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Standard Inspection Process - Version 3.0

Requirements for the Safe Food for Canadians Regulations

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.

Note

Only inspectors who have been trained on the common inspection approach (based on the integrated Agency Inspection Model-iAIM) should use this procedure. All other inspectors should follow existing procedures until they are trained.

On this page

Acronyms

CFIA
Canadian Food Inspection Agency
CNC
Categorization of Non-Compliance
CRM
Client Relationship Management (a Microsoft Dynamics software)
DSDP
Digital Service Delivery Platform
ERA
Establishment-based Risk Assessment
iAIM
integrated Agency Inspection Model
IMS
Issues Management System
LSTS
Laboratory Sample Tracking System
OG
Operational Guidance
OGE
Operational Guidance and Expertise
PCI
Preventive Control Inspection
PCP
Preventive Control Plan
RDIMS
Record Document and Information Management System
SIP
Standard Inspection Procedure
SOP
Standard Operating Procedure
SME
Subject Matter Expert
SRM
Specified Risk Material
SRRP
Standard Regulatory Response Process

Definitions

Deviation:
A disparity between the regulated party’s established preventive control plan (PCP) and the implementation of that preventive control plan.
Hazard:
A biological, chemical or physical property that may cause an unacceptable health risk.
Non-compliance:
A legal contravention of the applicable Acts and/or Regulations.
Risk:
The product of the severity of the consequences of a hazard and the likelihood of occurrence of these consequences.

1.0 Purpose

The Standard Inspection Process (SIP) is the common approach for conducting inspections across CFIA's 3 business lines (food, plant and animal health). The SIP follows the Integrated Agency Inspection Model (iAIM) in describing 4 standard inspection steps: preparing, conducting, communicating and following up on inspections.

2.0 Overview of the inspection

Canadian Food Inspection Agency (CFIA) inspectors conduct inspections to assess whether a regulated party is in compliance with regulatory requirements, and permission conditions (if applicable). There are 3 inspection task types: systems-based preventive control inspections, sample collection, and commodity inspections.

Preventive Control Inspection

The Preventive Control Inspection task type is used for the evaluation of a regulated party's preventive controls to achieve compliance with regulatory requirements. This could include a regulated party's systems-based approach that focuses on prevention as a way to achieve regulatory compliance.

Sample Collection

The Sample Collection task type is used for planned and as required samples which are submitted to the lab for analysis. This may include samples required for national sampling plans, verification against regulatory standards or requirements, complaints and investigations, surveys and surveillance.

Commodity Inspection

The Commodity Inspection task type is used for the verification of a regulated party's product or thing against regulatory standards or requirements. It enables the analysis of a product or thing done by inspection staff, as compared to the sample collection inspection task type which require inspection staff to submit samples to laboratories for analysis.

Business line specific inspection procedures and other guidance can be found on Merlin:

The 3 inspection task types can be used alone, or in combination, in a single inspection case. For example, if during a Preventive Control Inspection there is a need to verify compliance by using a different inspection task type: add a new inspection task using either Commodity Inspection task type or Sample Collection task type, and add the appropriate inspection task. Alternatively, if while conducting a Preventive Control Inspection, a sample is collected for a national sampling plan (Sample Collection task type) a new inspection case should be opened. Refer to the relevant business line guidance for the applicable inspection task types.

Figure 1: Descriptive text for the inspection process. Description follows.
Figure 1. Descriptive text for the inspection process

The rectangle at the top of the illustration states Standard Inspection Process.

The triangle in the middle represents the inspection task types that are included within an inspection case.

The inspection task types are listed from the left to right in a vertical orientation: Commodity Inspection, Preventive Control Inspection, Sample Collection.

The rectangle below the triangle represents the verification activities conducted as part of the inspection task types.

The 4 verification activities are listed in 2 columns from left to right: In the left column – Document and Record Review and Observation, and in the right column – Interview and Measurement.

Inspectors will use common inspection techniques for all 3 inspection task types to gather information and verify compliance to the regulations or permission conditions, as applicable. This information will be used to support compliance decisions and any regulatory actions when non-compliances are identified.

Inspection information will be entered and will reside in the Digital Service Delivery Platform (DSDP). Procedures for the use of the DSDP to capture inspection data can be found in Appendix A and on the DSDP Merlin page (internal access only) in conjunction with the business line and commodity specific guidance.

The inspection process

There are 4 steps for completing Preventive Control, Sample Collection and Commodity Inspections, as depicted in figure 2 below:

Figure 2: Descriptive text for the inspection process is represented by 4 boxes. Description follows.
Figure 2: Descriptive text for the inspection process is represented by 4 boxes.

Arrows lead from one box to the next in the following order:

Step 1: Prepare for the Inspection leads to

Step 2: Conduct the Inspection leads to

Step 3: Communicate the Inspection Results leads to

Step 4: Conduct the Follow-up Inspection

At any point in the inspection, advice and/or guidance may be needed. The process for requesting advice and guidance is as follows:

3.0 Step 1 – Prepare for the inspection

Objective:

Preparing for an inspection consists of 5 parts, as represented in figure 3 below. However, note that the steps involved in the preparation of the inspection may not necessarily follow a linear process.

Figure 3. Preparing for an inspection consists of 5 parts represented by 5 boxes. Description follows.
Figure 3. Preparing for an inspection consists of 5 parts represented by 5 boxes.

Arrows lead from one box to the next in the following order:

3.1 Determining the Scope of the Inspection,

3.2 Establishing the Team,

3.3 Reviewing Information,

3.4 Notifying the Regulated Party; and

3.5 Preparing the Tool Kit.

3.1 Determine the scope of the inspection

The scope will be determined by the trigger (reason) for the inspection. Refer to Section A.4.1 – Determine the Scope of the Inspection for more information.

A trigger is determined by program design. In the DSDP, there are 8 trigger options.

Names of triggers and when they are applied
Inspection trigger Applied when:
Preventive Control Inspection Plan Conducting a preventive control inspection as per the national workplan.
Sample Collection Plan Collecting a sample to be submitted to a lab as per the national workplan.
Commodity Inspection Plan Conducting a commodity inspection as per the national workplan.
Incident Response Conducting an inspection and/or control response to a suspect or realized risk.
Domestic Permission Conducting an inspection to support the issuance of a domestic permission.
Export Permission Conducting an inspection to support the issuance of an export certificate to a foreign country.
Import Permission Conducting an inspection to support the issuance of an import permission.
ASD Verification Conducting an inspection to verify that an alternate service provider meets CFIA requirements.

The scope of an inspection includes the following:

1. One or more of the following inspection task types:

2. One or more inspection tasks that are added to the inspection case in the DSDP. The inspection tasks may vary based on the inspection task type. A complete list of inspection tasks is available in the DSDP under Administration on the Site Map.

For information on accessing and creating an inspection case in the Digital Service Delivery Platform, refer to Section A.3 – DSDP inspection case information of Appendix A.

Planned and as required inspections

Planned inspections are conducted as part of the annual work plan. The scope will be defined by the work plan and is generally pre-determined before the inspection case is assigned to the inspector.

As required inspections are those inspections conducted in response to an event (for example, complaints, referrals, a request for inspection by the regulated party for export; or, where required by law for interprovincial marketing purposes, etc.).

3.2 Establish the team

Inspections may be conducted individually or in teams. The team may include subject matter experts (SMEs) to perform specific functions or provide additional support. The SMEs do not need to be present for the entire inspection.

When inspections are conducted by an inspector accompanied by SMEs, the SMEs serve in an advisory capacity. Regardless of whether an individual or a team is needed, the following general steps are required:

Consult with the supervisor to verify legal authorities related to conducting inspections with other government departments, prior to agreeing to conduct a joint inspection. In some cases, inspections may be conducted in conjunction with inspectors from other government (for example, provincial or federal) departments and from other CFIA programs.

