Classification:
Emergency situation
Report or confirmed illness
Product tampering which could result in injury.
Adverse finding by a regulatory agency of a hazard
Presence of an undeclared allergen in a product.
Priority situation
Temporary or medically reversible adverse health consequence and where the probability of serious adverse health consequences is remote.
Routine situation
Adulteration or misbranding not involving a health hazard.
2. Purpose
• The Product which are in circulation and
report to have or may present health hazard.
3. Responsibility
• MR/GM to give final decision on product
withdrawal.
• FSTL or report department to initiate and
communicate with all the personal involved in
the product withdrawal procedure.
4. Product withdrawal Classifications
• Emergency situation
1. Report or confirmed illness
2. Product tampering which could result in injury.
3. Adverse finding by a regulatory agency of a hazard
4. Presence of an undeclared allergen in a product.
• Priority situation
1. Temporary or medically reversible adverse health
consequence and where the probability of serious adverse
health consequences is remote.
• Routine situation
1. Adulteration or misbranding not involving a health hazard.
5. Action in case withdrawal
• Identifying the product, code date and issue
requiring.
• Serious hazard must high light that a health
risk is present.
• Business control must be placed on hold.
• They locate any product in transit and prepare
for replacement of product.
6. Depth of withdrawal
• Customer
1. This includes customers Food Axis.
• Storage Level
1. This includes in-house and rental storage
facility.
7. Gathering Information
• Withdrawal reasons-the actual or possible
prevalent problems and the events leading up to
the withdrawal.
• Product Identification-product name, batch no.,
date of production etc.
• Quantity of suspected product.
• Quantity of retained and distributed products.
• Distribution date.
• Corporate customer.
• What are the possible causes of the problem.
8. Identification of the scope of
withdrawal.
• GM/MR will provide a list of all export
customer.
• Manager Marketing provide the list of local
customer.
• List of the person(s), at each outlet who would
be responsible for action in respect of a
withdrawal of product will be maintained by
the company.
9. Identification of extent of the
withdrawal required:
• Production
• Storage/ final product store (rental storage
facility)
• Customer
11. Withdrawal operation:
• Contact customer by fax or telephone, requesting all products
affected to be isolated pending collection by the company must at 8
hours.
• If the contact not reply should be given to any parties outside the
company.
• Team shall arrange for all effected product to be rapidly uplifted
with the minimum of commotion.
• On return to the company, or other central point those items
affected shall be quarantined in such a manner to prevent in
advertent use, dispatch or inclusion in any subsequent production.
• Refund replacement product ASAP.
• Team monitoring effective and efficient withdrawal procedure.
• Theses units don't tally with dispatch.
12. Agencies to be informed regarding
the withdrawal of the product.
• In place, the police must be consulted before
further actions.
• Affect human health, consider health
department of the local authority.
• Laboratory should be warned of pending
action with respect.
• This would be a last resort situation and legal
advice would be advised.
13. Investigation and corrective /
preventive actions.
• MR/G.M is responsible to root cause analysis
of the problem and issue is resolved.
14. Disposal of the product after
withdrawal
• The disposal may be required to ensure that
there is no possibility of the product reaching
the public.
15. Validation
• To confirm that the product traceability and
withdrawal procedure are effective and
efficient well understood, the company
performs withdrawal exercises annually.
• Related document
• Complaint form
• Customer complaint log
• Recall log sheet.