Annex 1: Domestic food implementation verification tasks

On this page

• Pre-operational records verification
• Pre-operational on-site verification
• Sampling verification:
  • Sampling technique for verification testing and results of E. coli O157:H7/NM
  • Implementation of written protocol for listeria environmental sampling
  • Implementation of written protocol for listeria sampling of RTE products
• E. coli O157 incident response (see Operational procedure: Control response plan for the detection of E. coli O157:H7/NM in raw beef products)
• E. coli O157 trend analysis
• SRM On-Site Verification (See OG: Food Animal Slaughter Preventive Control Inspection – Implementation Verification, Appendix 4)
• SRM Records Verification (See OG: Food Animal Slaughter Preventive Control Inspection – Implementation Verification, Appendix 4)

Pre-operational records verification

Legal authorities

• Safe Food for Canadians Regulations (SFCR)
  • Trade: 8(1)(d)(2)(3)
  • Preventive controls (PC) – Biological, chemical and physical hazards: 47(1)(2)
  • PC – Maintenance and operation of establishment: 49, 50(1)(2)
  • PC – Preventive control plan (PCP): 86(1)(2)(3), 88, 89(1)(2)(3)(4)(5)(6)

Outcome

Effective sanitation of equipment, utensils, containers and premises is in place to maintain them in a clean and sanitary condition, prevent the risk of contamination of the commodity and the spread of disease.

Rationale

Improper or inadequate sanitation/biosecurity/bio-containment, activities can lead to contamination of commodities, premises, packaging materials and contact surfaces or the spread of diseases.

Performance criteria

• The establishment is kept clean and in a sanitary condition
• Any conveyance or equipment in the establishment used for manufacturing, preparing, storing, packaging or labelling of food or slaughtering of food animals is kept clean and in a sanitary condition
• The establishment as well as any conveyance or equipment are cleaned and sanitized in a manner that does not present a risk of contamination to the food
• Written procedures, if required, are in place and capable of delivering the requirements of the sanitation program and/or biosecurity/bio-containment program
• Effectiveness of cleaning, sanitizing and/or biosecurity/bio-containment is assessed using accepted methods or procedures, as applicable, including:
  • contact surfaces are free from contamination
  • swabbing/sampling is conducted in accordance with approved procedures

Verification activities

Document/records review

• Review the licence holder's written preventive control plan (PCP) related to pre-operational sanitation. Verify that:
  • any associated records that are indicated in the PCP, including the verification records, demonstrate that the licence holder effectively maintains control of hazards associated with pre-operational sanitation
  • the licence holder is able to demonstrate that a non-compliant situation is effectively controlled to bring hazards back into control and prevent the re-occurrence

Pre-operational on-site verification

Legal authorities

• SFCR
  • Trade: 8(1)(d)(2)(3)
  • Preventive controls (PC) – Biological, chemical and physical hazards: 47(1)(2)
  • PC – Maintenance and operation of establishment: 49, 50(1)(2)
  • PC – Preventive control plan (PCP): 86(1)(2)(3), 88, 89(1)(2)(3)(4)(5)(6)

Outcome

Effective sanitation of equipment, utensils, containers and premises is in place to maintain them in a clean and sanitary condition, prevent the risk of contamination of the commodity and the spread of disease.

Rationale

Improper or inadequate sanitation/biosecurity/bio-containment, activities can lead to contamination of commodities, premises, packaging materials and contact surfaces or the spread of diseases.

Performance criteria

• The establishment is kept clean and in a sanitary condition
• Any conveyance or equipment in the establishment used for manufacturing, preparing, storing, packaging or labelling of food or slaughtering of food animals is kept clean and in a sanitary condition
• The establishment as well as any conveyance or equipment are cleaned and sanitized in a manner that does not present a risk of contamination to the food
• Written procedures, if required, are in place and capable of delivering the requirements of the sanitation program and/or biosecurity/bio-containment program
• Effectiveness of cleaning, sanitizing and/or biosecurity/bio-containment is assessed using accepted methods or procedures, as applicable, including:
  • procedures to ensure contact surfaces are free from contamination
  • swabbing/sampling is conducted in accordance with approved procedures

Verification activities

On-site: Observation and interview

Select at least one room/area ^Footnote 1 where the licence holder has completed sanitation activities but has not  started the operation or processing. Verify with the licence holder that sanitation is completed and production is ready to begin.

• Go on-site prior to reassembly of equipment and visually verify that:
  • the room/area is clean and in a sanitary condition, in order to prevent the risk of contamination of the commodity
  • operations do not begin unless the room/area is clean, and in a sanitary condition
• Select at least three pieces of equipment in the selected room(s)/area(s) and verify that:
  • equipment is clean and in a sanitary condition, in order to prevent the risk of contamination of the commodity

Document/records review

• Review the licence holder's current pre-operational inspection record, if applicable, verify that:
  • the records reflect the conditions observed on site
  • the licence holder is able to demonstrate that a non-compliant situation is effectively controlled to bring hazards back into control and prevent re-occurrence

Sampling verification: Sampling technique for verification testing and results for E. coli O157

Legal authorities

• SFCA
  • General: 52
• SFCR
  • PC – Biological, chemical and physical hazards: 47(1)(2), 49
  • PC – PCP: 86 (1)(2)(3), 88, 89 (1)(2)(3)(4)(5)(6)
• Food and Drugs Act (FDA)
  • Food: 4(1)

Outcome

Licence holder meets the regulatory requirements related to product testing for control of Escherichia coli O157:H7 NM (E. coli O157).

