Operational procedure: As required food sample collection

1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff when conducting an as required sample collection under the Food Business Line (FBL).

This document is intended to be used in conjunction with CFIA guidance as referenced in section 3.0, reference documents.

2.0 Authorities

Safe Food for Canadians Act (SFCA)
Safe Food for Canadians Regulations (SFCR)
Food and Drugs Act (FDA) (as it relates to food)
Food and Drug Regulations (FDR) (as it relates to food)

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – Food regulatory response guidelines.

3.0 Reference documents

Common inspection references

Food inspection references

Commodity specific inspection references

Commodity specific guidelines and assessment criteria (SGAC) (accessible only on the Government of Canada network)

DSDP sample collection specific references

Annex B: DSDP data entry – CFIA sampled – sample results other than satisfactory (accessible only on the Government of Canada network – RDIMS 14996797)

4.0 Definitions

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

5.0 Acronyms

Acronyms are spelled out the first time they are used and are consolidated in the Food business line acronym list.

6.0 Operational procedure

This operational procedure provides inspection staff guidance when conducting an as required food sample collection under the FBL. Where more specific guidance is required than what is provided in the Standard inspection process (SIP), these will be indicated in this section.

An inspector may collect an as required sample when suspected problems need to be investigated and/or verified. As required samples are normally unplanned and collected in response to an event (for example, a complaint, a failed monitoring sample or when a potential non-compliance is identified, refer to Table 1 for as required triggers). An inspector may also collect an as required sample during a preventive control inspection to support an inspection decision. Refer to section 6.2.2 of the Food preventive control and traceability inspection – System verification for guidance on when it is appropriate to collect a sample to support inspection findings.

This operational procedure applies to as required samples collected at all regulated parties (including SFCA license holders and non-license holders), at all levels of distribution (including retail, manufacture, import and storage) and at the harvest area.

Sample collection operational guidance (OG) refers the inspector to the SIP for basic guidance on the 4 inspection steps. If the sample collection is being conducted to support a preventive control inspection (PCI) or commodity inspection currently underway, some or parts of the inspection steps will have already been completed.

6.1 Prepare for inspection

Refer to SIP, section 3.0, step 1 - Prepare for the inspection and Operational guideline: Food sample collection, section 6.1 Prepare for inspection. In addition to the general guidance provided in these documents, the following applies.

Inspectors should consult with their supervisor, Regional Program Officer (RPO), Area Recall Coordinator (ARC) / Regional Recall Coordinator (RRC), Regional Coordinator (RC), the Office of Food Safety and Recall (OFSR) and Laboratory Coordination Division at any point in the as required sampling process if questions arise.

Table 1. Recording inspection data in Digital Service Delivery Platform (DSDP)
DSDP field	DSDP data field selection
Inspection trigger	Choose one of the following triggers as appropriate: Incident Response Domestic Permission Export Permission Import Permission
Task type	Sample Collection
Inspection task level 1	Food Sample Collection Plan
Inspection task level 2	Select the appropriate analysis type: Microbiological Misrepresentation – Composition Extraneous Material Chemical Residue Other

Inspectors must determine the scope of the as required sample collection by considering:

the as required sample collection trigger (refer to Table 2 for examples)
the techniques and types of sample analysis required (refer to Table 3. Specific sample collection techniques applied during sample collection and Appendix 6: Types of analyses for food samples in Operational guideline: Food sample collection)
the commodity specific sampling methods required (refer to Table 4. Commodity specific sampling methods in Operational guideline: Food sample collection)

Table 2. As required sample collection triggers and when they are applied
As required sample collection trigger:	When applied a sample collection activity is required to:
Incident Response (Issues Management System (IMS) and/or DSDP)	Aid in verification of a suspect or realized risk
Domestic Permission (DSDP)	Support the issuance of a domestic permission
Import Permission (DSDP)	Support the issuance of an import permission
Export Permission (DSDP)	Support the issuance of an export permission

Additional steps should be considered when preparing for an as required sample collection activity (refer to Table 3).

