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Author Topic:   Quality Records Definition
irvs
Lurker (<10 Posts)

Posts: 1
From:Troy, MI, USA
Registered: Jun 2000

posted 25 July 2000 03:03 PM     Click Here to See the Profile for irvs   Click Here to Email irvs     Edit/Delete Message   Reply w/Quote
In Control of Quality Records, 4.16, there is the reference to "collection". What does this mean? Is it the person or position that generate the records? Is it a process that generates the record such as the internal audit? Thanks for any guidence.

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Jim Biz
Forum Wizard

Posts: 275
From:ILLINOIS
Registered: Mar 2000

posted 26 July 2000 10:02 AM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Our take on "Collection" is writing into our procedure - who is responsible for "gathering" the record after it has been comleted...and what they do with it ... of course we also keep a Q records listing showing index/access/storage method/ responsibilities for maintaining the files/ how long we keep them & how we dispose of them.

Hope this helps

Reagrds
Jim

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John C
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Posts: 134
From:Cork City, Ireland
Registered: Nov 98

posted 27 July 2000 03:53 PM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message   Reply w/Quote
irvs,
I think the clue is in the other words used along with 'collect', ie; identify, index. There can be many kinds of obscure quality records in various departments that the person arranging the quality system would not be aware of. It requires some kind of a search, through the organisation, or through the documentation, to identify the need or the records themselves then, presumably, collect them together in one place and index them so as to make it easier to decide whether we have compliance to the clause.
rgds, John C

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