Operational procedure: Meat Compliance Verification System (CVS)

Appendices

Appendix A: Organization of tasks
Appendix B: Operational guidelines specific to CVS section 4 tasks
Appendix C: Follow-up to a recall of a meat product regulated under Safe Food for Canadians Regulations (SFCR)
Appendix D: Action plans
Appendix E: List of operators/licence holders activities which do and do not require daily presence for each 12-hour period of production
Appendix F: Forms and templates

1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) Inspection Staff on how to conduct inspections using the Compliance Verification System (CVS) and how to document Daily Shift Inspection Presence (DSIP) in all licenced meat processing, storage^Footnote 1 and slaughter establishments. Inspectors will use this guidance to conduct verification of licence holders who are:

exporting
manufacturing
processing
treating
preserving
grading (Although operators are not required to obtain a licence under Safe Food for Canadians Regulations (SFCR) for grading, inspectors still need to verify compliance to the regulatory requirements regarding grading activity.)
packaging
labelling
storing

It also applies to the inspection of licence holders:

slaughtering food animals

Notes:

With SFCR coming into force, CFIA will no longer register establishments, but will issue licences to persons/businesses to carry out certain food related activities. Not all activities taking place at an establishment may be subject to the SFCR. Inspectors should follow the inspection process described in section 7 of this document only in relation to processes / products that are regulated under SFCR.
Only the inspectors who have been trained on the meat compliance verification system should use this procedure.

2.0 Authorities

CFIA is responsible to administer and enforce the following Acts and Regulations:

Safe Food for Canadians Act (SFCA)
Safe Food for Canadians Regulations (SFCR)
Food and Drugs Act (FDA)
Food and Drug Regulations (FDR)

3.0 Reference documents ^Footnote 2

3.1 References to be used when conducting verification tasks

A new suite of guidance to support inspectors under Safe Food for Canadians Act (SFCA) and SFCR has been developed and made available. The guidance documents have been divided between:

industry guidance
operational guidance

Inspectors should consult both, the industry guidance documents as well as the operational guidance documents when preparing for and conducting verifications using CVS.

Note: The industry and operational guidance documents are not regulated. These documents provide guidance to the industry to help them achieve compliance and to the inspectors to assess compliance against regulations.

3.1.1 Industry guidance

Inspectors can access the industry guidance documents. The inspectors can also search for guidance documents on specific topics using the Guidance Finder: Food. Industry guidance should be used when SFCR comes into force.

3.1.2 Operational guidance

Inspectors can access the operational guidance documents (internal access only). The inspectors can also search for guidance documents on specific topics using the Food specific reference document (FSRD)-SFCR regulatory and guidance reference – draft (internal access only) - RDIMS 10335891. Operational guidance should be used when SFCR comes into force. Inspectors can refer to the draft Introduction to the food specific reference document (FSRD) (internal access only) - RDIMS 10766305 for more information.

3.1.3 Other references

Inspectors can consult other documents when preparing and assessing compliance like the model systems which are examples of a Preventive Control Plan (PCP) approach. The Food Safety Enhancement Program (FSEP) and the Quality Management Program (QMP) are examples of types of PCPs. Both, FSEP and QMP are based on the Codex Hazard Analysis and Critical Control Point (HACCP) principles and, for many years, were utilized by the industry to ensure food is prepared under sanitary conditions and is safe to eat.

Note: Under SFCR, some food businesses will be required to have a written Preventive Control Plan (PCP) in place. Operators are encouraged to consult the online PCP tool to determine if they need a written PCP in place.

A PCP is a written plan outlining how you ensure that food is safe and fit for consumption and conforms to consumer protection and animal welfare requirements, as applicable. Using preventive controls to prevent, eliminate or reduce to an acceptable (safe) level hazards associated with food products is an internationally accepted approach based on the CODEX Alimentarius General Principles of Food Hygiene – PDF (59 kb).. PCP is not a new concept for most businesses in the meat industry. The operators/licence holders will have the flexibility to use an FSEP and/or QMP based approach to meet regulatory requirements or use other PCP approaches that have been developed by other food safety authorities, industry associations, international partners, or academia. The operator/licence holder must ensure that the guidance they choose to follow is relevant for their particular business, product or products, and market requirements.

Once reviewed and revised as necessary, businesses may continue to use their existing written FSEP or QMP as their PCP to be in compliance with the SFCA and SFCR.

3.1.4 Documents incorporated by reference (to SFCR):

Seventeen (17) documents have been incorporated by reference into the SFCR. Documents incorporated by reference have the same force of law as the regulation in which they are incorporated.

4.0 Definitions

Definitions are located in either of the following locations or as below:

Intensified inspection

Following indication(s) that an operator/licence holder is not effectively managing identified hazards, inspection personnel should increase the frequency of associated verification tasks and the scope of verification to detect if any deviation(s) could affect food safety. For example:

selecting more equipment than what is required as per the verification task during the pre-operational task or maintenance task
selecting other tasks that could be related to the control of the hazard at a different step in the process, or different area of the facility at an increased frequency
requesting the operator's representative to measure the temperature of more pieces of meat than they have planned in their PCP to demonstrate the inspector the critical limit was met everywhere in the cooking chamber

Each case being unique, the inspector and his supervisor should discuss the situation and seek guidance from expert when need is.

5.0 Acronyms

As a general rule, acronyms are expanded when used for the first time they are used in this document. These acronyms are consolidated in the food business line acronyms list.

DG: Director General
DO: Directors of Operations
DSIP: Daily Shift Inspection Presence
FSEP: Food Safety Enhancement Program
HACCP: Hazard Analysis Critical Control Point
NID: National Inspection Division
OAT: Outcome Assessment Task
OGE: Operational Guidance and Expertise
OP: Operational Procedure
PC: Process Control
POE: Port of Entry
QPIM: Quality, Planning and Integration Manager
RI: Responsible Inspector
RVO: Regional Veterinary Officer

6.0 General

6.1 Roles and responsibilities

6.1.1 Licence holder/operator

The responsibilities of the operator/licence holder are to:

produce safe, wholesome, properly labelled product(s) in compliance with the regulatory requirements (such as applicable acts, regulations and guidelines)
prepare, keep and maintain a PCP based on Codex Alimentarius guidelines
identify and correct deviations in a timely and appropriate manner
correct items requiring correction as identified by the CFIA
provide written programs and documentation as requested by the CFIA

6.1.2 Inspector

The responsibilities of the CFIA inspector are to:

ensure all applicable verification tasks are assigned to the establishment as per section 6.4 of this document
conduct verification tasks as per the role assigned by their supervisor
conduct verification tasks according to the established national frequency
complete verification worksheets and Inspection Report-Corrective Action Requests (IR-CARs) as per section 7.2 and 7.4 of this document
take action(s) and document, as necessary to protect public health, to protect consumers from fraud and to protect animal welfare or health as outlined in the "Food regulatory response guidelines"
seek guidance and program clarification using established communication pathways, as required
communicate verification task results to the operator/licence holder by issuing verification reports and IR-CAR, as defined in section 7.4 of this document
follow-up on items requiring correction, identified on the verification report as per section 7.6 of this document
follow-up on operator/licence holder's corrective measures in response to IR-CARs as per section 7.6 of this document
follow the regulatory enforcement actions and procedures as detailed in the "Food regulatory response guidelines"
maintain documentation as defined in section 7.7 of this document
submit electronic information as defined in section 7.7 of this document
complete a verification task comments submission form whenever the need for a change to a verification task is identified (see section 6.3 of this document). This form is forwarded to the area CVS coordinator for review and consideration
ensure that the most recent version of the CVS guidance document and task procedures is being referred to
review and update the online CVS establishment profile as per section 6.4 of this document
notify the supervisor via email that a profile is pending approval
participate in the completion of section 4 verification tasks when operationally feasible

6.1.3 Supervisor

The responsibilities of the supervisor are to:

schedule inspectors to ensure that all establishments are visited (meet DSIP requirements) and tasks are assessed at the prescribed frequency
allocate inspectors in a manner that provides resource flexibility while supporting the reporting requirements for DSIP
schedule inspectors to support their participation in completion of section 4 verification tasks
review and approve or reject the online CVS establishment profile as per section 6.4 of this document
notify the Responsible Inspector (RI) that the profile has been reviewed and approved or rejected
review CVS data reports to ensure awareness of trends and to identify potential areas of concern (for example: non-compliance that has not been corrected by the date specified by the inspector; repetitive situations of non-compliance; no identified non-compliance for long periods of time; task delivery rates etc.)
when concerns are identified as a result of reviewing the CVS data reports, follow-up with the inspector to gather information
communicate follow-up findings, including justification and rationale, up through the management chain of command to the Director General (DG)
provide support to inspection staff with respect to program and/or policy clarifications:
- questions related to CVS and verification task procedures are forwarded to the area CVS coordinator
- questions related to program and/ or policy issues are forwarded to the operational specialists
select and conduct verification tasks according to the verification process, as an inspector, when necessary
provide support to inspection staff with respect to situations of non-compliance and/ or enforcement
complete a verification task comments submission form whenever a need for change to a verification task is identified (see section 6.3 of this document). This form is forwarded to the area CVS coordinator for review and consideration

6.1.4 Regional Veterinary Officer (RVO)

The responsibilities of the RVO are to:

provide supervisory and/ or technical oversight at slaughter establishments
provide support to inspection staff with respect to program and/ or policy clarifications
provide support to inspection staff with respect to situations of non-compliance or enforcement
seek guidance and program clarification using established communication pathways, when needed
within CVS, wherever a "supervisory" responsibility exists, the RVO may fulfill that role as related to slaughter or veterinary specific activities:
- includes selecting and conducting verification tasks according to the CVS verification process, as an inspector, when necessary
- also includes reviewing and approving or rejecting the online establishment profile as per section 6.4 of this document
participate, as required in the completion of the section 4 verification tasks

6.1.5 Area CVS coordinator and regional CVS contacts

The responsibilities of the area CVS coordinator and regional CVS contacts are to:

support the delivery of CVS in their area/region
respond to issues and/ or questions about CVS and the verification task procedures from area operations staff and management. If clarification is required, seek advice from operational specialists, the area FSEP coordinator and the OGE
lead IR-CAR reviews requested by operator/licence holders and determines the outcome of the review; provides a response to the operator/licence holder
review proposed revisions, additions or deletions to the verification tasks received from Inspectors and supervisors with operational specialists. Submit the proposed revisions, additions or deletions to the Food Processing OGE for review and acceptance, by attaching the verification task comment submission form to an electronic Request for Action Form (e-RAF) (internal access only)

6.1.6 Area FSEP coordinator and regional FSEP contacts

The responsibilities of the area FSEP coordinator and the regional FSEP contacts are to:

respond to PCP and/or FSEP related issues/questions about verification tasks from the area CVS coordinator and operations staff
complete a verification task comments submission form whenever a need for change to a verification task is identified (see section 6.3 of this document). This form is forwarded to the area CVS coordinator for review and consideration
participate, as required, in the completion of the section 4 verification tasks

6.1.7 Area/Regional Operational specialists

The responsibilities of the operational specialists are to:

respond to meat program issues and/ or questions related to verification tasks from the area CVS coordinator and operations staff
provide support to the area CVS coordinator and operations staff as required
complete a verification task comments submission form whenever the need for change to a verification task is identified (see section 6.3 of this document). This form is forwarded to the area CVS coordinator for review and consideration.
participate, as required, in the completion of the section 4 verification tasks

6.1.8 National program specialists (Programs and Policy Branch/Food Import and Export Division)

The responsibilities of the national program specialists are to:

respond to issues/questions about verification tasks from the OGE
propose revisions, additions or deletions to the verification tasks as required when amendments are made to the applicable regulations and guidance. Submit the proposed revisions, additions or deletions to the Food Processing OGE for review and acceptance, by attaching the verification task comment submission form to an electronic Request for Action Form (e-RAF) (internal access only)

6.1.9 Operational Guidance and Expertise (OGE)

The responsibilities of the OGE is to:

respond to issues and/ or questions about CVS verification tasks from the area CVS coordinators and/ or the program and operations staff or managers that are submitted via an electronic Request for Action Form (e-RAF) (internal access only). Food Processing, Slaughter/Animal Health, Import/Export and Labelling OGE units are responsible for CVS questions related to their subject matter.
accept or suggest revisions to the verification task change requests received from program and operational specialists or area CVS coordinators (Food Processing OGE – See Section 6.3)
review, in consultation with the national program specialist, the national frequency for verification tasks at least annually, adjust and communicate the changes as required

6.1.10 Inspection Managers (IMs) and Directors of Operations (DOs)

The responsibilities of IMs and DOs are to:

ensure inspectors are allocated in a manner that provides resource flexibility while supporting the reporting requirements for DSIP
review CVS data reports to ensure awareness of trends and to identify potential areas of concern (for example: non-compliance that has not been corrected by the date specified by the inspector; repetitive situations of non-compliance; no identified non-compliance for long periods of time; task delivery rates etc.)
when concerns are identified as a result of reviewing the CVS data reports, follow-up with inspection staff to gather information
communicate follow-up findings, including justification and rationale, up through the management chain of command to the DG

6.2 Organization and frequency of verification tasks

See appendix A for more details on the organization of verification tasks.

6.3 Amendments to verification tasks

A verification task comment submission form (Form 5523) must be completed and submitted to the area CVS coordinator when verification task procedures need to be revised or when a new verification task is requested. Reasons for amendments may include, but are not limited to: change in regulatory requirements, change in importing countries' requirements, clarification of guidance, suggestions from inspectors or operation specialists to amend or reword a task etc.

The verification task comment submission form is available through desktop e-forms (See section 8.0 for more details). Instructions on how to complete the request are included with the form. The request on the verification task comment submission form must:

reflect the approach and style established for the tasks
support the common assessment for similar issues between groups/species
include accurate references to guidance and appropriate act and regulations
Only requests submitted on the verification task comment submission form will be considered. The form must follow the identified distribution path. The distribution path for the form is as follows:
forms initiated by field staff are distributed to the area CVS coordinator and further to the Food Processing OGE
forms initiated by area operations staff are distributed to the area CVS coordinator and further to the Food Processing OGE
forms initiated by Operational Guidance and Expertise (OGE) staff are distributed to the Food Processing OGE

At each step, the form is reviewed and adjusted, as required. When submitting the form to the Food Processing OGE, attach it to the e-RAF in SharePoint.

The area CVS coordinator reviews the proposed revisions, additions or deletions to the verification tasks received from inspectors and supervisors with area operational specialists. The proposed revisions, additions or deletions are then forwarded to the Food Processing OGE for review and acceptance.

Changes to the verification tasks are made by the Food Processing OGE in consultation with the the other OGE units as applicable. Changes that coincide with amendments to the guidance and/or Acts and Regulations are communicated via e-mail notification and/or directives, as required.

