H
hirogx
Hi All,
My company is in the process of acquiring ISO 13485 certification and we are missing a key SOP/WI on product label inspection. I came up with an Idea to use transparencies as a method to inspect product labels that we received from our contract manufacturer. They come in rolls of either 500 or 1000 pcs. My question is, what acceptance quality limit should be established in inspecting each roll? And if we were to inspect quantity, would having an outline of a roll of 500, 750, 1000 be sufficient enough to indicate whether each roll conforms? I'm also concerned that if this method of inspecting quantity requires that this form of test jig needs to be calibrated. Any thoughts, criticism, opinions are welcome. Thanks for your help guys!
~V
My company is in the process of acquiring ISO 13485 certification and we are missing a key SOP/WI on product label inspection. I came up with an Idea to use transparencies as a method to inspect product labels that we received from our contract manufacturer. They come in rolls of either 500 or 1000 pcs. My question is, what acceptance quality limit should be established in inspecting each roll? And if we were to inspect quantity, would having an outline of a roll of 500, 750, 1000 be sufficient enough to indicate whether each roll conforms? I'm also concerned that if this method of inspecting quantity requires that this form of test jig needs to be calibrated. Any thoughts, criticism, opinions are welcome. Thanks for your help guys!
~V