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SOP FOR HANDLING OF OUT OF CALIBRATION

SOP FOR HANDLING OF OUT OF CALIBRATION

PURPOSE: To lay down a procedure for handling of out of calibration of instruments.

SCOPE: This SOP is applicable for all the instruments available.

RESPONSIBILITY

Preparation of SOP: Officer /Sr. Officer QA Department.

Checking and Review of the SOP: Officer /Executive QA Department.

Approval of the SOP: Executive QA Department.

Authorization of SOP: Head QA/ Designee

ACCOUNTABILITY: Head QA shall be accountable for the implementation and compliance of the SOP.

PROCEDURE: If the instrument is found out of calibration, then user department shall affix the label as “Out of Calibration”.

The same information for instrument out of calibration shall be given to Department Head.

User Department Head shall inform to maintenance department to carry out in- house rectification of the instrument.

Maintenance department personnel shall rectify the defect, and then use the instrument after proper calibration.

In-case maintenance department is unable to rectify the defect, then inform to services engineer / manufacturer of the instrument.

Service engineer shall investigate and rectify the problem.

After the service of the instrument, it shall be re-calibrated. If the instrument passes all the calibration parameters then following procedure shall be followed before taking the instrument for regular use: –

The service report detailing the cause of failure, an action taken and remark if any shall be attached along with calibration records of the instrument.

If the performance of the instrument after the servicing is found satisfactory, use the instrument after calibration for routine usage.

If the external party fails to rectify the instrument, affix a status label “OUT OF ORDER”.

In case the instrument is out of order, replace the old instrument and arrange a new instrument.

The handling of out of calibration of Quality Control Department shall be handled as per QC SOP.

REFERENCE:

SOP for SOP.

Handling of Out of Calibration.

Categories: Quality Assurance
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