Process Validation - PTA Plastics
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Process Validation

A Full Process Validation Protocol

PTA Plastics offers full process validation following an IQ, OQ, PQ prtocol. Dimensions, CTF/CTQs and proposed datum structures are determined after early customer communication and a formal print review. Once an IQ report is drafted and the PFMEA, control plan and process flow are in place, our customers receive a formal process characterization report that highlights all of the scientific methods used to determine the nominal process, as well as the parameters used to challenge the process (DOE).

Validation

PTA has a standard validation protocol that is included in all tooling. We can build a custom protocol to meet your needs:

ISO 9001 Standard: Non-medical customers, included in quote cost
ISO 9001 Custom: Non-medical customers, included once scope is understood
ISO 13485 Standard: All medical customers, included in quote cost
ISO 13485 Custom: All medical customers, included once scope is understood

3-Piece FAIR

Once the process is established, a 3-piece FAIR of all print dimensions and a 30-piece capability study for all pre-determined CTF’s and CTQ’s is provided and reviewed with our customers. Mold changes or print adjustments are made and re-qualified prior to proceeding into the OQ run, where another capability study and FAIR are provided to validate any changes.

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Capability Study

Upon being released to production, a final capability study is performed during the PQ run. Our complete validation protocol is fully customizable to fit our customers needs and their requirements.