Poll: Should auditors promote the process approach?

[ISO 9001 Guy]

My point is not about various levels of documentation. I simply asked: "Since when is an activity not a process?" Trust me, I am very familiar with documentation and how all parts relate to one and other in a quality management system.

I think that you are now at the molecular details of a QMS. No need for me to go further. I wish you the very best with your mission.

Thank you.

Stijloor.

Sorry if my answer exceeded the question. Did the first sentence do it?

According to the ISO/IAF guidance, it appears, it is not MY mission. It sounds like somebody's mission, and I'm happy to help, but the guidance isn't directed at me personally--it appears to be directed at CBs, doesn't it?

 

[ISO 9001 Guy]

My point is not about various levels of documentation. I simply asked: "Since when is an activity not a process?" Trust me, I am very familiar with documentation and how all parts relate to one and other in a quality management system.

I think that you are now at the molecular details of a QMS. No need for me to go further. I wish you the very best with your mission.

Thank you.

Stijloor.

Molecular details add up, no? I wonder how many *millions?* of dollars worth of resources are wasted in the ISO 9001-certified supply chain with these molecular details? (Include those in sector schemes, too--ISO 13485, ISO/TS 16949, AS9100, even ISO 14000 . . .) I mean, collectively, if we added up the following operating costs in organizations using the element-by-element approach to comply with management system standards:

Time spent training employees to unnecessary "procedures" that do not describe processes, thereby wasting the time spent training (trainer and trainee), perhaps inviting the need for more training (and more documents) to address processes that go undefined by standard-based "procedures".

Time spent internally auditing unnecessary "procedures"? (Number of hours X hourly rate X 2--since these folks could be doing REAL work instead of spending that time auditing unwanted "procedures.")

Time spent adjusting/modifying these "procedures", management time reviewing and approving the procedures (initially) and updates thereto.

Resources spent administering these "procedures"--storing them, handling them, re-distributing them . . . retraining to them.

External auditor time dedicated to these "procedures" (if any).

Your chemical company, for example, Stijloor. Do they know how much the above costs are? Perhaps before it's dismissed as molecular detail, we should apply measurement first to determine its actual size. (Fact-based decision making . . . hmm.) Do we assume this cost is acceptable without measuring it? Or at least estimating it?

In organizations squeezing every dime, who has the luxury of accepting this muda (waste) that is errantly built into their QMSs? And this doesn't begin to measure the less tangibles that a poor concept of process/system/quality management promotes. Is this a good idea from a "management by example" perspective? What message does the element-by-element approach send to personnel: if requirements are unpopular (or not clearly understood), make complying more difficult and more costly than necessary? Confusing conformity is preferable to sensible quality management? Does management encourage employees to do things sensibly while training them to observe less-than-sensible procedures? Is this seriously how management would choose to manage quality if a sensible alternative was presented in the first place?

 

[Jen Kirley]

Is "Product Identification" a common organizational process? How about "Customer Property?" "Inspection and Test Status?" Are these processes? Where does the customer property process begin and end? Customer property doesn't even sound like a process--something that happens, something with a beginning and an ending. Certainly not a value-added realization process, generally speaking, is it?
If customer property is a process in your organization, is it one that requires management? Should management measure this process to improve this "process"?

Why are you asking me to, in effect place these subjects under an electron microscope? Most of us don't spend a great deal of effort in understanding where the customer property process, if it is recognized as a necessary part of the QMS, begins and ends. We usually work at doing it right: managing the customer property appropriately, maintaining traceability, etc. Call me a hack if it seems appropriate, but I don't have time to analyze it all that deeply. I'll look for effectiveness and conformance to internal and external requirements, and help build efficiency when and where I can. When I can do that it's a good day. When I can't, I muster my energy and resolve for the next opportunity. After all, I audit to three standards plus manage the Document Control system. Yes, I advocate to reduce the number of process documents and look for ways to suggest making the many documents cross reference each other better. I can do that based on my experience, which is good and something my people haven't had a lot of exposure to in their internal auditors.

I have been in a lot of places in my decades of QA service, and I have found it is usually this way in some degree or other. It's an imperfect world, but we generally do what we can with what we're given. We don't usually have a lot of time for philosophizing or navel examining.

 

[ISO 9001 Guy]

Why are you asking me to, in effect place these subjects under an electron microscope? Most of us don't spend a great deal of effort in understanding where the customer property process, if it is recognized as a necessary part of the QMS, begins and ends. We usually work at doing it right: managing the customer property appropriately, maintaining traceability, etc. Call me a hack if it seems appropriate, but I don't have time to analyze it all that deeply. I'll look for effectiveness and conformance to internal and external requirements, and help build efficiency when and where I can. When I can do that it's a good day. When I can't, I muster my energy and resolve for the next opportunity. After all, I audit to three standards plus manage the Document Control system. Yes, I advocate to reduce the number of process documents and look for ways to suggest making the many documents cross reference each other better. I can do that based on my experience, which is good and something my people haven't had a lot of exposure to in their internal auditors.

