Dairy Establishment Inspection Manual – Chapter 10 Prerequisite Programs
1.10.06 - Recall Program

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This task assesses a manufacturer's and importer's written recall procedure to ensure an effective recall of any lot of food from the market. This procedure helps to minimize the confusion that may result during a recall. The information in this document must be kept current. It should include details about the retrieval of information that is typically required during a recall. This includes:

  • The person or persons responsible (who does it).
  • The roles and responsibilities for coordination and implementation of a recall (what is done).
  • Methods to identify, locate and control recalled product (how and when it is done).
  • A requirement to investigate other products that may be affected by the hazard and that should be included in the recall.
  • Procedure for monitoring the effectiveness of the recall, e.g. effectiveness check to the appropriate level of distribution specified in the recall notice.
  • Immediate notification to the CFIA Area Recall Coordinator in the area or region where the manufacturer is located, or in the case of a provincially licensed establishment, the appropriate provincial authority. A list of CFIA Area Recall Coordinators is available on the CFIA website.

Flow charts are useful to summarize the steps involved in a recall.

Manufacturing records must be detailed enough to trace back a particular lot of product and even a specific ingredient or additive added to the product. Distribution records must be able to account for the total quantity of the lot produced. Parts of a lot that are on hand, on hold or reworked must also be referenced in the records. The distribution list should be product and lot code specific. If the distribution list is not specific, the manufacturer must be prepared to do a wider recall to bring back all implicated products.

The manufacturer must be capable of producing accurate information on a timely basis to verify that all affected product can be rapidly identified and removed from the marketplace. This can be demonstrated by complete manufacturing and distribution details for every lot.

The establishment must assess the effectiveness of their notification. This should include the number of accounts that were notified, the number of accounts that were contacted or checked to see if they had received the recall notification, method of confirming that the accounts were notified. A statement describing how they determined if the recall notification was effective, a statement of the recall notification effectiveness, i.e. satisfactory, not satisfactory, and a statement of corrective action to be taken where it is determined that the recall was not satisfactory.

Periodic testing (minimum of once per year) of the recall program must be done to verify the capability of the procedure to rapidly identify and control a code lot of potentially affected product and reconcile the amount of product produced, in inventory and in distribution. The establishment should be able to demonstrate the traceability of the affected product to the distribution centre level. Any deficiencies in the recall procedure must be identified and corrected.

An establishment must have a standard documented procedure which details the action taken when complaints are received on dairy products. The complaint should be taken by a designated individual. The complaint file should include recording of the initial complaint information, investigating the complaint and recording the findings and taking action based on the investigation findings. The investigation should be investigated by a trained person. When all the investigation findings are collected a decision of the action to be taken must be made. In some instances, a complaint investigation by the establishment may reveal that the product should be withdrawn from the market. This recall of product is undertaken when a product is considered to be a potential health hazard or in violation of government regulations. Should an establishment be unsure of the need for a recall or to ensure the action/decision is correct, they should contact the CFIA for consultation. The decision must include what to do with the affected product(s) and how to correct the problem.

Once the recall is complete and all the non-compliant product is removed from the marketplace, the manufacturer or importer must perform an assessment to determine the root cause of the recall. The establishment must develop and implement appropriate corrective measures to prevent the re-occurrence of the deficiencies or a similar violation which may result in future recall action. The establishment must review the current written procedures used in the manufacture/importation or sale of the non-compliant product and the appropriate changes must be made to prevent the re-occurrence. Detailed records must be kept by the establishment documenting that the assessment was completed and what corrective action was taken.

For further information on this task please refer to the Recall Plan - Manufacturers' Guide

Additional guidelines on food emergencies can be found in the Canadian Food Inspection Agency - Food Investigation Response Manual (CFIA).

Recall Program Summary Table
Table description

This table shows the tasks, ratings and inspection criteria for Recall Program.

Task Inspection Criteria
1.10.06.01 Recall Program (more to follow) (HS=3) (A) Documented Program
  1. Recall Procedures
    • Identifies all personnel and alternates (phone numbers)
      • lists roles and responsibilities
    • Outlines step-by-step procedures
      • extent and depth of recall
    • Specifies communication target groups, methods and channels
    • Specifies methods of control of returned product
      • instructions for product disposition
      • requirement to investigate other products affected
    • Includes methods to monitor recall effectiveness
      • number of accounts that were notified of the recall
      • number of accounts that were contacted or checked to see if they received the recall notification
      • method of confirming that the accounts were notified
      • statement describing how they determine if recall was effective
      • statement of recall effectiveness, i.e. satisfactory, not satisfactory
      • corrective action to be taken if recall not satisfactory
    • Testing of recall program (mock recall)
      • to be tested a minimum of once per year
      • to demonstrate the traceability of the affected product to the distribution centre level
      • description of test scenario
      • date of test
      • problems identified during the test
      • changes made to correct the problem
    • Immediate notification to the CFIA Area Recall Coordinator including the following information:
      • amount of product produced (inventory and distributed)
      • name, size, code, or lot number of recalled food
      • distribution area
      • reason for recall
    • Self-assessment and implementation of corrective measures to determine root cause
      • satisfactory follow-up
      • documentation of action taken
  2. Manufacturing (Production) Details
    • Product identification
    • Code, lot (permanent, legible)
      • establishment identification
      • day, month, and year produced
    • All ingredients/additives (code trace back)
    • Quantities (components and end product)
    • Initials of responsible operator
  3. Distribution Details
    • Name, address and phone number of all lot receivers
    • Location of non distributed lots
    • Date shipped
  4. Complaint File
    • Initial complaint information
      • taken by a designated individual
    • Investigation of the complaint and record of findings
      • by a trained person
    • Action taken

(B) Records

A representative sampling of the plant's records must be assessed.

  1. Records must be:
    • Accessible and complete
    • Clear, legible and permanent
  2. Information must indicate:
    • Recall incidences and follow-up
      • reason
      • recalled product identification
      • amount of recalled product involved
      • areas of distribution
      • information on other products implicated
    • Manufacturing (production) and distribution details for all lots
    • Deficiencies in recall program identified and corrected (recall effectiveness)
    • Results of mock recall
    • Results of self-assessment and corrective measures taken to prevent re-occurrence of a similar violation
    • Complaint file
  3. Retention
    • Past product's shelf life or a minimum of 1 year
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