SOP for Out of Calibration of Laboratory Instruments

Objective

To provide a written procedure for the action to be taken in the event of an Out of Calibration of Laboratory Instruments.

Scope

This standard operating procedure covers all the QC instruments

Responsibility

QC Officer/ QC Executive: Calibrate the instruments as per the calibration procedure.

QC Manager: Rectify the problem.

QA Manager: Review the records and govern the document.

Definition

The instrument shall be considered out of calibration if the data generated by it falls out of the range specified.

Procedure

The following actions should be taken in the event of the out-of-calibration (OOC) status of instruments.

• The person who has observed the instrument out of calibration shall immediately report the same to the Head of the department.
• An analysis shall be performed in the presence of the Head of a department to check whether the instrument is out of calibration and the same shall be reported to the QA personnel / QA Head.

ALSO READ: Checklist for OOS Investigations in Pharmaceutical Industry

• A status label 'OUT OF CALIBRATION' shall be affixed if the instrument is found out of calibration.
• Inform an internal expert to carry out in-house rectification of the instrument.
• The Head of the department shall initiate the internal calibration procedure in the presence of authorized QA personnel as per the calibration procedure mentioned in the respective SOP/user manual of the instrument.
• If the internal expert can rectify the defect, then use the instrument after proper calibration.
• If the internal calibration procedure fails due to some defect/damage in the instrument, authorized technical personnel shall be called for repair and external calibration.
• Once the said instrument is repaired then carry out internal calibration and ensure that it is working satisfactorily.
• In case an internal expert is unable to rectify the defect, call the supplier/manufacturer of the instrument.
• If the external expert performs the servicing satisfactorily, Once the said instrument is repaired then carry out calibration and ensure that it is working satisfactorily.
• In case an instrument is found out of calibration then the results of the previous calibration are reviewed.

• If the external expert fails to rectify the instrument, affix a status label ' OUT OF ORDER'.
• Arrange to replace the instrument in case an instrument is found out of calibration then the results of the previous calibration are reviewed.

Annexure

Annexure-1: Record for the out-of-calibration of instruments

Annexure-2: Instrument out of calibration labels

Abbreviations

SOP- Standard Operating Procedure

QAD- Department of Quality Assurance

Revision History

Nil

ALSO READ: Out of Specification & Out of Trend Investigations