Jun 1, 2008

Materials handling- contaminated product & paper based document system

The ISO 13485 auditor picked on us for not having a procedure for dealing with returned product that was contaminated. Fortunately, MD&DI was on top of this issue in a John Lincoln article in 1999.

Also there is a request to reorganize the design history file (DHF), device master record (DMR) and the "technical file". Is it too late to get a summer intern?

We're also trying to switch from a paper based documentation system to an electronic one. This seems to be fairly popular in the quality department, but it is actually more work for them. They still have to file away the master copies with the signatures and now they have to make sure the electronic versions get put in the right place. I'm all for it, but I'm confused by their uncharacteristic willingness to do more work. The main debate is do we do it going forward as we need documents or is someone going to scan them all in. I think its a little ridiculous to not just scan them all in now and be done with it, it will save time in the long run, but I think I'm going to lose that argument. Thats fine, it better be worded very carefully or I'll bide my time until I can write up a corrective action when I can't find an electronic document I need.


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ISO 13485 checklist

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