This is a ready-to-use summary report for a completed temperature mapping study. It closes the loop the protocol opened: results against acceptance, the worst-case positions, deviations, and the monitoring recommendation. Replace every <<FILL: ...>> placeholder with your specifics. A worked filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Report title | Temperature Mapping Study Summary |
| Report number | <<FILL: e.g. RPT-CHM-014>> |
| Parent protocol | <<FILL: protocol number and version>> |
| Unit / asset ID | <<FILL: UNIT NAME / ASSET ID>> |
| Rated condition | <<FILL: temperature +/- tolerance, RH if applicable>> |
| Study dates | <<FILL: from>> to <<FILL: to>> |
| Author | <<FILL: name, role>> |
1. Summary of activity
State what was executed, when, and to which protocol.
<<FILL: e.g. Empty (OQ) and loaded (PQ) distribution plus door-open recovery were executed on UNIT per protocol PQ-CHM-014 from DATE to DATE, using N calibrated data loggers over a 48 hour window that captured two defrost cycles.>>
2. Instrumentation and data integrity
| Field | Entry |
|---|---|
| Loggers used (count, make/model) | <<FILL>> |
| Logging interval | <<FILL>> |
| Pre-study calibration | <<FILL: certificate refs, all passed>> |
| Post-study calibration | <<FILL: certificate refs, all passed / any invalidated>> |
| Measurement uncertainty | <<FILL: +/- value; fraction of the band>> |
| Raw data retained at | <<FILL: location / record ID>> |
3. Results against acceptance criteria
| Logger | Location | Min (C) | Max (C) | Mean (C) | In band? |
|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | Yes / No | |||
<<FILL>> | <<FILL>> |
| Acceptance criterion | Result | Pass/Fail |
|---|---|---|
| All loggers within band at steady state | <<FILL>> | |
| Instantaneous spatial spread within limit | <<FILL>> | |
| Control sensor vs co-located logger | <<FILL>> | |
| Defrost transient within limit / recovery | <<FILL>> | |
| Door-open recovery | <<FILL>> | |
| MKT at or below labeled condition (if applicable) | <<FILL>> | |
| All loggers passed post-study calibration | <<FILL>> |
4. Hot spot, cold spot, and MKT
| Field | Entry |
|---|---|
| Hot spot (position, max) | <<FILL>> |
| Cold spot (position, min) | <<FILL>> |
| Empty vs loaded worst-case shift | <<FILL>> |
| MKT (if applicable) | <<FILL: value, method, Ea used>> |
5. Deviations
| Deviation # | Description | Disposition |
|---|---|---|
<<FILL or None>> | <<FILL>> | <<FILL>> |
6. Routine monitoring and alarm recommendation
| Field | Entry |
|---|---|
| Recommended monitoring probe location | <<FILL: the worst-case position>> |
| Recommended alarm setpoints | <<FILL: high / low, from the mapped envelope>> |
| Maximum door-open time (if set) | <<FILL>> |
| Load-line / usable-volume changes | <<FILL: none, or describe>> |
7. Conclusion
<<FILL: The unit meets / does not meet the acceptance criteria and is / is not qualified for routine use for RATED CONDITION, subject to the monitoring recommendation above.>>
8. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer | <<FILL>> | ||
| QA approval | <<FILL>> |
9. References
Parent protocol
<<FILL>>; thermal mapping program SOP<<FILL>>. USP General Chapter 1079 (MKT); WHO TRS temperature-mapping guidance; ICH Q1A(R2) for stability conditions.
Confirm the current version of each reference before issue.
Filled specimen
The following shows the report for an example upright freezer rated -20 degrees C +/- 5, 48 hour loaded study. The specifics are illustrative.
Results (excerpt)
| Logger | Location | Min (C) | Max (C) | Mean (C) | In band? |
|---|---|---|---|---|---|
| T1 | top front-left corner | -22.1 | -16.8 | -19.4 | Yes |
| T9 | center | -22.0 | -18.2 | -20.1 | Yes |
| T11 | inside door, mid-height | -21.0 | -15.4 | -18.3 | Yes (hot spot) |
| T12 | near coil | -24.1 | -20.6 | -22.4 | Yes (cold spot) |
Instantaneous spread reached 6.9 degrees C during a defrost transient, recovering within 14 minutes; outside defrost, spread stayed at or below 4.8 degrees C. All loggers passed post-study calibration. Uncertainty +/- 0.3 degrees C against a +/- 5 band.
Deviations: DEV-2026-0210, the 90 second door-open transient reached -14.9 degrees C, a brief excursion of the -15 band edge; dispositioned as acceptable under a defined maximum door-open time, with the top-door storage line lowered.
Monitoring recommendation: routine probe at the door zone (T11), the first-to-excurse position; alarm setpoints -25 low and -15.5 high; maximum door-open time 120 seconds.
Conclusion: the unit meets the acceptance criteria and is qualified for routine -20 degrees C +/- 5 storage, subject to the monitoring recommendation.
In this example the report ends where routine operation begins: it names the spot the live probe must watch and the alarm limits derived from the real envelope, so the qualified state and the monitored state are the same thing. A report that stops at “all points in band” and never places the probe leaves the most useful output of the study on the table.
Common inspection findings this report prevents
- A summary report with no raw-data link, so the result cannot be reconstructed.
- Hot and cold spots identified but never translated into a monitoring location.
- MKT quoted to wave away a sustained out-of-band condition.
- A door-open or defrost excursion visible in the data but absent from the conclusion.
How to adapt this report
- Set the report and parent-protocol numbers; carry the rated condition and acceptance criteria from the protocol verbatim.
- Populate the results table from the raw logger files, not a transcription.
- State MKT only where the labeled condition is defined with an MKT; for a hard-band freezer, judge against the band.
- Feed the monitoring recommendation into the unit’s monitoring configuration and requalification schedule.