3.3 Review information

Reviewing information is an important aspect of preparing for inspections. This includes information regarding the regulated party, the CFIA programs that the regulated party is associated with, their compliance history, applicable legislation and operational guidance and appropriate biosecurity measures to consider.

3.3.1 Regulated party/commodity information

For information on reviewing the regulated party's profile in the DSDP, refer to Section A.4.3 – Review Information of Appendix A.

3.3.2 Compliance history

For information on reviewing the regulated party's compliance history in the DSDP, refer to Section A.4.3 – Review Information of Appendix A.

3.3.3 Applicable requirements, documents

For information on requesting additional advice in the DSDP, refer to SOP Requesting Advice for an Inspection Case (internal access only – RDIMS 9855738).

3.3.4 Applicable biosecurity measures

For information on requesting additional advice in the DSDP, refer to SOP Requesting Advice for an Inspection Case (internal access only – RDIMS 9855738).

3.4 Notify the regulated party

CFIA inspectors have the authority to enter a regulated party's premises to perform inspections, announced or unannounced. The purpose of the inspection usually dictates if an announced or unannounced inspection is required. The inspectors are to use their judgement and consult with their supervisor to determine whether notification is required.

Notification may be given to the regulated party of an upcoming inspection to ensure that:

Notification can be provided verbally or in writing via an e-mail. The notification letter template (internal access only – RDIMS 11289579) can be used to assist in notifying the regulated party of a future inspection.

For information on completing the DSDP, refer to Section A.4.4 – Notify the Regulated Party of Appendix A.

3.5 Prepare the toolkit

For information on completing the DSDP, refer to Appendix A:

4.0 Step 2 – Conduct the inspection

Objective:

Conducting an inspection consists of the parts as represented in figure 4 below.

Figure 4. Conducting the inspection consists of 9 steps represented by 9 boxes. Description follows.
Figure 4. Conducting the inspection consists of 9 steps represented by 9 boxes.

Arrows lead from one box to the next in the following order:

4.1 Conducting the Opening Meeting,

4.2 Conducting the Initial Walkthrough,

4.3 Confirming the Scope, 4.4 Performing Inspection Tasks,

4.5 Determining if Immediate Action Is Required,

4.6 Determining Compliance,

4.7 Categorizing Non-Compliance; and

4.8 Determining the Timeframes for the Regulated Party to Complete Corrective Actions.

The 9th box under 4.8 has a dotted border with the title 4.9 Enforcement.

4.1 conduct the opening meeting

The purpose of the opening meeting is for the inspector to:

The opening meeting may be formal or a basic discussion of inspection details.

During the opening meeting the CFIA inspector will:

During the opening meeting the CFIA inspector may also where applicable:

Refer to Opening/Closing Meeting Checklists (internal access only – RDIMS 11289897) for an Opening Meeting Checklist that can be printed and taken out on inspection.

For information on completing the fields relating to the opening meeting in the DSDP, refer to Section A.5.1 – Conduct the Opening Meeting of Appendix A.

4.2 Conduct the initial walk-through

An initial walk-through is not mandatory for all inspection task types. The inspectors must use their judgement to determine if an initial walk-through is necessary.

If an initial walk-through (interior/exterior) is conducted then:

For information on completing the fields relating to the initial walk-through in the DSDP, refer to Section A.5.2 – Conduct the Initial Walk-through of Appendix A.

4.3 Confirm the scope

The following actions are required when confirming the scope:

Respect the preliminary scope where possible.

Potential reasons to amend (change, expand or reduce) the inspection scope include:

If outstanding non-compliances have been discovered in the initial walk-through, verify that interim measures are still effective. If the interim measures are no longer effective, and the applicable tasks are not already within the initial inspection scope, then expand the scope and perform the activities related to the outstanding non-compliances.

For information on confirming or adjusting the inspection scope in the DSDP, refer to Section A.5.3 – Confirm the Scope of Appendix A.

4.4 Perform inspection tasks

Inspectors can be assigned the following 3 inspection task types: Preventive Control Inspection, Sample Collection or Commodity Inspection.

For these inspection task types, inspection data will be captured within a DSDP inspection case, which could be initiated due to various DSDP triggers. Business line guidance will indicate which DSDP triggers and inspection tasks will be used. A complete list of tasks under the commodity inspection task type is available in the DSDP under Administration on the Site Map.

The 3 inspection task types can be used alone, or in combination, in a single inspection case. For example, if during a preventive control inspection there is a need to verify compliance by using a different inspection task type: add a new inspection task using either commodity inspection task type or sample collection task type, and add the appropriate inspection task. Alternatively, if while conducting a preventive control inspection, a sample is collected for a national sampling plan (sample collection inspection type) a new inspection case should be opened. Refer to the relevant business line guidance for the applicable inspection task types.

For information on the fields associated to all task types in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.4.1 Preventive control inspection

The preventive control inspection task type is used for the evaluation of a regulated party's preventive controls to regulatory requirements. This could include a regulated party's systems-based approach that focuses on prevention as a way for a regulated party to achieve regulatory compliance.

This inspection type will evaluate the regulated party's preventive controls as applicable to the regulated party's operation including prescribed requirements for animal and plant health, food safety and labelling, product quality, and composition.

Preventive control inspections may be required to evaluate systems based programs prior to approval, or to maintain the permission or status in specific programs.

The inspector will use the outcomes, verification activities and performance criteria related to each preventive control inspection sub-element to evaluate compliance of a regulated party's preventive controls against the applicable regulatory requirements and/or permission conditions. This evaluation could include the assessment of a regulated party's written program, documents and records, observations at the facility, measurements and interviews with employees. Each preventive control inspection sub-element will list the outcome, verification activities and performance criteria that will be required to perform the inspection.

4.4.2 Sample collection

The sample collection task type is used for planned and as required samples which are submitted to the lab for analysis.

Samples may be required for national sampling plans, verification against regulatory standards or requirements, complaints and investigations, surveys, surveillance, etc. Examples include sample collections for product identity, assessment for soil or pests, evaluation for toxins or disease, etc.

Business line guidance will provide procedures for the notification and submission of samples to the laboratories. The Laboratory Sample Tracking System (LSTS) will continue to be the main tool used by the CFIA to track and compile the information pertaining to laboratory samples. Business line operational guidance will describe the manner in which sampling information will be collected, analyzed and reported.

For information on capturing notes relating to taking samples in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.4.3 Commodity inspection

The commodity inspection task type is used for the verification of a regulated party's product or thing against regulatory standards or requirements. It enables the analysis of a product or thing done by inspection staff, as compared to the sample collection task type which require inspection staff to submit samples to laboratories for analysis.

Commodity inspections can consist of a wide range of inspection activities that are conducted by the inspector on the commodity including: label verification, crop inspection, specified risk material (SRM) inspection, etc.

The inspector will evaluate commodities based on applicable regulatory requirements and/or permission conditions. Business line operational guidance will describe the manner in which commodity information will be evaluated and reported.

For information on capturing notes relating to document and record reviews in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.4.4 Inspection verification activities for preventive control inspections, sample collection and commodity inspections

Inspectors will use a combination of inspection methods and techniques to assess compliance to regulatory requirements for all 3 inspection task types (Preventive Control, Sample Collection, and Commodity Inspection), including—where applicable:

4.4.4.1 Document and record review

The purpose of examining documentation is to:

Examples include processing records, complaint records, training records, sanitation records sample and testing results, certificates, receiving records, PCP, permission documents, etc.

If applicable, inspectors should review documentation and records using the following guidelines:

For information on capturing notes relating to document and record reviews in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.4.4.2 Observation

Observation is not limited to visual assessment alone; it may also include sensory factors such as using hearing, touch and smell.

