Hi,

Chapter H Rev V page 8-9 of 10

The purpose when to use deviation is stated, however, it doesn't say anything about when to expire a deviation? What is the industry standard on when to expire a deviation? Can we use deviation if we deviate on the process?

Thanks for any response,
Eve

Hi Eve,

I am not aware of any standard on expiration of deviations.
In the CMII standard deviations should never exist. With our fast and efficient CMII change process documents should always be revised before used and always contain the "correct" information - so no need for deviations (planned non-conformance).

Waivers can occur but should be rare.

Guido