Quality & Validation / IQ / OQ / PQ validation
Installation, operational, and performance qualification on your tooling and process.
We execute installation qualification (IQ) to document that the mold and process equipment are installed and operating to specification; operational qualification (OQ) to challenge the process window across its parameters and establish the limits that hold quality; and performance qualification (PQ) to demonstrate sustained, capable production at nominal settings.
Protocols and executed reports are delivered as part of your documentation package, with statistical sampling and capability (Cpk) data to support design transfer.
Validation runs on the actual mold and press that will make your parts — not a lookalike — so the qualified window, cavity-to-cavity balance, and capability data describe your production, not a demo. When you transfer a part to us, that evidence transfers with it.
Validated tooling and process is what lets a regulated build trust the parts coming off the press — and what an auditor expects to see. We run it on the molds and processes that make your parts, so the evidence is ready when you need it.
Change control works the same way: a tooling repair, a resin change, or a process move triggers the re-qualification it needs, documented — so your Device History Record never carries a gap an auditor can open.
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