Operational procedure: Food preventive control and traceability inspection – System Verification

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1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on preventive control (PC) and traceability inspection procedures for food (system-based inspection). The requirements for PC and traceability are prescribed in Parts 4 and 5, respectively, of the Safe Food for Canadians Regulations (SFCR).

This document is intended to be used in conjunction with other guidance documents as referenced in Section 3.0 of this document.

2.0 Authorities

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline: Food regulatory response guidelines.

3.0 Reference documents

References to be used when conducting verification activities of sub-elements found in Appendix 1: PC and traceability elements and sub-elements:

4.0 Definitions

Unless specified below, definitions are located in either the:

5.0 Acronyms

Acronyms are spelled out the first time they are used and are consolidated in the Food business line acronyms list.

6.0 Operational procedure

This OP provides inspection procedures specific to food PC and traceability inspections. Where more specific guidance is required to what is provided in the SIP, it will be indicated in this section, and is to be followed despite of what is indicated in the SIP.

The ERA establishment risk profile (login required) (accessible only on the Government of Canada network) must be reviewed every fiscal year a PC inspection is planned at an establishment, as per the Program direction: Preventive control inspections frequencies for food (accessible only on the Government of Canada network – RDIMS 11010733). Prior to the planned PC inspection, the inspector should review the ERA risk profile of the licence holder to confirm accuracy of the inherent risk factors, mitigation factors and the compliance factors identified.

The OP: Permissions verification of Safe Food for Canadians licence can be used as a reference to confirm accuracy of licensable activities which are identified in the ERA profile.

Prior to the opening meeting, the inspector contacts the licence holder's representative (for example, profile manager) to share a copy of their ERA profile with them. The inspector should use an encrypted email, according to direction for Safely share Protected B information (accessible only on the Government of Canada network) or it can be printed and given to the representative in person. The National Risk Profile (login required) (accessible only on the Government of Canada network) and ERA establishment risk profile (food) – Interpretation for inspectors and industry (accessible only on the Government of Canada network – RDIMS 14714959) can also be shared with the representative.

At this time, the inspector:

  • makes a request for the licence holder's representative to review their ERA profile and confirm the accuracy and, if required, point out any data elements of the profile that might appear to be inaccurate.
  • is not expected to request and/or review additional information that substantiates the licence holder ERA profile.

The outcome of this review is for the licence holder to confirm that their profile is accurate or that they intend to correct inaccuracies.

As a result of this review and interview or during any inspection, if discrepancies are noted between the information in the profile and the actual operation, the inspector:

  • verbally notifies the licence holder of discrepancies identified related to their inherent and mitigation risk factors, and encourages them to update their Additional establishment information in My CFIA
  • assesses discrepancies related compliance factor information, and makes any necessary corrections in the source data base (e.g. Digital Service delivery platform (DSDP)) as needed
  • sends an email to the ERA generic email account to notify the ERA team of the discrepancy identified, including the DSDP Establishment-ID and registration number (if applicable)

The date of the review will be recorded in the "NOTES" section of the establishment profile in DSDP.

6.1 Prepare for inspection

Refer to SIP section 3.0, Step 1 – Prepare for the inspection. In addition to the general guidance provided in SIP, the following applies:

  • Contact the licence holder to gather information regarding product(s) / process(es)
  • Inspectors are encouraged to consult the online PCP interactive toolto determine if a licence holder needs a PCP in place. A PCP is a written plan outlining how to ensure that food is safe, fit for human consumption and conforms to consumer protection standards
  • Where a PCP is required, obtain an up-to-date copy of the licence holder's PCP related to the sub-elements selected as part of the scope. This can be requested when the announced inspection is scheduled
  • Determine which sub-elements are applicable to the licence holder based on their licensable activities.
  • For sub-elements within the scope of the inspection", review their respective outcomes, performance criteria and verification activities (see Appendix 1)
  • For PC inspections which are part of a work plan (trigger: Preventive Control Inspection Plan), the required entire sub-element(s) will be assessed within the prescribed timeframes (Program direction: Preventive control inspections frequencies for food (accessible only on the Government of Canada network – RDIMS 11010733))
  • For PC inspections which are not part of a work plan (trigger: Incident Response, for example following a complaint, a recall or any unscheduled findings while conducting any inspection activities), it may be acceptable to complete only the part of the sub-element verification activities linked to the reason for this inspection
  • Search the Issues Management System (IMS) to determine if there are IMS files which may require a PC inspection, add the applicable sub-elements to the scope, if required and then add the IMS ID number(s) in the Additional reference ID field.

6.1.1 Further preparation steps in response to a recall

Note: consult the OG: Food incident response process, as required

When a supervisor/inspector is aware or is notified that a food recall has occurred, use the following instructions to verify whether the regulated party has effectively addressed the root cause of the recall.

These inspection activities are in addition to the food safety investigation already conducted by the lead investigator and captured in the IMS. Communication with the lead investigator is important to ensure that appropriate information is captured both in the IMS and DSDP.

If the recall was a result of a PC inspection, there is no need to create another inspection case in DSDP. The non-compliances identified during the verification of the applicable sub-element(s) and the food safety investigation are captured in the original DSDP inspection case.

If the inspector becomes aware of a recall either through notification or an IMS search, they should consult with the lead investigator as soon as possible to confirm whether:

  • the root cause originated at the recalling licence holder
  • the recalling licence holder was/is in a position to address the root cause and prevent reoccurrence
  • the recalling licence holder can take or has taken corrective actions to eliminate the root cause of the deviation

If answers to any of the above are "yes", then open a DSDP inspection case with "Incident response" as the trigger. Select the applicable inspection task type(s), based on the findings of the food safety investigation and which resulted in the recall. Capture all objective evidence supporting the non-compliance which was identified during the food safety investigation in the DSDP inspection case. Ensure the IMS recall file number is captured in the additional reference ID field in DSDP.

If answers to all of the above are "no", there is no need to conduct a PC inspection in response to this recall.

Table 1: Recording inspection data in Digital Service Delivery Platform (DSDP)
Inspection Triggers
  • Preventive control inspection plan
  • Incident response
Task Type
  • Preventive control inspection
Inspection Task Level 1
  • System verification
Inspection Task Level 2

Sub-elements:

6.2 Conduct the inspection

  1. 6.2.1 Confirm the scope
  2. 6.2.2 Conduct the verification activities
  3. 6.2.3 Impact assessment
  4. 6.2.4 Document the non-compliance
  5. 6.2.5 Categorise the non-compliance

Refer to SIP, section 4.0, Step 2 – Conduct the inspection. In addition to the general guidance provided in SIP, the following applies.

An initial walk-through is not mandatory for all inspections. The inspector uses their judgement to determine if an initial walkthrough is necessary, taking into consideration the tasks being conducted and the last time a walkthrough took place. In general, if a walkthrough has not occurred in the past 12 months, it should take place as part of the inspection.

Each licence holder within a food hub must be inspected independently (whether they own the food hub or are an operator). A food hub operator may use their own PCP or utilize a shared PCP with the food hub owner. Regardless, the PCP will be verified independently, for each licence holder as they are still responsible for the implementation of the PCP specific to their operations and are required to provide the proper documentation to verify the controls, when requested by the CFIA.

6.2.1 Confirm the scope

If a potential non-compliance is observed part way through an inspection or delivery of any other activity, which is not part of the selected scope, the following applies:

  • Where the entire sub-element has already been completed within the current defined frequency of inspection, only the applicable section(s) of the sub-element related to the observed potential non-compliance will be completed in a separate inspection case. The trigger for that inspection case will be "Incident response"
  • Where the entire sub-element has not been completed within the current defined frequency of inspection and, if time permits, the entire sub-element will be completed and added to an inspection case with the trigger "Preventive Control inspection Plan". In the event where the potential non-compliance is observed during a follow-up inspection, the appropriate sub-element must be added to a new inspection case with the trigger "Preventive Control inspection Plan".
  • Where the entire sub-element has not been completed within the current defined frequency of inspection and where time does not permit (consult with supervisor, if required), only the applicable section(s) of the sub-element related to the observed potential non-compliance may be completed in a separate inspection case. The trigger for that inspection case will be "Incident response". The entire sub-element still needs to be completed within the defined frequency for that licence holder
  • Where the potential non-compliances identified are directly related to an outstanding inspection report, determine if the interim measures are effective and record any findings in the associated follow-up inspection case by adding an inspection task and creating a non-compliance record to capture the information. The inspector must take appropriate control action, if required. See section 6.4.1 for communication of these inspection findings

6.2.2 Conduct the verification activities

Determine whether the licence holder meets applicable regulatory requirements by reviewing the Acts and Regulations listed in each sub-element and using the outcomes, performance criteria and verification activities as indicated in Appendix 1.

Under SFCR, some licence holders are required to have a PCP in place. If during the preparation of the inspection, it is determined that a licence holder is required to have a PCP, but does not have one, this constitutes a non-compliance to SFCR section 86. Refer to SIP, section 4.6 – Determine compliance, for further guidance.

As per section 47 of the SFCR, operators (regardless of whether they require a PCP or not) must identify and analyse biological, chemical and physical hazards that present a risk of contamination of a food and prevent, eliminate or reduce to an acceptable level the identified hazards by using control measures shown by evidence to be effective.

Where a PCP is required, the design and implementation of the PCP should include the requirements of a PCP found in SFCR Part 4, Division 6.

Where a PCP is not required by regulations:

  • The inspector would place more emphasis on conducting observations, interviews and if required, adding another inspection task type, i.e. sample collection or commodity inspection, to ensure the licence holder is meeting the requirements pertaining to PC and traceability

If written programs and documents are maintained to show compliance to PC and for evidence of effectiveness of control measures, a review should be performed to assist in determining compliance.

For Element 7: Traceability, control and complaints, licence holders/regulated parties are required to have documents and procedures as per the SFCR Part 4, Division 5, and Part 5.

The following elements and sub-elements provide guidance to inspectors on specific verification activities.

Element 1: Process and product controls

Element 2: Sanitation, biosecurity, bio-containment, pest control and chemicals

Element 3: Hygiene, biosecurity and employee training

Element 4: Equipment design and maintenance

Element 5: Physical structure, surroundings and maintenance

Element 6: Receiving, transportation and storage

Element 7: Traceability, control and complaints

Perform sufficient verification activities to determine whether the outcome(s) for the sub-element(s) have been met. Select the appropriate verification activities as indicated in Appendix 1 for each sub-element that will allow for the assessment of compliance.

During the course of a PC inspection, other inspection task types (such as sample collection and commodity inspection) can be conducted to support the information gathered to determine compliance. Caution should be exercised when deciding to take samples or conduct a commodity inspection when verifying compliance of PC and traceability. In some cases, sample collection or commodity inspections may not be useful to support an inspection assessment and could lead to a discrepancy between findings of the inspection and the results of the additional inspection task types.

