# Temperature Excursion Record (Deviation)

| Field | Entry |
|---|---|
| Deviation number | DEV-____ |
| Site / area / equipment | |
| Storage condition | ____ °C to ____ °C |
| Detected by | ☐ alarm ☐ routine review ☐ shipment logger ☐ other: |
| Detected on (date/time) | |
| Raised by | |
| Classification (initial) | ☐ minor ☐ major ☐ critical |

> Template from ValiTrac AI (valitrac.com/resources/templates). Adapt under your own document control. Written against EU GDP chapters 3 and 9, WHO TRS 961 Annex 9 and ICH Q1A(R2). Not a substitute for the applicable guideline or a qualified reviewer.

## 1. Immediate actions (containment)

| Action | Done by | Date/time |
|---|---|---|
| Alarm acknowledged | | |
| Affected product identified and placed on hold / quarantined | | |
| On-site cause checked (door, equipment, power, sensor) and corrected where possible | | |
| Backup storage used (if applicable) | | |

## 2. Excursion characterisation

| Item | Value |
|---|---|
| Monitoring sensor(s) / logger | |
| Start (first reading outside limits) | |
| End (first reading back within limits) | |
| Duration outside limits | |
| Peak / lowest temperature | |
| Time above / below limit (cumulative) | |
| Mean kinetic temperature of the period (if used, with justification) | |
| Sensor type (air / buffered) and whether product reached the excursion temperature | |
| Data quality checked (gaps, sensor fault, uncertainty at limit) | ☐ yes — notes: |
| Monitoring data / trace attached | ☐ |

## 3. Products affected

| Product | Batch / lot | Quantity | Storage requirement | Manufacturer excursion allowance / stability data reference | Previous excursions for this batch |
|---|---|---|---|---|---|
| | | | | | |

## 4. Impact assessment

For each product: compare the characterised excursion (magnitude, duration, cumulative history) with the manufacturer's stability data or excursion allowance. State the source document. Do not rely on MKT alone to justify exposure above a limit.

| Product / batch | Assessment | Conclusion (no impact / impact / further data required) | Assessed by |
|---|---|---|---|
| | | | |

## 5. Disposition decision

| Product / batch | Decision (release / reject / further testing / return to manufacturer) | Approved by (Responsible Person / QA) | Date |
|---|---|---|---|
| | | | |

Customers / manufacturers / authorities notified (if required): ☐ yes ☐ not required — details:

## 6. Root cause

Investigation method (5 whys, fishbone, other): ______

Root cause: ______ (distinguish symptom — "sensor drifted" — from cause — "no interim checks between calibrations").

## 7. Corrective and preventive actions (CAPA)

| # | Action | Type (corrective / preventive) | Owner | Due date | Status |
|---|---|---|---|---|---|
| 1 | | | | | |

Review of alarm limits, delays and monitoring positions triggered by this event: ☐ yes ☐ no — reference:

## 8. Effectiveness check

Method and date: ______ · Result: ______

## 9. Closure

| Role | Name | Signature | Date |
|---|---|---|---|
| Investigator | | | |
| Responsible Person / QA | | | |

Trend reference (site excursion log entry): ______