11- Calibration Audit Questions to be answered by GLP Laboratories.
Below is some of the actual audit questions gathered, most of it was taken from a vendor audit checklist.
- Does your organization have documentary evidence such as SOP for calibrations for every equipment in the laboratory?
- Does your organization has the following list: Including but not limited to
(a) Equipment master list
(b) Master Calibration schedule
(c) Frequency and time schedule for calibration of every equipment
(d) History Record/Maintenance Records managed and updated.
3. Updated Calibration record/report along with Old records of every equipment under use.
4. Is the calibration conducted under the prescribed environmental conditions?
5. Is the staff worker who is involved in the calibration been completely trained.
6. Is equipment re-calibrated at pre-determined intervals, following company SOPs.
7. Does the management follow 21cfr part11 compliance while conducting calibration?
8. What is labeling procedures for equipments which fail the calibration?
9. Does the reference standards or reference materials and other accessories used for calibrations appropriately stored, monitored and traceable to updated International standards?
10. Does your company have procedure to estimate the quality impact on the results if the equipment is found to be out of calibration?
11. Does your company have Out of Calibration SOPs, and clearly defined methodology to deal with such situations? (updated on 27.09.2020)