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Standard Inspection Process

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Acronyms

CFIA
Canadian Food Inspection Agency
CI
Commodity Inspection
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
SC
Sample Collection
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 contravention of the applicable Acts and/or Regulations
Objective evidence
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.
Risk
The product of the severity of the consequences of a hazard/concern 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/or permission conditions (if applicable). There are 3 inspection task types: 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 and/or permission conditions. This could include a regulated party's systems-based approach that focuses on prevention as a way to achieve 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 sample collection plan 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 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 is used to support compliance decisions and any actions taken by CFIA when non-compliances are identified.

Inspection information is entered and resides in the Digital Service Delivery Platform (DSDP). Procedures for the use of the DSDP to capture inspection data is found in Appendix A and on the DSDP Merlin page (accessible only on the Government of Canada network) in conjunction with the business line and commodity specific guidance.

The inspection process

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

Figure 2: 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. To request advice and guidance:

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. 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

3.5 Preparing the tool kit

3.1 Determine the scope of the inspection

The Digital Service Delivery Platform (DSDP) is the central repository for planning inspections and recording inspection data. Each DSDP inspection case has a trigger and scope which includes one or more inspection tasks. The scope is determined by the trigger (reason) for the inspection. Refer to Section A.4.1 – Determine the scope of the inspection for more information.

Business line guidance indicates which DSDP triggers (reason for inspection) apply for specific programs. In the DSDP, there are 8 trigger options.

Table 1: 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 in 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:

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 DSDP , 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 is defined by the program direction 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 service request for an import, domestic or export permission or where required by law for interprovincial marketing purposes).

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, determine:

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

Check to see if the regulated party has a party profile. If the party profile is not found in the DSDP, contact the regulated party and request that they enrol in My CFIA. If the regulated party does not enrol, follow the process outlined in the SOP Searching for Party Profiles and Establishments (accessible only on the Government of Canada network – RDIMS 10859888).

If the regulated party have previously been inspected by CFIA, review:

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

Review the regulated party's history including:

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

Review applicable regulatory requirements and/or permission conditions associated with the scope of the inspection and any additional relevant operational guidance and references.

For information on requesting additional advice in the DSDP, refer to SOP Requesting Advice for an Inspection Case (accessible only on the Government of Canada network, 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 (accessible only on the Government of Canada network – RDIMS 9855738).

3.4 Notify the regulated party to schedule an inspection (when required)

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.

Inspectors may notify the regulated party to schedule an inspection to ensure that:

Notification can be provided verbally or in writing via an e-mail. The notification letter template (accessible only on the Government of Canada network, 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

4.8 Determining the timeframes for the regulated party to complete corrective actions

4.9 Determine if response action is required

4.1 conduct the opening meeting

A preliminary step to conducting an inspection is to determine whether it is necessary to engage with the regulated party prior to initiating inspection activities. This level of engagement may be a simple greeting to notify the regulated party of the start of the inspection, or it may be a more formal opening meeting. A formal opening meeting is not always mandatory. For some inspections, (for example, surveying public lands for the presence of quarantine pests), engagement is not required.

When an opening meeting is required, the inspector will:

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

During the opening meeting the inspector will:

During the opening meeting the inspector may also (where applicable):

Refer to Opening/closing meeting checklists (accessible only on the Government of Canada network – 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 inspections. The inspector uses 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

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

Performing inspection tasks allows an inspector to verify a regulated party's compliance to regulatory requirements and/or permission conditions. DSDP inspection cases will normally include one or more inspection tasks of the three inspection task types (preventive control inspection, commodity inspection or sample collection).

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 the appropriate commodity inspection or sample collection task to the existing inspection case. Alternatively, if while conducting a preventive control inspection, a sample is collected for a national sampling plan (planned sample collection) a separate inspection case should be used. 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 and/or permission conditions. This could include a regulated party's systems-based approach that focuses on prevention as a way for a regulated party to achieve compliance.

This inspection type evaluates the regulated party's preventive controls as applicable to the regulated party's operation including regulatory requirements and/or permission conditions 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 uses 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 lists 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 or surveillance. Examples include sample collections for product identity, assessment for soil or pests, evaluation for toxins or disease.

Business line guidance provides procedures for the notification and submission of samples to the laboratories. The Laboratory Sample Tracking System (LSTS) is the main tool used by the CFIA to track and compile the information pertaining to laboratory samples. Business line operational guidance describes the manner in which sampling information is 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 requirements and/or permission conditions. 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, for example, label verification, crop inspection, specified risk material (SRM) inspection.

