Poll: Should auditors promote the process approach?

[ISO 9001 Guy]

Re: Should auditors promote the process approach?

I do not think it's the auditor's responsibility to promote the process approach. They should stick to what they are hired to do and that is audit in accordance to what they contractually agreed to do and if they personally use the process approach to do it, I am all for it. But here is my concern: when the auditor starts "promoting" (verbal or in writing) some beneficial approach or method, many companies will likely oblige because it's "what the auditor wants", not because it's in their best interest. There are many discussions here in The Cove about what auditors "suggested" and were sadly interpreted as a requirement. See what I mean?

Stijloor.

Auditors are hired to identify opportunities for improvement, are they not? The guidance seems to suggest that it's an auditor's job to inform their auditee clients if a poor approach is being used. That doesn't really seem to be such a stretch. For organizations using the standard-based, elemental approach, adopting the process approach is clearly an opportunity to promote good, efficient, effective quality management--isn't it? Isn't that what the guidance from ISO/IAF is saying quite clearly? What's the down side?

 

[AndyN]

You make some interesting points, however, they are a long way off my experiences and views, so I'll watch from the sidelines!

 

[Big Jim]

I'm getting the impression that many on this thread seem to be thinking that the process approach applies only to auditing. It is much more than that.

ISO 9001:2000/2008 IS a process approach. It cannot be separated out. You cannot comply to the standard without using the process approach.

Starting with the third paragraph in 0.2 Process approach (the other paragraphs are pertinent too):

"The interaction of a system of processes within the organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the 'PROCESS APPROACH'.

The fifth paragraph outlines:

"When used within the quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider PROCESSES in terms of added value,
c) obtaining results of PROCESS performance and effectiveness, and
d) continual improvement of PROCESSES based on objective measurement".

Section 0.2 goes on to introduce the Deming "Plan-Do-Check-Act" wheel.

And then there is the opening portion in 4.1 where the overall concept of a quality management system is introduced:

The organization shall
a) determine the PROCESSES needed for quality management system . . .
b) determine the sequence and interaction of these PROCESSES,
c) determine the sequence and interaction fo these PROCESSES,
d) ensure the availability and methods needed to ensure that both the operation and control of these PROCESSES are effective,
e) monitor, measure where applicable, and analyse these PROCESSES,
f) implement actions necessary to achieve planned results and continual improvement of these PROCESSES.

4.1 goes on to show that outsources PROCESSES need to be controlled.

In element 8.2.3 the standard requires monitoring and ,where applicable, measurement of the PROCESSES.

So I don't see how you can comply to the standard without applying the process approach.

Now if you are talking about a process based internal audit program, that is a slightly different matter.

 

[ISO 9001 Guy]

Jim, are you suggesting that because an organization is certified to ISO 9001:2008, then a process approach must have been used to implement the system (or else they would not have been certified)?

 

[Big Jim]

Jim, are you suggesting that because an organization is certified to ISO 9001:2008, then a process approach must have been used to implement the system (or else they would not have been certified)?

With all of the references and requirements in the standard that I listed, do you see another way?

 

[ISO 9001 Guy]

With all of the references and requirements in the standard that I listed, do you see another way?

Organizations become certified using a standard-based, or elemental approach all the time. How can you tell? They have procedures written to address the requirements--e.g., Product Identification, Inspection and Test Status, Preservation of Product, etc.--rather than writing procedures to address their processes--e.g., Shipping and Receiving, Manufacturing, etc. It's very common. Surely you have seen plenty of organizations using this uniform procedural structure, based upon the standard.

Common enough, in fact, that ISO/IAF APG recognizes a current need to help auditors and auditees alike understand the process approach. Ergo the guidance of 5 June 2009--some of it directed at CBs to ensure all auditors understand the process approach. Those who don't fail to understand the intent of the standard. So it's reasonable that ISO would urge CBs to ensure auditor competence with regard "particularly" to the process approach (from the guidance itself).

Don't you think all ISO 9001:2008 auditors should understand the process approach? Is there an advantage to client/auditee organizations to use auditors who are not competent in the approach endorsed by the standard, not to mention the proper approach for quality management?

 

[Big Jim]

Organizations become certified using a standard-based, or elemental approach all the time. How can you tell? They have procedures written to address the requirements--e.g., Product Identification, Inspection and Test Status, Preservation of Product, etc.--rather than writing procedures to address their processes--e.g., Shipping and Receiving, Manufacturing, etc. It's very common. Surely you have seen plenty of organizations using this uniform procedural structure, based upon the standard.
Common enough, in fact, that ISO/IAF APG recognizes a current need to help auditors and auditees alike understand the process approach. Ergo the guidance of 5 June 2009--some of it directed at CBs to ensure all auditors understand the process approach. Those who don't fail to understand the intent of the standard. So it's reasonable that ISO would urge CBs to ensure auditor competence with regard "particularly" to the process approach (from the guidance itself). Don't you think all ISO 9001:2008 auditors should understand the process approach? Is there an advantage to client/auditee organizations to use auditors who are not competent in the approach endorsed by the standard, not to mention the proper approach for quality management?

I have not seen one for a very long time. The real swing was when CB audits moved to the process approach instead of an element based checklist about early 2005. Even before they still needed a quality manual with an interaction of processes description and they needed to be able to demonstrate the points I pulled up on my last post.

When the auditing transition was made, there were a lot of companies with junk interaction charts that auditors had to deal with, but I have not seen a really bad one for some time.

 

[ISO 9001 Guy]

I have not seen one for a very long time. The real swing was when CB audits moved to the process approach instead of an element based checklist about early 2005. Even before they still needed a quality manual with an interaction of processes description and they needed to be able to demonstrate the points I pulled up on my last post.

When the auditing transition was made, there were a lot of companies with junk interaction charts that auditors had to deal with, but I have not seen a really bad one for some time.

So, when you run across an organization that has based its procedures on the elements of the standard--Product Identification or Product Identification and Traceability, Inspection and Test, Inspection and Test Status, Customer Property, Contract Review, Preservation of Product or Handling, Storage, Packaging, Preservation and Delivery--do you suggest to that auditee organization that "adopting the process approach" represents an opportunity for improvement and direct the organization to good information about the process approach?

 

[Randy]

Auditors should promote the effective meeting of requirements, the fulfillment of commitments made in the policy and the achievement of quality objectives....that's it.

The how, wheretoo's and wafore's is upto the organization being audited (Unless the process approach is and of itself a requirement)

 

[ISO 9001 Guy]

Auditors should promote the effective meeting of requirements, the fulfillment of commitments made in the policy and the achievement of quality objectives....that's it.

The how, wheretoo's and wafore's is upto the organization being audited (Unless the process approach is and of itself a requirement)

Effective meeting of requirements. The elemental approach is effective in meeting the letter of the requirements, but is not effective at meeting the intention of the standard. In aligning perfectly with a standard, procedures fail to align perfectly with an organization's own processes. The distinction between meeting the letter and meeting the intent should not be dismissed when discussing effectiveness.

Please see the attached articles regarding the process approach. (I wrote them myself years ago.)