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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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NCEs of External Origin

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.
*Food and Drug Administration. Code of Federal Regulations Title 21, part 820 Quality System Regulation, subpart A General Provisions, section 820.3 Definitions. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.3. Accessed April 13, 2017.