6.4 Assignment of verification tasks to an establishment

The inspector completes the establishment task profile by selecting verification tasks that are applicable to the establishment. This information is entered into the CVS database by the inspector. The establishment task profile template is available in the CVS application and will include all verification tasks that may be applicable to the establishment.

The establishment task profile is completed and / or reviewed by the inspector at the beginning of every fiscal year. The establishment task profile is also completed by the inspector when:

a new establishment begins operation
operations change in an establishment
program requirements change which impact the establishment and/ or the regulated activities
verification tasks are amended which impact the establishment

The establishment task profile must be approved by the supervisor prior to inclusion into the CVS data base.

Note: The supervisor must review and approve or reject the changes within 30 days of the changes being submitted. It is important to note that after 30 days the profile will revert back to the original state and the changes pending approval will be lost.

The Task Tracking table (internal access only) - RDIMS 3032387 is used by inspection staff to track the delivery of the verification tasks at each establishment. The task tracking table includes:

the establishment number
the task name
the task number
the task frequency
the field to enter the applicable rating or code when each task is completed

Note: Under the SFCR, operators/licence holders will have the freedom to build their PCP based on Codex HACCP principles or model them after FSEP or any of the globally accepted standards, for example, BRC, SQF etc. This means that the number of Critical Control Points (CCPs) for an operator/licence holder's written PCP may vary based on the model they choose to adopt.

In such cases, the inspector must ensure that the identified CCPs or control measures are verified using the specific verification tasks for the activity and not the generic CCP CVS Task 1.1.08. Additionally, the inspector must ensure that all additional specific requirements for CCPs are met (reference: SFCR, 89(1)(c)(iii)(iv)(v)) even though the CVS task procedure does not instruct inspectors to specifically do.

6.5 Scheduling and completion of verification tasks

Inspectors, supervisors and managers must ensure that verifications occur at varied times and all periods of production at the establishment are appropriately and proportionately covered. Certain verification activities will require the inspector to be present at the establishment during periods of non-production such as sanitation shifts, pre-operational inspections etc.

6.6 Operator's/licence holder's corrective actions and preventive measures

For the purpose of conducting verifications and meeting global food safety criteria, the operator should be able to demonstrate, to the inspectors, corrective actions taken to control non-compliant situations including implementing preventive controls to prevent recurrence.

During the verification if the operator/licence holder is unable to identify and/ or demonstrate preventive measures in place to prevent recurrence of the non-compliance, inspectors should ask the operator 'what measures will be taken to prevent the recurrence of the problem?' Operator's response should be documented. In the case where the licence holder/operator is unable to demonstrate the measures taken to prevent the recurrence of the problem and/or, when the inspector has evidence that those measure are not effective to prevent the recurrence, the inspector considers the corrective action to be incomplete and unsatisfactory.

7.0 Operational guidelines

There are seven steps to the verification task process:

Step 1 − Preparation for the verification
Step 2 – Gathering information to determine compliance
Step 3 – Assign compliance level
Step 4 – Communicate results and action required
Step 5 – Action plans and extension requests
Step 6 – Follow-up
Step 7 – File maintenance

Information related to these 7 steps and specific to section 4 verification tasks can be found in Annex B.

7.1 Step 1 - Preparation for the verification

7.1.1 Preparation for conducting verification tasks in sections 1, 2, 3, 5, 6

Prior to conducting a verification task, the inspector:

determines the verification tasks to be delivered by considering the following criteria and then prioritizes the order of delivery of the tasks based on relative risk:
- identifies if additional tasks need to be delivered as a result of the Outcome Assessment Task (OAT) (6.1.02)
- identifies any seasonal activities occurring and if there are any associated tasks with a mandated frequency related to the activity (for example CCP task, allergen task, etc.)
- identifies tasks on the task tracking table to be completed according to the minimum frequency
identifies written programs and documentation to be requested from the operator/licence holder
obtains written programs and documentation required to perform the verification task. This information may be requested from the operator/licence holder in advance

7.1.1.1 The Outcome Assessment Task (OAT) (6.1.02)

The OAT is used by the inspector to identify if tasks need to be selected for delivery. The goal of the OAT is to obtain a global picture of the integrity of the current processes in operation, the condition of the building, and the operating environment, by assessing the outcome of the control measures applied by the operator/licence holder.

Task 6.1.02 – OAT is conducted quarterly in slaughter and processing establishments. The OAT is conducted yearly in storages^Footnote 1.

Assessing the OAT observations and identifying tasks to be selected

Consider all information gathered during the OAT and the outcome of the operator/licence holder's control measures to determine if a more comprehensive inspection is required.

The following indicators indicate the needs for a more comprehensive inspection:

potential high risk to food safety, indicating the operator/licence holder's PCP may not be effective
a non-compliance to regulatory requirements, indicating the operator/licence holder's control measures may not be effective
potential fraudulent activities as per the consumer protection under SFCR (false and/or misleading labelling, etc.)

The inspector should select tasks using good judgement and principles of hazard analysis. To complete an outcome assessment, it is important to evaluate the cumulative impact of trends, the history of compliance, the actions already completed by the operator/licence holder, and the outcome observed during the on-site.

When the inspector determines, through the verification procedures of the OAT, that observations have no direct impact on food safety, do not compromise the intent of applicable legislation, and the outcomes do not represent a lack of control of identified hazards, the task(s) related to these findings do not need to be triggered. In such cases, the inspector should verbally notify the operator/licence holder of these findings.

The following examples are intended to be a guideline to demonstrate and assist in the assessment process when performing the OAT task. They are to be used in conjunction with the factors described above when making a decision. The list of examples is by no means exhaustive.

Consider if the operator/licence holder's PCP is working. When there are observations that may have an impact on the outcome of the PCP, ensure the operator/licence holder has had sufficient time to identify the issue and take appropriate corrective action(s). Consider if the operator/licence holder has previously identified the observation and scheduled corrective action(s). This may require revisiting the area to see if the issue was resolved, looking at the current record, and/or interviewing a company representative regarding actions which may have been taken. If the operator/licence holder's PCP is working and the issue(s) were identified and addressed, these tasks do not need to be selected
Is there a trend observed? Consider on-site observations, interviews, test results, complaints, previous CFIA inspection results, observations related to task(s) not selected, during the assessment of the previously completed 6.1.02, observations documented under code 9.1.10, etc. Is there a common link between findings? Does the repetitive nature of the issue cumulatively indicate a potential PCP integrity issue? If so, then the appropriate task(s) should be selected
Assess if a trend may demonstrate a need for a related task to be triggered or prioritized. For example, if there are repetitive pre-operational inspection observations, consider selecting the sanitation and/or water tasks, rather than the pre-operational task. Such findings may be an indicator that the previous steps in the process are ineffective (improper equipment disassembly prior to sanitation, improper chemical usage, insufficient sanitation practices, insufficient water supply, etc. to meet sanitation demands)
• Consider customer complaints where the operator/licence holder did not identify a root cause and/ or take appropriate corrective actions. Were any of the OAT observations related to the potential root cause for such complaints? For example, there was a complaint related to pieces of metal in a food product. During the OAT, there was damaged equipment observed and interview with the operator/licence holder indicated that the metal detectors had detected metal fragments around that time period. The operator/licence holder's investigation of the complaint did not identify equipment as a potential source or include an assessment of the metal detector results. The foreign material task and/or equipment maintenance task should be selected in this case
If there is a new or modified process validation where regulatory requirements mandate CFIA review prior to implementation (for example, a control that requires validation to prove effectiveness, or change in off-line reprocessing), select the appropriate task(s) as required
If the company implemented changes on-site, but during the interview it was noted that they did not update all parts of their PCP which could affect the integrity of their PCP, consider selecting the appropriate task(s). If the changes were made to the system accordingly, and the operator/licence holder demonstrated the system was updated and implemented, no tasks need to be selected

Note: If you have observed a cumulative trend that the company has not been updating their PCP accordingly, this may be a trigger for task 4.1.04 (see appendix B)

Evaluate the various factors related to changes in process and any mitigating information provided during the interview. Consider the level of impact on the effectiveness/integrity of the PCP. If the change represents a high level of risk, consider if a task needs to be selected.

**Examples**
Process that changed	Higher risk		Lower risk
Process that changed	Change factors	Impact	Change factors	Impact
Monitoring and/or verification frequency	Significantly decreased monitoring and/ or verification (for example, from weekly to once every 6 months)	Possible effectiveness of control may be compromised. If interview/on-site observations indicate a potential loss of control, consider selecting the related task(s)	Increased monitoring	Result is more frequent assessment by operator/licence holder. Minimal risk. No tasks selected.
New product line	New ground beef products, including production of precursor material	New steps, new process flows. Interview confirmed PCP was updated. Specific regulatory requirements for the control and testing of E.coli exist. Potential higher risk if not updated accordingly. Consider selecting the related task(s)	New ground pork product	New equipment is in place. Interview confirmed PCP was updated. No specific regulatory requirements. Minimal risk. No tasks selected.
New Piece of equipment	More complex (for example, RTE slicer, injector, grinder)	Significant changes to sanitation program, maintenance program, training of staff, process flow may change, etc. Consider selecting the related task(s).	Not complex (for example, new table, shovel, conveyor)	This type of equipment is already covered in sanitation and maintenance programs, not complex, no training needed, etc. Minimal risk. No tasks selected.

By using the above guidelines, select tasks to be conducted (if any) as a result of the OAT and document observations and conclusions onto the verification worksheet. The inspector may seek guidance from their established channels if they experience a difficulty in deciding if a task should be selected.

Any tasks selected as a result of the OAT should be considered for delivery and prioritized accordingly, as per section 7.1.1. Tasks selected as a result of the OAT must be delivered prior to the next OAT commencing. If the inspector requires assistance in completing all of the triggered tasks within this timeframe, the supervisor shall be notified as soon as possible.

Using the task tracking table and/or CVS worksheets, the inspector completing the OAT must verify that the tasks selected during the previous OAT were completed. If not, these tasks are to be coded as "E" or "I" along with the reason the tasks were not completed on the verification worksheet. The inspector should assess the information gathered during the current OAT to determine if the indicators persist, which would mean that the task(s) need to be selected again.

When an observation during the OAT requires control action(s) to be taken by the CFIA:

The inspector verbally notifies the operator/licence holder of the deficiency
The inspector ensures the situation (product, production, etc.) is under control, completes the OAT, and documents the observation(s). CFIA intervention indicates that the operator/licence holder's PCP or other control programs are ineffective. If time permits, the entire task is completed, rated "U" and an IR-CAR is issued. Or, if time does not permit, then the applicable sections of the task are completed, including record review, and an IR-CAR is issued following the timelines prescribed in section 7.4.3 of this document. The entire task must be completed at a subsequent visit.

7.1.2 Preparation for conducting section 4 verification tasks

See annex B

7.1.3 Preparation for conducting section 7 verification tasks

Inspectors must ensure that they have the necessary supplies, equipment and appropriate training to collect the sample(s). Establishment processing schedules must also be considered to ensure samples are collected as close to scheduled dates as possible.

7.2 Step 2 - Gathering information to determine compliance

7.2.1 Gathering information to determine compliance

The "verification task procedures" detail how to gather information for determining compliance for each task.

The tasks permit a thorough, in-depth evaluation of the operator/licence holder's compliance to regulations including development, implementation and maintenance of their PCP.

Inspectors should seek guidance and/ or clarifications, as required. Information can be gathered using four basic techniques:

examination of documentation and/ or records
visual/ on-site verification
interviews
product/ environmental sampling

Circumstances may prevent CFIA inspectors from attending a facility in person, or it may be more efficient to conduct part, or all of a verification task from a location other than the licence holder's place of business or establishment. Off-site interviews and/or document reviews can complement or replace on-site interviews and/or document reviews, when circumstances allow for effective compliance assessment. The decision to conduct these activities off-site can be made in consultation with a supervisor, and other subject matter experts (SME), if required.

Section 27 of the SFCA provides for the authority to an inspector to order the production of documents, information or samples for the purpose related to verifying compliance or preventing non-compliance with the SFCA.

This authority can be used for off-site inspections of PCP and traceability documents that are required respectively under sections 86 and 90 of the SFCR.

*Please note that section 22.1(1) of the FDA provides for a similar authority which is not applicable for the purpose of PCP and traceability document under the SFCA/R

When using the authority granted under section 27 of the SFCA, the inspector will:

identify the documents or any information deemed reasonable and necessary for their inspection, (be specific on dates of the document, describe the document /records, and only request what is related to the task(s) being assessed)
proceed by an order (preferably in writing for the purpose of proof and following enforcement measures in case of non-responsiveness)
identify the date and time for the document to be provided
identify the place where the document must be provided
identify the manner the document must be provided (by electronic means, by mail, etc.)

If the regulated party does not provide the information once it has been ordered, that is an offence per SFCA 39(1) and a violation under the Administrative Monetary Penalties (AMPs) regime.

Under SFCA and SFCR it is not always possible to take control actions as described without attending the physical location or "place". Inspectors will consult with their supervisor and other subject matter experts to determine the course of action if a control action needs to be carried out due to findings from an off-site inspection.

Examination of documentation and/ or records

The purpose of examining documentation and records is to:

ensure that regulatory requirements pertaining to documentation and records are being met
verify the validity of information gathered during on-site verification and interviews
verify that the regulated party's processes are implemented appropriately and are effective

Inspectors should review documents and records using the following guidelines:

assess written procedures that support the objectives of the task being conducted
review records to confirm that written procedures in place have been implemented effectively and that the regulated party's process is under control
review a cross-section of records to identify and observe any deviations and subsequent corrective actions taken
determine whether the corrective action has addressed the deviation or if there is an underlying, systemic problem
if there is a systemic problem that has potential impact to food safety or product compliance, gather additional information to verify that the control measures are implemented and effective

When reviewing the operator/licence holder's written program, the inspector should consider the following:

if written program(s) meet regulatory requirements
if the finding(s) demonstrate the integrity and effectiveness of the operator/licence holder's written program (such as no finding(s) that result in situations in which potential hazards are not controlled)

If one of the situations listed above is not met, it is considered a deviation that affects the integrity of the PCP. Therefore, the inspector must rate the associated task "U" and issue an IR-CAR. The inspector can always ask for support from the established channels before rating the task "U". The inspector must not wait for the section 4 verification tasks to identify these types of deviations.

If the integrity of the entire PCP is compromised, the inspector must contact the area FSEP coordinator who will evaluate the situation and provide the necessary support to the inspector.

Inspectors must review the operator/licence holder's written program and records at the establishment. Inspectors may obtain photocopies of these documents when the inspector believes, on reasonable grounds, that the documents are directly related to non-compliance with the SFCA, SFCR, and FDA, FDR and/ or other applicable legislation.

Records must be examined for completeness and accuracy. It is not necessary to examine all documentation that is available; a sample of the records produced since the last verification can be reviewed. If significant deviations and/ or problems are encountered, the inspector must expand the scope of record review to determine the extent of the problem. Inspectors must review a minimum of 5 records for each control measure (or all records since last time task completed if less than 5 generated) or 1 month for CCPs. Number of records reviewed can be expanded as needed based on findings.

