Temperature Excursion Report Generator

The duration matters as much as the magnitude: a momentary 9 °C blip and a four-hour hold at 9 °C are different events entirely, and stability budgets are written in time-at-temperature. Capture the peak, the duration above/below each limit, the cumulative exposure, the location/time and the logger that recorded it. Without duration, an excursion can't be assessed against stability — which is why 'it went out of range' is the start of the investigation, not the end.

Against documented stability data, not judgment: products carry stability budgets (allowable cumulative time outside label conditions) from their stability studies. Compare the assessed cumulative time-out-of-range to that budget; within budget supports release, beyond it supports rejection or a reduced shelf life. For repeated thermal stress, Mean Kinetic Temperature captures the effect a simple average misses. The MA holder/manufacturer holds the stability data — escalate when it's not in your hands.

MKT is a single temperature that expresses the cumulative thermal stress of a varying profile, weighting higher temperatures more heavily (via the Arrhenius relationship) than a simple average would. Use it when a shipment saw multiple or sustained fluctuations rather than one clean excursion — it answers 'what constant temperature would have done equivalent damage', which maps better to stability data than min/max alone. Our MKT calculator computes it from your readings.

Because the regulatory and business value is preventing recurrence, not just dispositioning one batch. A root cause without a corrective AND preventive action is an incomplete investigation — auditors specifically look for closed-loop CAPA, and operations that only disposition (never prevent) keep paying for the same failure. The CAPA field forces the question every excursion should answer: what changes so this lane/handler/step doesn't do this again?