Poll: Should auditors promote the process approach?

[DrM2u]

BTW you mentioned 6 sigma. IMHO six sigma is a management systems approach - merely pulling together a range of quality tools in a systematic approach.

IMHO, 6-Sigma is a systematic approach of aplying statistics to identify problems and/or opportunities for improvement (Define), assist with root cause analysis (Measure & Analyze), evaluate effectiveness of actions taken (Implement) and control the new process (Control). In best case, 6-Sigma is a statistical method for problem solving and improvement, nowhere near a business or quality management system. Don't confound 'system' with 'systematic'. If I am wrong, please explain why.

 

[DrM2u]

A question requiring an honest answer is, "Does management see value in ISO 9001 audits?" Really? Or is the value in retaining a certificate? (A similar question: does management really see value in a standard-based QMS beyond the certificate?)

Now here's another good idea for a poll! You should start it.

 

[Jen Kirley]

Agreed regarding clause 4.1.a; it is simple, direct and limited in scope. On the other hand, how is going clause by clause different that the time-proven ineffective 'element' approach promoted and used pre-ISO 9001:2000?!? Unfortunately life is complicated by things not being black and white (or whatever color combination you prefer). There is a lot of a grey area otehrwise we would not be having these debates. Perfect example: take the Bible. There is only one book called The Bible yet there are many religions that interpret it in their own way. Which is right and which is wrong? The one you subscribe to is right, the others are wrong until convinced otherwise. Why else would I have people knocking at my door trying to convince me that their version is the one to folow?!?

One of the things that QA professionals have done to limit our own progress is to infer that a clearly worded clause has implicit, deeper meaning than its words communicate. We are not alchemists.

The ISO standards were developed and worded to provide a framework for management system development, maintenance and growth. They are not the Bible, however. They are not mystical, and they are not worded in a way that requires a sage to interpret. Their directness is their strength, as it is on the organization's advantage to be able to understand and apply them based on their intelligence and pragmatism.

Organizations need to understand the difference between should and shall, and most do. It is confusing and damaging for auditors, both internal (me) and external, to impose deeper meaning than the standards' clause words convey, and muddle the shoulds and shalls based on guidance.

Now mind you I am all for the process approach. And as I said long ago, the standard is built to help establish that by simple virtue of including all the parts. It even has a nice picture in the Introduction to show how it all ties together.

But auditors are charged to assess and verify that an organization meets the standards' requirements. That limits our ability to enforce what is only mentioned as a "should" in the introduction. As client organizations' systems grow and mature, the element approach can be expected to evolve into a process approach to thinking; for the sake of this discussion I will define that as consideration of stakeholder needs and provisions.

An auditor can express approval when they get it right, or point out that effectiveness is being compromised by failure to consider the input/outputs of, and interactions with, related processes. But beyond that the auditor's role is understandably limited. In my view, if a QA professional wants to go farther, he/she should do so outside the role of auditor.

 

[DrM2u]

One of the things that QA professionals have done to limit our own progress is to infer that a clearly worded clause has implicit, deeper meaning than its words communicate. We are not alchemists.

The ISO standards were developed and worded to provide a framework for management system development, maintenance and growth. They are not the Bible, however. They are not mystical, and they are not worded in a way that requires a sage to interpret. Their directness is their strength, as it is on the organization's advantage to be able to understand and apply them based on their intelligence and pragmatism.

Organizations need to understand the difference between should and shall, and most do. It is confusing and damaging for auditors, both internal (me) and external, to impose deeper meaning than the standards' clause words convey, and muddle the shoulds and shalls based on guidance.

Now mind you I am all for the process approach. And as I said long ago, the standard is built to help establish that by simple virtue of including all the parts. It even has a nice picture in the Introduction to show how it all ties together.

But auditors are charged to assess and verify that an organization meets the standards' requirements. That limits our ability to enforce what is only mentioned as a "should" in the introduction. As client organizations' systems grow and mature, the element approach can be expected to evolve into a process approach to thinking; for the sake of this discussion I will define that as consideration of stakeholder needs and provisions.

