow Diagram. Description follows.
Description for Process Flow Diagram

This diagram is a flow chart showing the process flow for sprouts grown in water

The diagram lists the necessary steps from 1 - 18 to be taken in the sprouting and processing of sprouts grown in water.

Identified in pink ovals are the Critical Control Points (CCPs). These are next to boxes 8, Antimicrobial treatment; 11, Germination; 13, Final rinse and cooling/dehulling; and 16, Packaging/labelling/coding.

Identified in a blue rectangle with rounded corners is water. This leads to steps 7, Initial rinse; 8, Antimicrobial treatment; 9, Rinse after antimicrobial treatment; 10, Pre-germination soak and rinse; 11, Germination; 12, Harvesting; and 13, Final rinse and cooling/dehulling.

Potential for Biological (B) = Biological, Chemical (C) and/or Physical (P) hazards is indicated in parentheses next to each process step.

  1. Receiving (BCP). Leading to steps 2, Storage of growth regulators, plant nutrients and fertilizers; 3, Storage of antimicrobial treatment; 4, Storage of seeds; and 5, Storage of packaging material.
  2. Storage of growth regulators, plant nutrients and fertilizers (CP). Leading to step 11, Germination.
  3. Storage of antimicrobial treatment (CP). Leading to step 8, Antimicrobial treatment.
  4. Storage of seeds (BCP). Leading to step 6, Sorting and weighing.
  5. Storage of packaging material (BCP). Leading to step 16, Packaging/labelling/coding.
  6. Sorting and weighing (BCP). Leading to step 7, Initial rinse.
  7. Initial rinse (BCP). Leading to step 8, Antimicrobial treatment.
  8. Antimicrobial treatment (BCP). CCP-1B. Leading to step 9, Rinse after antimicrobial treatment.
  9. Rinse after antimicrobial treatment (BCP). Leading to step 10, Pre-germination soak and rinse.
  10. Pre-germination soak and rinse (BCP). Leading to step 11, Germination.
  11. Germination (BCP). CCP-2C. Leading to step 12, Harvesting.
  12. Harvesting (BCP). Leading to step 13, Final rinse and cooling/dehulling.
  13. Final rinse and cooling/dehulling (BCP). CCP-3BC. Leading to step 14, Removal of water/draining.
  14. Removal of water/draining (BCP). Leading to steps 15, Bulk cooling; and 16, Packaging/labelling/coding.
  15. Bulk cooling (BCP). Leading to step 16, Packaging/labelling/coding.
  16. Packaging/labelling/coding (BCP). CCP-4C. Leading to step 17, Storage.
  17. Storage (X°C ) (BCP). Leading to step 18, Shipping/distribution.
  18. Shipping/distribution (BCP).

Example of Completed Form 4: Plant Schematic

Construct the plant schematic diagram on Form 4.

Note: This form is to be specific for each establishment.

Indicate the flows of raw and finished products as well as employee traffic and, where a possible hazard exists, indicate the movement of packaging material, waste or garbage.

Include the flows of all ingredients and packaging materials from the moment they are received through storage, preparation, processing and packaging to finished product holding and shipping.

Indicate employee traffic patterns throughout the establishment from the time the employees enter the building. Include movement into change rooms, washrooms, lunchrooms, offices and maintenance, as well as the employees' movement through food production areas of the facility.

This diagram should be your primary tool for identifying potential areas of cross-contamination (e.g. locations where allergen ingredients, food additives, waste or raw ingredients could come into unplanned contact with product or where employees could cross contaminate product).

(See the Canadian Food Inspection Agency FSEP Manual - Section 3.2.4)

Note: The points of cross-contamination should be marked on the plant schematic and a full description of each of the identified hazards should be recorded on Form 5, 6 and/or 7, Form 8 and, where appropriate, Form 10 (examples of possible hazards that could be identified on Form 4 are provided on Form 5).

Example of Completed Form 5: Biological Hazards Identification

Pathogenic microorganisms where indicated in the generic model may include: Salmonella spp., Escherichia coli O157:H7), viruses (Hepatitis A virus, Norovirus, and Rotavirus), and parasites (Cyclospora spp. and Cryptosporidium spp.)

