PROTOCOLREFERENCE OUTLINE

Temperature Mapping Protocol

Mapping protocol that finds where a storage area is actually out of range: mapped loaded in the real pattern, sensors placed to find extremes rather than confirm the middle, duration covering real cycles and working activity, seasonal extremes and failure modes challenged, and permanent monitoring placed at the extremes the study found rather than where cabling is convenient. Maps to WHO TRS 1025 Annex 7 and USP <1079>.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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HOW TO FILL THIS IN
How to Map a Temperature-Controlled Storage Area, step by step →
REGULATIONS MAPPED
WHO TRS 1025, Annex 7USP <1079>
DOCUMENT TYPE
Protocol
LAST UPDATED
August 2026
PURPOSE

Mapping establishes the real distribution of temperature across a storage area under the conditions it actually operates in, so permanent sensors can be placed where an excursion will be detected. A store monitored at one convenient point is monitored at the place nobody needed to know about. Where the extremes are is a finding; where you then place the sensors is your determination.

What's Inside

✓Area description, loading pattern and the operating conditions under test, stated as they really are
✓Sensor placement with a written rationale per position, targeting suspected extremes rather than convenient mounting points
✓Duration, logging interval and the number of full operating cycles the study is required to capture
✓Seasonal extremes and failure modes challenged, including door opening, power loss and defrost cycles
✓Acceptance criteria stated before the run, including what constitutes an excursion for this particular area
✓Outcome mapped to permanent sensor positions and alarm setpoints, with the reasoning preserved for later review
✓Re-mapping triggers covering changes to layout, load, equipment, air handling and the building envelope

How to Use It

1Map the area loaded in the pattern product actually sits in; airflow in an empty room is not airflow around pallets
2Place study sensors to find extremes — doors, air outlets, floor and top rack, corners, external walls
3Run the study through real working activity, because a mapping over a quiet period captures only the easiest conditions
4Cover the seasonal extreme the area will actually experience, or repeat the study in the opposing season before concluding
5Place permanent monitoring at the extremes the mapping found, not where cabling and access happen to be convenient
6Define the re-mapping triggers now, since racking moved after the study silently invalidates the sensor positions it justified
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Area, Loading and Conditions
2Sensor Placement
3Duration and Cycles
4Seasonal Extremes and Failure Modes
5Outcome and Permanent Monitoring
6Re-Mapping Triggers
REGULATORY CONTEXT

WHO TRS 1025 Annex 7 sets the good storage and distribution practice expectations for temperature-controlled areas, including mapping before use and the placement of monitoring devices, and USP <1079> addresses monitoring of storage and distribution environments. Neither prescribes how many sensors your area needs, how long the study runs, or which season is worst case for your building — those determinations are yours, and this protocol asks you to record their rationale.

MAPPED STANDARDS
WHO TRS 1025, Annex 7USP <1079>
Browse the standards catalog →

WHERE NEXT

  1. FILL IT INHow to Map a Temperature-Controlled Storage Area →The procedure this template records, one step at a time.
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