HACCP Generic Model for Ready-To-Eat Fresh-Cut Vegetables
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The committee wishes to emphasize that the model described here is a Generic Model. It does not cover all Ready-to-Eat fresh-cut vegetable products and processes, nor does it list all possible associated hazards. This generic model is a template that can be adapted to most Ready-to-Eat fresh-cut vegetable operations. The process flow diagram in this generic model does not reflect the characteristics of any specific manufacturing line of any of the companies consulted by the committee, but rather represents the basic process steps of all companies consulted. The model reflects the entire manufacturing line, from receipt of the vegetables through to the shipping/distribution of Ready-to-Eat fresh-cut vegetables to hospitals, restaurants, institutions and retail outlets and includes the treatment of vegetables with sodium hypochlorite.
The HACCP team at each establishment is responsible for identifying and controlling all hazards specific to its operation 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 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 the hazards actually exist in the facility and to determine where each of those hazards is controlled at each step in the process. Where ingredients, procedures or processes differ from those in the generic model, the HACCP team should determine whether process steps should be added or removed. In addition, a hazard analysis should be conducted to determine whether any hazards should be added or removed and to determine where each of the additional hazards are controlled in the facility. Here are some examples:
- Use of whole leaf spinach or baby greens - While this generic model does not include whole leaf spinach or baby greens, if a manufacturer is adding these ingredients, a hazard analysis should be conducted to determine whether any additions or deletions should be made to the incoming ingredients and/or the process flow diagram as they appear in the generic model and to determine whether any hazards should be added to or deleted from those that are identified in order to develop a plant-specific HACCP plan.
- Use of a different antimicrobial treatment - While this generic model deals only with the use of sodium hypochlorite, if a different antimicrobial treatment is used by the facility, the manufacturer should conduct a hazard analysis to determine whether any additions or deletions should be made to the incoming ingredients and/or the process flow diagram as they appear in the generic model and to determine whether any hazards should be added to or deleted from those that are identified in order to develop a plant-specific HACCP plan.
- Addition of allergenic products (e.g., tree nuts, croutons or salad dressings or any other product containing allergens as an ingredient) - While this generic model does not deal with the addition of croutons or dressings (that may contain allergens) to a packaged salad, if a manufacturer adds any products that are considered allergens, or any products that contain allergenic ingredients, a hazard analysis should be conducted to determine whether any additions or deletions should be made to the incoming ingredients and/or the process flow diagram as it appears in the generic model and to determine whether any hazards should be added to or deleted from those that are identified in order to develop a plant-specific HACCP plan (e.g., at the steps associated with the receiving and storage of allergenic ingredients and/or products, at the steps where allergenic ingredients and/or products are added to the fresh-cut vegetables and at the step where the finished product is labelled).
- Temperature differential - If vegetables are received at the facility directly from the field prior to being cooled, the manufacturer should conduct a hazard analysis to determine whether any additions or deletions should be made to the process flow diagram as it appears in the generic model and to determine whether any hazards should be added or deleted to those that are identified in order to develop a plant-specific HACCP plan. A hazard associated with temperature differential between product and wash water should be considered by the manufacturer.
Following the hazard analysis, the manufacturer should compare the plant-specific HACCP plan to the generic model. If the manufacturer determines that a prerequisite program is fully controlling a hazard in its facility, but the generic model indicates a CCP is the control measure for the same hazard, the manufacturer should validate that the identified prerequisite program is able to fully control the hazard as described. 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. For additional information concerning the use of generic models, the FSEP Manual should be referenced.
The HACCP team at each establishment is also responsible for the 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) and the critical limits of the critical control points. If the manufacturer is unable to find a scientific study or government regulation to support the standard or critical limit used in the HACCP plan, the facility 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, the facility should carry out a validation to show that its process can consistently meet the standard. A validation of all control measures should be conducted at least once a year. During the yearly validation, all of the standards of the Prerequisite Programs (GMPs) as well as the critical limits of the critical control points 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 modification whenever any changes are made to the establishment, its processes or 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 referenced.
During the development of the generic model, 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.
Although the generic model was developed using the CFIA's FSEP approach, the committee endeavoured to adhere to the GPFHCL and the information found in the guidance document wherever possible. The committee recognized that differences exist between the GPFHCL and the FSEP approach. For example, under the FSEP approach, all of the information concerning transportation, receiving and storage of all incoming ingredients and materials is considered part of the Prerequisite Program (GMP), for Transportation, Purchasing/Receiving/Shipping and Storage, while in the GPFHCL and guidance document the criteria for the receiving of incoming ingredients and packaging materials are considered process related (found in Chapter 1 - Operational Controls [Section 1.4.1 and Section 1.4.2]) and are not considered GMP related (are not considered a Prerequisite Program). All other information for receiving is found in Chapter 6 - Transportation and Storage (Section 6.1) of the GPFHCL and guidance document.
It was decided that in order to be consistent with the FSEP approach, it would be assumed that manufacturers would identify receiving as a Prerequisite Program (GMP). If a manufacturer chooses to do this, the information from Sections 1.4.1 and 1.4.2 should be included with the information found in Section 6.1 (a prerequisite program). It would be considered acceptable if the manufacturer wishes to maintain a CCP at Receiving.
- Where applicable on Forms 5, 6 and 7 in the Controlled at column, the FSEP Prerequisite Program is identified as it is named in the guidance document (i.e., Transportation and Storage 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 reference information for the manufacturer. However, the section of the guidance document is not identified on Form 8. Only the name of the Prerequisite Program as it is identified in the guidance document is identified on Form 8.
- Washing of vegetables is assumed to be completed using automated equipment.
- The committee recognizes that there are many methods of antimicrobial treatment available for the treatment of fresh-cut vegetables. Sodium hypochlorite is the example of an antimicrobial treatment used in the generic model.
- Through in-plant evaluations, it was determined that the absorption of pathogens at cut surfaces as a result of temperature differentials related to vegetables in water and/or vegetables in antimicrobial treatments was a hazard that was not likely to occur. All of the facilities consulted received previously cooled and refrigerated product.
- In this generic model, specifically at CCP-2BC, it is assumed that the manufacturer will have developed plant-specific Standard Operating Procedures (SOPs) that have been validated to ensure that when the written procedures are followed the critical limit is met and the hazard is controlled. The procedures may be fully described on Form 10 or the SOPs may be referenced as in the generic model.
- The mixing/blending step appears in Form 3, the process flow diagram, as described in the Code of Practice. During the plant evaluation visits, it was determined that in general, the mixing/blending steps at most facilities are conducted prior to washing and drying. However, no change was made to the order of the steps in the generic model so as to ensure consistency with the code of practice and to demonstrate the location in the process flow for mixing/blending that has the lowest risk factor.
- This generic model includes a metal detector. It is considered a safety measure to control hazardous extraneous (metallic) hazards that are not controlled by the prerequisite programs (e.g., wear and tear of equipment resulting in metal shavings in the product at grinding). If a metal detector is part of the process, the hazards associated with that metal detector should be evaluated and controlled. The manufacturer must realize that the metal detector is only considered a safety measure to the level of the sensitivity of the machine. Below the critical limit, the hazard can no longer be controlled by the metal detector and the facility should determine how the hazard is to be controlled.
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