Process/product type name: Sprouts that are grown in water: alfalfa, onion sprouts, mung beans, etc.
List all Biological hazards related to ingredients, incoming material, processing, product flow, etc.
Identified Biological Hazards (Bacteria, parasites, viruses, etc.)Controlled at
Seeds - Presence of pathogenic microorganisms from contamination in the field, harvest or transport. -Transportation and Storage B2.1.3 (of the FSEP Manual)
- Section 1.4.1 (of the guidance document)
Seeds - Presence of visible contamination (e.g., pests, insects, rodents' and birds' droppings, moulds). -Transportation and Storage B2.1.3
- Section 1.4.1
Water/well water - Water not meeting Health Canada's Guidelines for Canadian Drinking Water Quality and any applicable provincial or municipal requirements, resulting in the presence of pathogenic microorganisms. - Premises A 4.1.1
- Section 3.4.1
Well water - Inadequate addition of chlorine resulting in failure to eliminate the presence of pathogenic microorganisms. - Premises A4.1.1
- Section 3.4.1
Packaging materials - Presence of pathogenic microorganisms due to contamination by faecal material from birds, rodents and insects. -Transportation and Storage B2.1.3
- Section 1.4.2
Packaging materials, seeds - Presence of pathogenic microorganisms from soiled/damaged or improperly handled packaging materials at the source. -Transportation and Storage B2.1.3
Section 1.4.2
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with pathogenic microorganisms due to improper employee handling or hygiene. - Personnel D1.1.1 and D2.1.1
- Section 5.1.1 and 5.2.1
1 Receiving - Acceptance of incoming materials and ingredients not meeting specifications (i.e., not meeting standards as described on the specification sheet for each incoming ingredient and/or material). -Transportation and Storage B2.1.3
- Section 1.4.1 and 1.4.2
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination with pathogenic microorganisms due to contamination from overhead structures. - Premises A2.1.1 and A2.1.2
- Sanitation and Pest control E1.1.1
- Sections 3.2.1, 3.2.3 and 4.1.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12. 13. 14. 15, 16, 17, 18 - Contamination of product with pathogenic microorganisms from contaminated air (ventilation system). - Premises A2.3.1
- Section 3.2.3
1, 4, 5, 6, 7, 8, 9, 10, 11, 12. 13. 14. 15, 16, 17, 18 - Contamination with pathogenic microorganisms due to contact with pests (insects, rodents, birds). - Sanitation and Pest control E2.1.1
- Section 4.2.1
4, 5 - Contamination of seeds and/or packaging material with pathogenic microorganisms due to exposed packaging material/damaged packaging resulting from improper storage procedures. - Transportation and Storage B2.2.2
- Section 6.2.1
4, 17 - Growth of pathogenic microorganisms and moulds due to inappropriate storage temperatures/humidity (damp storage conditions). - Transportation and Storage - B2.2.1 and B2.2.2
- Section 6.2.1 and 6.2.3
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with pathogenic microorganisms from containers, tools and equipment that have not been properly cleaned and disinfected. - Sanitation and Pest control E1.1.1
- Section 4.1.1
7 Initial rinse - Presence of pathogenic microorganisms on seeds as a result of improper rinsing (e.g., inadequate volume of water, inadequate agitation, inadequate surface in contact with water, or inadequate number of rinses [i.e. not continuing to rinse until the rinse water remains clear]). - 8 Antimicrobial Treatment of Seeds
CCP-1B
8 Antimicrobial treatment for seeds - Survival of pathogenic microorganisms (Salmonella spp., E. coli O157:H7) due to improper disinfection (e.g., inadequate concentration of antimicrobial treatment solution, inadequate contact time of seeds with antimicrobial treatment solution, inadequate agitation, inadequate volume of antimicrobial treatment solution, inadequate water temperature). - CCP-1B
8, 9, 10, 11, 12, 13, 14, 15, 16 - Cross-contamination with pathogenic microorganisms due to inadequate operational separation between areas (i.e., employee hygiene procedures between areas, boot dips, floor sprays etc.). - Premises A2.1.81
- Section 3.2.1
9, 10, 11 - Growth of pathogenic microorganisms due to time/temperature abuse (i.e., use of warm rinse water / warm room). - 13 Final Rinse and Cooling/Dehulling CCP-3BC
10 Pre-germination soak and rinse - Presence of pathogenic microorganisms as a result of inadequate rinsing after soaking (i.e., after soaking in warm water in a warm room has resulted in bacterial growth). - 13 Final Rinse and Cooling/Dehulling CCP-3BC
11 Germination - Cross-contamination of sprouting seeds with pathogenic microorganisms due to backflow or cross-connected pipe. - Premises A2.1.1
- Section 3.4.1
13 Final Rinse and Cooling/Dehulling - Growth of pathogenic microorganisms due to time/temperature abuse as a result of delays between harvesting and final rinse and/or cooling/dehulling. - CCP-3BC
13 Final Rinse and Cooling/Dehulling - Growth of pathogenic microorganisms due to time/temperature abuse as a result of elevated water temperature, insufficient flow and/or insufficient volume to ensure water temperature remains cold and cools sprouts. - CCP-3BC
13 Final Rinse and Cooling/Dehulling - Growth of pathogenic microorganisms due to time/temperature abuse as a result of insufficient cold water changes/changeovers during rinsing and/or use of warm water during rinsing. - CCP-3BC
14 - Removal of Water/Draining - Growth of pathogenic microorganisms due to time/temperature abuse (i.e., activity is occurring in a warm room). - Transportation and Storage B2.2.1
- Section 1.8.1
15 Bulk cooling - Growth of pathogenic microorganisms due to time/temperature abuse (i.e., inadequate cooling). - Transportation and Storage B2.2.1
- Section 1.8.1
16 Packaging/Labelling/Coding - Contamination of sprouts with pathogenic microorganisms from packaging material as a result of damage or soiling of containers/packaging material during storage. - Transportation and Storage B2.2.2
- Section 1.5.1 and 6.2.1
16 Packaging/Labelling/Coding- Failure to apply correct/legible code date, resulting in inability to recall product. - Recall F1.2.1
- Section 1.7.1 and 8.2.1
17 Storage - Growth of pathogenic microorganisms due to time/temperature abuse (i.e., inappropriate temperatures/ humidity in storage). - Transportation and Storage B2.2.2
- Sections 6.2.3 and 3.2.3
17 Storage - Contamination of sprouts with pathogenic microorganisms due to inadequate separation from incoming ingredients and materials (e.g., seeds, packaging materials, other raw products). - Transportation and Storage B2.2.2
- Section 6.2.3
17 Storage - Growth of pathogenic microorganisms due to excess time of storage (i.e. product stored past “Best Before” date and/or stock not rotated properly). - Transportation and Storage B2.2.2
- Section 6.2.3
17 Storage - Contamination with pathogenic microorganisms in storage due to damaged containers resulting from improper storage procedures. - Transportation and Storage B2.2.2
- Section 6.2.3
17 Storage - Contamination with pathogenic microorganisms in storage due to damaged containers resulting from improper employee hygiene and/or handling procedures. - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1and 5.2.1
18 Shipping - Growth of pathogenic microorganisms due to time/temperature abuse (i.e., inadequate control of temperature of room or carrier). - Transportation and Storage B1.1.1 and B2.2.2
- Section 6.1.2
18 Shipping - Contamination with pathogenic microorganisms due to damaged containers as a result of improper loading and shipping procedures. - Transportation and Storage B1.1.1 and B1.1.2
- Section 6.1.1
18 Shipping - Contamination with pathogenic microorganisms due to damaged containers as a result of improper employee handling and/or hygiene procedures. - Personnel - D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1
18 Shipping - Contamination with pathogenic microorganisms as a result of loading sprouts onto a carrier that is unacceptable for the transportation of food (e.g., cleanliness of carrier, state of repair of carrier).. - Transportation and Storage B1.1.1
- Section 6.1.1
18 Shipping - Contamination with pathogenic microorganisms as a result of transporting sprouts on the same carrier as non-ready-to-eat products (e.g. raw meat). - Transportation and Storage B1.1.1
- Section 6.1.1
Form 4 - Plant Schematic - B1 - Entrance to germination room and B2 - Entrance to packaging room - Improper employee hygienic procedures between rooms resulting in contamination with pathogenic microorganisms. (i.e., improper use of foot dips / hand dips / change of clothing).
Note: B1 and B2 should appear on Form 4 - Plant Schematic
- Personnel D1.1.1 and D2.1.1
- Section 5.1.1 and 5.2.1
Form 4 - Plant Schematic - B2 - Entrance to germination room and B2 - Entrance to packaging room - Concentration of sanitizers in hand dips / foot dips inadequate to control pathogenic microorganisms.
Note: B1 and B2 should appear on Form 4 - Plant Schematic
- Premises A2.1.1
- Section 3.2.1

