A cold-chain procedure defines normal shipment steps and the decision path for an excursion. It identifies product conditions, the person performing each task, required records and decision authority. Preparation, transport and delivery each have a defined check and time.
A procedure closes its gaps when cold chain basics cover the excursion as clearly as the normal day.
Define the product and process first
Take each product criterion from the approved product specification, customer instruction or quality source approved for that operation. The measured value may be air, product or package surface temperature; the procedure must state where the sensor goes and which value controls the decision.
FAO's control-of-operation guidance connects defined food processes, monitoring records and corrective actions for deviations. Complete the template below for your products, equipment and assigned roles.
The normal flow lists shipment identity, product and batch, equipment, pre-loading check, transport record, delivery reading and receiver confirmation in order. If each step has no owner and no evidence, the text remains an instruction and does not produce a traceable record.
| Procedure section | Fields to write | Working question |
|---|---|---|
| Product criterion | Product, batch, acceptance condition, measurement point | Which approved criterion applies to this load? |
| Normal flow | Preparation, loading, transport, delivery step | Who owns each step? |
| Evidence | Sensor, photo, timestamp, form | Which record will be shown later? |
| Excursion | Event outside the expected condition and first action | Who places the load on hold? |
| Escalation | First contact, backup, senior decision authority | How does the sequence continue if the first person is absent? |
| Final disposition | Release, rework, return or rejection reason | Who signs the decision? |
| Version | Owner, effective date, review record | Where is the reason for change kept? |
Separate the excursion flow from the normal flow. When an alarm or nonconforming reading appears, prevent uncontrolled use of the product, maintain appropriate storage conditions and record the event. Check the method and device where needed; a second reading does not erase the first. Make the location, status and owner of the held load visible.
Write the first operational contact, the qualified backup if that person cannot be reached, and the final decision authority in the notification order. A backup is not merely someone with a phone number; the person should be assigned and competent to assess the product and procedure.
Do not combine equipment failure, measurement doubt, an open door, delay and delivery refusal in one line saying “notify the responsible person.” Each event can have its own first containment action, evidence, hold decision and escalation sequence.
Separate hold from final disposition. A hold is a temporary status that prevents unauthorised dispatch or use while the assessment is completed. Final disposition is the result of reviewing records, product criteria and an authorised assessment. The procedure should distinguish who applies the hold label from who approves release, return, rework or rejection and records the reason.
Hypothetical example: if a delivery lacks its temperature record, the operator logs the batch and last known location and holds the product under appropriate conditions for review. The quality owner requests the missing file and reviews available evidence. A later acceptable reading does not fill the unrecorded transport interval.
Keep records, evidence and time together
For each event, capture the discovery time, measurement time, sensor or device identity, measurement point, product and batch, door or equipment state, action taken, people notified and decision time. Use system timestamps and describe the delay instead of guessing its duration.
Show the procedure owner, approver, effective date and next review date on the document. If the product criterion, equipment, route, customer instruction or a corrective action changes, record the version reason and affected sections.
Walk through normal dispatch and an exception with the operator. Correct gaps, approve the new version and replace outdated copies at the point of use. The responsibility table details decision authority; the shift handover guide covers unfinished work.
