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

Wes Bucey

Quite Involved in Discussions
#31
Re: Degree of evidence

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.
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.
 
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Stijloor

Staff member
Super Moderator
#32
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.
Very interesting. Are you a 3rd Party Auditor?

Stijloor.
 

Jim Wynne

Staff member
Admin
#33
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.
There is no good reason to use the "major" and "minor" classifications in internal audits. A thing either conforms or it doesn't, and it should be left to management to decide what the risks are. In third-party auditing, "major" is associated with systemic breakdowns, "minor" denotes what appears to be a more-or-less isolated NC, and "OFI," when used, does not denote a nonconformity.
 
K

Ka Pilo

#34
Re: Degree of evidence

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.
Should be put in the ISO 9001 Internal Auditing section.
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.
This appears to support the "categorization of nonconformity."
There is no good reason to use the "major" and "minor" classifications in internal audits.
If so, one might argue that ISO 9001 is applying a restraint on the categorization of the NC although the necessity of corrective action will presumably not be hindered.
 

Wes Bucey

Quite Involved in Discussions
#35
to: Stijloor - I often act as a surrogate auditor as part of a consulting assignment, especially when helping organizations implement internal auditing as a real value-added activity versus the "lip service" audits I've seen over the years.

More importantly, to eliminate any taint of Kwality Kop where the auditor gets orgasmic when he/she can say, "Gotcha!" to some poorly trained mope on the factory floor.

And, of course, as a confirmed Demingite, "operator error" is NEVER a stopping point in the root cause analysis.

CORRECTIVE ACTION:
There ALWAYS needs to be a root cause analysis once parties agree a N/C does exist. It is not always clear whether a corrective action is required. I can think of some, not many, situations where the root cause cannot be corrected or eliminated and some where the net cost of effective corrective action exceeds the value of the affected customer contract.
 
K

kgott

#36
as a confirmed Demingite, "operator error" is NEVER a stopping point in the root cause analysis..
In most organisations I have worked for; proceeding to ask questions like
is the operator poorly trained or supervised is an invitation to have the supervisory team and perhaps the rest of the management team decend on oneself like a ton of bricks.
 
J

JaneB

#37
In most organisations I have worked for; proceeding to ask questions like
is the operator poorly trained or supervised is an invitation to have the supervisory team and perhaps the rest of the management team decend on oneself like a ton of bricks.
True. Which is why (as an internal auditor ) one needs to pay very careful attention to being objective, to citing actual evidence and to phrase one's findings carefully. Nothing will incite 'tons of bricks' more quickly than telling managers/supervisors either how to do their jobs, or that they aren't doing them. (Leave that to an external auditor, if you must ;) Or a consultant.
 
J

JaneB

#38
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.
I don't want to have any auditor - internal or external - get 'nitpicky'. Ever.
 

Wes Bucey

Quite Involved in Discussions
#39
In most organisations I have worked for; proceeding to ask questions like
is the operator poorly trained or supervised is an invitation to have the supervisory team and perhaps the rest of the management team decend on oneself like a ton of bricks.
Right! A big part of what I do with setting up internal auditing in a consulting assignment is instill tact and diplomacy to avoid having an auditing team [or ANY part of the quality system] becoming Kwality Kops (kind of like the idiot Keystone Kops running around in the silent comedies which were staples of early TV children's shows in the early 50's.) Jane gets the idea.

True. Which is why (as an internal auditor ) one needs to pay very careful attention to being objective, to citing actual evidence and to phrase one's findings carefully. Nothing will incite 'tons of bricks' more quickly than telling managers/supervisors either how to do their jobs, or that they aren't doing them. (Leave that to an external auditor, if you must ;) Or a consultant.
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.
I don't want to have any auditor - internal or external - get 'nitpicky'. Ever.
It may be OK to OBSERVE the little things - the key is how the auditor regurgitates those observances in his report to make a meaningful and valuable (to the organization) contribution toward improvement rather than a personal boast of the auditor's superiority.

As I wrote -

<SNIP>
More importantly, to eliminate any taint of Kwality Kop where the auditor gets orgasmic when he/she can say, "Gotcha!" to some poorly trained mope on the factory floor.<SNIP>
 
K

kgott

#40
I agree 100% but sometimes no matter tactful one is it still happens. In fact when I broached the issue with a production manager who done his quince every 5 minutes; on my last job about poor quality of workmanship, I suggested that he organise for me to take new starters around and show them examples of good and bad workmanship on the units so they know what’s required, which would give me an opportunity to re-enforce what was ok and what was not ok.

What I got in response was 'these blokes know what’s required but they are not the sharpest knives in the block’ that’s why we have to get up em.’

This response stumped for a bit and I tried again to get this training going another time at a ‘team’ meeting but I got the same response from an even more senior manager.

One of the things I’ve learned over the years is that most management, at least at the levels I have encountered, seem to be negatively disposed towards those below them in the hierarchy. I find myself wondering if ‘these blokes are not the sharpest knives in the block’ is a manifestation of ‘I don’t know how to help someone else do a better job.’ syndrome. I think Deming had something to say in that line.
 
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