Example of Completed Form 6: Chemical Hazards Identification

Process/product type name: Sprouts that are grown in water: alfalfa, onion sprouts, mung beans, etc.
List all Chemical hazards related to ingredients, incoming material, processing, product flow, etc.
Identified Chemical HazardsControlled at
Seeds - Presence of pesticide (including herbicide and fungicide) residues above the maximum allowable residue limits. Form 9
Seeds - Presence of visible discolouration on bag and/or seeds indicating presence of lubricants or other industrial chemicals from field equipment. - Transportation and Storage B2.1.3 (of the FSEP Manual)
- Section 1.4.1 (of the guidance document)
Seeds - Presence of undeclared allergenic ingredients (e.g., sesame seeds, soy and wheat). -Transportation and Storage B2.1.3
- Section 1.4.1
Water/well water - Presence of heavy metal (e.g., arsenic), pesticides, excess chlorine. - Premises A4.1.1
- Section 3.4.1
Packaging materials/antimicrobial treatments/growth regulators /plant nutrients/fertilizers - Non-food-grade material and/or not suitable for intended use. - Transportation and Storage B2.1.3
- Section 1.4.1 and 1.4.2
Packaging materials/antimicrobial treatments /growth regulators/plant nutrients/fertilizers - Not appropriate for use with or on foods, or not used in accordance with manufacturer's instructions. - Transportation and Storage - B2.1.1
- Sections 1.4.1 and 1.4.2
Antimicrobial treatments/growth regulators/plant nutrients/fertilizers - Concentration is not the same as what appears on the label of the container. - Transportation and Storage B2.1.3
- Section 1.4.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination of non-allergenic seeds with allergenic seeds as a result of improper employee handling. - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1
1 Receiving - Acceptance of incoming materials and ingredients not meeting specifications (i.e., not meeting standards as described on the specification sheet for each incoming ingredient and/or material). - Transportation and Storage B2.1.3
- Section 1.4.1 and 1.4.2
1 Receiving - Contamination of seeds with non-food Chemicals or chemical residues (cleaners, sanitizers, lubricants) at Receiving as a result of improper receiving procedures. - Transportation and Storage B2.1.3
- Section 1.4.1 and 1.4.2
1 Receiving - Contamination of seeds with non-food Chemicals or chemical residues (cleaners, sanitizers, lubricants) at Receiving as a result of improper sanitation procedures resulting in overspray or contact with chemical residues. - Sanitation and Pest control E1.1.1
- Section 4.1.1
1 Receiving - Contamination of seeds with non-food Chemicals or chemical residues (cleaners, sanitizers, lubricants) at Receiving as a result of improper equipment maintenance procedures resulting in contamination with lubricants/oil, etc. - Equipment C1.1.1
- Sections 2.1.1, 2.1.2 and 2.1.3
2 Storage - growth regulators, plant nutrients, fertilizers - Contamination of seeds, sprouts and/or packaging materials due to improper storage of chemicals. - Transportation and Storage B2.2.3 and B2.2.4
- Section 6.2.2
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with non-food Chemicals (e.g., cleaners/sanitizers/lubricants) as a result of improper storage of seeds/sprouts resulting in damaged packaging and exposed products. - Transportation and Storage B2.2.2
- Sections 6.2.1 and 6.2.2
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with non-food Chemicals (e.g., cleaners/sanitizers/lubricants) as a result of improper sanitation procedures resulting in overspray or contact with chemical residues. - Sanitation and Pest control E1.1.1
- Section 4.1.1
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with non-food Chemicals (e.g., cleaners/sanitizers/lubricants) as a result of improper equipment maintenance procedures resulting in contamination with lubricants/oils, etc. - Equipment - C1.1.1
- Sections 2.1.1, 2.1.2 and 2.1.3
4, 17 - Cross-contamination with allergenic products due to inappropriate storage of allergenic product. - Transportation and Storage B2.2.2
- Section 6.2.1
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with residues of cleaning agent and sanitizer left on containers, tools and equipment that have not been properly cleaned and/or disinfected. - Sanitation and Pest control E1.1.1
- Section 4.1.1
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Cross-contamination by allergenic product(s) due to failure to clean properly between processing of products that contain allergens and products that do not. - Sanitation and Pest control E1.1.1
- Premises A2.1.1
- Sections 3.2.1 and 4.1.1
8 Antimicrobial treatment for seeds - Contamination of seeds with excess concentrations of antimicrobial treatment due to improper chemical application rates (chlorine or other). - 13 Final Rinse and Cooling/Dehulling CCP-3BC
9 Rinse after antimicrobial treatment - Rinse insufficient to reduce concentration of antimicrobial treatment in sprouts. - 13 Final Rinse and Cooling/Dehulling CCP-3BC
10 Pre-germination soak and rinse - Contamination of sprouts with excess concentrations of growth regulators/plant nutrients/fertilizers and/or antimicrobial treatments due to improper chemical application rates. - 11 Germination CCP-2C
11 Germination - Contamination of sprouts with excess concentrations of growth regulators/plant nutrients/fertilizers and/or antimicrobial treatments due to improper chemical application. - CCP-2C
11, 16 - Contamination of sprouts caused by chemical leaks (lubricants) from equipment (e.g., drum and conveyor). - Equipment C1.1.1
- Sections 2.1.1, 2.1.2 and 2.1.3
12, 13, 14, 15, 16, 17, 18 - Contamination of sprouts with allergenic sprouts as a result of improper employee handling. - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1
13 Final Rinse and Cooling/Dehulling - Contamination of sprouts with excess concentrations of antimicrobial treatment due to improper rinsing (resulting in failure to reduce the concentration of antimicrobial treatment in rinse water run-off). - CCP-3BC
16 Packaging/Labelling/Coding - Contamination from inks/solvents as a result of equipment that is not properly maintained and/or set up. - Equipment C1.1.1
- Sections 2.1.1, 2.1.2 and 2.1.3
16 Packaging/Labelling/Coding - Contamination from inks/solvents as a result of improper storage of inks/solvents. - Transportation and Storage B2.2.3
- Section 6.2.2
16 Packaging/Labelling/Coding - Presence of allergens in product that is not identified to contain allergens on the label as a result of improper operational procedures (i.e., packaging product that does not contain allergens prior to packaging product that contains allergens without a full clean-up in between). - Premises - A2.1.1
- Sanitation and Pest Control E1.1.1
- Sections 1.6.1, 3.2.1 and 4.1.1
16 Packaging/Labelling/Coding - Presence of undeclared allergens due to incorrect label application and/or incorrect list of ingredients (e.g., soy, sesame, wheat). - CCP-4C
- Sections 1.2.1, 1.6.1.and 1.9.1
17 Storage - Chemical contamination from refrigerant leak (e.g., ammonia) due to improper equipment maintenance procedures. - Equipment C1.1.1
-Sections 2.1.1, 2.1.2 and 2.1.3
18 Shipping - Contamination from incompatible products or materials on the shipping trailer. - Transportation and Storage B1.1.1
- Section 6.1.1

Example of Completed Form 7: Physical Hazards Identification

Process/product type name: Sprouts that are grown in water: alfalfa, onion sprouts, mung beans, etc.
List all Physical hazards related to ingredients, incoming material, processing, product flow, etc.
Identified Physical HazardsControlled at
Seeds - Presence of hazardous extraneous material from the fields and harvesters (e.g., stones, wood, metal, screw, glass). - 13 Final Rinse and Cooling/Dehulling CCP-3BC
Seeds - Presence of hazardous extraneous material as a result of improper employee handling procedures at the source (e.g., stones, wood, metal, glass). - Transportation and Storage B2.1.3 (of the FSEP Manual)
- Section 1.4.1 (of the guidance document)
Seeds - Presence of hazardous extraneous materials due to damaged packaging as a result of improper handling procedures at the source (e.g., stones, pebbles, wood, metal, glass). - Transportation and Storage B2.1.3
- Section 1.4.1
Packaging materials, antimicrobial treatments, growth regulators, plant nutrients, fertilizers - Presence of hazardous extraneous material as a result of improper handling procedures at the source. - Transportation and Storage B2.1.3
- Sections 1.4.1 and 1.4.2
Water/well water - Presence of hazardous extraneous material (metallic). - Premise A4.1.1
- Section 3.4.1
1 Receiving - Acceptance of incoming materials and ingredients not meeting specifications (i.e., not meeting standards as described on specification sheet for each incoming material and/or ingredient). - Transportation and Storage B2.1.3
- Section 1.4.1 and 1.4.2
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination with hazardous extraneous material due to improper employee handling (e.g., jewellery, pens, paper clips falling into product). - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with hazardous extraneous material due to the introduction of foreign material into product as a result of dirty or poorly maintained overhead structures. - Premises A2.1.1 and A2.1.2
- Section 3.2.1
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with hazardous extraneous material due to the introduction of foreign material into product as a result of damaged packaging material resulting in exposed or open product due to poor storage conditions. - Transportation and Storage B2.2.2
- Sections 6.2.1 and 6.2.2
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with hazardous extraneous material due to the introduction of foreign material into product as a result of damaged packaging material resulting in exposed or open product due to poor employee handling procedures. - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 - Contamination with hazardous extraneous material due to the introduction of foreign material into product as a result of improper maintenance procedures. - Equipment C1.1.1
- Sections 2.1.1, 2.1.2 and 2.1.3
6 Sorting/Weighing - Failure to remove product containing hazardous extraneous material and/or failure to remove hazardous extraneous material (e.g., stones, pebbles, wood, metal, glass) - 13 Final Rinse and Cooling/ Dehulling CCP-3BC
7 Initial Rinse - Mung beans - Presence of hazardous extraneous material due to failure to remove hazardous extraneous material (e.g., stones, pebbles, wood, metal, glass). - 13 Final Rinse and Cooling/ Dehulling CCP-3BC
13 Final rinse and Cooling/Dehulling - Mung bean sprouts - Presence of hazardous extraneous material (e.g., stones/pebbles) due to failure to remove as a result of improper maintenance of equipment. - CCP-3BC
13 Final rinse and Cooling/Dehulling - All Other Seed Sprouts - Presence of hazardous extraneous material (e.g., stones/pebbles) due to failure to remove. - CCP-3BC
17 Storage - Contamination with hazardous extraneous material as a result of improper storage conditions resulting in damaged containers and/or exposed product. - Transportation and Storage B2.3.1
- Section 6.1.1
17 Storage - Contamination with hazardous extraneous material as a result of improper employee handling procedures resulting in damaged containers and/or exposed product. - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1
18 Shipping - Contamination with hazardous extraneous material due to damaged containers as a result of improper condition of transport vehicle. - Transportation and Storage B1.1.1
- Section 6.1.1
18 Shipping - Contamination with hazardous extraneous material due to damaged containers as a result of improper loading and arranging procedures. - Transportation and Storage B1.1.2
- Section 6.1.1
18 Shipping - Contamination with hazardous extraneous material due to damaged containers as a result of improper employee handling procedures resulting in damaged containers and/or exposed products. - Personnel D1.1.1 and D2.1.1
- Sections 5.1.1 and 5.2.1

Example of Completed Form 8: CCP Determination

CCP Determination
Incoming material/process step/hazards on schematic diagram Category and identified hazard

Determine if fully controlled by Prerequisite Program.

