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.

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

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