Poll: Should auditors promote the process approach?

[ISO 9001 Guy]

If an user has to read ISO 9001 like "The Da Vinci Code", looking for subliminal nuances, in search of the holy grail, we are all doomed. There are (and we have discussed it here) questionable guidance from the IAF and the TC 176, especially a couple of "official" ISO 9001 interpretations. The IAF has developed Mandatory Documents as part of the Management System certification Conformity Assessment process. If they want something to happen consistently and be auditable, during the accreditation body oversight activities, a Mandatory Document is the proper channel; not a guidance document, which by definition, carries little weight in the eye of the registrants.

I sent the following question to TC 176: "Does a QMS defined by an element-by-element approach meet the requirements of ISO 9001:2008, 4.1a?"

I don't know that it will receive a response. While some have expressed that the question is not appropriate, the IAF sectretary seems to think TC 176 will be happy to answer the question. So, we'll see. I hope it doesn't hurt to consider what implications the result of this "yes/no" would be.

If it does receive a response, and the response comes back, "yes," then the process approach will seem to remain just a good idea endorsed by the standard.

However, if the response to the question comes back, "no," then would THAT mean definitively that the element-by-element approach does NOT meet the requirements of ISO 9001:2008, 4.1a? If this turned out to be the case, and a CB contracted by an organization to assess conformity to ISO 9001:2008 is legally bound to assess conformity to the requirements of 4.1a, would an auditor working for a CB be lawful in considering a QMS defined by the element-by-element approach as being compliant to 4.1a? In other words, would we be talking about legal enforceability here? If THAT turned out to be the case, and I were a CB, I would be very interested in ensuring that all of my auditors were competent "particularly" with regard to the process approach, wouldn't you?

Pesky little details. (Or is it good risk analysis to ponder these things?)

 

[Jim Wynne]

In fact, it seems ISO/IAF share your concern (from ISO/IAF APG Guidance on: Understanding the process approach (5 June 1009):
"A certification body should ensure that all its auditors have received sufficient training regarding the requirements in ISO 9001, particularly those on the process approach..."

It seems that ISO/IAF is wrong here, unless there's some method of expressing requirements in the standard (ISO 9001) that I don't know about. You do realize that by characterizing the process approach as a requirement, the passage quoted above creates more confusion than it clears up, I hope?

Here's the problem, as I see it, wrt your understanding of this issue, and the attempts to clarify it: you have not established your thesis in such a way that anyone can clearly agree or disagree with it in the way you seem to be hoping for. You seem to think that QMS documentation that's structured element-by-element is antithetical to, and absolutely incompatible with implementation of the process approach; your entire argument seems to hinge on this idea.

Unfortunately, you haven't demonstrated in any meaningful way that this is true. While it's possible that in some instances a QMS documented element-by-element also does not follow the process approach, one doesn't necessarily follow the other in a logical, inevitable progression. You seem to have reached your conclusion via some route other than the construction of logical antecedents.

 

[dknox4]

I agree that auditor competence in the process approach is needed because they will most likely encounter and audit process-based systems to varying degrees. My issue is with promotion of something that is not required. There are many best-ways to do things, but any one best-way will not work for all organizations. IMO I think promotion leads to opinion-land, and I think it's wise for auditors to stay away from there.

 

[Jim Wynne]

I like your definitions. One could identify (ascertain the origin of) QMS processes by looking at the elements of the standard. One could identify (ascertain the nature of) QMS processes by looking at the elements of the standard. And, one could identify (ascertain the definitive characteristics of) QMS processes by looking to the elements of the standard. In all three cases, organizations incorrectly identify their "processes" yet can still demonstrate conformity because they have simply identified them.
However, "To establish or ascertain definitely, as after consideration, investigation, or calculation," or to "determine" QMS processes affecting quality, an organization is required to REALLY figure it out (definitely), as after considering the intent of the requirements and investigating into how they apply to their existing (real) QMS processes. Organizations that have failed to accomplish this fairly simple exercise have failed to properly determine QMS processes.

