About Non Conformance

A non-conformance 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). Each non-conformance can be related to multiple defects.

A defect for a non-conformance is created in Unit Operations, Work Queue, and/or Receiving Inspection. It then appears in Non Conformance, where you can perform the following tasks:
  • Access the defects associated with a non-conformance.
  • Create a disposition plan.
  • Dispose defects.
  • Maintain a record of non-conformances and corrective actions taken to address them.
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.