Add a Recall / Withdrawal

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Managing a Product Recall (Video)

1. Enter Recall / Withdrawal Incident Details

Enter Recall / Withdrawal Incident Details
  1. Select the date of the Recall/Withdrawal.
  2. The type of Recall/Withdrawal is displayed here. 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 totalled 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. Select your risk value. You can use the report section to justify the value chosen.

2. Make Recall / Withdrawal Decision

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 choose 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 on the decision made.

3. Prepare Recall / Withdrawal Plan

Prepare Recall / Withdrawal Plan
  1. The Recall/Withdrawal team members, their function and their contact details defined in the programme will appear here. You can update the information if applicable.
  2. The Recall/Withdrawal plan consists of several important functions and tasks. The tasks appear by default when the record is created (based on the checklist selected in the programme), 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

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

Complete Recall / Withdrawal Reconciliation
  1. To reconcile the Recall/Withdrawal, you should enter the quantity of product that 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. 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

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 how 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

Conduct Post Recall / Withdrawal Review

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

Note: You can click the Actions drop-down on the top right of the record to attach important documents etc., click Actions > Add Attachments.