TOP-10 Observation related to calibration
- Calibration
work sheets/Annexure are missing
- No
formal procedure for out of calibration and change management.
- Calibrations
not done as per schedule.
- Documented
calibration / inspection records are not updated.
- In
many calibration manual error calculations were noticed.
- Several
Hand written reports were not readable and insufficient.
- Calibration
procedures do not include specific directions and limits for accuracy and
precision or provisions for remedial action.
- Routine
calibration of equipment is not performed by following necessary documented
procedures.
- Methodology
describing the calibration of instruments, is not being followed.
- Deviations
in calibrations not being reported or closed within per time frame.
- Laboratory
documents are not having important information and records
- Master
calibration Traceibility Record not available
- Vendor
Audit record not available.
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