When appropriate to do so, and/or when circumstances may prevent CFIA inspectors from attending a facility in person, documents and/or records may be reviewed off-site. These documents can be requested from the licence holder as part of the verification activities, and can be sent by e-mail, fax, delivered or mailed (hard-copy), or for very large files a FTP can be requested (see My IT Centre TI "Accounts and access"). The inspector can connect with the licence holder by e-mail, telephone, fax, or other secured communication platforms to ask questions about the PCP or records supporting the control measures.

Visual/ on-site observations

On-site observations are not limited to visual observations alone but include inspection of an establishment using our senses like hearing, touching and smelling.

The purpose of the on-site verification is to gather information to determine:

acceptability of the food being produced (for example, no contamination observed, no unacceptable odours, etc.)
if the conditions of the establishment could impact food safety or regulatory compliance
if the conditions and functioning of the equipment could impact food safety or regulatory compliance (for example, labelling)
if the employees are conducting work related activities in a hygienic manner and, when applicable, as per the established procedures

Interview employees

The purpose of the interview is to confirm that the employee:

understands and follows the procedures to produce safe and compliant food
understands corrective actions to be taken when issues or deviations arise, including actions to control affected or potentially affected product(s)
is aware of the importance of, and keeps accurate records, as applicable
If the inspector encounters a situation where the operator/licence holder is unwilling or unable to take action(s) to protect public health, protect consumers from fraud or protect animal welfare or health, the inspector must initiate actions to control the situation (See "Food regulatory response guidelines" for more information).

When appropriate to do so, and/or when circumstances may prevent CFIA inspectors from attending a facility in person, interviews can be conducted off-site. These can occur via the telephone, e-mail or fax if the identification of the interviewee can be verified. These interviews are not to replace on-site observations when the verification task indicates to go on-site and observe conditions and/or procedures, The on-site observation is still necessary in these circumstances.

7.2.2 Unscheduled verification findings (stumble-on)

While conducting a task or other inspection activity, if the inspector identifies a deficiency that is not related to the current verification activity (i.e. a stumble-on), the following actions must be initiated:

the inspector verbally notifies the operator/licence holder of the deficiency
the inspector is responsible for taking action(s) when necessary, to protect public health, to protect consumers from fraud and to protect animal welfare or health. Any time an inspector is required to take control of such a situation, an IR-CAR must be issued. The inspector adds the verification task related to the deficiency to the scope of the current verification activity
if time permits, the entire task is completed, rated "U" and an IR-CAR is issued. Or, if time does not permit, then the applicable sections of the task are completed, including record review, and an IR-CAR is issued following the timelines prescribed in section 7.4.2 of this document. The entire task must be completed at a subsequent visit
if the deficiency does not require immediate action(s) to be taken by the CFIA, the responsible inspector must record a brief description of the observation on the verification worksheet (CFIA/ACIA 5470) under the "activities conducted to assess compliance" (Box 10) using code 9.1.10. These observations will be considered and assessed at the next completion of the OAT (6.1.02) to determine if related task(s) require selection

Note: These actions also apply to any non-compliance identified during food safety investigations (recalls).

7.2.3 Identifying non-compliance that is related to an open IR-CAR

Important!

The guidance below must be applied when the observed non-compliance is directly related to the non-compliance identified in the open IR-CAR. If the observed non-compliance relates to the same task associated with the IR-CAR, but is not the same situation/type of non-compliance, the inspector must issue a separate IR-CAR.

When non-compliance is observed during completion of a regularly scheduled task or as a stumble-on and is directly related to a non-compliance already identified in an open IR-CAR, the inspector must consider the following:

is there a risk to food safety, consumer protection and humane treatment of animals
has the operator/licence holder attempted to correct the problem and is in control of the situation

Ultimately, the inspector must judge whether the situation demonstrates a loss of control by the operator/licence holder.

If it is evident that the operator/licence holder is unable to control the hazard(s), the inspector:

takes control action(s) as necessary to ensure the process/ situation is back under control
documents these actions/activities on the follow-up section of the IR-CAR. This will serve as 'information gathered' to support the decision as to whether or not to close the IR-CAR when the date for completion of corrective measures arrives
immediately informs the operator/licence holder that the information will be documented on the IR-CAR and will be considered to determine whether the IR-CAR can be closed or not
enters a "U" on the worksheet and notes the original IR-CAR number in the "items requiring correction" field on the verification worksheet. A new IR-CAR is not generated, however, it may be necessary for the operator/licence holder to implement revised corrective actions. This must be discussed during the meeting with the operator/licence holder. This information gathered supports the decision as to whether or not to close the IR-CAR when the date for completion of corrective measures arrives

If it is evident that the operator/licence holder is in control, the inspector:

enters an "A" on the verification worksheet for the task was being conducted as per the prescribed frequency

For example:

an IR-CAR is issued as a result of non-compliance identified with the CCP- cooking of bologna. The monitoring procedures and record keeping are not implemented as per the written program. One week later, while talking with employees and checking records in the cooking room, the inspector notices the exact same non-compliance for the CCP-cooking of wieners. The inspector must take immediate action(s) as necessary and document the non-compliance observed and, if applicable, the action(s) taken on the follow-up section of the open IR-CAR. The inspector must enter a "U" on the worksheet for the related task and note the original IR-CAR number in the "items requiring correction" field on the verification worksheet
an IR-CAR is issued as a result of non-compliance identified for detection of fecal contamination on offals. The following week, non-compliance is noted for the detection of fecal contamination on carcasses. Although it may be the same task related to the non-compliance (CCP task), it is necessary to issue a new IR-CAR because these are not the same control points. The cause and corrective actions will be different
an IR-CAR is issued as a result of a breakdown of the ventilation system which resulted in condensation above the product without appropriate action by the operator/licence holder. The following week condensation is also present elsewhere in the plant but there is no immediate food safety risk. The operator/licence holder has been able to demonstrate that adequate measures to control and correct the issue have been taken. It is not necessary to document this information on the open IR-CAR since the inspector considers that the operator/licence holder is in control of the situation and there is no immediate risk to product safety

Note: In slaughter establishments, the supervisory veterinarian is responsible to review and sign the IR-CAR. In the absence of the supervisory veterinarian, this activity may be delegated to a person designated by the supervisory veterinarian with the responsibility to review and sign the IR-CAR.

7.2.4 Verification worksheet

The Verification worksheet (5470) is completed by the inspector and is used to record:

establishment information
proof of DSIP
verification task performed or applicable code
activities conducted to assess compliance
level of compliance (rating) or code assigned to each task
items requiring correction

The verification worksheet is completed each time the inspector or the CFIA team visits the establishment. The applicable activity codes 9.1.12 or 9.1.13 must be recorded on the verification worksheet once every 12 hour period of production regardless of whether a compliance verification task was completed or not. The time in and time out (24 hour format) and the total time the inspector is present (excluding breaks and lunchtime) must be entered on the same line as the codes.

The activity codes 9.1.14 or 9.1.15 must be recorded on the verification worksheet once every 12 hour period of production when the establishment is operating outside their approved workshift. These codes must be used whether a compliance verification task was completed or not. The time in and time out (24 hour format) and the total time the inspector is present (excluding breaks and lunchtime) must be entered on the same line as the codes.

Activity code 9.1.16 establishment walk-through

The activity code 9.1.16 for establishment walk-through is completed once per quarter in slaughter and processing establishments, during one of the months when task 6.1.02 (OAT) is not scheduled to be delivered. The inspector walks through the facility to ensure no non-compliances requiring immediate action are noted.

At the completion of the walk-through, the inspector enters on the verification worksheet activity code 9.1.16, rates it "C" and enters the following in the activities conducted to assess compliance column:

toured the establishment to obtain an overall picture of the condition of the establishment

During the tour of the establishment, the inspector is responsible for taking action(s) when necessary to protect public health, to protect consumers from fraud and to protect animal welfare or health. Any time the inspector is faced with an unscheduled observation while walking through the facility, the inspector follows section 7.2.2 of this document i.e. unscheduled verification findings.

If the inspector is unable to complete the establishment walk-through before the end of the quarter, the inspector records 9.1.16 on the work sheet and uses code "E" or "I" as per coding verification tasks and activity codes.

Note: The exterior of the building and the employees facilities are not to be visited during this walk-through.

Activity code 9.1.16 must only be recorded on the verification worksheet once per quarter. The worksheet is for use by the inspector only and not for presentation to the operator/licence holder. Information related to items requiring correction will automatically populate the Verification Report which is then presented to the operator/licence holder.

Activity codes (unscheduled verification findings and daily presence)

9.1.10 - unscheduled verification findings (stumble-on's) – used to document unscheduled verification findings which do not require immediate CFIA action
9.1.12 - establishment is visited - proof of DSIP and administrative functions first 12 hour period of production
9.1.13 - establishment is visited - proof of DSIP and administrative functions second 12 hour period of production
9.1.14 - establishment is visited outside the operator/licence holder's approved workshift - proof of DSIP and administrative functions first 12 hours
9.1.15 -establishment is visited outside the operator/licence holder's approved workshift - proof of DSIP and administrative functions second 12 hours
9.1.16 - establishment walk-through is completed once per quarter in slaughter and processing establishments, during one of the months when task 6.1.02 is not scheduled to be delivered

Only daily presence activity codes 9.1.12, 9.1.13 must be selected on the establishment task profile (as applicable). Activity code 9.1.16 for establishment walk-through must be selected on the establishment task profile for slaughter and processing establishments.

Coding verification tasks and activity codes

E - the inspector is unable to complete a task or an activity according to the assigned frequency because the establishment/process was not operating. The inspector only assigns this code to the task when the frequency for the task has expired. For tasks without a prescribed frequency, this code is applied to any tasks that were selected by the previous OAT (6.1.02) and were not completed by the time the next OAT (6.1.02) is delivered. Activity codes 9.1.12 and 9.1.13 are coded "E" to indicate the establishment was NOT operating (meat operations) during the applicable 12 hour period, regardless of whether or not it was visited
I - the inspector is unable to complete a task or an activity according to the assigned frequency for a reason other than the establishment/process was not operating. The inspector only assigns this code to the task when the frequency for the task has expired. This code is applied to any tasks that were selected by the previous OAT (6.1.02) and were not completed by the time the next OAT (6.1.02) was delivered. Activity codes 9.1.12, 9.1.13, 9.1.14 and 9.1.15 are coded "I" to indicate the establishment was operating (meat operations) during the applicable 12 hour period but NOT visited
P - task started but not completed (rating is pending).This code is used when an Inspector begins a task and is unable to complete it during that visit. It is also used when a sample is submitted to a laboratory and results are pending. When the results of the sample are received the inspector would make a new entry and apply the appropriate rating
C - task or activity was completed and rating is not required. This code is used when a task or activity does not require a rating and applies to some current issue tasks that are in the form of a survey and certain tasks where a rating does not apply. Activity codes 9.1.12, 9.1.13, 9.1.14, 9.1.15 and 9.1.16 are coded "C" to indicate the establishment was visited

7.2.5 HACCP/ PCP verification worksheet

The HACCP/ PCP verification worksheet (CFIA/ACIA 5522) is used by the FSEP specialist inspector to record:

the verification scope
the activities conducted to assess compliance

7.3 Step 3 - Assign compliance level

Each task is assigned a level of compliance and rated accordingly. Based on the information gathered during the completion of a verification task, inspectors assign one of the following levels of compliance:

Acceptable level of compliance (task rated "A")
Unacceptable level of compliance (task rated "U")

7.3.1 Acceptable level of compliance (A)

The level of compliance is acceptable when the information gathered demonstrates:

there are no deviations that:
- could cause or have caused product contamination or adulteration
- affect the integrity and effectiveness of the PCP or other control programs
- presents a risk to consumer protection (fraudulent activity)
- affect animal welfare and/ or health
- contravene requirements related to CFIA Inspector facilities and/or stations
there are no deviations to the applicable export requirements

The inspector may identify minor items that have no impact on food safety and/or do not compromise the intent of applicable legislation. In this case, the level of compliance is still considered acceptable and the task is rated "A".

7.3.2 Unacceptable level of compliance (U)

The level of compliance is unacceptable when the information gathered demonstrates:

there are deviations to the applicable regulatory requirements or PCP that:
- could cause or have caused product contamination or adulteration
- affect the integrity and effectiveness of the PCP or other control programs
- presents a risk to consumer protection (fraudulent activity)
- affect animal welfare or health
- contravene requirements related to CFIA Inspector facilities and/or stations
there are deviations to applicable export requirements

Whenever a verification task is rated as "U" (when non-compliance is identified that is related to an open IR-CAR, see section 7.2.3) an IR-CAR must be issued as per sections 7.4.2 and 7.4.3.

7.3.3 Guidance for assigning a level of compliance

Inspectors must assess all of the information gathered prior to assigning a compliance level to a task. Every situation has to be assessed based on the context and using professional judgment to make compliance determination(s).

Inspectors should ask themselves the following questions during the analysis of information gathered:

is the situation a violation to a standard prescribed in the regulations (for example, microbiological standards, labelling standards, general standards related to control programs or PCP design)
when the situation is linked to the PCP or other mandatory control programs:
- has the information gathered demonstrated that the PCP or the mandatory control program is not designed or maintained to control the hazards inherent in the operator's/license holder's operations
- will the situation result in the manufacture, storage or sale of a food product that may pose a risk to the consumer
- has the operator/licence holder's controls in place failed to identify the unsatisfactory situations observed during the verification? (Inspectors must use judgment with regards to isolated events)
- has the operator/licence holder failed to implement effective corrective actions if the operator/licence holder's control measures in place have identified an unsatisfactory situation,
- is the situation generalized/recurrent
will the situation result in the marketing of a food product that leads the consumer to believe something about the product that is not true
is the situation a violation of an export requirement
does the situation result in cruel treatment of animals
will the situation directly affect control of animal health

Note: If the inspector answers yes to any of the questions above, the task should be rated 'unacceptable'.

If the answer to all questions is no, the task should be rated 'acceptable'. Documentation of the items observed is required if there is an added value (this means that the inspector determines that a follow-up is required and that keeping track of these items will demonstrate trends of non-compliance). These items are documented on the verification worksheet and presented to the operator/licence holder in the verification report.

What is meant by "deviations that could cause product contamination or adulteration"?

The operator/licence holder's PCP failed to identify and/or control a biological, chemical or physical hazard in a product or in the environment which may compromise the safety of the product being produced. For example:

product not regulated under the SFCR that is not properly identified and segregated
employees in contact with product are not adhering to hygienic practices
not doing a full clean up after processing products that contain allergens
not controlling condensation over exposed product
not controlling the cross-contamination of raw and cooked products
allowing inedible material to come in direct or indirect contact with edible product
not controlling evisceration accidents resulting in contamination of equipment, employees and/or area
not cleaning the floors and walls adequately due to overcrowded conditions
inadequate lighting that that does not allow operator's/license holder's employees to determine whether a substance on product is fecal material
temperature abuse of product which could result in an increased bacterial load
not meeting the thermal process critical limit and not taking an action
improper labelling of allergens
unacceptable laboratory results that demonstrate that the product contains unacceptable levels of a pathogen, a chemical contaminant or any other substance that is prohibited

What is meant by "compromises the integrity and effectiveness of the PCP"?

