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Standard inspection procedure

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements are being phased in over the following 12 to 30 months. 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

CAO
Complaints and Appeals Office
CFIA
Canadian Food Inspection Agency
CNC
Categorization of Non-Compliance
CSA
Canadian Standards Association
CSRD
Commodity Specific Reference Document
DIN
Drug Identification Number
DSDP
Digital Service Delivery Platform
iAIM
integrated Agency Inspection Model
IMS
Issues Management System
LSTS
Laboratory Sample Tracking System
OG
Operational Guidance
OGE
Operational Guidance and Expertise
PCP
Preventive Control Plan
PPE
Personal Protective Equipment
SIP
Standard Inspection Procedure
SOP
Standard Operating Procedure
SME
Subject Matter Expert
SRRP
Standard Regulatory Response Process

Definitions

Deviation:
A disparity between the regulated party's established preventive control plan 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 Procedure (SIP) is the common inspection approach for conducting inspections of regulated parties. This procedure applies a consistent method of inspection across the 3 business lines (food, animals and plants) according to the integrated Agency Inspection Model (iAIM); and describes the procedural guidance for conducting inspections, based on the 4 basic inspection steps described in the iAIM.

2.0 Overview of the inspection

Canadian Food Inspection Agency (CFIA) inspectors conduct inspections to verify compliance with regulatory requirements, and permission conditions – if applicable. The purpose of the inspection process is to assess whether a regulated party meets regulatory requirements, with or without a written Preventive Control Plan (PCP).

Inspectors use a combination of onsite inspection and evaluation techniques for assessing compliance and evaluating the impact of non-compliance. Verification activities can include making visual observations, evaluating documentation, interviewing personnel, sampling, measuring, testing, and commodity inspection. The SIP will provide inspectors with the flexibility to adapt to different situations that may arise during an inspection.

The type, frequency, and intensity of the CFIA's oversight activities will be proportional to the risks that need to be managed. The inspector will be able to assess the potential impact of non-compliance to determine whether further actions are required; including taking appropriate control and enforcement action (refer to the Operational Guidance: OG14954 – Standard Regulatory Response Process.

The inspection process

The SIP uses several inspection techniques and is divided into 4 basic inspection steps.

Figure 1: Descriptive text for the inspection process is represented by 4 blue boxes
Descriptive text for the inspection process

Figure 1: Descriptive text for the inspection process is represented by 4 blue 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

Guidance may be requested at any point throughout the inspection process, from the initial review of inspection procedures to problem solving when issues are identified during inspection to documenting and following-up on non-compliance.

The process is as follows:

Standard inspection procedure

3.0 Step 1 – Prepare for the inspection

Objective:

Figure 2. Preparing for an inspection consists of 5 parts represented by 5 blue boxes
Descriptive text for Preparing for an inspection

Figure 2. Preparing for an inspection consists of 5 parts represented by 5 blue 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.

Note

The steps involved in the preparation of the inspection do not necessarily follow a linear process.

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

3.1 Determine the scope of the inspection

The scope of the inspection is defined by the inspection tasks that are included in the case. These inspection tasks are identified based on the reason for the inspection (for example, Import, Export, Compliance Verification, Complaints/Referrals, etc.)

Inspectors can be assigned the following 3 inspection task types:

For information on accessing and creating an inspection case in the Digital Service Delivery Platform, refer to Section 4.0 – Create an Inspection Request of Appendix IV.

3.1.1 Planned inspections

Planned inspections are conducted as part of the annual work plan that is developed at the beginning of the fiscal year. The scope will be defined by the work plan and is generally pre-determined before the inspection case is assigned to the inspector. For PCP inspections, the inspector will cover the entire PCP sub-element(s).

3.1.2 Unplanned inspections

Unplanned inspections are those inspections conducted in response to an event (for example, complaints, follow-up to non-compliance, referrals, a request for inspection by the regulated party for export; or, where required by law for interprovincial marketing purposes, etc.). The scope will be defined by the reason for the inspection (refer to section 4.3 of Appendix IV for more information). For PCP inspection task types – depending on the situation – it may be necessary for the inspector to review the entire sub-element.

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.

Note

Inspectors are responsible for carrying out the inspection. When inspections are conducted by an inspector accompanied by SMEs, the SMEs serve in an advisory capacity.

If a team approach is required:

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. Consult with the supervisor to verify legal authorities related to conducting inspections with other government departments, prior to agreeing to conduct a joint inspection.

3.3 Review information

3.3.1 Regulated party/commodity information

For information on reviewing the regulated party's profile in the DSDP, refer to Section 5.1 – Review Information of Appendix IV.

3.3.2 Compliance history

For information on reviewing the regulated party's compliance history in the DSDP, refer to Section 5.1 – Review Information of Appendix IV.

3.3.3 Applicable requirements, documents

For information on requesting additional guidance in the DSDP, refer to Section 5.2 – Applicable requirements, documents of Appendix IV.

3.3.4 Applicable biosecurity measures

For information on requesting additional guidance in the DSDP, refer to Section 5.2 – Applicable requirements, documents of Appendix IV.

3.4 Notify the regulated party

CFIA inspectors have the authority to enter a regulated party's premise to perform inspections, announced or unannounced. The purpose of the inspection usually dictates if an announced or unannounced inspection is required. The inspectors are expected 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. Refer to the notification letter template (internal access only – RDIMS 11289579), for a template that can be used to assist in notifying the regulated party of a future inspection.