The inspector evaluates commodities based on applicable regulatory requirements and/or permission conditions. Business line operational guidance describes the manner in which commodity information is 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 use a combination of inspection verification activities to assess compliance to regulatory requirements and/or permission conditions for all 3 inspection task types (preventive control inspection, 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.

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 or presence of soil. This section also allows for specific descriptors to be documented such as tattoo identification, lot identification and breed, or example.

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

At any time when conducting an inspection, where it is determined that there is a potential for human, animal or plant health, or the environment or economy/trade to be severely impacted, inspectors may need to take control action by conducting the following:

For information on capturing notes relating to control actions in the DSDP, refer to Section A.5.2 – Conduct the initial walk-through Actions of Appendix A.

4.6 Determine compliance

During this step, inspectors interpret and analyze the information collected during the inspection to determine compliance with regulatory requirements and/or permission conditions. Inspectors take into account all inspection information gathered and make determinations and decisions regarding compliance.

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.

If no non-compliance is observed during the inspection proceed to Section 5.0 Step 3 – Communicate the inspection results.

If non-compliance is observed, proceed to Section 4.7 Categorize 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 4.7.1 to 4.7.4) 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 regulatory response process, if required. Refer to the SRRP.

The Categorization of Non-Compliance Process document (accessible only on the Government of Canada network – RDIMS 11292219) outlines the process for CNC.

4.7.1 Identify the non-compliance type and sub-type

Identify the type and sub-type of non-compliance based on the information collected during the inspection.

Select all applicable types and sub-types that reflect the impact caused by the non-compliance. see below for a list of non-compliance types.

Table 2: The characteristics associated to the non-compliance types and sub-types
Type Sub-type 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 (for example, 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 unfair 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)

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, use the Guide for determining the severity of consequences of non-compliance (accessible only on the Government of Canada network – RDIMS 11289853) to help determine the level of severity (low, medium or 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 used in section 4.7.4.

4.7.3 Determine the likelihood of occurrence

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

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 is available to help determine likelihood of occurrence:

If the consequence of the non-compliance has already occurred, 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

Categorize the non-compliance based on its impacts using Figure 5 below:

Figure 5: CNC Matrix. 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 and the boxes are coloured yellow.

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 and the boxes are coloured orange.

A high severity of consequence results in minimal CNC for unlikely likelihood of occurrence represented by a yellow box, moderate CNC for likely likelihood of occurrence represented by an orange box, and severe CNC for very likely likelihood of occurrence represented by a red box.

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, repeat steps in sections 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. In the meantime, effective interim measures must be taken to address any non-compliance.

The timeframe to complete corrective actions must reflect the severity of the impact of the non-compliance and take into consideration, when possible, the time required for the regulated party to address the root cause and permanently correct the non-compliance. Timeframes are assigned by the inspector based on Table 3. 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 measure 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 3. Timeframe guidelines 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

Where a corrective action was implemented prior to the closing meeting, the non-compliance record and a corrective action due date that aligns with the category of non-compliance must still be recorded in DSDP. A follow-up inspection will need to be conducted based on the timeframe for the category of non-compliance to ensure that permanent corrective action have been implemented.

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 section A.5.5 – Determine Non-Compliance and section A.5.6 – Entering Timeframe for Regulated Party to Complete Corrective Actions of Appendix A.

4.9 Determine if response action is required

In addition to determining the timeframe for corrective action, assess if control measures, enforcement actions or actions on a permission are warranted before the follow-up inspection.

Guidance on these assessments can be found in the Standard regulatory response process, the Enforcement and investigation file referral standard (EIFRS), and in business line policy or guidance.

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. Communicating the inspection results represented by 4 boxes. Description follows.
Figure 6. There are 3 steps to communicating the inspection results represented by 3 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 Schedule CFIA follow-up inspection

5.1 Conduct closing meeting

A closing meeting is held once the inspection and all inspection tasks are completed. The closing meeting may be formal or an informal discussion of inspection results. 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:

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

Refer to Opening/closing meeting checklists (accessible only on the Government of Canada network – 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 is the DSDP inspection report. In certain situations, an inspection report may not be issued. Refer to program specific guidance for more information.

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

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 (accessible only on the Government of Canada network – RDIMS 6159161).

Once the inspection report has been submitted to the regulated party and all required fields in the inspection case have been completed, the inspection case must be deactivated (closed) to prevent any further editing.

Reminder: Only details of the 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 Scheduling CFIA follow-up inspections

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

Timeframes for follow-up inspections are based on the regulated party's timeframe for corrective action, as per section 4.8. Use Table 4 below to guide scheduling of follow-up inspections.

