What it means
Use the affected product's qualified temperature limits and logger rules, since a range for another medicine, food item or route is not an acceptable default. A shipment can contain multiple products with different stability limits, so map exposed pallets to their own instructions instead of applying the most forgiving range to the whole vehicle.
WHO storage and transport guidance discusses temperature-controlled distribution, but its pharmaceutical examples do not set a universal threshold for every food or medical product. Preserve raw readings, device identity, calibration and clock information before filtering noise, because a filtered curve alone may conceal gaps or a poorly placed sensor.
If a logger appears faulty, obtain qualified corroborating data or leave the condition uncertain, as a sensor fault is not evidence the contents stayed in range. Reconcile the logger's serial number to its calibration record and to the vehicle or package it monitored.
Place the physical goods on hold where the quality plan requires it, with quantities and pallet IDs, and assess time and temperature together using product-specific stability evidence. A brief alert near an open door and a prolonged refrigeration failure can have very different consequences.
Restoring the refrigeration unit does not decide whether exposed stock can be used. The authorized quality owner should document release, testing, return or destruction with the basis for the decision, and drivers or dispatch should not improvise a release rule.
Reconcile the physical outcome to inventory, keeping disposal evidence and final quantity, so destroyed stock does not stay available because the system still shows a positive quantity. If goods were delivered before the alarm was noticed, record their downstream location and escalate through the authorized path.
A case counts as closed for the rate only when investigation and disposition evidence are complete, and the organisation should state whether closure also requires a completed corrective action. Show quarantined goods and their age beside the closure percentage, since a rushed decision improves the rate without making a shipment safer.
Customer notice, insurer or regulatory duties and recall responsibility sit with their own owners and deadlines. Investigate the operational cause separately, such as door seal, loading duration, route or alarm coverage, because each leads to different prevention.
A sharp spike at loading may be a door event or poor sensor placement, and the reviewer should use validated load maps instead of deleting an inconvenient data point. Link alarms from the same episode to one controlled investigation while keeping the underlying readings.
In practice
Real-world examples.
Example
A refrigerated trailer carrying yoghurt shows 11 minutes above range when the doors were open at a dock. The quality manager reviews the product stability data, releases the load with a documented rationale and closes the case.
Example
A pharmaceutical shipment's logger shows a three-hour gap in readings during a border delay. The case stays open because a sensor fault is not proof of safe temperatures, and the stock is held until qualified evidence supports a decision.
Example
A seafood importer destroys a pallet after a refrigeration failure. The case is closed only after the disposal record is attached and the pallet is removed from available inventory.
Formula
Calculation
Closure rate = Eligible excursion cases with authorized investigation and disposition / All eligible excursion cases x 100. Show open quarantined cases separately.
Worked example. A fictional vaccine distributor logs 25 eligible excursion cases in a quarter, and 20 have a documented investigation, a signed disposition and, where required, a corrective action.
- Closure rate = 20 / 25 x 100 = 80%.
- The 5 open cases hold 40 pallets in quarantine, and the oldest has been open for 12 days, so both figures are reported next to the 80%.Case study
Seen in the real world.
This illustrative and fictional case follows Northgate Biologics, an invented supplier of temperature-sensitive products. Its dashboard showed 96% of excursion cases closed, but a review found that many were closed when the driver confirmed the refrigeration unit was working again, without any product decision. Northgate redefined closure to require a signed disposition from the quality owner, reconciled inventory and a named root cause. Reported closure fell to 62% overnight, which was uncomfortable but accurate, and within a quarter it rose to 90% as the backlog of held pallets was properly dispositioned. The team also found that most excursions came from long loading times, which a loading-dock change then reduced.
Watch out
Common mistakes.
- Closing because the vehicle was repaired without reviewing product.
- Using a generic temperature range for all goods.
- Treating missing sensor data as proof no excursion occurred.
Questions
People also ask.
Does a short excursion always ruin goods?
No. Qualified product review determines disposition.
Can a driver close the case?
Only under the applicable approved quality procedure and authority.
What if the logger failed?
Record an evidence gap and investigate with other qualified sources.
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