Before considering the use of additional inspection task types to support an inspection finding, consider the following:

  • The purpose for using another inspection task type:
    • Is it to verify that a non-compliance exists?
    • Is it to link the product or commodity to a potential non-compliance?
  • Whether action can be taken based on the results
  • Whether the results provide further information regarding compliance with regulatory requirements
  • Consult with the supervisor to determine the relevance of using other inspection task types as well as laboratory capability and capacity

There may be situations where inspectors are conducting a task where a non-compliance relating to the same task has been observed during a previous inspection and the date for completion of corrective action has not yet passed. In these situations, the inspector must:

  • conduct the entire task as planned, however would not capture the same findings from the outstanding non-compliance in the new case.
  • capture any findings related to the outstanding inspection report in the follow-up case by adding an inspection task and creating a non-compliance record to capture the information.
  • focus on the effectiveness of interim measures and whether or not the licence holder is in control of non-compliant situations when determining if there is a non-compliance that needs to be captured in the follow-up case.
  • take appropriate control action, if required. See section 6.4.1 for communication of these inspection findings.

6.2.3 Impact assessment

Complete an impact assessment for each sub-element where a non-compliance has been identified. The purpose of an impact assessment is to:

  • evaluate if the non-compliance has an impact on food safety based on how the food commodity is affected, for each sub-element where non-compliance is identified
  • collect data inputs for the ERA/IRAM model compliance factors regarding PC and traceability inspection results

An impact assessment has three levels of impact which are defined as:

  • Direct:compliance verification of the sub-element identifies non-compliance that has a direct impact on food safety whereby the food commodity is directly affected
  • Potential:compliance verification of the sub-element identifies non-compliance that has a potential impact on food safety whereby the food commodity is not directly affected
  • No impact:compliance verification of the sub-element identifies non-compliance whereby there is no impact on food safety

Use the "ERA impact assessment inspection reference document (accessible only on the Government of Canada network – RDIMS 12598976)" for guidance on determination of impact.

Conduct one impact assessment per sub-element assessed when non-compliance is identified. Determine the impact on food safety based on how the food commodity is affected (i.e. direct, potential or no impact); regardless of whether there is one or more non-compliance or if one regulation supports more than one sub-element. Consider the objective evidence related to the sub-element and how the food commodity is affected to determine the impact assessment result.

The impact assessment is conducted using the objective evidence / information supporting the non-compliance.

The "ERA/IRA Impact Assessment" is a mandatory field in DSDP;

DSDP data entry requirement is as follows:

  1. In the 'Is Non-Compliance Observed?' field of the inspection task screen:
    • If non-compliance has not been observed:
      • Select 'No'
      • Impact assessment is not conducted
    • If non-compliance has been observed
      • Select 'Yes'
      • Proceed to enter the impact assessment result
  2. Select the appropriate impact assessment result in the 'ERA/IRA Impact Assessment' field of the inspection task screen
  3. Continue data entry process

6.2.4 Document the non-compliance

For food, more than one regulatory reference can be captured in a non-compliance record. The regulatory reference(s) will be based on the findings within each sub-element being assessed at the time of inspection. For example:

  • If there is non-compliance with SFCR sections 50 to 81; SFCR section 49 should also be referenced to link the operator to the non-compliance. Sections 50 to 81 have details of the requirements for the establishments and section 49 states who (operator) must maintain and operate what (establishment) according to which requirements (SFCR sections 50 to 81)
  • If there is a non-compliance with SFCR section 89 (content of preventive control plan); SFCR section 86 must also be referenced in the same non-compliance record as that is the regulation which actually requires the licence holder to prepare, keep and maintain a PCP that meets the provisions of SFCR section 89 in addition to any other applicable regulatory reference that is found to be non-compliant within the sub-element being assessed
  • When a PCP is required, if commodity specific regulations are contravened, SFCR 86/89 and/or 88 should also be referenced in the same non-compliance record depending on whether the related section of the PCP was not developed, maintained or implemented, which resulted in the non-compliance to that commodity specific regulation

For food, when non-compliance(s) are determined when assessing a sub-element, all regulatory reference(s) and the objective evidence which support the non-compliance(s) should be documented in one non-compliance record.

For example, when assessing sub-elements and a PCP is required:

  • 3.1 Hygiene and biosecurity; non-compliance was found with SFCR sections 49, 77 and 88 for employees not washing their hands and
  • 5.2 Buildings; non-compliance was found with SFCR sections 49, 57 and 88 for the accumulation of dirt that presents a risk of contamination of the food due to the poor design of the facility.

There will be two non-compliance records created, one for non-compliances found under sub-element 3.1 and another one for non-compliances found under sub-element 5.2

Note: If required, an additional non-compliance record may be created for one sub-element when there are unrelated issues. For example, when assessing sub-element 5.2, if non-compliance is found under ventilation and humidity control systems and exterior and interior building structures, separate non-compliance records can be created.

Refer to SIP section A.5 Step 2 – Conduct the inspection for the completion of the inspection case, ensuring only the applicable related permissions verified as part the inspection have been selected.

6.2.5 Categorise the non-compliance

Since a non-compliance record may have more than one regulatory reference with supporting objective evidence, the categorization of non-compliance should be based on the sum of all the documented objective evidence within that non-compliance record.

6.3 Communicate the inspection results

Refer to SIP, section 5, Step 3 – Communicate the inspection results. Additionally, licence holders are responsible to implement interim corrective measures to mitigate any risks to human health, animal welfare or food misrepresentation immediately. These interim measures are to be documented in the closing meeting notes.

6.4 Conduct the follow-up inspection

Refer to SIP, section 6.0, Step 4 – Conduct the follow-up inspection. In addition to the general guidance provided in SIP, the following applies to this OP:

  • For every non-compliance record, create a follow – up inspection case to record follow-up details by selecting "Create follow up" from the non-compliance record within the parent case. The follow-up should be scheduled as soon as possible following the regulated party's Date for Completion of Corrective Action
  • When conducting the follow-up inspection, perform sufficient verification activities to determine if the non-compliance(s) have been addressed and the outcome(s) for the sub-element(s) have been met
  • Not all of the verification activities, as outlined in the sub-element, will need to be conducted, depending on the situation; a number of factors (such as the compliance history of the licence holder, the categories of the non-compliances, etc.) will influence the depth of the follow-up inspection. For example:
    • It may be acceptable to complete only the part of the sub-element verification activities linked to the reason for the inspection
    • For an establishment with a history of repeated non-compliances within a certain sub-element, the inspector may need to conduct more verification activities to ensure that the licence holder not only has addressed the non-compliance, but also still meets the outcome of that sub-element
  • For recall and complaint inspection cases, in addition to capturing the findings of the follow-up inspection in DSDP, the corrective actions implemented by the recalling firm should also be captured in the IMS by referring to the DSDP Inspection report. Where required, the inspector conducting the follow-up inspection is responsible for communicating the results to the individuals responsible for the IMS

6.4.1 Assess follow-up inspection results

Refer to SIP, section 6.4, Assess follow-up inspection results. In addition to the general guidance provided in SIP, the following applies to this OP:

If a state of compliance is not re-established, then the inspector:

  • takes control actions and/or recommends enforcement actions, as required, as per the Standard regulatory response process
  • documents the verification activities which support these findings, in the inspection task record within the follow-up case that was created from the non-compliance record in the parent case
  • creates a non-compliance record in the follow-up inspection case ensuring the objective evidence includes the date and findings from that date
    • this non-compliance record will not be categorized and therefore will not have corrective action date. Any subsequent timelines for the completion of corrective measures will be determined and communicated via the enforcement process.

The follow-up inspection case must remain open until compliance is re-established and all follow-up inspection activities and the appropriate control and/or enforcement actions are complete, or until the licence has been cancelled. When a case cannot be closed (deactivated) after a follow-up inspection, the inspection report must be issued by other means than through the portal (such as in person/email/fax). Ensure the end date on the inspection report is correct prior to issuing.

If subsequent follow-up inspections are required, create a new inspection task record within the follow-up inspection case to enter the findings, create another non-compliance record and issue an inspection report after each inspection.

Once compliance has been achieved and control and/or enforcement actions are complete, create a final non-compliance record without an associated sub-element or task, indicating in the objective evidence that "Licence holder found to be in compliance on [date of inspection]" then issue the report and close (deactivate) the follow-up inspection case.

For general inquiries related to this OP, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

7.0 Appendix 1: PC and traceability elements and sub-elements

The information presented for each element and sub-element is organised as follows:

  • Legal authorities: the connections to regulatory requirements and supporting information. Other regulatory references not listed may be used, if applicable
  • Outcome: a state where the PCs / traceability achieves regulatory compliance
  • Rationale: explains the potential impacts of the PCs / traceability on the outcome in each sub-element
  • Performance criteria: based on regulatory requirements; can be used by industry to help them achieve regulatory requirements and by inspectors to help them verify regulatory requirements
  • Verification activities: the process that an inspector should follow to verify the licence holder's compliance to regulatory requirements via review of the applicable PCs / traceability requirements and performance criteria in each sub-element. This section is further sub-divided into:
    • document/record review
    • on-site: observations and interview

Note: When selecting types and number of items (for example, room, equipment, product, process, label, conveyance, container, interviewee, record, etc.) to inspect, consider the information gathered during the opening meeting,  the initial walk-through and the following:

Inspectors may use discretion to expand verification of recommended items, as required

Inspectors will select all available items if it is not possible to select the minimum number of recommended items

Element 1: Process and product controls

Sub-element 1.1a: Incoming inputs

Note: This sub-element covers the sourcing/purchasing of incoming inputs, including imported inputs, while sub-element 6.1 covers the receiving step. For imported food inputs, refer to the sub-element 1.3 for additional legal authorities.

Legal authorities

SFCA

  • Prohibitions: 6(1)

SFCR

  • Trade: 10, 14(1)(a)(i), 15, 18
  • PC – Biological, chemical and physical hazards: 47(1)(2)
  • PC – Conditions respecting establishments: 52 (b), 62(1)(2)
  • PC – PCP: 86 (1)(2)(3), 87, 88, 89 (1)(2)(3)(4)(5)(6)
  • Commodity-specific requirements – Processed egg products: 102(1)(2)
  • Commodity-specific requirements – Fish: 107
  • Organic products – International trade and import: 357(1)(2)(3)(4)
  • Packaging: 186(a)(i, ii, iii, iv, v, vi, vii), 208

FDA

  • Food: 4(1), 6(1)(2), 7

Outcome

The sourcing of incoming inputs is controlled to achieve regulatory compliance.

Rationale

Inadequate input controls could result in non-compliance (for example, product contamination, inadequate processing, misrepresentation of the product, infestation, residues, etc.).

Performance criteria

When sourcing for incoming inputs (for example, ingredients, raw materials, packaging materials and chemicals), a licence holder should ensure that hazards are identified and control measures are in place to ensure that the incoming inputs are suitable for their intended use and do not provide a source of contamination. Additionally, measures are in place to ensure ingredient information is complete, truthful and not misleading and also accurately represents the commodity and its content, and meets regulatory requirements.