For information on completing the DSDP, refer to Section 5.3 – Notify the Regulated Party and Schedule the Inspection of Appendix IV.

3.5 Prepare the toolkit

4.0 Step 2 – Conduct the inspection

Objective:

Figure 3. Conducting the inspection consists of 8 steps represented by 8 blue boxes.
Description text for Figure 3. Conducting the inspection

Figure 3. Conducting the inspection consists of 8 steps represented by 8 blue boxes. Arrows lead from one box to the next in the following order: 4.1 Conducting the Opening Meeting, 4.2 Doing the Initial Walkthrough, 4.3 Confirming the Scope, 4.4 Conducting the Inspection, 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.

4.1 conduct the opening meeting

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

During the opening meeting the CFIA inspector will:

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 6.1 – Conduct the Opening Meeting of Appendix IV.

4.2 Do the initial walk-through

The purpose of the initial walk-through (interior/exterior) is to:

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.

For information on completing the fields relating to the initial walk-through in the DSDP, refer to Section 6.2 – Do the Initial Walk-through of Appendix IV.

Inspection scope

Respect the preliminary scope where possible.

A justification to amend the scope must be of significant impact. Potential reasons to amend the inspection scope include:

Other justifications to expand the scope:

If the scope is amended during the on-site inspection, inform regulated party management of the scope revision and justifications.

Update the inspection case accordingly with the justification for amending the preliminary inspection scope.

4.3 Confirm the scope

As outlined in Section 4.2 – Initial Walk-through – if there are outstanding non-compliances, verify that interim measures are still effective. If the interim measures are no longer effective, and the applicable sub-elements are not already within the initial inspection scope, then expand the scope and perform only the activities related to the outstanding non-compliances.

Refer to Table 4 in Section 6.3 for more information.

For information on confirming or adjusting the inspection scope in the DSDP, refer to Section 6.3 – Confirm Scope of Appendix IV.

4.4 Conduct the inspection

Inspectors can be assigned the following 3 inspection task types

All three inspection tasks use common inspection techniques 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.

For information on the fields associated to all task types in DSDP, refer to Section 6.4.1 – Inspection Task Types of Appendix IV.

4.4.1 PCP inspection

A PCP inspection involves the evaluation of the regulated party's preventive controls, with or without a written PCP, against regulatory standards or requirements.

4.4.1.1 Preventive control plans

A preventive control plan (PCP) describes a systems-based approach that focusses on prevention as a way for a regulated party to achieve regulatory compliance. It is recognized internationally as an effective method to minimize hazards and mitigate risks.

Regulated parties have the flexibility to design their PCP according to their needs. The requirements found in a PCP are similar to any system that identifies hazards and aims to control them. As such, existing systems (for example, Quality Management Program or Food Safety Enhancement Program) may not require changes in order to align with the PCP approach.

A PCP must address regulatory requirements as applicable to the regulated party's operation including prescribed requirements for animal and plant health, food safety and labelling, product quality, and composition. A PCP may be a written plan, depending on applicable regulations.

A PCP approach accommodates most systems currently in use by industry, and provides the regulated party with the flexibility to consider using a number of existing process control or quality management type systems, such as:

Depending on the applicable regulations and the nature of the operation, regulated parties could develop their PCP to include some or all of the following 7 elements and 18 sub-elements:

CFIA verification activities may focus on one, some or all of these 18 sub-elements.

4.4.1.2 PCP general requirements

Depending on regulatory requirements, the regulated party should design and implement a system that addresses the following PCP requirements:

Hazards and controls

Identifying hazards and determining appropriate and valid controls is the foundation of a prevention-based system.

Depending on regulatory requirements, a regulated party's hazard analysis and control measures in their PCP should:

Monitoring procedures

Monitoring confirms that all control measures are followed.

Depending on regulatory requirements, a regulated party's monitoring procedures in their PCP should:

Verification procedures

Verification procedures confirm that monitoring and quality control procedures are followed, and that control measures are capable of consistently achieving the outcome.

Depending on regulatory requirements, a regulated party's verification procedures in their PCP should:

Corrective action procedures

If a hazard is not controlled, implementing and analysing corrective actions is a key part of maintaining an effective system. A PCP should outline the steps the regulated party intends to take to appropriately correct a deviation.

Depending on regulatory requirements, a regulated party's corrective action procedures in their PCP should:

Management review (by the regulated party)

Regularly reviewing the PCP and its associated records allows the regulated party to assess its ongoing effectiveness.

Depending on regulatory requirements, a regulated party's management review plans should:

Record keeping

Records are evidence that the regulated party has implemented the preventive controls as designed and that they are effective to meet regulatory requirements. Regulated parties will generate a number of different types of records, suitable to their operations. These must be available for review by the CFIA.

The PCP will need to identify all records associated with each element of the system's design, and will need to note where and for how long the records will be retained. Depending on regulatory requirements, a regulated party's PCP for records should also include:

4.4.1.3 Conducting a PCP inspection

During a PCP inspection, inspectors determine whether the regulated party meets applicable regulatory requirements. The following techniques are applicable for PCP inspections:

The inspector verifies compliance to regulatory requirements and assesses if outcomes are achieved for the PCP sub-elements in the inspection scope. The following items are considered:

The general requirements of a PCP may be best practices or regulatory requirements depending on the applicable regulation. If best practices have not been adopted, it may be an indicator of an ineffective PCP, and this can be investigated further through the verification activities.

The PCP elements and sub-elements with outcomes, performance criteria and verification activities can be found in Appendix II.

