What to do when a cold room has a temperature excursion: a checklist

Published 6 October 2026. 6 minute read.

Short answer: stop the affected stock from being picked first, then find out what happened. In order: confirm the excursion is real, block the stock in your warehouse or ERP system, record the times and temperatures, have quality assurance assess each product against its stability data, then release or reject with a signed, documented decision.

A temperature excursion is any period in which a product is outside the range on its label or in its storage profile, for example a 2 to 8 °C vaccine store reading 9.4 °C. Good Distribution Practice expects a wholesaler to notice it, protect the product, investigate, and keep a record of what was decided and why. This checklist follows that order. Adapt it to your own written procedure; your procedure is what an inspector will hold you to.

The first fifteen minutes

Confirm it is real. Check a second sensor or the unit's own display. A single reading during a door opening or a defrost cycle is not an excursion; a sustained run of readings is. Most procedures define a grace period, often around fifteen minutes, before an event counts.
Stop the stock leaving. Block the affected batches so they cannot be picked or shipped. This is the step that most often happens too late: the logger knows at 09:30, and the stock ships at 11:00 because nobody told the warehouse system.
Protect the product. If the room is still out of range, move the stock to a qualified backup unit and note the time of the move. Keep it physically separate and labelled as on hold.
Tell quality assurance. By phone or by an alert they will actually see. An email to a shared inbox on a Friday evening does not count.

The same day

Record the facts. When the excursion started and ended, the highest or lowest temperature reached, which unit, which logger, and whether the logger's calibration is in date.
List what was in the room. Every material and batch, with quantities, at the time of the excursion. Your ERP's stock for that storage location is the source; a list from memory is not.
Check what already left. If anything was picked between the start of the excursion and the block, you now have a second problem: tracing and possibly recalling it. The length of this list is the cost of a late block.
Find the cause. A door left open, a compressor fault, a power cut, an overloaded room. Note what was done about it.

The decision

Assess each product. Compare the time and temperature with the manufacturer's stability data, or ask the marketing authorisation holder. Different products in the same room can get different answers.
Decide, and sign. Release or reject each batch. The decision needs a named person, a time and a reason. A shared login or an unsigned spreadsheet line is the usual audit finding here.
Make the system match the decision. Released stock goes back to unrestricted use; rejected stock stays blocked until it is destroyed or returned.
Close the record. One file with the temperature trace, the stock list, the assessment, the signed decisions, the cause and the corrective action.

What inspectors tend to ask

How long after the excursion started was the stock blocked?
How do you know which batches were affected?
Who decided, when, and on what basis?
Could anyone have changed this record afterwards?

If the honest answer to the first question is "the next working day", the gap is not in monitoring. Most wholesalers already have loggers. The gap is between the logger and the stock system.

Where the time goes

In a manual process, steps 2 and 6 depend on a person noticing an alarm, working out which batches are in that room, and blocking each one by hand. ColdLatch does those steps itself: when an excursion is confirmed it looks up the unrestricted stock at that SAP plant and storage location, proposes a block for each batch, and alerts QA. A QA user approves with their password and a reason, the block is posted to SAP, and every step lands in an audit log that cannot be edited.

This article is general guidance, not regulatory advice. Follow your own approved procedures and the guidelines that apply to your licence.

Next: How to block a batch in SAP S/4HANA after a temperature excursion