Verification activities

  • Select at least one product manufactured/prepared/processed by the licence holder and determine the ingredients used in that product or for licence holders who only package / label, select at least one incoming food product
  • Select at least one food product knowingly non-compliant when imported, in accordance with section 18 of SFCR (if applicable)
  • Select at least two incoming chemical products which come in contact with food (for example, processing aid) and/or food contact surfaces (FCS) (for example, sanitizer)
  • Select at least one direct food contact packaging material

Document/records review

  • Where a written PCP is required:
    • Review the licence holder's hazard analysis to ensure they have identified and analysed the biological, chemical and physical hazards that present a risk associated with the selected inputs/materials and use identified effective control measures
    • Review the control measures/measures for the selected inputs/materials to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Review documents related to the selected inputs and verify they can demonstrate that applicable PCs are effectively implemented. Examples of documents could include:
      • Specifications sheet
      • letters of no objection from Health Canada (issued until March 31, 2025), or other references from Health Canada on the safety, suitability or acceptability for use
      • certificates of analysis
      • a letter of guarantee that the product is safe, suitable for use, meets specifications and the regulated requirements of the commodity (for example, Supplier Food Safety Assurance Program)
      • competent authority certification, export eligibility list as per foreign country competent authority, third-party audit evaluations
    • Review documentation for verification procedures to substantiate that the PCP, in relation to the control measures for the selected inputs, has been implemented
    • Review documents demonstrating that the licence holder is effectively able to identify non-compliances, bring hazards back into control and prevent re-occurrence
    • Documents reflect the conditions on site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the licence holder meets requirements of SFCR section 47 and to determine if the applicable PCs are effectively implemented
    • Review documentation, if any, to demonstrate that the licence holder is effectively able to identify non-compliance, bring hazards back into control and prevent re-occurrence
    • Documents, if any, reflect the conditions observed on-site

On-Site: Observation and interview

  • Observe that control measures are being implemented when receiving incoming inputs/materials. Verify that ingredients, packaging materials and non-food chemicals being unloaded:
    • are from an approved supplier
    • are on the supplier list, if applicable
    • match the purchase order and specification
  • For food inputs, verify that:
    • they have labels applied or attached which, or are accompanied by documentation which, is legible and have the required information
    • when non-compliant foods have been imported (in accordance with SFCR section 18), they have been brought back into compliance within 3 months, including all label information
  • Where a PCP is required:
    • Interview at least one person responsible for sourcing inputs/materials to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for receiving inputs/materials to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of inputs/materials to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for inputs/materials to determine if they understand and are following procedures (if there are) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (if there are) as set out by the licence holder

Sub-element 1.1bc: Product formulation, specifications and processing

Legal authorities

General

  • SFCA
    • Prohibitions: 6(1)
  • SFCR
    • Trade: 10, 15
    • PC – Biological, chemical and physical hazards: 47(1)(2)
    • PC – PCP: 86 (1)(2)(3), 87, 88, 89 (1)(2)(3)(4)(5)(6)
  • FDA
    • Food: 4(1), 6(1)(2), 7
Product formulation and specifications (b)
  • SFCR
    • PC – Treatment and processes: 48(1)(2)(3)(4)
    • Commodity-specific requirements – Eggs: 100
  • FDR
    • Part B – Foods: Divisions 2 – 27
Processing (c)
  • SFCR
    • PC – Interpretation and application: 45
    • PC – Treatments and processes: 48(1)(2)(3)(4)
    • Commodity-specific requirements – Processed egg products: 103(1)(2)
    • Commodity-specific requirements – Meat products and food animals: 125(1)(2), 126, 156, 157, 158, 159, 166(1)(2)
    • Grades and grade names – beef carcasses: 328(1)(2)(3)
    • Conditions for grading certain foods – Grading of eggs: 332(1)(2), 333(1)(2)
    • Conditions for grading certain foods – Grading of livestock carcasses: 334, 335(a)(b)(c)(e), 337, 338(1)(2)(3)
    • Grading certificates: 339(1)
Outcome

The process is controlled to achieve regulatory compliance.

Rationale
  • Inaccurate product formulation and/or mixing could result in non-compliance (for example, product adulteration, inadequate processing, or pesticide residues, allergen contamination, etc.)
  • Inadequate process control measures could lead to biological, chemical and physical hazards that present a risk of contamination of a food and products that do not meet commodity specific requirements
Performance criteria

b) For product formulation and specifications, the licence holder:

  • has formulas for each product that is being prepared
  • has specifications for each product
  • uses inputs (i.e. additives and other substances) that are permitted in and on the commodity

c) For processing, the licence holder has:

  • a description of:
    • processing steps, associated control measures and critical limits (if applicable)
    • commodity movement (for example, process flow diagram)
    • commodity changeover procedures
  • critical limits supported by evidence to be effective (for example, validated using scientific data)
  • measures in place to meet the applicable consumer protection provisions related to food safety
Verification activities

b) Product formulation and specifications

Select as applicable to the operations at the establishment:

  • At least one product manufactured by the licence holder (also applicable to c) Processing)
  • At least one product to which a standard has been applied
  • At least one product to which a grade has been applied
Document/records review
  • Where a PCP is required:
    • Review the control measures for the product formulation and specifications to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • For product(s) selected, review documents related to product formulation and specifications to ensure:
      • regulatory requirements are met
      • that additives and chemicals are appropriate for use in and on the commodity and applied within approved limits
      • grades, specifications and standards of identity are defined and accurately reflect to the applicable regulatory requirements
    • Review documentation for verification procedures to substantiate that the PCP, in relation to the selected control measure, has been implemented
    • Verify documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documentation, if any, and interview, if applicable, to demonstrate that the PCs are effectively implemented
    • Review documentation, if any, to demonstrate that the licence holder is effectively able to identify and bring hazards back into control and prevent re-occurrence
    • Verify that documents, if any, reflect the conditions observed on-site
On-Site: Observation and interview
  • Observe grading activities, if applicable, to ensure they are being conducted as per regulatory requirements
  • Where processing aids/food additives/vitamins/minerals are used; observe to ensure their addition is being conducted as per regulatory requirements and as described in the licence holder's PCP, if applicable
  • Where a standard of identity is applicable to the selected product(s); observe the formulation of the product to ensure that it is carried out as described in the licence holder's PCP in order to meet the standard, if applicable
  • Where a PCP is required:
    • Interview at least one person responsible for developing product formulation and specifications to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of product formulation and specifications to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for product formulation and specifications to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

c) Processing

Select the process(es) associated with the product(s) manufactured at the establishment and selected in b) Product formulation and specifications

Document/records review

Request the licence holders hazard analysis for the process selected and go onsite to verify that all processing steps and cross contamination points have been included

  • Where a PCP is required:
    • Review the licence holder's hazard analysis for the process selected to ensure they have identified and analysed the biological, chemical and physical hazards and have identified control measures, including CCP's, for each identified hazard at all processing steps and cross contamination points
    • For all control measures applied at CCPs, verify that:
      • The critical limits stated in the licence holder's plan meet any applicable regulatory requirements and are supported by evidence of effectiveness
      • The documentation for monitoring, verification and corrective action procedures substantiates that the PCP, in relation to the selected CCP(s), has been implemented and provides evidence that the control measures are effective
      • Documents supporting the selected control measure, monitoring, verification and corrective action procedures have been identified
      • Documents reflect the conditions observed on-site

      Note: definition of a critical control point (CCP) is found in SFCR section 45. Inspectors must consider this definition and not only what the licence holder has identified the control measures as, in their PCP

    • Select at least two processing steps not associated with a CCP. At those steps, select one hazard and verify that the identified control measure:
      • Is designed to control that hazard
      • Has documents that support the selected control measure and verification procedure
  • Where a PCP is not required:
    • Review associated documentation, if any, and interview if necessary, to determine if the licence holder meets requirements of SFCR section 47 and to demonstrate that the PCs are effectively implemented
    • Review documentation, if any, to demonstrate that the licence holder is effectively able to identify non-compliance, bring hazards back into control and prevent re-occurrence
    • Documents, if any, reflect the conditions observed on-site
On-Site: Observation and interview
  • When a written PCP is required, for each CCP associated with the process(es) selected:
    • Observe procedures and at least one person responsible for monitoring the process. Verify the following:
      • Each related procedure is effective to control the hazard as intended
      • Monitoring is conducted as specified by the licence holder's procedure as written
      • Monitoring procedure is effective to control the hazard as intended
    • Interview at least one person responsible for monitoring the process to verify that they can describe/demonstrate:
      • How to complete the monitoring procedures and their response is consistent with the licence holder's procedures
      • When to initiate corrective action procedures and their response is consistent with the licence holder's procedures
    • Interview at least one person responsible for corrective action procedures to verify that they can describe/demonstrate:
      • How to complete deviation and corrective action procedures and their response is consistent with the licence holder's procedures
    • Interview at least one person responsible for verification procedures to verify that they can describe/demonstrate:
      • How to complete the verification procedures and their response is consistent with the licence holder's procedures
  • When a PCP is not required:
    • Observe and interview at least one employee responsible for implementing control measures that would meet the definition of a CCP, to ensure the control measures are effective at preventing or eliminating hazards, or reducing them to an acceptable level
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 1.2: Product controls

Note: This sub-element can be assessed by adding a sample collection or commodity inspection task type to the inspection case in DSDP in order to assess compliance, if required

