The analyst is primarily responsible for conducting out-of-specification investigations and ensuring accurate laboratory test results. They should be aware of the potential problems likey to occur when conducting the tests and be alert at the time of testing to identify the problems responsible for the out-of-specification results.
CGMP 211.160(b)(4) holds the analyst responsible for ensuring that the instruments used for out-of-specifications meet the established specifications. It requires the analyst to use only properly calibrated instruments.