Verification vs Validation of off site cnc machining for parts of medical device

JPhillips

Registered
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.
 

yodon

Leader
Super Moderator
You may be conflating (product) V&V with process validation. Generally speaking, the OQ activity will likely confirm that you are meeting your requirements for intended use ("verification" if you will). The whole IQ/OQ/PQ effort is effectively the validation. The other things you list are sound business practices but may not be needed to "just" show the process is validated.

The process to validate would focus just on making the part. Other things like cleaning and sterilization would have their own validation efforts.
 

saintmk

Registered
After reading through other threads on the control of CNC programs, I am interested in getting feedback to understand the following: Do aerospace and medical companies have a strategy for classifying their change handling systems based on the significance of program changes? Specifically, how do they categorise changes that are considered Major, Minor, or Insignificant? Additionally, I appreciate that any changes to a CNC program must be linked to a Quality Management System (QMS).
 

yodon

Leader
Super Moderator
As far as major/minor go in the medical device field, we're generally talking about changes to the product and 'major' changes need to be coordinated with regulatory bodies. There are some rules / guidelines somewhere, but it's things like new functionality, labeling changes, sterilization changes, etc. We generally take the approach that the change request has a field to indicate whether it's a reportable change (with rationale one way or the other). There are also 'major' changes to the Quality System that are supposed to be reported to the certification body. Again, in the change request, we indicate whether it's reportable.

Presumably, your CNC program is used in execution of the QMS (e.g., for inspection / test purposes) so it would be considered an application that should be validated (and re-validated after changes).
 
Top Bottom