Legal authorities
  • SFCA
    • Prohibitions: 6(1)(2)(3)
  • SFCR
    • Trade: 10
    • PC – Treatments and processes: 48(2)(3)(b)(vi)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
    • Traceability: 92(1)(2)(3)(4)(5)
    • Commodity-specific requirements – Eggs: 98(1)(b)
    • Commodity-specific requirements – Fresh fruits and vegetables: 110, 111
    • Commodity-specific requirements – Meat products and food animals: 125(1)(2), 151, 155(2)(3), 156(b), 157, 158, 159
    • Ministerial Exemptions: 175
    • Inspection legends: 180(1)(2)(3), 181, 182, 183, 185
    • Packaging – general: 186
    • Packaging – Standard container sizes: 188(1)
    • Packaging – Standard of fill for processed fruit or vegetable products: 195, 196, 197
    • Labelling: 199, 201, 202, 203(1), 204, 205(1), 206(1)(2)(3),207, 208, 209, 210(1)(2)(3), 214, 215, 216, 217, 218(1)(2), 219(1), 220, 221, 222, 223(1)(2)(3), 224(1)(2), 225, 226, 227(1)(2), 228, 229(1)(2)(3), 230, 231, 232, 233(1)(2)(3), 234(1)(2)(3), 235, 236, 237(1)(2), , 239, 240, 241(1)(2)(3), 243, 244, 245(1)(2)(3)
    • Labelling – Dairy products: 246, 247, 248, 249(1)(2)(3)(4), 250(1)(2), 251, 253
    • Labelling – Eggs: 254, 256(1)(2)
    • Labelling – Processed egg products: 258, 259, 260
    • Labelling – Fish: 262(1)(2), 266,
    • Labelling – Fresh fruits or vegetables: 268(1)(2), 269(1)(2)(3), 270(1)(2), 271
    • Labelling – Processed fruit or vegetable products: 272, 273, 274(1)(2)(3)
    • Labelling – Honey: 276, 277(1)(2), 278, 279(1)(2)
    • Labelling – Maple products: 281
    • Labelling – Edible meat products: 282(1)(2), 283(1)(2), 284(1)(2), 286, 287(1)(2)(3),289, 290, 291, 292, 293, 294 , 296(1), 297(1)(2)(3), 298
    • Labelling – Exceptions: 299
    • Grades and grade names: 306(1)(2)(3)(4), 307, 308(1)(2), 309, 311, 312, 313
    • Grades and grade names – Eggs: 314(1)(2)(3), 315, 316
    • Grades and grade names – Fish: 317, 318, 319
    • Grades and grade names – Fresh fruits or vegetables: 320(1)(2)(3), 321
    • Grades and grade names – Processed fruit or vegetable products: 322(1)(2)
    • Grades and grade names – Honey: 323, 324
    • Grades and grade names – Maple syrup: 325
    • Grades and grade names – Beef carcasses: 326, 327, 329
    • Grades and grade names – Poultry carcasses: 330(1)(2), 331
    • Conditions for grading of certain foods – Grading of eggs: 332(1)(2), 333(1)(2)
    • Organic products: 353(1)(2)(3), 354, 355(1)(2), 356(1)(2), 357(1)(2), 359(1)(2)(3), Schedule 2, 3, 6, 9
  • FDA
    • General – Advertising: 3
    • Food: 5, 6, 6.1
  • FDR
    • Part B – Foods: Divisions 1 – 28
    • Part D: Vitamins, minerals and amino acids
Outcome

End products meet regulatory requirements including appropriate packaging and product identification.

Rationale

Inadequate commodity controls could result in:

  • inaccurate and/or incomplete information on product identification
  • end product that is not compliant
Performance criteria
  • End productFootnote 1 identification: information is complete, truthful and not misleading. It also accurately represents the commodity and its content, and meets regulatory requirements
  • End productFootnote 1 specification: end product is evaluated for compliance with regulatory requirements where they exist and as per licence holder's specification
Verification activities

a) End product identification

  • Select at leastFootnote 2 two consumer-prepackaged product
  • Select at leastFootnote 2 one non-consumer prepackaged product
  • Select at least one inedible material
Document/records review
  • For the end products selected:
    • Where a PCP is required:
      • Review the measures for the end product identification to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • For all licence holders (with or without a PCP):
      • Review the label development process to ensure the measures identified in the PCs have been applied
      • Review measures to ensure appropriate labels are applied to the correct end products
      • Review associated records, if applicable
On-site: Observation and interview
  • Observe the application of labels to ensure that the licence holder is following their written program, if applicable
  • Where a PCP is required:
    • Interview at least one person responsible for end product identification to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for label development to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of end product identification to determine if they understand and are following procedures as set out by the licence holder
    • 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 written PCP
  • Where a PCP is not required:
    • Interview at least one person responsible for implementing control measures related to end product identification to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

b) End product specification

Document/records review
  • Where a PCP is required:
    • Review the measures for the end product specification to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
  • If applicable, review end product sampling and testing records
On-site: Observation and interview
  • Observe the licence holder's procedures to ensure end product is evaluated for compliance to regulatory requirements and/or licence holder's specifications
  • Where a PCP is required:
    • Interview at least one person responsible for end product evaluation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of end product evaluation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for implementing the control measures related to end product evaluation to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 1.3: Import controls

Note: This sub-element will apply to food commodities which are imported solely for sale and distribution in their imported state. A licence holder with import activities only is not required to identify an establishment when applying for a licence. Therefore, verification activities must be recorded in an inspection case at the party level.

When a licence holder have both import and domestic preparation activities for inter-provincial and/or export trade under the same licence, any imported food commodities that they use as ingredients in their process will be covered under sub-element 1.1a. Imported food commodities, for direct sale and distribution in their imported state, will be assessed under sub-element 1.3.

The following table can be used as a guide to determine when to use sub-elements 1.1a and/or 1.3, as well as where to capture the associated inspection findings in DSDP.

Licence activities associated to the party Details of the activities S.E 1.1a S.E 1.3 Inspection findings
Import activity only The food is imported and only sold in its imported condition X √ Party Level
Import and domestic preparation (process/ treat/ preserve/manufacture) activities All imported foods are processed/treated/preserved/manufactured, for inter-provincial and/or export trade and none are sold in their imported condition. √ X Establishment Level
Import and domestic preparation activities Where some imported foods sold in their imported condition, and some imported foods are processed/treated/preserved/manufactured, for inter-provincial and/or export trade.

√

applicable to foods further processed for interprovincial and/or export

√

applicable only to foods sold in their imported condition

 Establishment Level
Import activity only Where some imported foods are sold in their imported condition, and some imported foods are processed/treated/preserved/manufactured, for intra-provincial trade (without SFC licence activity). X √ Party Level
Legal authorities
  • SFCA
    • Prohibitions: , 6(1), 10(1)(3), 11
  • SFCR
    • Trade: 8(1)(2)(3), 9(1)(2), 11(1)(2), 13(1)(2)(3)(4), 14(1)(2), 19(1)(2), 21, 23(1)(2), 25
    • PC – Biological, physical and chemical hazards: 47(3)
    • PC – PCP: 86(1)(2)(3), 88, 89(1)(2)(4)
    • Commodity-specific requirements – Eggs: 96, 97, 98(1)
    • Commodity-specific requirements – Processed egg products: 104
    • Commodity-specific requirements – Fish: 105(1)(2), 106(1)(2)
    • Commodity-specific requirements – Fresh fruits or vegetables: 113(1)(2), 114(1)(2)(3), 115, 116, 117(1)(2), 118(1)(2), 119
    • Commodity-specific requirements – Trade of fresh fruits or vegetables: 122(1)(2)
    • Commodity-specific requirements – Meat products and food animals: 167
    • Organic Products: 357(1)(2)(3)
  • FDA
    • Importation and interprovincial movement of food: 6(1)(2)(3)
  • FDR
    • Importations: A.01.040 – A.01.044
Outcome

Imported food commodities meet regulatory requirements.

Rationale

Ineffective strategies to source and verify imported food commodities could result in food commodities not meeting Canadian requirements.

Performance criteria

Control measures and sourcing are done to ensure that food commodities meet Canadian requirements. Possible strategies include:

  • Selecting suppliers whose exports are certified by a foreign country competent authority
  • Selecting suppliers who are identified on a list of eligible exporters by a foreign country competent authority
  • Selecting suppliers who are subject to internationally recognized third-party evaluations
  • Evaluation to confirm suppliers can meet Canadian requirements
  • Selecting suppliers who conduct regular sampling and testing and provide certificates of analysis; and use accredited or recognized sampling and testing laboratories to do testing
Verification activities

Select at least two different imported food products

Document/records review
  • Review:
    • The licence holder's hazard analysis to ensure they have identified and analysed the biological, chemical and physical hazards associated with the selected imported foods and have identified control measures
    • The control measures identified as part of the hazard analysis for the selected imported foods to verify compliance to regulatory requirements, including PCP requirements set out in SFCR 89, if applicable, and performance criteria
    • The measures for the end product identification and specification for the selected imported products to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Records related to control measures, product identification/specification measures, and sourcing to verify compliance with Canadian requirements for the selected food to ensure they can demonstrate that PCs are implemented and effective, for example:
      • Certificates of analysis
      • 3rd Party results
      • Competent authority certification
      • Product specifications
    • If the licence holder knowingly imports non-compliant food (in accordance with SFCR section 18) and sends that food to another licence holder to bring it back into compliance, ensure the importer has received assurances that the process is completed within 3 months
  • Where a PCP is required:
    • Review the licence holder's PCP for imported foods to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
On-site: Observation and interview
  • If possible, observe the receipt and assessment of an imported shipment to verify that the licence holder's PCP (if applicable) is being followed and all applicable regulatory requirements have been met
  • Interview at least one employee responsible for sourcing and verifying compliance of imported products to determine if they understand and are following procedures as set out by the licence holder
  • Ensure products that do not meet the SFCA/SFCR that are imported for export contain a label that bears the expression "Imported for Export" or "importé pour l'exportation" and are intended to be manufactured, processed, treated, preserved, graded, packaged or labelled for the purpose of exporting it

Sub-element 1.4: Export Controls

Note: This sub-element will apply to licence holders with "preparing food for export" and/or "exporting food" as activities on their licence (including sole exporters). Sourcing of products to manufacture for export is covered under SE 1.1a.

The intent of this sub-element is to verify whether Canadian requirements related to export are met. The applicable tasks in Annex 2 of the Operational procedure: Food preventive control inspection – Implementation verification verify if licence holders meet foreign country requirements, as needed.

Legal authorities
  • SFCA
    • Prohibitions: 6, 10(1)(3), 12, 13(1)
    • Registrations and licences: 20(3)(4)
  • SFCR
    • Trade: 15(1)(2), 16(1)(2)(3), 19(1), 17(1)(2)(5), 22(1)(2), 23(1)(2), 24, 25
    • PC – Conditions respecting establishments: 61(b)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(5)
Outcome

Exported commodities meet regulatory requirements.

Rationale

Commodities that do not meet Canadian requirements could reach the Canadian marketplace if controls are inadequate.