This response seems to indicate that you didn't read what you were responding to, or did read it and chose to ignore it in favor of definitions that suit your purpose. The language cries out for mercy while you keep tightening the screws.

 

[ISO 9001 Guy]

It seems that ISO/IAF is wrong here, unless there's some method of expressing requirements in the standard (ISO 9001) that I don't know about. You do realize that by characterizing the process approach as a requirement, the passage quoted above creates more confusion than it clears up, I hope?

Here's the problem, as I see it, wrt your understanding of this issue, and the attempts to clarify it: you have not established your thesis in such a way that anyone can clearly agree or disagree with it in the way you seem to be hoping for. You seem to think that QMS documentation that's structured element-by-element is antithetical to, and absolutely incompatible with implementation of the process approach; your entire argument seems to hinge on this idea.

Unfortunately, you haven't demonstrated in any meaningful way that this is true. While it's possible that in some instances a QMS documented element-by-element also does not follow the process approach, one doesn't necessarily follow the other in a logical, inevitable progression. You seem to have reached your conclusion via some route other than the construction of logical antecedents.

A QMS defined by the element-by-element approach does not exemplify the process approach.

A QMS defined by the element-by-element approach does not meet the intent of 4.1a.

I hold both positions and you are free to disagree with them. But can't we agree to disagree again?

 

[Jen Kirley]

Are you recommending companies (or not) for registration based on your judgment of their process approach in accordance with 4.1a?

 

[ISO 9001 Guy]

Are you recommending companies (or not) for registration based on your judgment of their process approach in accordance with 4.1a?

I have not been instructed to do so by my CB (yet?). But my CB tells everyone that the process approach is the right thing, so I am not offering advice when I raise "adopting the process approach" as an opportunity for improvement to auditees who have employed an element-by-element approach. Until my CB requires me to raise it as a nonconformity, it is still appropriately regarded as an observation or an opportunity for improvement.

 

[Jen Kirley]

I have not been instructed to do so by my CB. But my CB tells everyone that the process approach is the right thing, so I am not offering advice when I raise "adopting the process approach" as an opportunity for improvement to auditees who have employed an element-by-element approach. Until my CB requires me to raise it as a nonconformity, it is still appropriately regarded as an observation or an opportunity for improvement or a statement of fact, as my CB regards them.

I would like to see how such an observation was worded. Of course it wold be hard for me to fully understand without seeing the process in question, but I would be very interested in how you'd write an observation based on something a standard does not say.

Is something like a process map enough to make the difference for you - something like a mall map to show how it all fits together?

 

[ISO 9001 Guy]

I would like to see how such an observation was worded. Of course it wold be hard for me to fully understand without seeing the process in question, but I would be very interested in how you'd write an observation based on something a standard does not say.

Is something like a process map enough to make the difference for you - something like a mall map to show how it all fits together?

I appreciate the inquiry, but, whew, let's deal with one problem at a time for a while, okay? Thanks! I mean, I can already see the debate raging over what I suggest as a simple solution. Things can get unnecessarily over-complicated here very quickly, it seems. Ultimately, it's up to CBs to decide what constitutes proper treatment of this issue--so long as it's effective. To "promote" the process approach, reference to 4.1a might be appropriate, but that would require auditors to understand WHY it would be appropriate.

 

[Jen Kirley]

I appreciate the inquiry, but, whew, let's deal with one problem at a time for a while, okay? Thanks! I mean, I can already see the debate raging over what I suggest as a simple solution. Things can get unnecessarily over-complicated here very quickly, it seems.

Now there's something I agree with - things did get very complicated here. But why do you back off now?

I think we've beat the concept of process approach to a bloody, lifeless pulp. I look forward to more practical things, such as what it would look like so as to satisfy a registrar. What is a simple solution? I think I missed it.