Table 4: 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

The follow-up should be scheduled as soon as possible following the regulated party's Date for Completion of Corrective Action. However, there may be situations where the follow-up guidelines in Table 4 are not practical. For example, where seasonal operators are not in operation at the time of the follow-up inspection or do not have recently produced products for CFIA to verify compliance, follow-up inspections for these situations can be conducted at the start of the next season's operations, or at the next planned inspection. Additionally, timeframe for corrective action completion by the regulated party may be specified in guidelines found in business line or commodity specific guidance.

5.4 Review request for extension to timeframe for corrective action completion

In some situations, a regulated party may require more time to implement permanent corrective action than the timeframe originally allocated. For example, a regulated party may require major capital initiatives or additional time to satisfactorily implement corrective actions such as restoring building structures or purchasing new equipment. Where there is no impact on food/plant/animal health and the environment, timeframes to complete corrective action may be extended.

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

Written requests for extensions must be submitted prior to the original established completion date.

The request includes:

5.4.2 Granting and denying requests for an extension

An extension can be granted when:

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.

Extension requests may be denied when criteria set out above and in section 5.4.1 are not met.

5.5 Formal review of 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 can request a formal review by submitting the reason of the request in writing to the inspection supervisor prior to the Date for Completion of Corrective Action indicated on the inspection report and no later than 14 calendar days after the report issue date. It is important to note the regulated party must have interim measures in place to control any immediate risk, weather or not the regulated party requests a formal review of the inspection results. The submission for the request for review must include the DSDP inspection report and must clearly identify the section(s) of the report to be reviewed.

When the Inspection Supervisor receives the formal request for review from the regulated party, they should:

Following review with the Inspection Supervisor and other subject matter experts (Inspection Advisors, Inspection Team, Inspection Manager, etc.), the lead inspector decides whether to confirm or modify the inspection results.

If the lead inspector decides to modify the inspection results, they should:

The lead inspector documents the result of the review and the rationale for their decision using the Formal review record of decision template (accessible only on the Government of Canada network – RDIMS 20412890). The lead inspector uses the information from this document to complete the Formal review decision notification letter template (accessible only on the Government of Canada network – RDIMS 18868227).

The lead inspector uploads a copy of the Record of Decision, the Formal Review Decision Letter and the original Request for Formal Review in the Documents sub-grid of the Inspection case as document type "Decision Document".

The lead inspector should communicate the decision within 10 calendar days of receipt by sending a copy of the Formal Review Decision Letter to the regulated party with a copy to their supervisor. This will allow time for the regulated party to pursue the right to recourse, should it be required.

In situations where the disagreement can not be resolved, the regulated party should be directed to CFIA's Right to recourse information found in the Compliance and enforcement policy.

6.0 Step 4 – Conduct the follow-up inspection

Objective:

Figure 7. Conducting the follow-up inspection. 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 4, 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 the verification activities necessary 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.

Complete the inspection report if a state of compliance is re-established.. However, if a state of compliance is not re-established:

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 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) (accessible only on the Government of Canada network) which are referenced in each section of this document, where applicable. These contain useful screenshots and information on navigating, creating various records and amending information. They can be found on the DSDP landing page on Merlin (accessible only on the Government of Canada network).

A.2 Overview of the DSDP

There are 5 distinct modules for CFIA's use of the DSDP:

The DSDP is a tool that gives Agency staff the ability to issue export certificates and permissions (such as licences, permits, and registrations), capture inspection data, document compliance decisions, complete technical reviews, generate inspection reports, and assess and manage risk.

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.

Online system access for both training and production environments in the DSDP can be found on the Merlin DSDP web page (accessible only on the Government of Canada network). This site provides information related to training and support.

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

National Centre for Permissions Agents

Data integrity and security

The DSDP inspection case contains data collected during the inspection that includes selections from reference data lists, entry of inspection specific data and inspector notes. This information entered in a Note in DSDP is not editable by the inspection case owner as soon as it is saved. However, all other information is editable until the case is deactivated. Records created in DSDP cannot be deleted so inspectors should be diligent before creating records. The system does have an audit function that can keep track of when changes are made and by whom. 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 is assigned a different inspection task), or a single inspector is solely responsible for all data entry within the inspection case.

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 National Centre for Permissions may create an inspection case. For planned work, inspection cases may be uploaded in the DSDP at the start of the fiscal year. 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 (accessible only on the Government of Canada network – 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 (accessible only on the Government of Canada network).

