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.
ASQ Auditing Handbook (4th edition-page 99): An auditor must sort and classify facts based on the severity of the problem, the frequency of occurrence, and the risks associated with the problem. Most quality system certification/registrar auditors are trained to report nonconformances, and consequently, many auditors of registered organizations adopt the same method of reporting. A nonconformance or finding may be classified as systemic or isolated, major or minor, or it may be assigned a severity level or graded (such as A, B, or C), depending on its effect on the product, service, process, or system.
As you see classificaiton of non-conformities may be changed for each certification bodies. Each certification body has its own procedures for classification. The method you mentioned above is common pratice which is used by many certification bodies.
Fulfillment of a requeriment (expectation estabilished, mandatory or implicit - ISO 9000:2015. 3.6.4.) in the Quality Management System(QMS) - ISO 19011:2018. 3.20.
2. Non-conformance (Minor or Major)
Breakdown of a requeriment in the Quality Management System(QMS) - ISO 19011:2018. 3.21. Requires Corrective Action to document action taken. Root cause analysis is required for Corrective Actions. Minor / Major Non-conformance are Non-Conformance optional categories to determine the Non-conformance affectation grade in the QMS.
3. Observation / Opportunity for Improvement (OFI)
All observations of audit are Opportunities for Improvement (OFI), however all Opportunities for Improvement have various sources as audit results and evaluations of the Quality Management System. Observations are deviations to the requeriments recorded on an Audit Action List generally and they could affect the Quality Management System. Observations / Opportunities for Improvement requires to be identified and selected to implement a required action - ISO 9001:2015. chapter 10 numeral 10.3.