The purpose of observations is to gather information to evaluate whether:

For information on capturing notes relating to observations in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.4.4.3 Interview

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

For information on capturing notes relating to observations in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.4.4.4 Measurement

Measurements taken during the course of an inspection, support compliance decisions and allow the completion of assigned inspection tasks activities. Measurement includes activities such as taking temperature, humidity, moisture content, presence of soil, etc. This section also allows for specific descriptors to be documented such as tattoo identification, lot identification, breed, etc.

For information on capturing notes relating to measurements in the DSDP, refer to Section A.5.4.1 Inspection Verification Activities for Preventive Control Inspections, Sample Collection and Commodity Inspections of Appendix A.

4.5 Determine if immediate control action is required

The inspector will take the following actions where there is a potential for human, animal or plant health, or the environment or economy/trade to be severely impacted:

For information on capturing notes relating to control actions in the DSDP, refer to Section A.5.2 – Capture Regulatory Response Actions of Appendix A.

4.6 Determine compliance

During this step, the inspector interprets and analyzes the information collected during the inspection (inspector notes) to determine compliance with regulatory requirements and permission conditions. The inspector takes into account all objective information and makes determinations and decisions regarding the compliance of the regulated party.

4.6.1 Compliance decision and reference

Any non-compliance must be reported, regardless if permanent corrective actions were implemented by the regulated party before the end of the inspection.

A non-compliance is a contravention of a regulatory requirement or failure to meet permission conditions.

A non-regulatory non-compliance is a failure to meet permission conditions, which are not stipulated in legislation. The inspector identifies during data entry whether the non-compliance is regulatory or non-regulatory.

4.6.2 Objective evidence

Objective evidence is clear and factual information, derived from verification activities and the common inspection techniques, which support a non-compliance. This information is provided on the Inspection Report that will be submitted to the regulated party once the inspection is completed.

Information selected as objective evidence should be in an adequate amount and level of detail required for another inspector to reach the same compliance decision. In addition, a non-compliance may be supported by objective evidence observed in one or more inspection tasks.

The regulated party must be in compliance at all times; however, it is recognized that they may need time to take permanent corrective action when non-compliance occurs. In the meantime, effective interim measures must be taken to address any non-compliance.

For information on capturing the non-compliance and objective evidence in the DSDP, refer to Section A.5.5 – Determine Compliance of Appendix A.

4.7 Categorize non-compliance

The categorization of non-compliance (CNC) assesses the potential consequences of a non-compliance and the likelihood of occurrence. The purpose of categorizing a non-compliance is to inform:

The process of CNC is organized into 4 steps (Sections 4.7.14.7.4) which seek to answer questions raised intuitively when assessing the level of impact that may result from a non-compliance.

The category of non-compliance is based on the impacts of the individual non-compliance, not on the compliance history or intent of the regulated party. Compliance history and intent will be taken into account as part of the enforcement function: see Standard Regulatory Response Process.

Under the iAIM, hazards/concerns (health, environmental, economic, consumer protection, trade, etc.) must be managed or eliminated during production, processing, importing or distribution.

Regulated parties are responsible to:

The effectiveness of preventive controls and mitigation depends on their ability to:

The Categorization of Non-Compliance Process document (internal access only – RDIMS 11292219) outlines the process for CNC.

4.7.1: Identify the non-compliance type

Purpose: To identify the type of non-compliance based on the information collected during the inspection.

Select all applicable types/hazards/concerns that reflect the impact caused by the non-compliance; see below for a list of non-compliance types.

The characteristics associated to the non-compliance types and hazards/concerns.
Type Hazard/ Concern Characteristics
Health
(human, animal, plant)
Biological Any pathogen, pest or vector of a pathogen or pest that poses a danger to human, animal or plant health or the environment (e.g., bacteria, viruses, parasites, prions, insects)
Health
(human, animal, plant)
Chemical A chemical substance that is not normally found in a commodity; or that exceeds allowable levels in a commodity and poses a danger to human, animal or plant health or the environment (for example, veterinary drugs, contaminants, pesticides, toxins)
Health
(human, animal, plant)
Physical Any foreign material that is not normally found in or on a commodity; or that poses a danger to human, animal or plant health or the environment
Health
(human, animal, plant)
Allergen The presence of undeclared or improperly declared allergens
Health
(human, animal, plant)
Nutritional Incorrect nutritional composition in a commodity
Health
(human, animal, plant)
Animal Welfare Conditions of the environment or situations/practices that may cause avoidable injury, avoidable suffering or death of animals (for example, overcrowding, restricted space, improper ventilation)
Environmental Other Any issues that may create an environmental concern (for example, contamination from plants with novel traits, invasive alien species)
Economic Consumer protection, Fraud, Misrepresentation, Risk to industry sector, Other Issues resulting in economic gain for the regulated party; economic loss to consumers, competitors or industry sector because use of unfair or deceptive practices
Trade Risk to export eligibility, Other Issues affecting or having the potential to affect domestic or international trade or relations
Other Other No effect on humans, plants, animals, the environment, the economy or trade

4.7.2: Determine the severity of consequence(s)

Purpose: To determine the severity of the consequence of the non-compliance if the consequences were to occur.

The 3 levels of severity of consequences are defined as:

Low: exposure to the hazard/concern is not likely to cause any adverse consequences for humans, plants, animals, the environment, the economy or trade

Medium: exposure to the hazard/concern could result in temporary or non-critical consequences to humans, plants, animals or the environment or have a moderate effect on the economy or trade

High: exposure to the hazard/concern could cause permanent disability or death for humans, plants, animals, or serious effects on the environment, the economy or trade

If there is insufficient information to determine severity, then use the Guide for Determining the Severity of Consequences of Non-Compliance (internal access only – RDIMS 11289853) to help determine the level of severity (low, medium, high). If the guide does not provide enough information to help in the determination of the severity, then the severity is "high" until demonstrated otherwiseFootnote 2.

The severity of consequences is represented on the horizontal-axis in Figure 5 below.

4.7.3: Determine the likelihood of occurrence

Purpose: To determine the likelihood of occurrence of the consequences of the non-compliance, based on the controls of the regulated party over the hazard or concern.

The 3 levels of likelihood are defined as:

Very Likely: There are little or no control(s) in place, the controls are not effective or there is high potential for exposure to the hazard or concern.

Likely: There are some control and/or mitigation measures in place and there may be gaps, inconsistency, or some potential exposure to the hazard or concern.

Unlikely: The controls are in place and effective. Mitigation addresses the issue and there is minimal potential exposure to the hazard or concern.

In order to determine the level of likelihood, consider the inspection results related to control measures.

Review control measures that reduce, mitigate or increase the likelihood of occurrence. Consider the regulated party's controls from initial inputs to end use.

Determine the likelihood of occurrence – very likely, likely or unlikely. Below are some considerations when making the determination:

Depending on the inspection type, different information will be available to help determine likelihood:

If the consequence has already occurred, then the probability of occurrence is very likely in all cases and for all types of inspection tasks.

The likelihood of occurrence is represented by the vertical-axis in the CNC Figure 5 used in section 4.7.4.

4.7.4: Categorize the non-compliance

Purpose: To categorize the non-compliance based on its impacts.

Categorize each non-compliance using Figure 5:

Figure 5: CNC Matrix – The horizontal axis represents the severity of consequences and is divided into low, medium and high. Description follows.
Figure 5: CNC Matrix – The horizontal axis represents the severity of consequences and is divided into low, medium and high.

The vertical axis represents the likelihood of occurrence and is divided into unlikely, likely and very likely.

A low severity of consequence results in minimal CNC for any likelihood of occurrence.

A medium severity of consequence results in minimal CNC for unlikely likelihood of occurrence and moderate CNC for likely and very likely likelihood of occurrence.

A high severity of consequence results in minimal CNC for unlikely likelihood of occurrence, moderate CNC for likely likelihood of occurrence, and severe CNC for very likely likelihood of occurrence.