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 inspection record for sample collection and commodity inspection task types, under the field Commodity destined for field:

A.3.2 Work tasking and assigning an inspection case

Recently created and uploaded planned inspection cases can be found in the DSDP in the inspection case queue and will be identified with an "Active" status. Inspection cases should be 'Routed' to an inspector by a supervisor, or alternately, the inspector can 'Pick' an inspection case. These steps will ensure that:

  1. the work status of the case is updated to 'Assigned'
  2. the 'Worked by' column will be filled with the name of the user who has been assigned or who has chosen the inspection case. This function facilitates the quick visualization of all the inspection cases that have been assigned in the queue

The SOP Inspection work tasking (accessible only on the Government of Canada network – 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 (accessible only on the Government of Canada network).

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 (accessible only on the Government of Canada network – RDIMS 9881497) and the SOP Preparing for an Inspection (accessible only on the Government of Canada network – 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

Time spent completing an inspection task is limited to the time spent conducting the verification activities related to the task (as per the guidance in section 4.4 – Perform inspection tasks).

Time spent preparing, conducting the initial walk-through and opening/closing meetings is to be distributed evenly amongst the inspection tasks in scope. For example, if there are 6 inspection tasks and the inspector took 1 hour to prepare and 0.5 hours for the walk-through, then an additional 0.25 hours for each of the 6 inspection tasks would be recorded.

Each inspection team member (if more than 1 inspector is involved for the assigned inspection) is responsible for recording the amount of time spent to the nearest quarter hour on the inspection task.

Non-compliance record

Time spent completing a non-compliance record is limited to the moment a non-compliance is identified, the categorization of the non-compliance and the determination of the timeframes for completion of the corrective actions of any regulatory response actions in relation to that non-compliance.

Travel time

Record the total cumulative time to the nearest quarter hour spent on travelling to and from the inspection site by all inspectors/staff involved with the inspection case in the travel time spent field of the inspection details section of the inspection case. For example, if 2 inspectors are conducting an inspection together and it takes 1 hour to travel to the site and back, then record 2 hours in the travel time spent field.

If there are multiple sites to visit in a day, then only record travel time to a site in the inspection cases. The last site inspected must include travel back to the office in its associated inspection case. For example, an inspector travels 0.5 hours to site A, then travels 1 hour to site B, 1.5 hours to site C, followed by 2 hours to return to the office, then record 0.5 hours in the inspection case for Site A, 1 hour in the inspection case for Site B, and 3.5 hours in the inspection case for Site C.

The lead inspector is responsible for ensuring this information is entered in the travel time spent field.

Note: 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 (accessible only on the Government of Canada network – RDIMS 9839405) for instructions on entering time entry records. Refer to specific business line guidance to confirm additional instructions for recording time.

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 (accessible only on the Government of Canada network – 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, brief 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. Information recorded should be in an adequate amount and level of detail required for another inspector reach the same compliance decision. In addition, a non-compliance may be supported by inspection findings from one or more inspection tasks.

Refer to the following 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 (accessible only on the Government of Canada network – 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

For manually created inspection cases, once the scope has been established to validate the 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. A complete list of tasks under each 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 add inspection tasks in the "Inspection Tasks" sub-grid. Inspection tasks are described using the following fields:

For export-triggered inspections the inspection task details 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 sub-grid (for sample collection task types); and the inspection verification activity tab (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 (accessible only on the Government of Canada network – RDIMS 9852125).

A.4.3 Review information

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

Note: Since this information may be sensitive (for example, door codes) and subject to change, this information should be captured in a secure RDIMS file and this file number can be referenced in the notes field of the establishment record. This notes field is also used by the National Centre for Permissions office, therefore, ensure the title of the note is clear to avoid confusion.

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):

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

Refer to the SOP Preparing for an inspection (accessible only on the Government of Canada network – 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 (accessible only on the Government of Canada network – 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 (accessible only on the Government of Canada network – 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 required.

A new inspection case is required if the new inspection task is conducted for a different purpose than identified in the Inspection trigger of the initial inspection case. For example, if conducting a preventive control inspection and collecting a sample related to a National Sampling Plan, then use a separate inspection case with the appropriate inspection trigger

If a new inspection task needs to be added, add it in the Inspection Tasks sub-grid in the main inspection page. Please refer to section 'Add to scope' in the SOP Conducting an inspection (accessible only on the Government of Canada network – RDIMS 9839405)

If an inspection task must be removed from the inspection, please refer to section 'Remove from scope' in the SOP Conducting an inspection (accessible only on the Government of Canada network – RDIMS 9839405)

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, supplemental information, interview, observation and findings fields. When conducting a commodity inspection, an additional commodity details field is available. When conducting a sample collection, an additional sample record sub-grid is available.

Information captured in the various verification activity fields does not appear on the inspection report (except for Commodity Description field in the commodity inspection task and the Sample Description field in the sample details record of the sample collection task). 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?' checkbox.