Where a written PCP and/or records are not required by regulation, the inspector would place more emphasis on conducting observations, interviews and, if required, samples and measurements.

4.4.2 Sample and test inspection

A sample and test inspection task type is for samples that are taken by the inspector and sent to a laboratory for analysis. The inspector will conduct sampling of the environment (for example, Listeria swabbing, etc.) and/or commodity as required. The samples may be required for a variety of purposes, including planned surveillance sampling, directed sampling, compliance testing, etc. The inspector will notify and send the samples to the appropriate laboratory as per established procedures. The laboratory will conduct the required test(s) (for example, biological, chemical, physical, product identity) and forward the results to the inspector. LSTS (Laboratory Sample and Tracking System) will continue to be the main tool used by the CFIA to track and compile the information pertaining to laboratory samples.

The inspector will refer to commodity specific guidance for more information regarding sampling program guidelines.

4.4.2.1 Conducting a sample and test inspection

Sampling consists of 4 steps:

4.4.3 Commodity inspection

Commodity inspections can consist of a wide range of inspection tasks that are taken by the inspector on the commodity; including: performing tests, retail inspections, site inspections, and compliance and enforcement activities, etc. The commodity inspections may be required for a variety of purposes, including planned surveillance, compliance testing, export requirement assessment, etc. The inspector will document all evaluations completed (for example, container integrity evaluation, label reviews, net quantity verification, assessment of live animal or plant and its materials, pest trap identification, humane transport, etc.) within the inspection case.

4.4.3.1 Conducting a commodity inspection

Refer to the appropriate Business Line and/or commodity guidance to complete the required inspection task(s).

4.4.4 Common inspection techniques

Inspectors will use a combination of inspection methods and techniques to assess compliance to regulatory requirements for all 3 inspection task types (PCP, Sample and Test, and Commodity Inspections), 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 on site using the following guidelines:

For information on capturing notes relating to document and record reviews in the DSDP, refer to Appendix IV:

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:

For information on capturing notes relating to observations in the DSDP, refer to Appendix IV:

4.4.4.3 Interview

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

For information on capturing notes relating to interviews in the DSDP, refer to Appendix IV:

4.4.4.4 Sampling (product and environmental) and measurement

Sample and measurement includes direct inspection of the product (for example, net quantity verification; label verification) measurements (for example, temperature, humidity) and samples.

The purpose of sampling and measurement is to: support the information gathered during the inspection; and complete assigned inspection tasks activities.

Sampling and measurement for compliance verification for PCP-type inspection

Samples and measurements can be taken to support the information gathered during the inspection. In some situations, sampling or measurement may be the only means of verifying that the product is compliant.

However, sampling and measurement is only one tool that can be used to verify compliance. In some cases, sampling and measurement may not be useful in determining compliance and could lead to a discrepancy between observations and the sample results.

Before taking a sample or measurement, inspectors should consider:

  • The guidance according commodity or sampling program.
  • What is the purpose for taking the sample or measurement?
    • Is it to verify that an issue exists?
    • Is it to link the product or commodity to an issue?
  • Can the CFIA take action on the results?
  • Will the results provide further information regarding compliance with regulatory requirements?

If the analysis will not support the inspection activity to verify compliance, samples or measurement should not be taken for this purpose.

Inspectors may consult with their Supervisor to determine the relevance of product and environmental analysis as well as laboratory capability and capacity.

For information on capturing notes relating to samples and measurements in the DSDP, refer to Appendix IV:

4.5 Determine if immediate control action is required

The inspector will take the following steps 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 6.6 – Capture Regulatory Response Actions.

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. 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

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

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

For PCP inspection task types, refer to the CSRDs for the links between the PCP sub-elements and applicable requirements to be captured in the non-compliance record in DSDP (see Appendix III

For Commodity Inspection and Sample & Test inspection task types refer to applicable program guidance and requirements.

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.

Non-regulatory non-compliances include requirements under voluntary program that are not cited in regulations; any other kind of individual permission; or any license condition not set out in law.

This option should not be used within DSDP unless stated in program or commodity-specific guidance. Failure to meet with a best practices manual is not a form of non-compliance.

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 DSDP, refer to Section 6.5 – Determine Compliance of Appendix IV.

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 – 4.7.4) which seek to answer questions raised intuitively when assessing the level of impact that may result from a non-compliance.

Note

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 (SRRP).

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 Table 1 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)
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)
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
Allergen The presence of undeclared or improperly declared allergens
Nutritional Incorrect nutritional composition in a commodity
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 Any issues that may create an environmental concern (for example, contamination from plants with novel traits, invasive alien species)
Economic 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 Issues affecting or having the potential to affect domestic or international trade or relations
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 1.

The severity of consequences is represented on the horizontal-axis in Figure 4 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/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.

Depending on the inspection type, different information will be available to help determine likelihood. If a Commodity Inspection or Sample and Test or is done outside of a PCP inspection, then PCP controls and performance criteria are not considered in the assessment of Likelihood of Occurrence. Otherwise these controls can be considered.

The likelihood of occurrence is represented by the vertical-axis in the CNC Figure 4 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 4:

Figure 4: CNC Matrix - The horizontal axis represents the severity of consequences and is divided into low, medium and high.
Descriptive text for Figure 4: CNC Matrix

Figure 4: 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 CHC for unlikely likelihood of occurrence represented by a yellow box and moderate CNC for likely and very likely likelihood of occurrence represented by orange boxes. 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 2 non-compliance type or hazard/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 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 6.7 – Categorize Non-Compliance of Appendix IV.

