SOP -1.5.4b THERMOMETER VERIFICATION RECORD

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Temperature Probe Calibration / Verification Procedure<br>Frequency of calibration / verification:

All temperature probes have a Calibration Certificate against National Standards when purchased. Calibration Certificates will be kept by the Technical and Compliance Manager.
Each temperature probe will be internally verified on a weekly basis by trained Technical assistant/ QA personnel using a temperature water bath with cold water (water must be stored in a fridge at max. Temperature 5°C), to ensure accuracy in the range of operation.
1. LOW TEMPERATURE CHECK – ICED WATER/IW (-1oC to. 1oC)
Place tip of thermometer(s) probe into crushed ice mixed with cold water - leave for few minutes and then record reading (when stable for 3sec). Sequence: Dip both the master thermometer and test thermometer(hand held) together at the same time, record the readings at the same time and compare.
2. HIGH TEMPERATURE CHECK – BOILING WATER/BW (99oC to 101oC)
Place tip of thermometer(s) probe into boiling water from a kettle and record reading (when stable for 3sec). Sequence: Dip both the master thermometer and test thermometer(hand held) together at the same time, record the readings at the same time and compare. Critical Limits: The reading of a thermometer and the master probe not to be more than 0.5oC
Corrective action: If the reading differs more than ±0.5oC from master probe reading, then remove & replace faulty thermometer. Notify Manager

Water baths will be externally calibrated to a National Standards on an annually basis. The Technical and Compliance Manager is responsible for organizing it and keeping records of the Calibration Certificates.
Methods of calibration / verification:
A temperature probe is issued to each member of staff working in Quality Assurance/ Control daily - factory. The Manager issues to all QA equipment and maintains a Master List detailing the Identification Number / Code of the temperature probe unit.
Individual staff members are not responsible or authorised to adjust the equipment. Only the T/C Manager may repair or adjust the equipment. The user may only use the temperature probes in a manner fit for its purpose.
To verify the temperature probe with the Water Bath (by QA personnel):

- Half fill the bath with ice cubes and clean cold water. Leave it to cool down for approximately five minutes.
- Insert the temperature probe into the holes provided in the bath cover.
- Plug in the water bath and allow a few minutes for the bath temperature to stabilise. (Please note that if you leave it too long the water temperature will start to warm up to reach the ambient temperature).
- Switch on the temperature probe and compare the reading from your probe against the displayed reading on the water bath.
- Record the reading
- Records of all temperature probes readings for the previous week will be signed by relevant department supervisor on a weekly basis.

To Calibrate the Water Bath:
- Once a year the water bath needs to be sent to a certified laboratory to be calibrated against National Standards.
- Calibration Certificates will be kept by the QA Manager.

Acceptable Equipment Tolerances:
Each type of temperature probe used for checking temperatures has an accuracy range:
Type: Accuracy:
-SuperFast Thermapen 5 ±0.5°C

Corrective Actions to be taken if outside tolerance:
In the event that a temperature probe reads outside the acceptable tolerances (see before), must be reported immediately to the Technical Manager. The Temperature Probe will be sent to be re-calibrated externally or will be replaced by a new one.
It is the responsibility of each member of staff to maintain the condition of the unit and to report to the Technical Manager if it is faulty or fails its calibration.
A record will be kept of each unit’s maintenance. If a temperature probe is repaired or disposed of it will be recorded in the QA Equipment Repair Register

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