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

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 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

Safe Food for Canadians Act (SFCA)
Safe Food for Canadians Regulations
Health of Animals Act (HAA)
Health of Animals Regulations (HAR)
Food and Drugs Act (FDA) (as it relates to food)
Food and Drug Regulations (FDR) (as it relates to food)

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:

Documents incorporated by reference have the same force of law as the regulations in which they are incorporated. 17 documents have been incorporated by reference into the SFCR
Operational guidance (OG) (accessible only on the Government of Canada network) provides information on how inspectors perform their inspection activities and must be used in conjunction with industry guidance that provides information on how industry can comply with the regulations. A good understanding of the Standard inspection process (SIP) is required in order to apply this OG
Industry guidance (IG) provides guidance for inspectors, partners and stakeholders to comply with applicable acts and regulations
Establishment-based risk assessment (ERA) (accessible only on the Government of Canada network):
- Inspector reference – ERA establishment risk profile verification (accessible only on the Government of Canada network -RDIMS 13932052): provides guidance on risk factors (inherent risk factors, mitigation factors and compliance factors) and corresponding data sources
- ERA establishment risk profile (food) – Interpretation for inspectors and industry (accessible only on the Government of Canada network - RDIMS 14714959): provides guidance to inspectors and industry on how to interpret the establishment risk result
- Additional establishment information checklist and Additional establishment information in My CFIA – Glossary of terms: provide definitions for risk factors and sub-products
Other references can be consulted when assessing compliance such as the model systems which are examples of a preventive control plan (PCP) approach. For example, the Codex Alimentarius general principles of food hygiene, which is utilized by the international food industry to ensure food is prepared under sanitary conditions and is safe to eat and on which many PCP approaches, including the former Food safety enhancement program (FSEP) and the Quality management program (QMP), are based. The licence holder must ensure that the guidance they choose to follow is relevant to their particular business, product(s) and market requirements
Note:
- Inspectors should consult both the IG documents as well as the OG documents
- Inspectors can search for IG and externally posted OG documents on specific topics using the Guidance Finder: Food
- Although the IG documents are not regulatory, these documents provide guidance to industry to help them achieve compliance and to inspectors to assess compliance against regulations

4.0 Definitions

Definitions are located in the documents listed below or as a defined word where it is intended to supersede the definitions within the glossary documents:

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 operational procedure (OP) provides inspection procedures specific to food PC and traceability inspection. 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 notwithstanding of what is indicated in the SIP.

Prior to the first planned PC inspection, within the current defined frequency of inspection cycle, as per the Program direction: Preventive control inspections frequencies for food (accessible only on the Government of Canada network – RDIMS 11010733), the inspector should review the ERA establishment risk profile (login required) (accessible only on the Government of Canada network) of the licence holder to confirm accuracy of the inherent risk factors and mitigation 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. The inspector 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
assess discrepancies related compliance factor information, and makes any necessary corrections in the source data base (e.g. DSDP, IMS) as appropriate
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 Digital Service delivery platform (DSDP).

6.1 Prepare for inspection

Refer to SIP section 3, 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 tool to determine if a licence holder needs a written 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 written PCP is required, obtain an up-to-date copy of the licence holder's written 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 example:
- if the licensable activity is solely to import food, the applicable sub-elements will be 1.3, 7.1 and 7.2
- if an establishment is certified with CanadaGap, activities which are not covered under the scope of certification but are on their licence would require inspection
For sub-elements within the scope of the inspection task type, review their respective outcomes, performance criteria and verification activities (see Appendix 1)
For inspections which are part of a work plan (trigger: preventive control inspection (PCI) plan), the required entire sub-element(s) will be assessed within the prescribed timeframes
For inspections which are not part of a work plan (trigger: incident response following a complaint or recall), 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(s) in the Additional reference ID field.
- Refer to OG: Responding to food complaints (accessible only on the Government of Canada network – RDIMS 13899359) as required. If there are IMS files and it is determined that no inspection is required, capture this information and the rationale of why the inspection is not required in the Notes tab located on the main page of the inspection case, as per SIP A.4.3 Review information

6.1.1 Further preparation steps in case of a recall

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 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 Digital Service Delivery Platform (DSDP).

If the recall was a result of a PC inspection, there is no need to create another 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 case.

