Cl. 4.2.2 - Quality Manual includes a description of the interaction between the ...

D

DrM2u

#11
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

Hmmm, looks like something posted here a while ago.....:notme:
It is possible. I am not taking credit for coming up with the concept, just for making it work for my clients and building onto it.
 
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J

JaneB

#12
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

Virajs,
Keep in mind that the important thing overall is the knowledge that you gain from the exercise - I think more important than the result in this case.

It can be quite complex to try and describe or diagram process interactions, and there are various ways to accomplish it. Note: It doesn't have to be a diagram - it can be as simple as writing a paragraph or two (say) of text. After all, the wording says a description.

Many people attempt to draw it as a diagram, and there are many different ways and models. A few have been posted here - you'll find many others in the attachments if you search the Post Attachments List (look at that long green bar with that name at the top of the screen).

You'll find they tend to fall into some broad categories:
  1. those that just copy the Standard - a kind of 'straight down the line' model (see the model at the left in DrM2U's post) which then basically just adds on their procedures to the diagram; not very useful in my opinion
  2. those that attempt to capture 'all' their processes - see the model on the right in DrM2U's post for example or perhaps the one titled QMS overview example; can be useful IF the organisation understands and uses it
  3. the original - may not look anything like anyone else's, but usually means a lot to the organisation

But do keep in mind: the important thing is to be aware of the interactions, not to spend ages trying to draw 'em up or explain them.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#13
Credit where Credit is Due

Hmmm, looks like something posted here a while ago.....:notme:
It is possible. I am not taking credit for coming up with the concept, just for making it work for my clients and building onto it.
Ummmmm, then can we get a link or info as to the "...something posted here a while ago..." so we can give credit where credit is due?

Thanks in advance!
 
I

ISO 9001 Guy

#14
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

Why would someone describing the sequence and interaction of their QMS processes NOT include all of their QMS processes? I suppose if your system is composed of a bunch of procedures that are non-processes, you might exclude some from the description of sequence and interaction. Otherwise, it's a good idea when describing seq and int to describe the seq and int of all the QMS processes, isn't it?
Is there some value to omitting QMS processes from the description?
 

Stijloor

Staff member
Super Moderator
#15
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

Why would someone describing the sequence and interaction of their QMS processes NOT include all of their QMS processes? I suppose if your system is composed of a bunch of procedures that are non-processes, you might exclude some from the description of sequence and interaction. Otherwise, it's a good idea when describing seq and int to describe the seq and int of all the QMS processes, isn't it?
Is there some value to omitting QMS processes from the description?
Dan,

One of the reasons is that the model that is typically used, becomes too cluttered. I like the 30,000 ft view depicting the flow from order to invoice and the details in the various separate process maps and supporting documentation.

It's like Google Maps, I like to zoom in, but also zoom out to get a better understanding of where I'm going.

Stijloor.
 
I

ISO 9001 Guy

#16
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

I agree. Viewing processes from the 30,000-foot view, as you say, is useful in laying out QMS processes and their sequence and interaction. When diagrams are requested by clients or auditors, I like block diagrams because they define processes at an appropriate level: 30,000 feet. Defined at this level, I see no reason why QMS processes should be omitted. A QMS IS a system of processes--management processes.

ISO 9001:2008 4.1a requires the organization to determine the processes needed for the QMS, while 4.1b requires the organization to determine the sequence and interaction of these processes. (Italics mine.) It seems that in defining a QMS, an organization should determine all of the processes impacting quality, shouldn't it? Isn't that kind of the point?

By requiring the sequence and interaction of processes to be described somehow, it's a good idea to include all processes comprising the system--assuming the processes are sensibly defined. Those who allow the standard to identify their processes surely have a mess to deal with. But that very well might have been part of the intention of the requirement to define seq and int. Those who have allowed the standard to identify their realization processes should recognize by going through the seq and int exercise that there IS no seq between standard-based "procedures," and their interaction will always be confusing at any level. I don't think the idea is to omit procedures that don't fit into a description of the sequence and interaction of QMS processes; delete them instead.

The attached is a hybrid between my previous two posted examples. Again, diagrams aren't necessary, but sometimes a picture is helpful. This one depicts the four primary processes of a small machine shop, in order of appearance. I like the icons showing the support processes, simply because they show precisely which support processes support which primary processes--to demonstrate a fairly clear interaction between the processes. It also shows an example of how the requirements of ISO 9001 are addressed in process fashion.

Many make the mistake of looking to the standard to identify their processes (e.g., "Product Identification" or "Inspection and Test Status"), which results in a confusing smattering of "procedures" describing (or failing to describe) real processes--the ones that were being operated and managed before ISO 9000 came along. Like the requirements they reflect, there is no particular sequence or interaction between the requirements, thus there is no particular sequence or interaction between procedures based upon these requirements.

But there is definitely a very real sequence and interaction between real processes affecting quality (e.g., sales, purchasing, receiving, production, shipping). These are the processes to which procedures should have been dedicated in the first place, rather than to the disparate requirements of the standard. Properly defined, the sequence and interaction of these processes is not difficult to convey in a variety of formats, such as the above sequenced list. A block diagram such as the attached shows all of the QMS processes and how they relate. In this particular case, with the exception of "calibration", the support structure is very similar for each realization process; the "calibration" process only supports two realization processes: Shipping and Receiving, and Production. In more sophisticated organizations, the interaction of the support structure might be slightly different.

At any rate, once (real) QMS processes have been determined, the standard requires their sequence and interaction to be determined as well. If you say you have a QMS process--a management process affecting quality--then the standard reasonably requires you to determine how it fits into the quality management system. Although this is terribly difficult to do if a bad approach was used to define and document the system, that doesn't mean the principle should be abandoned. In the case of a standard-based system, a block diagram showing real processes while also identifying which requirements (and thus which procedures) apply to each QMS process might help clarify the confusion (sic).

To define a QMS as a system of processes affecting quality--which is what a QMS is--it seems a description of those processes and their sequence and interaction is common sense, doesn't it?

Sorry to ramble . . .
 

Attachments

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D

DrM2u

#17
Re: Credit where Credit is Due

Ummmmm, then can we get a link or info as to the "...something posted here a while ago..." so we can give credit where credit is due?

Thanks in advance!
I have not seen a similar example in here however I have seen a couple of close examples during previous audits that I expanded and built on. Kind of like BOSCH: 'we don't invent the weel, we make it better' (or something like that).
 
D

DrM2u

#18
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

I was asked for an editable copy of the sample quality manual, so here it is.
 

Attachments

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#19
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

The attachment unzips to a file named: "Company Overview.pub"

Only Word for Windows can open a .pub type of file as far as I can tell. A standard .doc file would be a better choice.
 
D

DrM2u

#20
Re: Cl. 4.2.2 - Quality Manual includes a description of the interaction between the

The document was created in MS Publisher to preserve the layout and released in pdf format for better control. Someone with patience and more knowledge of Word than me could easily convert it to Word if necessary. :)
 
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