* If yes = indicate "Prerequisite Program" and proceed to next identified hazard.

* If no = proceed to question 1 (Q1).
Q1. Could a control measure be used by the operator at any process step?

* If no = not a CCP. Identify how this hazard will be controlled before and after the process. Then proceed to the next identified hazard.

* If yes = describe the measure and proceed to Q2.
Q2. Is it likely that contamination with the identified hazard could occur in excess of the acceptable level or could increase to an unacceptable level?

* If no = not a CCP. Proceed to the next identified hazard.

* If yes = proceed to Q3.
Q3. Is this process step specifically designed to eliminate or reduce the likely occurrence of the identified hazard to an acceptable level?

* If no = proceed to Q4.

* If yes = CCP. Enter its number in the last column.
Q4. Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to an acceptable level?

* If no = CCP. Enter its number in the last column.

* If yes = not a CCP. Identify subsequent (controlling) step and proceed to the next identified hazard.
CCP number

* Proceed to next identified hazard.
Seeds Biological
Presence of pathogenic microorganisms from contamination in the field, harvest or transport.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Seeds Biological
Presence of visible contamination (e.g., pests, insects, rodents' and birds' droppings, moulds).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Seeds Chemical
Presence of pesticide (including herbicide and fungicide) residues above the maximum allowable residue limits.
No
No
Control at the farm level.
See Form 9.
Seeds Chemical
Presence of visible discolouration on bag and/or seeds indicating presence of lubricants or other industrial chemicals from field equipment.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Seeds Chemical
Presence of undeclared allergenic ingredients (e.g., sesame seeds, soy, wheat).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Seeds Physical
Presence of hazardous extraneous material from the fields and harvesters (e.g. stones, wood, metal, screw, glass).
No
Yes
Inspection and initial rinse step
 Yes N/A Yes
13 Final Rinse and Cooling/Dehulling
CCP-3BC
Seeds Physical
Presence of hazardous extraneous material as a result of improper employee handling procedures at the source (e.g., stones, wood, metal, glass).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Seeds Physical
Presence of hazardous extraneous materials due to damaged packaging as a result of improper handling procedures at the source (e.g., stones, pebbles, wood, metal, glass).
Yes
Prerequisite Program:
Transportation and Storage B2.1.3
Water/well water Biological
Water not meeting the Health Canada's Guidelines for Canadian Drinking Water Quality and any applicable provincial or municipal requirements, resulting in the presence of pathogenic microorganisms.
Yes
Prerequisite Program:
Premises - A4.1.1
Water/well water Chemical
Presence of heavy metal (e.g., arsenic), pesticides, excess chlorine.
Yes
Prerequisite Program:
Premises - A4.1.1
Water/well water Physical
Presence of hazardous extraneous material (metallic).
Yes
Prerequisite Program:
Premises - A4.1.1
Well water Biological
Inadequate addition of chlorine resulting in failure to eliminate the presence of pathogenic microorganisms.
Yes
Prerequisite Program:
Premises A4.1.1
Packaging materials Biological
Presence of pathogenic microorganisms due to contamination by faecal material from birds, rodents and insects.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Packaging materials, seeds Biological
Presence of pathogenic microorganisms from soiled/damaged or improperly handled packaging materials at the source.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Packaging materials/antimicrobial treatments/growth regulators/plant nutrients/fertilizers Chemical
Non-food-grade material and/or not suitable for intended use.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Packaging materials/antimicrobial treatments/growth regulators/plant nutrients/fertilizers Chemical
Not appropriate for use with or on foods, or not used in accordance with manufacturer's instructions.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.1
Packaging materials/antimicrobial treatments/growth regulators/plant nutrients/fertilizers Physical
Presence of hazardous extraneous material as a result of improper handling procedures at the source.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
Antimicrobial treatments/growth regulators/plant nutrients/fertilizers Chemical
Concentration is not the same as what appears on the label of the container.
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Biological
Contamination with pathogenic microorganisms due to improper employee handling or hygiene.
Yes
Prerequisite Program:
Personnel D1.1.1 and D2.1.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Biological
Contamination with pathogenic microorganisms due to contamination from overhead structures.
Yes
Premises - A2.1.1 and A2.1.2
Sanitation and Pest Control - E1.1.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Biological
Contamination of product with pathogenic microorganisms from contaminated air (ventilation systems).
Yes
Prerequisite Program:
Premises - A2.3.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Biological
Contamination with pathogenic microorganisms due to contact with pests (insects, rodents, birds)
Yes
Prerequisite Program
Sanitation and Pest Control - E2.1.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Chemical
Contamination of non-allergenic seeds with allergenic seeds as a result of improper employee handling.
Yes
Prerequisite Program:
Personnel - D1.1.1 and D2.1.1
1, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Physical
Contamination with hazardous extraneous material due to improper employee handling (e.g., jewellery, pens, paper clips, etc., falling into product).
Yes
Prerequisite Program:
Personnel - D1.1.1 and D2.1.1
1 Receiving Biological
Acceptance of incoming materials and ingredients not meeting specifications (i.e., not meeting standards as described on the specification sheet for each incoming ingredient and/or material).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
1 Receiving Chemical
Acceptance of incoming materials and ingredients not meeting specifications (i.e., not meeting standards as described on the specification sheet for each incoming ingredient and/or material).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
1 Receiving Chemical
Contamination with non-food chemicals or chemical residues (cleaners, sanitizers, lubricants) at Receiving as a result of:

 

  1. improper receiving procedures and/or
  2. improper sanitation procedures resulting in overspray or contact with chemical residues, and/or
  3. improper equipment maintenance procedures resulting in contamination with lubricants/oil, etc.
Yes

Prerequisite Program:
  1. Transportation and Storage - B2.2.2
  2. Sanitation and Pest Control - E1.1.1
  3. Equipment - C1.1.1
1 Receiving Physical
Acceptance of incoming materials and ingredients not meeting specifications (i.e., not meeting standards as described on the specification sheet for each incoming ingredient and/or material).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.3
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Chemical
Contamination with non-food chemicals (e.g., cleaners/sanitizers/lubricants) as a result of:
  1. improper storage of seeds/sprouts resulting in damaged packaging and exposed products.
  2. improper sanitation procedures resulting in overspray or contact with chemical residues
  3. improper equipment maintenance procedures resulting in contamination with lubricants/oils etc.
Yes

Prerequisite Programs:
  1. Transportation and Storage - B2.2.2
  2. Sanitation and Pest Control - E1.1.1
  3. Equipment - C1.1.1
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Physical
Contamination with hazardous extraneous material due to the introduction of foreign material into product as a result of:
  1. dirty or poorly maintained overhead structures and/or
  2. damaged packaging material resulting in exposed or open product due to poor storage conditions and/or
  3. damaged packaging material resulting in exposed or open product due to poor employee handling procedures and/or
  4. improper maintenance procedures.
Yes