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

the source of the incident 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 problem that caused the deviation
- Note: consult the OG: Food incident response process as required

If answers to any of the above are yes, then open a DSDP case with incident response as the trigger. Select the applicable inspection task type(s), based on the findings of the 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 case. Ensure the IMS recall 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 perform a PC inspection in response to this recall.

Table 1: Recording inspection data in Digital Service Delivery Platform (DSDP)
DSDP Triggers	Preventive control inspection plan Incident response
DSDP Inspection task type	Preventive control inspection
DSDP Inspection level 1 task	System verification
DSDP Inspection level 2 task	Sub-elements: 1.1a Incoming inputs, 1.1bc Product formulation, specifications and processing, 1.2 Product controls, 1.3 Import controls, 1.4 Export controls 2.1 Sanitation, biosecurity and bio-containment, 2.2 Pest control, 2.3 Chemicals 3.1 Hygiene and biosecurity, 3.2 Employee training 4.1 Equipment, design and maintenance 5.1 Premises and surroundings, 5.2 Buildings, 5.3 Water, ice and steam, 5.4 Waste disposal 6.1 Receiving, transportation and storage 7.1 Traceability and control, 7.2 Complaints

6.2 Conduct the inspection

6.2.1 Confirm the scope
6.2.2 Conduct the verification activities
6.2.3 Impact assessment

Refer to SIP, section 4, Step 2 – Conduct the inspection. In addition to the general guidance provided in SIP, the following applies.

6.2.1 Confirm the scope

If a potential non-compliance is observed part way through a planned inspection, 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 non-compliance will be completed in a separate case. The trigger for that 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 this inspection case
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 non-compliance may be completed in a separate case. The trigger for that case will be 'Incident response'. The entire sub-element still needs to be completed within the defined frequency for that licence holder

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 written PCP in place. If during the preparation of the inspection, it is determined that a licence holder is required to have a written PCP, however they do not have one, this may constitute a non-compliance to SFCR 86. Refer to SIP, section 4.6 – Determine non-compliance, for further guidance.

As per SFCR 47, all licence holders (regardless of whether they require a written PCP or not) are required to identify and analyse hazards and prevent, eliminate or reduce the identified hazards to an acceptable level using control measures shown by evidence to be effective.

Where a written 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 written 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, licence holders 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.

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

6.2.3 Impact assessment

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

evaluate the impact of non-compliance 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 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 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 commodity is affected to determine the impact assessment result.

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

The impact assessment is a mandatory field in DSDP; DSDP data entry requirement is as follows:

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
Select the appropriate impact assessment result in the 'Impact Assessment' field of the inspection task screen
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 50 to 81; SFCR 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) needs to maintain and operate what (establishment) according to which requirements (SFCR 50-81)
If there is a non-compliance with SFCR 89; SFCR 86 should also be referenced in the same non-compliance record as that is the regulation which actually requires the licence holder to have a PCP that meets the provisions of SFCR 89 in addition to any other applicable regulatory reference that is found to be non-compliant within the sub-element being assessed

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:

3.1 Hygiene and biosecurity, non-compliance was found with SFCR 49, 77 and 88 for employees not washing their hands and
5.2 Buildings, non-compliance was found with SFCR 49, 57 and 88

There will be two non-compliance records created, one for non-compliances found under SE 3.1 and another one for non-compliances found under SE 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 SE 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.

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 results

Refer to SIP, section 5, Step 3 – Communicate the inspection results. In addition to the general guidance provided in SIP, the following applies:

It is the responsibility of the licence holder to implement interim corrective measures to mitigate any risks to human health, animal welfare or food misrepresentation immediately. These interim corrective measures are documented in the closing meeting notes
In addition to the inspection report generated from DSDP, if there are non-compliances identified, complete a cover letter to accompany the inspection report when communicating the results of the inspection to a licence holder
This letter is a necessary part of the written report that must be provided to a licence holder to satisfy the requirements of SFCR 36(1)
This cover letter must set out the grounds for a suspension and the period within which corrective action must be taken in order to avoid a suspension
A Template covering letter for food inspection reports (accessible only on the Government of Canada network – RDIMS 12787033) is available for this purpose.