Performance criteria
  • Written procedures and records can demonstrate that the commodity to be exported meets regulatory requirements
  • Controls are in place for commodities that do not meet Canadian regulatory requirements, for example segregation

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for export controls to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
    • For meat, verify that the licence holder has procedures to ensure that only eligible products are received and exported, or used for further processing in products intended for export
  • Where a PCP is not required:
    • Review associated documentation, if any, and interview, if applicable, to demonstrate that the PCs are effectively implemented
    • Review documentation, if any, to demonstrate that the licence holder is effectively able to identify and bring hazards back into control and prevent re-occurrence
    • Verify that documents, if any, reflect the conditions observed on-site
    • For licence holders with only "exporting food" activity on their licence, review associated documentation, if any, and interview, if applicable, for control measures that ensure products are sourced from licence holders that meet regulatory requirements
  • Review certificate control procedures, if documented, and interview to verify that certificate controls are in place and are effectively implemented
    • Review at least two export certificates previously issued without an inspection of the load (for example online certificates of free sale) against the supporting export documents (for example, certificate request, shipping records, production records, label records, bill of lading) and traceability records to verify that the shipment that was exported reflects the information on the certificate
On-site: Observation and interview
  • Go on-site and verify that:
    • Licence holders with only the "exporting food" activity on their licence are following their procedures to source products from licence holders that meet regulatory requirements
    • Commodities for export are segregated appropriately, as per SFCR sections 16 and paragraph 61(b), if necessary
  • Where a PCP is required:
    • Interview at least one person responsible for implementation of export controls to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of implementation of export controls to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required
    • Interview at least one person responsible for implementation of export controls to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Element 2: Sanitation, biosecurity, bio-containment, pest control and chemicals

Sub-element 2.1: Sanitation, biosecurity and bio-containment

Legal authorities
  • SFCR
    • Trade: 8
    • PC – Maintenance and operation of establishment: 49, 50(1)(2), 52
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
    • Commodity-specific requirements – Eggs: 101
  • FDA
    • Prohibited sales of food: 4
    • Unsanitary manufacture, etc., of food: 7
Outcome

Effective sanitation of equipment, utensils, containers and premise is in place to prevent contamination of the commodity; and ensure effective biosecurity and bio-containment in order to prevent the introduction, establishment or 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 appropriate methods

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for cleaning, sanitation, biosecurity and biocontainment to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Confirm that the PCP meets the outcome of this sub-element with regards to:
      • the sanitation schedule/frequency for all equipment and rooms
      • cleaning and sanitizing procedures (the methods and procedures for equipment and room cleaning, chemical use, CIP/COP cleaning procedures, equipment disassembly and assembly, cross-contamination prevention, where necessary)
      • housekeeping and sanitation procedures required during operations
      • pre-operational inspection procedures
      • environmental sampling procedures, if applicable
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site

On-site: Observation and interview

Select at least two rooms/areas and three pieces of equipmentFootnote 3

  • If necessary Footnote 4, prior to start of operation and reassembly of equipment, but after the verification of sanitation controls by the licence holder, select at least 3 pieces of equipment Footnote 3 and visually verify that cleaning, sanitizing and/or biosecurity and bio-containment procedures have effectively removed dirt, debris or any other contamination risk. Look for evidence of dirt, debris and residual material on direct food contact surfaces, including containers and utensils
    • For CIP/COP systems, select components of the processing system for dismantling (by the processor) and physically examine to ensure they are visibly clean. Focus on elements of the system that are difficult to clean, for example, plates in an HTST or elbows in a piping system or valves.
  • During sanitation:
    • Observe that cleaning and sanitation and/or biosecurity and bio-containment activities are being conducted according to the manufacturer's instructions (or equivalent) and documented procedures and schedule (if required)
    • Verify that cleaning and sanitizing and/or biosecurity and bio-containment processes:
      • effectively control cross-contamination (for example, floor sprays are not contaminating food contact surfaces, high pressure air and water hoses are not used in areas where they could contribute to food contamination), and that there are no other sources of cross-contamination
      • are performed using appropriate and adequate temperature, chemical concentrations and pressures
      • are performed according to procedures for disassembly, maintenance and sanitation
      • for equipment cleaned and sanitized using CIP/COP systems, are done according to procedures
  • Where a PCP is required:
    • Interview at least one person responsible for cleaning and sanitation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for biosecurity and bio-containment to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of cleaning and sanitation and/or biosecurity and bio-containment to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for cleaning and sanitation and/or biosecurity and bio-containment to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 2.2: Pest control

Legal authorities
  • SFCR
    • Trade: 8
    • PC – Maintenance and operation of establishment: 49, 51(1)(2)(3)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
  • FDA
    • Prohibited sales of food: 4(1)(2)
Outcome

An effective control program is in place for pests to prevent entry, to detect and eliminate pests and to prevent contamination of the commodity.

Rationale

Pests (for example, insects, rodents, birds) can contaminate commodities, inputs, packaging materials and contact surfaces.

Performance criteria
  • The establishment is protected against the entry of any animal that presents a risk of contamination to the food
  • No animal is allowed into the facility or conveyance unless the animal is:
    • a food that is intended to be manufactured, prepared, stored, packaged or labelled in the facility or conveyance
    • a food animal that is intended to be slaughtered in the facility or conveyance regardless of whether the meat product that may be derived from it is intended to be exported or sent or conveyed from one province to another
    • an animal that is intended to be used in the manufacturing or preparing of a food in the facility or conveyance
  • There is a documented program for prevention, control and removal of pests, if required
  • There is a schedule for monitoring for evidence of pest activity, if required

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for pest control to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
  • If there is evidence of pests, review documents to:
    • confirm what actions have been taken to correct the issue, including identification of the pest; source of infestation; and measures to prevent reoccurrence
    • identify if there are any trends
On-site: Observation and interview

Select at least one room/area where food is handled or stored Go on-site and verify:

  • There is no evidence of pests
    • Pest control devices (if used) are installed as per the map, functioning as intended and that there is no evidence of pests
    • Any measures that are taken for the purposes of complying with the above must not present a risk of contamination of a food
  • Where a PCP is required:
    • Interview at least one person responsible for pest control to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of pest control to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for pest control to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 2.3: Chemicals

Legal authorities
  • SFCR
    • Trade: 8
    • PC – Maintenance and operation of establishment: 49, 51(3), 52, 74(2)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
  • FDA
    • Prohibited sales of food: 4(1)(2)
Outcome

Chemicals are stored and used in a manner and under conditions that do not impact negatively on human or animal health or the environment.

Rationale
  • The use of improper chemical concentration, application or rinsing procedures can lead to both chemical and biological contamination
  • Improperly stored chemicals can lead to contamination of food commodities
Performance criteria
  • All sanitizers, agronomic inputs and non-food chemical agents that are in the establishment are properly and clearly identified
  • All sanitizers, agronomic inputs and non-food chemical agents are suitable for their intended use and do not present a risk of contamination of the food
  • All sanitizers, agronomic inputs and non-food chemical agents are handled and used
    • in a manner that does not present a risk of contamination to the food; and
    • according to any manufacturer's instructions
  • Specification sheets for chemicals used in biosecurity/ bio-containment, sanitation, treatment, and pest control are maintained
  • If required, documentation is maintained that supports appropriate use of chemicals and prevents contamination of commodities, equipment, tools or contact surfaces

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for storing, monitoring and dispensing of chemicals to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
  • Confirm the following:
    • There are specification sheets available for each chemical
    • Chemicals used on commodities or contact surfaces meet the requirements of the applicable legislation
On-site: Observation and interview
  • Verify that chemicals are:
    • stored in a manner which does not pose a risk of food contamination
    • clearly identified
    • dispensed with utensils or equipment used only for chemicals
  • Confirm that label instructions for any chemicals used are being followed (for example, concentration, application time etc.)
  • Confirm that chemicals are applied in a manner that prevents cross-contamination
  • Where a PCP is required:
    • Interview at least one person responsible for storing, monitoring and dispensing of chemicals to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of chemicals' storage, monitoring and dispensing to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for storing, monitoring and dispensing of chemicals to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Element 3: Hygiene, biosecurity and employee training

Sub-element 3.1: Hygiene and biosecurity

Legal authorities
  • SFCR
    • Trade: 8
    • PC – Maintenance and operation of establishment: 49, 59(1)(2), 60, 61, 66(2), 67(1)(2), 76, 77, 78, 79, 80, 81
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
  • FDA
    • Prohibited sales of food: 4(1)
Outcome

Employees and visitors are not a source of contamination.

Rationale

Employees and visitors who do not follow hygienic and biosecurity practices can cause contamination or spread diseases.

Performance criteria
  • To prevent the contamination of a food, any person who enters or is in an area of an establishment where food is manufactured, prepared, stored, packaged or labelled, or where a food animal is slaughtered:
    • wears clothing, footwear and protective coverings such as gloves, hairnets, beard nets and smocks, that are in good condition, clean and in a sanitary condition, appropriate for the food and appropriate for the activity being conducted
    • refrains from spitting, chewing gum, using tobacco products, eating, unnecessarily contacting the food and acting in any other way that presents a risk of contamination of the food and from wearing or using any object or substance that may present a risk of contamination of the food
    • maintains personal cleanliness:
      • by cleaning and if necessary, by sanitizing their hand etc.:
        • immediately upon entering the area
        • immediately after using the lavatory
        • immediately before beginning to conduct an activity, and
        • at a frequency appropriate for the food and the activity being conducted
      • by sanitizing protective coverings and footwear
    • works from high to low risk areas (for example, from cleanest to dirtiest area)
  • Persons working in an area where food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered, and who has a disease or illness, symptoms of a disease or illness, or has an open or infected lesion, reports them
  • The licence holder prevents any person from entering or being in an area of the establishment where food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered when they:
    • are suffering from a communicable disease
    • are known to be a carrier of a communicable disease
    • have an open or infected lesion

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for hygiene an biosecurity to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview

Select at least one room/area where food is being manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered

  • Confirm that effective biosecurity and hygienic practices are implemented. For example:
    • Employees/visitors are washing and/or sanitizing hands when required (for example, when returning to the processing area)
    • Employees/visitors are using adequate protective coverings and footwear, as required
    • Protective coverings and footwear are properly maintained and stored in a sanitary manner prior to use
    • Employees/visitors are adhering to proper hygienic practices (for example, no food, gum, tobacco and follows personnel health status requirements), and
    • Access to the room(s)/area(s) is(are) controlled to prevent the risk of contamination
    • Established traffic patterns and related procedures (for example, coded smocks) for employees and visitors are adhered to
    • Personal objects are prevented from contaminating the commodity (for example, falling into the commodity)
  • Where a PCP is required:
    • Interview at least one person responsible for hygiene and biosecurity to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of hygiene and biosecurity to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for hygiene and biosecurity to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 3.2: Employee training

Legal authorities

  • SFCR
    • PC – Maintenance and operation of establishment: 49, 75
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
    • Commodity-specific requirements – Meat products and food animals - 135(1)(a)
Outcome

Employees have adequate technical knowledge and understanding of operations or processes for which they are responsible and of how they may impact human health, the environment and other regulatory requirements.

Rationale
  • Employee training and hygiene contribute to the production of safe food, and effective biosecurity practices
  • Proper training promotes an understanding of the risk of biological, chemical and physical contamination and the employee's role in maintaining hygiene and biosecurity
Performance criteria
  • Any person involved in the manufacturing, preparing, storing, packaging or labelling of a food or in the slaughtering of a food animal has the competencies and qualifications necessary to carry out their duties
  • If required, a written description of training requirements and training records for employees responsible for activities under the PCP are in place and maintained
  • Effectiveness of training is verified

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's written PCP for employee training to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify that the licence holder's training program includes:
      • all elements applicable to the operation
      • any additional external technical training that is necessary to ensure current knowledge of equipment and process technology (for example, licences/certification required to operate equipment – HTST operator/ licence holder's certification, retort operator/licence holder certification, Provincial certification)
  • For all licence holders (with or without a PCP):
    • Select at least one employee (for example, those in processing, storing, packaging or labelling of a food). Verify that the licence holder can demonstrate that the employee(s) have the competencies and qualifications as they relate to the licence holder's Hygiene and biosecurity program
    • Select at least one employee responsible for the delivery of a CCP (if applicable) and verify that the licence holder can demonstrate that the employee(s) have the appropriate competencies and qualifications
    • Select at least one employee responsible for the delivery of other control measures (for example, those in relation to SFCR sections 50 to 81). Verify that the licence holder can demonstrate that the employee have the appropriate competencies and qualification
    • Meat products only – Select at least one employee for handling animals/usage of employee for handling or stunning of animals during receiving, moving and stunning. Verify that the licence holder can demonstrate that the employee have the appropriate competencies and qualification
On-site: Observation and interview
  • Where a PCP is required:
    • Interview at least one employee responsible for verification of a control measure to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • For all licence holders (with or without a PCP):
    • Observe employees selected as per above to confirm they have the appropriate technical knowledge to carry out their respective duties. For example, they may need an understanding of:
      • potential sources of contamination, infestation or infection
      • proper handling of food, and animal commodities and inputs (for example, temperature control, segregation of animal or food commodities)
      • personal hygiene
      • equipment maintenance and calibration
      • general sanitation and cleanliness
    • Interview at least one employee to confirm they have the appropriate technical knowledge to carry out their respective duties and that they understand and are following the procedures and training material as set out by the licence holder.