Deviations from the design or the implementation of the PCP which results in situations in which identified hazards are not controlled. For example:

the operator/licence holder is not performing the monitoring and/or verification procedures at the frequencies specified in the operator's PCP which results in a loss of control of the identified hazard
the operator/licence holder is not conducting the monitoring and/or corrective action procedures as specified in the written program (CCP) which results in a loss of control of the identified hazards
the operator/licence holder is following the written PCP but it is not effective to meet the regulatory requirements
the operator/licence holder is producing new products and the PCP has not been maintained / updated which results in situations where hazards are not controlled

What is meant by "compromises the integrity of other control programs"?

Deviations from the design or the implementation of a control program which results in situations in which potential hazards are not controlled or in deceiving consumers on the quality of a food product. For example:

the operator/licence holder is not following domestic pathogen reduction in program for poultry (or another validated approach) which results in a loss of control of the quality of the food product
the operator/licence holder is not following the Fundamentals of Post-mortem Defect Management Program and/or the Fundamentals of the Post-mortem Examination Program

(For example the Modernized Poultry Inspection Program (MPIP) presentation control program and/or the Modernized Slaughter Inspection Program in Hogs (MSIP)) which results in situations in which potential hazards are not controlled.

What is meant by consumer protection (fraudulent activity)?

Fraud indicates a violation of regulations which results in deceiving consumers on the nature, origin, quality or quantity of a food product. For example:

false/ misleading labelling information
AA meat packaged in boxes labelled AAA
pork and beef sausages labelled as all beef sausages

What is meant by "affects animal welfare"?

Violation of regulations which result in:

inhumane treatment of animals in the yard/barn
inhumane stunning or bleeding of animals prior to slaughter

What is meant by "affects animal health"?

Related to ante-mortem inspection:

failure to segregate animals exhibiting signs of foreign animal disease - for example in hogs, vesicular lesions on the snout
failure to train plant staff perform ante mortem inspection or screening for possible foreign animal diseases or zoonosis

Related to livestock traceability:

failure to record and report any identification or tag numbers or animals coming through the premise (required under the national identification regulations of the federal health of animals)
failure to keep records or respond to deviations in livestock identification and or poultry flock sheets
failure to identify and keep records for vehicles used to transport animals

Related to Specified Risk Material (SRM):

failure to implement an effective program to exclude SRM from animal feeds, pet foods and fertilizers

Related to biosecurity:

failure to ensure that poultry crates and transport vehicles are free of visible organic matter when leaving the establishment
failure to maintain a foreign animal disease contingency plan

Related to special situation disease control or depopulation:

failure to comply with regulations when slaughtering animals under special order or licence (for example, cervid slaughter, "animals designated by animal health as "of concern", TB reactors)
failure to identify those animals transported under permit or special A.H. circumstance

What is meant by "contravenes requirements related to CFIA Inspector facilities and/or stations"?

Deviations that result in:

occupational health and safety of inspectors being compromised
ergonomic considerations being compromised
impeded and unsafe access to travel to and from inspection stations to other areas of the establishment
failure to provide amenities as prescribed by SFCR, 58 (4) and 69

7.4 Step 4 - Communicate results and action required

Results of the verification tasks are communicated to the operator/licence holder through two documents:

the verification report (see 7.4.1)
the IR-CAR (see 7.4.2)

Note: For the purpose of this guidance, the Inspection Report - Corrective Action Request will be referred to as an IR-CAR.

These reports are available through desktop e-forms (See section 8). Detailed instructions are included with each form and are available in two formats: as pop-up help (help appears when you place the cursor over a field) and as a printable instruction page.

These documents are presented to the operator/licence holder in accordance with the following guidance:

meetings with the operator/licence holder (see 7.4.3)
HACCP based PCP design closing meetings (see appendix B)

7.4.1 Verification report

The verification report is used to communicate any items requiring correction by the operator/licence holder identified during the completion of the verification tasks (other than those deviations recorded on an IR-CAR). All information that appears on the verification report is automatically populated from the data entered by the inspector on the verification worksheet.

The verification report must be issued to operator/licence holders of processing and slaughter establishments once per week even if no deficiencies have been identified.

The verification report is issued at least yearly at storage establishments^Footnote 1

7.4.2 Inspection Report - Corrective Action Request (IR-CAR)

An IR-CAR is issued to an operator/licence holder by CFIA inspectors whenever a verification task is assigned an unacceptable level of compliance. The IR-CAR identifies the non-compliance and requires the operator/licence holder to implement corrective measures by a specified date. The IR-CAR also describes the information gathered during the follow-up inspection conducted after the date for completion of corrective measures specified on the IR-CAR.

When non-compliance is identified, the inspector must prioritize their activities to ensure that immediate inspectional control is initiated and actions are taken as appropriate. It is the responsibility of the operator/licence holder to implement temporary measures as necessary in order to meet the regulatory requirements prior to continuing the process/activity. The operator/licence holder then must investigate the cause of the deviation and apply corrective actions to bring the control measure, CCP or other regulatory requirement under control. These corrective actions must be implemented immediately.

Operator/licence holder must document the evidence that the control measures are effective, as per SFCR 89 (1)(c)(i), as applicable, including identifying and documenting any actions taken to control the situation. In order to achieve this, operators / licence holders can utilize guidance found in recognized food safety programs. These include model systems (FSEP Manual, QMP), interpretive guidance on corrective actions and any other model recognized in the industry. The inspector must endeavour to complete the related task as soon as possible and assign a level of compliance. If the task is rated "U" Unacceptable, the inspector must issue the IR-CAR no later than three (3) calendar days of completion of the task for which the non-compliance was identified. In the interim, if necessary, the immediate/short term measures still need to be implemented that will allow operations to resume. These measures are documented on the IR-CAR as part of the operator/licence holder's actions as per component 2 below.

The date for corrective measures specified by the inspector should reflect the seriousness of the non-compliance and the time required by the operator/licence holder to correct the non-compliance. In cases where food safety is affected, immediate corrective actions to restore control of the hazard must be implemented. In most instances, the time for completion of corrective measures is 60 calendar days from the date the IR-CAR is issued. Other factors to consider when the inspector is determining a date for corrective measures are impact on food safety, consumer protection, humane handling of animals, repeated instances of the same non-compliance and the time that may be required by the operator/licence holder to correct the non-compliance. Due to the nature of some corrective actions (such as construction, etc.) more than 60 days may be permitted for the completion of corrective measures.

Note:

In the case of Port Of Entry (POE) violations, dates specified in the IR-CAR for completion of corrective measures must adhere to any procedures outlined in "Port-of-entry (POE) violations and non-compliances".
In the case of the date specified for corrective measures for IR-CARs issued following a food recall, see appendix C of this document.
In slaughter establishments, the supervisory veterinarian is responsible to review and sign the IR-CAR. In the absence of the supervisory veterinarian this may be delegated to a person designated by the supervisory veterinarian with the responsibility to sign and date the IR-CAR.

7.4.2.1 Guidance for the description of the non-compliance

The non-compliance must be described in clear, factual and concise terms. The description of the non-compliance includes two components:

Component 1:

Each CVS task procedure contains a statement at the top (following the regulatory references), highlighted in orange colour which is the 'outcome' statement for that particular task. This statement describes what is being assessed when conducting the task. When non-compliance is identified, it means that outcome (as per the statement) is not being achieved and/ or met. Therefore, the form of the statement used as Component 1 should switch from positive to negative or from negative to positive (depending of the initial form of the outcome).

For example: For task 1.1.08, the outcome statement reads "Operator/licence holder meets the regulatory requirements related to effectively implementing a HACCP based PCP." This is what is being assessed during task 1.1.08. If an IR-CAR must be issued under this task, Component 1 would state: "Operator/licence holder does not meet the regulatory requirements related to effectively implementing a HACCP based Preventive Control Plan."
Component 2:

Describe the deficiency in clear and factual terms:
- that accurately reflects the deficiency identified
- does not offer solutions or opinions
- is related to the task
The description of deficiencies must:
- include what was observed, measured or obtained through interviews as they relate to the deficiency. Include where and when deficiencies were noted as well as the name or title of anyone interviewed. For example: "May 10, 2016 10:45 am observation made in the cutting room."
- if deficiencies were noted during the record review, include a summary of the review related to the deficiency. Include the name and date of the records reviewed and the deficiency noted.
  
  For example: "Reviewed the cooking reports that the responsible employee was completing during the on-site visit. Critical limit was not met at 9h20 and at 10h50. Monitoring records indicated 'acceptable' both times and thus ineffective in detecting that the critical limit was not met."
- if deficiencies were noted during written program review, include the name of the written program reviewed and the deficiencies noted. For example: "HACCP plan X, CCP2B: Monitoring procedures do not meet HACCP based PCP requirements. No frequency identified."
- if the operator/licence holder took control of product(s), animal(s) or thing(s), include a summary of the control and, if applicable, disposition of the affected product, animal or thing
- If the CFIA took action to control a product or thing, include a summary of the action. This action includes the application of a held tag, seizure and detention of a meat product or thing, refusal to certify a product for export or the initiation of a mandatory recall

7.4.3. Meeting with the operator/licence holder

In slaughter and processing establishments, the inspector must meet with the operator/licence holder at least once a week to discuss findings and any IR-CARs and/or the verification report. In storage establishments^Footnote 1, this meeting must occur no later than one week after a task was rated "A" with items requiring corrections or at least yearly if there are no items requiring correction. During meetings with the operator/licence holder, the inspector must communicate in a clear professional manner. The operator/licence holder may also want to share information or concerns at this time. In addition, the inspector and operator/licence holder must discuss other pertinent issues such as policy changes, planned changes at the establishment etc.

If there are no items requiring correction, the inspector:

informs the operator/licence holder that there were no findings to include on the Verification Report for the week (for the year in storages^Footnote 2)
signs the Verification Report which indicates "No Items Requiring Correction"
obtains the operator/licence holder representative's signature on the Verification Report to indicate that they were notified that there are no items requiring correction for the week (for the year in storages)
provides the operator/licence holder representative with a copy of the Verification Report

If a verification report is issued to the operator/licence holder with items requiring correction, the inspector:

discusses the items requiring correction listed on the verification report and the developing trends of non-compliance that those items reveal
informs the operator/licence holder that items requiring correction listed on the verification report require correction within 30 calendar days of the date the verification report was issued and that a failure to correct these deviations may result in the issuance of an IR-CAR
informs the operator/licence holder that after 30 calendar days of the date the verification report was issued, the CFIA will follow-up to verify that the items requiring correction have been corrected
obtains the operator/licence holder representative's signature on the verification report to indicate they were notified of the items requiring correction and they agree to correct these items within 30 calendar days of the date the verification report was issued. If the operator/licence holder fails to sign the report, the inspector notes on the report that the operator/licence holder refused to sign the report and that a copy was left with operator/licence holder representative's (name) and (title). The items still require correction and the inspector follows-up after 30 days
provides the operator/licence holder representative with a copy of the verification report

If an IR-CAR was issued to the operator/licence holder, the inspector:

discusses the non-compliance with the operator/licence holder and clarifies any concerns or questions that the operator/licence holder may have regarding the description of the non-compliance.
discusses with the operator/licence holder that they must implement corrective actions to return to a state of compliance and implement corrective actions for preventing or eliminating identified hazards or reducing them to an acceptable level. The operator/licence holder must document the evidence that the control measures are effective, as per SFCR 89 (1)(c)(i) and 89(1)(d)(viii), as applicable, including identifying and documenting any actions taken to control the situation. In order to achieve this, operators / licence holders can utilize guidance found on CFIA's website or in recognized food safety programs. CFIA guidance includes model systems (FSEP Manual, QMP) as well as interpretative and industry guidance available about corrective actions.
informs the operator/licence holder that the corrective actions(s) must be fully implemented by the date specified by the inspector (see section 7.4.3).
informs the operator/licence holder that corrective actions will be reviewed during follow-up to the IR-CAR
informs the operator/licence holder that the IR-CAR cannot be closed until the effectiveness of the corrective actions have been verified by CFIA. CFIA follow-up will occur on or after the date for completion of corrective actions specified on the IR-CAR (see section 7.6.2).
informs the operator/licence holder that a failure to implement corrective measures in relation to the non-compliance noted by the date specified in the IR-CAR may result in the initiation of the process to suspend the operator/licence holder's licence pursuant to sub-section 35(a) and (c) of the SFCR
obtains the operator/licence holder representative's signature on the IR-CAR to acknowledge receipt of the IR-CAR and notifies the operator/licence holder that by signing the IR-CAR they are still able to follow the recourse options available to them (see section 7.4.4). If the operator/licence holder refuses to sign the IR-CAR, the inspector:
- notes in the description of non-compliance section of the IR-CAR that the operator/licence holder refused to sign the IR-CAR, and that a copy was left with the operator/licence holder representative's name and title
- informs the operator/licence holder that they must follow section 7.4.4 if they wish to request a review of the IR-CAR
- informs the operator/licence holder that they are required to correct any deficiencies described on the IR-CAR that have an immediate impact on food products, animal welfare, animal health or consumer protection while the IR-CAR is subject to the review process
if the operator/licence holder refuses to correct the deficiencies described on the IR-CAR that have an immediate impact on food products, animal welfare, animal health or consumer protection, the inspector must take control action(s) as necessary and document the actions taken on the follow-up section of the IR-CAR
provides the operator/licence holder representative with a copy of the IR-CAR

7.4.4. Request for review of an IR-CAR

An operator/licence holder may request a review of an IR-CAR no later than 14 calendar days from the date the IR-CAR was issued. The operator/licence holder must submit the reason for the request in writing, to the area CVS coordinator. The request for review must include a copy of the IR-CAR as well as all relevant information that can be used by the area CVS coordinator to make a decision.

The operator/licence holder is required to correct the deficiencies described on the IR-CAR that have an immediate impact on food products, animal welfare, animal health or consumer protection, while an IR-CAR is subjected to the review process. If the operator/licence holder refuses to correct these deficiencies, the inspector must take enforcement actions.

The area CVS coordinator is responsible to:

review the request submitted by the operator/licence holder
contact the operator/licence holder to confirm receipt of the request and, as required, to seek clarification or further information
advise the responsible inspector and supervisor of the request
seek expertise from operational specialists or the OGE where necessary
lead IR-CAR reviews requested by operator/licence holders and determines the outcome of the review

A written decision is returned to the operator/licence holder with a copy sent to the responsible inspector, supervisor and the responsible operation specialists.