The objective evidence should clearly support the categorization decision.

If a non-compliance has more than oneFootnote 3 non-compliance type or hazard or concern identified, then repeat 4.7.1 to 4.7.4 until the most severe category is identified and record the most severe category in the DSDP. In addition, identify whether a different requirement may be applicable to the other non-compliance type(s).

For information on capturing the categorization of non-compliance in the DSDP, refer to Section A.5.5 – Determine Compliance of Appendix A.

4.8 Determine timeframe for regulated party to complete corrective actions

The regulated party is required to be in compliance at all times; however, it is recognized that they may need some time to take permanent corrective action when non-compliance occurs. The timeframe to complete corrective actions must reflect the severity of the impact of the non-compliance as well as take into consideration, when possible, the time required for the regulated party to address the root cause and correct permanently the non-compliance. These timeframes are assigned by the inspector based on Table 1 (where those timeframes are not applicable, more suitable guidelines may be found in Business Line or Commodity specific guidance).

For example, a non-compliance that requires immediate action should be identified to the regulated party and must be addressed with an interim or permanent corrective action. If an interim measure is put in place, the inspector may allow up to 10 days for the regulated party to complete the permanent corrective action.

Note

For all non-compliances, the timeframe to complete corrective actions is calculated starting the day after the regulated party was notified by the inspector of the non-compliance.

Table 1. Timeframes for regulated party to complete corrective actions associated to the non-compliance categories
Non-Compliance Category Timeframe for Regulated Party to Complete Corrective Action (in calendar days)
Severe Up to 10 days
Moderate Up to 60 days
Minimal Up to 180 days

Note

Timeframe to complete corrective actions is calculated as 0 for non-compliances where permanent correct action was taken prior to the closing meeting.

For information on capturing the timeframe(s) to complete corrective actions and to whom the non-compliance was reported to in the DSDP, refer to Appendix A:

4.9: Enforcement

Any thing that is not in compliance with regulations may be subject to enforcement by CFIA. The enforcement response is initiated when non-compliance occurs. The Standard Regulatory Response Process outlines the steps taken in response to the non-compliance.

For information on capturing the regulatory response in the DSDP, refer to Section A.5.5.2 – Capture Regulatory Response Actions of Appendix A.

5.0 Step 3 – Communicate the inspection results

Objective:

Note

For inspections that span more than 1 day, a brief end-of-day discussion can be held to summarize the events of the day and to plan for the remainder of the inspection. The end of day discussions may precede a formal closing meeting, in order to notify the regulated party of any non-compliance that have been identified prior to the completion of the inspection. The timeframes for the regulated party to complete corrective actions are calculated starting the day after the regulated party was notified by the inspector of the non-compliance.

Figure 6. There are 4 steps to communicating the inspection results represented by 4 boxes. Description follows.
Figure 6. There are 4 steps to communicating the inspection results represented by 4 boxes.

Arrows lead from one box to the next in the following order:

5.1 Conducting the Closing Meeting,

5.2 Issuing inspection report and finalizing the inspection case,

5.3 Determining the Timeframes for a CFIA Follow-Up Inspection; and

5.4 Reviewing Requests for Extension to a Timeframe for Corrective Action Completion.

5.1 Conduct closing meeting

A closing meeting is held once the on-site inspection and all inspection tasks are completed. The closing meeting may be formal or a basic discussion of inspection details. The purpose is to provide verbal feedback to the regulated party regarding the results of the inspection, and any non-compliance observed. In the situation where the inspector requires additional clarification (for example—with the supervisor at the CFIA office to review/validate inspection information) the closing meeting may be conducted up to a few days after the on-site inspection.

During the closing meeting, the inspector may where applicable:

The inspector must notify their supervisor immediately if there is disagreement from the regulated party over the categorization of the non-compliance, any action taken by the inspector or the potential impact on the regulated party's operations or the commodity.

Refer to Opening/Closing Meeting Checklists (internal access only - RDIMS 11289897) for a Closing Meeting Checklist that can be printed and taken out on inspection.

For information on capturing notes relating to the closing meeting in the DSDP, refer to Section A.6 – Communicate the Inspection Results of Appendix A.

5.2 Issue inspection report and finalize the inspection case

The inspection documentation presented to the regulated party will be the Inspection Report.

The purpose of the Inspection Report is to communicate to the regulated party:

The inspector returns to the office, completes the inspection report and submits it to their supervisor for review and approval (if applicable).

Once the report is approved by the supervisor, the inspector will send it to the regulated party via the DSDP portal, as well as other means if requested (for example, email, fax, etc.). If the regulated party requests a meeting to discuss the inspection report, the inspector is to use their judgement to decide if a phone call, or subsequent meeting is needed. The report should be signed by the inspector.

In certain instances, an inspection report may not be required to be submitted for sample collection, and commodity inspections. Refer to program specific guidance for instances where this may occur.

Review the CFIA Fee Schedule for fees that are linked to inspection tasks. Apply the fees according to the Operational procedure (OP/PO-175): Collection and invoicing of user fees for cost recoverable inspection activities and service requests (internal access only – RDIMS 6159161).

Once the Inspection Report has been submitted to the regulated party, signed, and all required fields in the inspection case have been completed, the inspection case must be deactivated (closed) to prevent any further editing. A follow-up inspection will be considered a separate inspection case.

Reminder: Only non-compliance and objective evidence is to appear on the inspection report. Recommendations and opinions are not appropriate.

For information on completing the remaining fields, generating an inspection report and saving this report in the DSDP, refer to Appendix A:

5.3 Determine timeframes for CFIA follow-up inspections

Follow-up inspections are conducted to verify that the permanent corrective actions are implemented and effective to reach compliance.

Timeframes for follow-up inspection are based on the regulated party's timeframe for corrective action (Section 4.8). Use Table 2 below, to guide scheduling of follow-up inspections.

Table 2 – Timeframes for CFIA follow-up inspections for the non-compliance categories
Non-Compliance Category Timeframe (in calendar days) for CFIA follow-up inspection
Severe Immediate or after the timeframe given to the regulated party
Moderate and Minimal After the timeframe given to the regulated party or at the next scheduled inspection.

There may be situations where the follow-up guidelines in Table 2 are not practical (for example, when the timeframe for corrective action completion by the regulated party is not based on Table 1 but rather on guidelines found in business line or commodity specific guidance). For example, there may be situations where seasonal operators are not in operation at the time of the follow-up inspection and do not have recently produced products for CFIA to verify compliance. Follow-up inspections for these situations will be conducted at the start of the next season's operations; or at the next planned inspection.

The regulated party may require major capital initiatives and/or additional time, to satisfactorily address the non-compliance; such as for the restoration of building structures, purchasing of new equipment that must be ordered from another country, etc.

Where there is no impact on food/plant/animal health and the environment, follow-up timeframes may be extended. Refer to Section 5.4 below for the conditions for regulated parties to request an extension for corrective action completion.

5.4 Review request for extension to timeframe for corrective action completion

In extenuating circumstances, more time may be required to address non-compliance(s) than the time period originally allocated. A written request can be made by the regulated party for an extension to the timeframe for completing corrective actions.

The following describes the information required and circumstances to be considered for the review and decision on whether or not an extension request should be granted.

5.4.1 Information required for assessing the request

5.4.2 Granting requests for an extension

For information on capturing an extension in the DSDP, refer to Section A.6.4 – Request for Extension to Timeframe to Correct Non-compliance of Appendix A.

5.4.3 Denying requests for an extension

Extension requests may be denied when requirements set out in sections 5.4.1 and 5.4.2 are not met.

5.5 Appealing the inspection results

If the regulated party disagrees with the inspection results, they should contact the lead inspector named on the inspection report as a first step. If the concern continues to be unresolved, the regulated party should be directed to speak with the inspector's supervisor (manager or director level). The disagreement may involve:

If the disagreement is not resolved, the regulated party should be directed to the CFIA's complaints and appeals process.

