When the product is unsafe.
WHAT TRIGGERS ACTION
A failed test Customer illness reported Visible contamination Treatment failure discovered A regulatory instruction
WHAT TO DO IMMEDIATELY
Stop production and despatch Quarantine product held Establish which batches are affected Establish what is already distributed
WHY BATCH IDENTIFICATION FIRST
Everything else depends on knowing the scope.
WHAT TO ESTABLISH NOW, BEFORE ANY INCIDENT
Whether your records could tell you which customers received which batch.
WHY NOW
The answer determines whether you could respond at all.
WHAT TO DO ABOUT DISTRIBUTED PRODUCT
Contact distributors and retailers Withdraw it Record what was recovered
WHAT TO NOTIFY
The regulator, per the requirements.
WHY PROMPTLY
Delay compounds harm and it is treated seriously.
WHAT TO DO ABOUT REPORTED ILLNESS
Take it seriously immediately Record details Cooperate with any investigation Do not dismiss it
WHY NOT DISMISS
It may be the first indication of a wider problem.
WHAT TO ESTABLISH
The cause, thoroughly.
WHAT CAUSES TO EXAMINE
Treatment failure Storage contamination Packaging contamination Staff hygiene Source deterioration
WHAT TO CHANGE
Whatever allowed it.
WHAT TO RECORD
Everything: findings, decisions, actions and communications.
WHAT TO NEVER DO
Continue supplying while investigating Conceal the position
WHY
The harm continues and the consequences multiply.