Rationale

E. coli O157 contamination of raw beef is a hazard likely to occur, and the use of any meat components derived from a contaminated carcass to make finished raw ground beef products (FRGBP) or beef product processed for raw consumption (BPPRC) is considered a risk to human health.

Performance criteria

• The control measures set out in the document Preventive Control Requirements for Biological Hazards in Meat Products for the biological hazard associated with E. coli O157 in meat products must be used by a licence holder who manufactures, processes, treats or packages precursor material or beef products processed for raw consumption. 
• The licence holder must have procedures to sample and test for E. coli O157 in each lot of raw meat products derived from beef or veal commonly used or intended to be used to make FRGBP or BPPRC, including trims, bench trims, coarse ground beef or veal, finely textured beef or veal, hearts, head meat, cheek meat, tongue roots, weasand meat and primal and sub-primal cuts.
• Licence holders who generate and process these precursor materials (PM) will be required to test these products for E. coli O157, unless the:
  • PM will not be used to make FRGBP or
  • PM or BPPRC is derived from a lot of source materials which was sampled and tested according to these procedures

Verification activities

On-site: Observation and interview

• Observe the licence holder sampling ^Footnote 2 (interview, if necessary), verify that:
  • all sampling procedures, as specified in the licence holder's written control program for E. coli O157 are adhered to as it pertains to:
    • lot isolation and identification
    • aseptic sampling techniques
    • selecting the sub-samples so that they are from the outside surface of the sampled meat product and representative of the entire lot
• Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures. Verify this response is consistent with the licence holder's program.

Document/records review

• Request the licence holder's E. coli O157 testing results since the last verification conducted by the CFIA and the written PCP related to product sampling for E. coli O157
• Review the licence holder's testing records and other documentation related to licence holder's sampling program for E. coli O157, verify that:
  • the licence holder has used an accredited laboratory for both screening and confirmatory testing of E. coli O157
  • the laboratory has used an approved screening and/or confirmation methodology
• Review all end product sampling and testing results records produced since the last verification conducted by the CFIA to identify and observe any corrective actions taken, where possible. Note any inconsistencies (e.g. gaps, anomalies)
• Confirm that the licence holder:
  • has notified CFIA in writing of all positive (and unconfirmed presumptive positive) results
  •  is able to demonstrate that a non-compliant situation is effectively controlled to bring  hazards back into control and prevent re-occurrence
• Refer to the Operational procedure: Control response plan for the detection of E. coli O157:H7/NM in raw beef productsin the event of positive test results

Sampling verification: Implementation of written protocol for listeria environmental sampling

Legal authorities

• SFCR
  • PC – Biological, chemical and physical hazards: 47(1)(2), 49, 50(1)
  • PC – PCP: 82, 86, 88, 89, 168

Outcome

Licence holder can demonstrate control of biological hazards related to ready-to-eat (RTE) food contact surfaces (FCS).

Rationale

Sampling and testing of FCS in RTE areas where food is prepared, as well as the equipment used to prepare the food, will determine the presence of L. monocytogenes or any Listeria species (spp.).

Performance criteria

In order to demonstrate compliance with SFCR 47(2), licence holders producing RTE food products that are exposed to the environment after processing could implement the IG Control measures for Listeria monocytogenes in ready-to-eat foods.

If the licence holder does not follow the interpretive guidance mentioned above and presents a different means of demonstrating control, the inspection team should consult with CFIA specialists to verify the validity.

Verification activities

Document/records review

• Review the licence holder's written PCP related to environmental sampling of RTE FCS
• Review the licence holder's environmental sampling results of RTE FCS received since the last verification conducted by the CFIA. Verify that:
  • the testing frequency for licence holder's sampling of FCS demonstrates control of the hazard (control can be demonstrated by following the sampling frequency as indicated in the IG "Control measures for Listeria monocytogenes in ready-to-eat foods" or by using other validated approach)
  • for samples that test positive for Listeria spp. (without confirmation of L. monocytogenes) and L. monocytogenes, verify that:
    • the licence holder has implemented appropriate controls to bring hazards back in control
    • licence holder's records substantiate that the controls have been implemented effectively
    • Refer to the Operational procedure: Control response plan for the detection of Listeria in the ready-to-eat processing environment

On-site: Observation and interview

• Observe and interview the designated employees conducting sampling activities
• Review the licence holder's testing records and other documentation related to licence holder's sampling program for RTE FCS
• Verify that:
  • the licence holder is following its written protocol for sample collection, shipping procedure and maintenance of the integrity of samples
  • the licence holder indicates, for each sample submitted, the method of analysis that is to be used by the laboratory
  • the samples are sent to an accredited laboratory that uses approved screening and/or confirmation methodology, as applicable

Note: the task will remain open until the receipt of laboratory results for the licence holder's sampling observed by the inspector. If the laboratory results are not "satisfactory", the task remains open until follow up sampling is completed by the licence holder. Refer to the Operational procedure: Control response plan for the detection of Listeria in the ready-to-eat processing environment for further action as required.

