Managing a Product Recall (Video)

1. Enter Recall / Withdrawal Incident Details

  1. Select the date of the Recall / Withdrawal.
  2. Select the type of Recall / Withdrawal. It will either be an ‘Actual Recall / Mock Recall’ or an ‘Actual Withdrawal / Mock Withdrawal’.
  3. Enter the reason / incident details leading to the Recall / Withdrawal.
  4. Select the affected products and enter the Brand, Quantity, Batch Number, Date of Manufacture, Durability Date and Production Line. If you enter multiple products then the quantity will be totaled at the bottom of the table.
  5. Confirm whether the distribution of the affected product has been suspended. Enter any relevant notes to this.
  6. Enter the Start and Finish Date/Time for the Recall / Withdrawal.
  7. Conduct a brief risk assessment of the incident and enter your justification.
  8. Alternatively conduct an advanced risk assessment using a Probability by Severity matrix.

2. Make Recall / Withdrawal Decision

  1. Complete the Recall / Withdrawal decision tree questionnaire. As you answer each question you will be driven to the next logical question. You can chose to make a note in the report field justifying your answer to each question.
  2. Once you have completed the decision tree questionnaire a decision will be displayed for action.
  3. Enter any relevant details pertaining to the decision made.

3. Prepare Recall / Withdrawal Plan

  1. Select the Recall / Withdrawal team members, their function and their contact details. You should also select alternative team members.
  2. The Recall / Withdrawal plan consists of a number of important functions and tasks. The tasks are added by default when the record is created however you are free to add, remove or change these tasks to suit the needs of your own Recall / Withdrawal event. For each task you should set the person responsible and a deadline by which the task should be completed. As each task is completed you can update the ‘completed by’ person and date.

4. Keep Recall / Withdrawal Event & Action Log

The Recall / Withdrawal Event & Action log allows you to keep a record of any pertinent events or actions.

  1. Select the function the event or action relates to.
  2. Select the date of the event or action.
  3. Enter the details of the event or action.
  4. Select the person who reported the event or action.

5. Complete Recall / Withdrawal Reconciliation

  1. In order to reconcile the Recall / Withdrawal you should enter the quantity of product which is currently in stock, which has been returned and which has been destructed (consumed) in the supply chain. For anything else you can use the Other field and make a note in the reconciliation report as to what this relates to.
  2. This will give you a total unaccounted product.
  3. And a variance against your original Recall / Withdrawal quantity as determined in the first section above.
  4. Enter your reconciliation report including any relevant details.

6. Close out Recall / Withdrawal

  1. Complete the close out questionnaire making a note in the report column where necessary.
  2. The close out notification allows you to record any notifications made to customers or regulatory bodies concerning the Recall / Withdrawal.
  • Select the customer or organization from the contacts module.
  • Select the date they were notified.
  • Select the means by which they were notified (email, phone, letter etc).
  • Enter the specific contact person who was notified.
  • Enter any other relevant notes relating to the notification.

7. Conduct Post Recall / Withdrawal Review

You should conduct a final Recall / Withdrawal review and enter your report here.