6.4 Conduct follow-up

Refer to SIP, section 6, Step 4 – Conduct the follow-up inspection. In addition to the general guidance provided in SIP, the following applies to this OG:

For every non-compliance record, create a follow–up case in DSDP to record follow-up details by selecting "Create follow up" from the non-compliance record within the parent case. Ensure that the "Due date" in the follow-up case in DSDP matches the "Complete corrective action by" date, found in the non-compliance record. The follow-up should be scheduled as soon as possible following the regulated party's corrective action due date
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 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 files, 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 is responsible for communicating the results to the individuals responsible for the IMS

6.4.1 Assess follow-up inspection results

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
creates a non-compliance record ensuring the objective evidence includes the date and findings from that date
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

The follow-up inspection case must remain open until compliance is re-established and can only be closed (deactivated) once follow-up inspection activities and the appropriate control and/or enforcement actions are complete. As the case cannot be closed (deactivated) at this time, the inspection report must be issued by other means than through the portal (such as in person/email/fax).

If subsequent follow-up inspections are required, create a new inspection task record 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 Operational Guidance Document, 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

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

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 PC achieves regulatory compliance
Rationale: explains the potential impacts of the PC 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 PC 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 and the following:

product(s) being manufactured during the inspection
volume of production
diversity of products/processes
complexity of products/processes
risk profile as per Section 8, Scope and inspection prioritisation within each commodity sector, of the Program direction – Preventive control inspection frequencies for food (accessible only on the Government of Canada network – RDIMS 11010733)
whether one process applies to multiple commodities
new products/processes
trends (consumer complaints / non-compliant sample results)
review of previous inspection
information found in the Food Animal Slaughter PCI Operational Guidance

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
Sub-element 1.1bc: Product formulation, specifications and processing
Sub-element 1.2: Product controls
Sub-element 1.3: Import controls
Sub-element 1.4: Export 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

Legal authorities

SFCA

Prohibitions: 6(1), 10(1), 11, 12, 13(1)

SFCR

Trade: 8(1)(d)(2)(3), 9(1)(2), 10, 14(1)(a)(i), 15
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 – Dairy products: 94
Commodity-specific requirements – Eggs: 97, 98(1)(b)(c)(2), 99(1)(2)(3)
Commodity-specific requirements – Fish: 107
Commodity-specific requirements – Fresh fruit or vegetables: 113(1)(2), 114(1)(2)(3), 115, 116, 118(1), 120
Commodity-specific requirements – Meat: 175
Organic products – International trade and import: 357(1)(2)(3)(4)
Schedule 2
Packaging:186(a)(i, ii, iii, iv, v, vi, vii), 208

FDA

Food: 4(1), 6(1)(2), 7

Note: For imported food inputs, refer to the sub-element 1.3 for additional legal authorities.

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.

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 finished product
Select at least two 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 associated with the selected inputs/materials and have identified control measures
- Review the control measures for the selected inputs/materials to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 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
  - letters of no objection from Health Canada, 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 written PCP is not required:
- Review associated documents, if any, and interview, if necessary, to determine if the licence holder meets requirements of SFCR 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
Where imported meat products:
- requiring an inspection are received by establishments designed for inspection of imported meat products, the product is handled as per SFCR 14(1)(a)(i) until it is inspected and released by the CFIA.
- are received by designed establishments other than establishments registered for inspection of imported meat products, the product is only admitted if there is evidence that the product has been inspected and released by the CFIA.
Where a written 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 written PCP is not required:
- Interview at least one person responsible for inputs/materials 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) as set out by the licence holder

Element 1: Process and product controls

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

Legal authorities

General

SFCA
- Prohibitions: 6(1), 10(1), 11, 12, 13(1)
SFCR
- Trade: 8(1)(2)(3), 9 (1)(2), 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 – Dairy products: 94
- Commodity-specific requirements – Eggs: 95(1)
- Commodity-specific requirements – Processed egg products: 102(1)(2), 103(1)(2)
- Commodity-specific requirements – Meat products and food animals: 125(1)(2), 126, 154(1)(2), 155 (1)(2)(b), 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, drug 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 there are formulas for each product that is being prepared
has there are specifications for each product
uses inputs (i.e. additives and other substances) that are permitted in and on the commodity

c) Processes have:

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 written 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 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 written 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 written PCP, if applicable
Where a written 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 written 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

