SOP AMU-067 · Part 4
Product Recall SOP
The eight recall levels from initial alert to management-approved closure.
Recall Triggers
- Product safety concern
- Incorrect ingredient
- Serious contamination concern
- Wrong label
- Undeclared allergen
- Regulatory instruction
- Critical packaging failure
- Serious batch quality issue
Level 1 — Initial Alert
Anyone discovering a potential serious issue must immediately inform the Quality Manager and the Managing Director. Do not wait for the weekly meeting.
Level 2 — Stop Sale
Affected product status becomes HOLD — DO NOT SELL. Immediately block:
- Warehouse stock
- Website stock
- Marketplace stock
- Franchise stock
- Distributor stock where applicable
Level 3 — Identify Batch
- SKU
- Batch
- Production date
- Quantity produced
- Quantity imported
- Quantity in warehouse
- Quantity sold
- Customers affected
- Partners affected
Level 4 — Trace Customers
Factory
Shipment
Warehouse
Order
Customer
Level 5 — Notification
- Regulatory authority
- Manufacturer
- Distributor
- Franchisees
- Customers
- Insurance company
- Legal advisors
Communications must be centrally approved.
Level 6 — Recovery
- Stop-use instruction
- Return instructions
- Replacement
- Refund
- Additional approved guidance
Level 7 — Root-Cause Investigation
- What happened?
- Why?
- Which control failed?
- Who was affected?
- Could another batch be affected?
- What corrective action is required?
Level 8 — Closure
- Affected stock controlled
- Customer actions completed
- Required regulatory steps completed
- Root cause identified
- CAPA implemented
- Management signs closure
Use: AMU-F21 — Product Recall Report.