Referencing and Controlling Labels & Stickers used internally throughout Production

[rdesmond]

Hello! We are working toward ISO 13485 compliance. What methods and/or suggestions do people have for referencing and/or controlling labels and stickers used internally throughout the production process, i.e. acceptance, reject stickers, part number stickers, etc. Some are relatively generic, off-the-shelf and others print-out from our MRP system. If, for example we control MRP labels via change control & design cannot change w/o CR, is this sufficient? Any help is very much appreciated! Thanks.

 

[regina_q]

Re: Controlling labels & stickers

We are ISO13485-registered and what has worked for us is a description of verbiage that will show...that is, if we have accepted a part then the procedure says the part is identified with a label indicating it is "accepted". The Quality group can then buy any label they want as long as those words are on the label. Conversely, for labels that are printed from MRP, our documentation indicates the content contained on the label through a part specification. Our label stock (one PN) and the printed label (a separate PN) both have specifications that are under change control. Hope that helps.