Prerequisite Programs:
  1. Premises- A2.1.1 and A2.1.2
  2. Transportation and Storage - B2.2.2
  3. Personnel - D1.1.1 and D2.1.1
  4. Equipment - C1.1.1
2 Storage - growth regulators, plant nutrients, fertilizers Chemical
Contamination of seeds, sprouts and/or packaging materials due to improper storage of chemicals.
Yes
Prerequisite Program
Transportation and Storage - B2.2.3 and B2.2.4
4, 5 Biological
Contamination of seeds and/or packaging material with pathogenic microorganisms due to exposed packaging material/damaged packaging resulting from improper storage procedures.
Yes
Prerequisite Programs:
Transportation and Storage - B2.2.2
4, 17 Biological
Growth of pathogenic microorganisms and moulds due to inappropriate storage temperatures/humidity (damp storage conditions).
Yes
Prerequisite Program:
Transportation and Storage - B2.2.1 and B2.2.2
4, 17 Chemical
Cross-contamination with allergenic products due to inappropriate storage of allergenic product.
Yes
Prerequisite Programs:
Transportation and Storage - B2.2.2
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Biological
Contamination with pathogenic microorganisms from containers, tools and equipment that have not been properly cleaned and disinfected.
Yes
Prerequisite Program:
Sanitation and Pest Control - E1.1.1
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Chemical
Contamination with residues of cleaning agent and sanitizer left on containers, tools and equipment that have not been properly cleaned and/or disinfected.
Yes
Prerequisite Program:
Sanitation and Pest Control - E1.1.1
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Chemical
Contamination by allergenic product(s) due to failure to clean properly between processing of products that contain allergens and products that do not.
Yes
Prerequisite Program:
Sanitation and Pest Control - E1.1.1
Premises - A2.1.1
6 Sorting/Weighing Physical
Failure to remove product containing hazardous extraneous material and/or failure to remove hazardous extraneous material (e.g., stones, pebbles, wood, metal, glass).
No
Yes
Removal of stones and pebbles at rinsing/cooling step
Yes No Yes
13 Final Rinse and Cooling/
Dehulling
CCP-3BC
7 Initial rinse Biological
Presence of pathogenic microorganisms on seeds as a result of improper rinsing (e.g., inadequate volume of water, inadequate agitation, inadequate surface in contact with water or inadequate number of rinses [i.e., not continuing to rinse until the rinse water remains clear]).
No
Yes
Monitor to ensure adequate volumes of water, adequate agitation, adequate surface in contact with water and/or adequate number of rinses
Yes No 8 - Antimicrobial Treatment of Seeds
CCP-1B
7 Initial rinse Physical
Presence of hazardous extraneous material due to failure to remove (e.g., stones, pebbles, wood, metal, glass).
No
Monitor to ensure sufficient rinsing Yes No Yes
13 Final Rinse and Cooling/
Dehulling
CCP-3BC
8, 9, 10, 11, 12, 13, 14, 15, 16 Biological
Cross-contamination with pathogenic microorganisms due to inadequate operational separation between areas (e.g., proper employee hygiene procedures between areas, boot dips, floor sprays, etc.).
Yes
Prerequisite Program:
Premises - A2.1.1
8 Antimicrobial treatment for Seeds Biological
Survival of pathogenic microorganisms (i.e., E. coli O157:H7, Salmonella spp.) due to improper disinfection (e.g., inadequate concentration of antimicrobial treatment solution, inadequate contact time of seeds with antimicrobial treatment solution, inadequate agitation, Inadequate volume of antimicrobial treatment solution, inadequate water temperature).
No
Yes
Monitoring the antimicrobial treatment (e.g., concentration of antimicrobial treatment/contact time/ agitation, volume of antimicrobial treatment solution, fresh solution of antimicrobial treatment used for each sprout lot).
Yes Yes CCP-1B
8 Antimicrobial treatment for Seeds Chemical
Contamination of seeds with excess concentrations of antimicrobial treatment due to improper chemical application rates (chlorine or other).
No
Yes
Proper addition of antimicrobial.
Proper rinsing of sprouts.
Yes No Yes
13 Final Rinse and Cooling/Dehulling
CCP-3BC
9, 10, 11 Biological
Growth of pathogenic microorganisms due to time/temperature abuse (i.e., use of warm rinse water/warm room).
No
Yes
Monitoring the rinse water temperature and room temperature.
Yes No Yes
13 Final Rinse and Cooling/
Dehulling
CCP-3BC
9 Rinse after antimicrobial treatment Chemical
Rinsing insufficient to reduce concentration of antimicrobial treatment in sprouts.
No
Yes
Rinse seeds as described in the SOP to meet GMP levels.
Yes No Yes
13 Final Rinse and Cooling/Dehulling
CCP-3BC
10 Pre-germination soak and rinse Biological
Presence of pathogenic microorganisms as a result of inadequate rinsing after soaking (after soaking in warm water in a warm room has resulted in bacterial growth).
No
Yes
Monitor the water temperature of the soak.
Monitor the room temperature.
Ensure the rinse follows proper procedures.
Yes No Yes
13 Final Rinse and Cooling/ Dehulling
CCP-3BC
10 Pre-germination soak and rinse Chemical
Contamination of sprouts with excess concentrations of growth regulators/ plant nutrients/fertilizers and/or antimicrobial treatments due to improper chemical application.
No
Yes
Monitoring the mixing of growth regulators/plant nutrients/fertilizers and/or antimicrobial agents to ensure proper concentrations are used
Yes No Yes
11 - Germination
CCP-2C
11 Germination Biological
Cross-contamination of sprouting seeds with pathogenic microorganisms due to backflow or cross-connected pipe.
Yes
Prerequisite Program:
Premises - A2.1.1
11 Germination Chemical
Contamination of sprouts with excess concentration of growth regulators/plant nutrients/fertilizers and/or antimicrobial treatments due to improper chemical application.
No
Yes,
Monitoring the addition of chemicals
Yes No No CCP-2C
11 Germination,
16 Packaging/Labelling/Coding
Chemical
Contamination of sprouts caused by chemical leaks (lubricants) from equipment (e.g., drum and conveyor).
Yes
Prerequisite Program:
Equipment - C1.1.1
12, 13, 14, 15, 16, 17, 18 Chemical
Contamination of sprouts with allergenic sprouts as a result of improper employee handling.
Yes
Prerequisite program:
Personnel - D1.1.1 and D2.1.1
13 Final Rinse and Cooling/Dehulling Biological
Growth of pathogenic microorganisms due to time/temperature abuse as a result of unnecessary delays between harvesting and final rinse and/or cooling/dehulling.
No
Yes
Monitoring the time from harvesting to final rinse and/or cooling
Yes Yes CCP-3BC
13 Final Rinse and Cooling/Dehulling Biological
Growth of pathogenic microorganisms due to time/temperature abuse as a result of elevated water temperature, insufficient flow and/or insufficient volume to ensure water temperature remains cold and cools sprouts.
No
Yes
Monitoring the flow, volume and temperature of rinse water
Yes Yes CCP-3BC
13 Final Rinse and Cooling/Dehulling Biological
Growth of pathogenic microorganisms due to time/temperature abuse as a result of insufficient cold water changes/changeovers during rinsing and/or use of warm water during rinsing.
No
Yes
Monitoring changing of rinse water and the temperature of rinse water
Yes Yes CCP-3BC
13 Final Rinse and Cooling/Dehulling Chemical
Contamination of sprouts with excess concentrations of antimicrobial treatment due to improper rinsing (resulting in failure to reduce concentration of antimicrobial treatment in rinse water run-off).
No
Yes
Monitor the concentration of antimicrobial treatment
Monitor the rinsing/irrigating procedures.
Yes No No CCP-3BC
13 Final Rinse and Cooling/Dehulling - Mung bean sprouts Physical
Presence of hazardous extraneous material (e.g., stones/pebbles) due to failure to remove as a result of improper maintenance of equipment.
Yes
Prerequisite Program:
Equipment - C1.1.1
13 - Final Rinse and Cooling/Dehulling - All other sprouts Physical
Presence of hazardous extraneous material (e.g., stones, pebbles, wood, metal, glass, etc.) due to failure to remove.
No
Form 9 - GAP
14 Removal of Water/Draining Biological
Growth of pathogenic microorganisms due to time/temperature abuse (i.e. activity is occurring in a warm room).
Yes
Prerequisite program:
Transportation and Storage - B2.2.1
15 Bulk Cooling Biological
Growth of pathogenic microorganisms due to time/temperature abuse (i.e. activity is occurring in a warm room).
Yes
Prerequisite program:
Transportation and Storage - B2.2.1
15 Bulk Cooling Biological
Growth of pathogenic microorganisms due to time/temperature abuse (i.e. inadequate cooling).
Yes
Prerequisite program:
Transportation and Storage - B2.2.1
16 Packaging/Labelling/Coding Biological
Contamination of sprouts with pathogenic microorganisms from packaging material as a result of damage or soiling of containers/packaging material during storage.
Yes
Prerequisite program:
Transportation and Storage - B2.2.2
16 Packaging/Labelling/Coding Biological
Failure to apply correct/legible lot code resulting in inability to recall product.
Yes
Prerequisite Program:
Recall - F1.2.1
16 Packaging/Labelling/Coding Chemical
Contamination from inks/solvents as a result of:
  1. equipment that is not properly maintained and/or set up and/or
  2. improper storage of inks/solvents.
Yes

