Another obvious identification comes from a complaint from your clients/providers. These occurrences will almost always initiate the corrective action process.
So what exactly constitutes a “complaint?” According to the FDA, "any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, reliability, safety, or effectiveness of a product or service after it is released for distribution."*
This is an example of an external source of quality data. It is information the laboratory obtains from outside of the organization or department.
