Poll: Should auditors promote the process approach?

[ISO 9001 Guy]

This kind of response, which I see throughout this thread, is rather silly, is somewhat condescending as if there is one authority (e.g.: "I was hoping not to just spoon feed it."), and is essentially troll bait. It keeps this thread running around in little circles.

I will leave the thread open, but caution those of you who are getting emotional about 'the process approach' vs. 'the element-by-element approach' that your string is being pulled (aka your button is being pushed). This has to be one of the longest circular, and in general nonsensical, discussion threads I have ever seen.

From this point on: Participate at your own risk.

Please understand, I don't view myself as a sole authority about ISO 9001 or the process approach. No, no, no. The question was directed solely at me, however, about what I would consider evidence. (On that topic, I guess I am the authority?) I was hoping to offer the answer in a different way, since such an open question, and since I had answered it previously in so many words (I thought). I was trying to get at the characteristics of a controlled process to consider what I might constitute evidence of "application" of the process approach. These same characteristics are often recognized at the individual process or activity level, but not at the system level.

Jennifer had previously conveyed how the principles of process approach are present at a process level, even within an element-by-element system. Trying to respect this view (a valid observation) while formulating the response started me off wrong. Sorry about that. (I will apologize to her in PM, too.)

Also, I regret the "spoon-feeding" comment. By it, I meant "just give the information." (Accelerated learning techniques--of which I am only basically aware--frown upon simply giving information, but assisting in the digestion of the information. The prior might be called "spoon feeding.") I sincerely regret any offense tendered.

Thanks for putting up with me, everyone, and especially to you, Marc.

 

[ISO 9001 Guy]

I'll chime in. Fun this is NOT. There have been numerous very direct questions asked of ISO guy, with very unclear or unconnected answers/responses, given.

Those operating process-based QMSs see more value in their audits in general. Why? Because when auditors--internal or external--are auditing real processes, they focus on the processes. No time is wasted reviewing element-by-element procedures; only real procedures are reviewed. No time is wasted auditing conformity to "planned arrangements" captured in documents that do not address processes.

Using the process approach to audit results in a more efficient audit. An audit of a process-based QMS is more valuable than an audit of an element-by-element system.

 

[ISO 9001 Guy]

The difference between the two questions is relevant to answering the question. A company can apply process approach principles--thus applying the process approach in some sense--yet fail to apply the process approach at the system level (by defining it using an element by element approach).

I hedged my bets and answered a little of both. (You might notice the question changed slightly as I was answering it, too, from the original inquiry about 8 management principles.)

 

[ISO 9001 Guy]

I think we could have avoided a lot of hassle by avoiding repeating jargon from the beginning and talked more about the actual subject.

I have an idea. Why don't you post a paper on the subject in the Reading Room? Then maybe you could answer our questions at your own pace, and provide some practical, useful, real world guidance that we could actually apply in the workplace. This thread is devolving into a coy game of egos.

Could we use the previously attached articles? Though dated, they are relevant to the discussion, don't you agree?

 

[John Martinez]

Re: Should auditors promote the process approach?

While the "Process Approach" makes a lot of sense, it is a recommendation and not a requirement. If an organization decides to audit based on the clause-by-clause approach, that is their choice. If the process approach is not well understood or not well implemented, it may be a better choice for such an organization.

Stijloor.

While there is no requirement for an organization to perform process based internal audits (ISO 9001), how can you state that it is not a requirement in light of all of 4.1?????

 

[Jim Wynne]

Re: Should auditors promote the process approach?

While there is no requirement for an organization to perform process based internal audits (ISO 9001), how can you state that it is not a requirement in light of all of 4.1?????

Can you clarify your question? In the first part of it you say (correctly) that there is no requirement, and then in the second part you suggest that there is a requirement. The OP is suggesting that documenting a system element-by-element and the process approach can't peacefully coexist. Do you agree?

 

[ISO 9001 Guy]

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 effectively 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 . . ."

With all of the talk of effectiveness prior to this post, I oddly forgot one word in the above finding. (A thanks to my mentor for pointing it out.)

 

[outoftown]

It's been a while since I posted and I apologize if similar postings have covered what I'm about to say. I have worked over 15 years for various CBs and am as probably well-versed in the process approach as anyone. I can state from experience that depending on the CB, the process approach is discouraged or misunderstood at some and barely tolerated at others. I lost two auditor jobs at different CBs for following a results-based process auditing approach. At a large, well known CB, I was chatised by a trainer less than three months ago for not having evidence of auditing each and every clause that she listed by each item on the agenda. My evidence instead focused on the inputs, outputs, resources and measures of effectiveness. She stated I forgot what I learned in "Auditing 101" were her exact words. I was so flabbergasted with what she was saying I was speechless. I was also asked to leave another CB several years ago with the explanation from the ops manager that "I'm not sure what you are doing and we may hire you back as a consultant to train us one day, but it doesn't fit with what we are currently doing." I began to realize and I think this has been exacerbated by the consolidation of CBs that the competence of the audit staff must be set at the lowest common denominator, so the clients will not notice a difference in the level of service provided. If you want a process-based audit and are stuck with a compliance-only based auditor, my advice is to get that auditor banned from returning. If others sent by the CB also do not meet your expectation of process approach auditing, the best thing to do is change CBs. Before you blame the CBs for not endorsing a process approach, keep in mind the management at most of these CBs earned their keep during the ISO 1994 and QS9000 era. Most look at ISO 9001:2008 and TS 2009 as not requiring substantially different knowledge in order to audit. Personally I was given only 16 hours of training for ISO 9001:2000 and for TS16949 there was rarely any training after QS9000 except review of IAOB findings and coaching to pass the exam. The IAOB has screened out some auditors that did not understand the process approach but I am still somewhat surprised by the number of TS auditors that know better but still ignore a process approach. Examples of this include not caring what processes the client has identified or not using these processes for their agenda, ignoring the process descriptions, ignoring key measures, asking for and looking at procedures with every interviewee, auditing based on the number of records sampled, rather than the determination of process effectiveness and efficiency. One CB requires their TS auditors to count the number of interviewees and determine the ratio of personnel audited to the total number of employees. The top management is sometimes left out of the audit, but as long as that ratio is high... The message here is quantity wins over quality.

 

[Jim Wynne]

<snip>
I have worked over 15 years for various CBs and am as probably well-versed in the process approach as anyone. I can state from experience that depending on the CB, the process approach is discouraged or misunderstood at some and barely tolerated at others. I lost two auditor jobs at different CBs for following a results-based process auditing approach. At a large, well known CB, I was chatised by a trainer less than three months ago for not having evidence of auditing each and every clause that she listed by each item on the agenda.<snip>

I don't think you should be surprised at an employer being displeased at your doing something other than what was (probably) clearly expected, whether you consider it right or wrong. It seems that you want to turn CB audits into glorified internal audits. The purpose of a CB audit is to verify compliance with the standard, such that an audited company may achieve or maintain certification. If you returned from audits without evidence in the form expected by the CB, they would be correct (imo) in being unhappy about it. "The organization" should be doing its own process audits, and a CB auditor should look for evidence in that direction, but again, the purpose of a CB audit is to verify compliance with the standard.

 

[Jen Kirley]

My understanding is that CBs are required to audit the complete standard, at least within the registration cycle (if not annually) so if you had missed some elements (it may even have been a case of incomplete recordkeeping in your notes) I would not be surprised to learn your employer was upset.