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).
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
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.
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.
ABOUT PTA PLASTICS
Supporting new product introduction and speed to market, PTA Plastics is a progressive custom plastic injection molder – specializing in engineering for low/medium volume and high mix solutions. An in-house tool room with deep moldmaking competencies led by a cohesive team of Employee-Owners, PTA Plastics serves the medical industry, defense industry, and safety & security.