4.8 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 2 (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 corrective action 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 2. 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

Table 2: Timeframes for regulated parties to complete corrective actions based on the non-compliance category. The table illustrates 2 columns – Non-Compliance Category and Timeframe for Regulated Party to Complete Corrective Action (in calendar days). Severe, moderate and minimal non-compliance categories are up to 10 days, up to 60 days and up to 180 days respectively.

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 IV:

4.9: Enforcement

Anything 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 (SRRP) outlines the steps taken in response to the non-compliance.

For information on capturing the categorization of non-compliance in the DSDP, refer to Section 6.6 – Capture Regulatory Response Actions of Appendix IV.

5.0 Step 3 – Communicate the inspection results

Objective:

Note

For inspections that span more than one 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 the 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 5. There are 4 steps to communicating the inspection results represented by 4 blue boxes
Description text for Figure 5. There are 4 steps to communicating the inspection results

Figure 5. There are 4 steps to communicating the inspection results represented by 4 blue boxes. Arrows lead from one box to the next in the following order: 5.1 Conduct the Closing Meeting, 5.2 Issue the Inspection Report, 5.3 Determine 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 formal closing meeting is held once the on-site inspection and all inspection tasks are completed. Its purpose is to discuss and 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 supervisor at CFIA office, review/validate inspection information); in that case, the closing meeting may be conducted up to a few days after the on-site inspection.

During the closing meeting, the inspector:

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 7.1 – Closing Meeting of Appendix IV.

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 both the inspector and the regulated party. No additional costs or surcharges should be incurred to obtain the signatures. If unable to obtain a signature from the regulated party, then a justification is to be documented in the inspection case.

If the sample analysis results are not expected to be available for periods exceeding one month (for example, surveillance samples), then complete the inspection task as per the guidance in Section 6.4.2.6 of Appendix IV. Do not generate an inspection report and close (deactivate) the inspection case once all other required fields in the inspection case are completed. Once the results are obtained, if it is determined that there is a non-compliance, then the inspection case should be reactivated as per the guidance in section L.7.5; the inspection task should be updated and an inspection report can be generated at this time.

In addition, in certain instances, an inspection report may not be required to be submitted for Commodity Inspections and Sample & Test Inspections. Refer to program specific guidance for instances where this may occur.

For an Export triggered inspection, refer to Export OG (under construction) for supplementary steps to be taken by the Inspector in the Export Case.

Review the CFIA Fee Schedule for fees that are linked to inspection tasks. Apply the fees according to the commodity specific guidance.

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 new 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 IV:

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 3 below, to guide scheduling of follow-up inspections.

Table 3 – 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.

Table 3: Timeframes to schedule a follow-up inspection based on the non-compliance category. Severe non-compliance category results in a follow up immediately or after the timeframe given to the regulated party. Moderate and minimal non-compliance category results in a follow up 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 3 are not practical (for example, when the timeframe for corrective action completion by the regulated party is not based on Table 2 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.

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 7.4 – Request for Extension to Timeframe to Correct Non-Compliance of Appendix IV.

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.

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 6. Conducting the follow-up inspection consists of 4 steps represented by 4 blue boxes.
Description text for Figure 6. Conducting the follow-up inspection

Figure 6. Conducting the follow-up inspection consists of 4 steps represented by 4 blue boxes. Arrows lead from one box to the next in the following order: 6.1 Schedule the Follow-Up Inspection, 6.2 Determine the Scope of the Follow-Up Inspection, 6.3 Conduct the Follow-Up Inspection; and 6.4 Assess 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 3, 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 8.1 – Create a follow-up case of Appendix IV.

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 and the outcome(s) for the sub-element(s) have been met. Not all of the verification activities will need to be conducted, depending on the situation; a number of factors (such as the compliance history of the regulated party, the categories of the non-compliances, etc.) will influence the depth of the inspection. For example, for an establishment with a history of repeated non-compliances within a certain sub-element, the inspector may need to conduct more verification activities to ensure that the regulated party not only has addressed the non-compliance, but also still meets the outcome of that sub-element.

Follow the procedures outlined in Table 4 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).

Note

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

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 tasknot in the intended inspection scope, if:

For outstanding non-compliances within sub-elements or other inspection task 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 8.2 – Capture Inspection Information of Appendix IV.

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:

7.0 Appendices

Appendix I: Biosecurity summary

This appendix provides horizontal guidance for the Inspectorate to make decisions with respect to biosecurity measures. It provides a summary of the information found in the Biosecurity for Inspection Activities OG for inspectors to incorporate biosecurity concepts into daily activities. Commodity specific biosecurity information can be accessed through Merlin under Business Line information. Key terms and definitions can be found in the Biosecurity for Inspection Activities OG.

Biosecurity principles

Biosecurity is a set of measures used to minimize the introduction and spread of hazards (pests, diseases and contaminants). Hazards can be transferred through many means including but not limited to: hands, footwear, clothing, equipment and vehicles. A biosecurity breach can have devastating impacts on human, animal or plant health, food safety, the economy and the environment. Everyone has a role to play in biosecurity and it is vital that CFIA inspectors take measures to reduce the risk of becoming a vector for hazards while conducting daily inspection activities.

Biosecurity measures involve 3 concepts to be used by CFIA staff. These elements of these concepts are designed to work together and are not mutually exclusive.

