Operational procedure: Visual examination of container integrity

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1.0 Purpose

The purpose of this document is to provide Canadian Food Inspection Agency (CFIA) inspection staff with the procedure to verify that low acid and acidified low acid food in hermetically sealed containers in Canada is safe, wholesome and meets the requirements of the Safe Food for Canadians Act and Regulations (SFCA/R) and the Food and Drugs Act and Regulations (FDA/R).

The presence of any serious container defect in lots of low-acid and acidified low-acid foods in hermetically sealed containers renders the lot of food unacceptable for sale or distribution in Canada. The presence of serious defects results in potential or realized loss of container integrity or microbial contamination.

This document is intended to be used in conjunction with the Standard inspection process and the Food inspection guidance: sample collection.

The guidance outlined below may be used to aid in the assessment of a preventive control plan (PCP) related sub-element, sample collection plan, commodity inspection or as part of a food safety investigation or follow-up to a complaint.

This document is intended to be used in conjunction with CFIA guidance as referenced in section 3, reference documents.

2.0 Authorities

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

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:

For the purpose of this document the following definitions apply:

Acidified low-acid food
is a food that has been treated by pickling or fermentation so as to attain an equilibrium pH of 4.6 or lower after heat processing (for example, pickles).
Commercially sterile
means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage.
Container
means the individual hermetically sealed can or package (retort pouch) containing the food product. For the purpose of this procedure, this definition does not include other packaging types such as glass, semi-rigid or rigid plastic, plastic cans with metal ends and paperboard containers.
Cull
means the removal of containers with serious defects from a lot of low-acid or acidified low-acid foods.
Disposition
means any action taken on an affected food to bring it into compliance or to remove it from the Canadian marketplace, such as relabelling, reworking, culling, exporting, destruction, etc.
Hermetically sealed
means a container designed and intended to be secure against the entry of microorganisms, including spores.
Lot
means a number of containers limited to one container type and size, one product type and style, one label, originating from one processing establishment.
Low-acid food
means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85.
Qualified
means competent or suitable for a particular job or activity. This may include a combination of formal education or training, knowledge, experience, skills, abilities or evaluation that would make a person suitable to perform a particular activity or duty.
Reinspection
means the examination of a previously inspected lot for the presence of serious defects.
Serious defect

means any container;

  • which is swollen; or
  • which has, or had, microbial growth in the container contents: or
  • which shows evidence that the hermetic seal is lost or seriously compromised; or
  • which is unsuitable for distribution and sale as stipulated in the Food and Drugs Act section 4 and/or section B.27.003 and B.27.005 of the Food and Drug Regulations

These defects are described in the Metal can defects: identification and classification and the Flexible retort pouch defects manual - Identification and classification.

5.0 Acronyms

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

6.0 Operational procedure

This operational procedure provides inspection guidance specific to Food business line - Visual examination of container integrity. Where more specific guidance is required than what is provided in the SIP, it will be indicated in this section.

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

6.1 Prepare for inspection

Refer to SIP, section 3, step 1 - Prepare for the inspection. In addition to the general guidance provided in SIP, the following applies.

Enter inspection information into the Digital service delivery platform (DSDP) as per the following:

Table 1. Recording inspection data in Digital Service Delivery Platform (DSDP)
DSDP field DSDP data field selection
Trigger
  • Choose one of the following triggers as appropriate:
    • Preventive control inspection plan
    • Sample collection plan
    • Commodity inspection plan
    • Incident response
Task type Commodity inspection
Inspection level 1 task Perform test
Inspection level 2 task Container integrity

See Operational Guidance: Interim guidance on entering food commodity inspection data into DSDP (accessible only on the Government of Canada network - RDIMS 12369415) and SOP Conducting an inspection (accessible only on the Government of Canada network - RDIMS 9839405) for further information on how to enter a commodity inspection in DSDP.

6.1.1 Prepare the toolkit

See section 3.0 of Visual examination of commercially sterile low-acid and acidified low-acid foods packed in hermetically sealed containers.

Additionally, a knife or tool to open cases and remove labels is necessary but should be used with caution to avoid damage to the cans.

