Compliance matrix for the molder

[cityjack]

Afternoon all,

I am putting together a PPAP for my molder and as part of that PPAP, I am to request of them a filled out compliance matrix. Does anyone have an example compliance matrix with plastic part requirements I may look at please? I mean other than some simple snap fit checks of the parts on the line after being ejected from the mold, tolerance checks, as well as some color checks, what else would I put?

Thanks

Sid

 

[Jboezi]

I have qualified a molded medical component after a tooling modification through a DOE. Our application only required OQ/PQ. We monitored mold time, pressure, and temperature.

300+ Components were split into two OQ runs; min and max. The goal of the OQ is to verify that the boundary conditions still meet specification. The min group ran all three parameters at the minimum settings while the max group had all three at the max settings. We inspected 1/3 of each run to their drawings for statistical analysis of the process. A number of each group were built into prototypes for physical testing.

After passing the OQ and verifying our process window we ran three PQ runs of 1000+ units each, each executed at nominal settings, with different operators and machine shut downs in between.




Mechanical design engineer

http://www.johnboezi.com