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iso 13485 - medical device qms, labels and labeling (general), work instructions (wi)
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Old 5th April 2013, 11:30 AM
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Please Help! Writing a Product Label Inspection Work Instruction

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!

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Old 5th April 2013, 01:21 PM
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Re: Need opinions on writing Product Label Inspection Work Instruction

Howdy hirogx,

Welcome to the Cove!

So you're trying to inspect the labels for accuracy of content?
Or inspect the rolls for the proper number of labels per roll?

Enjoy the day!

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Old 6th April 2013, 02:03 AM
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Re: Writing a Product Label Inspection Work Instruction

Dear,

Good day. I worked in MNCs and according to my experience its not possible to announce all rolls are OK.

For Label specifications you can take random sample for dimensions, color, weight, paper type and one roll or more for running online.

Whenever any dimensional or color problem is found in the center or at the end of roll, its kept separated and sent to supplier for compensation.

This situation (label complaints) also depends on selection of suppliers.

Regards,

Ghulam Mustafa
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