Documentation Organization (Matrix) "HELP"

H

Herman

#1
#1
I am currently a Manufacturing Engineer for a new start up medical device contract manufacturer. We currently do not have a quality engineer and the general manager and myself are sharing these duties. It is my task to organize a document control system that is in place, but not yet organized. We currently have a string of documents such as procedures, forms, records/logs, work instructions. What I am looking for is a simple matrix that I can utilize to help me set up the organization of these documents into a single numbering system. The way they are currently numbered is that each catagory has its own prefix (i.e. WI for work instruction and so on and so forth). Can anyone help me with this problem?

Thanks

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QMS for Medical Device Companies
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D

David Mullins

#2
#2
I'm keen to see the feedback on this one myself. My new employer has the office I'm at ISO 9001 certified/registered, but not the other dozen offices spread around Australia and SE Asia (and their certified office is extremely short on objective evidence, and long on dodgy meaningless procedures).

What they do have is a mother of a document numbering system.

Document identification is to be in accordance with the following format:
DDDDDD_KKK_NNNNN_CC
where:
· “DDDDDD” is the 6 digit job or project number and office code combined.
· “KKK” identifies the Document Type Code (refer to list below)
· “NNNNN” is the 5 digit document number which is independent of project but unique to the particular business unit (consecutive ordinal numbers from 0001). {Note if you currently have been using a similar ordering and are at , say, 0859, you could continue with the same number sequence (eg. 00860) and so provide good continuity.}
· “CC” is the 2 digit version/issue of the document: “numeric” for issued documents but an “alpha” for pre-issue draft versions.
Note: All letters to be in upper case.

DOCUMENT ELECTRONIC STORAGE (FILENAMES)
To facilitate ease of transfer and storage of electronic documents, file identification is to be in accordance with the following format (compatible with PC use):
DDDDDD_KKK_NNNN_CC_Freeform.Ext
where:
· “DDDDDD, KKK, NNNNN, CC” are as the document number above
· “FreeForm” is the document title and optional
· “Ext” is the filename extent automatically generated by the software package.
Note: All letters to be in Upper case.


Examples

For a Perth administrative letter requesting payment of an invoice, the document number would be:

600001_ADM_00945_00.doc

For a Perth proposal or quote associated with Job No 600235, the document number would be:

600235_PTQ_00946_00.doc

For a Perth document of a Test Procedure for Job No 600276, the document number would be:

600276_TPR_00947_00.doc

The first update of this procedure would have the number

600276_TPR_00947_01.doc

For an Adelaide document to provide an Interface Control Document for Job No 504496, the draft document number at sequence 11657, would be:

504496_ICD_11657_aa.doc

which would be issued after review at

504496_ICD_11657_00.doc

The next update and re-issue would then have the document number

504496_ICD_11657_01.doc


AND ON IT GOES FROM THERE.

Needless to say I am intending to change this system, as the other offices, upon which this system is being applied, don't like it too much - wonder why?


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D

David Mullins

#3
#3
Sorry, I've taken the question a step further than Herman. I'm looking at one system for ALL documents, this includes Project Management, design, drawings, memo's, minutes, templates, etc. So I'm not just looking at procedures, instructions, manuals and forms.

The ultimate truth is that the numbering SYSTEM really only matters to quality people, and confused engineers. Nobody else cares, as long as there is a means of differentiating between document A and document B.

The main problem I have is that my new employer is applying a job control numbering system to documentation, which provides individual identifying numbers/codes, but they make no sense like the QM, SOP, WI analogy.

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A

Al Dyer

#4
#4
100% agree with David. It doesn't matter if a document is labeled abs, xyz, 123 etc...

The more "intricate" the numbering system the more chance there is for error.

I do believe that the system should be robust enough to have traceability of a level III document back to the Level II procedure.

Example:

Policy: QS-000
Procedure: QS-031, Contract Review Procedure
Form: qs-031-A, Feasibility Study Form
Instruction: wi-031-01, Feasibility Instruction

Just a thought.

ASD...

[This message has been edited by Al Dyer (edited 01 December 2000).]

[This message has been edited by Al Dyer (edited 01 December 2000).]
 
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