Hi All!
I am in the same boat as Steve right now, trying to set up proper documentation for component (sub-assembly) in-process
quality records.
Can anybody advise if you use a form or a summary report on subassemblies, or a DHR-type form for every incoming component? For example, if you receive in 500 PCB's, do you record on paper each test result down to a serial number level, or would you prefer to create a summary report, including ranges, number of parts accepted, number of parts rejected, rework dispositions, etc - - at a job or batch level? The summary would tell you how many you got, who the inspector was, job number, that sort of thing, but you could probably get away with much less documentation
We have some flexibility under 13485 and QSR to move, but our QMS is boggin us down, and requiring we do DHR forms on every single board.
Comments, please!!!! I need some help.
Thanks,
Madly RA'd in Cheeseland