What is the degree of evidence needed to report a nonconfomity?

somashekar

Staff member
Super Moderator
#21
Re: Degree of evidence

That said, it is helpful to consider that the organization will very likely be interested in tangible evidence so I am disinclined to simply say "So-and-so said such-and-such" as a writeup because people can say anything. They may be mistaken from lack of insight, exaggerating, suffer momentary confusion and so on.
Considering the fact that the question is about internal auditing (Ka pilo has opened this in ISO 19011 - Quality and Environmental Management Systems Auditing > Internal Auditing) this is exactly what I was having in my mind. The internal auditor must to a great extent be able to see an objective evidence that supports a statement of evidence , and on the other side again look for evidence when the auditee states " All is well "
Then comes the systemic part of the evidence. The internal auditor must further look for any systemic fault rather than a one off case.
It is not uncommon for many in internal audit to just write NC about missing signature and missing form number and such.
A seen evidence and mention of same in the NC statement is far better than just a heard evidence.
 
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Marcelo

Inactive Registered Visitor
#23
A seen evidence and mention of same in the NC statement is far better than just a heard evidence.
It's not. The problem is that people (meaning certification bodies and such) rely too much on written evidence, and everyone thinks that what you need to have is things written.

This is not what is expected by the standards. A "heard" evidence, or any other fact, is as good a a written one.
 

Marcelo

Inactive Registered Visitor
#24
Another problem which might be the case here - people tend to think that any NC needs a correcive action, so it's usually a burden having an NC.

If you point anything which is a NC as an NC in this frame of mind, it's IS buerdensome.

However, NCs always need an analysis, but they may or may not need an corrective action. So, with this in mind, even if you point to individual NCs, wht it does mean is that those things are "non-fulfillment of a requirement" and needs to be investigated. In the case of a really particular problem, you investigate and decide that there's no need for a corrctive action because it was a particular problem, no a systemic one. This makes pointing a NC as defined by the standard less burdensome. On the other hand, if your analysis does conclude that it's a systemic problem, than you need a corrective action.
 
Last edited:

somashekar

Staff member
Super Moderator
#25
It's not. The problem is that people (meaning certification bodies and such) rely too much on written evidence, and everyone thinks that what you need to have is things written.

This is not what is expected by the standards. A "heard" evidence, or any other fact, is as good a a written one.
No disagreements., however from an internal audit point of view and based on the OP's question about degree of evidence (1 or many) my tips on this would be for systemic deficiencies, rather than hear say.
 

Marcelo

Inactive Registered Visitor
#26
No disagreements., however from an internal audit point of view and based on the OP's question about degree of evidence (1 or many) my tips on this would be for systemic deficiencies, rather than hear say.
Understood, however I would also disagree (and it's obviously a personal opinion).

My view at the moment is that internal auditors should be picky and find individual AND systemic problems. And then outside auditors should focus on systemic stuff.

This is because internal auditors have better ways, more time, and etc. to nitpick. Outside auditors should be more focused in the system as a whole, and should rely on internal auditors to find the individual stuff.
 

Jim Wynne

Staff member
Admin
#27
Re: Degree of evidence

When attending Lead Auditor training for TS 16949, an auditee's statements were certainly considered evidence and could be included as part of the NC description. We specifically practiced them.

That said, it is helpful to consider that the organization will very likely be interested in tangible evidence so I am disinclined to simply say "So-and-so said such-and-such" as a writeup because people can say anything. They may be mistaken from lack of insight, exaggerating, suffer momentary confusion and so on.

However, in event of a breakdown somewhere an investigation can, and should include testimony as part of the body of evidence.
:2cents:
Yes, statements of fact are considered audit evidence:

From ISO 19011:



Emphasis mine.

Stijloor.
I absolutely agree that auditee statements may be considered part of a body of evidence, but we need to be careful about what's characterized as "fact." In the example I gave earlier, where an operator reported the recent use of an obsolete document, if there is no further corroboration the statement shouldn't be considered factual. On the other hand, if an auditee states that a certain required procedure isn't followed, and it's ascertained by observation that the procedure isn't followed, the original statement may be considered one of fact and should be considered objective evidence.

Before an utterance may be considered a "statement of fact," some form of corroboration will almost always be necessary.
 

Jim Wynne

Staff member
Admin
#28
Re: Degree of evidence

An anecdotal assertion might be, as I said, a basis for further investigation. That doesn't alter the fact that the assertion itself shouldn't be considered objective evidence. Before a nonconformity statement can stand up, it must be supported by evidence directly observed.
Would it mean that a NC statement can begin or end with " As stated by the responsible manager " being the evidence ... ?
It's conceivable, but unlikely, that the manager's statement will be (or should be) all of the evidence. I've seen instances where supervisors, when asked about how some process proceeds, give an answer that doesn't reflect the requirement or the actual practice. This might be evidence that the supervisor is ill-trained, inexcusably ignorant of the requirements, or has just made a simple mistake.
 

Wes Bucey

Quite Involved in Discussions
#30
Re: Degree of evidence

From ISO 9000:2005:

3.8.1
objective evidence
data supporting the existence or verity of something
NOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.
Don't you just love the high tone of the committee that wrote the Standard, using verity instead of "truth?":sarcasm:
 
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