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Now THAT'S a quality process!
26 comments- TAGS:iso 9000, qp, wi
- IT TOPICS:Government & Regulation, Management
This start-up company makes medical devices, and it's going through the ISO 9000 certification process, reports a pilot fish who's suffering through it.
"It's painful to document all the things we think we should be doing before they actually occur -- much like explaining to a toddler why he shouldn't touch the stove," fish says.
"As I was leafing through our three-inch binder of beginning work instructions, I noticed one of our WI footers had a QP."
Translation: In among the work instructions is a quality procedure -- or at least that's what fish assumes. But she quickly figures out that the line at the bottom of the page is just mistyped; the correct information is on the header at the top of the document.
So fish sends an e-mail to the guy in charge of the ISO work to let him know his people have put the wrong footer on the document.
And he responds -- with instructions for fish to send him a document change request to change the footer to the appropriate WI number.
Then, he says, he'll assign a tracking number and send the DCR to the document owners to approve the change.
And after the change is approved and made, then he can have them sign it in ink and replace the copy in fish's binder.
"A week's process for someone's lack of attention to detail!" sighs fish.
"The amazing part is that the ISO guy seems to have this amazing combination of horrid 'speeling,' 'grammer' and 'speach.' I would gladly write up a process for that!"
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