1.0 PURPOSE :
The purpose of SOP is to specify the guidelines which deals with the situations when the equipment’s calibrations are found to be out of order in the Maintenance Department.
2.0 SCOPE:
This SOP describes in detail the method to deal with out of calibration situations while calibrating the equipment in Maintenance Department.
3.0 RESPONSIBILITY:
The responsibility to deal with situations when the calibrations are found to be out of order lies with the staff of rank not lower than Engineer of Maintenance Department.
The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager - Maintenance, Head of Production and Head of QAD respectively.
4.0 METHOD:
4.1 Calibration of the equipment’s shall be carried out as per the schedule.
4.2 During calibration, if any of the equipment is found out of order, record the same in the calibration format.
4.3 The equipment shall be repaired and re calibrated for its suitability. As an alternative, till this equipment is repaired, if other equipment is available this also can be used for investigation purpose.
4.4 Intimation shall be given to QA department for further investigation through Inter office correspondence.
4.5 QA reviews the batch analysis data on the batches taken in the equipment when it was observed to be out of calibration and a report shall be submitted with conclusions and recommendations if any.
5.0 RECORDING:
The responsibility of recording the details in the format lies with the staff of rank not lower than the Chargeman of Maintenance department.
Equipment, calibrations, engineering, guidelines