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Please Review my High Level QM (Quality Management) Process Map

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H

hrrvett

#23
Thank you everyone for your comments - they have helped tremendously.

I would like to take the time to discuss Patricia's flow. (I would have done this sooner but I have been quite ill and am just now catching up with things.)

First let me say that I hate to post comments on the board knowing that I cannot share the document and that overall, I may not answer your question. However, I respect Patricia and her property and will try my best to offer what I can.

Second, I've tried writing this post multiple times to include as much detail as possible and to ensure that it is as clear as possible. So please bear with me if it's still not clear - just ask me for clarification. :notme:

Patricia, if I write anything that is contradictory to your model, please correct me.

Patricia's "flow" was quite helpful and gave me a clear global understanding of the quality management system (I hadn't thought of it in those terms previously). She has both a static version (for posting) and an animated version (great for training) that are very professional, both in appearance and meaning.

It is not like most models or flows that you see. (that's a good thing in my mind) So I don't want you to think that you're going to get a "first we have sales, then purch, etc." You won't get that type of a model. Those processes are included in the model but are grouped into higher level processes (i.e., instead of "shipping" or "packaging", you might have "product realization"). It organizes the processes into MOPs, COPs, SOPs and shows how they interact at a very high level. It basically shows how inputs from the organization are fed into management and how they are then fed back into the organization but with more bells and whistles.

In regards to not changing for 4 years, I understand and believe it. The reason is because her model does not go into detail with the lower level processes such as "obtain part #" or "request quote" but rather keeps it high level and refers to processes as "product realization" for example. However, her model does specify the steps for product realization in this instance but generically (this is where some specifics to your company can easily be entered and this may require some minimal change over the years - however, I doubt it unless your company changes operations completely). An example is she may specify "mfg process validation" under product realization as a sub-process but she doesn't go into detail about you first obtain parts, build, test, review, approve, etc. So, a company that does not manufacture would not have "mfg process validation" under product realization but 5 years down the road, they may begin manufacturing and would have to modify the model. Does that make sense?

:topic:just a side note, since her model is very accurate, I am concerned with the fact that many models may technically be an infringement strictly because there are only so many ways one can model the ISO system at a top level. So I'm not sure if I agree with it just like I don't understand why ISO copyrights their info. The fact that most QMs border on infringement does not seem right - honestly, if we're following the system who cares if we used the same terminology. ...in fact, most auditors flip out if you don't use practically the same wording...not the best auditors but many of them... A very black and white view and I know that most QMs shouldn't model the ISO but their company processes but the principle is the same IMO. :2cents: But at the same time, this is Patricia's hard work of many many years so I do not mean to disrespect her at all. I am very thankful that she provided me another way to view the QMS.

Her model does demonstrate sequence as well. I think the animated version demonstrates this more effectively but the static version does as well. Many people have discussed that some flows do not show sequence effectively. I tend to disagree slightly only because it is hard to demonstrate sequence with businesses. Many processes seem to happen interchangeably - one not really coming first or last all the time, sometimes it's even hard to say which one really came first...chicken and egg. However, it is clear in Patricia's model.

I am torn between including a high level model or a mixed level model. I believe I will include both in our QM or integrate them. I believe my company needs to see both how the QMS runs at a system level and at a lower level (sales, then purch, then receiving, etc). I don't really see ISO requiring one or the either just the processes to run an effective QMS. (Sorry Pat, you may disagree with me.) I think the higher level is definitely needed and Pat's model shows this beautifully and the lower level is needed at least at the procedure level and perhaps at the QM briefly. A lot of times, it is hard for employees to look at a high level model and determine what "box" they fit into...that's primarily why I think we might need a mixed level model. (I'm running my version over with Pat to ensure it doesn't infringe on her copyright out of respect but I can't imagine it does - then I will post it.)

Further, I created a model that I felt was a bit more simplistic (doesn't have the whistles) and slightly easier to understand visually; at least for me. I forwarded it to Patricia because it may be infringement of the copyright and I thought I could offer some visual modifications. Perhaps she will allow that one to be shared but that is not up to me.

The bottom line is that I understand Patricia's model and believe that it applies to all companies. It is probably one of if not the best models that I have seen. (I would say the best but I like the one I modified for her better :notme::lol:) It is very valuable information that any company could use.
Is it required for your Quality System to work effectively? Probably not.
Could it help in the understanding of the system and ensuring that it runs correctly? Most likely than not, most definitely. (unless you already share this mentality and then it's just a great visual tool)
Would I adopt it if you're operating an up and running system that is working for your company? No only for the idea of "if it's not broke don't fix it."
Would I adopt it if you're beginning a system or updating it? Definitely.

I apologize for the lengthy post and hope that I have helped.:)
 
H

hrrvett

#24
I just wanted to add my mgmt model. (This is not the modified version that I sent to Patricia so please forgive as it is not as visually appealing as I would like.)

There are some changes that I need to make (adding control of NC product, adding change control, moving design and repair to product realization, moving the requirements box out of the customer area, etc) but I wanted to post something sooner than later so that you can see my ideas. I'll post the modified one when its complete after the holidays.

I hope everyone has a great holiday!
 

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J

JaneB

#25
I quite agree that my process map, or flowchart, or whatever you want to call it is lacking and over-simplified. But this is also intentional. You see I've been where Hrrvett has been. I've spent months mapping out entire business processes and in the end they really never contributed much value. Processes continually changed and it became a paperwork exercise to keep up, all the while we were losing focus on the quality of the product being shipped.
Andy, I tend to agree with you. I've also spent one heck of a lot of time trying to work on maps & diagrams of a whole system... and seriously questioned the value. These days, I don't waste much a lot of time on it.

