Charles Wathen
Involved - Posts
Hi everyone - great to be back.
We recently went through an internal equipment audit, and our auditor did not like the fact that we perform all of our calibrations before the end of the month. We do not use exact dates. The problem the auditor brought up was that we did not have verbiage in our DOP that says it's okay to exceed the calibration date by ~30 days.
For example, if we calibrate on 5/1/2016, with an interval of 6 months, the next due date for us would be November 2016; however, if we calibrate it on 11/30/2016, it would be ~30 days after we first calibrated the instrument. We've been doing this for 30 years, and it never came up until now in an internal audit.
The auditor wants us to place some verbiage in our DOP that says it's okay to exceed the calibration date. I'm not really sure what kind of verbiage I need to state. We do perform a bi-annual review of all of our calibration intervals, where we make increases or decreases. We've been doing this for 10+ years. We also have a system in place that any instrument with 3 out of tolerances in a row goes to a CAPA for investigation. We review this each month.
Anyone have recommendations on the verbiage? I've done some searches on the net, and one stated:
We recently went through an internal equipment audit, and our auditor did not like the fact that we perform all of our calibrations before the end of the month. We do not use exact dates. The problem the auditor brought up was that we did not have verbiage in our DOP that says it's okay to exceed the calibration date by ~30 days.
For example, if we calibrate on 5/1/2016, with an interval of 6 months, the next due date for us would be November 2016; however, if we calibrate it on 11/30/2016, it would be ~30 days after we first calibrated the instrument. We've been doing this for 30 years, and it never came up until now in an internal audit.
The auditor wants us to place some verbiage in our DOP that says it's okay to exceed the calibration date. I'm not really sure what kind of verbiage I need to state. We do perform a bi-annual review of all of our calibration intervals, where we make increases or decreases. We've been doing this for 10+ years. We also have a system in place that any instrument with 3 out of tolerances in a row goes to a CAPA for investigation. We review this each month.
Anyone have recommendations on the verbiage? I've done some searches on the net, and one stated:
But realistically, due dates are put there for the convenience of auditors. If you have been performing periodic surveillance of your equipment with formal or even informal spot checks, you know very well if it is functioning within your requirements. Calibration intervals should be assigned by valid statistical methods and the increased risk of using an item a few days past its due date is extremely low if you have done your job and assigned a realistic interval.