Standards

Hi everyone, I was going through my old documentation on auditing related topics and came across the types of findings in an audit.  There wasn't a source in my documentation for the definitions but I thought I got it from an ASQ auditing course.  See below:

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.

2. Observation

    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.

There are not exact or common classification of non-conformities. Only ISO 19011-6.4.8: "Nonconformities can be graded depending on the context of the organization and its risks. This grading can be quantitative (e.g. 1 to 5) and qualitative (e.g. minor, major)."

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.

Hi Jeff, I would like to throw this into the fray. I was trying to determine if 'concern' is a defined audit term or just a colloquialism. In my search I ran across the attached ASQ document. It is from some EE working group c. 2014. For observation it has "member derived" as the source; for OFI it has COS-2-03, 3.3.3 as the source. It would be great if there was a master glossary, with sources ... audit-terminology.pdf The link is https://asq.org/ee/2014/08/audit-terminology.pdf

This isn't quite what you were asking, but my source for the distinction between "major" and "minor" nonconformities is ISO 17021-1:2015, which defines a major as any "nonconformity that affects the capability of the management system to achieve the intended results," while a minor "does not affect the capability" etc. etc. I think your use of "observation" might be a local convention, because I have also seen "observation" used as a blanket term for any data point whatsoever: good, bad, or indifferent. (Or else the people I heard had it wrong, of course.)

Types of finding in an audit:


1. Conformance.


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.