Yes, Andy's is a simplified version. But it shows quite smoothly the main flow through to the customer, & what are core business & what are supporting processes (though yes, I'd add in planning & the NC/CA etc as well!). Frankly, I'd rather use simplified diagrams than the ones that try to put the whole kit & caboodle in & become very hard to follow. Any diagram that needs a lot of description to interpret it tends not to be very useful.

I found hrrvet's busy and complicated - I found Andy's refreshingly clear.

Let's not lose sight of the fact that nowhere in 9001 does it actually have a requirement for a process map or a system diagram. Neither of those phrases appear in it anywhere.

There are many ways to meet the requirements for sequence & interaction of processes - eg, references in individual procedures, interlinked IT systems, hyperlinked web docs, etc etc.

Patricia, it is not fair or reasonable IMO to criticise Andy's auditor for accepting this - his auditor is in a position to audit the whole system. We aren't.
 
H

hrrvett

#26
I found hrrvet's busy and complicated
I'm not sure what you found complicated - perhaps the whole thing. But I think it's pretty straight forward, ultimately which is all that matters. If you could elaborate, I would appreciate it.

I mentioned that I would repost my tentative "finished product" and here it is. There is some explanation that is probably needed which makes it not so "straight forward" as some but much more comprehensive IMO.

Layout:
The requirements for the QS come in at the top. There are four "key processes": system (SOP2s), mgmt (MOPs), support (SOPs), and customer (COPs). The "system (SOP2s)" encapsulates everything as internal audits and control of doc/records touch everything.

Explanation:
There are sort of two models here. The first is the mgmt level processes, which are the arrows stemming out of the MOPs (blue square). Essentially, data from the SOPs, COPs, and SOP2s (green, pink, and yellow) is fed into the MOPs (mgmt - blue) and then CAPAs are fed back for correction and improvement.

Then, you have the other key processes for the company, not just mgmt. This is shown by the dotted black line. The MOPs and SOPs feed into the COPs which ultimately feed into the customer.

That's sort of the explanation in a nut shell. If you have feedback, I'd love to discuss and improve my model. If you'd like to use it, please do so.

Thanks!
 

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michellemmm

Quest For Quality
#27
I'm not sure what you found complicated - perhaps the whole thing. But I think it's pretty straight forward, ultimately which is all that matters. If you could elaborate, I would appreciate it.

I mentioned that I would repost my tentative "finished product" and here it is. There is some explanation that is probably needed which makes it not so "straight forward" as some but much more comprehensive IMO.

Layout:
The requirements for the QS come in at the top. There are four "key processes": system (SOP2s), mgmt (MOPs), support (SOPs), and customer (COPs). The "system (SOP2s)" encapsulates everything as internal audits and control of doc/records touch everything.

Explanation:
There are sort of two models here. The first is the mgmt level processes, which are the arrows stemming out of the MOPs (blue square). Essentially, data from the SOPs, COPs, and SOP2s (green, pink, and yellow) is fed into the MOPs (mgmt - blue) and then CAPAs are fed back for correction and improvement.

Then, you have the other key processes for the company, not just mgmt. This is shown by the dotted black line. The MOPs and SOPs feed into the COPs which ultimately feed into the customer.

That's sort of the explanation in a nut shell. If you have feedback, I'd love to discuss and improve my model. If you'd like to use it, please do so.

Thanks!
I think your map is absolutely beautiful...This is one of the best ones I have ever seen....:applause:

Since you asked for feedback.....:2cents:

If I was doing this map, I would reposition the "Management Review" process.

To me, Management Review is one of the most important processes in QMS. I hate Management Reviews that mimic "Staff Meetings." Management Review should align business processes with QMS. MR should align business objectives with quality objectives. It should deepen management commitment and deliver direction and blood flow to the heart of a QMS. Management review is not just an event. The result of MR is synchronized approach to the future of QMS....

This may not be an expressed requirements, but I think of MR as a forum for implanting the continual improvement ...

Fantastic!! Thank You.
 

RoxaneB

Super Moderator
Super Moderator
#28
hrrvett, two quick questions:

1. Why is "Customer its own input and in with Requirements?

I'd suggest listing them all as inputs...equal to each other.

2. Why is Purchasing a support process?

Even before I accepted the transfer into Procurement, I deemed them a core process. If they don't acquire products as necessary, an organization will have a difficult time finishing the product. And considering how some vendors are key to the process, I'd move Procurement over to a the customer process section. Granted, this may be more of a philosophical discussion.
 

michellemmm

Quest For Quality
#29
I found hrrvet's busy and complicated - I found Andy's refreshingly clear.
Many consultants and auditors cannot distinguish between "Flow Charts" and "Process Maps".... Many prefer to read long "how to" procedures than analyze a map...Makes their conformance auditing easy...

Process maps are supposed to be complicated and portray complex management system structure and interactions. Relationships are not always linear...

I found hrrvet's chart refreshingly informative.
 
H

hrrvett

#30
hrrvett, two quick questions:

1. Why is "Customer its own input and in with Requirements?

I'd suggest listing them all as inputs...equal to each other.
Good suggestion - THANKS!!

2. Why is Purchasing a support process?

Even before I accepted the transfer into Procurement, I deemed them a core process. If they don't acquire products as necessary, an organization will have a difficult time finishing the product. And considering how some vendors are key to the process, I'd move Procurement over to a the customer process section. Granted, this may be more of a philosophical discussion.
I went back and forth with this one and since our QS is new, we might change it. The ultimate reason why I put in the SOPs is because I think of SOPs as something that is triggered by Mfg, which purchasing would be in my company. The customer doesn't trigger the purchasing process but they do trigger the MFG process.

But you're absolutely right - sort of philosophical. We may change it to a COP but at least you know why I put it where I did. :)

Have a good one!
 
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