Process sheet - in PQ or OQ ?

[Suhas]

Hey Medical Molders!
Do you place the process sheet in the PQ or the OQ?
Suhas

[brentb]

Hey Medical Molders!
Do you place the process sheet in the PQ or the OQ?
Suhas


OQ because that is when the process is finalized.
Keep on Molding!

brent

[rickbatey]

As a non-medical molder, I must ask: What is PQ and OQ?

[Perleshachar]

OQ.= operation qualification
PQ= process qualification

[brentb]

Operational Qualification (OQ shows if the equipment (mold/machine,etc) is capable (as I understand it) PQ validates the process and if it is robust.

My granny used to say, "mind your Ps and Qs". Never asked what was a P or Q!.

Keep on molding!

brent

[rickbatey]

Thanks to all!

[brentb]

Rick,

Ya gots to get with the acronyms. started out in the military and now in the business world LOL FYI

KOM (Keep On Molding!

brent

[plasticformer]

In our Medical operation, we develop the preliminary process sheet in our benchmarking studies waaaay before IQ! We test the highs, and lows in our OQ, test and measure, so when we get to PQ we use the nominal set points on the process sheet, test 2 lots of plastic, run 3-hour runs, test, measure. If everything is OK, we are validated!

CM

[rickbatey]

Brent-I can't text (fingers are too large for the small buttons), and the only acronyms I know-love-use involve plastic resins?! Guess I'm showing my age a bit! I still pretty much use my company cell as a PHONE! But I do have to send/replay to texts, and keep notes in it versus carrying a huge pad with me!
I do know CRS! I Can't Remember S#$&, as I live it day to day!
KOM!

[Suhas]

Thanks Plasticsformer,
That is an interesting approach. So let me get this: Initial Process - IQ - OQ with nominal?
Regards,
Suhas

[brentb]

A process sheet is generated throughout the mold qualification process with us. The final process sheet is after the whole qualification process is completed and control plan written.

Keep On Molding
brent

[pjhall]

Our approch is similar to Plasticsformer. We establish a "min" and "max" Process called OQmin and OQmax; 80 parts for OQmin and 80 parts for OQmax. Then the process is put back to the nominal settings for the PQ runs. We run PQ1, PQ2, and PQ3 each containing 500 parts. 10 parts are collected a the the beginning, 10 in the middle, and 10 at the end of run for each PQ.

We then measure the predetermined critical dimension for the 160 OQ parts and the 90 PQ parts. If all is well we are qualified. A controled process tolerances (CPT) form is then made using the OQmin OQmax process settings and needs to be filled out at the start and end of every production run. The molding Machine IQ is included in the final qualification binder.