The inspector will describe in the follow-up section of the IR-CAR any decision taken by the CFIA with regard to the review process. The CFIA written decision must be attached to the IR-CAR.

If the decision is to uphold the IR-CAR, the area CVS coordinator will assign a new due date for the completion of corrective measures if deemed appropriate.

If the decision is to overturn the IR-CAR, the IR-CAR will be cancelled (closed). The inspector must note in the follow-up section of the IR-CAR that the IR-CAR was overturned as a result of a review by the CVS area coordinator and a copy of the closed IR-CAR provided to the operator/licence holder.

7.5 Step 5 – Action plans and extension requests

7.5.1 Action plans

Corrective actions are an integral component of an effective PCP. Appendix D of this document is a model operator's / licence holders may decide to use to plan and implement corrective actions. The information the operator/licence holder will document using this model would meet SFCR 89(1)(c)(vii) and SFCR 89(1)(d)(viii) regarding the documentation of evidence that the PCP was implemented.

Appendix D also gives a model that operators/licence holder may choose to use when an action plan is requested by competent authorities. For example, occurrences where CFIA is notified in writing of an official POE violation related to exported product and the foreign competent authority requests a written response (see here). Also see appendix D of this document for more information.

7.5.2 Request for an extension to implement corrective actions

The CFIA may grant an extension to the date for completion of corrective actions under the following circumstances:

food safety is not compromised
the operator/licence holder is unable to meet the specified date for completion of corrective actions due to reasons beyond their control
the operator/licence holder submits a written request for an extension before the specified date for completion of corrective actions
the written request includes the reason for the extension and a proposed new completion date

Note: All criteria must be met in order to qualify for an extension to the completion date.

If an extension is requested by the operator/licence holder, the inspector must attach the written request to the IR-CAR and record the following information in the follow-up page of the IR-CAR:

if the extension was accepted or not by the CFIA
if the extension was not accepted, the reasons for refusal
the new specified date the operator/licence holder has committed to for completion of the implementation of corrective actions

The inspector must provide the operator/licence holder's representative with a copy of the follow-up page of the IR-CAR.

7.6 Step 6 - Follow-up

Inspector follows-up on:

items requiring correction listed on the verification report
non-compliance identified on the IR-CAR

7.6.1 Follow-up on items requiring correction listed on the verification report

Responsible Inspector (RI) is required to follow-up on the resolution of the items requiring correction that are identified on the verification report as they become due. If the RI is unable to complete the follow-up, the RI makes arrangements with the supervisor to assign this work to another inspector.

When the verification report is issued, the operator/licence holder has 30 calendar days to correct the identified item. The inspector may follow-up at any time during that period, if the operator/licence holder has corrected the item.

After the 30 day period for correction is over, the inspector must ensure they complete follow-up for every item within the next 30 calendar days. During the follow-up the inspector determines if the items were resolved by the operator/licence holder.

To conduct the follow-up on items requiring correction listed on the verification report the inspector:

asks the operator/licence holder of the actions that were taken to resolve the identified item
verifies that the actions taken by the operator/licence holder by observing, inspecting, interviewing or reviewing records
verifies that the actions taken were effective to correct the items

The inspector must document the activities that were conducted to follow-up on the verification report. If it is determined that the item(s) requiring correction were resolved by the operator/licence holder, the inspector conducting the follow-up must choose the appropriate entry from the results field on the report and enter their name and the date of the follow-up. The inspector must provide the operator/licence holder with a copy of the updated verification report.

If the inspector determines that the item(s) requiring correction were not adequately resolved by the operator/licence holder, the inspector conducting the follow-up must choose the appropriate entry from the results field on the report and enter their name and the date of the follow-up. The inspector must provide the operator/licence holder with a copy of the updated verification report. The related task must be completed at a subsequent visit to the establishment. If at that time a similar non-compliance is identified, then an IR-CAR may be issued. If the inspector is unable to complete the task at a subsequent visit, the inspector must make arrangements with the supervisor to assign this work to another inspector.

7.6.2 Follow-Up on non-compliance identified on the IR-CAR

The CFIA will follow-up on the resolution of any non-compliance identified on the IR-CAR as soon as possible after the non-compliance has been corrected by the operator/licence holder but no later than 30 calendar days after the specified date of completion of corrective measures.

If non-compliance is observed during the course of conducting follow-up activities that demonstrates that the operator/licence holder is not in control, the inspector:

takes control action(s) as necessary to ensure the process is back under control.
documents the actions/activities on the follow-up section of the IR-CAR. This will serve as information gathered to support the decision as to whether or not to close the IR-CAR when the date for completion of corrective actions arrives
informs the operator/licence holder immediately that this information will be documented on the IR-CAR and will be considered to determine whether the IR-CAR can be closed or not

Note: Only situations that directly relate to the original IR-CAR should be documented as follow-up information. Non-compliances that are not related to the original IR-CAR cannot be documented in the follow-up section of the IR-CAR under review. In this case a new IR-CAR must be issued.

In order to conduct a follow-up inspection to the non-compliance(s) identified on the IR-CAR to determine if the IR-CAR can be closed, the inspector evaluates the following items:

the inspector reviews the operator/licence holder's document(s) that demonstrate(s) the implementation of corrective actions to address the non-compliance described in the IR-CAR.
the corrective actions taken to eliminate the cause by:
- observing conditions at the establishment
- reviewing any records generated by the corrective actions
- reviewing any written programs amended as a result of the corrective actions
- interviewing any affected personnel
the actions to prevent recurrence (preventive measures)
the acceptability of the product disposition, if applicable and not verified at the time the IR-CAR was issued by:
- reviewing and evaluating any records generated by the food safety assessment and product disposition

The inspector records the information gathered during the follow-up inspection in the "follow-up" section of the IR-CAR. The information must include:

the inspector's name and the date the follow-up inspection was conducted
any disposition of product, if applicable and not documented at the time the IR-CAR was issued
the name and date of any records reviewed
the name and date of any amended written programs reviewed
the name or title of anyone interviewed
any conditions observed at the establishment

If the inspector determines that the corrective actions were effective to correct the non-compliance and to prevent the recurrence of the deviation, the inspector completes the appropriate fields of the IR-CAR and the IR-CAR is closed. A copy of the closed IR-CAR is provided to the operator/licence holder.

If the inspector determines that the corrective actions were not effective, the inspector records the information gathered which supports the decision for refusing to close the IR-CAR in the follow-up section of the IR-CAR and the IR-CAR remains open. The information must include a list of the items that were not adequately corrected by the operator/licence holder. The inspector initiates control actions and/or recommend enforcement actions, as required, as per the Standard regulatory response process. A copy of the follow-up section of the IR-CAR is provided to the operator/ licence holder. The operator/ licence holder must be informed of the next step that will be taken by the CFIA.

7.7 Step 7 - File maintenance

Depending on the type of document, the following records are to be maintained either electronically or in hard copy at the establishment.

Note: A document is a record. Records may be stored electronically or in paper form (hard copy) with the exception of those that bear signatures. Hard copies must be kept of records that bear signatures.

Electronic records must be accessible to all staff that may require access (stored in RDIMS or on a shared drive with appropriate access rights).

Document	How long to retain a copy of each document
Establishment task profile	2 years
Task tracking table	2 years
Verification worksheet	2 years
HACCP based PCP design verification worksheet	2 years
Pre-licence verification checklist	10 years
Verification report (with original signatures)	10 years
IR-CAR including all follow-ups (with original signatures)	10 years

An electronic copy of the following documents is to be emailed to the CVS collector. Data from these documents is entered into the CVS database.

Document	When to email the document to the CVS collector
Verification worksheet	Verification worksheets must be submitted no later than one (1) week after the date of completion. The only exception is storages^Footnote 1, where the worksheet must be submitted no later than a week after a report is issued to an operator/licence holder or, at least, once a year.
IR-CAR	When the IR-CAR is first issued and once the IR-CAR is closed

8.0 List of forms

The table below lists all forms used during the completion and maintenance of verification tasks. Official documents described by this table can be accessed through your local CFIA inspector, veterinarian or CVS coordinator.

Name of form	Use	Platform	Form number
Verification task procedures	Provides detailed procedures on how to perform each verification task.	Microsoft Word	Not applicable
Verification task comment submission form	Used to submit proposals to create a new task or change the content or wording of an existing task	Desktop eForms	CFIA/ACIA 5523 (internal access only)
Establishment task profile	Used by the inspector to assign verification tasks to an establishment	CVS Online Application	Not applicable
Task tracking table	Used by inspection staff in each establishment to track completion of the verification tasks	Excel	Not applicable
Verification worksheet	Used by the inspection staff to track verification results and daily presence and populates the information that appears on the Verification Report	Desktop eForms	CFIA/ACIA 5470 (internal access only)
Pre-licence verification checklist	Used by inspection staff for task 4.1.03 for verification/review of significant changes to an already existing HACCP based PCP	Excel	Not Applicable
HACCP system/ PCP verification worksheet	Used by inspection staff to build the scope of section 4 CVS tasks (4.1.04, 4.2.01, 4.2.02, 4.2.03 and 4.3.01) and to record the activities conducted to assess compliance	Adobe	CFIA/ACIA 5522 (internal access only)
Verification report	Presented to the operator/licence holder to communicate non-compliances not noted on an IR-CAR	Desktop eForms	CFIA/ACIA 5470 (internal access only)
Inspection Report - Corrective Action Request (IR-CAR)	Issued to the operator/licence holder each time a task assigned an unacceptable level of compliance	Desktop eForms	CFIA/ACIA 5472 (internal access only)

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF) (internal access only).

Appendix A: Organization of tasks

A.1 Organization

Sections	Title	Sub-sections	Title
1	HACCP based Preventive Control Plan implementation	1	Specific control measures for product safety
		2	Prerequisite programs and control measures
		3	Slaughter/processing requirements and control programs
		4	Current issues
		5	Process controls
2	Consumer protection and other domestic requirements	1	Labelling
		2	CFIA stations and facilities
		3	Grading program
		4	Current issues
		5	Product segregation
3	Export	1	Export USA
		2	Export other than USA
		3	Export all countries
		4	Current issues
4	Comprehensive HACCP based Preventive Control Plan review	1	HACCP based PCP design effectiveness
		2	In-depth review
		3	Food recall
		4	Current issues
5	Animal welfare and animal health	1	Animal welfare and animal health
5	Animal welfare and animal health	4	Current issues
6	Outcome Based Verification	1	Outcome assessment
7	Sampling	1	operator/licence holder sampling
		2	CFIA domestic sampling
		4	Current issues

The verification tasks are organized into seven (7) sections and related sub-sections.

Section 1: HACCP based PCP implementation

The following sub-sections include verification tasks related to HACCP based PCP implementation and specific control programs/ measures.

Sub-section 1: Specific control measures for product safety
Sub-section 2: Prerequisite programs and control measures
Sub-section 3: Slaughter/processing requirements and control programs
Sub-section 4: Current issues
Sub-section 5: Process controls

Sub-section 1: Specific control measures for product safety

The control measure verification tasks are designed to assess the implementation and effectiveness of the operator/licence holder's HACCP based PCP to meet regulatory requirements. The tasks include: reviewing the written procedure and the records, interviewing, and observing to ensure that the written procedures being implemented.

The tasks in this sub-section may include operator/licence holder identified CCPs or other specific control measures recognized by the CFIA. In the case where operator/licence holder identified CCPs or other control measures are covered by another verification task in section 1 – sub-sections 2, 3 or 5, that CCP or control measure must be verified under that specific task instead of a sub-section 1 task.

Sub-section 2: Prerequisite programs and control measures

The prerequisite program and control measure verification tasks are designed to assess the implementation and effectiveness of the operator/licence holder's prerequisite programs and/ or control measures to meet regulatory requirements. The tasks include: reviewing the selected written prerequisite program and/ or control measures and records, interviewing, and observing to ensure that the procedures being implemented.

Sub-section 3: Slaughter/processing requirements and control programs

These verification tasks are designed to assess the implementation and effectiveness of the operator/licence holder's control programs, as well as compliance with other regulatory requirements related to slaughter and processing operations. The tasks include: reviewing any written control programs, reviewing records, directly observing and interviewing to determine if the regulatory requirements are met and the control programs are implemented effectively as described.

Sub-section 4: Current issues (applies to all sections)

The current issues verification tasks are developed as required. Tasks may be developed in the following situations:

extraordinary requests from the President of the CFIA
need for data collection on a specific subject of interest
survey to industry

Sub-section 5: Process controls

These verification tasks are designed to assess the implementation and effectiveness of the operator/licence holder's process controls. The tasks include reviewing any written programs, reviewing records, conducting independent and correlation tests, directly observing and interviewing to determine if the regulatory requirements are met and the process controls are implemented effectively as described.

Section 2: Consumer protection and other domestic requirements

The verification tasks included in this section are designed to assess compliance with consumer protection and other domestic regulatory requirement not covered under section 1.

The following sub-sections include verification tasks related to consumer protection and other domestic regulatory requirements.

Sub-section 1: Labelling
Sub-section 2: CFIA stations and facilities
Sub-section 3: Grading program
Sub-section 4: Current issues
Sub-section 5: Product segregation

Section 3: Export

The export verification tasks are designed to assess compliance with export requirements. The tasks include: directly observing if requirements are respected, reviewing any required written control programs, and reviewing records.

Each of the following sub-sections includes verification tasks related to export requirements.

Sub-section 1: Export USA
Sub-section 2: Export other than USA
Sub-section 3: Export all countries
Sub-section 4: Current issues

Section 4: Comprehensive HACCP based PCP review

The tasks included in section 4 are organized in 4 sub-sections:

sub-section 1: HACCP based PCP design effectiveness
sub-section 2: In-depth review
sub-section 3: Food recall
sub-section 4: Current issues

Sub-section 1: HACCP based PCP design effectiveness

The goal of verification tasks in this sub-section is to verify that the operator/licence holder's HACCP based PCP:

is designed to effectively control food safety hazards
meets the SFCA and SFCR requirements
is updated and maintained as changes occur to ensure food safety hazards remain under control

The HACCP based PCP design tasks are conducted and led by an FSEP specialist inspector. An FSEP specialist inspector is an inspector trained and evaluated to deliver section 4 tasks and SFCR licence reviews. In addition and where applicable, they provide advice and training to regional staff on PCP, FSEP and CVS related topics and carry out other area delegated responsibilities.

Task 4.1.03 – Changes and addition to an existing HACCP based PCP

This task is to be conducted in occasions where an operator/licence holder modifies its HACCP based PCP related to meat products in a fashion where it poses a high risk potential to food safety or humane treatment of animals.

The supervisor (or designate) must notify the area FSEP/CVS coordinator (or designate) of the modification of an existing HACCP based PCP.

