Getting contract manufacturers in line

I've spent a great deal of time recently corresponding with our US based main contract manufacturer on various quality issues, mostly paperwork. These guys assemble the electronic/computer part of the device and they're used to consumer electronics assembly. Using this company is about 40% cheaper than a company that specialized in medical device electronics and was ISO 13485 certified.

We basically came along, sent them our documentation SOP and told them to follow it while doing any work for us. This didn't happen so we have a bunch of Manufacturing Process Instructions (MPIs) that don't work as device history records (DHRs) and have a few dozen errors such as scribble outs, blanks, no calibration dates, etc that don't fly in the medical device industry. So we've rewritten everything for them and trained their line on what we require and made good progress. I've learned my lesson though and will hand hold the next group through the documentation requirements.

We also ended up providing them with calibrated test setups to make it easier to track equipment used and match what we expected. Now we're ready to go though and will be making thousands of these in no time! Or maybe closer to a dozen and then make a bunch of improvements, we'll see what happens.