Can NonConformance (NC) be raised against Effectiveness? (Ineffectiveness)

Stijloor

Staff member
Super Moderator
#91
Uh... just a simple notification to you, Stijloor- I'll be referring to this in the future!:yes::agree1: Of course, credit will go where credit is due!:)

Thank you for the information.
Hello Brad,

:topic:Thank you for your nice feedback. I use this "story" at the beginning of my internal audit course.

I explain it to the group as follows: "When you audit a process, I would like for you to verify these five things:"
  1. Is the information present? (Documents)
  2. Do people know it? (Implemented)
  3. Are they doing it? (Comply)
  4. Is it working? (Effective)
  5. Is it getting better? (Improving)
Participants relate to the progression of these five concepts very well.

Then I ask them to list examples of the objective evidence for each, what it consist of, and how to obtain it. The results are recorded on a flipchart and used as ongoing reference during the course.

This works very well.

Stijloor.
 
Elsmar Forum Sponsor
#92
Would someone help me? I don't know the difference.........

Actually audits are performed to look for conformance, not compliance. It's very important to understand the difference between the two.
 
#93
There's some great stuff surfacing in this post! In my experience of doing all manner of audits and having trained thousands of auditors, I must admit to having a problem telling internal auditors they have to ask about improvements each and every time they do an internal audit.

As Randy posted (extracted from the ISO 9001 requirements), it's the internal auditors job to verify that the system is implemented and maintained, and there's not a mention of improvement. What if a process is implemented and maintained, gives good results (to the stated objectives) but isn't being improved? Is that an audit non-conformity? I'd like to see an auditor try to make it stick with management, if it was written! Most organizations I've worked in, the management team would throw a fit if auditors kept reporting that something needed improvement - and I don't mean corrective action type improvement, I mean real improvement!

Surely, based on the results of process performance, the results of the audits telling management if the process is being implemented and maintained, it's up to them (management) to decide on what needs improvement. Isn't that the purpose of a QMS Management Review?

IMHO, this is where the line between external auditor behaviours and what internal auditors should be doing has been made very fuzzy because people mix the two, thinking (well intentioned as it may be) that they have the same aims.
 
Last edited:

Doug Tropf

Quite Involved in Discussions
#94
There's some great stuff surfacing in this post! In my experience of doing all manner of audits and having trained thousands of auditors, I must admit to having a problem telling internal auditors they have to ask about improvements each and every time they do an internal audit.
ISO 13485 differs from ISO 9001 in that it does not contain explicit requirements for continual improvement.
 

Colin

Quite Involved in Discussions
#95
There's some great stuff surfacing in this post! In my experience of doing all manner of audits and having trained thousands of auditors, I must admit to having a problem telling internal auditors they have to ask about improvements each and every time they do an internal audit.
Andy, I understand where you are coming from on this. I normally recommend that auditors take a look at how mature the process is before seeking too much by the way of improvement. If it is a relatively new process I would concentrate more on the conformance issues (QMS and standard). When the process is more mature, it seems less useful to just check conformance so we need to push a bit harder and look more at improvement or the audit becomes less useful to the organisation.
 

Randy

Super Moderator
#96
Would someone help me? I don't know the difference.........

Actually audits are performed to look for conformance, not compliance. It's very important to understand the difference between the two.
No problem....

conformance = meeting voluntary requirements (like the "shalls")

compliance = meeting mandated requirements (such as regulatory,legal, customer)

The next revision of 9001 will emphasize "conformance"just as 14001, 18001 and other standards do now.

We can have a nonconformance for not complying (compliance is an element of conformance in many cases)
 
D

David DeLong

#97
No problem....

conformance = meeting voluntary requirements (like the "shalls")

compliance = meeting mandated requirements (such as regulatory,legal, customer)

The next revision of 9001 will emphasize "conformance"just as 14001, 18001 and other standards do now.

We can have a nonconformance for not complying (compliance is an element of conformance in many cases)
Randy:

Could you please tell us your source for the definition of conformance? I have been checking through my ISO 9000, TS 16949 and my AIAG TS auditing training books and cannot find your defintion.

Thanks
 
#98
No problem....

conformance = meeting voluntary requirements (like the "shalls")

compliance = meeting mandated requirements (such as regulatory,legal, customer)

The next revision of 9001 will emphasize "conformance"just as 14001, 18001 and other standards do now.

We can have a nonconformance for not complying (compliance is an element of conformance in many cases)
I sincerely hope not.........if we are going to be basing business systems on such narrow 'hair splitting' definitions, then the auditing function is going to go even further down the drain, IMHO......
 

Stijloor

Staff member
Super Moderator
#99
Randy:

Could you please tell us your source for the definition of conformance? I have been checking through my ISO 9000, TS 16949 and my AIAG TS auditing training books and cannot find your defintion.

Thanks
Hello David,

From ISO 9000:2005.

3.6 Terms relating to conformity

3.6.1
conformity
fulfilment of a requirement (3.1.2)

NOTE The term “conformance” is synonymous but deprecated.

3.6.2
nonconformity
non-fulfilment of a requirement (3.1.2)

3.6.3
defect
non-fulfilment of a requirement (3.1.2) related to an intended or specified use

NOTE 1 The distinction between the concepts defect and nonconformity (3.6.2) is important as it has legal connotations, particularly those associated with product liability issues. Consequently the term “defect” should be used with extreme caution.

NOTE 2 The intended use as intended by the customer (3.3.5) can be affected by the nature of the information, such as operating or maintenance instructions, provided by the supplier (3.3.6).


I hope this helps.

Stijloor.
 
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