Expert: Michael Anisfeld - 12/30/2007

Question
HOW i can i address failure in analytical instruments calibration failure

Answer
If an analytical instrument fails its calibration (is out-of-tolerance), then you need to do the following:

FROM NOW INTO THE FUTURE:
a. recalibrate and correct the instrument;
b. shorten the time period to the next recalibration (if it was every 12 months make it every 3 or 6 months).

FROM NOW BACK INTO THE PAST:
c. calculate by what percentage the instrument was out of tolerance (for example 1.3%);
d. go back in time to when the last acceptable calibration occurred on the instrument, and then find out which product/materials have been testing, between then and now, on the instrument;
e. recalculate all test results between then and now, incorporating the 1.3% out-of-tolerance factor;
f. If any tests are now recalculated as Out-Of-Specification (OOS), you need to make a decision as to whether to recall the product, or ........?????