Note: The "Task Complete?" checkbox cannot be checked unless a Task Time Entry is created within the task.

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

For information on the use of this field refer to Business Line specific guidance.

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 (accessible only on the Government of Canada network – 9839405). 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 (accessible only on the Government of Canada network – 9839405). 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 (accessible only on the Government of Canada network – 9839405). 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 (accessible only on the Government of Canada network – 9839405). 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 sample details record in the Sample Records sub-grid for each sample taken. Within this record, capture:

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

Refer to the SOP Manage samples (accessible only on the Government of Canada network – 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, use a 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. The content in this field will appear on the inspection report. 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 and can be used 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.

Note: Any non-compliance must be reported, regardless if permanent corrective actions were implemented by the regulated party before the end of the inspection. Determine the appropriate reference(s), whether it is a regulatory reference a or non-regulatory reference.

ERA/IRA Impact assessment

The ERA/IRA 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 (accessible only on the Government of Canada network) for further information. The ERA/IRA Impact Assessment only appears when the inspector selects "yes" in the Is Non-Compliance Observed?" dropdown in the inspection task record of the preventive control inspection task when the Inspection Task Level 1 is Compliance Verification of a System.

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 the timeframe for completion of corrective actions. The Category of Non-Compliance field is found in the non-compliance record.

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

For all preventive control inspection (PCI) tasks, it is mandatory to enter a response in the ERA/IRA 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 operational guidance.

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.

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 (accessible only on the Government of Canada network – 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:

Note: Commodity details (for commodity task type only)

Objective evidence

Objective evidence is facts obtained from the inspection activities that support a 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: "The sanitation program is not implemented as written in their preventive control plan. On June 10, 2011 10:45 am it was observed that, the employee on the packaging line for the orange soda did not follow written procedures to clean up after a bottle explosion (SFCR 88)."

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, therefore their preventive control plan was not implemented as written (SFCR 88).

Note: The Regulatory and Non-Regulatory References, the Objective Evidence and the Supporting Inspection Tasks will appear on the inspection report.

A.5.5.2 Capture regulatory response actions

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

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 3 in Section 4.8 of the SIP) in the Date for Completion of Corrective Action 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:

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

Refer to SOP Managing non-compliance (accessible only on the Government of Canada network – 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 Date for Completion of Corrective Action field will appear on the inspection report.

Note: The Date for Completion of Corrective Action is to be used in relation to any enforcement actions taken. Refer to the Operational Guidance: Standard regulatory response process.

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 (accessible only on the Government of Canada network – RDIMS 9852255).

To complete and close the inspection case:

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 complete the inspection case business process flow).

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 (accessible only on the Government of Canada network – 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 (for example, 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 (accessible only on the Government of Canada network – RDIMS 9852255).
    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 (for example, in person).
  6. Upload and save signed report, if applicable.
    1. If signatures have been obtained, 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. Use the DSDP Inspection Case Review Tool (accessible only on the Government of Canada network – RDIMS 18048494) to check your work prior to closing the inspection case
  3. 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 (accessible only on the Government of Canada network – RDIMS 9852255)

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 follow-up case.

A.6.5 Amending a closed inspection

If the inspection case needs to be amended:

  1. notify and obtain approval from your supervisor
  2. re-activate the inspection case and any associated records that require amendment (as per the SOP)
  3. click on the Amendment check box in the inspection case (Status and Priority sub-section)
  4. change the required fields in the inspection case (see A.6.5.1 to amend a non-compliance record)
  5. capture in a Notes tab in the main inspection case, a detailed description and rationale for the amendments that were completed. This could include notes from meetings with inspection managers, subject matter expertise consultation or information from meetings with the regulated party.
  6. deactivate the inspection case

Refer to the section 'amending the inspection case' in the SOP Amending a closed inspection case (accessible only on the Government of Canada network – RDIMS 10367954) for information on how to reactivate a case.

A.6.5.1 Amending a non-compliance record

The non-compliance record created in the DSDP inspection case cannot be removed when an inspection decision is changed (for example, from non-compliant to compliant). To update the inspection case with the revised inspection decision, first re-activate the records that need to be modified.

Within the implicated Non-Compliance record:

Within the Inspection Task:

Re-issue the inspection report to the regulated party. Refer to Update, Close and Cancel an Inspection Case (accessible only on the Government of Canada network – RDIMS 9852255), Section 3.9 Attaching the inspection report to the inspection case for further information.

If a follow-up case was created for the non-compliance, the follow-up case should be deactivated with the deactivation reason: Cancelled – Inspection Decision Reversed

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

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