QC process condition report showed that oven dew point was set at 90ºC, cooking time 3.4-
3.6 min throughout production lot which were not conform to process specification where
dew point is 80ºC and cooking time is 4 min without a note or comment regarding this
matter in the record. In addition, the validation of cooking parameters was done at 80ºC
dew point and 4 min cooking time which was not covered the actual parameters set in
production