Does your company use or reference level IV documents in their Quality plan?

[Al Dyer]

Answer honestly, Does your company use or reference level IV documents in their Quality plan?

Looking for explanation as to why if you you do!!!!

 

[Laura M]

Most of the systems I've set up reference forms in the level 2 or 3. I usually correlate the form number to the procedure or work instruction. I think it just makes life easier - after all with control meaning to prevent unintended use - how can you not control them? Some Level 4's have the instructions right on the document.

 

[Kevin Mader]

Hey Al,

I once referenced Level 4 in my Document Pyramid as Records. However, I took it out shortly there after since it seemed only to confuse the matter. Now, I basically reference the Quality Program as a three tier pyramid with the records a detached fourth section.

I don't know that it matters how many levels one creates. However, the one level serves all, or the unstructured Quality Program appears to me to be the most confusing approach. We had a discussion along these lines a few years back, so by doing a search you might find some interesting information. In those days, I was not big on the unstructured, one-level serves all back then based on a consulting job I took on. However, Marc commented back then that in his opinion, he saw no way in getting around having the hybrid of both the structured and unstructured programs. I think he is right on this point and have recognized that within the systems/programs I have set up, I had both represented.

Regards,

Kevin

 

[JodiB]

Not sure if I understand

Al, do you mean are level 4 documents mentioned in the quality manual? Or do you really mean quality plan? The reason I ask is because we have quality plans (project quality plans to be specific) and I don't understand if you mean those.

If you mean in general, do we mention level 4 documents...In the QM I've outlined our documentation as 5 levels : 1)Quality Manual, 2) System level procedures and work instructions, 3)Department and Regional level procedures and work instructions, 4) project specific procedures and 5)manuals and quality plans.

I have forms, templates. labels, and records as separate from the hierarchy - just listed as additional documentation bullet points.

Within our quality plans, we really only mention the applicable procedures for the project (usually the operations manual plus any project specific procedures).

 

[M Greenaway]

Forms are referenced as a level 4 document in QS9000, if you are interested.

In this high tech age will we see the end of this necessary structure to documents that dont mean anything to anyone. If I were an operator I would like a single point of contact to the information I want. Couldnt QMS text be in a searchable database that provides a set of results to a keyword, such as provided by Yahoo and other internet search engines.

 

[Al Dyer]

Lucinda,

I was meaning the typical document structrure as outlined in QS,TS,ISO, etc... that calls out four levels of documentation.

I was not lookink far enough down into individual quality (improvement) projects/plans.

From my experience there seems to be a generalized structure as follows:

Level I: Quality Policy Manual
Level II: Procedures
Level III: Forms, templates, instructions,documents
Level IV: ??????????????????????????.

I was looking for input on why people denote level IV documents for a future cove project.

I'll post futher personal views when an if applicable, just on a fishing trip right now!

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To all so far, thanks for the input and keep it up?
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Are Level IV documents required? (just a teaser)

 

[gpainter]

We have a four tier system
Quality Manual
System Procedures
Work Instructions
Records/objective Evidence

 

[Al Dyer]

GP,

Where would, sayyyyyy, your corrective action or preventive action form fit in the structure?

No right or wrong, just interested.

 

[David Mullins]

amazed!

If you don't use or reference forms and records in your QMS what do you do for objective evidence?

(AL - you did use the term Quality Plan!)

 

[energy]

Uh Uh

Originally posted by Al Dyer
Lucinda,
I was meaning the typical document structrure as outlined in QS,TS,ISO, etc... that calls out four levels of documentation.

Don't think so...Don't know about QS, TS, but I could find nothing in the standard that references a document pyramid such as 4 levels. I'll do a search later but this issue has a thread some where. We will use Level 4, for forms and records. 3 will be work instuctions. Quality Plan will be 2, manual will be 1.