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 associated for the selected process(es) and have identified all processing steps and control measures
- Review the control measures for the selected process(es) to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria.
  Note: definition of a critical control point (CCP) is found in SFCR 45. Inspectors must consider this definition and not only what the licence holder has identified the control measures as, in their written PCP
- For process(es) selected, review documents to confirm that:
  - control measures are being implemented at each step to control the identified hazards
  - control measures are designed to control the identified hazards
- For CCP's:
  - 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
- For non-CCPs:
  - The documentation for verification procedures substantiates that the PCP, in relation to the selected control measure, has been effectively implemented
  - Review documents demonstrating that the licence holder is effectively able to identify non-compliances, bring hazards back into control and prevent re-occurrence
- Verify documents reflect the conditions observed on-site
Where a written PCP is not required:
- Review associated documentation, if any, and interview if necessary, to determine if the licence holder meets requirements of SFCR 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

For the process(es) selected, verify that the licence holder has:
- included all process steps in their hazard analysis
- identified all hazards applicable to each step
Observe the product throughout the process to ensure that measures are in place to prevent cross-contamination
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)

Element 1: Process and product controls

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), 10(3), 11, 12, 14(1)(2)(3)
SFCR
- Trade: 8(1), 9(1)(2), 10, 18(1)(2), 19(1)
- 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), 189(1)(2)(3)(4), 190, 191(1)(2), 192, 193(1)(2)
- 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), 238, 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, 252, 253
- Labelling – Eggs: 254, 255, 256(1)(2), 257(1)(2)
- Labelling – Processed egg products: 258, 259, 260
- Labelling – Fish: 262(1)(2)(3), 264, 265, 266, 267
- Labelling – Fresh fruits or vegetables: 268(1)(2)(4), 269(1)(2)(3), 270(1)(2), 271
- Labelling – Processed fruit or vegetable products: 272(1), 273, 274(1)(2)(3)
- Labelling – Honey: 275(1)(2), 276, 277(1)(2), 278, 279(1)(2)
- Labelling – Maple products: 280(1)(2), 281
- Labelling – Edible meat products: 282(1)(2), 283(1)(2), 284(1)(2), 286, 287(1)(2)(3), 288(1)(2), 289, 290, 291, 292, 293, 294 , 295, 296(1), 297(1)(2)(3), 298
- Labelling – Exceptions: 299, 300, 301, 302(1)(2), 303
- 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: 331(1), 332(2), 333 (1), 333(2)
- Organic products: 353(1)(2)(3), 354, 355(1)(2), 356(1)(2), 357(1)(2), 359(1)(2)(3), Schedule 2, 3, 4, 6, 7, 8, 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 product^Footnote 1 identification: information is complete, truthful and not misleading. It also accurately represents the commodity and its content, and meets regulatory requirements
End product^Footnote 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 least^Footnote 2 two consumer-prepackaged product
Select at least^Footnote 2 one non-consumer prepackaged product
Select at least one inedible material

Document/records review

For the end products selected:
- Where a written PCP is required:
  - Review the control measures for the end product identification to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria confirm that the PCP meets the outcome for this sub-element
- For all licence holders (with or without a written 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 written 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 written 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 written PCP is required:
- Review the control measures for the end product specification 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 written 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 written 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 written 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)

Element 1: Process and product controls

Sub-element 1.3: Import controls

Note: This sub-element will apply to food commodities which are imported solely for sale and distribution in its imported state. For example, when a licence holder have both import and domestic activities 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 its 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 1.3, as well as where to capture the associated inspection findings.

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 food 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 (process/ treat/ preserve/manufacture) activities	Where some imported food is sold in its 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 food is sold in its 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: 4, 10(1)(3)
SFCR
- Trade: 8(1)(2)(3), 9(1)(2), 10, 11(1)(2), 13(1)(2)(3)(4), 14(1)(2), 15(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: 95(2), 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), 123(4)
- 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 commodities

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 for the selected imported foods to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
- Records related to control 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
Where a written PCP is required:
- Review the licence holder's written PCP for imported foods 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
Where a written 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 written 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

Element 1: Process and product controls

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)

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)
- Commodity-specific requirements – Meat products and food animals: 168(1)(2)

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

Review the licence holder's written PCP (if required) for export controls to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR section 89 and performance criteria
Review documentation (if required) for verification procedures to substantiate that the written PCP has been implemented
Verify that the licence holder's written PCP (if required) controls and segregates commodities destined for export that do not meet Canadian requirements and ensures those commodities are not distributed in Canada
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

