Evidence of Review and Approval



We have an adequate review and approval process for document control but don't necessarily have objective evidence to prove it. A). Should we include the name of the reviewer in the footer, B). Should we document the review and approval process in a controlled document, or C). Do we need "objective evidence" at all or will our control of the documents be the proof?

Jim Biz

Our situation - and my personal opinion is that we took the issue to an extreame.

We show review and apprroval of documents (and their attached/listed reference materials) by our 4.5 procedure language that says - "the ISO Manager will draft/Review the document to the stadards and show approval by signature/The Plant Manager will compare wording to avctual practices and aprove by signature and the Responsible Area Manager will do the same... No document is deemed "Reviewed/APPROVED/or part of the ISO system unless and until it is signed by all responsible parties and recorded in the ISO guy's master list. (there must be a better way - Grin)



The procedure we follow is simple (I think)!. Our document approval/review process says, "concerned department head will write/review the procedure and the QA Chairperson (thats me) will approve the same for adequacy and suitability for use".

All such documents, till the time incorporated into the QA manual, will be marked as "preliminary". Our documents will show the revision date/revision number/person revised.

Hope this is clear.


David Mullins

An adequate process with no records!!
Now if we could just get rid of customer requirements!!!

Originator/reviewer/approver/authoriser/etc. - none of these people have to appear on the document. The document must have an individual ID, by which it is controlled. It must be reviewed and approved - this can be confirmation by email or a note on a burger wrapper, so long as that's what the procedure says (yes it must be described in a controlled procedure), and the proof is available. Personally I find people signing off directly on the original document itself the quickest way, but it isn't in keeping with the technological advances made to control documents, increase your IT staff levels, blowing capital on computer storage space, speed and software updates, and making quality people even more of an enigma.

Document control consumes too much time as it is. Why make the simple things more complex?

It must be time for my medication, but one more thing. Review and approve at the correct level for a document. Managers don't have sufficient intimacy with shop floor processes to review documents at this level, however approval may be appropriate for them. Likewise, approval of system level documents should be tasked to the most senior person in the organisation who can hold a pen, press a keyboard, or eat a burger.



barb butrym

Quite Involved in Discussions
I have gone from red lines on the controlled document signed and dated to the electronic magic of passwords and email with electroic change forms and attachments...it all depends on what makes sense for the task at hand.

A simple company of a few souls and one set of procedures sure does not command the same detail as one of several hundred souls with control stations through out the plant.

Sometimes a combination is the best way...then use a matrix to detail which doc type requires what type of control/review and by whom.....

And yes, you do need evidence

[This message has been edited by barb butrym (edited 26 April 2000).]
Top Bottom