Re: Degree of evidence
FWIW:
I usually look for a difference between "outliers" and systemic faults before I'm willing to assess a MAJOR N/C. Usually, I assign "OFI" for outliers. I might be more willing to assign an OFI than a "minor" because I would get too bogged down trying to explain the difference between MAJOR and MINOR to people not trained as auditors whereas the concept of an Opportunity For Improvement certainly keeps me from thinking of myself as a detested Kwality Kop from the 50's, 60,s and 70's.
If an obsolete document has been observed at a point of use, there is no question, or there shouldn't be, whether a nonconformity exists. The existence of the document is the only objective evidence necessary to support the contention. However, if the contention is that the entire document control system has broken down, you'll need more evidence than a single out-of-place obsolete document to support it.
An example of evidence that shouldn't be considered objective is a verbal assertion by an operator that until 20 minutes ago, an obsolete document was being used. This is not something directly observed by the auditor, and as such shouldn't be used as the basis of a nonconformity finding. It might be cause for further investigation.
In internal audits there should be no question of subjectivity, because "major" and "minor" classifications aren't helpful. Either a nonconformity exists or it doesn't, and the need for and extent of corrective action should be left to management.
An example of evidence that shouldn't be considered objective is a verbal assertion by an operator that until 20 minutes ago, an obsolete document was being used. This is not something directly observed by the auditor, and as such shouldn't be used as the basis of a nonconformity finding. It might be cause for further investigation.
In internal audits there should be no question of subjectivity, because "major" and "minor" classifications aren't helpful. Either a nonconformity exists or it doesn't, and the need for and extent of corrective action should be left to management.
I usually look for a difference between "outliers" and systemic faults before I'm willing to assess a MAJOR N/C. Usually, I assign "OFI" for outliers. I might be more willing to assign an OFI than a "minor" because I would get too bogged down trying to explain the difference between MAJOR and MINOR to people not trained as auditors whereas the concept of an Opportunity For Improvement certainly keeps me from thinking of myself as a detested Kwality Kop from the 50's, 60,s and 70's.