6.0 Step 4 – Conduct the follow-up inspection

Objective:

Figure 7. Conducting the follow-up inspection consists of 4 steps represented by 4 boxes. Description follows.
Figure 7. Conducting the follow-up inspection consists of 4 steps represented by 4 boxes.

Arrows lead from one box to the next in the following order:

6.1 Scheduling the Follow-Up Inspection,

6.2 Determining the Scope of the Follow-Up Inspection,

6.3 Conducting the Follow-Up Inspection; and

6.4 Assessing the Follow-Up Inspection Results.

6.1 Schedule the follow-up inspection

Schedule the follow-up inspection, according to the guidance provided in Section 5.3, Table 2, as appropriate. Prepare for the follow-up inspection following the guidance in Step 1 - Preparation.

6.2 Determine the scope of the follow-up inspection

To determine the scope of the follow-up inspection, the inspector:

For information on creating the follow-up inspection case in the DSDP, refer to Section A.7.1 – Access the Follow-up Inspection Case and Capture Inspection Information of Appendix A.

6.3 Conduct the follow-up inspection

Conduct the follow-up inspection using the guidance in Step 2 – Conduct the Inspection, and Step 3 – Communicate the Inspection Results to verify that non-compliance is corrected and a state of compliance is re-established and reoccurrence is prevented.

When conducting the follow-up inspection, perform enough verification activities to determine if the non-compliance(s) have been addressed.

Follow the procedures outlined below to determine the appropriate action to take for outstanding non-compliances. The procedures may vary based on the timeframe for corrective actions identified on the initial inspection report and the effectiveness of the corrective actions (permanent or interim).

For all outstanding non-compliances, discuss their status with the regulated party during the opening meeting. During the on-site inspection, verify that the interim measures that were taken by the regulated party are effective in addressing any non-compliance(s) where the timeframe for corrective actions has not yet passed.

For outstanding non-compliances associated to sub-elements or other inspection task not in the intended inspection scope, if:

For outstanding non-compliances within sub-elements or other inspection tasks in the intended inspection scope, if:

Note

At the time of follow-up, it may be necessary to re-categorize an outstanding non-compliance. The inspector will need to take into account circumstances at the time of the follow-up. The re-categorization of a non-compliance will result in a re-evaluation of the time frame for completion of corrective action.

For information on capturing notes and any non-compliance identified during a follow-up in the DSDP, refer to Section A.7.1 Assess the Follow-up Inspection Case and Capture Inspection Information of Appendix A.

6.4 Assess follow-up inspection results

Assess the results of the follow-up inspection.

If a state of compliance is re-established, then complete the inspection report.

However, if a state of compliance is not re-established, then:

Note

A state of compliance is re-established when permanent corrective measures are effective and regulatory requirements are met.

Appendix A: Recording inspection information in the Digital Service Delivery Platform (DSDP)

A.1 Purpose

The purpose of this appendix is to provide guidance to all CFIA inspection staff on accessing, creating, assigning and completing inspection cases in the DSDP. This guidance is in relation to the guidance provided in the Standard Inspection Process for those sections where specific DSDP instructions are required.

Additional instructions on the use of DSDP are provided within the DSDP Standard Operating Procedures (SOPs) (internal access only) which are referenced in each section of this document (where applicable). These contain useful screenshots and information on navigating, creating various records, amending information, etc. They can be found on the DSDP landing page on Merlin (internal access only).

A.2 Overview of the DSDP

There are 4 distinct modules for CFIA's use of the DSDP:

Enrollment
Inspection
Permissions
Export

The DSDP case management structure is organized into 2 levels: services requested by industry such as export service requests or permission requests are considered parent cases, while the inspection cases generated to support industry requests and permissions are considered child cases. This case management structure facilitates industry enrollment and service requests, the assignment of work tasks, the management of inspection cases, and monitoring and reporting for risk assessment.

My CFIA is the web-based portal for industry to enroll and request permissions in the DSDP. For CFIA users, the DSDP can be accessed using the online Client Relationship Management (CRM) application, or Resco, which is a mobile CRM application that can also work offline. Not all functions in CRM are available on Resco, such as access to permission and export cases.

Online system access for both training and production environments in the DSDP can be found on the Merlin DSDP web page. This site provides information related to training and support. Refer to the Resco Mobile CRM Application SOP (internal access only - RDIMS 10396672) for more guidance on the Resco application, and issues to be aware of when working offline.

Roles and responsibilities of DSDP users

The administration of the DSDP and the creation and completion of inspection cases in the DSDP are assumed by different CFIA users, depending on their roles and responsibilities and the levels of access granted for these responsibilities. The following list provides a summary of responsibilities for different CFIA users.

Lead Inspector

Inspection team members

Supervisor

DSDP Administrator

Centre of Administration Agents

Data integrity and security

The DSDP inspection case contains data collected during inspection that includes selections from reference data lists, entry of inspection specific data and inspector notes. This information is editable by the inspection case owner during the active period of the inspection and all data is 'locked' once the inspection case is closed. The completed inspection data and the Inspection Report have a security level of Protected B.

Entry of data into a single field by more than 1 user at the same time will result in the system overwriting existing data and only keeping the most recent entry. Due to this limitation, during team inspections, it is recommended that work is divided up among the team so that each inspector is responsible for entering data into specific assigned fields (for example, each inspector enters data in a different inspection tasks), or a single inspector collects all of the information.

Should changes to inspection data be required after the inspection case is closed, a specific process must be followed for approval to make the amendment and to enable the system to track the change correctly. Refer to Section A.6.5 below for more information.

A.3 DSDP inspection case information

A.3.1 Create and validate an inspection case

Inspection cases can be created several ways. For export service requests, the inspection cases are generated from the export case via the DSDP. For permission requests, the Centre of Administration may create an inspection case. At other times, supervisors or inspectors may be required to create an inspection case. Regardless of where the inspection case is created, a validation step must occur to allow the inspection case to enter the inspection case queue and for inspection data to be populated within the case. Before an inspection case can be validated, there are several mandatory fields which must be completed. If these required fields have not been completed, the DSDP will alert the user with the appropriate fields that require attention in order for the validation to occur.

Refer to the SOP Creating an Inspection Request(internal access only – RDIMS 9852034) for information on creating and validating an inspection case. A training module specific to creating inspection requests in the DSDP can be found on Merlin - DSDP learning and training (internal access only).

DSDP Inspection triggers and establishing scope to validate the inspection case

Before an inspection case can be created in the DSDP, a fundamental field that is required for completion is the DSDP trigger field. These triggers are the reasons for the inspection, and include the following: preventive control inspection plan, sample collection plan, commodity inspection plan, incident response, domestic permission, export permission, import permission, and ASD Verification. Refer to the Section 3.1 Determine the Scope of the Inspection for a complete description of triggers in the DSDP.

Only 1 inspection trigger can be selected for an inspection case. Therefore inspection activities conducted for different purposes (trigger), with different inspection tasks, should be captured in separate inspection cases. For example, if during the same visit, a preventive control inspection is completed, and surveillance samples are required for a sample collection plan, the tasks relative to each of these inspection triggers should be captured in separate DSDP inspection cases. Refer to the DSDP case management practices for each business line for additional information.

DSDP data entry requirement to categorize commodity or thing inspected:

Within the DSDP task level for all 3 inspection task types, under the field Commodity destined for indicate if the commodity or thing is associated with: "import" or "export" or "domestic" (select all that apply).

Note: Food business line inspectors are not required to indicate this information for any Preventive Control Inspection (PCI) tasks.