I have been in a lot of places in my decades of QA service, and I have found it is usually this way in some degree or other. It's an imperfect world, but we generally do what we can with what we're given. We don't usually have a lot of time for philosophizing or navel examining.

"I have found it is usually this way in some degree or other." Sadly true. Taking the time up front to clearly understand requirements can spare us--in some degree or other--from engaging in non-value-added activities for the sake of conformity. Don't you agree? It's just good QA, isn't it? But understanding these requirements properly might not require a microscope, as you suggest. In fact, sometimes we get too close to things to see them properly, denying ourselves a perspective of their natural context.

Does your organization operate element-by-element procedures?

If so, do you know how much it costs to operate that system, relative to a process-based system?

If not (meaning you are not using the element-by-element approach), I am glad too much time/effort is not consumed with these "processes" (e.g., customer property, product identification, etc.). Because if "procedures" were dedicated to such "processes," that would be dedicating too much time and effort.

 

[Richard Pike]

In general many people in this thread seem to be confusing the Role of Quality Representatives - and Quality Auditors. If the Quality Rep has missed or is unable to demonstrate an effective compliant QMS then it is their competence that should be brought into question!

The PRIME responsibility of Auditors is to AUDIT! Identifying improvement actions "adding value" is secondary! If initial and subsequent Auditors had done the effective compliance evaluation properly, then there would be absolutely no need for the discussion as to if Auditors should "pressurize" organizations to "more formally" follow a Process Approach!

Note: as for ISO - they cannot change the rules after a contract has been entered into- only on formal Standard upgrade / re-issue.

 

[Big Jim]

In general many people in this thread seem to be confusing the Role of Quality Representatives - and Quality Auditors. If the Quality Rep has missed or is unable to demonstrate an effective compliant QMS then it is their competence that should be brought into question!

The PRIME responsibility of Auditors is to AUDIT! Identifying improvement actions "adding value" is secondary! If initial and subsequent Auditors had done the effective compliance evaluation properly, then there would be absolutely no need for the discussion as to if Auditors should "pressurize" organizations to "more formally" follow a Process Approach!

In an ideal world, yes. I run into very few such companies. What should we do with the companies that fall way short? Should we try to help within the bounds of "value added"? I think we should.

 

[Jen Kirley]

"I have found it is usually this way in some degree or other." Sadly true. Taking the time up front to clearly understand requirements can spare us--in some degree or other--from engaging in non-value-added activities for the sake of conformity. Don't you agree? It's just good QA, isn't it? But understanding these requirements properly might not require a microscope, as you suggest. In fact, sometimes we get too close to things to see them properly, denying ourselves a perspective of their natural context.
Does your organization operate element-by-element procedures?
If so, do you know how much it costs to operate that system, relative to a process-based system?
If not (meaning you are not using the element-by-element approach), I am glad too much time/effort is not consumed with these "processes" (e.g., customer property, product identification, etc.). Because if "procedures" were dedicated to such "processes," that would be dedicating too much time and effort.

I think failure to use a process approach is a symptom, not a cause, and I would approach it as such. Reactive versus pragmatic thinking, immaturity of systems, cultural dysfunction and other factors can all contribute to what I'll call a paint-by-numbers QMS versus a more elegant, process based approach.

I have worked in places where nothing I could ever do would change them. Finally the management turned over to the yoiunger generation and, I expect, improvements came about in time. By the time that happened I had had enough and moved on to save my own dignity and sense of worth. But before I left, I handed the outgoing presiden't daughter my stack of p and n charts from a CNC process, and my calculations for ROI if they chose to enclose and climate control the space. She breathed a fervent "Thank you!" and I never saw her again.

Will the process approach save them money? Possibly, but it can be almost impossble to isolate a single independent variable and know that is saving or costing a company money. Oh we have the math and all those little charts, but human behavior remains the last frontier and chances are good that no matter how hard one tries to convert the heathens so to speak, it may or may not get done and they may turn out fine in any case.

I think we are making this subject way too complex and philosophical. It's not. Bottom line is, to maintain impartiality there is precious little a CB can do to promote the process approach. If that was not the case, it would get more than a wishful-thinking sermon in the Introduction 0.2.

However, to treat it as an added activity ignores what 0.2 is saying: the Standard itself promotes the process approach via its clauses and requirements. Even if they are just checking the boxes, a fully compliant organization will have the rudiments of a process approach regardless if it's got religion, so to speak. What it chooses to pursue from there is its own doing. Auditors can tell organizations when they get it right or wrong, why and by how much, but have the authority to do little else.