Element 4: Equipment design and maintenance

Sub-element 4.1: Equipment design and maintenance

Legal authorities
  • SFCR
    • PC – Treatments and processes: 48(3)(b)(ii)(iv)
    • PC – Maintenance and operation of establishment: 49, 53, 54 (c), 55, 65 (1)(2), 74(2)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
    • Commodity-specific requirements – Meat products and food animals: 135 (2)
    • Conditions for grading of certain foods – Grading of livestock carcasses: 335(c)(f)(g), 336(1)(2)
  • FDA
    • Prohibited sales of food: 4(1)
    • Unsanitary manufacture, etc., of food: 7
Outcome
  • Equipment, utensils and containers are:
    • designed, maintained and used in a manner that does not result in contamination of commodities or packaging materials
    • effective for the purpose for which they are intended
  • Controlling or measuring devices used to meet regulatory requirements are calibrated for accuracy
Rationale
  • Poor design and installation can impair cleaning and maintenance of equipment
  • Improper maintenance and use of equipment may lead to contamination
  • Improper calibration of controlling/measuring devices may lead to inadequate processing, incorrect formulation or misrepresentation of the food
Performance criteria
  • The conveyances or equipment that are used to manufacture, prepare, store, package or label food or slaughter food animals are:
    • appropriate to the food or food animal and activity conducted; and function as intended
    • designed, constructed, and maintained to prevent contamination of the food
    • constructed of and maintained using materials that are suitable for the manufacturer's intended use
    • equipped with instruments to control, indicate and record any parameters that are necessary to prevent contamination of the food
    • accessible for cleaning, sanitizing, maintenance and inspection
    • capable to be disassembled for cleaning and sanitizing, if necessary
  • If the material used in the construction or maintenance of conveyances or equipment presents a risk of contamination to the food, the material is:
    • corrosion-resistant
    • durable
    • capable of withstanding repeated cleaning and, if necessary to prevent contamination of the food, sanitizing, unless the equipment is intended for single-use; and
    • free of noxious constituents
  • The surfaces of the conveyances or equipment that may come into contact with food and which may present a risk of contamination of the food are:
    • smooth
    • free from pitting, cracks and flakes; and
    • non-absorbent
  • The conveyances or equipment used to manufacture, prepare, store, package or label food or slaughter food animals are used, maintained and, if necessary, calibrated:
    • according to the manufacturer's instructions; and
    • in a manner that does not present a risk of contamination of the food
  • The conveyances or equipment that are used for handling any contaminated materials, any waste, or any other inedible things, if they come into contact with those materials, waste and things meet the applicable requirements found in SFCR section 53 pertaining to conveyances or equipment that are used for manufacturing, preparing, storing, packaging or labelling food or slaughtering of food animals

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for equipment design and maintenance to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
      • If available, the list of all equipment, utensils, containers, controlling or measuring devices and instruments requiring maintenance and/or calibration is kept current
      • The licence holder has documents to substantiate that they are following their procedure and frequencies for equipment maintenance and calibration
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Select at least two pieces of equipment and two utensils used in the manufacturing, preparing, storing, packaging or labelling of a food.
    • Verify that the selected pieces of equipment and utensils are:
      • appropriate for the food and for the activity being conducted
      • designed and constructed to prevent risk of food contamination
      • constructed of and maintained using materials that are suitable for their intended use and, if those materials present a risk of contamination of the food, that are:
        • corrosion-resistant
        • durable
        • capable of withstanding repeated cleaning and, if necessary to prevent the risk of contamination of the food, repeated sanitizing, unless the equipment is intended for a single use
        • free of any noxious constituent
      • equipped with instruments to control, indicate and record any parameters (for example, smokehouse, retort, pasteurisers etc.) that are necessary to prevent the risk of food contamination
      • function as intended
      • accessible and easily disassembled, if necessary (for cleaning, sanitizing, maintenance or inspection purposes)
      • smooth, free from pitting, cracks and flakes and non-absorbent when they are in contact with food
  • Select at least two pieces of equipment that require regular maintenance and impact food safety.
    • Observe and interview (if necessary) to verify that the selected pieces of equipment are being utilized and maintained in accordance with the manufacturer's instructions and in a manner that does not present a risk of contamination of the food
  • Select at least one CIP/COP system, only if applicable.
    • Observe and interview (if necessary) to verify the system has been designed, installed and maintained in a sanitary and effective manner in order to prevent contamination of the equipment being cleaned and sanitized using the system, or the food being processed using the equipment
  • Select at least two pieces of monitoring equipment or controlling devices that may impact food safety.
    • Observe and interview (if necessary) to verify the following:
      • The calibration procedures and frequencies specified in the licence holder's written program are adhered to, where applicable
      • The licence holder can demonstrate the calibration procedures are based on the equipment manufacture's manual or equivalent or the licence holder can demonstrate the reasons for the variation from the published procedures
  • Where a PCP is required:
    • Interview at least one person responsible for equipment design and maintenance to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of equipment design and maintenance to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for equipment design and maintenance to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Element 5: Physical structure, surroundings and maintenance

Sub-element 5.1: Premises and surroundings

Legal authorities
  • SFCR
    • Trade – Interprovincial trade, import and export: 8
    • PC – Maintenance and operation of establishment: 49, 51(1)(2)(3), 56(1)(2)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
  • FDA
    • Prohibited sales of food: 4(1)
    • Unsanitary manufacture, etc., of food: 7
Outcome

Conditions of the premises and surroundings do not contribute to contamination, infection or infestation of regulated commodities.

Rationale

Outside sources of contamination can compromise the safety, health and/or quality of the commodity.

Performance criteria
  • The surroundings/roadways are maintained to minimize refuse, dirt, dust, fumes and other environmental contaminants and pest harbourage areas
  • If any land presents a risk of contamination of the food, measures are taken to eliminate the risk
  • If any establishment is located near any place or thing that presents a risk of contamination of the food, measures are taken to eliminate the risk
  • An establishment is protected against the entry of any animal that presents a risk of contamination to the food
  • In the case of any land that forms part of an establishment, measures are taken to prevent the entry of any animal that presents a risk of contamination to the food

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for premises and surroundings to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Observe outside property to confirm that sources of external contamination are controlled (for example, build-up of garbage, pest harbourage areas, dirt, dust, fumes and other environmental contaminants)
  • Where a PCP is required:
    • Interview at least one person responsible for premises and surroundings to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of premises and surroundings to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for premises and surroundings to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 5.2: Buildings

Note: Buildings may include establishments, facilities, conveyances, vessels where regulated activities are conducted

Legal authorities

General

  • SFCR
    • Trade: 8
    • PC – Maintenance and operation of establishment: 49
    • PC –PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
  • FDA
    • Prohibited sales of food: 4(1)
    • Unsanitary manufacture, etc., of food: 7

a) Exterior and interior building structures

  • SFCR
    • PC – Maintenance and operation of establishment: 50(1), 51(1)(2)(3), 55, 57, 58(1)(2)(3)(4), 68, 69
    • Commodity-specific requirements – Meat products and food animals: 135(2)
    • Conditions for grading of certain foods – Grading of livestock carcasses: 335(f), 336(1)

b) Hygienic flow and separation

  • SFCR
    • PC – Maintenance and operation of establishment: 57(a), 59(1)(2), 60, 61, 62(1)(2), 66 (1)(2)
    • Commodity-specific requirements – Meat products and food animals: 155(3)

c) Lighting

  • SFCR
    • PC – Maintenance and operation of establishment: 63(1)(2)
    • Condition for grading of certain foods – Grading of livestock carcasses: 335(d)

d) Ventilation and humidity control systems

  • SFCR
    • PC – Maintenance and operation of establishment: 64(a)(d), 65(1)(2)
    • Commodity-specific requirements – Meat products and food animals: 134

e) Employee facilities

  • SFCR
    • PC – Maintenance and operation of establishment: 60, 66(1)(2), 67(1)(2)(3), 70(1)
Outcome

Buildings are designed, constructed and maintained to support the activity being conducted; support cleaning and sanitation; and prevent the entry of pests and contaminants.

Rationale
  • Proper facility design, construction and maintenance prevent or mitigate the entry of pests and contaminants
  • Cleanable surfaces will support effective cleaning, and minimize the build-up of unsanitary conditions (for example, presence of bacteria, mould)
  • Separation or control between incompatible operations helps to prevent cross-contamination
Performance criteria

a) Exterior and interior building structures

  • The interior and exterior of any facility or conveyance where food is manufactured, prepared, stored, packaged or labelled, or where food animals are slaughtered is designed, constructed and maintained to meet regulatory requirements
  • Where required, the establishment is designed, constructed and maintained to meet regulatory requirements related to CFIA's inspection stations and office facilities

b) Hygienic flow and separation

  • Where there is potential for cross-contamination, incompatible operations are controlled by physical separation or other effective means

c) Lighting

  • There is sufficient light to allow the intended activity to be conducted effectively
  • Lighting equipment (bulbs and fixtures) that is located where breakage could contaminate commodities is protected, as needed
  • Any light fixtures in the establishment can withstand repeated cleaning and, if necessary to prevent contamination of a food, repeated sanitizing

d) Ventilation and humidity control systems

  • The facility or conveyance where food is manufactured, prepared, stored, packaged or labelled, or where food animals are slaughtered is equipped with a ventilation system that provides sufficient air exchange to control moisture and minimize condensation
  • If the facility or conveyance where food is manufactured, prepared, stored, packaged or labelled is equipped with a heating, cooling or humidity-control system, the system functions as intended

e) Employee facilities

  • When present, the location, design, construction and installation of employee facilities (for example, washrooms, lunch rooms and change rooms) do not contribute to or cause contamination of commodities or production areas
  • An adequate means of hygienically washing and drying hands and personal protective equipment (for example, boots) is provided (including wash basins and a supply of safe water)
  • The location of hand-washing and sanitizing stations does not contribute to or cause contamination of commodities
  • The hand cleaning and sanitizing stations permit effective cleaning of hands
Verification activities