A.3.2 Work tasking and assigning an inspection case

Recently created inspection cases can be found in the DSDP in the inspection case queue and will be identified with an "active" status. Inspection cases can be 'routed' to an inspector by a supervisor, or alternately, the inspector can 'pick' an inspection case. The SOP Inspection Work Tasking (internal access only – RDIMS 9881497)

provides specific information on assigning inspection cases, locating inspection cases in a queue, transferring cases to another sub-district, self-assignment and adding/removing multiple inspectors. A training module specific to work tasking in the DSDP can be found on Merlin - DSDP learning and training (internal access only).

Once the case has been assigned, the system changes the Work Status field in the inspection case to "Assigned".

A.3.3 Declining an inspection case

Inspection cases can be declined by an inspector and be subsequently re-assigned to another inspector by the supervisor. Declining an inspection case can only occur when the Work Status field indicates "Assigned" and a reason is entered into the system.

Refer to the SOP Inspection Work Tasking (internal access only – RDIMS 9881497) and the SOP Preparing for an Inspection (internal access only – RDIMS 9852125) for more information on how to decline and re-assign an inspection case.

A.3.4 Recording time within the inspection case

The amount of straight timeFootnote 4 spent on an inspection by CFIA inspection staff must be recorded in the DSDP within the inspection case. Inspection time should be recorded for each inspection task, non-compliance, and for travel as follows:

Inspection tasks
Non-compliance record
Travel time

Please note that time not directly related to conduct the inspection (general administration, break and lunch) is not to be tracked in the inspection case. Refer to SOP Conducting an Inspection (internal access only – RDIMS 9839405) for instructions on entering time entry records.

A.3.5 Notifications using DSDP

If required, inspectors and supervisors (or other users) can communicate within an inspection case via the notification task option in the DSDP. These notification tasks can be generated within the DSDP as needed, at any time until the inspection case is closed. Notifications can take 3 forms: CRM Tasks, system generated email notifications and manually generated email notifications. Refer to SOP Notification Tasks in Inspection Case (internal access only – RDIMS 9852266) for a detailed explanation of notification types and procedures to follow.

A.3.6 Note taking guidance

Information gathered by the inspector during an inspection may:

In general, notes captured in the DSDP should be clear, succinct and straightforward, avoid the use of acronyms (in order to facilitate the review of information), be based on facts (not recommendations) and be pertinent to the section in which they are entered.

The notes should reflect all of the verification activities conducted by the inspector, even if compliance is being observed. For example, a note should be captured in the specific record field to describe all of the records reviewed (including date, location and name of the document) and that compliance was achieved.

With respect to the amount of details to record in the DSDP, inspectors and supervisors should default to their training and experience. Where verification activities show possible non-compliances, more detailed notes are required. Refer to the following guidance and training material for more information on appropriate notes to take during an inspection:

Digital recordings may also be used to support inspection information. Refer to Operational Guideline (OG-14794) Use of Digital Recording (Camera, Video, Audio) Devices during Inspections (internal access only – RDIMS 10356321) for more information.

Reminder: Pertinent inspection-related information supporting a compliance decision must be captured within the appropriate and designated fields in the inspection case. The Notes tab located on every DSDP record is locked after saving. Any corrections must be done via a new note with corrections recorded

A.4 Step 1 - Prepare for the inspection

A.4.1 Determine the scope of the inspection

Once the scope has been established to validate the inspection case, the scope of the inspection may be modified by the inspector. The scope of the inspection will include the inspection task type (preventive control inspection, commodity inspection or sample collection) and the level 1 and 2 inspection tasks required. A complete list of tasks under the commodity inspection task type is available in the DSDP under Administration in the Site Map. Refer to business line specific guidance which will provide the appropriate inspection tasks for the specific business line program.

Select and enter the inspection tasks in the "Inspection Tasks" sub-grid. Inspection tasks are described using the following fields:

For Export-triggered inspections the inspection task detail field is automatically populated with a more detailed description of the inspection task that needs to be conducted.

Refer to business line specific guidance to confirm the trigger, inspection task types and inspection tasks appropriate for the inspection case. Additional pertinent information may be required for the inspection as per business line guidance. This information can be added to the task record: in the commodity details field (for commodity inspection task types); in the sample record field (for sample collection inspection task types); and the inspection verification activity field (for preventive control inspection task types).

A.4.2 Establish the team

The determination of establishing a team is found in the SIP and relevant business line guidance. The steps for adding a team member to an inspection case can be found in the SOP Preparing for Inspection (internal access only – RDIMS 9852125).

A.4.3 Review information

Review the information in the DSDP inspection case in addition to the guidance in the 'Review information' section of the SIP:

A.4.4 Notify the regulated party

If the inspection is announced, and the regulated party was notified, then enter the name of the Regulated Party representative who confirmed the inspection, in an appropriately titled Note tab in the main inspection page.

Once the inspection is scheduled (announced or unannounced inspection), then:

The Work Status field in the inspection case will automatically be updated to "Inspection Scheduled".

Refer to the SOP Preparing for an Inspection (internal access only – RDIMS 9852125) for more information.

A.5 Step 2 – Conduct the inspection

A.5.1 Conduct the opening meeting

To capture information on the opening meeting in the DSDP, add a new meeting record from the Sitemap sub-area, as per the instructions in 'Hold opening meeting' section of the SOP Conducting an Inspection (internal access only – RDIMS 9839405). In this meeting, capture the following information:

Once the inspection has begun on the premises of the regulated party, ensure that the Work Status field in the inspection case is set to "Inspection in progress" and adjust it if needed.

A.5.2 Conduct the initial walk-through

When conducting an initial walk-through:

Refer to Section 'Conduct Walkthrough' of the SOP Conducting an inspection (internal access only – RDIMS 9839405) for more information on where to input this information.

A.5.3 Confirm the scope

If at any point during the inspection an observation is made that may require a response, it will need to be determined whether to add an inspection task to the existing case or whether a new inspection case is warranted.

A.5.4 Perform inspection tasks

Inspection verification activity fields common to preventive control inspection, commodity inspection, and sample collection task types include measurements, document and record review, interview and observation fields. When conducting a commodity inspection, an additional commodity details field is available. When conducting a sample collection, an additional sample record field is available.

Information captured in the various verification activity fields does not appear in the inspection report (except for the Sample Description field). Where inspection information reflects a non-compliance, this information should be copied to the findings field.

Before exiting the inspection task page, ensure the status and scope section is completed with the scope change, 'is non-compliance observed' field, and 'task complete' field.

A.5.4.1 Inspection verification activities for preventive control inspections, sample collection, and commodity inspections

Document and record review

For any records or documents reviewed, capture notes in the Document & Record Review open text field in the Inspection Verification Activities section of the Inspection Task. See section 'Inspection verification activities' of the SOP Conducting an inspection. The note should include:

Observation

Capture observation notes in the Observations open text field in the Inspection Verification Activities section of the Inspection Task. See section 'Inspection verification activities' of the SOP Conducting an inspection. The notes should include:

Interview

Capture interview notes in the Interviews open text field in the Inspection Verification Activities section of the Inspection Task. See section 'Inspection verification activities' of the SOP Conducting an inspection. The notes should include:

Measurement

To capture information about measurements that are taken without submitting a sample, create a Measurements record in the Inspection Verification Activities section of the appropriate Inspection Task. See section 'Capture measurement information' of the SOP Conducting an inspection. Within the Measurements record, capture the Measurement Type:

If the activity conducted is not listed in the Measurement Type field, then add an appropriate Commodity Inspection task that best describes the activity completed.

Within the Measurements record, capture:

Document

Documents can be attached in the Documents sub-grid. Care should be taken to only attach documents relevant to a potential non-compliance or a regulatory response action, in order to prevent overburdening the system. To attach a document, click on the save button and leave the Document Type field blank, then provide notes and the file you wish to attach in the Notes section.

