Process Model diagram and processes

[kkamp]

Hi everyone!
I have seen in the forum that you talk about the Process Model diagram, and I want to understand: are these processes different from those implemented by the company? Or are these processes related to documentation?

Attached one of the process model diagram that appears in the forum

 

[Steve Prevette]

I would say the example you showed is a model a company can use to show how individual processes fit together into a company wide whole, which should take in Customer Requirements and result in Customer's Satisfaction. I woudl suspect that this would be implemented with an overall systems document, and individual procedure docuements for each box.

Is that the explanation you are looking for?

 

[kkamp]

I would say the example you showed is a model a company can use to show how individual processes fit together into a company wide whole, which should take in Customer Requirements and result in Customer's Satisfaction. I woudl suspect that this would be implemented with an overall systems document, and individual procedure docuements for each box.

Is that the explanation you are looking for?

Hi @Steve Prevette. Maybe I explained my doubt wrong, I will reformulate the question.
Are the processes that are included in a Quality Manual the ones in the image (which are related to what appears in the ISO 13485 standard) or are they the company's processes?

I have seen in numerous examples of Quality Manuals that the processes are always those that appear in the image I attached, so I have that doubt.
Thanks.

 

[Steve Prevette]

I must admit I don't understand your "doubt". Some companies may choose to use that diagram as is, some may modify it to suit their needes. When an auditor comes in, they will be auditing to do you have a workable structure, you documented it, and how effective is it. Quality policies and Quality Manuals vary widely from company to company, but the big question is -are they effective. And even beyond the audit / auditor - is the company successful?

 

[Bev D]

Hi
Are the processes that are included in a Quality Manual the ones in the image (which are related to what appears in the ISO 13485 standard) or are they the company's processes?

I have seen in numerous examples of Quality Manuals that the processes are always those that appear in the image I attached, so I have that doubt.
Thanks.
[/QUOTE]
I also don’t understand your ‘doubt’ or question. The image shows processes that are generally used or required by all organizations in some form. A companies processes don’t have to have those exact ‘titles’…

 

[kkamp]

I must admit I don't understand your "doubt". Some companies may choose to use that diagram as is, some may modify it to suit their needes. When an auditor comes in, they will be auditing to do you have a workable structure, you documented it, and how effective is it. Quality policies and Quality Manuals vary widely from company to company, but the big question is -are they effective. And even beyond the audit / auditor - is the company successful?

I understand that the processes that appear in the image are related to the QMS. However, a company may have its own processes defined, such as a company that designs and develops medical devices:
- Conceptual design
- Check
- Validation
- Etc.
My question is: in the Quality Manual, is the QMS process map or the company's process map included?

 

[Steve Prevette]

Of course it should be the company's process. What good is the QMS if you just put a bunch of stuff in it that "looks good"?

Now, if you are significantly diverging from the ISO model, you may need to justify that. But don't make the QMS manual a "big honking binder: (ala Dilbert) that just sits on a shelf to look pretty.

 

[kkamp]

Of course it should be the company's process. What good is the QMS if you just put a bunch of stuff in it that "looks good"?

Now, if you are significantly diverging from the ISO model, you may need to justify that. But don't make the QMS manual a "big honking binder: (ala Dilbert) that just sits on a shelf to look pretty.

Ok, I understand. Should only one process map be included? Are sub process or procedure, and activity maps left out? And if those maps are not excluded, where in the documentation are they attached?

 

[Steve Prevette]

Usually you have a grand overall process map in the QMS, and the QMS links to lower level procedures. Such as in "my world" of statistics, there was the company QMS, which flowed down to a QA Plan, which included as a section how to do performance analysis and trending. Yes, there was a how to do trending diagram. We had cross reference lists in the QMS to lower level procedures and a document control system.

I think you are over-thinking this. You need to write your company mission / vision/ QMP / Financial Documents / Testing Documents / etc etc etc so they work together as a system for your company. Working with the Department of Energy, there were documents like this that told us what were the standard for a QMS, but not how to write a QMS. Such as Quality Management System — NNSA Directives

As an example, for documentation they specify:

6.2. DOCUMENTATION REQUIREMENTS The level and type of documentation established for NNSA is reviewed periodically to ensure it remains appropriate for the following: • Activities performed, • Methods used, • Complexity of processes and their interactions, and • Skills and capabilities required by personnel.

They didn't tell us WHAT the documentation had to be, but what needed to be covered.