Prerequisite Programs:
  1. Equipment - C1.1.1
  2. Transportation and Storage - B2.2.3
16 Packaging/Labelling/Coding Chemical
Presence of allergens in product that is not identified to contain allergens on the label as a result of improper operational procedures (i.e. packaging product that does not contain allergens prior to packaging product that contains allergens without a full clean-up in between).
Yes
Prerequisite Program:
Premises - A2.1.1
Sanitation and Pest Control - E 1.1.1
16 Packaging/Labelling/Coding Chemical
Presence of undeclared allergens due to incorrect label application and/or incorrect list of ingredients (e.g., soy, sesame, wheat).
No
Yes
Verification of the list of ingredients to ensure the label is correct.
Yes Yes CCP-4C
17 Storage Biological
Growth of pathogenic microorganisms due to time/temperature abuse (i.e., inappropriate temperatures/humidity in storage).
Yes
Prerequisite Program:
Transportation and Storage - B2.2.2
17 Storage Biological
Contamination of sprouts with pathogenic microorganisms due to inadequate separation from incoming ingredients and materials (e.g., seeds, packaging material, other raw products).
Yes
Prerequisite program
Transportation and Storage - B2.2.2
17 Storage Biological
Growth of pathogenic microorganisms due to excess storage time (i.e., product stored past “Best Before” date and/or stock not rotated properly).
Yes
Prerequisite Program:
Transportation and Storage - B2.2.2
17 Storage Biological
Contamination with pathogenic microorganisms in storage due to damaged containers resulting from:
  1. improper storage procedures and/or
  2. improper employee hygiene and/or handling procedures.
Yes

Prerequisite Programs:
  1. Transportation and Storage - B2.2.2
  2. Personnel - D1.1.1 and D2.1.1
17 Storage Chemical
Chemical contamination from refrigerant leak (e.g., ammonia) due to improper equipment maintenance procedures.
Yes
Prerequisite Program:
Equipment - C1.1.1
17 Storage Physical
Contamination with hazardous extraneous material as a result of:
  1. improper storage conditions resulting in damaged containers and/or exposed product and/or
  2. improper employee handling procedures resulting in damaged containers and/or exposed products.
Yes

Prerequisite Programs:
  1. Transportation and Storage - B2.2.2
  2. Personnel - D1.1.1 and D2.1.1
18 Shipping Biological
Growth of pathogenic microorganisms due to time/temperature abuse (i.e., inadequate control of temperature of room or carrier).
Yes
Prerequisite Program:
Transportation and Storage - B2.1.1 and B2.2.2
18 Shipping Biological
Contamination with pathogenic microorganisms as a result of loading sprouts onto a carrier that is unacceptable for the transportation of food (e.g., cleanliness of carrier, state of repair of carrier).
Yes
Prerequisite Program:
Transportation and Storage - B1.1.1
18 Shipping Biological
Contamination with pathogenic microorganisms due to damaged containers as a result of:
  1. improper loading and shipping procedures and/or
  2. improper employee hygiene and/or handling procedures
Yes

Prerequisite Program:
  1. Transportation and Storage - B1.1.1 and B1.1.2
  2. Personnel - D1.1.1 and D2.1.1
18 Shipping Biological
Contamination of sprouts with pathogenic microorganisms as a result of transporting sprouts on the same carrier as non-ready-to-eat-products (e.g., raw meat).
Yes
Prerequisite program
Transportation and Storage B1.1.1
18 Shipping Chemical
Contamination from incompatible products or materials on the shipping trailer.
Yes
Prerequisite Program:
Transportation and Storage - B1.1.1
18 Shipping Physical
Contamination with hazardous extraneous material due to damaged containers as a result of:
  1. improper condition of transport vehicle and/or
  2. improper loading and arranging procedures and/or
  3. improper employee handling procedures resulting in damaged containers and/or exposed products.
Yes

Prerequisite Program:
  1. Transportation and Storage - B1.1.1
  2. Transportation and Storage - B1.1.2
  3. Personnel - D1.1.1 and D2.1.1
Form 4 - Plant Schematic B1 - Entrance to Germination Room and B2 - Entrance to Packaging Room Biological
Concentration of sanitizers in hand dips/foot dips inadequate to control pathogenic microorganisms.
Yes
Prerequisite Program:
Premises - A2.1.1
Form 4 - Plant Schematic B1 - Entrance to Germination Room and B2 - Entrance to Packaging Room Biological
Contamination with pathogenic microorganisms due to Improper employee hygienic procedures between rooms, resulting in contamination with pathogenic microorganisms (i.e., improper use of food dips/hand dips/change of clothing).
Yes
Prerequisite Programs
Personnel - D1.1.1 and D2.1.1

Example of Completed Form 9: Hazards not controlled by the Operator

Process/product type name: Sprouts that are grown in water: alfalfa, onion sprouts, mung beans, etc.
List here any Biological, Chemical and Physical hazards that are not controlled by the operator
HazardsIndicate how the hazard could be addressed (cooking instructions, public education, "use before" date, etc.)
Chemical

Seeds

Presence of pesticide (including herbicides and fungicides) residues, lubricants or other industrial chemicals above maximum allowable limits.
Control at the farm level.
Education in agricultural methods to encourage the use of GAP.
Physical

13 Final Rinse and Cooling/Dehulling - Other seeds (besides mung beans)

Presence of hazardous extraneous material (e.g., stones, pebbles, wood, metal, glass, etc.) due to failure to remove.
Control at the farm level.
Education in agricultural methods to encourage the use of GAP.

Example of Completed Form 10: HACCP Plan - Critical Control Points

Process/product type name: Sprouts that are grown in water: alfalfa, onion sprouts, mung beans, etc.
Process StepsCCP/Hazard NumberHazard DescriptionCritical LimitsMonitoring ProceduresDeviation ProceduresVerification ProceduresHACCP Records
8 Antimicrobial treatment for seeds CCP-1B Biological
Survival of pathogenic microorganisms (i.e., E. coli O157:H7, Salmonella spp.) due to improper disinfection (e.g., inadequate concentration of antimicrobial treatment solution, inadequate contact time of seeds with antimicrobial treatment solution, inadequate agitation, inadequate volume of antimicrobial treatment solution, inadequate water temperature).
Antimicrobial treatment that can achieve a minimum 3 log reduction of the microbial pathogenic microorganisms of concern (i.e., Salmonella spp. and E. coli O157:H7).

Example: 2000 ppm of calcium hypochlorite or sodium hypochlorite for 15–20 minutes or 6–10% hydrogen peroxide for 10 minutes.

Seeds well agitated in large volumes of antimicrobial treatment solution, i.e., at least five times the volume of antimicrobial treatment for the amount of seeds.