On-site: Observation and interview

Verify that:
- The licence holder is following their procedures to source products that meet regulatory requirements
- Commodities for export are segregated appropriately, as per SFCR section 16, according to the licence holder's written PCP, if applicable
Review certificate control procedures, if documented, and interview to verify that certificate controls are in place and are effectively implemented
- Review at least two previously issued export certificates 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
Where a written 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 written 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
Sub-element 2.2: Pest control
Sub-element 2.3: 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 approved procedures

Verification activities

Document/records review

Where a written PCP is required:
- Review the licence holder's written PCP for cleaning, sanitation, biosecurity and biocontainment to verify compliance to regulatory requirements, including applicable PCP requirements set out in SFCR 89 and performance criteria
- Confirm that the written 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, 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 written 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 equipment^Footnote 3

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
  - where applicable, have detailed procedures for disassembly, maintenance and sanitation (especially for slicing/cutting ready-to-eat foods)
- If necessary and/or if it possible, prior to start of operation, visually verify that cleaning, sanitizing and/or biosecurity and bio-containment procedures have effectively remove dirt, debris or any other contamination risk. Look for evidence of dirt, debris and residual material on direct commodity contact surfaces, including containers and utensils
Where a written 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 written 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 written PCP is required:
- Review the licence holder's written PCP for pest control 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 written 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 that contains pest control devices (if applicable).

Review the map of the pest control devices in this room/area (if applicable) and go on-site to confirm that pests do not present a risk of contamination. Verify the following:
- 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written PCP is not required:
- Interview at least one person responsible for storing, monitoring and storage 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
Sub-element 3.2: 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 written PCP is required:
- Review the licence holder's written PCP for hygiene an biosecurity 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 written 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 written 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 written 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 – 135(1)(a)(b)

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 written 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 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 written 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 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 written PCP is required:
- Interview at least one employee responsible for verification of the written procedures 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 written PCP is not required, consider the following:
- 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)(b), 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 or incorrect formulation

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 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 written PCP is required:
- Review the licence holder's written PCP for equipment design and maintenance 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
  - 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 written 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 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 written 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 written 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
Sub-element 5.2: Buildings
Sub-element 5.3: Water, ice and steam
Sub-element 5.4: Waste disposal

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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 food, 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 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 required, 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 154 and 155)

Verification activities

Document/records review

Where a written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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 written PCP is required:
- Review the licence holder's written 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 written 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 written 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 written 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:Verify that stock rotation to maintain suitability, quality and safety has been met
- 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 written 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 written 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
Sub-element 7.2: 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 licence holder's 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 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 the cause of the recall and/or control action was identified and if this information was used to make adjustments 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 can demonstrate the ability to maintain product identification throughout the process until final packaging
- if applicable, the licence holder 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 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 related to product safety and product misrepresentation are investigated to determine root cause and corrective actions are 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 the igation and notification, complaints and reactions 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

Date modified:: 2024-03-28

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

On this page

1.0 Purpose

2.0 Authorities

3.0 Reference documents

4.0 Definitions

5.0 Acronyms

6.0 Operational procedure

6.1 Prepare for inspection

6.1.1 Further preparation steps in case of a recall

6.2 Conduct the inspection

6.2.1 Confirm the scope

6.2.2 Conduct the 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

6.2.3 Impact assessment

6.2.4 Document the non-compliance

6.2.5 Categorise the non-compliance

6.3 Communicate the results

6.4 Conduct follow-up

6.4.1 Assess follow-up inspection results

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

Element 1: Process and product controls

Sub-element 1.1a: Incoming inputs

Legal authorities

SFCA

SFCR

FDA

Outcome

Rationale

Performance criteria

Verification activities

Document/records review

On-Site: Observation and interview

Element 1: Process and product controls

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

Legal authorities

Product formulation and specifications (b)

Processing (c)

Outcome

Rationale

Performance criteria

Verification activities

Document/records review

On-Site: Observation and interview

Document/records review

On-Site: Observation and interview

Element 1: Process and product controls

Sub-element 1.2: Product controls

Legal authorities

Outcome

Rationale

Performance criteria

Verification activities

Document/records review

On-site: Observation and interview

Document/records review

On-site: Observation and interview

Element 1: Process and product controls

Sub-element 1.3: Import controls

Legal authorities

Outcome

Rationale

Performance criteria

Verification activities

Document/records review

On-site: Observation and interview

Element 1: Process and product controls

Sub-element 1.4: Export Controls

Legal authorities

Outcome

Rationale

Performance criteria

Verification activities

Document/records review