Temperature Excursion Investigation Report

Document type	Report
Topic area	Drug Product
Level	Intermediate
Updated	September 2026

This is a ready-to-use investigation report for a cold chain temperature excursion detected at receipt or during transit. Replace every <<FILL: ...>> placeholder with your own specifics and route the completed report through your normal document control, review, and approval. A worked filled specimen follows. Verify each cited reference against the current source before you rely on it.

Document control header

Field	Entry
Document title	Temperature Excursion Investigation for Shipment `<<FILL: shipment ID>>`
Document number	`<<FILL: e.g. DEV-2026-0142>>`
Version	`<<FILL>>`
Date opened	`<<FILL>>`
Product / lot / patient ID (as applicable)	`<<FILL>>`
Linked shipping qualification protocol/report	`<<FILL: ref>>`
Investigation owner	`<<FILL: e.g. Quality>>`

1. Purpose

This report documents the investigation into a temperature excursion detected during shipment <<FILL: shipment ID>>, characterizes its magnitude and duration, evaluates it against the product’s qualified range and stability data, determines root cause, and records the disposition decision and any corrective action.

2. Summary of the event

Field	Entry
Detection point	`<<FILL: receipt inspection / in-transit alarm>>`
Qualified range	`<<FILL: e.g. 2 to 8 degrees Celsius for up to 96 hours>>`
Logger reading(s) triggering the investigation	`<<FILL>>`
Shipper type and lane	`<<FILL>>`

3. Excursion characterization

Metric	Value
Magnitude (peak deviation from range)	`<<FILL: e.g. 0.5 degrees above upper limit>>`
Duration outside range	`<<FILL>>`
Mean kinetic temperature across the affected period, per USP <1079.2> methodology	`<<FILL: calculated value>>`
Number of logger positions showing the excursion	`<<FILL>>`

4. Evaluation against product data

State plainly whether the characterized excursion, including the calculated mean kinetic temperature where applicable, falls inside or outside what the product’s stability data and shipping qualification data show as tolerable. A mean kinetic temperature within the acceptable range is one input to this evaluation, not a stand-alone justification; state the evaluation and its basis in full, including the shipping qualification report reference this excursion is being compared against.

<<FILL: narrative evaluation and conclusion>>

5. Root cause investigation

Candidate cause	Investigated	Finding
Charge state at dispatch (see chain-of-custody log)	`<<FILL>>`	`<<FILL>>`
Number and duration of handoffs versus qualified assumption	`<<FILL>>`	`<<FILL>>`
Orientation / handling during transit	`<<FILL>>`	`<<FILL>>`
Unplanned delay, customs hold, or carrier deviation from planned routing	`<<FILL>>`	`<<FILL>>`
Logger malfunction or placement error	`<<FILL>>`	`<<FILL>>`
Determined root cause		`<<FILL>>`

6. Pattern check

State whether this lane, shipper type, or carrier has shown a prior excursion within <<FILL: lookback period, e.g. the prior 12 months>>. A repeat pattern on the same lane is not closed as an independently explained event; it triggers a requalification of the lane per the shipping qualification protocol, referenced here: <<FILL: ref, or "no prior excursion on this lane in the lookback period">>.

7. Disposition decision

Field	Entry
Disposition	`<<FILL: release / reject / further characterization required>>`
Decision basis	`<<FILL: reference to section 4 evaluation>>`
Decided by	`<<FILL: Quality role, name>>`
Date	`<<FILL>>`

8. Corrective action

Action	Owner	Due date	Status
`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`

9. References

USP General Chapter <1079.2>, Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products (verify current status before citing). ICH Q1A(R2), Stability Testing of New Drug Substances and Products. Linked shipping qualification protocol and report.

10. Approvals

Role	Name	Signature	Date
Investigator (Quality)	`<<FILL>>`
Reviewer (Manufacturing Science)	`<<FILL>>`
Approver (QA)	`<<FILL>>`

Filled specimen

Extract for an example excursion during a maximum-load winter shipment. Company, product, and numbers are illustrative.

Field	Entry
Shipment	SHIP-2026-004417, dry vapor shipper, qualified below minus 150 degrees Celsius for 96 hours
Detection	Near-lid logger showed a rise to minus 148 degrees Celsius at hour 90 of a 92-hour transit, flagged at receipt review
Characterization	Magnitude 2 degrees above the qualified ceiling equivalent margin, duration approximately 45 minutes before recovery, one of two logger positions affected
Evaluation	Compared against the shipping qualification report for this lane, which showed the same near-lid position holding within range at hour 90 during the winter maximum-load qualification run with a 1-degree margin; this shipment’s reading used most of that margin but did not cross the product’s actual cryopreservation stability threshold, per the linked stability data
Root cause	Shipper held 5 hours between charge and dispatch, longer than the 2-hour maximum observed during qualification runs, consistent with a slightly reduced thermal reserve at dispatch
Pattern check	No prior excursion on this lane in the past 12 months
Disposition	Released, based on the margin analysis in the evaluation and confirmation the cryopreservation stability threshold was not approached
Corrective action	Add a maximum hold-before-dispatch limit of 2 hours to the dispatch procedure, matching the qualification study’s tested condition

Common findings this report prevents

An excursion closed as “within range” using a simple average temperature rather than a mean kinetic temperature calculation or a defined margin comparison against the qualification data.
Root cause left at “unknown” with no check against the dispatch chain-of-custody log’s charge-state and hold-time data.
No check for a repeat pattern on the same lane before closing the investigation as an isolated event.
A disposition decision made or effectively made by logistics rather than documented as a Quality decision.

How to adapt this report

Set your document number and link it to the specific shipment record and chain-of-custody log.
Calculate mean kinetic temperature using your own validated method or software, and cite the current USP <1079.2> methodology by reference, never by verbatim reproduction of chapter text; the paired Mean Kinetic Temperature Calculation Worksheet structures the inputs and retained dataset behind the figure entered in section 3.
Complete the pattern check in section 6 against your own lane history before closing the investigation.
Route corrective actions into your standard CAPA system if the finding points to a systemic gap rather than a one-time event.