Poll: Should auditors promote the process approach?

[Paul Simpson]

To be clear, ISO TC 176 clearly promotes the process approach, right?

In answer to your question I would say TC 176 has written the process approach into the requirements and guidance standards ISO publishes. Whether they promote the approach or not through their actions is a moot point.

 

[ISO 9001 Guy]

In answer to your question I would say TC 176 has written the process approach into the requirements and guidance standards ISO publishes. Whether they promote the approach or not through their actions is a moot point.

My reply you quoted was in response to your observation that, "The ISO committee developing ISO 9001 is made up of quality profesionals understanding quality requirements." I thought by that you were crediting TC 176 for knowing what they were talking about.
Are you now saying what they promote is a moot point?

 

[Paul Simpson]

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.

If in doubt I always refer to the dictionary definition. Ask Oxford the online Oxford English dictionary defines system here. As (Option 4) 'an organized scheme or method' - I think that covers 6 sigma - don't you?

Just for information - covered on another thread somewhere ISO was debating whether the new work item to develop guidance on 6 sigma should come under TC 176 (for quality management systems) or TC 69 (I think) for statistical methods. In the end it is under TC 69 with liaison input from TC 176.

 

[ISO 9001 Guy]

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.

If I were to suggest the wording of a finding, given the careful scrutiny (and poor interpretation) of my words so far in this poll, how can you even ask your question?

 

[Jen Kirley]

If I were to suggest the wording of a finding, given the careful scrutiny (and poor interpretation) of my words so far in this poll, how can you even ask your question?

Oh come on, don't be coy. Educate me. Pretty please.

 

[Paul Simpson]

My reply you quoted was in response to your observation that, "The ISO committee developing ISO 9001 is made up of quality profesionals understanding quality requirements." I thought by that you were crediting TC 176 for knowing what they were talking about.
Are you now saying what they promote is a moot point?

If we want to go back to basics my original post to this thread was to say that the poll should be about quality professionals promoting the process approach. This doesn't mean that quality professionals: 1) promote this, or 2) even understand the approach. TC 176 members are a subset of the wider quality community so you can read into my comment what you like.

You are unlikely to promote a moot point - more likely to closely examine / test it.

 

[ISO 9001 Guy]

If in doubt I always refer to the dictionary definition. Ask Oxford the online Oxford English dictionary defines system here. As (Option 4) 'an organized scheme or method' - I think that covers 6 sigma - don't you?

Just for information - covered on another thread somewhere ISO was debating whether the new work item to develop guidance on 6 sigma should come under TC 176 (for quality management systems) or TC 69 (I think) for statistical methods. In the end it is under TC 69 with liaison input from TC 176.

When discussing ISO 9001 issues, it's useful to use the definitions in ISO 9000:2005. That way, everyone is talking the "language of the standard." When discussing quality management systems, the ISO 9000:2005 definitions for process and system are very important. And procedure. And (quality) management system.

 

[ISO 9001 Guy]

Oh come on, don't be coy. Educate me. Pretty please.

Ok, I'll give it a shot. Just for you.

Let's assume a machine shop operating an element-by-element QMS.
If directed to write it up as a nonconformity, it might look like this (on steroids):

ISO 9001:2008, 4.1a states that, "The organization shall . . . a) determine the processes needed for the quality management system and their application throughout the organization."

Because your realization processes are [. . . confirmed by whatever basis during stage 1]: Sales, Purchasing, Receiving, Production, and Shipping, while the QMS is defined (Quality manual , rev Z, x.y.z) as being composed of the following realization processes [guessing here, as they could be based on 1994 requirements!]: "Planning of Product Realization," "Customer-Related Processes," "Product Identification," "Production and Service Provision," Identification and Traceability," "Customer Property," "Preservation of Product," . . . the QMS as defined does not reflect QMS processes. [Notice an auditor really wouldn't even need to visit the organization to suspect this documentation structure if the documents were provided ahead of time.]

Although the "Customer-Related Processes" procedure ("Contract Review" procedure?) corresponds to the Sales process and the Purchasing procedure corresponds to the Purchasing process, the balance of the "procedures" do not address the remaining realization processes--Receiving, Production, and Shipping--in a process approach fashion. Rather, an element-by-element approach is apparent. [The existing correlation between the two realization procedures and their respective processes appears to be coincidental, as the applicable requirements naturally pertain to these two realization processes; further, the balance of the QMS "procedures" addressing realization requirements appear to confuse activities and processes, again failing to properly determine processes needed for the management system.]

Thus, by failing to determine processes needed for the quality management system, the organization has CLEARLY not met the requirements of ISO 9001:2008, 4.1a to "determine the processes needed for the quality management system." Please refer to the following guidance regarding the process approach . . . [ISO/IAF APG guidance . . . N544R. . . ISO 9000:2005 . . . ISO 9001:2008 . . . not a lot out there, really, is there? ISO 9004:2009 could be referenced, but only after organizations have adopted the process approach, it seems. Then sustain it.]

As an observation, it might look more like this:

The QMS, as defined, is in questionable conformity with the intent of ISO 9001:2008, 4.1a. [Use as much of the language from the above finding as you like to properly describe the nature of the finding.] This finding is raised as an observation pending further direction to raise it as a nonconformity. [?] And/or . . . an opportunity to streamline and simplify the defined QMS exists. And/or . . . what other opportunities for improvement might the process approach offer? Again direct the auditee to good information about the process approach.

Another thought: it seems common practice to offer thinly-veiled (and not necessarily inappropriate) advice by saying, "I've seen other companies do it successfully this way . . ." If this "commentary" is acceptable, all an auditor needs to know is one good example of a company using the process approach. "I've seen XYZ company use the process approach . . ."

 

[Jen Kirley]

I have some questions.

If they aren't doing Product Realization, why not write it up under 7.1?

If they are doing an element-by-element approach and have a process as rquired in element 7.1, why is it getting written up as not having a process approach?

What if the output of their planning was a process called Production, into which they wrapped up the process of not only planning of production, but its inputs such as customer requirements and considerations, etc?

Is this about not meeting the requirements of the Standard, or not exhibiting doing so in a way that would give you confidence they were applying a process approach?

 

[ISO 9001 Guy]

Oh come on, don't be coy. Educate me. Pretty please.

By way of further education, if you like, when it comes to writing findings, auditors should carefully understand the ISO/IAF APG Guidance on: Documenting a Nonconformity. When the criteria in the guidance are applied properly, many, many less-than-helpful findings simply go away. Including all of them based solely upon an auditor's opinion. Again, "promoting" the process approach is not an auditor's opinion. According to the guidance, it's their job. It's the rest of the opinions they should keep to themselves.