I get audited several times a year, either internally or externally by the FDA, BSI, KEMA, etc. Recently, the FDA said that our calibration certificates need to be reviewed and signed. There is nothing in any regulation that states calibration certificates need to be reviewed 100%. I do perform a 10% monthly sample of each technician. I look for the following:
1. Following written calibration procedure for the instrument
2. Does the tech have a training record on file for the instrument he calibrated
3. Is the calibration certificate filled out correctly?
Any issues discovered are communicated directly to the technician, and I also use it as a training tool in my quarterly staff meetings with all the calibration staff. The main purpose of the record review is to assess the quality of work the technician is performing to, and also use it as a merit tool at the end of the year. The goal is to have less than 5% of paperwork related errors, and no leeway on following procedures.
So my question is: are there any docs that state this as a requirement for calibration records?
Thoughts?
1. Following written calibration procedure for the instrument
2. Does the tech have a training record on file for the instrument he calibrated
3. Is the calibration certificate filled out correctly?
Any issues discovered are communicated directly to the technician, and I also use it as a training tool in my quarterly staff meetings with all the calibration staff. The main purpose of the record review is to assess the quality of work the technician is performing to, and also use it as a merit tool at the end of the year. The goal is to have less than 5% of paperwork related errors, and no leeway on following procedures.
So my question is: are there any docs that state this as a requirement for calibration records?
Thoughts?