H
Haisoj Lesleh
Hi all,
We have an odd problem at my company. Our senior engineer modified the user's manual for our medical device. However, he misspelled a few words, and some of them are misspelled in such a way that could cause significant confusion to a first time user of our medical device. Unfortunately, the proof of the document was sent over to a couple of managers (both busy people) who glanced over the proof and signed off. The proof which went to the printers had the errors in it. We can't blame the printers for this problem - it's all on us. When the shipment arrived, another set of eyes finally discovered the typos.
Now I am working to fix this mess from a Quality perspective. We can't do a Non-Conforming Product report because the product conforms perfectly to the proof we sent to the printers. A Corrective & Preventative Action plan might be appropriate, but it is difficult to identify the root cause. Do we say that the senior engineer needs more training on how to use the spell check feature in his design program? We could do remedial training and document it. Or should we create a whole new SOP for writing technical documents which will have stricter rules in place for all documents? Or do we just say, "Hey, we all make mistakes sometimes. Try to spell it right next time." The only problem with the last option is that I don't know where the ISO 13485 form is for that...
Thanks in advance for any help.
We have an odd problem at my company. Our senior engineer modified the user's manual for our medical device. However, he misspelled a few words, and some of them are misspelled in such a way that could cause significant confusion to a first time user of our medical device. Unfortunately, the proof of the document was sent over to a couple of managers (both busy people) who glanced over the proof and signed off. The proof which went to the printers had the errors in it. We can't blame the printers for this problem - it's all on us. When the shipment arrived, another set of eyes finally discovered the typos.
Now I am working to fix this mess from a Quality perspective. We can't do a Non-Conforming Product report because the product conforms perfectly to the proof we sent to the printers. A Corrective & Preventative Action plan might be appropriate, but it is difficult to identify the root cause. Do we say that the senior engineer needs more training on how to use the spell check feature in his design program? We could do remedial training and document it. Or should we create a whole new SOP for writing technical documents which will have stricter rules in place for all documents? Or do we just say, "Hey, we all make mistakes sometimes. Try to spell it right next time." The only problem with the last option is that I don't know where the ISO 13485 form is for that...
Thanks in advance for any help.