Student

Dear Bill, Dan, Scott and Scot,

We need your help in CAPA TC meeting. We will appreciate if you help. Raise issues below:

Random VTF/Complaint VTF

Numerous situations have arisen where manufacturers have been required to stop production on certified parts because of the current process of Random and Complaint VTFs.

Since the procedures and results of these Random and Complaint VTFs often results in unwarranted availability problems, CAPA should consider establishing a sub committee to discuss alternative approaches.

Two suggestions to consider are:

Complaint VTF:

Now every complaint involves purchasing a complaint part and performing a VTF. This process is time consuming and, because of vehicle variability, sometimes the results of these VTFs are questionable. The net result, is stopped production and interrupted availability of parts which may be perfectly fine.

The most important concern is that the VTF process be improved. Additionally, however, perhaps CAPA could consider using and SPC approach to complaint VTFs. For example, a complaint VTF should be initiated if the complaint ratio is something like 0.27%, which translates into the CAPA standard of CPK 1.33. This approach would result in better availability, and a more reasonable and cost effective approach to complaint investigation.

Random VTFs:

CAPA is in the midst of fine tuning the VTF process. However, as the random VTF process stands today, it is not the most accurate way of evaluating manufacturing consistency, and probably never will be. The variability in vehicles, even when measured on Shark machines, is not an accurate gage for expensive tool adjustments. Perhaps CAPA should consider some type of factory related inspection, which is more repeatable than the VTF approach, to validate part consistency. This would likely increase part availability and lower program costs.

When Karen, David, Jack & Jeff meet with you, they will let you know the details.

Best Regards,