Q
QltyGrl
Hi,
I work for a very small medical device manufacturing company (< 10 employees). We are currently working on ISO 13485 certification and I have been assigned the task of validating all of our machines, processes, products, etc. The task is very daunting and I do not come from a QA background but am a recent transplant into the field. I am really struggling with designing validation protocols and although I have read the GHTF guidance document and have done a lot of reading on using IQ/OQ/PQ as a validation tool I still am very confused when it comes to OC and how to design a protocol for a CNC machine.
I understand that IQ has to do with installation, training, preventative maintenance, etc. and I understand the with PQ you are qualifying the machines ability to consistenly product a conforming product but I am totally lost when it comes to OQ.
I would greatly appreciate any and all assistance. If anyone has an example they can share of a validation protocol written for a CNC machine that would be wonderful. Please keep in mind that I am no statistician and am still learning a lot about the world of quality.
Thanks in advance for all assistance!
I work for a very small medical device manufacturing company (< 10 employees). We are currently working on ISO 13485 certification and I have been assigned the task of validating all of our machines, processes, products, etc. The task is very daunting and I do not come from a QA background but am a recent transplant into the field. I am really struggling with designing validation protocols and although I have read the GHTF guidance document and have done a lot of reading on using IQ/OQ/PQ as a validation tool I still am very confused when it comes to OC and how to design a protocol for a CNC machine.
I understand that IQ has to do with installation, training, preventative maintenance, etc. and I understand the with PQ you are qualifying the machines ability to consistenly product a conforming product but I am totally lost when it comes to OQ.
I would greatly appreciate any and all assistance. If anyone has an example they can share of a validation protocol written for a CNC machine that would be wonderful. Please keep in mind that I am no statistician and am still learning a lot about the world of quality.
Thanks in advance for all assistance!