About Non-Conformance

A Non-Conformance (NC) occurs when a serial/lot contains a defect (that is, it does not meet the specification or requirement of a process, system, internal policies and procedures, customer requirements, or regulatory body).

A defect is always associated with a single non-conformance record. One or more defects may be associated with the same non-conformance when created at the same time, such as logging defects on multiple material lots or due to failed variable specifications.

While a defect may be logged from multiple applications, the disposition process is performed in the Non-Conformance application. You can perform the following actions in the Non-Conformance application.
  • Access the defects associated with a non-conformance using the search functionality
  • Initiate and submit dispositions
  • Edit defects
  • View defect traceability and history
  • Manage defect plans.
Note:
After a non-conformance is created, the associated serial/lot and operation are placed on hold, and the operators working on that serial/lot are clocked off by default. However, this behavior can be changed to keep the operator clocked on.