  1. Exclusion limits the introduction of hazards into a premises. Exclusion measures are performed before entering a premises.
  2. Management minimizes the movement of hazards within a premises. Management measures are performed within a premises particularly when moving from area to area.
  3. Containment limits the release of hazards outside of a premises. Containment measures are performed before exiting or leaving a premises.

Biosecurity concepts

Figure 7 - Diagram of the biosecurity concepts.
Descriptive text for Figure 7 - Diagram of the biosecurity concepts

Figure 7 – Diagram of the biosecurity concepts. Exclusion limits the introduction of hazards into a premises. This is illustrated by an arrow that leads to a red X before the premises. Different areas within the premises are illustrated by a green and yellow rectangle. A double ended arrow crosses the coloured sections of the premises rectangle with a red X illustrating management of hazards within the premises. An arrow leads out of the premises rectangle to a red X illustrating the containment of hazards from the outside environment.

Biosecurity levels

Biosecurity measures are divided into four levels.

  1. Basic Biosecurity (Level 1)
  2. Routine Biosecurity (Level 2)
  3. Enhanced Biosecurity (Level 3)
  4. Containment Biosecurity (Level 4)

Each level represents a set of biosecurity measures. It is recognized that not all activities delivered by CFIA inspectors will be a "perfect" fit into one of the four biosecurity levels. Therefore, some risk determination and judgement may be necessary for an inspector to determine the most appropriate combination of precautionary measures. Generally, the risk of the hazards increases from Level 1 to Level 4.

Determining the required level of biosecurity

The level of biosecurity required is based on risk. Proactive biosecurity is based on the assumption that a hazard could be present. It is vital that inspectors are aware of the existing and/or potential hazards involved with inspection activities and plan accordingly. The biosecurity level required depends on:

When conducting inspection activities CFIA inspectors must:

The five steps of disinfectant application.

  1. physically remove all visible debris from the surface of the area to be disinfected
  2. wash and scrub all surfaces with hot soapy water
  3. rinse
  4. apply the disinfectant as per manufacture's recommendations
  5. allow for the required contact time

Follow the manufacturer's recommendations for application paying strict attention to the concentration required and contact time. Follow local government regulations regarding the application of disinfectants to ensure compliance with environmental legislation.

Figure 8: Inspection activities and biosecurity levels. Activities of increasing risk are grouped as increasing biosecurity levels.
Descriptive text for Figure 8: Inspection activities and biosecurity levels

Figure 8: Inspection activities and biosecurity levels. Activities of increasing risk are grouped as increasing biosecurity levels. The 4 biosecurity levels are illustrated with chevrons – Basic Biosecurity Level 1, Routine Biosecurity Level 2, Enhanced Biosecurity Level 3 and Containment Biosecurity Level 4. Each chevron is attached to a text box detailing the type of inspection activity related to the level in ascending order. Basic biosecurity level 1 applies to activities where there is low risk of contact with potential hazards. No contact is anticipated with potentially hazardous material or areas that could result in a contamination. Arriving clean and leaving clean reflects the very minimal biosecurity measures required. Routine biosecurity level 2 applies to activities where there is moderate risk of contact with potential hazards. This biosecurity level is considered the standard for day to day activities. Enhanced biosecurity level 3 applies to activities where there is a high risk of contact with potential hazards. A higher risk has been identified (suspected or confirmed hazard including non-regulated hazard that is highly transmissible or a regulated hazard that is not highly transmissible). Inspectors visit premises with vulnerable animals or plants inspectors visit premises producing specific products destined to a susceptible population (high risk). Industry (and provincial/territory governments) are primarily responsible for managing non-regulated highly transmissible hazards. Adherence to enhanced biosecurity measures on entry and exit from restricted access zones and implementing downtime between visits to other susceptible populations is important to mitigate these risks. Containment biosecurity level 4 applies to activities where there is a high risk of contact with potential hazards that requires the implementation of control functions. This level is used when a regulated highly transmissible hazard or public health concern is suspected or has been identified. Specific biocontainment, hazard response and surveillance measures will be in place. All activities will be halted and access to the premises highly restricted and controlled.

Refer to the "Biosecurity Measures by Activity and Level" document (internal access only – RDIMS 11292267) for a guide to biosecurity measures that should be applied based on the level

Appendix II: PCP elements and sub-elements

The PCP Elements and Sub-elements provide guidance for inspectors on specific verification activities related to the PCP. The information presented for each element and sub-element of the PCP is organized as follows:

PCP element 1: Process and product controls

Sub-element 1.1: Process controls

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
The process is controlled to achieve regulatory compliance.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

PCP element 1: Process and product controls

Sub-element 1.2: Product controls

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

PCP element 1: Process and product controls

Sub-element 1.3: Import controls

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Imported commodities meet regulatory requirements.

Rationale:

Performance criteria:

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

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 1: Process and product controls

Sub-element 1.4: Export controls

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Exported commodities meet foreign country import requirements and conditions and Canadian export requirements, where applicable.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

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

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

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Effective sanitation of equipment, utensils, containers and premise is in place to prevent contamination of the commodity; and ensure effective biosecurity and bio-containment in order to prevent the introduction, establishment or spread of pests and/or disease.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

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

Sub-element 2.2: Pest control

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

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

Sub-element 2.3: Chemicals

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 3: Hygiene, biosecurity and employee training

Sub-element 3.1: Hygiene and biosecurity

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Employees and visitors are not a source of contamination.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 3: Hygiene, biosecurity and employee training

Sub-element 3.2: Employee training

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 4: Equipment design and maintenance