Water temperature of X as required for effective antimicrobial treatment of seeds as indicated on the label of the antimicrobial chemical.

Fresh antimicrobial treatment solution used for each sprout lot.

Note: Critical limits must be validated during the development of the HACCP Plan and validated at least once per year.

See the following Web link to review the information on validation in the FSEP manual.
For each batch/lot of seeds, the CCP-1B Monitor takes the temperature of the water using a hand held thermometer (as per CCP-1B Temperature Monitoring Procedures) to ensure that the water temperature meets the critical limit.

CCP-1B Monitor mixes the antimicrobial treatment solution required as per the SOP for Mixing Antimicrobial Treatment Chemicals based on the weight of the batch to ensure that at least 5 times the volume of antimicrobial treatment solution is used for the amount of seeds.

CCP-1B Monitor tests the antimicrobial treatment as per the SOP for Mixing Antimicrobial Treatment Chemicals to ensure the concentration meets the critical limit.

CCP-1B Monitor then adds the antimicrobial treatment to the seeds.

CCP-1B Monitor agitates the seeds in the antimicrobial treatment x times then records the time for the start of disinfection and the completion of disinfection (or the belt speed) to ensure adequate mixing and contact time with all seeds as per the SOP for Mixing Antimicrobial Treatment Chemicals.

CCP-1B Monitor records the volume of the antimicrobial treatment solution used, the volume of water used (total volume of antimicrobial treatment solution used), the weight of seeds, the agitation of the seeds and the belt speed or contact time on the CCP-1B Monitoring Record. Signs and dates.
If the concentration of the disinfecting solution does not meet the critical limit (i.e., 2000 ppm or the hydrogen peroxide level is not 6–10%), or the water temperature does not meet the critical limits prior to use, CCP-1B Monitor adjusts solution and retests as per the SOP for Mixing Antimicrobial Treatment Chemicals. If the concentration of the antimicrobial treatment solution or the water temperature cannot be adjusted to meet the critical limits, or if the contact time, agitation or volume of the antimicrobial treatment solution is not adequate, the CCP-1B Monitor holds all product since the last good check as per the Hold Procedures and notifies CCP-1B Authorized Person. Records all findings, corrective actions, date and signature on CCP-1B Monitoring Record.

CCP-1B Authorized Person performs a food safety assessment as per Food Safety Assessment Procedures. If food safety has been compromised, the product is held, tested and subsequently released, reworked or destroyed.

If food safety has not been compromised, the CCP-1B Authorized Person releases the product.

CCP-1B Authorized Person reviews all corrective actions to ensure they are completed and effective in controlling the deviation as well as to ensure any affected product is controlled. If any issues are identified, takes immediate corrective action as described above.

CCP-1B Authorized Person determines the root cause of the deviation to assess whether this is an isolated incident and/or whether preventative corrective actions must be developed to prevent reoccurrence.

CCP-1B Authorized Person records the description of the deviation, the corrective action (including date completed) and preventative measures on CCP-1B Deviation Record. Signs and dates.
Once every Y time period, the CCP-1B Verifier observes the CCP-1B Monitor to ensure the CCP-1B Temperature Monitoring Procedures and the SOP for Mixing Antimicrobial Treatment Chemicals are being followed and the critical limits are met. Signs the CCP-1B Monitoring Record, dates and records “observation” to indicate a procedure check was conducted.

Once every Y time period, the CCP-1B Verifier reviews “X” number of CCP-1B Monitoring Records, and associated CCP-1B Deviation Records , along with corrective actions completed since the last verification to assess completeness and to ensure critical limits are met. Signs and dates.

If deviations are found for any of the above procedures, the CCP-1B Verifier follows the CCP-1B Deviation Procedures. When the CCP-1B Monitor is not following written procedures, reinforcement, training or retraining will be provided.

CCP-1B Authorized Person collects x samples following the criteria set in the Health Canada' s Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water to assess microbiological testing of spent irrigation water and finished product to be tested for microbial pathogenic microorganisms of concern 48 hours after the start of germination.

Every Y lots/batches of product at X time period during the irrigation/final rinse, CCP-1B Authorized Person collects x samples of rinse water run-off (spent irrigation water) and sprouts following the criteria set in Health Canada's Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water and sends the samples to the lab to be tested to ensure pathogenic microorganisms of concern meet the standards indicated in the FSPGSM document.

Records on CCP-1B Verification Record. Received results are reviewed by the CCP-1B Authorized Person to ensure that the requirements are met as outlined in the FSPGSM document. Signs and dates.

If results do not meet the requirements, CCP-1B Authorized Person takes the corrective actions outlined in the Deviation Procedures for this CCP, which are found in the SOP for Mixing Antimicrobial Treatment Chemicals.
CCP-1B Monitoring Record

CCP-1B Deviation Record

CCP-1B Verification Record

Microbiological testing results

SOP for Mixing Antimicrobial Treatment Chemicals

Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water

Food Safety Practices Guidance for Sprout Manufacturers
11 Germination CCP-2C Chemical
Contamination of sprouts with excess concentrations of growth regulators/plant nutrients/fertilizers and/or antimicrobial treatments due to improper chemical application.
Growth regulators/plant nutrients/fertilizer/antimicrobial treatment solutions must be mixed and added to the seeds as per the label directions for approved use, in accordance with the SOP for Mixing Growth Regulators/Plant Nutrients/Fertilizers/Antimicrobial Treatments. For each batch/lot of seeds, the CCP-2C Monitor mixes the growth regulator/plant nutrients/fertilizer and/or antimicrobial treatment solution that is required based on the weight of the batch and the instructions on the label using the SOP for Mixing Growth Regulators/Plant Nutrients/Fertilizers/
Antimicrobial Treatments.

Records the volume of the growth regulator/plant nutrient/fertilizer and/or antimicrobial treatment solution used, the volume of water used (total volume of growth regulator/plant nutrient/fertilizer/antimicrobial treatment solution used), and the weight of seeds on the CCP-2C Monitoring Record and signs and dates the record.
If deviations are encountered, the CCP-2C Monitor holds all products since the last good check as per Hold Procedures. Notifies CCP-2C Authorized Person. Records all findings, corrective actions, date and time completed on CCP-2C Deviation Record.

CCP-2C Authorized Person performs a food safety assessment as per the Food Safety Assessment Procedures. If food safety has been compromised, the product is held, tested and subsequently released, reworked or destroyed.

If food safety has not been compromised, the CCP-2C Authorized Person releases the product.

CP-2C Authorized Person reviews all corrective actions to ensure that they are completed and are effective in controlling the deviation as well as any affected product. If any issues are identified, takes immediate corrective action as described above.

CCP-2C Authorized Person determines the root cause of the deviation to assess whether this is an isolated incident and/or whether preventative corrective actions must be developed to prevent reoccurrence.

CCP-2C Authorized Person records the description of the deviation, the corrective action (including date completed) and preventative measures on CCP-2C Deviation Record. Signs and dates.
Once every Y time period, the CCP-2C Verifier observes the CCP-2C Monitor performing the monitoring function to ensure the SOP for Mixing Growth Regulators/Plant Nutrients/Fertilizers/Antimicrobial Treatments is being followed and the critical limits are met. Signs the CCP-2C Monitoring Record, dates and records “observation” to indicate a procedure check was conducted.

Once every Y time period, the CCP-2C Verifier reviews “X” number of CCP-2C Monitoring Records and the associated CCP-2C Deviation Records, as well as corrective actions completed since the last verification to assess completeness and to ensure critical limits are met. Signs and dates.

If deviations are found for any of the above procedures, the CCP-2C Verifier follows the CCP-2C Deviation Procedures. When the CCP-2C Monitor is not following written procedures, reinforcement, training or retraining will be provided.
CCP-2C Monitoring Record

CCP-2C Deviation Record

SOP for Mixing Growth Regulators/Plant Nutrients/Fertilizers/Antimicrobial Treatments

Food Safety Assessment Procedures

Hold Procedures
13 Final Rinse/Cooling/Dehulling CCP-3BC Biological
Growth of pathogenic microorganisms due to time/temperature abuse as a result of delays between harvesting and final rinse and/or cooling/dehulling.