6.1.2 Identify and locate lot

Prior to inspecting a lot, the inspector should have adequate access to the entire inspection lot and then obtain the following information:

  • location of the lot
  • name and address of the legal agent
  • lot size (number of cases, containers per case)
  • lot codes and their interpretation
  • brand name
  • product type and style of pack
  • container type and size
  • processing establishment
  • country of origin

6.2 Conduct the inspection

Refer to SIP, section 4, step 2 – Conduct the inspection. In addition to the general guidance provided in the SIP, the following applies.

Inspection is to be conducted, in a well lit space, on containers that are labelled and in their final state. For domestic product, inspection of bright stacked (unlabeled) cans is not recommended as further control measures that remove defective cans from the lot (for example, dud detection) may be in place.

As labels are to be removed, importers would need to have labelling as an activity on their licence in order to re-label inspected containers. Otherwise, importers may get another licence holder with the activity of labelling on their licence to re-label the containers or they may dispose of the inspected containers.

Note: importers and/or operators do not have the authority to apply a foreign inspection legend, which is on the label. For imported meat products, the foreign inspection legend can only be applied under the direct supervision of a delegate of the foreign competent authority.

6.2.1 Visual inspection procedure

6.2.1.1 Inspect the selected containers

Sample and inspect 200 low acid or acidified low acid containers according to the Visual examination of commercially sterile low-acid and acidified low-acid foods packed in hermetically sealed containers. For lots having less than 200 containers, the entire lot should be examined.

Also, see section 4.1.1 and 4.2 of the Metal can defects – Identification and classification for details on Double Seam examination and Can Integrity examination and evaluation processes and section 4.1.1 of the Flexible retort pouch defects manual - Identification and Cassification for details on visual examination of pouches

6.2.1.2 Determine compliance

Use the Metal can defects – Identification and classification and Flexible retort pouch defects manual - Identification and classification to assess the integrity of each container inspected and classify defects detected. Compliance is determined by the presence/absence of a serious defect.

When an inspector needs to further assess a defect, the inspector may consult with other people knowledgeable in the area of container integrity defects (such as other experienced inspectors or subject matter experts) and/or submit the containers in question to the laboratory for further analysis (metal containers only). See b) below for more information on laboratory analysis.

Can tear downs, as referenced in the Visual examination of commercially sterile low-acid and acidified low-acid foods packed in hermetically sealed containers, may be done to aid the inspector in defect classification, however, laboratory analysis is the official determination. As part of the analysis to determine compliance, the lab will conduct tear downs to determine tightness and overlap.

Unsatisfactory inspection results: When the results of the visual examination are unsatisfactory (one or more serious defects are found):

  1. consider detaining the inspection lot. Refer to Operational procedure: Procedure for seizure and detention, authorizing movement and disposition
    • for metal containers, refer to the CFIA Sampling Information (accessible only on the Government of Canada network) for guidance in selecting an appropriate number of containers as per the directed sampling plan of the commodity and send to the laboratory for commercial sterility and container integrity analysis. Note: the laboratory analysis is the official confirmation of the container integrity verification
    • If the job assessment on the laboratory report of analysis is:
      • satisfactory: release the lot
      • investigative: more information is required to determine if the sample is compliant
        • continue with inspection activities to collect supplementary objective evidence to support the determination of compliance and enter the compliance decision in DSDP
        • a PCI may be required for further follow up
      • unsatisfactory: determine disposition of the lot (see 6.3.1 below)
  3. determine the cause and the extent of the issue (for example other lots produced on the same malfunctioning line, other lots produced with the same defective containers, other companies using the same defective containers) and detain other suspect lots, if necessary
  4. determine if the lot(s) have been distributed and if so, follow the guidance in the Operational guideline – Food incident response process (accessible only on the Government of Canada network - RDIMS 6108635)
6.2.1.3 Capturing notes related to commodity inspection and samples in DSDP

For information on capturing notes relating to commodity inspections in DSDP, refer to Appendix A section 5.4.1 of the SIP and section 3.5.1. of the DSDP SOP INS- Conducting an inspection (accessible only on the Government of Canada network - RDIMS 9839405).

In addition to capturing an accurate description (brand name, common name, net quantity, lot number) of the commodity inspected in the "Commodity Description" field in DSDP, enter the same commodity description in the "objective evidence" field along with the non-compliances found so that it appears in the final inspection report.

