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Temperature Mapping

Temperature mapping report: a worked example

A complete mapping report for a 2–8 °C cold room, with the actual numbers: per-sensor statistics, hot and cold spots, an excursion, data-quality findings and the acceptance decision. Demo data throughout.

ValiTrac AI editorialUpdated 2026-09-137 min read

Demo data. Every value below is fabricated to illustrate the structure of a mapping report. It is not a real study, describes no real facility, and must not be presented as evidence for any space.

Most guidance tells you what sections a mapping report should have. This one shows the sections filled in, because the difficulty is never the table of contents — it is knowing how much detail each number needs, and what to do when a position fails. The study below is a 2–8 °C cold room, mapped loaded, over three days.

1. Study information

Study identification (demo data)
FieldEntry
Report numberMAP-REP-0042, version 1.0
Protocol referenceMAP-PROT-0042 v2, approved 2 March
AreaCold room CR-2, 46 m³, set point 5.0 °C
Storage condition2.0 °C to 8.0 °C (inclusive)
Loading conditionLoaded — 71 % of pallet positions occupied, representative of routine stock
Study period11 March 08:15 to 14 March 08:15 (72 h)
Season / ambientLate winter; external 4–11 °C, plant room 19–23 °C
Study identification (demo data)

2. Dataset and calibration

Dataset summary (demo data)
ItemValue
Loggers12 × single-channel, 0.01 °C resolution
CalibrationAccredited laboratory, certificate CAL-24-7781, points 0.0 / 5.0 / 10.0 °C
Reported uncertaintyU = 0.30 °C (k = 2) at 5.0 °C
Post-study verificationAll 12 within 0.05 °C of the pre-study ice-point check
Sampling interval5 minutes, identical on every logger
Records864 per logger, 10 368 total
Unit°C, confirmed in the logger configuration and the export header
Time zoneUTC+00:00, no daylight-saving transition in the period
Dataset summary (demo data)

3. Data quality

Checks are run before any statistic is computed, and every finding gets a decision rather than a shrug.

Data-quality findings and decisions (demo data)
FindingDetailDecision
GapS09, 25 minutes (5 readings) during the 12 March downloadAccepted with limitation — outside the excursion window; noted in section 8
Duplicate timestampsNone
FlatlinesNone beyond 3 consecutive identical readings, within resolutionAccepted
Abnormal jumpsS04, one 1.8 °C step at 11 March 14:02Retained — coincides with the logged door opening, physically plausible
Out-of-range readingsNone outside the calibrated 0–10 °C spanAccepted
ScopeS12 is the external ambient referenceExcluded from acceptance by design, per protocol §5
Data-quality findings and decisions (demo data)

4. Configuration used for the analysis

  • Limits: 2.0 °C to 8.0 °C inclusive, applied to all in-scope sensors for the whole study.
  • Excursion: any reading outside the limits, with duration reported; no permitted grace period was claimed.
  • Hot spot: highest per-sensor maximum, confirmed against the highest mean. Cold spot: the mirror of that.
  • Decision rule: a position is accepted only if its extreme plus the expanded uncertainty stays inside the limits (guard band w = U = 0.30 °C), per ILAC-G8.
  • In scope: S01–S11. Out of scope: S12 (ambient reference).

5. Results

Per-sensor statistics over 72 hours (demo data)
SensorLocationMinMaxMeanSDFinding
S01Rack A, top, front4.27.15.60.52Within limits
S02Rack A, bottom, beside door3.16.24.60.61Cold spot
S03Rack A, mid, rear4.56.45.30.38Within limits
S04Rack B, top, front4.77.45.90.57Within limits
S05Rack B, mid4.46.95.50.41Within limits
S06Rack B, bottom, rear3.66.04.90.44Within limits
S07Rack C, top, below light fitting5.08.46.30.68Hot spot · excursion
S08Rack C, mid4.67.25.70.49Within limits
S09Rack C, bottom4.16.55.20.45Within limits · 25 min gap
S10In front of the evaporator outlet2.95.84.30.66Coldest air, no product stored
S11Geometric centre4.66.75.40.40Within limits
S12External ambient (reference)4.011.27.81.90Out of scope
Per-sensor statistics over 72 hours (demo data)

Study-wide, across the eleven in-scope sensors: minimum 2.9 °C, maximum 8.4 °C, mean 5.3 °C. Quoting only that summary would hide both of the findings that matter, which is why the per-sensor table comes first.

6. Hot and cold spots

Extremes by the pre-defined criterion (demo data)
SensorLocationValueConfirmed by mean?
Hot spotS07Rack C, top, below light fitting8.4Yes — also the highest mean at 6.3 °C
Cold spotS10Evaporator outlet2.9Yes — also the lowest mean at 4.3 °C
Coldest product positionS02Rack A, bottom, beside door3.1Yes — lowest mean of the product positions
Extremes by the pre-defined criterion (demo data)

S10 sits in the evaporator air stream where no product is stored, so it is reported as the coldest air but S02 is the position that governs the cold end for product. Both are stated; collapsing them into one number is how a report becomes misleading.