An auditor can express approval when they get it right, or point out that effectiveness is being compromised by failure to consider the input/outputs of, and interactions with, related processes. But beyond that the auditor's role is understandably limited. In my view, if a QA professional wants to go farther, he/she should do so outside the role of auditor.

Now this I agree with! An auditor should not impose or demand anything beyond the requirements of the standard. The most an auditor can do is to suggest for consideration certain topics. It is up to the organization to decide if the suggestion is worth a dime or not. Also, there is nothing that prevents an organization from politely asking an imposing/demanding/off-base auditor from ending the audit and leaving the facilities then asking the CB for another auditor.

Just like you said, organizations' ignorance or lack of knowledge often results in following the directions of ... what's a nice word ... wanna-be auditors. So, should you realy blame only the auditor or should the organization share in the blame also?!? Like you said, 'organizations need to understand the difference between should and shall (...)'. it is not auditor's responsibility to ensure that. That responsibilitiy starts with the MR and should trickle through the organization. At least IMO.

 

[ISO 9001 Guy]

Now here's another good idea for a poll! You should start it.

Please be my guest!

 

[ISO 9001 Guy]

Now this I agree with! An auditor should not impose or demand anything beyond the requirements of the standard. The most an auditor can do is to suggest for consideration certain topics. It is up to the organization to decide if the suggestion is worth a dime or not. Also, there is nothing that prevents an organization from politely asking an imposing/demanding/off-base auditor from ending the audit and leaving the facilities then asking the CB for another auditor.

Just like you said, organizations' ignorance or lack of knowledge often results in following the directions of ... what's a nice word ... wanna-be auditors. So, should you realy blame only the auditor or should the organization share in the blame also?!? Like you said, 'organizations need to understand the difference between should and shall (...)'. it is not auditor's responsibility to ensure that. That responsibilitiy starts with the MR and should trickle through the organization. At least IMO.

I hope we can see the ANAB-approved? distinction between consulting and "educating" as previously discussed.

Attending clients' certification audits for years, I became accustomed to hearing auditors offering advice without knowing it. (A lot of it awful advice at that.) "I like to see it this way . . ." "Or you should do it that way. . ."

Although perhaps less common now, the continuing problem is this: organizations (still) follow routines that were adopted to comply with advice given years ago, errant advice that never should have been tendered. But now it seems we're concerned that we can't provide uniform education to correct the error. So organizations are stuck with dysfunctional QMSs because we can't tell them? IAF seems to formally be not only giving permission, it seems ISO/IAF is clearly directing CBs to do so.

Also, to underscore the distinction between consulting and education, in "promoting" the process approach as prescribed by the guidance, it would not be the personal opinion of an auditor that the process approach should be promoted, it's the official opinion of the appropriate authority.

 

[ISO 9001 Guy]

All that is fine, but it's not being asked for in 4.1a; IMO that clause is simple, direct and limited in scope.

Do you think it is the intention of 4.1a for organizations to determine their processes according to the elements of the standard (and write procedures accordingly, element-by-element)?

 

[Stijloor]

Do you think it is the intention of 4.1a that organizations determine their processes according to the elements of the standard (and write procedures accordingly, element-by-element)?

That's up to the organization. Whatever works for them.
(And I am a process approach guy... )

Stijloor.

 

[ISO 9001 Guy]

That's up to the organization. Whatever works for them.
(And I am a process approach guy... )

Stijloor.

Have you seen lots of companies for whom the element-by-element procedures are useful and helpful to personnel managing or performing processes? Can you give examples?

 

[Stijloor]

Have you seen lots of companies for whom the element-by-element procedures are useful and helpful to personnel managing or performing processes? Can you give examples?

The (quality systems) world did not come to an end when the clause-by-clause approach was more prevalent. I have seen excellent- and pi$$-poor examples of both. If processes deliver the expected results in a safe, effective and efficient manner, and the customer is very happy, I really am not too worried what approach is being used.

One of my Clients (a chemical company) has their system still modeled in a traditional manner and they show outstanding results in the areas or safety, quality, delivery, customer satisfaction and financial performance.

Stijloor.