Equipment Calibration & Maintenance

Equipment Calibration and Maintenance. The Manufacturer shall establish and maintain a preventive maintenance and calibration program for all equipment, instruments, and measuring devices used in the manufacture, testing, and storage of products. All critical instruments shall be calibrated at defined intervals using standards traceable to the National Institute of Standards and Technology (NIST) or equivalent national metrology body. Calibration records shall include the instrument identification number, calibration date, calibration results (as-found and as-left readings), acceptance criteria, next calibration due date, and the identity of the person performing the calibration. Any instrument found to be out of calibration shall trigger an investigation to assess the impact on product quality for all batches tested or manufactured since the last successful calibration. Equipment preventive maintenance shall be performed according to a documented schedule, and maintenance records shall be maintained for the life of the equipment. Equipment shall be clearly labeled with its calibration or maintenance status.