 

[ISO 9001 Guy]

I think failure to use a process approach is a symptom, not a cause, and I would approach it as such. Reactive versus pragmatic thinking, immaturity of systems, cultural dysfunction and other factors can all contribute to what I'll call a paint-by-numbers QMS versus a more elegant, process based approach.

I have worked in places where nothing I could ever do would change them. Finally the management turned over to the yoiunger generation and, I expect, improvements came about in time. By the time that happened I had had enough and moved on to save my own dignity and sense of worth. But before I left, I handed the outgoing presiden't daughter my stack of p and n charts from a CNC process, and my calculations for ROI if they chose to enclose and climate control the space. She breathed a fervent "Thank you!" and I never saw her again.

Will the process approach save them money? Possibly, but it can be almost impossble to isolate a single independent variable and know that is saving or costing a company money. Oh we have the math and all those little charts, but human behavior remains the last frontier and chances are good that no matter how hard one tries to convert the heathens so to speak, it may or may not get done and they may turn out fine in any case.

I think we are making this subject way too complex and philosophical. It's not. Bottom line is, to maintain impartiality there is precious little a CB can do to promote the process approach. If that was not the case, it would get more than a wishful-thinking sermon in the Introduction 0.2.

However, to treat it as an added activity ignores what 0.2 is saying: the Standard itself promotes the process approach via its clauses and requirements. Even if they are just checking the boxes, a fully compliant organization will have the rudiments of a process approach regardless if it's got religion, so to speak. What it chooses to pursue from there is its own doing. Auditors can tell organizations when they get it right or wrong, why and by how much, but have the authority to do little else.

The difference between "identify" (2000) and "determine" (2008) in 4.1a might be more than just a little detail. Please entertain my myopic philosophical excursion into this deliberate change of one little word. As a dictionary buff, you might appreciate the distinction. Although this wording change is not a change in the intent of the standard, it might clarify that intent a little. (And perhaps lend it some enforceability.)

"Identifying" a QMS process might be accomplished simply by saying what it is. So, one might "identify" "Customer Property" as being a QMS process, just as one might "identify" a product with a label. Then we can then tell what it is--identify it--by its label. Or by its name. If we have named our QMS processes according to the elements of a standard, we have succeeded in identifying them, have we not? We have named them or identified them or labeled them as such.

"Determining" a QMS process might be more than just saying what it is, or naming it. It seems "determining" QMS processes would require one to "figure out what those processes are," not simply label them or SAY what they are.

So, it might be that those who have identified the elements of the standard as being their QMS processes (or, they have named their QMS processes after the elements of the standard) have not determined their own processes. In other words, those using an element-by-element approach have not figured out what their QMS processes ARE and defined them accordingly. (Of course they HAVE figured those processes out--they operate them every day.)

A QMS defined according to the element-by-element approach FAILS to properly determine and define which organizational processes affect quality. Figuring out what those processes REALLY are and defining them accordingly seems crucial to managing a system of processes, doesn't it? It seems 4.1a actually requires it.

 

[Jen Kirley]

The difference between "identify" (2000) and "determine" (2008) in 4.1a might be more than just a little detail. Please entertain my myopic philosophical excursion into this deliberate change of one little word. As a dictionary buff, you might appreciate the distinction. Although this wording change is not a change in the intent of the standard, it might clarify that intent a little.
"Identifying" a QMS process might be accomplished simply by saying what it is. So, one might "identify" "Customer Property" as being a QMS process, just as one might "identify" a product with a label. Then we can then tell what it is--identify it--by its label. Or by it's name. If we have named our QMS processes according to the elements of a standard, we have succeeded in identifying them, have we not? We have named them or identified them or labeled them as such.
"Determining" a QMS process might be more than just saying what it is, or naming it. It seems "determining" QMS processes would require one to "figure out what those processes are," not simply label them or SAY what they are.
So, it might be that those who have identified the elements of the standard as being their QMS processes (or, they have named their QMS processes after the elements of the standard) have not determined their own processes. In other words, those using an element-by-element approach have not figured out and defined what their QMS processes ARE. Figuring out what those processes REALLY are seems crucial to managing a system of processes, doesn't it? It seems 4.1a actually requires it.

Give. Me. A. Break. I am dealing with a spectrum of people, most of whom possess advanced degrees, who care not a whit about the nuances between identify and determine. So far it's enough for me that they do a decent 5-Why analysis. I do not know if we will ever reach the mysticism of this kind of process approach.

 

[ISO 9001 Guy]

Give. Me. A. Break. I am dealing with a spectrum of people, most of whom possess advanced degrees, who care not a whit about the nuances between identify and determine. So far it's enough for me that they do a decent 5-Why analysis. I do not know if we will ever reach the mysticism of this kind of process approach.

I'm happy to agree to disagree here. (Let's also include the mysticism part about something we agree to disagree upon. I see nothing mystical about it in the least. Once you understand it, the element-by-element approach is what seems surreal.)
Thanks.