For information on capturing samples as part of an Inspection Task within an Inspection Case, refer to DSDP SOP INS - Manage samples in an inspection case (accessible only on the Government of Canada network - RDIMS 9852138).

6.3 Communicate the results

Refer to SIP, section 5, step 3 – Communicate the inspection results.

6.3.1 Disposition of the lot

Lots, which do not meet Canadian requirements upon initial inspection are not permitted for sale or distribution in Canada.

Refer to Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food for disposition options and specific considerations based on type of disposition.

If culling is the proposed disposition method, culling of the lot must be done as per written PCP corrective actions. Follow the SIP to verify that proposed corrective actions, including the culling procedure to be implemented, are effective to ensure the safety of the food in the containers and that 6.1 - Part 4 of Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food is met.

Note:

  • culling shall not be permitted if the nature and quantity of the serious defect indicate that culling would not be effective in removing these defects from the lot
  • culling shall not be permitted when a serious defect cannot be visually detected
  • culling of swollen or leaking containers shall not be permitted when:
    • the presence of swollen or leaking containers is related to underprocessing; or
    • there is no evidence of visible serious container integrity defect; or
    • swollen containers cannot be related to an overfill
  • culling shall be conducted by qualified personnel but does not need to be done in the presence of an inspector
  • if the product to be culled has been seized, refer to 6.2.1- Authorizing the movement or alteration of a seized product of the Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food

Record the disposition of the lot in the DSDP as per Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food.

6.4 Conduct follow-up

Refer to SIP, section 6, step 4 – Conduct the follow-up inspection. In addition to the general guidance provided in the SIP, the following applies.

Create a follow-up case in DSDP. See SOP Managing a non-compliance record (accessible only on the Government of Canada network - RDIMS 9906406).

Follow-up should be conducted to verify that the non-compliance of the food is corrected, a state of compliance is re-established and that reoccurrence is prevented through the PCP.

If the culling option is chosen as part of the corrective actions, the effectiveness of the cull must be assessed.

6.4.1 Assessment of the cull (if applicable)

6.4.1.1 Reinspection

Reinspection is one way to verify the effectiveness of the cull. Depending on resources, a team approach is recommended. Reinspection without a cull is not permitted as no corrective actions have been implemented to ensure the safety of the food in the containers.

In addition to reinspection of the lot, the inspector(s) can also inspect the defective containers culled from the lot to observe the number and types of defects.

Other assessment options should be discussed with the inspector's supervisor, Regional Program Officer (RPO) and National Operations Specialist in Operational Guidance and Expertise (OGE), if necessary, prior to assessment.

6.4.1.2 Sampling and examination

Ensure that the entire lot is available and accessible for reinspection. Sample 1250 containers from throughout the lot.

Table 2. Selection of Containers
Number of containers per case Number of cases to sample Number of containers to pick from case
5 or less 250 all
6 to 12 209 6
13 to 60 105 12
61 to 250 79 16
251 or more 55 24

Using the table above, identify the number of containers in a case, select the required number of cases to be opened for inspection, and examine the required number of containers from each case sampled. Visually inspect the containers as per 6.2.1.1 above.

For lots having less than 1250 containers, the entire lot should be examined and the total number of containers inspected recorded in DSDP.

6.4.1.3 Assess follow-up inspection results

If the results of the reinspection or laboratory results from the directed sample show:

  • no serious defects – witness destruction of defective culled containers and release/permit distribution of acceptable portion of lot;
  • 1 or more serious defects - the lot may not be offered for sale or distribution. The following options are available:
    • destruction of the lot under the supervision of the inspector. Containers must be individually opened or punctured prior to disposal in appropriate waste disposal unit and witnessed by the inspector; or
    • removal of the lot from Canada, if imported, with inspector approval

Refer to Operational guideline: Assessing, monitoring and documenting the disposition of non-compliant food and Operational procedure: Ordering removal, or destruction of unlawful food imports. Note: a second cull/reinspection is not permitted.

Enter the findings of the reinspection, laboratory results, final decision and final disposition into the follow up case in DSDP as per 6.2.1.3.

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

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