Sub-element 4.1: Equipment design and maintenance

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Equipment, utensils and containers are designed, maintained and used in a manner that does not result in contamination of commodities or packaging materials; and are effective for the purpose for which they are intended. Controlling or measuring devices used to meet regulatory requirements are calibrated for accuracy.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/Records Review

On-site: Observation and interview

PCP element 5: Physical structure, surroundings and maintenance

Sub-element 5.1: Premises and surroundings

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 5: Physical structure, surroundings and maintenance

Sub-element 5.2: buildings

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

PCP element 5: Physical structure, surroundings and maintenance

Sub-element 5.3: Water, ice and steam

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Water, ice and/or steam that comes into contact with regulated commodities is safe for its intended use.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 5: Physical structure, surroundings and maintenance

Sub-element 5.4: Waste disposal

Legal authorities – Refer to Commodity Specific Reference Document

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

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 6: Receiving, transportation and storage

Sub-element 6.1: Receiving, transportation and storage

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
If applicable, commodities (including inputs) and packaging materials are transported, received and stored in conditions that maintain integrity and prevent damage, spoilage and contamination.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 6: Receiving, transportation and storage

Sub-element 6.2: Animal transportation

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Animals are transported humanely, in accordance with regulatory requirements.

Rationale:

Performance criteria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 7: Traceability, control and complaints

Sub-element 7.1: Traceability and control

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Commodities are adequately identified to enable removal from the marketplace or other movement restrictions. Non-compliant commodities are effectively controlled by preventing entry into commerce, rapid retrieval if distributed and disposal, as appropriate. CFIA is notified, where required by the Act or Regulations, of a non-compliant product.

Rationale:

Performance criteria:

The traceability and control system must be able to:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

PCP element 7: Traceability, control and complaints

Sub-element 7.2: Complaints

Legal authorities – Refer to Commodity Specific Reference Document

Outcome:
Complaints related to diseases, pests, safety, product misrepresentation and animal transport are investigated to determine root cause and corrective actions are taken.

Rationale:

Performance citeria:

Verification activities/ guidance for inspectors:

Documentation/records review

On-site: Observation and interview

Appendix III: Commodity-specific reference documents and cross-walks

Commodity-specific reference documents

These documents associates requirements to the sub-elements of a PCP

Animal
Plant
Food

Cross-walks

These documents associate legacy activities or current inspection activities to inspection tasks in DSDP

Animal
Plant
Food

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

Acronyms:

CRM
Client Relationship Management (a Microsoft Dynamics software)
DSDP
Digital Service Delivery Platform
LSTS
Laboratory Submission Tracking System
MS Dynamics
Microsoft Dynamics
OG
Operational Guidance
PCP
Preventative Control Plan
RDIMS
Record Document and Information Management System
SIP
Standard Inspection Procedures
SOP
Standard Operating Procedures
PCP
Preventive Control Plan

1.0 Purpose

The purpose of this Appendix is to provide guidance to trained supervisors and inspectors on accessing, creating, assigning and completing inspection cases in the DSDP, in relation to the guidance provided in the Standard Inspection Procedures. For more information on how to use DSDP and for screenshots of the system, please refer to the applicable DSDP SOPs within each section of this appendix.

1.1 Intended audience

Any CFIA user who is required to conduct an inspection using the Standard Inspection Procedures and DSDP. This includes, but is not limited to, Inspectors and Inspection Supervisors.

2.0 Roles and responsibilities

These roles can be assumed by various people and positions, depending on the current practices within your program.

Lead Inspector

Inspection team members

Supervisor

DSDP Administrator

National Service Center Agents

Centre of Administration Agents

3.0 Overview of the DSDP

3.1 RESCO (Mobile CRM) vs CRM

DSDP can be accessed using the online 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.

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.

3.2 Standard operating procedures (SOPs)

The SOPs referenced in this document are technical documents to assist with the use of DSDP. These contain useful screenshots and information on navigating, creating various records, amending information, etc.

3.3 Data security

The inspection worksheet in DSDP 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. the system doesn't prevent modification by users granted access to a case.

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.

Changes needed after the case is closed must follow the amendment process to obtain approval to make the amendment, as well as have the system track the change correctly. Refer to Section 7.5 Amending a Closed Inspection for more information.

3.4 Note taking guidance

Information gathered by the inspector during an inspection should:

In general, notes captured in DSDP should be clear 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 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 the Operational Guideline (OG-14794) Use of Digital Recording (Camera, Video, Audio) Devices during Inspections (internal access only – RDIMS 10356321) for more information.

Reminder: All inspection-related information supporting a compliance decision must be captured within the appropriate and designated fields in the worksheet. The Notes tab located on every DSDP record cannot be locked and changes cannot be tracked, and therefore, the information contained within it would not stand up to scrutiny if the inspection resulted in legal action.

3.5 Accessing DSDP

To access CRM, refer to the ESDP Foundational CRM Help Tool (internal access only – RDIMS 9839734) for more information on logging in and basic navigation information, as well as the available training materia

Contact the BSU (DSDP Support) if you have any issues accessing DSDP at the following email address: DSDP Support / Support PPES (CFIA/ACIA) cfia.dsdpsupport-supportppes.acia@canada.ca

4.0 Create an inspection request

4.1 Create and validate an inspection request

Refer to the SOP Creating an Inspection Request (internal access only – RDIMS 9852034) for information on creating an inspection request, and validating the request in order for it to become an inspection case.

Note

In order to validate an inspection request, inspection tasks must be added to the request. Refer to section 4.3 of this appendix (Determine the Scope of the Inspection) for more information on selecting tasks.

