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Re-mapping and risk analysis

Neither Storage Rules No. 260n nor the EEC Guideline sets a fixed “every N years” interval. Mapping must be repeated based on risk analysis and assessment, and whenever changes occur. This is more flexible, but it requires the organization to document the justification for its decision.

Mandatory triggers

EventWhy the picture changesWhat to do
Layout changes, extensions, new gatesheat gains and airflows changefull mapping of the zone
Replacing, relocating or adding air conditioners, evaporators, heatingthe distribution of cold and heat changesfull mapping in the affected seasons
New racks, change in storage heightstratification and circulation changemapping with a new height grid
Relocation or replacement of temperature monitoring devicesyou must confirm that the new points reflect the riskmapping or a justification based on data from the previous study
Cold room repairs: insulation, evaporator, refrigeration unitequipment characteristics change24–72 h study with tests

Triggers from monitoring results

The EEC Guideline considers re-mapping appropriate if monitoring reveals excursions beyond the operating ranges whose causes have not been identified. Signals to watch for in the monthly data review:

  • recurring alarms at the same point at the same time of day;
  • drift of a monitoring point’s mean temperature from season to season;
  • increasing amplitude of daily fluctuations;
  • longer recovery time of a cold room after the door is opened;
  • complaints about product condition with no obvious cause.

According to the EEC Guideline, changing refrigeration equipment settings within the storage range does not require re-mapping. For example, changing a cold room setpoint from +5 °C to +4.5 °C with a +2…+8 °C range.

Risk analysis: a simple matrix

Score each zone on five factors from 1 to 3 points, add up the scores, and use the total to set the frequency of scheduled reviews.

Factor1 point2 points3 points
Margin to limits in the last mappingmore than 2 °C1–2 °Cless than 1 °C
Dependence on the external environmentroom inside a buildinginsulated warehouseborders the outside, loading dock, roof
Deviations over the past yearnoneisolated, with known causerecurring or unexplained
Changes in warehouse operationsnonehigher throughputnew processes, 24/7 operation
Product sensitivitystable productstemperature-sensitivevaccines, biologics, high value
An example approach that an organization can set out in its SOP. It is not a legal requirement.
Total scoreRisk levelGuideline for scheduled re-mapping
5–7lowupon changes and deviations; annual review of monitoring data
8–11mediumscheduled study in the critical season every 2–3 years
12–15highannually in the critical season, or after every season with deviations

Seasonal studies

For the initial mapping of a warehouse, the EEC Guideline recommends at least two studies: in summer and in winter. For re-mapping, it is sufficient to repeat the season in which the initial study and monitoring data show the smaller margin to the limits. A retained placement layout with numbered points makes results from different years comparable.

How to document the decision

  1. Annual review

    Summary of monitoring data, deviations, and changes to premises and equipment.

  2. Risk assessment

    Scores for each zone and a conclusion on whether mapping is needed.

  3. Decision

    An approved plan: which zones, in which season, to what extent.

  4. Execution and comparison

    A report comparing the results with previous ones and updating the monitoring points.

Frequently asked questions

How often should a warehouse be mapped?

The law sets no fixed frequency. Mapping is repeated based on risk analysis and assessment, and whenever the building or equipment changes. Many organizations set scheduled re-mapping every 1–3 years depending on the risk.

Is mapping needed after cold room repairs?

Yes, if the repair affected the insulation, evaporator, refrigeration unit or structure: the equipment characteristics change, and previous results no longer serve as evidence.

Do both seasons need to be repeated?

As a rule, it is enough to repeat the critical season, the one in which past data show the smaller margin to the limits.

What counts as a deviation with no identified cause?

An excursion beyond the operating limits that cannot be explained by door openings, equipment failure, a power outage or another documented cause.

Need mapping or qualification? Send us your floor plan — we will calculate the number of points and the timeline.

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