Examples of electronic documents that may be attached within an inspection task:

Sample records (for sample collection task type only)

Within the inspection task, create a new record in the Sample Records section for each sample taken. Within this record, capture:

Refer to business line specific guidance for DSDP inspection case management requirements.

Refer to the SOP Manage samples (internal access only – RDIMS 9852138) for more information on how to create, complete and manage samples in the DSDP.

Commodity details (for commodity inspection task type only)

Whether performing a planned or as required commodity inspection, create a new Commodity inspection task, even if the activity was conducted to confirm results obtained during a preventive control inspection.

Capture an accurate description of the commodity (or thing) inspected for future reference in the Commodity Description field. Use the other verification activity fields to capture the results of the commodity inspection.

Findings

Use the Findings field to capture any notes obtained from the verification activities that will be useful to potentially support a non-compliance. The information contained in the Findings field will populate the Non-Compliance record to draft the objective evidence.

A.5.5 Determine compliance

If no non-compliances were found during the inspection of a task, then select 'No' in the 'Is Non-Compliance Observed?' field of the Inspection Task, record the amount of time it took to complete the task in the Task Time Entries sub-grid and check the box 'Task Complete?' field.

If a non-compliance has been identified, then select 'Yes' in the 'Is Non-Compliance Observed?' field of the Inspection task.

Impact assessment:

For all preventive control inspection (PCI) tasks, it is mandatory to enter a response in the Impact Assessment field which will appear when the 'Is Non-Compliance Observed?' field is marked as 'yes', select the appropriate option within the drop-down field, as per business line OG.

Note

Currently this field is only being used for the Food business line. For Plant and Animal business lines, this field is still mandatory to complete and ‘no impact’ must be selected from the drop-down field.

Impact assessment and Non-compliance categorization

The Impact assessment is a field in the DSDP used to gather inspection task data that is required for the establishment-based risk assessment model (ERA). It is one of the compliance factors used in the calculation of the Establishment Risk Result. Please refer to the ERA SharePoint page (internal access only) for further information. The Impact assessment is only completed for the Preventive Control Inspection task type and is found in the inspection task record.

The Category of non-compliance is a field in the DSDP used to determine the potential consequences of the non-compliance and the likelihood of occurrence. The non-compliance categorization determines the level of response the CFIA needs to take to mitigate risk and restore compliance. The Category of non-compliance field is found in the non-compliance record.

The impact assessment is not to be considered during the categorization of the non-compliance.

A.5.5.1 Creating a non-compliance record

A non-compliance record can be created from the main inspection page in the Non-Compliance sub-grid. Refer to the SOP Managing a Non-Compliance (internal access only – RDIMS 9906406) for additional instructions for capturing the type and sub-type of non-compliance, regulatory and non-regulatory references.

These are the required steps to create the non-compliance record:

1. Select the appropriate Type of Non-Compliance

2. Select the Sub-Type of Non-Compliance

3. Save the record

4. Modifying the Name field

5. Add Regulatory or Non-regulatory References

6. Add Supporting Inspection Tasks

7. Complete the Objective Evidence

Objective evidence

Objective evidence is facts obtained from the inspection activities that support a regulatory non-compliance. This evidence should be derived from specific notes taken during the inspection, and be presented in a clear and factual manner. This information will be provided to the regulated party in the inspection report. Only information directly related to the non-compliance should be captured as objective evidence. This field is limited in space, so information entered here should be clear and concise.

The details must include what was observed, measured or obtained. Include where and when the objective evidence was noted as well as the title of anyone interviewed.

For example: "June 10, 2011 10:45 am, the employee on the packaging line for the orange soda did not follow written procedures to clean up after a bottle explosion."

If the non-compliance was noted during record or documentation review, include the title/code and date of the records reviewed, and the finding. For example: "Reviewed the Cooking Reports XY for May 2011. Deviations were identified by quality control on May 5th, 6th, and 7th which indicated the product was undercooked. Further review of shipping records on May 12th and 13th indicated that the product was distributed without taking any corrective action".

Note

The Regulatory and Non-Regulatory References, the Objective Evidence and the Supporting Inspection Tasks will appear on the Inspection Report.

8. Categorize the Non-compliance

9. Select the most appropriate option from the Generic Non-Compliance Statement drop-down menu. Note: The Generic Non-Compliance Statement will appear on the inspection report.
Select from the following options:

  1. Regulated party's PCP does not meet regulatory requirements – Select when a non-compliance can be linked to a PCP that was not designed to meet the regulatory requirements.
  2. Regulated party's PCP is not effective – Select when a PCP is not effective in meeting the regulatory requirements.
  3. Regulated party's PCP is not implemented – Select when the PCP has not been implemented as designed.
  4. Domestic commodity does not meet regulatory requirements – Select when a domestic commodity has been found non-compliant during the course of a commodity inspection or sample collection inspection.
  5. Imported commodity does not meet regulatory requirements – Select when an imported commodity has been found non-compliant.
  6. Commodity does not meet foreign importing country requirements – Select when a commodity to be exported has been found non-compliant.
  7. Permission conditions not met by the regulated party – Select when the non-compliance can be linked to permission conditions which have not been met.
Note

When an inspection report is generated for a case that does not have any non-compliances, it will have the following generic statement 'Requirements assessed at the time of the inspection were found to be compliant'.

10. Complete the Non-Compliance reported fields

A.5.5.2 Capture regulatory response actions

If any control and/or enforcement actions were taken during the course of the inspection, then:

A.5.6 Entering timeframe for regulated party to complete corrective actions

To capture information relating to timeframes for regulated parties to complete corrective actions:

  1. Enter the timeframe to complete corrective actions (based on the guidance in Table 1 in Section 4.8 of the SIP) in the Complete Corrective Actions By field.

A.5.7 Creating follow-up inspection cases from the non-compliance record

The follow-up to a non-compliance may be conducted within an already existing and scheduled inspection case or a new follow up inspection case can be created.

If a new inspection case is required, then:

  1. Enter the proposed follow-up date in the Follow-up Inspection Date field based on the timeframes for conducting a follow-up inspection. See Table 2 in Section 5.3 of the SIP for the timeframes for conducting a follow-up and Section 6.0 for more information on creating follow-up inspection cases.
  2. Capture relevant notes related to the follow-up in the Potential Follow-up Actions field.
  3. Once this information has been entered, the follow-up case can automatically be created by clicking on the Create Follow-up button at the top of the page.

If it is determined that the follow-up to this non-compliance can occur at the next scheduled inspection, then:

  1. Check the Follow-up Next Inspection Indicator box.
  2. Ensure that the task(s) associated with the non-compliance have been added to the follow-up inspection's scope.
  3. Reference the previous non-compliance in the Related Non-Compliance field in the follow-up inspection case.
  4. Within each inspection task conducted for the purpose of a follow-up, check the box "Inspection For The Purpose of Follow-up?".

Refer to SOP Managing non-compliance (internal access only - RDIMS 9906406) for more information and additional steps to ensure that the follow-up inspection case is properly assigned and validated. Refer to the business line specific case management practices for additional information on managing DSDP cases.

Note

The Complete Corrective Actions By field will appear on the inspection report.

Note

The Follow-up Inspection Date and Complete Corrective Actions By dates are to be used in relation to any enforcement actions taken (refer to the Operational Guidance: OG14954 - Standard Regulatory Response Process - RDIMS 9146498).

Refer to the section 'Complete the Non-Compliance Response Details' tab (if applicable) in the SOP Managing a Non-Compliance record; and refer to the business line specific case management practices for additional information on managing DSDP cases

A.6 Step 3 – Communicate the inspection results

A.6.1 Conduct closing meeting

Follow the same procedures as described in Section A.5.1 Conduct the Opening Meeting, except select "Closing Meeting" in the Type of Meeting field.