4.2 Assigning an inspection case

Refer to SOP Inspection Work Tasking (internal access only – RDIMS 9881497) for more information on assigning inspection cases.

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

4.3 Determine the scope of the inspection

Enter the scope of the inspection in the "Inspection Tasks" sub-grid. Inspection tasks are described using the following fields:

When adding Commodity, and Sampling and Testing inspection tasks, additional information (beyond the L1 and L2 task descriptions) should be provided to the inspectors to appropriately describe the task to be completed, such as the commodity or area to be targeted, the sampling plan number, etc. This information can be added in the Commodity details field (for commodity inspection tasks) or in the appropriate fields within a Sample Record.

Note

These inspection task levels are not related to the levels described in Appendix I: Biosecurity.

The inspection tasks assigned may vary based on the Inspection Source and the Request Type for the inspection.

Select the appropriate inspection tasks for the following inspection sources:

Only 1 inspection source can be selected in a case, therefore inspection activities conducted for different purposes, with different inspection tasks, should be captured in separate inspection cases. For example, even if during the same visit, a PCP inspection is completed, and some surveillance samples are collected, the tasks relative to each of these inspection sources should be captured in separate inspection cases. However, if the same inspection task is being completed for multiple purposes (for example, sub-element 1.1 to follow-up on a previous non-compliance and to assess a complaint), then the inspection task should be entered in a single inspection case.

Refer to the SOP Creating an Inspection Request (internal access only – RDIMS 9852034) for more information on adding Inspection Tasks.

5.0 Step 1 – Prepare for the inspection

5.1 Review information

To complete the review of information in DSDP:

If during the preparation, you identify that the regulated party's location has not been entered, then refer to Section 3.1.1 of the Conduct an Inspection SOP (internal access only – RDIMS 9839405) for more information on how to proceed.

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

5.2 Applicable requirements, documents

Refer to SOP Requesting Guidance for an Inspection Case (internal access only – RDIMS 9855738) for more information on how to request guidance from another CRM user (for example, supervisor) during an inspection.

5.3 Notify the regulated party and schedule the inspection

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 should automatically be updated to "Inspection Scheduled".

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

5.4 Recording time within the inspection case

The amount of straight timeFootnote 5 spent on an inspection by CFIA inspection staff can be recorded in DSDP, within the inspection case. Time can be recorded for each inspection task, non-compliance, and travel time as follows:

Note

Please note that time not directly associated to the conduct of the activity (general administration, break and lunch) is not to be tracked in the inspection case.

5.5 Manual notifications using DSDP

Notifications tasks can be manually generated within DSDP-CRM, as needed, at any time until the inspection case is closed. Manual notifications can be sent using CRM tasks, as well as emails within the system.

CRM tasks are for specific situations to communicate between users; especially between inspector and supervisor. There are a several notification types available to choose, that will apply to different steps of the inspection:

The following explains how to manually generate a notification from a CRM Task Record:

Once all communications are complete and the task is finalized, ensure to set the task as completed using the "Mark Complete" button. The last user to receive the task would be responsible for setting the task as completed.

If the notification you wish to send is not related to the CRM task types listed above, then you may choose to send a user generated email notifications. Ensure that the subject line for your notification includes the inspection case number, as the notification does not automatically include a link to it.

Refer to SOP Notification Tasks in Inspection Case (internal access only – RDIMS 9852266) for a detailed explanation of notification types and procedures to follow.

5.6 Declining a case

If you are unable to complete the required inspection, the inspection case can be declined in order to be subsequently re-assigned to another inspector by the supervisor. Please note that declining an inspection case can only occur when the Work Status indicates "Assigned".

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.

6.0 Step 2 – Conduct the inspection

6.1 Conduct the opening meeting

To capture information on the opening meeting in DSDP, add a new meeting record from the Sitemap sub-area, as per the instructions in Section 3.1 of the SOP Conducting an Inspection (internal access only – RDIMS 9839405). In this appointment, 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

For more information on how to capture information related to the opening meeting, refer to Section 3.1 of the SOP Conducting an inspection (internal access only – RDIMS 9839405).

6.2 Do the initial walk-through

When conducting an initial walkthrough:

Refer to Section 3.2 of the SOP Conducting an inspection (internal access only – RDIMS 9839405) for more information on where to input this information.

6.3 Confirm scope

If at any point during the inspection, an inspection task must be added to the scope, then:

If an inspection task must be removed from the inspection, then:

Refer to Section 3.3 of the SOP INS Conducting an inspection (internal access only – RDIMS 9839405) for more information on how to add and remove inspection tasks from the scope.

6.4 Conduct the inspection

To capture information relating to the inspection tasks, select an inspection task to access its associated Inspection Task record.

6.4.1 Inspection task types

There are three inspection task types in DSDP

As you proceed with conducting the inspection task that you have been assigned, ensure that the "Status and Scope" sub-section of the record is kept up-to-date, including:

6.4.2 Verification activities

Information captured in the various verification activity fields do not appear in the inspection report (except for the Sample Description field). It is not necessary to duplicate notes in these verification activity fields within an inspection task (for example, capture notes in both the findings and observation fields).