The Area FSEP/CVS coordinator (or designate) will:

establish if the addition/change represent a high or low risk
establish if task 4.1.03 is required to be delivered (using the guidance found below)
in cases where 4.1.03 is required to be conducted, establish if implementation can start until the task is complete
make the necessary arrangements so a FSEP specialist inspector is assigned to the completion of the review
advise the operator/license holder's representative of that decision

Additional guidance for the area FSEP/CVS coordinator (or designate) to establish if task 4.1.03 should be conducted when an operator/license holder modifies its HACCP based PCP.

The area FSEP/CVS coordinator (or designate) must review the changes and determine if it poses a high risk or a low risk potential for food safety or humane treatment of animals:

High risk potential

Loss of control of the process could result in a significantly high risk. High risk category products or processes may involve any of the following criteria:

The process involves a kill step to eliminate microbial contaminants, or a step to reduce them to an acceptable level. For example, pasteurization, sterilization, cooking, drying, fermentation, acidification
Hazards are inherent to the process and the product is considered ready to eat, without further processing by the consumer
The production involves a complex recipe. It may involve the use of chemical hazards (for example, nitrates) or involve a product that addresses serious nutritional concerns
Humane treatment of animals, including the handling, stunning and bleeding, is impacted by the change (for example, the written PCP includes stunning of animals and the licence holder starts ritual slaughter without stunning)

For every change that poses a high risk potential, task 4.1.03 must be conducted. The area FSEP/CVS coordinator (or designate) determines if the review should be conducted prior or after implementation. In that determination, they consider different factors such as:

was there any high risk process at this establishment prior to the change or is that new (for example, the PCP already include the cooking into RTE products in a smoke house and it now will include cooking in a kettle; the PCP already included or excluded stunning of animals)
the compliance history of the operator/license holder in maintaining its HACCP based PCP (HACCP system), if any

When required prior to implementation, task 4.1.03 must be completed within 30 calendar days from receipt of the complete written procedures.

Lower risk potential

Lower risk category products or processes may involve any of the following criteria:

Hazards are inherent to the process but the processing controls are not designed to eliminate these hazards. Rather, the controls (such as proper sanitation and temperature control) are meant to prevent contamination or to prevent an increase to existing biological hazards. Product will be further processed by the consumer/client, who may need to follow specific handling and storage instructions. While it is necessary to minimize these hazards, deviations will moderately increase the health risks associated with the final product
Products are ready to eat but do not pose significant health hazards on their own
Humane treatment of animals is not impacted by the change (for example, the written PCP already includes stunning of animals and the licence holder starts ritual slaughter with stunning)

For every change that poses a low risk potential, task 4.1.03 must not be conducted.

Task 4.1.04 – Outcome of HACCP based PCP maintenance

This task is conducted at a minimum frequency of at least once every two years in all processing establishments, slaughter establishments, and storages^Footnote 1 by an FSEP specialist inspector and the responsible inspector (when operationally feasible).

Task 4.1.04 may also be performed when triggered by the OAT (6.1.02) or when the integrity of the HACCP based PCP is compromised. The supervisor (or designate) will notify the area FSEP coordinator (or designate) of the need for immediate support. The area FSEP coordinator will contact the supervisor and/or regional FSEP specialist inspectors and/or managers (as required) to evaluate the situation and when deemed appropriate, have task 4.1.04 delivered.

Sub-section 2: In-depth review

The goal of the in-depth review tasks is to verify that the operator/licence holder's HACCP based PCP is designed and implemented to effectively control the risk(s) associated with contamination by pathogens or other specific hazards. The in-depth review tasks are designed to focus on the hazard of concern. Any inspection findings observed outside of the scope should be addressed in accordance with section 7.2.2 of this document.

The in-depth review tasks are conducted in these situations:

when intensified inspections do not resolve the state of extended non-compliance after the following occurs:
- repetitive unsatisfactory test results indicating there may be a health risk associated with a product, either distributed in the marketplace or not, and/or
- confirmed illness/death cases related to food
if selected as a related task to address unscheduled verification findings during a food safety investigation (recall) related to the specific hazard, or
at the request of senior management

The in-depth review team may include but is not limited to:

the area/regional FSEP specialist
the veterinarian in charge (supervisory veterinarian)/responsible inspector
the responsible inspector
the regional veterinary officer
the regional program officer (meat)
the operational specialist

Other experts from national or area programs/operations/science/enforcement could be included in the in-depth review team, as deemed necessary for the situation.

Sub-section 3: Food recall

See appendix C for more guidance on actions required when a food recall is initiated for a meat product regulated under SFCR.

Task 4.3.01 (maintenance after a recall) must be initiated within 30 days from the original due date of the last IR-CAR issued in relation to the recall. Task 4.3.01 is completed by an FSEP specialist inspector as the lead, with assistance from the RI of the establishment. If no IR-CAR was issued as a result of the recall, then task 4.3.01 does not need to be completed. If the IR-CAR was issued under a subsection 4.2.00 "in-depth review" task, then task 4.3.01 does not need to be completed. The goal of task 4.3.01 is to verify that the operator/licence holder maintained their written HACCP based PCP accordingly following a recall.

Section 5: Animal welfare and animal health

The animal welfare and animal health verification tasks are designed to assess compliance with regulatory requirements. The tasks include: reviewing any written control programs, reviewing records, directly observing and interviewing to determine if the regulatory requirements are met and the control programs are implemented effectively as described.

Each of the following sub-sections includes verification tasks related to animal welfare and animal health.

Sub-section 1: Animal welfare and animal health
Sub-section 4: Current issues

Section 6: Outcome assessment

This section includes tasks that will be used by CFIA for purposes other than verifying operator/licence holder's compliance to acts and regulations and assigning a compliance level. This section includes the outcome assessment task which is used to evaluate the outcome of the control measures applied by the operator/licence holder by obtaining a global picture of the current processes, building conditions, and operating environment. The inspector will use the results of the assessment to trigger and prioritize verification tasks for delivery when situations are observed that may impact food safety, constitute fraudulent activities, or indicate the operator/licence holder's PCP may not be effective.

Section 7: Sampling

This section incorporates both, operator/licence holder sampling activities as well as the CFIA sampling activities. Tasks that verify export sampling requirements are located in section 3.

Sub-section 1: operator/licence holder sampling

operator/licence holder sampling tasks focus on elements of prescribed and non-prescribed sampling programs. This includes verifying written plans, sampling activities, frequencies and results. operator/licence holders are required to notify the CFIA of non-compliant product(s) and environmental results.

Based on the task guidance, if an IR-CAR is issued there may be follow-up sampling required. Follow-up samples and results received must be documented on the follow-up section of the IR-CAR. Follow-up sampling results do not require additional IR-CARs to be issued.

The only exception is in the case where an operator/licence holder notifies the CFIA of a positive Listeria environmental sample result. The inspector will issue an IR-CAR under task 7.1.02. Results of testing should be considered under task 7.1.04.

This ensures the positive product sample is differentiated from the environmental sample in CVS. Corrective actions scheduled and implemented by the operator/licence holder can be the same actions for both IR-CARs provided it meets the requirements and addresses both non-compliances.

Sub-section 2: Domestic CFIA sampling

These tasks encompass the scheduled domestic sampling plans conducted by CFIA inspectors in the field. It should be noted that these sampling tasks differ from other CVS tasks. The task rating is determined by the analysis result and not by the information gathered. In addition, there are no criteria to verify other than the sample collection. Each task will contain a certain amount of follow-up guidance. However, in each case the current guidelines must always be consulted.

Domestic – Microbiological sampling

In the case of domestic meat products sampled in accordance with the CFIA's microbiological sampling program, non-compliant or unsatisfactory product analysis results indicate that the operator/licence holder does not meet the regulatory requirements related to the manufacturing of edible meat products.

Follow-up samples that are related to an initial non-compliant or unsatisfactory result must be documented on the follow-up section of the IR-CAR. Non-compliant or unsatisfactory follow-up sampling results do not require additional IR-CARs to be issued.

The only exception is in the case where product samples are collected as a result of non-compliant environmental sampling results (task 7.2.11). The product sample must be collected and documented on the verification worksheet under task 7.2.01. If the product analysis result is non-compliant, another IR-CAR is issued under task 7.2.01.

This ensures the positive product sample is differentiated from the environmental sample in CVS. The corrective actions scheduled and implemented by the operator/licence holder can be the same actions for both IR-CARs provided it meets the requirements and addresses both non-compliances.

A.2 Task numbering

Each verification task is assigned a number. This number represents the section, sub-section, and sequential task number. The first part of the task number indicates the section, the second part indicates the sub-section, and the last part of the task number represents the sequential task number.

For example:

Task 2.2.02 is in section 2: consumer protection and other domestic requirements; sub-section 2: CFIA stations and facilities; and is the second task in this sub-section.
Task 3.1.02 is in section 3: export; sub-section 1: export USA; and is the second task in this sub-section.

A.3 Task frequency

Some verification tasks are assigned a minimum frequency. These frequencies are determined considering the:

impact on food safety
HACCP based PCP guidelines
type of control measures identified at the establishment
regulatory requirements
export requirements
state of compliance of the industry as a whole

Other verification tasks are to be conducted:

when they are selected as a result of the Outcome Assessment Task (OAT) − 6.1.02 or when the inspector identifies a deficiency that is not related to the current verification activity (i.e. a stumble-on); or
as required (the tasks provide an explanation of when it is required to conduct these tasks).

A.4 Verification procedures

The compliance verification system task procedures provide detailed procedures for each verification task. Each verification task procedure includes the following information:

section and sub-section
task number
task title
minimum frequency for delivery
date the task was last revised
references to the SFCA and SFCR and other applicable regulations
provisions of the SCFA and SFCR subject to administrative monetary penalties (information to be provided when available)
outcome of the task
the procedure to follow when completing each task to ensure the uniformity of application across the country; each verification task procedure includes:
- the requirements being assessed by each task
- how the inspector must assess the operator/licence holder's compliance to requirements.

Appendix B. Operational guidelines specific to CVS section 4 tasks

Although this appendix presents information pertinent only to section 4 tasks, inspectors must use this information in conjunction with the rest of the information found in this guidance document.

B.1 Step 1: Preparation for conducting section 4 verification tasks

B.1.1 Development of a scope for task 4.1.03 – Changes and addition to an existing HACCP based PCP

The scope will be limited to parts of the HACCP based PCP that would be affected by the addition/change (for example, specific control measures, CCP, recipe, label, shelf-life, other validation, etc.).

In case the inspector does not have sufficient information to build the scope, they may request additional information from the operator/licence holder. The inspector may choose to interview the company representative to select the appropriate sections of the operator/licence holder's HACCP based PCP to review.

B.1.2 Development of a scope for task 4.1.04 – Outcome of HACCP based PCP maintenance

The verification scope will include a review of the following documentation associated with:

the operator/licence holder's hazard analysis document / HACCP plan(s) Forms 1 to 9 (or equivalent)
control measures related to incoming ingredients, incoming material, production steps and areas where there is a potential for cross-contamination selected during the initial onsite visit (see task description)
selected control measures (CCP's and other control measures such as prerequisite programs) (see below)

Definition of "control measure" under SFCR 45

"Control measure means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of a food or to reduce the hazard to an acceptable level."

Even though a PCP is required to have measures ensuring that non-food safety requirements are met (for example, consumer protection and humane handling), only control measures related to food safety should be considered under section 4 tasks. PCP components related to consumer protection and humane handling must be verified using section 2 and 5 CVS tasks.

Under SFCR, the operator/licence holder has the flexibility to combine several controls for identified hazards into one or separate them out in their written program. In order to establish the scope, inspectors are encouraged to use table 1 provided below. Each control listed in the table should count as 1 control measure, regardless if the operator has grouped or separated these controls in their written HACCP based PCP.

Example:

Sanitation, typically counts as one control measure to control hazards associated with the activity. However, the operator/licence holder could chose to keep it as a control measure by itself or combine sanitation with the equipment maintenance.

Table 1: Grouping of control measures to use for scope selection during tasks 4.1.04 and 4.3.01 (unless the operator/licence holder has identified them as CCP)
Group 1	Group 2	Group 3
Premises Sanitizing installations Water and ice potability Transportation, purchasing, receiving, shipping and storage Receiving Shipping Temperatures of areas Ingredients, finished products and packaging materials handling, storage and rotation Ingredients / finished products temperature during production Equipment Preventative maintenance of equipment Equipment calibration Personnel General food hygiene Sanitation Sanitation Recall Recall system Product coding and labelling Operational programs Allergens – Weighing /blending/mixing /formulation Allergens – rework Allergens – labelling of finished products Allergens – control of cross-contamination Formulation and addition of food additives Modified atmosphere packaging Food processing aids Detection and/or removal of foreign material	Premises Building design and construction Building maintenance Lighting Ventilation – air exchange and filters Ventilation – air flow Ventilation – air utilized in processing equipment that comes into product contact Waste and inedible/food waste products Hand washing stations Water treatment Water – prevention of back-flow or back siphonage Water filters Water / steam - volume, temperature and pressure Water / ice storage Transportation, purchasing, receiving, shipping, and storage Carriers design, construction, maintenance, cleaning, temperature and usage Carriers - loading, arranging and unloading Purchasing Returned, defective or suspect product Non-food chemicals Equipment Equipment - design, construction and installation Pest control Pest control Operational programs Allergens - new or modified product formulations Allergens - purchasing Allergens - new or modified labels Allergens - receiving of ingredients and externally printed labels Allergens - disposal of obsolete materials Control the contamination of product by foreign material	Premises Outside property Light bulbs and fixtures - breakage Employees washrooms – hand cleaning stations Employees washrooms, lunchrooms and change rooms - maintenance Personnel General food hygiene training Technical training

Selection of control measures for the scope

Using the instructions below, the verification task procedure and the CFIA/ACIA 5522 worksheet, control measures are selected to review the outcome and effectiveness of the operator/licence holder's HACCP based PCP.

1. Select control measures related to any trends identified in the information gathered which demonstrate that the integrity of the HACCP based PCP may be compromised.

The CFIA team must review CFIA inspection records and discuss findings/concerns with the local inspection staff to determine which sections of the operator/licence holder's HACCP based PCP might be compromised. Repetitive issues which are related could indicate that the operator/licence holder has not maintained their HACCP based PCP effectively and it may be compromised. Assess the following when looking for such trends:
- operator/licence holder's compliance history (repetitive verification reports and/or IR-CARs) including effectiveness of corrective actions
- consumer complaints investigated by the CFIA
- CFIA sampling results, including the operator/licence holder's corrective action when unsatisfactory results were obtained
- product detentions and other enforcement actions taken
2. Select control measures related to the changes and/or situations that impact the operator/licence holder's HACCP based PCP.

