FDA 483 Tips #4

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

  1. Equipment owner is responsible for the tagging of equipment. A post work visual review should be done.
  2. Walk around should be done before the vendor leaves.

Your expecting Quality Work to be performed by your vendor  to support your Quality Product.

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