Process Approach Litmus Test - Procedure Titles

[Jen Kirley]

Re: Process Approach Litmus Test

Those are guidance documents. Organizations are certifying to ISO 9001:2008, not the supporting guidance documents. Please excuse my nit-picking, as I am an auditor and I focus on black and white as much as possible. If you had said a process approach litmus test is that a QMS includes processes for (subjects) I could have followed along. But I don't audit titles of documents. I audit their content.

That said, I can't describe how often I have wished for single-source process documents (could be web pages too) that show how all the individual process documents fit together to serve as something like "Control of customer property." But even they wouldn't be of much more than passing interest, as they would be serving more like a schematic.

 

[Stijloor]

Re: Process Approach Litmus Test

Dan,

No disagreement here. I believe that most of us consultants/auditors/practitioners/quality systems folks will agree. But there is no "Shall" in ISO 9001:2008 that states that the process approach "shall" be used.

That's my point.

Stijloor.

 

[AndyN]

Re: Process Approach Litmus Test

I'm not seeing the point here - the 'litmus test' of what? As has been stated, document titles don't mean much without context. The standard doesn't demand any specific 'approach' and a well defined system might still have documents which, without further information, appear to be formed on the individual requirements of ISO 9001. Let's face it, the structure of any QMS is the organization's choice, including what to call something, or where a document called a 'procedure' resides in that structure.

Are you thinking "conventional wisdoms" here? Or "out of the box"?

 

[Marc]

I think this is essentially a rehash of this old thread: Should auditors promote the process approach? which is something like 320+ posts about what is these days a relative term - Process Approach.

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

Dan,

No disagreement here. I believe that most of us consultants/auditors/practitioners/quality systems folks will agree. But there is no "Shall" in ISO 9001:2008 that states that the process approach "shall" be used.

That's my point.

Stijloor.

Arguing whether the process approach is required is tantamount to arguing whether the standard allows cheating or not. It appears many on-line practitioners are happy to provide a complete set of documents that address the requirements of the standard. This exemplifies the elemental approach and is contrary to the process approach. So elemental approachers are very common and often they mistake themselves for process approachers.
I get a kick out of the on-line experts who appear to understand the process approach, then they turn around and sell you sets of documents addressing the standard rather than addressing organizations' processes.
See what I mean?
Also, because the standard is one of effectiveness, organizations using an elemental approach have not effectively met the requirements of ISO 9001:2008, 4.1. Such documentation reveals that rather than determining processes, elemental approachers have effectively identified the requirements of the standard as being or as being included among, their organizational processes. (Evidence? The procedures that are dedicated to requirements rather than being dedicated to processes.)

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

Can you provide an example of an organization whose processes are: Customer Property, Product Identification, Inspection and Test Status, and Preservation of Product? Were these any organization's processes before ISO 9000?

I mean, organizational process were operating before ISO 9000 came along. Yet only after pursuing ISO 9000 registration did they choose to view processes according to the requirements of the standard--as is reflected by their QMS procedures.

When QMS procedures reflect the clauses or sub-clauses of the standard's realization requirements, an elemental approach is apparent. According to the ISO/IAF Auditing Practices Group, as released in official guidance (www.iso.org/tc176/ISO9001AuditingPracticesGroup) an elemental approach should be noticed during stage 1 auditing. And the audit should stop until the requirement to use a more sensible approach is understood.

 

[Stijloor]

Re: Process Approach Litmus Test

Can you provide an example of an organization whose processes are: Customer Property, Product Identification, Inspection and Test Status, and Preservation of Product? Were these any organization's processes before ISO 9000?

I mean, organizational process were operating before ISO 9000 came along. Yet only after pursuing ISO 9000 registration did they choose to view processes according to the requirements of the standard--as is reflected by their QMS procedures.

When QMS procedures reflect the clauses or sub-clauses of the standard's realization requirements, an elemental approach is apparent. According to the ISO/IAF Auditing Practices Group, as released in official guidance (www.iso.org/tc176/ISO9001AuditingPracticesGroup) an elemental approach should be noticed during stage 1 auditing. And the audit should stop until the requirement to use a more sensible approach is understood.

From that site:

Disclaimer

The contributions on this website have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176 or the International Accreditation Forum (IAF).