Sampling verification: Implementation of written protocol for listeria sampling of RTE products

Legal authorities

• SFCR
  • PC – Biological, chemical and physical hazards: 47(1)(2)
  • PC – PCP: 82, 86 (1), 88, 89, 156, 168

Outcome

Licence holder can demonstrate control of biological hazards related to Ready To Eat (RTE) food.

Rationale

Sampling and testing of RTE foods will determine the presence of L. monocytogenes.

Performance criteria

In order to demonstrate compliance with SFCR 47(2), licence holders producing RTE food products that are exposed to the environment after processing could implement the IG Control measures for Listeria monocytogenes in ready-to-eat foods.

If the licence holder does not follow the interpretive guidance mentioned above and presents a different means of demonstrating control, the inspection team should consult with CFIA specialists to verify the validity.

Verification activities

Document/records review

• Review the licence holder's written PCP related to RTE product sampling
• Review the licence holder's RTE product sampling results received since the last verification conducted by the CFIA.  Verify that:
  • the testing frequency for licence holder's sampling of RTE products demonstrates control of the hazard (control can be demonstrated by following the sampling frequency as indicated in the IG "Control measures for Listeria monocytogenes in ready-to-eat foods" or by using other validated approach)
  • for samples that are not "satisfactory", verify that:
    • the licence holder has implemented appropriate controls to bring hazards back in control
    • licence holder's records substantiate that the controls have been implemented effectively
    • Refer to the Operational procedure: Control response plan for the presence of Listeria monocytogenes in a ready-to-eat (RTE) food product

On-site: Observation and interview

• Observe and interview the designated employees conducting sampling activities. Verify that:
  • the frequency of sampling is being adhered to as per the licence holder's sampling written program
  • the licence holder is following the written program for sample collection, shipping procedure and maintenance of the integrity of samples
  • the licence holder indicates, for each sample submitted, the target pathogens and the method of analysis that is to be used by the laboratory
  • the samples are sent to an accredited laboratory

Note: the task will remain open until the receipt of laboratory results for the licence holder's sampling observed by the inspector. If the laboratory results are not "satisfactory", the task remains open until follow up sampling is completed by the licence holder. Refer to the Control response plan for the presence of Listeria monocytogenes in a ready-to-eat (RTE) food product for further action as required.

E. coli O157 trend analysis

Legal authorities

• SFCR
  • Preventive controls (PC) – Biological, chemical and physical hazards: 47(2)
  • PC – Preventive control plan (PCP): 86(1), 88, 89(1)(c)

Outcome

Licence holder meets the regulatory requirements related to monitoring of Escherichia coli O157:H7/NM (E. coli O157) trends and High Event Period (HEP).

Rationale

E. coli O157 contamination of raw beef is a hazard likely to occur, and the use of any meat components derived from a contaminated carcass to make finished raw ground beef products (FRGBP) or beef product processed for raw consumption (BPPRC) is considered a risk to human health.

Performance criteria

Control measures for the biological hazard associated with E. coli O157 in meat products must be used by a licence holder who manufactures, processes, treats or packages precursor material or beef products processed for raw consumption.  The licence holder's procedures to monitor for the presence of E. coli O157 must include a procedure to identify trends in the results of the sampling and testing for E. coli O157.

Verification activities

Document/records review

• Review licence holder's written PCP related to E. coli 0157
• Review the licence holder's monitoring for E. coli O157 to detect trends. Verify that:
  • the licence holder's procedures to monitor for the presence of E. coli O157 include a procedure to identify trends in the results of the sampling and testing for E. coli O157 and that:
    • the licence holder implements the monitoring procedure as written
    • in the case where the monitoring procedures identify a trend which may indicate a loss of control of the process (in other words, an increase in the number of samples that test positive for E. coli O157), a procedure for notifying an inspector of the trend identified and for performing a root cause analysis;
  • the licence holder maintains criteria/limits to define periods where analysis indicates a potential loss of control by:
    • establishing HEP criteria (as applicable)
    • performing root cause analysis and taking appropriate corrective actions when analysis indicates a potential loss of control
    • in the case where the monitoring procedures indicate a high event period, implementing a procedure for notifying an inspector of the finding and for conducting an investigation to determine if the lots of PM or BPPRC that tested negative and the lots of untested intact primal and sub-primal products from the same source material as the raw beef products that tested positive, are contaminated with E. coli O157