Use of Remarks Section
There are several reasons for using the Remarks feature in the inspection software.
Limitations of the Inspection Software
The inspection software used for conducting MQSA inspections has limitations, in that the numbers or YES/NO answers that are entered do not always tell a complete story for the inspection. In many cases, important details about facility conditions will be missed, unless the inspector uses the Remarks to record this useful information. For example, if an interpreting physician or radiologic technologist failed to meet a specific initial training requirement, the amount of training they actually obtained may be important when the facility responds to the finding. If an interpreting physician had one month of training in mammography and another had no training in mammography, the amount of training that is needed for these physicians is qualify is different. Also, the degree to which each failed to meet the requirement is different. In the area of quality control (QC) testing, the software only records the worst month for lack processor QC data. If ten months have data missing at the same level as this "worst" month, this information should be recorded in the Remarks.
Equipment - unknown models
While we try to keep the manufacturer and model tables in the inspection software up to date, inspectors may find new or unknown models of equipment. When an inspector finds that a manufacturer and/or model of an x-ray unit or film processor is present at the facility, but is not on the list in the inspection software, he or she should make sure that the manufacturer name and model number are recorded in the Remarks.
Remarks do not replace e-mail
While the information recorded in the Remarks for inspections is very useful, inspectors should not use e-mail to send important messages to FDA. There are too many inspections and too many Remarks sections in each inspection for FDA to scan all inspections looking for messages to FDA. If an inspector needs to submit an important message to FDA, then he/she should use the e-mail feature on their laptop computer.