Documentation Out of Control - What classifies as a Controlled Document?

#21
Andy:

I hope this information will be useful to you.

A Document is any material, electronic, hardcopy, video or pictorial that outlines a process, guides or instructs, and requires revising. This incldes Master Forms or Templates.

Samples:
Internal Documents requiring control are Work Instructions, Quality Manual, Processes, etc.

External Documents requiring control are MSD Sheets, Ministry of Labour Health and Safety Manuals, Manufacturer Specifications, etc.
These require revising by the body forwarding them to you, however once you receive the update it is your responsibility to ensure the old is replaced with the new.

Once you take a document and add substance and a signature (objective evidence or proof of an action)it then becomes a record.

You probably could get away with a retention period of 12 years right across the board. This would depend on the company. I generally advise my clients to take a hard look at their records and put into place what they actually do. For instance it might be wise to keep an employment record for 1 year past employee termination. A service record for a certain period of years after the warranty is up, etc.

Any document or literature that does not require revising and is therefore used for reference only is not considered a Controlled Document. Possibly some of what you term as 400 masks could be considered as Reference Only.

In ISO 9001/2/3:1994 wherever 4.16 and in ISO 9001:2000 4.2.4 are mentioned are the areas requiring a record to be kept.

Sample:ISO 9001:1994
4.1.3 Management Review
The record is the minutes taken.

4.4.6 Design Review.
The record of the review.

4.4.7 Design Verification.
The record of the verification.

4.9 Process Control
The records are those showing qualified processes, equipment(maintenance sheets, etc.) and personnel(training records).

A Controlled Document List would include:
all documents Internally Controlled, such as Master Forms, Templates, Quality Manual, Procedures (listed individually if each has a separate Authorization),etc.
all documents Externally Controlled
include their revision level.

all Software and their version, such as Auto Cad 16, etc.

Any questions please contact me.

awk
 
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A

Andy Bassett

#22
Sorry accidental double post.

[This message has been edited by Andy Bassett (edited 21 November 2000).]
 
A

Andy Bassett

#23
Many thanks for all the comments so far, especially AWK, whose points i will take on board.

Maybe i can just tell you what we have done.

All our EDP generated documents are effectively controlled (This is relatively simple because most of the work is done by the server). Why have we done this? Because it is more trouble to distinguish between a document that needs controlling and one that doesnt for the employees.

A Document Approval Matrix has been created that lists which documents need to be approved and where the original approved hardcopy lives. Why have we done this? Because as the latest copy of a document is always on the EDP Server, we cannot see the need for a Document Matrix as normally used (ie to define the latest revision status of the document). BTW We are not allowing electronic signatures because our EDP experience is not up to it. Also the only hardcopy of documents that we allow in the company is the original signed. No other copies are allowed.

We dont ever talk about Quality Records, only Documents. Why have we done this? Because we cannnot see any difference between the two, for us the handling and storage problems are the same. Ie After a car is built we want to have available for a certain time all the documentation that is relevant for that car going together. It doesnt matter if it is a parts list or a Test Protocoll.

We standardised the retention time for everything at 12 years. (ie all EDP/electronic files documents mentioned in the Approval Matrix). Why did we do this, becuase it is too much trouble to define different retention periods for different documents.

It took us a long time to agree the guideline, but i do feel that it is the easiest to understand and administer.

Please post any questions you may have about this guideline so that i can establish if there are any holes in it.

Regards

------------------
Andy B

[This message has been edited by Andy Bassett (edited 21 November 2000).]
 
E

energy

#24
harrington-group.com has a great document control system for mutiple users that you can download for free for thirty days. No, I don't work for them, but, I've used it. Have their Corrective Action program right now with plans to get the Document Control A.S.A.P. (I have a new job so it will take some time to sweet talk the boss) The address may not be correct but the search engine will find it. Good Luck
 
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