Hi,

Attached is a new document control procedure, for a new quality system. I have a bit of experience at previous companies, but this forum has really helped a lot.

Would anyone care to comment on the adequacy of this procedure?

Many thanks,

Tim

I would have a question about related documents being vague.

-All related procedures----
-All related forms----

Would it be beneficial to reference specific procedures and instructions that further define document control activities?

Al...

Hi,

Attached is a new document control procedure, for a new quality system. I have a bit of experience at previous companies, but this forum has really helped a lot.

Would anyone care to comment on the adequacy of this procedure?

Many thanks,

Tim
Pretty nice job http://elsmar.com/Forums/images/smilies/appl.gif . Plain, correctly spelled, straight ahead, active-voice English, and the bases seem to be pretty well covered. I do have a couple of questions, though.

1.1The Quality Manager is responsible for ensuring this procedure is followed, and is authorized to control all quality system documentation, data, and records. The Quality Manager may designate and authorize qualified, trained personnel to carry out this procedure, as needed.

What's the difference between "documentation," "data" and "records"? Should they be defined? How is data controlled?

You're right....I "shall" delete references to data and records. Those are covered elsewhere anyway.

Thanks a lot!

My one concern is with the approval authority.

Does the Quality Manager or VP have sufficient insight in all functional areas to "approve documents for adequacy prior to issue".

Normally I have the functional manager also approve the document.

My one concern is with the approval authority.

Does the Quality Manager or VP have sufficient insight in all functional areas to "approve documents for adequacy prior to issue".

Normally I have the functional manager also approve the document.


I thought about this, too, but I noticed the OP is from a 26-person company. Frequently in a situation like that, the VP or the QM know all about everything that goes on at the company.

I thought about this, too, but I noticed the OP is from a 26-person company. Frequently in a situation like that, the VP or the QM know all about everything that goes on at the company.

Frequently the VP and QM only think they know all about everything that goes on at the company. ;)

Yes, it's only 26 people. How did you know that?

And yes, between the QM and the VP, we know it all! ;-)


Ooops....I just realized how you knew that...never mind!

The procedure is quite good. I would like to add in scope that this procedure is applicable to other quality system documents that are not manual, procedures or forms. What about various lists, job descriptions, work instructions?

Secondly the procedure does not address the requirement of "prevent unintended use of obsolete documents". You may need to retain one copy of obsolete documents for information purposes.