The CFIA team must interview the appropriate operator/licence holder's representative(s) to determine whether any of the following situations have occurred:
- change due to new regulatory requirements
- new product
- new product line that could potentially cause cross-contamination
- new ingredient and/ or incoming material that comes in contact with the product or is used for preparing the product
- new ingredient and/ or product that contains allergen
- new process step
- new technology or piece of equipment that impacts the level of a hazard (such as eliminate, reduce or increase the level of biological, chemical or physical hazards)
- potential of cross-contamination due to new/on-going construction or change in the product flow and or employee traffic patterns
- new control measure for an identified hazard
- change in product description (shelf life, labelling instruction, finished product distribution, etc.)
- change in product formulation
- change in processing methods that required new training and new control measures
- change in production volume that impacts the product flow, sanitation schedule, employee training, etc.
- change in sanitation/cleaning procedures (such as decrease or increase of time, temperature, chemical strength during CIP operations)
- change in the application of current control measure at a CCP (for example, change in critical limit)
- change in the application of a current control measure
- emergence of a previously unidentified hazard
- company's unsatisfactory lab results
- consumer or client complaints
If any of these changes and/or situations have occurred, the CFIA team must consider their impact on the integrity of the HACCP based PCP, food safety and regulatory compliance and subsequently, select the appropriate control measures to include in the scope based on this assessment. The focus of this task is to verify that the operator/licence holder has effectively maintained their HACCP based PCP following the change and that their HACCP based PCP is up-to-date and compliant.
3. Select additional control measures, as required, to make up the minimum number of control measures to be reviewed.

The scope of task 4.1.04 must include:
- the CCP's from at least one HACCP based PCP plan but limited to 10 (if the operator's PCP does not follow a HACCP based approach or if the operator's written HACCP based PCP contains more than 10 CCPs), if applicable
- at least 10 control measures (but no more than 20) (including the control measures that are related to the incoming material / ingredient, processing steps and areas of potential cross-contamination).
If the number of non-CCP control measures selected as a result of the previous 2 sections and during the on-site visit (see task 4.1.04 verification procedure) does not meet this minimum number, select additional control measures considering the grouping of the control measures in table 1.

The control measures have been grouped according to their impact on food safety (see table 1), with group 1 having the most impact and group 3 having the least. Emphasis should be given to group 1 but other control measures may be selected from the other groups to verify a broader cross section of the operator/licence holder's food safety program, or to vary what was selected as part of the scope during the previous section 4 task.

Development of a scope when triggered by task 6.1.02 and/or request for support when integrity of the HACCP based PCP is compromised (task 4.1.04)

The scope selection must be based on the reasons this task was triggered. Use the information gathered from task 6.1.02 and/or review verification worksheets, verification reports and IR-CARs, discussion with the responsible inspector and/or their supervisors, and interview with the operator/licence holder's representative to select the appropriate sections of the operator/licence holder's HACCP based PCP to review. The scope must include a review of the HACCP based PCP control measures that may be impacted.

There are no minimum or maximum limitations to scope selection, when triggered by 6.1.02. The scope shall focus on the areas of concern only, based on information gathered. This will determine if the PCP is effectively maintained. Any inspection findings observed outside of the scope of this task should be addressed in accordance with section 7.2.2 of this document.

Opening meeting with the operator/licence holder representative(s) for task 4.1.04

During the opening meeting, the FSEP specialist inspector:

introduces the members of the CFIA team to the operator/licence holder representative(s)
explains the purpose of the assessment of the HACCP based PCP design and how it differs from the day-to-day verification that is done by the inspector. The goal of task 4.1.04 is to determine if:
- the HACCP based PCP was effectively maintained, as needed
- written control measures are designed and implemented to address all hazards associated with the licence holder's/operator's activities and premises
- the observed outcomes demonstrate effective controls
presents the partial verification scope and obtains the applicable written programs and other related documentation from the operator. Explain to the licence holder/operator that the scope will be finalized after the initial on-site visit (unless the task was triggered during the OAT).
confirms the expected duration of the verification according to the scope
explains that observations may be communicated verbally, during the course of verification for which no inspection report will be issued and no follow-up activities will take place
explains that it is the operator/licence holder's responsibility to take notes and apply corrective actions throughout their system for any verbal observations

B.1.3 Preparation for conducting section 4 in-depth review tasks

Steps prior to conducting an in-depth review

Prior to conducting an in-depth review at the establishment, the CFIA team must review all relevant data and analyze the issues surrounding the trigger for the in-depth review.

Relevant data may include:

CVS documentation including worksheets, inspection report, IR-CARs and operator/licence holder's corrective actions
consumer complaints
enforcement data
CFIA and operator/licence holder laboratory results

The CFIA must provide the operator/licence holder advance notice of the visit.

Opening meeting with the operator/licence holder representative(s)

During the opening meeting, the FSEP specialist inspector:

introduces the members of the CFIA team to the operator/licence holder representative(s)
explains the purpose of the in-depth review. The goal of tasks 4.2.01, 4.2.02 and 4.2.03 is to determine if:
- the written PCP is designed and implemented to efficiently control the hazards associated with one specific pathogen.
- the operator/licence holder has identified the source of a recent and/or persistent presence for one specific pathogen.
the observed outcomes demonstrate effective controls.
discusses the scope of the in-depth review (the scope of the in depth review is pre-determined by type of in-depth review task being conducted)
obtains the operator/licence holder's written programs and other related documentation
confirms the expected duration of the in-depth review

Note:

the results of the in-depth review are presented to the operator/licence holder on an IR-CAR
the operator/licence holder must re-evaluate existing corrective action(s) they have scheduled (if any) and then may revise and combine them in order to address all open IR-CARs related to the same non-compliance

B.1.4 Preparation for conducting task 4.3.01

Steps prior to conducting task 4.3.01

Prior to conducting task 4.3.01 at the establishment, the FSEP specialist inspector must:

provide the operator/licence holder advance notice of the visit
review all available relevant data related to the food safety investigation and recall which triggered the delivery of task 4.3.01. Relevant data may include:
- CVS worksheets (including observations documented under 9.1.10) and verification reports, IR-CARs, operator/licence holder's corrective actions
- consumer complaints
- Issues Management System (IMS) file(s)
- CFIA and/or operator/licence holder laboratory results

Opening meeting with the operator/licence holder representative(s)

During the opening meeting, the FSEP specialist inspector:

introduces the members of the CFIA team to the operator/licence holder representative(s)
explains the purpose of task 4.3.01 The goal of task4.3.01 is to determine if:
- the HACCP based PCP was effectively maintained, as needed
- written control measures are designed and implemented to address all hazards associated with the licence holder's/operator's activities and premises
- the observed outcomes demonstrate effective controls
discusses the scope of the task
obtains the operator/licence holder's written programs and other related documentation
confirms the expected duration of the review

B.2 Step 2: Gathering information (additional guidance on gathering information during task 4.1.04)

For any observations which may indicate a potential lack of control of a hazard, the CFIA team must verify if the operator/licence holder can demonstrate control through another section of their HACCP based PCP.

If a review of the operator/licence holder's HACCP based PCP indicates that a control measure is missing, incomplete, or does not meet regulatory requirements to the point where there is an observable impact on the effectiveness of the outcome of the control of a hazard, add only the specific parts of the operator's hazard analysis document (or equivalent document i.e. HACCP plan forms 1 -9) to the scope. Then verify if the specific hazard identification, description, and control(s) are also missing or incomplete. The entire document, form and/or HACCP plan should not be reviewed. CFIA must select and review only the appropriate sections of the hazard analysis document/ HACCP plan directly related to the uncontrolled hazard.

Select the specific product characteristic, ingredient, process step, or cross contamination point related to the uncontrolled hazard observed and review the associated hazard descriptions and identified controls for these items. Inspectors should verify that the presented document:

has effectively identified all the incoming material, process step or flows and the related hazard(s)
contains description of all associated hazards and these are accurate
contains an accurate analysis and determination of control measures (CCPs and other control measures)
contains an accurate identification of hazards identified as not controlled by the operator/licence holder (if applicable)

It is only necessary to gather sufficient information to demonstrate that the operator's/ licence holder's HACCP based PCP was not effectively maintained to meet the outcome of the control measures reviewed. Therefore, it is not the responsibility of the CFIA team to generate a complete list of non-compliances identified throughout the operator/licence holders' entire HACCP based PCP. It is the operator/licence holder's responsibility to ensure that any observations are corrected throughout their entire HACCP based PCP.

B.2.1 Unscheduled verification findings (stumble-on)

When an unscheduled verification finding is identified during the section 4 tasks, the following actions must be initiated:

the FSEP specialist inspector verbally notifies the operator/licence holder of the deficiency
if the non-compliance is observed outside of the scope selected for the section 4 task which requires control action(s) to be taken by CFIA, this is considered an unscheduled verification finding. The FSEP specialist inspector (if the RI is not present) takes control actions, notifies the RI and the supervisor. An IR-CAR is issued and followed-up on by the responsible inspector
if a non-compliance is observed outside of the scope selected for the section 4 task, but does not require control action(s) to be taken by CFIA, the responsible inspector or the FSEP specialist inspector must use the code 9.1.10 and note on the verification worksheet CFIA/ACIA 5470 in the "activities conducted to assess compliance" a brief description of the finding which will be reviewed and assessed during the delivery of the next OAT (6.1.02).

B.3 Step 3: Assigning a level of compliance for tasks 4.1.04 and 4.3.01 with an outcome-based approach

There is no option for an "A" – acceptable rating with items requiring correction, for tasks 4.1.04 and 4.3.01. When the task is rated "A" the observations are verbally communicated to the operator/licence holder and identified under inspector notes.

All observations gathered during the completion of the tasks must be assessed against the outcome on the effectiveness of the HACCP based PCP to determine the rating. If a non-compliance with observable impact is noted, and is related to the scope selected for tasks 4.1.04 or 4.3.01, then the observations are considered evidence that the PCP's control measure is not effective to ensure the PCP is effectively controlling the identified hazard.

As part of the Food Safety Enhancement (FSEP) Manual, specific forms and a pre-requisite program structure were developed, along with other tools such as the reference database for hazard identification and generic models. These resources can be used by an operator/licence holder when developing their written HACCP based PCP. However, it is acceptable if an operator/licence holder uses other globally accepted models and/ or control program(s) and/or resources (for example, BRC, SQF etc.). The content must meet the minimum requirements outlined in the SFCR, must be based Codex Alimentarius guidelines, HACCP principles, and other applicable acts and regulations.

Observations of non-compliances to the FSEP manual related to program design are not rated as unacceptable as the operators/licence holders can use any model system they chooses to meet regulatory requirements. They should neither be included in an IR-CAR nor communicated verbally to the operator.

Observations of non-compliances related to the preparation and maintenance of the programs that do not have an observable impact on the outcome are not rated as unacceptable. Such observations will be verbally communicated to the operator/licence holder. Program design observations that have an observable impact on the outcome of the control of the hazard are rated as "U" unacceptable.

However, there are some exceptions to this. The following design-related written program observations would be rated "U" unacceptable:

critical limits of CCPs not meeting lethality / validated standards
- validation determines critical limits and food safety parameters to be met. Critical limits and other standards may not be valid if they do not match what is presented in the validation documentation. On-site observations would be important to determine if CFIA control is warranted
incomplete validation of critical limits
- there is no supporting evidence that the standard is effective to control hazard. Validation determines critical limits and food safety parameters to be met. Critical limits and other standards may not be valid if they are not supported by complete validation documentation. On-site observations would be important to determine if CFIA control is warranted
entire control measure is missing. For example:
- there is no written program associated with a control measure
integrity of the HACCP based PCP is compromised, regardless on on-site findings

On-site observations would determine if CFIA control is warranted and if hazard controls are in place

B.4 Step 4: Communicating results

B.4.1 Guidance for description of the non-compliance for IR-CARs issued under tasks 4.1.04 and 4.3.01

due to the large scope of tasks 4.1.04 and 4.3.01, some observations may not necessarily be related to the IR-CAR issued. When such observations are included in an IR-CAR, they detract from the focus of the essential non-compliance. The focus of tasks 4.1.04 and 4.3.01 should be the outcome. Any evidence documented should provide clear support for the unsatisfactory rating. The CFIA team conducting tasks 4.1.04 and 4.3.01 will assess the information gathered to conclude if the observations indicate that the integrity of the operator/licence holder's HACCP based PCP has been compromised
every observation does not necessarily need to be documented if it provides no additional value to the finding. The operator/licence holder is not only responsible for addressing the observations identified by the inspector, but also for correcting the issue(s) throughout their HACCP based PCP
the goal of tasks 4.1.04 and 4.3.01 is to determine if:
- the HACCP based PCP was effectively maintained, as needed
- written control measures are designed and implemented to address all hazards associated with the licence holder's/operator's activities and premises
- the observed outcomes demonstrate effective controls

This should be reflected in the way the IR-CAR is written. The beginning of description of the non-compliance of an IR-CAR should be worded as follows:

Component 1 (for tasks 4.1.04 and 4.3.01)

The operator/licence holder does not meet the regulatory requirements related to preparing, keeping and maintaining an effective written HACCP based PCP.

The operator/licence holder is responsible for ensuring this issue is addressed throughout the entire HACCP based PCP and ensuring all regulatory requirements are met. Measures must also be applied to enhance the operator/licence holder's activities regarding the maintenance of its PCP so they will be able to maintain an effective and up-to-date PCP. Observations were made which indicate non-compliance(s) were identified and demonstrates that the licence holder failed to prepare and maintain a preventive control program (PCP) that meets regulatory requirements. These observations include, but are not limited to….
Component 2

Describe the deficiency in clear and factual terms that:
- accurately reflect the deficiency identified
- does not offer solutions or opinions
- is related to the task
The deficiencies included in component 2 must only include those which support the decision to issue the IR-CAR. The inspector must avoid including long lists of examples in order to illustrate the observed deficiencies. It is the operator/licence holder's responsibility to ensure the deficiencies are corrected in every applicable section of their HACCP based PCP.

Note:
- if deficiencies were noted during written program review, include the name of the written program reviewed and the deficiencies noted
- include what was observed, measured or obtainedthrough interviews as they relate to the deficiency. Include where and when deficiencies were noted as well as the name or title of anyone interviewed. For example, "January 15th, 2019 at 10:45 am observed in the cutting room."
- if deficiencies were noted during the record review, include a summary of the review related to the deficiency. Include the name and date of the records reviewed and the deficiency noted.
  For example: "Reviewed the cooking reports and the employee responsible for completing, during the on-site visit. Critical limit was not met at 9h20 and at 10h50. Monitoring records indicated 'acceptable' both times and thus ineffective in detecting that the critical limit was not met."
- if the operator/licence holder took control of product(s) or thing(s), include a summary of the control and, if applicable, disposition of the affected product(s) or thing(s).
- if the CFIA took action to control a product or thing, include a summary of the action. This action includes the application of a held tag, seizure and detention of a product or thing, refusal to certify a product for export or the initiation of a mandatory recall.

B.4.2 HACCP based PCP design closing meeting

The CFIA team responsible for verifying the outcome of the operator/licence holder's HACCP based PCP (tasks 4.1.04 and 4.3.01) conducts a closing meeting with the operator/licence holder's representative.

