# Temperature Mapping Protocol

| Field | Entry |
|---|---|
| Protocol number | MAP-PROT-____ |
| Version | 1.0 |
| Site / area | |
| Author | |
| Reviewer | |
| Approver (Quality) | |
| Effective date | |

> Template from ValiTrac AI (valitrac.com/resources/templates). Adapt under your own document control. Written against WHO Technical Supplement 8 (TRS 961 Annex 9), EU GDP chapter 3 and EU GMP Annex 15. Not a substitute for the applicable guideline or a qualified reviewer.

## 1. Purpose

State why the study is performed (initial qualification before use / re-mapping after change / periodic re-qualification) and what decision it supports.

## 2. Scope

- Storage area(s) and equipment covered (identifier, location, volume, description):
- Products / storage condition(s) in scope (e.g. 2–8 °C refrigerated; 15–25 °C controlled room temperature):
- Loading condition for this study: ☐ empty ☐ loaded (representative) ☐ simulated load (describe)
- Season / ambient condition targeted, and justification:

## 3. References

- Site SOPs (list):
- WHO TRS 961 Annex 9 and Technical Supplement 8
- EU GDP 2013/C 343/01, chapter 3 (and chapter 9 if transport)
- EU GMP Annex 15 (if GMP)
- Product storage requirements (source documents):

## 4. Responsibilities

| Role | Name | Responsibility |
|---|---|---|
| Study owner | | Protocol, execution, report |
| Facilities / engineering | | Equipment operation, event log |
| Quality | | Review and approval |
| Contractor (if any) | | Loggers, placement, data delivery |

## 5. Acceptance criteria

| Item | Criterion |
|---|---|
| Temperature limits (inclusive) | ____ °C to ____ °C at every in-scope sensor for the whole study |
| Excursion definition | Any reading outside the limits (or: > ___ consecutive minutes outside, justified by: ______) |
| Sensors in scope for acceptance | All product-position sensors; ambient/reference sensors excluded |
| Treatment of measurement uncertainty at the limit | ☐ simple acceptance ☐ guard band (w = ___) — decision rule: |
| Humidity (if applicable) | ____ %rh to ____ %rh |
| Recovery after door opening / power test (if applicable) | Return within limits within ____ minutes |
| Action on failure | ☐ exclude position(s) ☐ remediate and re-map ☐ product-specific assessment |

## 6. Sensor plan

- Number of sensors: ____ (rationale from geometry, risk points and limits; not from loggers available)
- Placement principle: product height, in air product sees; corners high/low; centre; doors; evaporators/HVAC outlets and returns; external walls; roof; top/bottom of racking; existing/intended monitoring positions
- Attach a diagram with numbered positions.

| Sensor ID | Logger serial | Location description | Height | Rationale |
|---|---|---|---|---|
| S01 | | | | |
| S02 | | | | |
| … | | | | |

## 7. Equipment and calibration

| Item | Requirement |
|---|---|
| Loggers | Calibrated by an accredited laboratory at points spanning the study range (e.g. ___, ___, ___ °C); certificates attached |
| Accepted logger uncertainty | ≤ ____ °C (k = 2) |
| Post-study check | ☐ as-found verification of ____ % of loggers against a reference |
| Clocks | Synchronised to ____ before placement; time zone: ____ (DST handled: yes/no) |
| Unit | °C confirmed in logger configuration and export |

## 8. Sampling interval and duration

- Sampling interval: ____ minutes (typically 1–5 min to resolve door events and defrost)
- Minimum duration: ____ hours (24–72 h small units; ≥ 1 week for rooms/warehouses including a weekend and delivery days)
- Start criterion: after ____ minutes of sensor equilibration
- Planned challenge tests: ☐ door open ____ s ☐ power failure ____ min ☐ defrost cycle capture

## 9. Execution and event log

Record during the study: placement verification (photos), start/stop times, door openings, deliveries, defrost cycles, HVAC events, set-point changes, ambient weather, any deviation from this protocol.

## 10. Data handling and quality checks

Before analysis, confirm: unit; monotonic timestamps, no duplicates, consistent interval; gaps per sensor with duration; flatlines; abnormal jumps; oscillation; every column mapped to a sensor ID and location. Each finding receives a decision: excluded / corrected (with record) / accepted with limitation. Raw exports retained unchanged.

## 11. Analysis method

- Per-sensor statistics: minimum, maximum, mean, standard deviation (and range)
- Hot spot: sensor with the highest ____ (maximum / mean); cold spot: lowest ____ — confirmed by the other statistic
- Excursions: sensor, start, end, duration, peak
- Acceptance evaluated per section 5, including the uncertainty treatment
- Software / method used (and its verification status):

## 12. Report contents

Study information; dataset and calibration evidence; data-quality findings and decisions; configuration; per-sensor statistics; hot and cold spots; excursions; limitations; findings and recommendations (including monitoring locations); deviations; review and approval; version history.

## 13. Re-mapping triggers

Layout or racking change; HVAC/refrigeration change or major service; change of use or storage condition; periodic review interval of ____ (risk-based); adverse monitoring trend.

## 14. Approval

| Role | Name | Signature | Date |
|---|---|---|---|
| Author | | | |
| Reviewer | | | |
| Quality approval | | | |