Procedures describing the calibration of instruments and apparatus are deficiently written or followed.
Related FDA483/Warning Letter
b) The two calibration points evaluated were 0 C and 100 C, thus there was no challenge to the actual range of operation which were mentioned to be [redacted] C to [redacted] C.
http://www.fda.gov/
Options
Select calibration points ±10 degrees of operational set point
Or
Use a 3 point calibration strategy to show linearity
Quick poll questions
How many are using a process similar to ±10 degrees ?
How many are using a 3 point calibration process?
Are the results statistically checked for linearity ?
How many use a stated range (23 to 27 C)
How many use a stated temperature (25C ±2 degrees)
Related FDA483/Warning Letter
In addition, I observed another [redacted] that is connected to your [redacted] with (A) no tag or sticker to indicate its calibration status.
http://www.fda.gov
b) A calibration certificate was provided showing that the thermometers used within the laboratory refrigerators were calibrated at the established interval, but that the (B) vendor neglected to re-label it.
http://www.fda.gov
IF IT’S NOT DOCUMENTED IT’S NOT DONE
- Equipment owner is responsible for the tagging of equipment. A post work visual review should be done.
- Walk around should be done before the vendor leaves.
Your expecting Quality Work to be performed by your vendor to support your Quality Product.