If an IR-CAR was issued to the operator/licence holder, the FSEP specialist inspector:

discusses the non-compliance(s) with the operator/licence holder and clarifies concerns or questions that the operator/licence holder may have regarding the description of non-compliance
informs the operator/licence holder that a failure to implement corrective measures in relation to the non-compliance noted by the date specified in the IR-CAR may result in the initiation of the process to suspend the operator/licence holder's licence pursuant to sub-section 35(a) and (c) of the SFCR
the timelines specified by the inspector should reflect the seriousness of the non-compliance and the time required to correct the non-compliant section of the HACCP based PCP. Due to the nature of HACCP based PCP design task, IR-CARs generated as a result may require a specified timeline for completion of corrective measures that is over 60 days
informs the operator/licence holder that they must implement corrective actions for preventing or eliminating the identified hazards or reducing them to an acceptable level and must document the evidence that the control measures are effective, as per SFCR 89 (1)(c)(i), as applicable, including identifying and documenting any actions taken to control the situation. In order to achieve this, operators / licence holders can utilize guidance found in recognized food safety programs. These include model systems (FSEP, QMP), interpretative guidance on corrective actions and any other model recognized in the industry.
obtains the operator/licence holder representative's signature on the IR-CAR to acknowledge receipt of the IR-CAR and notifies the operator/licence holder that by signing the IR-CAR they are still able to follow the recourse options available to them (see section 7.4.4). If the operator/licence holder refuses to sign the IR-CAR, the inspector:
- notes in the description of non-compliance section of the IR-CAR that the operator/licence holder refused to sign the IR-CAR, and that a copy was left with the operator/licence holder representative's name and title
- informs the operator/licence holder that they must follow section 7.4.4 of this document if they wish to request a review of the IR-CAR
- informs the operator/licence holder that they are required to correct any deficiencies described on the IR-CAR that have an immediate impact on food products, animal welfare, animal health or consumer protection while the IR-CAR is subject to the review process
if the operator/licence holder refuses to correct the deficiencies described on the IR-CAR that have an immediate impact on food products or animal health the inspector must take action as necessary and document the actions taken on the follow-up section of the IR-CAR.
provides the operator/licence holder's representative with a copy of the IR-CAR

If no IR-CAR was issued to the operator/licence holder, the FSEP specialist inspector:

discusses observations made during findings that did not support the issuance of an IR-CAR but that could evolve into a trend of non-compliance if not addressed by the operator/licence holder (if any)
informs the operator/licence holder that no follow-up activities will take place and that the operator/licence holder is responsible to continue maintaining their HACCP based PCP, including the corrections of the findings discussed

B.5 Step 5: Action plans and request for an extension to implement corrective actions

No specific information is available for section 4 tasks. See section 7.5 of this document.

B.6 Step 6: Following-up on non-compliances identified in an IR-CAR related to section 4

The focus of the follow-up for task 4.1.04 is to verify that the operator/licence holder's PCP is capable of identifying the types of non-compliances identified on the IR-CAR. The follow-up to IR-CAR's issued under task 4.1.04 includes:

a review of the corrections of the non-compliances specifically identified in the IR-CAR
a review of the actions taken to prevent the reoccurrence of the operator's/licence holder's default to maintain and efficient and up-to-date HACCP based PCP

Note: The operator/licence holder is only required to have applied corrective actions to parts of their HACCP based PCP which was referenced in the IR-CAR issued. The follow-up would not expand outside the original scope. The operator/licence holder is still responsible for applying corrective actions throughout the entire HACCP based PCP, on a later date.

B.7 Step 7: File maintenance

No specific information is available for section 4 tasks. Consult section 7.7 of this document.

Appendix C: Inspection activities in response to a meat product regulated under SFCR

When a supervisor/inspector becomes aware that a food recall has occurred, they are to use the following instructions to verify whether the licence holder 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 the Inspection Report (IR-CAR).

If the recall is a result of a planned or permission inspection, there is no need to conduct an additional CVS task. The non-compliances identified during the food safety investigation and the verification of the applicable task will be captured in the follow-up section of the IR-CAR.

If the inspector becomes aware of a recall either through notification, or if it is determined that one has occurred when conducting the OAT, they will consult with the lead investigator as soon as possible to confirm whether:

the source of the incident originated at the recalling firm
the recalling licence holder was/is in a position to address the root cause and prevent reoccurrence
the 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 (under revision) as required

If answers to any of the above are yes, select the appropriate task and conduct it as per section 7.2.2 Unscheduled verification findings (stumble-on). All non-compliances identified during the food safety investigation in response to the recall will be treated as unscheduled verification findings and will serve as evidence that an IR-CAR is warranted. These findings, as well as any other findings as a result of the verification of the applicable task, will be captured on the IR-CAR. The RI will rate the related CVS task (such as: 1.1.09, 1.2.13, 4.2.02, 7.1.04, etc.) "Unacceptable" and Issue the IR-CAR. Ensure the recall number from the IMS is captured in the body of the IR-CAR.

If answers to all of the above are no, there is no need to conduct a task in response to this recall. The RI will treat the observations of the recall investigation as an unscheduled verification finding, as per section 7.2.2 of this document and will record the following information on the verification worksheet (CFIA/ACIA 5470) under "activities conducted to assess compliance" (box 10) using code 9.1.10:

"[Product description] recalled. Food safety investigation determined that no actions could have been taken by the licence holder to prevent the recall. See IMS # [xyz]. No further follow-up activities required."

Follow-up will be completed by the RI. If the IR-CAR cannot be closed, the RI initiates enforcement actions as per Food regulatory response guidelines.

Throughout the food safety investigation, the RI will work with the lead investigator. The lead investigator is responsible for ensuring all required information is entered into the IMS. The RI is responsible for documenting all follow-up activities on the "follow-up" section of the IR-CAR(s).

Appendix D: Action plans

Corrective actions are an integral component of an effective preventive control plan (PCP). This document presents one model that the operators/licence holders can use to plan and implement corrective actions. The information the operators/licence holders would document using this model would meet SFCR 89(1)(c)(vii) and SFCR 89(1)(d)(viii) regarding the documentation of evidence that the written HACCP based PCP was implemented. Operators may choose to utilize any other globally accepted model that meets SFCR and other regulatory requirements.

Component 1 - Description of the problem

The objective is to accurately describe the problem, which will assist to identify the:

action to be taken on affected or potentially affected product, other things or animals
immediate measures necessary to restore control of the deviation
root cause(s)

Operators/licence holders must collect information to find out the exact problem. One situation of non-compliance is typically the result of multiple problems or causes.

what is the non-compliance
did the problem affect product
where is the problem located
how widespread is this problem
does the deficiency affect other areas of the facility or HACCP based PCP
when did the problem occur
who is involved in this problem
is this the first time the problem occurred

Written action plan: Component 1 - Description of the problem

describe the problem as it relates to the non-compliance

Component 2 - Person(s) responsible for corrective measures

The objective is to determine the people who have the knowledge, time, authority and competence to correct the non-compliance.

Written action plan:

identify the name or title of person(s) responsible for the immediate/short term and preventative measures

Component 3 - Description of immediate or short term measures

The objective is to:

control affected product or other thing(s)
take immediate measures to restore control over the deviation so that food products are produced and/or animals are handled according to legislative requirements

Written action plan: Component 3 - Description of immediate or short term measures

describe the measures taken on affected or potentially affected product, animals or other thing(s)
describe the results of the assessment completed to determine if other products, animals or other things were implicated
describe the food safety assessment performed or to be performed on the affected or potentially affected product including any disposition of product
describe the immediate / short term measures taken to restore control over the deviation until permanent/preventative measures are planned and implemented
describe the procedure to verify the effectiveness of immediate/short term measures taken
list records used to document the actions taken

Note: Depending on the non-compliance, immediate measures may/ may not be required.

Component 4 - Identification of root cause(s)

The objective is to identify the root cause(s) so operator/licence holder can form appropriate and comprehensive corrective measures that will prevent the recurrence of the deviation.

Start with the problem description:

why was the deviation not detected prior to the notification by an external party (i.e. CFIA, foreign country, auditors) (if applicable)
identify all potential causes (environment, equipment, personnel, training, written programs, etc.)
some causes have already been corrected by immediate measures
identify the root cause(s)

Written action plan: Component 4 - Identification of root cause(s)

describe root cause(s)

Component 5 - Description of preventative measures

The objective is to identify and implement corrective measures to eliminate the root cause(s) and prevent recurrence of the deviation.

Written action plan: Component 5 - Description of preventative measures

describe the preventative measures
establish a date for completion of each planned preventative measures
list records used to document the preventative measures taken

Component 6 - Description of activities planned to verify the effectiveness of preventative measures

The objective is to provide feedback as to whether or not further adjustment is necessary.

The assessment is the application of temporary procedures, tests or other evaluations to determine the effectiveness of the measures taken to correct the problem.

Examples:

on-site assessment of corrective measures taken
ensuring that staff is adhering to new procedures/instructions by observing and interviewing them
temporarily increasing sampling
temporarily increasing monitoring procedures

If the problem is not resolved:

additional corrective measures are required

Written action plan: Component 6 - Description of activities planned to verify the effectiveness of preventative measures

describe the activities planned to verify the effectiveness of preventative measures
establish a date for completion
list the records used to document the activity

Appendix E: List of operators/licence holders activities which do and do not require daily presence for each 12-hour period of production^Footnote 3

E.1 Activities which require daily presence for each 12-hour period of production

Preparing meat or poultry for packaging or for further processing into meat or poultry food products. Examples of activities include slaughtering, boning, cutting, slicing, grinding, injecting, pumping, adding ingredients through other mechanical means, formulating, assembling, packaging or labelling meat or poultry components of meat or poultry food products
Applying inspection markings to any product

E.2 Activities which do not require daily presence for each 12-hour period of production

Receiving meat or poultry, spices, or other ingredients
Receiving and sorting returned products
Shipping inspected and properly labelled products
Moving product within the establishment in order to physically position it for further processing (for example: staging) or storage
Performing sanitation activities in accordance with its written sanitation procedures
Performing a monitoring activity that it has established in its HACCP/PCP as required by SFCR 89 (1)(c)(iv) (for example, monitoring the chilling of carcasses after slaughter, or monitoring the cooking temperatures of meat products)
Performing a verification activity that it has established in its HACCP/PCP as required by SFCR 89 (1)(c)(vi) (for example the verification of the equipment calibration, and sanitation procedures)
Performing pre-shipment records review
Performing corrective actions in accordance with its HACCP based PCP or sanitation Standard Operating Procedures (SOPs) that do not include any of the activities noted in section E.1 of this table
Collecting or testing samples of its products

Appendix F: Forms and templates

Standard regulatory response process
Operational Procedure (OP-150-2014) – Procedure for Following up on the Underlying Cause(s) of a Food Recall (internal access only) - RDIMS 6033538
Food specific reference document (FSRD)-SFCR regulatory and guidance reference – draft (internal access only) - RDIMS 10335891
Introduction to the food specific reference document (FSRD) (internal access only)
Food business line acronyms list (internal access only) - RDIMS 10660735
Form- CFIA/ACIA 5523 (internal access only)
Form- CFIA/ACIA 5470 (internal access only)
Form- CFIA/ACIA 5522 (internal access only)
Form- CFIA/ACIA 5472 (internal access only)
Annex A- RDIMS (internal access only)

Operational procedure: Meat Compliance Verification System (CVS)

On this page

Appendices

1.0 Purpose

2.0 Authorities

3.0 Reference documents Footnote 2

3.1 References to be used when conducting verification tasks

3.1.1 Industry guidance

3.1.2 Operational guidance

3.1.3 Other references

3.1.4 Documents incorporated by reference (to SFCR):

4.0 Definitions

5.0 Acronyms

6.0 General

6.1 Roles and responsibilities

6.1.1 Licence holder/operator

6.1.2 Inspector

6.1.3 Supervisor

6.1.4 Regional Veterinary Officer (RVO)

6.1.5 Area CVS coordinator and regional CVS contacts

6.1.6 Area FSEP coordinator and regional FSEP contacts

6.1.7 Area/Regional Operational specialists

6.1.8 National program specialists (Programs and Policy Branch/Food Import and Export Division)

6.1.9 Operational Guidance and Expertise (OGE)

6.1.10 Inspection Managers (IMs) and Directors of Operations (DOs)

6.2 Organization and frequency of verification tasks

6.3 Amendments to verification tasks

6.4 Assignment of verification tasks to an establishment

6.5 Scheduling and completion of verification tasks

6.6 Operator's/licence holder's corrective actions and preventive measures

7.0 Operational guidelines

7.1 Step 1 - Preparation for the verification

7.1.1 Preparation for conducting verification tasks in sections 1, 2, 3, 5, 6

7.1.1.1 The Outcome Assessment Task (OAT) (6.1.02)

7.1.2 Preparation for conducting section 4 verification tasks

7.1.3 Preparation for conducting section 7 verification tasks

7.2 Step 2 - Gathering information to determine compliance

7.2.1 Gathering information to determine compliance

Examination of documentation and/ or records

Visual/ on-site observations

Interview employees

7.2.2 Unscheduled verification findings (stumble-on)

7.2.3 Identifying non-compliance that is related to an open IR-CAR

Important!

7.2.4 Verification worksheet

7.2.5 HACCP/ PCP verification worksheet

7.3 Step 3 - Assign compliance level

7.3.1 Acceptable level of compliance (A)

7.3.2 Unacceptable level of compliance (U)

7.3.3 Guidance for assigning a level of compliance

What is meant by "deviations that could cause product contamination or adulteration"?

What is meant by "compromises the integrity and effectiveness of the PCP"?

What is meant by "compromises the integrity of other control programs"?

What is meant by consumer protection (fraudulent activity)?

What is meant by "affects animal welfare"?

What is meant by "affects animal health"?

7.4 Step 4 - Communicate results and action required

7.4.1 Verification report

7.4.2 Inspection Report - Corrective Action Request (IR-CAR)

7.4.2.1 Guidance for the description of the non-compliance

7.4.3. Meeting with the operator/licence holder

7.4.4. Request for review of an IR-CAR

7.5 Step 5 – Action plans and extension requests

7.5.1 Action plans

7.5.2 Request for an extension to implement corrective actions

7.6 Step 6 - Follow-up

7.6.1 Follow-up on items requiring correction listed on the verification report

7.6.2 Follow-Up on non-compliance identified on the IR-CAR

7.7 Step 7 - File maintenance

8.0 List of forms

Appendix A: Organization of tasks

A.1 Organization

Section 1: HACCP based PCP implementation

Sub-section 1: Specific control measures for product safety

Sub-section 2: Prerequisite programs and control measures

Sub-section 3: Slaughter/processing requirements and control programs

Sub-section 4: Current issues (applies to all sections)

Sub-section 5: Process controls

Section 2: Consumer protection and other domestic requirements

Section 3: Export

3.0 Reference documents ^Footnote 2

Appendix E: List of operators/licence holders activities which do and do not require daily presence for each 12-hour period of production^Footnote 3