7. Excursions

Readings outside 2.0–8.0 °C (demo data)
#SensorStartDurationPeakEvent
1S0712 March 10:4014 min8.4Goods-in delivery; door held open 9 min (event log ref EL-118)
Readings outside 2.0–8.0 °C (demo data)

One excursion, at the hot spot, during a logged delivery. No excursion occurred at the cold end: S10's 2.9 °C minimum is inside the limit, and with the guard band applied it remains inside.

8. Acceptance decision

The acceptance criterion is applied with the decision rule from section 4, not to the bare statistics. With U = 0.30 °C and a guard band of w = U, the internal acceptance band is 2.30 °C to 7.70 °C.

Acceptance evaluation at the extremes (demo data)
PositionExtremeWith uncertaintyAgainst 2.0–8.0 °C
S07 (hot)8.408.70Outside the limit even before the guard band — fail
S02 (cold, product)3.102.80Inside the acceptance band — pass
S10 (cold, air)2.902.60Inside the acceptance band — pass
All other in-scope≤ 7.40 / ≥ 3.60≤ 7.70 / ≥ 3.30Inside the acceptance band — pass
Acceptance evaluation at the extremes (demo data)

Outcome: the study does not meet its acceptance criteria. Ten of eleven in-scope positions pass; S07 fails. A report that buried this in a summary paragraph would be the problem, not the excursion.

9. Limitations

  • Late-winter ambient only. The behaviour of S07 under summer ambient is not demonstrated, and the light fitting's contribution would be expected to compound with a warmer plant room.
  • One loading configuration, at 71 % occupancy. Full occupancy was not tested.
  • S09 has a 25-minute gap; its statistics rest on 859 of 864 readings.
  • No power-failure challenge was run; recovery behaviour after a supply interruption is unknown.
  • Three days captures two deliveries and six defrost cycles — enough for routine behaviour, not for rare events.

10. Findings and recommendations

  • Exclude the top level of Rack C from product storage until remediated, and mark it physically.
  • Relocate or shield the light fitting above S07, then re-map that position; a targeted re-map is proportionate because the cause is identified and local.
  • Place routine monitoring at S07 (hot) and S02 (coldest product position), not at the control probe.
  • Set the monitoring alert at 7.5 °C and the alarm at 8.0 °C, so the alert gives time to act before the product limit is reached.
  • Review door discipline at goods-in: a 9-minute opening caused the only excursion in the study.
  • Re-map on change of racking, HVAC or use, and at the next periodic review in 24 months.

11. Review and approval

Approval block (demo data)
RoleDecision
AuthorIssued for technical review
Technical reviewerReviewed — agrees the S07 failure and the targeted re-map
Quality approvalApproved with the exclusion of Rack C top level pending re-map
Approval block (demo data)

Until all three are signed, the report stays marked draft and not technically approved. That status is part of the record, not a formality.

How to use this

Take the structure, not the numbers. The blank version of this report is available as a template, and the checklist covers what to settle before the loggers go in. If you have your own logger export, the MKT and excursion calculator will compute the statistics section for you in the browser.

Frequently asked questions

What does a temperature mapping report look like?
It is a standalone technical record: study identification, dataset and calibration evidence, data-quality findings, the analysis configuration, per-sensor statistics, hot and cold spots, excursions with durations, the acceptance decision, limitations, recommendations and signed approvals. The worked example above shows each section filled in.
Should a mapping report show the raw per-sensor data?
It should show per-sensor statistics and reference the raw export, which is retained unchanged as the original record. Printing 10 000 readings helps nobody; hiding which sensor produced which extreme helps nobody either.
What happens if one position fails the acceptance criteria?
The report says so plainly. The usual outcomes are excluding that position from storage, remediating the cause and re-mapping it, or assessing the affected product specifically — each recorded with its rationale and approved. A failure handled openly is a working quality system; a failure smoothed over is a finding waiting to happen.
Does measurement uncertainty have to be in the acceptance decision?
The product limits do not move, but the decision rule states how uncertainty is treated when a reading sits near a limit. The example applies a guard band equal to the expanded uncertainty, so a position is accepted only if its extreme plus U stays inside the limits.
How long should a mapping report be?
Long enough that someone who was not present can follow it, and no longer. The example above is a complete report for a single room; the per-sensor table and the excursion list do most of the work.

References

  1. [1]WHO Technical Supplement 8 to TRS 961 Annex 9: Temperature mapping of storage areas (2015)
  2. [2]EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
  3. [3]ILAC-G8:09/2019 — Guidelines on Decision Rules and Statements of Conformity

General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.

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