An NCE management system captures and analyzes data about actual and potential non-conformances in products or services, so that systematic problems can be identified and then corrected to improve the quality of those products/services. Often, the process is reserved for the reporting of adverse events, sentinel events, or near-misses. NCE programs can extend the QMS to address any problem with a laboratory product/service as an opportunity for improvement. A formally documented NCE program is essential for continued customer satisfaction, efficient business practices, and improved patient safety.
This course aims to explain NCE management in detail so that the reader is knowledgeable in using their organization’s NCE system, and/or to serve as a framework for implementing a new NCE management system in their laboratory.
We will begin by defining some commonly used terms.