a) Exterior and interior building structures

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for exterior and interior building structures to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • If applicable. ensure CFIA office facilities and CFIA inspection stations are designed, constructed and maintained to meet regulatory requirements
  • Go outside. Observe building exterior and verify the following:
    • The exterior of the building is maintained to prevent entry of pests and contaminants
    • Air intakes and exhausts, as appropriate, are filtered or positioned to prevent the introduction of contaminants
  • Select at least one room/area with the highest impact on food safety and one other room/area and verify the following:
    • Floors, walls, ceilings, windows and doors are suitable for their use and made of appropriate materials (for example, non-porous materials in food preparation areas) that will withstand cleaning and are sealed to prevent cross-contamination
    • The size and layout is adequate to accommodate the activity being conducted and the equipment used in the activity
    • Floors, ceilings, walls, windows, doors and overhead structures are designed, constructed and maintained in such a way that they do not become a source of contamination (for example, there is no peeling paint, cracks and crevices, stains, water leakage, mould growth and other signs of poor condition which could affect food safety)
    • Floors are draining properly by looking for signs of pooling water
    • Openings to exterior areas are protected or effective control measures are in place
    • Windows and doors are tight-fitting (for example, there are no signs of light around the edges of windows and doors which may indicate a potential entry for pests)
    • There are no signs of water or fluid leakage (for example, hydraulic lines, waste water etc.)
  • Where a PCP is required:
    • Interview at least one person responsible for exterior and interior building structures to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of exterior and interior building structures to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for exterior and interior building structures to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

b) Hygienic flow and separation

Documentation/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for hygienic flow and separation to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Observe building and verify that the design ensures that incompatible operations are controlled by physical separation or other effective means. Look for controls such as:
    • physical separation, for example, walls, doors, windows
    • sequencing of production
    • separate processing lines
    • washrooms, lunchrooms and change rooms do not present a risk of contamination to a food
    • enclosed areas are provided for the handling of inedible meat products
    • the storage of waste products does not present a risk of contamination
  • Where a PCP is required:
    • Interview at least one person responsible for hygienic flow and separation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of hygienic flow and separation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for hygienic flow and separation to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

c) Lighting

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for lighting to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Select at least one room/area and verify the following:
    • There is sufficient light to allow the intended activity to be conducted effectively, for example lighting is adequate to:
      • accurately read instruments
      • conduct monitoring and/or verification activities
      • lighting does not alter the natural colour of a commodity when colour is used to make a safety decision
    • Lighting equipment (bulbs and fixtures) are cleanable and if located where breakage could contaminate commodities, is protected
  • Where a PCP is required:
    • Interview at least one person responsible for lighting to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of lighting to determine if they understand and are following procedures as set out by the licence holder
    • interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for lighting to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

d) Ventilation and humidity control systems

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for ventilation to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • non-compliant situations have been effectively addressed
      • documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Select at least one room / area with the highest impact on food safety and one other room / area. Verify the following:
    • There is appropriate air pressure (for example, positive or negative), where necessary, to prevent the risk of contamination (for example, air flow into clean areas is not contaminated)
    • Condensation does not negatively impact the safety of the commodity
    • Ventilation provides sufficient air exchange to control moisture and minimize condensation
    • Ventilation systems are adequately maintained (for example, filters are installed)
  • Where a PCP is required:
    • Interview at least one person responsible for ventilation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of ventilation to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for ventilation to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

e) Employee facilities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for employee facilities to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Where employee facilities (hand cleaning and sanitizing stations, lavatories, showers, drinking water stations and break rooms or change rooms) are necessary to prevent the contamination of a food,verify that they are present and that:
    • they are appropriately equipped and adequate in number and in size for the number of persons using them
    • they are capable of withstanding repeated cleaning and, if necessary to prevent contamination of a food, repeated sanitizing
    • are located so that they are readily accessible
    • hand cleaning and sanitizing stations permit the effective cleaning of hands
    • lavatories are located and maintained so that they do not present any risk of contamination of a food
  • Where a PCP is required:
    • Interview at least one person responsible for employee facilities to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of employee facilities to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for employee facilities to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 5.3: Water, ice and steam

Legal authorities
  • SFCR
    • Trade: 8
    • PC – Treatments and processes: 48(3)(b)(vii)
    • PC – Maintenance and operation of establishment: 49, 50, 52, 53, 56(1)(2), 57, 70(1)(2)(3)(4), 71(1)(2)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
  • FDA
    • Prohibited sales of food: 4(1)
Outcome
  • Water, ice and/or steam that comes into contact with regulated commodities is safe for its intended use
  • Water, ice and/or steam which is used in the facility is safe and adequate for its intended use
Rationale
  • Water, ice and steam can be used for a variety of purposes (for example, sanitation, hand washing, as an ingredient or processing aid, water provided to livestock); it is important that water be safe for its intended use
  • Water, ice and steam can be a source of biological, chemical or physical contaminants
Performance criteria
  • Any water, ice and steam that may contact food is
    • potable, unless there is no risk of contamination of the food if it is not potable
    • protected against contamination
  • As appropriate to the food and activity being conducted in an establishment, and if applicable to the food animal intended for slaughter, the establishment is supplied with water, ice and steam that are safe and adequate for their intended use
  • Any systems that supply water that might come into contact with food are not cross-connected with any other system, unless measures are taken to eliminate any risk of contamination to the food
  • Any treatment of water, steam or ice is applied in a manner that does not present a risk of contamination of the food
  • Equipment is designed, installed and maintained in a manner that will not jeopardize the safety of water

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for water, ice and steam to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
  • Confirm the water safety and suitability for its intended use, for example by reviewing water sampling/potability results of:
    • source water (for example, municipal water, well water, holding tank)
    • water at its point of use (for example, water for washing hands or as an ingredient for the food, drinking water for animals, re-used/re-circulated water)
  • If water is treated, confirm that any chemicals used are accepted for that use and that appropriate procedures are followed
  • Review facility schematics and records to confirm:
    • there is no cross-contamination between safe and unsafe water supplies unless measures are taken to mitigate the risks
    • equipment design, installation and maintenance do not jeopardize water safety
On-site: Observation and interview
  • Verify the following:
    • Where non-potable water is used, the line(s) are clearly and distinctly identified
    • All hoses, taps or other similar sources of possible contamination are designed to prevent the risk of contamination (for example, back flow or back siphonage)
    • The volume, temperature and pressure of the potable water/steam are adequate for all operational and cleanup demands
    • Any treatment of water, steam or ice must be applied in a manner that does not present a risk of contamination of a food. This may include any chemically treated water (for example, water conditioning, ozonation and chlorination) that has direct product impact or is used on product contact surfaces is potable
    • In respect of each application of the scheduled process to a low-acid food, a description of any treatment of the cooling water where water is reused/re-circulated, the water is treated and maintained so that no risk to safety and suitability of food products occurs if water is treated, confirm that any chemicals used are accepted for that use and that appropriate procedures are followed
    • If the establishment's water supply is from a private well or holding tank, adequate protection is afforded to prevent the risk of contamination
    • If the establishment has any water filters on water lines or in equipment, select at least one water filter and verify the following:
      • The licence holder can demonstrate that the filter has been changed as per the filter manufacturer's recommendations or equivalent or the licence holder can demonstrate the reasons for the variation from the published recommendation
      • The filter is installed
    • Water, ice and steam handling and storage equipment to ensure that it is designed, installed and maintained in a manner that will not jeopardize water safety
  • Where a PCP is required:
    • Interview at least one person responsible for water, ice and steam to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of water, ice and steam to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for water, ice and steam to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Sub-element 5.4: Waste disposal

Legal authorities
  • SFCR
    • Trade: 8
    • PC – Maintenance and operation of establishment: 49, 54, 58(2), 60, 66(1)(2)
    • PC – PCP: 86(1)(2)(3), 87, 88, 89(1)(2)(3)(4)(5)(6)
    • Commodity-specific requirements – Meat products and food animals: 154(2), 155(1)(2)(3)
  • FDA
    • Prohibited sales of food: 4(1)
    • Unsanitary manufacture, etc., of food: 7
Outcome

Effluent, waste and inedible handling, storage and disposal systems are designed, constructed and maintained to prevent contamination of regulated commodities, and the environment.

Rationale
  • An effective waste and inedible removal and disposal system reduces pest harbourage and the risk of contamination of the environment, commodities, inputs, packaging material, contact surfaces or the safe water supply
  • Cleanable and properly identified containers and utensils used for waste and inedible prevent cross-contamination
  • The presence of mechanisms to avoid backflow (for example, trapping, venting) prevents sewer gases, pests, micro-organisms or other contaminants from entering the establishment through the plumbing system
Performance criteria
  • Equipment and areas designated for the handling of waste and inedible are identified, of suitable capacity, secured and cleaned to avoid attracting pests
  • Contaminated materials, waste and inedible are removed and/or disposed of at a sufficient frequency and in a manner that prevents contamination of the food
  • Waste and inedible disposal, including effluent lines, does not contaminate commodities, preparation areas or the environment
  • Drainage and sewage systems are adequate for the volume and type of effluent being produced during normal processing and cleaning operations, and backflow is prevented.Inedible meat products are handled and identified as per regulatory requirements (SFCR sections 154 and 155)

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for waste disposal to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • non-compliant situations have been effectively addressed
      • documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview
  • Verify the following:
    • Waste and inedible equipment and containers are only used for that purpose, are identified, secured and cleaned
    • Waste and inedible disposal does not contaminate commodity preparation areas (for example, leakage and spillage)
    • Drainage and sewage systems are adequate for the volume and type of effluent
    • Waste and inedible is removed and/or disposed of at a frequency that is sufficient to prevent the risk of contamination of a food and in a manner that does not present a risk of contamination of a food
    • There are no odours that are uncharacteristic of the commodity as they may be indicative of a potential waste disposal issue
    • For meat facilities, all non-Specified Risk Material (SRM) products are kept completely separate from all SRM materials through-out the facility
  • Where a PCP is required:
    • Interview at least one person responsible for waste disposal to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of waste disposal to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for waste disposal to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Element 6: Receiving, transportation and storage

Sub-element 6.1: Receiving, transportation and storage

Legal authorities
  • SFCA
    • Sending, conveying, importing or exporting in accordance with regulations: 10(1)
  • SFCR
    • Trade:8, 14(1)(a)(i),15, 22(1)(b)
    • PC – Maintenance and operation of establishment:49, 50(1)(2), 53, 54, 59(1) (2), 61, 62(1)(2), 64, 65(1)(2), 72, 73, 74(1)(2)
    • PC – PCP:86(1)(2)(3), 88, 89(1)(2)(3)(4)(5)(6)
    • Commodity-specific requirements – Fish:108
  • FDA
    • Prohibited sales of food: 4(1)
    • Unsanitary manufacture, etc., of food: 7
Outcome

If applicable, food commodities (including inputs, for example, ingredients, raw materials), packaging materials and chemicals are transported, received and stored in conditions that maintain integrity and prevent damage, spoilage and contamination.

