This document details the procedure for the Operation and Calibration of the Refrigerator. It is the policy of XYZ Limited that the written procedure shall be followed for operation and calibration of the refrigerator and its use monitored to ensure that the instrument gives consistently accurate and reproducible results in compliance with regulatory requirements.
This procedure is to be applied at the time of Operation and Calibration of the Refrigerator.
RESPONSIBILITY
Persons along with their responsibilities are given below:
Executive — Corporate Quality Assurance:- To prepare the SOP.
Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly
Manager — Quality Control:- To ensure implementation of SOP.
Standard Operating Procedure for the Freezer
Refrigerator calibration procedure
Ensure that the instrument is clean and
free from dust.
Check the PowerPoint is ON/OFF.
Check whether the Refrigerator is locked or not.
Open the door of the Refrigerator/Freezer by using the handle provided.
Check whether the light is working or not.
Check the temperature of the Refrigerator/Freezer.
Use the provided Shelves as per your requirement.
Close the door and check the lock.
Maintain the Logbook of the Refrigerator as per Appendix III (XYZ/CQA/SOP-041/FR-03)
Record the Daily temperature of the Refrigerator as per Format for Daily Temperature Monitoring Appendix II ( XYZ/CQA/SOP-041/FR-02)
calibration (Frequency: quarterly)
Take a beaker of 100 ml capacity.
Fill the beaker with 80 ml of silicone oil.
Place the beaker containing silicon oil on the lower shelf of the refrigerator.
Dip the calibrated and certified
thermometer in the beaker containing silicon oil.
Close
the door of the refrigerator, and wait for 15 minutes to stabilize the temperature
inside the refrigerator
Observe
the temperature of a calibrated thermometer
Repeat steps for all the shelves of the refrigerator/freezer.
Record the observations on Appendix I (XYZ/CQA/SOP-041/FR-01), Calibration Record of Refrigerator
Compare the result with acceptance criteria
and take valid calibration authorization from the Section In charge.
Affix the calibration status tag on the
instrument.
Report any discrepancy observed during the calibration of the instrument to the Section In-charge or his representative for
corrective and preventive action.
The section In-charge or his representative
will take the necessary action and report the same to the Manager – Quality
Assurance.
Affix the ‘Under Maintenance’ label on the instrument.
Precautions
Take the reading when an instrument has
attained constant temperature in the chamber.
Check the Calibration of the Thermometer.
Always
place a thermometer in such a way, As not to touch the surface of the dipping bottle.
Handle
the instrument carefully.
Disconnect
the instrument at the time of cleaning of the instrument.
Download:> Logbook and Appendix I, II