MARKETS AND INDUSTRIES
ISO CERTIFICATIONS
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ISO 9001:2015
CONNECTICUT
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ISO 9001:2015
COLORADO
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ISO 13485:2016
CONNECTICUT
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ISO 13485:2016
COLORADO

A FULL PROCESS VALIDATION PROTOCOL

PTA Plastics offers full process validation following an IQ, OQ, PQ protocol. 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).

Process Validation

VALIDATION AND A 3-PIECE FAIR

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

Process Validation
Process Validation

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.