Equipment and temperature
Equipment and temperature under control, with a history for each piece of equipment.
Refrigerators, freezers, water baths and incubators with an acceptable range and calibrated thermometers; maintenance and calibrations recorded with attachments; and control frequency checked on a grid.
- Daily round with out-of-range readings highlighted
- Thermometers with certificate and expiry date
- Interventions with date, description and attachments
In the laboratory routine
Care for the result starts before the analyzer
Storage conditions, maintenance and calibration affect reagents, controls and samples. Brazil's RDC 978/2025 requires these conditions and interventions to be recorded, and the records must be accessible during audits and inspections.
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The challenge
Temperature readings on paper
Paper forms require transcription to calculate compliance for the period and keep little context about what happened.
In QualiChart
Each reading is recorded with date, time and the person responsible. Out-of-range values are highlighted before saving and count toward the conformity rate for the period.
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The challenge
Thermometers and calibrations about to expire
A reading is only meaningful with a calibrated thermometer, and tracking the expiry dates of several certificates takes organization.
In QualiChart
Each piece of equipment stores its thermometers with certificate number, calibration date and expiry date, which also appear in the temperature report.
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The challenge
Maintenance kept apart from control
Corrective maintenance may explain a deviation in IQC, but the record is often kept in another system.
In QualiChart
Interventions stay with the equipment, with date, description and attachments, and the equipment dashboard gathers errors for the period, maintenance dates and the Pareto chart.
How it works
From setup to the daily round
Register the temperature-controlled equipment
Type, location and acceptable range, such as 2 to 8 °C for a refrigerator, with the calibrated thermometers.
Do the round
Record the current temperature of each piece of equipment or of all of them at once, noting defrosting and cleaning when they occur.
Document the excursion
An out-of-range reading receives a note on the occurrence and the intervention; the following readings show the return to the range.
Record maintenance and calibrations
Interventions with date, description and attached certificates or work orders, and the 30-day grid to check whether each control was performed.
Capabilities
Caution continues outside the analyzer.
Track refrigerators and other equipment with defined limits, measurement history and records of who took each reading.
- Equipment panelErrors in the period, maintenance dates, high-CV percentage and Pareto chart.
- InterventionsMaintenance and calibrations with date, description and attachments.
- Entry auditA 30-day grid to check that every control was run.
- Temperature with calibrated thermometersRefrigerators, freezers, water baths and incubators, with the thermometer certificate and due date.
- Daily rounds and excursionsOut-of-range readings highlighted, with the event and intervention recorded.
Requirements and good practice
What regulations require of equipment
- RDC 978/2025 · Art. 96
Equipment operating at a controlled temperature must have, at a minimum, measurements recording the maximum, minimum and current temperature.
Read the source - RDC 978/2025 · Art. 95
The storage of in vitro diagnostic products and biological material must ensure their preservation, even in the event of a power failure.
Read the source - RDC 978/2025 · Arts. 92 and 93
Preventive and corrective maintenance must be recorded according to the instructions for use, as must the equipment's measurements and verifications.
Read the source - ISO 15189:2022 · 6.3 and 6.4
Environmental conditions must be monitored when they influence results, and equipment must be maintained, verified and recorded.
Read the source
Each temperature record stores the current reading, with the equipment's range in force. If the procedure also requires the maximum and minimum for the period, keep that record according to the thermometer used.
Which equipment can I monitor?
Refrigerators, freezers, water baths, dry block heaters, incubators and the room itself, each with its own acceptable range.
How are readings recorded?
The team records the current temperature on the equipment panel or in the round, which shows one row per piece of equipment. Each reading identifies the date, time and person responsible.
How do I check that controls are being performed?
The entry audit shows, for each instrument, a grid of the last 30 days with how many runs were recorded per analyte on each day.
Is the temperature report suitable for inspections?
The report includes the equipment and its range, the thermometers with certificate and expiry date, the statistics for the period and every record with date, time, person responsible and status.
Further reading
Related content
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