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PROCESS VALIDATION

Process Validation - PTA Plastics

Process Validation - PTA Plastics
IQ, OQ, and PQ

A Full Process Validation Protocol

PTA Plastics provides comprehensive process validation in accordance with an IQ, OQ, PQ protocol. The determination of dimensions, CTF/CTQs, and proposed datum structures occurs following early customer communication and a formal print review.

Following the completion of the IQ report and establishment of the PFMEA, control plan, and process flow, our customers are presented with a formal process characterization report. This report highlights the scientific methods utilized to identify the nominal process, along with the parameters employed for process validation through Design of Experiments (DOE).

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Validation and 3-Piece FAIR

PTA Plastics maintains a consistent validation protocol that is integrated into our tooling. We are able to construct a customized protocol that caters to your individual requirements.

After establishing the process, we provide and review a 3-piece FAIR for all print dimensions and a 30-piece capability study for all pre-determined CTF’s and CTQ’s with our customers. Prior to the commencement of the OQ run, mold changes or print adjustments are thoroughly evaluated and re-qualified. Subsequently, a capability study and FAIR are conducted to validate the impact of these modifications.

Once it is released to production, a final capability study is carried out as part of the PQ run. The customization options for our complete validation protocol are extensive, allowing us to accommodate the unique needs and requirements of our customers.

Process Validation - PTA Plastics
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