Table 3. Potential additional steps for as required sample collection
If sample collection includes:	Then:
A potential food safety incident	Consult with the Office of Food Safety Recall (OFSR) and refer to: Food incident response process (FIRP) Protocol for CFIA's Sharing of Information during Food Safety Investigations and Recalls
Commodity specific sample	Refer to: Food Sample Collection Plan (accessible only on the Government of Canada network) CFIA sampling information (accessible only on the Government of Canada network) Food misrepresentation direction (accessible only on the Government of Canada network – RDIMS 13862494) Food inspection guidance: sample collection (accessible only on the Government of Canada network)
Urgent or investigative samples Uncertainty as to where to send sample for analysis A sampling plan quota that has been reached and additional samples are required	Contact: Laboratory Coordination Services
Taking a sample to verify: permission requests Preventive Controls (PC) traceability	Refer to: Food preventive control and traceability inspection – System verification Food inspection guidance: permission issuance Operational procedure: Permissions verification of Safe Food for Canadians licence
Taking a sample when non-compliance is suspected	Refer to: Operational procedure: Responding to food complaints (accessible only on the Government of Canada network – RDIMS 13899359) Standard regulatory response process Operational guideline: food regulatory response guidelines Operational procedure: official sample collection
Taking a sample that requires the lot be ordered not to move pending results	Refer to: Standard regulatory response process Food incident response process (FIRP) Operational guideline: food regulatory response guidelines

6.2 Conduct the inspection

Refer to SIP, section 4.0, step 2 - Conduct the inspection and Operational guideline: Food sample collection, section 6.2 Conduct the inspection. In addition to the general guidance provided in these documents, the following applies.

6.2.1 Record information

Sample collection data is captured in the Laboratory Sample Tracking System (LSTS). Samples should also be tracked in DSDP and/or IMS depending on the trigger for the sample collection. If using both DSDP and IMS ensure the IMS file number is inputted into DSDP in the "Additional Reference IDs" field and the DSDP case number is inputted into the IMS file. Refer to Table 4 for examples of when sample collection data may be recorded into each system.

Table 4. Data systems for as required sample collection
Data System:	When used:	Additional resources:
LSTS (sample collection data)	LSTS is the primary system for collecting data on sample information and resulting laboratory assessments for as required samples.	LSTS User Services User Guide (accessible only on the Government of Canada network – RDIMS 3495373)
DSDP (sample tracking data)	DSDP is used to capture time taken for sample collection, other than satisfactory sample results and follow-up unless the task is triggered by a complaint or the Food incident response process (FIRP). Note: Task time entries recorded in DSDP will include the time associated with collecting the sample, the time taken to enter the samples into LSTS and DSDP, and prepping the samples for shipping.	DSDP Standard Operating Procedures (SOPs) (accessible only on the Government of Canada network) DSDP Inspection Case Management Guidance (accessible only on the Government of Canada network – RDIMS 14671957)
IMS (sample tracking data)	IMS is used to track sample collection activities when the sample collection task is triggered by a complaint or food safety investigation. Note: Time spent on the food safety investigation and/or complaint follow-up, including, but not limited to the recall activities, effectiveness checks etc. should be tracked in IMS	Issues Management System User Manual (accessible only on the Government of Canada network – RDIMS 1599661) Food incident response process (FIRP)

If a new DSDP case is created for an as required sample, one of the four triggers listed in Table 2 must be chosen and the appropriate task data must be entered.

If as required samples are collected as part of a PCI, commodity inspection, or sample collection activity, the inspector is not required to create a new case. The inspector can add a DSDP inspection task for the as required sample to the existing case, starting at Inspection task level 1. Refer to Table 1 for data entry details.

The first part of the sample collection task is now complete; the sample has been collected and sent to the lab for analysis. The second part of the sample collection task will be initiated once the sample results are received.

