Process Validation - PTA Plastics

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).


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.