A.6.2 Complete the inspection case

Once the Inspector has completed the inspection, has obtained all necessary information and is ready to issue the inspection report, they will need to complete the inspection in the DSDP. For further guidance on the steps to take to complete the inspection case, refer to the SOP Update, Close and Cancel an Inspection Case (internal access only – RDIMS 9852255).

These are the required steps to complete and close the inspection case:

  1. Ensure that all inspection tasks have been marked complete by clicking on the checkbox next to the field Task Complete, located in each inspection task.
  2. Capture the last day of the inspection at the establishment in the End Date field.
  3. The related case output field is for sending results of the inspection to the export or permission parent case. For Export and Domestic Permission inspection triggers, complete the Related Case Output field based on the following guidance:
    • Pass - when no deviations to the Regulatory or Non-Regulatory references applicable to this inspection were found.
    • Fail - Deviations to the Regulatory or Non-Regulatory references applicable to this inspection were found.
    • Pass Modified - If the product or lot did not meet importing country requirements applicable to this inspection, but deviations were brought into compliance as per importing country and CFIA's acceptable policy and there are no more deviations to the Regulatory or Non-Regulatory references applicable to this inspection. Additional information on the changes or reasons for selecting this must be provided in the Feedback for Service Agent field.
  4. Enter the total time spent on inspection tasks, total time spent on non-compliance and total time spent on travel and confirm they are accurate. Then select the Confirm Total Time checkbox in the Inspection Details section.

If at any point during the inspection you are unable to complete it because you are awaiting further guidance or sample results, the inspection must be put on hold. The Status Reason field in the main inspection case must be changed to the appropriate option.

A.6.3 Issue inspection report and close the inspection case

A.6.3.1 Issue the inspection report

The Inspection Report is not saved automatically. The Run Report button simply generates a report based on the information present in the inspection case at that time. The inspection report must be generated and saved prior to closing the inspection case.

In instances where an Inspection Report is not required, do not generate and attach the inspection report to the inspection case. In addition the Primary Delivery Method, Date and Report Completed fields can be left blank. However, capture the date that the decision to not issue the report was taken in the Report Issue Date (this is a mandatory field to close the inspection case).

The following steps will need to be performed to save a copy of the inspection report as it was issued at the time of the inspection.

  1. Determine if a report review is required
    1. The purpose of the Report Review Required field is for instances where there may be further review requested by the Supervisor. The Supervisor selects this at the time of assigning the inspection case. The inspector will see the Report Review Required field marked 'yes' in the 'Complete inspection' tab of the inspection case when it is required.
    2. For steps to take to submit the inspection report for review, please refer to the section 'Report review required…' in the SOP Update, close and cancel inspection case (internal access only – RDIMS 9852255).
  2. Check off the Report Complete field. This field is to determine when the report is ready to be generated and uploaded to the case. It is to be checked off if there is no report review required, or if a report review has been completed and approved.
  3. Enter the date in Report Issue Date field
  4. Generate and save the report in the documents sub-grid of the inspection case
    1. A copy (i.e. PDF) of the Inspection Report must be saved, by attaching the copy in the Documents sub-grid on the main inspection case page with final inspection report selected for document type. Once a copy of the report is saved in the Documents sub-grid, it is automatically posted on the regulated party's external portal once the case is closed (deactivated). If the report is not saved, it will not be made available to the regulated party through the MyCFIA portal.
  5. Capture the Report Delivery Method

    Refer to the section 'Report Delivery Method' in the SOP Update, close and cancel inspection case.

    1. If the inspection report is only delivered through the My CFIA portal, select the option "Portal only".
    2. If the inspection report is delivered through the My CFIA portal and also through another method, select the other method the report was delivered (i.e. In Person).
  6. Upload and save signed report (if applicable)
    1. If signatures have been obtained, then the signed report should be scanned and attached to the Documents sub-grid (with final inspection report selected for document type).
Note

Only 1 inspection report will appear on the regulated party's external portal for each inspection case. The newest document to be attached in the Documents sub-grid labelled as "Final Inspection Report" will be posted on the portal.

A.6.3.2 Close the inspection case
  1. Complete the Populate and Lock case closed fields in the 'Closed Case Details' section. This will ensure all of the case closed fields in the inspection case related to a party's profile will not change once the case is closed.
  2. There are 2 main options when closing the inspection case (closed or cancelled). There are instances where you may be unable to complete the inspection. In these situations, 1 of the cancelled options must be selected from the deactivate list. If the inspection is fully completed, the 'closed – inspection complete' option must be selected from the deactivate list. Refer to the section 'Deactivate/Close an Inspection Case' in the SOP Update, close and cancel inspection case.

A.6.4 Request for extension to timeframe to correct non-compliance

An inspection case should not be reactivated in order to amend an agreed upon extension to a timeframe to complete corrective actions. If an extension to the timeframe to correct a non-compliance has been granted, the lead inspector should enter the information in the 'Notes' tab in the follow-up case. Attach a copy of the written submission provided by the regulated party in the Notes tab along with the justification and include any other relevant changes made to the inspection case.

A.6.5 Amending a closed inspection

Prior to amending a closed/deactivated inspection case, send a formal request to the BSU (DSDP Support) at the following email address: DSDP Support/Support PPNS (CFIA/ACIA) cfia.dsdpsupport-supportppns.acia@canada.ca. In this email, provide the case number, as well as the reason for reactivating the case.

If the case is to be amended:

  1. Notify and obtain approval from your supervisor and the BSU.
  2. Re-activate the inspection case (as per the SOP).
  3. Click on the Amendment check box in the inspection case (Status & Priority sub-section).
  4. Change the required fields in the inspection case.
  5. Capture in a Notes tab in the main inspection case, a detailed description of the amendments that were completed.

Refer to the section 'Amending the Inspection Case' in the SOP Amending a Closed Inspection Case (internal access only – RDIMS 10367954) for information on how to reactivate a case.

A.7 Step 4 – Conduct the follow-up inspection

This section is about entering the information into the DSDP to support conducting the follow up inspection.

A.7.1 Access the follow-up inspection case and capture inspection information

The follow up case, once validated, will be in the inspection case queue. Use the same guidance provided for conducting an inspection and communicating inspection results. See Section A.5.0 for capturing information relating to the follow-up inspection.

References

SOP Monitoring inspection cases – (internal access only – RDIMS 9913443)

SOP Creating an Inspection Request – (internal access only – RDIMS 9852034)

SOP Inspection Work Tasking – (internal access only – RDIMS 9881497)

SOP Preparing for an Inspection – (internal access only – RDIMS 9852125)

SOP Requesting Advice for an Inspection Case – (internal access only – RDIMS 9855738)

SOP Notification Task in an Inspection Case – (internal access only – RDIMS 9852266)

SOP Conducting an Inspection - (internal access only – RDIMS 9839405)

SOP Manage Samples – (internal access only – RDIMS 9852138)

SOP Managing a Non-Compliance Record – (internal access only – RDIMS 9906406)

SOP Update, Close and Cancel Inspection Case – (internal access only – RDIMS 9852255)

SOP Amending a closed inspection case – (internal access only – RDIMS 10367954)

SOP Resco Mobile CRM Navigation – (internal access only – RDIMS 10396672)

SOP Searching For Party Profiles and Establishments – (internal access only – RDIMS 10859888)

Integrated Agency Inspection Model (iAIM)

Standard Regulatory Response Process

Standard Permissions Procedures

SIP Inspectors Toolkit – (internal access only – RDIMS 11289973)

SIP Guide for Determining the Severity of Consequences – (internal access only – RDIMS 11289853)

SIP Opening and Closing Meeting Checklist – (internal access only – RDIMS 11289897)

SIP Notification Letter Template – (internal access only – RDIMS 11289579)

SIP Category of Non-Compliance Process – (internal access only – RDIMS 11292219)

SIP Biosecurity Measures by Activity and Level – (internal access only – RDIMS 11292267)

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