Feedback on proposed restructure of Quality Management System (QMS)

[JaneB]

Hello 01mercy

Typically organizations have the 4 tier quality management structure with Level 1 as the Quality Manual, Level 2 as procedures supporting the requirements of the Standard, Level 3 as work instructions supporting the operations and Level 4 as Records....

While this may be 'typical' in your average manufacturing company, perhaps, I'm going to take issue with your statement that appears to infer it is 'typical' in general, Ajit. It isn't.
Almost none of the companies I've worked with have that kind of structure, and it certainly neither works for, nor supports, most service companies or IT/software companies, etc. Might have been true once, but I disagree that it is these days.

 

[01mercy]

Dear Jane B,

Thank you for your opinion on the statements given by Ajit.

However, to add value to the discussion.
Can you tell me your experience with the companies you worked with and also tell me why this tier structure in you opinion does not work or support a system?

Thank you very much.

 

[JaneB]

Mercy,
If you're happy with Ajit's advice, take it. If you seek more more information, try doing some searches - there's been a huge amount already written (not only by me) in previous threads that should address your questions.

 

[t.PoN]

I have to agree with Jane.
What am i getting used to see is Process Procedure, Department Procedure, Product Procedure ....etc.

Some name it procedures, other instructions but actually its up to the organisation definition.

others may refer to the Hierarchy of Documents to actually the authority to issue a policy or procedure (when its not centralized).

 

[Ajit Basrur]

While this may be 'typical' in your average manufacturing company, perhaps, I'm going to take issue with your statement that appears to infer it is 'typical' in general, Ajit. It isn't.
Almost none of the companies I've worked with have that kind of structure, and it certainly neither works for, nor supports, most service companies or IT/software companies, etc. Might have been true once, but I disagree that it is these days.

You are right

 

[Mike_H]

I am interested in some examples of a Quality Manual that doesn't mirror the standard as some of the aging manuals tended to do. Nevertheless, ISO does require a manual with; scope statement, any exclusions, reference to documented procedures (only those required by the std?) , some description of the interaction between processes (is this meant to represent only processes necessary for your business or all support processes etc..it could be read either way). I never did understand the pure benefit of this , is it to specifically demonstrate you have analysed your business processes and "put it on display"? Thoughts very much appreciated...

 

[t.PoN]

Ok, forget the ISO standard for a second.
What does your organisation have as a governance?
What do you have for anyone (new employee, customer ...etc) to make them understand your system, your processes ....etc.

that is the Quality Manual in my opinion. that what is required by the ISO standard.

For your remark

documented procedures (only those required by the std?)

The documented procedure is not what some called the 6 standard procedure. its all the necessary documentation required by your system to operate effectively.

 

[JaneB]

tPon - that is absolutely excellent advice you give,

Mercy, you say you are

...committed to set up a QMS that works for the work floor and that gives structure and clearity to the different departments, in short to make it work

Which sounds great.
But you also say

I'm now thinking of the structure to put this hierarchy in and what I know from my previous work is that the structure of the clauses in ISO9001 are followed as a structure in the Qmanual and I want to use it also for the folder structure of the documents. Than the structure in the manual is one on one the same as the storing structure of the documents.

My strongest advice is: DO NOT use the structure of the standard!!
It's not compatible with your stated intent for a start (practical, works for shop floor etc) and that way lies madness (again, search previous threads for more about why).
If that's the only model you've ever seen I can understand your believing that's the Best or the Right Way to do it.
It Just Isn't So.
The.'best' way is what works well for your organisation, in a nutshell.
Don't over-complicate things. Keep it simple. (Do you really need all those codes and numbers?)
Work with the shop floor etc to find a model that is simple, practical and that works for them.
Then - and only then! Cross check back against the standard to see you've covered off all essentials. never start from the Standard and never, never, ever! use it as a structure.

 

[Mike_H]

Ok, forget the ISO standard for a second.
What does your organisation have as a governance?
What do you have for anyone (new employee, customer ...etc) to make them understand your system, your processes ....etc.

I follow what you're saying ...we have nothing at all. That's why I'm interested in talking about the approach others have taken, or failing that I'll take my best shot.:

 

[t.PoN]

I follow what you're saying ...we have nothing at all. That's why I'm interested in talking about the approach others have taken, or failing that I'll take my best shot.:

I am afraid that its really difficult to help.

the organisation is a very complex thing. you'll find the one designed as task oriented, the functional oriented ....etc.
you'll have organisations with the tough guy culture, or process culture....etc.

as it differs, the consultation process differs. you could be have an advisory style or an intervention style ...etc.
you can give the process owner a full control in how to manage his process. other times you need to tell him how to do it and enforce it.

We can tell you to use the flow chart, turtle diagram, ....and all the tools but how to use them best..... it is really a tough one.

Examples of Quality Manuals and Tools are all over this forum are available on this forum. if you want a specific industry then we can give you examples, but how did we come up with this final product is the know how that you need.