Rationale
  • Proper loading, unloading and storage prevents contamination and ensures commodities reach their destination in a suitable condition
  • Proper temperature and humidity control prevents spoilage and contamination of the commodities
Performance criteria

a) Conveyances

  • Conveyances used for the transport of commodities to, from and within the premises:
    • are clean and protect the commodity from contamination, damage and deterioration (including temperature and humidity controls)
    • are not being used to transport any material or substance that might cross-contaminate or adulterate the commodity
    • are loaded, arranged and unloaded in a manner that prevents damage and contamination of the inputs and/or end products (for example, packaging damaged during unloading)

b) Storage areas

  • Storage areas allow the:
    • separation of commodities and other materials, including returned commodities
    • protection of the food commodity and other materials (i.e. packaging materials) from contamination
    • when required, control of temperature and humidity to prevent deterioration and spoilage (for example, food not left out at ambient temperatures for prolonged periods)
    • stock to be rotated to maintain suitability, quality and safety

Verification activities

Document/records review
  • Where a PCP is required:
    • Review the licence holder's PCP for receiving, transportation and storage to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
    • Verify the following:
      • Any associated documents, including verification records, can demonstrate that the PCs are effectively implemented
      • Non-compliant situations have been effectively addressed
      • Documents reflect the conditions observed on-site
  • Where a PCP is not required:
    • Review associated documents, if any, and interview, if necessary, to determine if the PCs are effectively implemented
    • Non-compliant situations have been effectively addressed
    • Documents, if any, reflect the conditions observed on-site
On-site: Observation and interview

a) Conveyances

  • Go on-site during loading and unloading of conveyances and visually confirm the following:
    • Any conveyance that is used to carry food to or from the establishment, and that is loaded or unloaded at the establishment:
      • is designed, constructed and maintained to prevent contamination of the food
      • is clean and protect the commodity
      • is capable of maintaining the temperature and humidity at levels that are appropriate for the food
      • if necessary to prevent contamination of the food, is equipped with instruments that control, indicate and record temperature and humidity levels
      • does not contain:
        • any animals, other than a food animal that is intended to be slaughtered in the facility or conveyance
        • pest control products, as defined in the Pest Control Products Act
        • any other material or substance that presents a risk of contamination of that food
    • The material that is used to construct and maintain the conveyance:
      • is suitable for the intended use of the conveyance
      • is clean and in a sanitary condition at the time of unloading or loading
    • If the material used to construct or maintain the conveyance presents a risk of contamination to the food (for example, comes into contact with the food), the material is:
      • durable
      • capable of withstanding repeated cleaning and, if necessary to prevent contamination of the food, sanitizing
      • free of noxious constituents
    • The licence holder unloads/loads food from the conveyance at the establishment in a manner that does not present a risk of contamination to the food
    • The licence holder unloads/loads a food animal that is intended to be slaughtered from or onto a conveyance at the establishment in a way that does not cause a risk of contamination to the food
  • Where a PCP is required:
    • Interview at least one person responsible for controls related to conveyances to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of controls related to conveyances to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for conveyances to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)
    • If a 3rd party is contracted by the licence holder for transportation, interview the licence holder's staff to determine how they verify that transportation requirements have been met

b) Storage Areas

  • Verify that returned, defective or suspect product is clearly identified and stored in a designated area
  • Verify that stock rotation to maintain suitability, quality and safety has been met
  • Select at least one cooler (if applicable) and one other storage area used to store inputs (i.e. ingredients) and/or product and go on-site and verify that the storage area:
    • maintains appropriate environmental temperature and humidity, as per the licence holder's written program, for storage of a commodity (for example, ingredients, products, inputs) that requires environmental control, and that there is no risk of deterioration (for example, products to be stored at validated temperatures)
    • provides:
      • necessary controls for separation (i.e. allergen controls), including returned commodities (where required)
      • protection of the commodity from contamination
  • Select at least one freezer (if applicable) used to store ingredients and/or product and verify that the freezer:
    • maintains appropriate environmental temperature and humidity, as per the licence holder's written program, for storage of a commodity (for example, ingredients, products, inputs) that requires environmental control, and that there is no risk of deterioration (for example, meat products to be stored to maintain a frozen state, i.e. no evidence of thawing)
    • provides:
      • necessary installations for separation (where required), including returned commodities
      • protection of the commodity from contamination
  • Select at least one room/area where ingredients and products are handled, stored or prepared and verify the following:
    • Ingredients, finished products and packaging materials are handled and stored in a manner to prevent damage, deterioration and contamination
    • Where appropriate, ingredients and finished products present in processing rooms are managed in a manner to prevent increase of temperature above acceptable validated temperatures
    • Ingredients and finished products are not left out in adverse conditions which would impact safety, health or quality (for example, freezing, thawing or sweating)
  • Select at least one room/area where packaging materials are handled or stored and verify that the packaging materials are handled and stored in a manner to prevent damage and/or contamination
  • Select at least one non-food storage area and verify that all equipment, conveyances, utensils, containers, starter products (for example, seedlings and nursery stock), agronomic inputs, and controlling and measuring devices used in commodity preparation and storage are properly stored in a manner that prevents contamination
  • Where a PCP is required:
    • Interview at least one person responsible for storage areas to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for verification of storage areas to determine if they understand and are following procedures as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures
  • Where a PCP is not required:
    • Interview at least one person responsible for storage areas to determine if they understand and are following procedures (written or verbal) as set out by the licence holder
    • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures (written or verbal)

Element 7: Traceability, control and complaints

Sub-element 7.1: Traceability and control

Legal authorities
  • SFCA
    • Recall order: 5
  • SFCR
    • Trade: 8
    • PC – Investigation and notification, Complaints and recall: 82(1)(2), 84(1)(2)(3)(4), 85
    • Traceability: 90(1)(2)(3), 91, 92(1)(2)(3)(4)(5)
    • Commodity-specific requirements – Meat products and food animals: 165(1)(a-c)(4)
Outcome
  • Commodities are adequately identified to enable removal from the marketplace or facilitate other movement restrictions
  • Non-compliant commodities are effectively controlled by preventing entry into commerce or rapid retrieval if distributed and disposed of, as appropriate
  • Where required by the Act or Regulations, CFIA is notified of a non-compliant product
Rationale

Identifying, controlling and removing affected commodities quickly and effectively minimizes health risk to the public.

Performance criteria
  • The traceability system must be able to:
    • trace commodities/inputs to the source level, for example ingredients
    • trace commodities (including by-products) to the next point of distribution
    • maintain accurate traceability records
  • The control system (notification and recall) must be able to:
    • stop any further distribution and sale
    • contact customers and the CFIA
    • retrieve the implicated commodities, including segregation if needed

Verification activities

Document/records review
  • Review the written program for traceability and controls (notification and recall) to verify compliance to regulatory requirements and performance criteria. Verify the following:
    • The licence holder has prepared, keeps and maintains a document that sets out a recall procedure that enables the effective recall of a food, containing:
      • the name of a contact person who is responsible for the procedure
      • the name of a contact person who is responsible for conducting recalls
    • The licence holder/regulated party has prepared and keeps documents that set out:
      • the common name and the lot code or other unique identifier that enables the food to be traced
      • the name and principal place of business of the person for whom the food was manufactured, prepared, produced, stored, packaged or labelled (trace forward)
      • unless the product is sold directly at retail, the date on which it was provided and the name and address of the person to whom it was provided. (trace forward)
      • the name of any input that has been incorporated into a food, as well as the name and address of any supplier of that input, and the date on which it was supplied (trace back)
    • The licence holder has documentation related to the latest recall simulation or actual recall and that they have, at least once every 12 months,:
      • conducted a recall simulation, based on the recall procedure
      • prepared a document that sets out the details of how the recall simulation was conducted
      • documented the results of the simulation; the documents are kept for two years after the day on which the recall simulation was completed
  • Review records to identify any previous recalls and confirm that commodity was effectively recalled/controlled (quantity in inventory, distributed and returned) and disposed of or handled as per procedures and that the CFIA was notified
    • Determine if corrective actions were put in place in response to the cause of the recall to prevent recurrence
On-site: Observation and interview
  • Select at least one work-in-progress (WIP) or ingredient (including outputs) and verify that:
    • the licence holder/regulated party can demonstrate the ability to maintain product identification throughout the process until final packaging
    • if applicable, the licence holder/regulated party can demonstrate the ability to maintain identification of pre-mixed ingredients and ingredients that are part of reworked product
  • Select at least one prepackaged/consumer prepackaged food product (if applicable) and verify that:
    • the product is labelled with the common name of the food, the name and principal place of business of the person by or for whom the food was manufactured, prepared, produced, stored, packaged or labelled and a lot code (consumer prepackaged food) or other unique identifier that enables the food to be traced.
  • Select at least one product that that has been distributed and verify that the licence holder/regulated party can trace:
    • the product one step forward to determine where it was distributed
    • the inputs one step back to identify their source
  • Interview at least one person responsible for verification of traceability and control to determine if they understand and are following procedures as set out by the licence holder
  • Interview at least one person responsible for initiating actions to bring hazards back under control to determine if they understand and are following procedures

Sub-element 7.2: Complaints

Legal authorities
  • SFCR
    • PC – Investigation and notification, complaints and recall: 82(1) (2), 83(1) (2), 85
Outcome

Complaints are investigated to assess if they are related to product safety and misrepresentation, and to determine the root cause and corrective actions to be taken.

Rationale

If complaints are not investigated to mitigate risks, this could lead to the production, distribution and/or sale of unsafe food and/or product misrepresentation.

Performance criteria
  • The licence holder prepares, keeps and maintains a document that describes the food complaint procedure used for receiving, investigating and responding to complaints related to food, including imported food
  • Upon receiving a food complaint, including a complaint on an imported food, the licence holder implements a food complaint procedure
  • The licence holder prepares a document that describes the
    • details of the complaint
    • results of the investigation
    • actions taken based on the results of the investigation
  • The licence holder keeps the document for at least two years after the day on which they have completed the actions taken as a result of the investigation

Verification activities

Document/records review
  • Review the licence holder's notification/complaint file. Verify the following:
    • The licence holder has prepared, keeps and maintains a document that sets out a procedure for receiving, investigating and responding to complaints that are received related to food
    • The licence holder has implemented their written procedure
  • Review at least one month of the complaint file and associated records (including at least one complaint related to a food safety issue since last verification). Verify the following:
    • The licence holder has prepared documents that set out the details of each complaint, the results of the investigation and actions taken based on those results
    • The documents are kept for two years after the day on which the actions were completed
On-site: Observation and interview
  • For at least one complaint (a food safety complaint, if applicable) verified during record review, interview/observe the following:
    • Verify that the licence holder has taken corrective actions in response to the complaint
    • Verify that corrective actions have been implemented and have effectively addressed the root cause
  • Interview at least one employee responsible for complaint handling and investigation to determine if they understand and are following complaint procedures as set out by the licence holder
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