Once all the audit data has been gathered accordingly, auditor will need to analyze and determine the data, to be classified in which category of audit finding. In general, there are 3 types of Audit Findings. They are: Non-conformance, Observation and Opportunity For Improvement a.k.a. (OFI).
In this article, we will teach you how to classify audit finding and show you the definition of each audit findings quickly. You will also find how to write effective Corrective Action Requests (CARs) in the coming article.
- 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.
- This type of finding also known as a major non-conformance/ a systemic finding.
- 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 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 OFI, but more supporting data should be included to encourage action by auditor.
How to differentiate audit finding as a non-conformance or observation?
Classify as non-conformance:
If finding requires the analysis and/or elimination of a root cause.
If it requires a change to the current process.
CARs should be initiated.
Classify as Observation:
If root cause analysis is not indicated.
Next: Writing Effective CARs