We do medical implants for knees, hips and shoulder, and we custom built our press.
And now I need to validate a new type of press working with hydraulic pressure, this hydraulic pressure is built with a pump powered by compressed air. It’s a new technology for us, and we have seriously begin validation only last year, so I’m still searching for good reference.
The IQ should be fine based on the checklist posted this January on this site, but I will have to work harder for the OQ and PQ.
Just like that, I was working today on the pFMEA for the process that will take place on that new press, this pFMEA will generate answer and solution for the writting of the work instructions.
Is it a good practice to wait until every documents are done before starting the validation ( or qualification ) of an equipement? Because, as I said previously, I’m still struglying to create the work instructions for the production of the finish goods, the instruction for maintenance, calibration, logbook, … and so on.
I also did a DFMEA for this new press, is it a good idea to do both a dFMEA and a pFMEA for one new equipment ? Because those operations takes way too much time, if I refer to the perception of my VP…
Thanks