1. Non-conformance (Minor or Major)
Breakdown, or partial breakdown of a process in the Quality Management System(QMS)
An audit non-conformance typically requires:
-Root cause analysis
-Root cause elimination
-Change to how the process is to be performed
Requires Corrective Action Request to document action taken.
Minor deviation from an otherwise well-implemented process.
Minor oversight on the part of the auditee.
Root cause analysis is not often required for observations.
Observations may be recorded on an Audit Action List.
Observation may be treated as a minor non-conformance when multiple similar nature of observations were detected on Audit Action Item List.
3. Opportunity for Improvement (OFI)
OFI is a finding based on facts and data that shows a potential improvement opportunity.
Action is not required for an OFI.
Can anyone point me to a source for these or are these just industry standard definitions? Does anyone have any recommendations for better terminology to use?
Thanks for any input.