6.4.2.1 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 3.4.2 of the SOP Conducting an Inspection (internal access only – RDIMS 9839405). The note should include:

6.4.2.2 Observations

Capture observation notes in the Observations open text field in the Inspection Verification Activities section of the Inspection Task (see Section 3.4.2 of the SOP INS Conducting an Inspection (internal access only – RDIMS 9839405). The notes should include:

6.4.2.3 Interviews

Capture interview notes in the Interviews open text field in the Inspection Verification Activities section of the Inspection Task (see Section 3.4.2 of the SOP INS Conducting an Inspection (internal access only – RDIMS 9839405). The notes should include:

6.4.2.4 Measurements

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 3.4.4 of the SOP INS Conducting an Inspection (internal access only – RDIMS 9839405).

Within the Measurements record, capture the Measurement Type. Examples ofmeasurement typeincludes the following:

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:

6.4.2.5 Documents

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:

6.4.2.6 Samples

Create a new sample record by creating a new Sample and Test inspection task, even if the sample was taken to confirm results obtained during a PCP inspection.

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

If the sample results are expected to be received within a month, then the inspection case should remain active until laboratory results are entered into the inspection task.

If, however, if a result is not expected for a significant period of time (more than 1 month), then:

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

6.4.2.7 Commodity inspections

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

6.4.2.8 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 within is more easily referenced in the Non-Compliance record to draft the objective evidence.

6.5 Determine compliance

If no non-compliances were found during the inspection of a task, then:

If non-compliance has been identified, then:

Note

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

Objective Evidence

Objective evidence are 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".

6.6 Capture regulatory response actions

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

If the enforcement action must be followed up on within a set time frame, then:

Note

The Regulatory Response Type field, where the Response Status is marked "Issued" will appear on the Inspection Report.

6.7 Categorize non-compliance

To capture the categorization of each non-compliance:

Note

The Generic Non-Compliance Statement will appear on the inspection report.

6.8 Timeframe for regulated party to complete corrective actions and scheduling follow-ups

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

New follow-up cases should be created after the initial inspection, in discussion with the supervisor. If it is determined that the follow-up to this non-compliance can occur at the next scheduled inspection, then:

If a new inspection case is required, then:

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.

Note

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

7.0 Step 3 – Communicate the inspection results

7.1 Conduct closing meeting

Follow the same procedures as described in Section 6.1 Conduct the Opening Meeting of this appendix, except select "Closing Meeting" in the Type of Meeting field.

7.2 Complete the worksheet

To complete the DSDP Inspection worksheet:

If at any point during the inspection, the inspection must be put on hold to await further guidance or sample results, then change the Status Reason field in the main inspection case to the appropriate option.

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

For Export and Permission triggered inspection sources, complete the Related Case Output field based on the following guidance:

For an Export triggered inspection, refer to Export OG for supplementary steps to be taken by the Inspector in the export inspection case.

7.3 Issue and save the final inspection report

Prior to issuing the Inspection Report, it should be determined whether the information should be subject to an approval from the Supervisor. An approval is required if the Report Review Required field is marked "Yes", or if an issue arises during an inspection (to be discussed with the supervisor). If the report requires approval, then:

Once all the required fields are completed, if an inspection report is to be generated, then:

Once all of these steps have been completed, click on the box next to the Report Completed field, which will change the Work Status in the inspection case to "Report Completed". In addition, click on the Populate and lock Party Case Closed fields in order to lock all of the fields related to an account (to prevent them from changing).

Note

The inspection report for a case that did not find any non-compliances will have the following generic statement Requirements assessed at the time of the inspection were found to be compliant.

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).

Once the inspection is completed, the inspection case must be closed (deactivated). Refer to the SOP Update, close and cancel inspection case (internal access only – RDIMS 9852255) for more information on deactivating the inspection case.

Please see an example of an inspection report in the SOP Update, close and cancel an inspection case (internal access only – RDIMS 9852255).

7.4 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 a notes tabin the follow-up [new] case, along with a copy of the written submission provided by the regulated party. Change the follow-up date, if required, to accommodate the extension.

The lead inspector should include an appropriately titled CRM Note in the main inspection case page to provide a justification and describe changes that were made in the DSDP (for example, changed timeframe from this date to another).

7.5 Amending a closed inspection

Prior to amending a closed/deactivated inspection case, send a formal request to the BSU (ESDP Support) at the following email address: DSDP Support / Support PPES (CFIA/ACIA) cfia.dsdpsupport-supportppes.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:

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

8.0 Step 4 – Follow-up inspection

8.1 Create a follow-up case

To create a new follow-up inspection case, follow the procedures provided in Section 6.8 of this appendix. In addition to the guidance provided in Section 4.0 of this appendix, ensure to:

Note

These fields will be automatically completed if the follow-up case was created from the Create Follow-up button (refer to section 6.8).

In addition, within each inspection task conducted for the purpose of a follow-up, check the box "Inspection For The Purpose of Follow-up?".

Refer to the SOP Creating an Inspection Request (internal access only – RDIMS 9852034) for the procedures to validate the inspection request and assign the case.

8.2 Capture inspection information

Use the same guidance from Sections 6 through 8 of this Appendix for capturing information relating to the follow-up inspection.

Ensure that the Inspection for the Purpose of Follow-up? checkbox within the inspection task records is checked for each task that was completed as a follow-up.

8.2.1 Capture non-compliances for follow-up inspections

If the non-compliance persists beyond the timeframe for completing corrective actions or the interim measures are no longer effective for managing the outstanding non-compliance, then:

If a non-compliance within a sub-element in scope persists, but the timeframe for completing corrective actions has not yet passed (and the interim measures are still effective), then:

Proceed to complete all of the required fields in the Non-Compliance record as per Sections 6.6 to 6.8 of this Appendix.

References

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