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

Has an organization employing elemental procedures effectively met the requirements of 4.1? No. Rather, elemental procedures demonstrate a confusion between requirements and processes. So, no: they have not effectively met the requirements of 4.1a, or any of the requirements of 4.1.
In fact, to put it bluntly, they are evidence that somebody has missed the point of what a QMS is.
Using a standard intended to assess QMSs as a guide for QMS document structure is basically paying lip service to the requirements yet it is still today widely regarded as best practice. (Look at all the ISO 9001 procedure sets available on-line--documents based upon the requirements rather than on processes.)
The requirements of 4.1 are all about processes--real processes. Documents structured according to the standard's requirements and designed to meet those requirements (by pandering to them) are not procedures (by definition, as they do not address organizational processes). Not only are they not required by the standard, they demonstrate nonconformity with the standard--they demonstrate that processes needed for the QMS have not been effectively determined. How? At least some of the identified processes are not, and never were, organizational processes in the first place.
So, yes, the standard does effectively require a process approach. But so many in the industry have been promoting an elemental approach as best practices for decades, it's kind of hard for them to turn around now and find a problem with what they have insisted upon for years. See what I mean?

 

[Marc]

Re: Process Approach Litmus Test

Arguing whether the process approach is required is tantamount to arguing whether the standard allows cheating or not. <snip>

That's a bit of a stretch to relate the two.

To repeat what many have said: Show me the *Shall*. So far I have have only seen arguments that it is a good idea (as if it wasn't already the way every business works).

What get's me is this: I am 61 and I'm retired. I have worked with a lot of companies over the years. I wrote this back in the mid 1990's: The Organization as a System, Subsystems, and Processes. The "presentation" has been updated a few times over the years, but the essentials are still the same. Businesses are a set of processes and they interact. If they didn't they couldn't run. To use a car analogy, if you don't connect the fuel line to the fuel tank, the car will not run. Appropriate systems *have* to interact.

This is one of my favourite slides from back then:

When people started throwing out "The Process Approach" around 2000 I knew this would happen. Just like "Six Sigma" (which I consider a set of tools) is being sold as (to some degree) an ideology, "The Process Approach" is trotted out as some sort of new, magical cure-all. It is neither new, not a cure-all.

Heck - Back when I was in college in the 1970's my major was biology. We were taught that everything is a system - A set of processes and their underlying sub-processes, sub-sub-processes, etc. - Whether they be animals, plants, or, in fact, the world as a whole. That is one thing about college that made it easy for me to understand the business world. The courses that taught me about the interaction of processes/systems were:

Biology
Chemistry
Anthropology
Physics
Math (several courses)​

To take these courses you had to have a good understanding of the aspect of *ALL* things that everything, the entire earth, is a series of processes (aka systems).

If one wants to think about it a bit, there isn't anything that isn't connected to something else in one way or another. In the context being discussed being businesses, one may not always *think* of these as processes, but that's what they are.

I also think there are misconceptions in all this. There have been, and I believe always will be, auditors who audit to the requirements of ISO 9001 (which is what this is really all about with respect to this discussion). There are bad auditors who neglect looking at the *interaction* of processes closely. Yet - Even back in the early 1990's when I was working with companies implementing ISO 9001, and doing auditing, I (and the other auditors and consultants I knew) did not simply implement and/or audit to the requirements of ISO 9001 in a vacuum. We looked at each process. We looked at procedures defining the processes and when we did that we looked at process interactions. We had to. That's the way every individual process works. Every process has one or more inputs and one or more outputs. We had to ensure that outputs from any given process were inputs to one or more successive processes in the chain. We then followed trails from one process to the next to ensure that the outputs were effectively being input to the successive process and that the successive process did in fact use the inputs as described in their related procedure(s).

Back in college we never spoke of a "process approach", but it was everywhere and understood for what it was and is - Everything is a process (aka system), and every process has at least one input and at least one output. Taking a combination of chemicals and mixing them together can produce a reaction. That reaction is a set of processes which occur in which things change just as a series of processes in an assembly line where we in business call it "transforming" (e.g.: from raw material to finished product, each intermediate processes transforms what was input into it).

That is not to say that some companies are not "sick". That is to say, there are processes that are supposed to interact, but one or more process is broken. One that I see break a lot is Contract Review.

"The Process Approach" as seen today is a sales pitch.

 

[ISO 9001 Guy]

Re: Process Approach Litmus Test

I tried to post this as a reply to another post. (Sorry.)
So another reason to adopt the process approach: it makes sense. Effectively claiming a process for each requirement (by dedicating a procedure to each) is cheating and the only ones benefiting are consultants and auditors. Organizations--customers in this arrangement--are left rightly confused by a smattering of elemental procedures that do not correspond to their own processes.
The objective of cheating is generally to achieve an objective by exerting LESS effort than would otherwise be expended by not cheating. Those using an elemental approach are basically cheating, yet they often exert MORE effort bending over backwards pandering to the standard than they would if they simply complied in the first place. Whoever thought this was clever outclevered themselves.
The process approach is just good sense. (A difference between common sense and good sense?)