Growth of pathogenic microorganisms due to time/temperature abuse as a result of insufficient cold water changes/changeovers during rinsing and/or use of warm water during rinsing.

Growth of pathogenic microorganisms due to time/temperature abuse as a result of elevated water temperature, insufficient flow and/or insufficient volume to ensure water temperature remains cold and cools sprouts.

Chemical
Contamination of sprouts with excess concentrations of antimicrobial treatment due to improper rinsing (resulting in a failure to reduce concentration of antimicrobial treatment in rinse water run-off).
For each batch/lot of sprouts, the time from the start of harvest to the start of final rinse and/or cooling/dehulling must not exceed X minutes.

Mung bean sprouts

- A constant overflow of water out of the trough must occur.

- The water temperature must be X degrees or less.

All other seed sprouts

- Water used for the final rinse and/or cooling/dehulling of the sprouts must be X degrees or less and must be changed for each rinse.

Rinsing of the sprouts is conducted for not less than Y time period (note: may be a belt speed) with volumes and flow of water as per SOP CCP-3BC Final Rinse and Cooling/Dehulling to ensure proper rinsing of sprouts so as to reduce the concentration of the antimicrobial treatment in rinse water run-off.
CCP-3BC Monitor records the time at the start of the harvest and the time at the start of the cooling for each batch/lot on the CCP-3BC Monitoring Record to ensure that the critical limit is not exceeded.

Once every Y time period, CCP-3BC Monitor takes the temperature of the water used for the final rinse as per CCP-3BC Temperature Monitoring Procedures SOP to ensure that the water temperature meets critical limits. Records all findings on the CCP-3BC Monitoring Record. Signs and dates.

Mung beans - Once every Y time period, CCP-3BC Monitor observes the water overflowing from the trough to ensure that the critical limit is met as per the SOP
CCP-3BC Final Rinse and Cooling/Dehulling. Records all findings on the CCP-3BC Monitoring Record. Signs and dates.

All other seed sprouts - CCP-3BC Monitor changes the water for rinsing between each lot/batch of sprouts, at a minimum, and records the volume of water used. Records water changes on the CCP-3BC Monitoring Record. Signs and dates.

CCP-3BC Monitor records the start of the rinse/cooling cycle and the finish of the rinse/cooling cycle for each batch of sprouts to ensure that the critical limit is met. Records on CCP-3BC Monitoring Record. Signs and dates.
If deviations are encountered, CCP-3BC Monitor holds all products since the last good check as per Hold Procedures. Notifies CCP-3BC Authorized Person. Records all findings, corrective actions on CCP-3BC Record. Signs and dates.

CCP-3BC Authorized Person performs a food safety assessment as per Food Safety Assessment Procedures. If food safety has been compromised the product is held, tested and subsequently released, reworked or destroyed.

If food safety has not been compromised the CCP-3BC Authorized Person releases the product.

CCP-3BC Authorized Person reviews all corrective actions to ensure they are completed and they are effective in controlling the deviation as well as any affected product. If any issues are identified, this person takes immediate corrective action as described above.

CCP-3BC Authorized Person determines the root cause of the deviation to assess whether this is an isolated incident and/or whether preventative corrective actions must be developed to prevent reoccurrence.

CCP-3BC Authorized Person records the description of the deviation, the corrective action (including date completed) and preventative measures on CCP-3BC Deviation Record. Signs and dates.
Once every Y time period, CCP-3BC Verifier observes the CCP-3BC Monitor performing the monitoring function to ensure the SOP CCP-3BC Final Rinse and Cooling/Dehulling is being followed and the critical limits are met. Signs the CCP-3BC Monitoring Record, dates and records “observation” to indicate a procedure check was conducted.

Once every Y time period, CCP-3BC Verifier reviews “X” number of CCP-3BC Monitoring Records and associated CCP-3BC Deviation Records and corrective actions completed since the last verification to assess completeness and to ensure critical limits are met. Signs and dates.

If deviations are found for any of the above procedures, the CCP-3BC Verifier follows the CCP-3BC Deviation Procedures. When the CCP-3BC Monitor is not following written procedures, reinforcement, training or retraining will be provided.

Every Y lots/batches of product at X time period during the irrigation/final rinse, CCP-3BC Authorized Person collects x samples of rinse water run-off (spent irrigation water) and sprouts according to the criteria set out in Health Canada's Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water and sends the samples to the lab to be tested to ensure that the concentration of antimicrobial treatment solution in rinse water at the end of the final rinse does not exceed Y (e.g., chlorine levels must not exceed what is allowed in the Guidelines for Canadian Drinking Water Quality) and that the microbiological testing results meet the standards indicated in the Guidance document. Records on CCP-3BC Verification Record. Received results are reviewed by the CCP-3BC Authorized Person to ensure that the standards for verification are met. Signs and dates.
CCP-3BC Monitoring Record

CCP-3BC Deviation Record

CCP-3BC Verification Record

CCP-3BC Temperature Monitoring Procedures SOP

SOP CCP-3BC Final Rinse and Cooling/Dehulling

Food Safety Assessment Procedures

Hold Procedures

Health Canada' s Guidance for Industry: Sample Collection and Testing for Sprouts and Spent Irrigation Water
16 Packaging/Labelling/Coding CCP-4C Chemical
Presence of undeclared allergens due to incorrect label application and/or incorrect list of ingredients. (e.g., soy, sesame, wheat).
Correct label applied to the product.

List of ingredients on the label must match the ingredients in the product.
Once every Y time period, Monitor checks the label being applied/applied to the product to ensure that:

 

The information on the label matches the product being packaged, and the ingredient list on the label matches the product being packaged as per the CCP-4C Label Check SOP to ensure that the critical limits are being met.

CCP-4C Monitor records results on the CCP-4C Monitoring Record. Signs and dates.
If a deviation occurs, Monitor stops packaging/labeling/coding and notifies Authorized Person. Records on CCP-4C Deviation Record. Signs and dates.

Authorized Person places product and labels on hold from the last good check as per Hold Procedures, and performs a food safety assessment as per Food Safety Assessment Procedures. If food safety has been compromised, the product is held, tested and subsequently released, reworked (e.g., repackaging/relabelling correctly) or destroyed.

If food safety has not been compromised the Authorized Person releases the product.

CCP-4C Authorized Person reviews all corrective actions to ensure they are completed and they are effective in controlling the deviation as well as any affected product. If any issues are identified, takes immediate corrective action as described above.

CCP-4C Authorized Person determines the root cause of the deviation to assess whether this is an isolated incident and/or whether preventative corrective actions must be developed to prevent reoccurrence.

CCP-4C Authorized Person records the description of the deviation, the corrective action (including date completed) and preventative measures on CCP-4C Deviation Record. Signs and dates.
Once every Y time period, the CCP-4C Verifier observes the CCP-4C Monitor performing the monitoring function to ensure the CCP-4C Label Check SOP is being followed and the critical limits are being met. Signs the CCP-4C Monitoring Record, dates and records “observation” to indicate a procedure check was conducted.

Once every Y time period, CCP-4C Verifier reviews “X” number of CCP-4C Monitoring Records and associated CCP-4C Deviation Records and corrective actions completed since the last verification for completeness so as to ensure critical limits have been met. Signs and dates.

If deviations are found for any of the above procedures, the CCP-4C Verifier follows the CCP-4C Deviation Procedures. When the CCP-4C Monitor is not following written procedures, reinforcement, training or retraining will be provided.
CCP-4C Monitoring Record

CCP-4C Deviation
Record

CCP-4C Label Check SOP

Hold procedures

Food Safety Assessment Procedures
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