6.2.2 Determine if immediate control action is required

Review the sample results once received to determine next steps. If sample results indicate the need to control a potential risk, inspectors will follow the Food incident response process (FIRP). Refer to SIP section 4.5 Determine if immediate control action is required for additional information.

Refer to Food inspection guidance: incident response for further guidance that may be applicable to sample results requiring further action.

6.2.3 Determine compliance

The inspector is required to review the results to determine compliance based on the reason for sampling. Refer to SIP section 4.6 Determine compliance.

Sample results reported as anything other than satisfactory require further action and must be documented in DSDP and/or in IMS.

If a sample is non-compliant, consult SIP, section 4.7 Categorize non-compliance. A non-compliance record must be created in DSDP and/or the IMS file must be updated accordingly.

6.2.4 Categorize non-compliance

Non-compliant as required samples are categorized based on the sampling trigger (Table 2), the risk and the potential impact. Refer to the SIP, section 4.7 for more information.

6.2.5 Record sample results in DSDP and/or IMS

Refer to Table 5 for further information on how the inspectors will record the sample results in DSDP and IMS.

Table 5. Record the sample results in DSDP and/or IMS
Result	Action / Resources
Satisfactory	If a DSDP case was opened, satisfactory results should not be entered into DSDP and would not need to be communicated to the regulated party, unless the lot was ordered not to be moved pending results. If an IMS issue was opened, Satisfactory results should be entered into IMS. Refer to Issues Management System User Manual (accessible only on the Government of Canada network – RDIMS 1599661), as applicable, for additional information.
Other than satisfactory	If a DSDP case was opened, refer to Annex B: DSDP data entry – CFIA sampled – sample results other than satisfactory (accessible only on the Government of Canada network – RDIMS 14996797) beginning at step 6. If a DSDP case needs to be reactivated, refer to Annex B: DSDP data entry – CFIA sampled – sample results other than satisfactory (accessible only on the Government of Canada network – RDIMS 14996797). If a DSDP case was created, refer to SOP Creating an Inspection Request (accessible only on the Government of Canada network – RDIMS 9852034), for instructions on how to add a DSDP inspection task and SOP Manage Samples (accessible only on the Government of Canada network – RDIMS 9852138) for instructions on how to complete the information in the inspection task. If an IMS issue was opened, other than satisfactory results should be entered into IMS. Refer to Issues Management System User Manual (accessible only on the Government of Canada network – RDIMS 1599661), as applicable, for additional information.

6.3 Communicate the results

Refer to SIP, section 5.0, step 3 – Communicate the inspection results and Operational guideline: Food sample collection, Ssection 6.3 Communicate the inspection results. In addition to the general guidance provided in these documents, the following applies. Refer to Table 6 for additional information on how to communicate the sample results for as required sample collection.

Table 6. Communicate sample results
Reason for sample collection:	Details on results communication:	Additional Resources:
Food safety investigation / Complaint follow up	Inspectors performing the sampling activities should communicate results to the lead inspector / recall coordinator / OFSR and/or the regulated party as applicable. Laboratory results generated by the CFIA for either a complainant's sample that was turned over to the CFIA or for a sample taken by the CFIA in relation to the complaint investigation may be communicated to the complainant.	Protocol for CFIA's Sharing of Information during Food Safety Investigations and Recalls Operational procedure: Responding to food complaints (accessible only on the Government of Canada network – RDIMS 1599661)
To verify compliance at a regulated party	If the lot is ordered not to be moved, the inspector will communicate the results and/or the next steps to the regulated party, for example if product may be released or further action is required. When non-compliant domestic samples are identified, Area/Regional Operations may communicate the results to the appropriate Provincial authorities for follow-up.	Preventive controls Preventive control plan (PCP)

6.4 Conduct follow-up

Refer to SIP section 6.0, step 4 – Conduct the follow-up inspection.

For general inquiries related to this operational guidance document, follow established communication channels, including submitting of an electronic Request for Action Form (e-RAF) (accessible only on the Government of Canada network).

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