A fundamental FACT requirement is that programs function as integrated operational units. This means that there must be evidence of interaction among all of the components. Evidence of this type of exchange is formally required in some of the standards. It is important to look for such interactions when you perform the inspection of your particular area. For example, is the Collection Facility interacting and sharing information with the Clinical Program and the Processing Facility? Do the personnel know how this information is communicated and where to find it?

 

This type of communication is a particularly important part of the quality management program. Is information being exchanged to ensure real or developing problems can be efficiently identified and remedied? Is the program being reviewed as a whole in addition to examination of each of its component parts? Is there evidence of ongoing meetings in the form of minutes?

 

A comparison of notes between the members of the inspection team prior to the exit interview may also help this process.