I have read about every discussion with respect to verification vs validation of cnc machining processes for medical devices. We machine pieces of titanium for a medical device at a third party machine shop. I have used the input from everyone, used our control plan to develop a PFMEA, and using a risk based approach based on the PFMEA, and think I have formulated a verification plan that involves;
1. IQ, OQ, PQ of the cnc machines at 3rd party location (if that is even feasible)
2. FAI and LAI of parts at machine shop
3. Identify CTQ's for control
4. Define sample sizes for AQL for measurement of CTQ's of parts produced.
5. Process Control Charts
6. Operators training
7. Regular reviews of AQL effectiveness
8. Document, Document, Document
9. Feedback loop
10. Continuous Improvement
My questions are;
1. Is there a path for Verification vs Validation if we can measure CTQ's of parts produced on cnc machines?
2. If there is no path to Verification, does my Validation plan seem credible for medical devices?
There are steps like cleaning, sterilization, and packaging that can not be verified, but I am specifically interested in all of your thoughts with respect to the machining of parts at a 3rd party shop, and still meeting FDA requirements.
I thank you all in advance for your valuable input.
1. IQ, OQ, PQ of the cnc machines at 3rd party location (if that is even feasible)
2. FAI and LAI of parts at machine shop
3. Identify CTQ's for control
4. Define sample sizes for AQL for measurement of CTQ's of parts produced.
5. Process Control Charts
6. Operators training
7. Regular reviews of AQL effectiveness
8. Document, Document, Document
9. Feedback loop
10. Continuous Improvement
My questions are;
1. Is there a path for Verification vs Validation if we can measure CTQ's of parts produced on cnc machines?
2. If there is no path to Verification, does my Validation plan seem credible for medical devices?
There are steps like cleaning, sterilization, and packaging that can not be verified, but I am specifically interested in all of your thoughts with respect to the machining of parts at a 3rd party shop, and still meeting FDA requirements.
I thank you all in advance for your valuable input.