Process Qualification Options
Quality is excellent. We also appreciate proactive efforts regarding our special projects...Medical Applications, customer since 1996
Every product Polymer manufactures is qualified prior to production.
Standard Qualification Includes:
Process Qualification / Capability study
Analysis of key product characteristics to ensure process is repeatable. The parts represent the production process, with no "extra" or "special" processing performed.
"FAIR" First Article Inspections
Measurements performed by PCI, on production indicative parts, to see if they meet customer specifications/required tolerances and quality control requirements.
Sample Submissions
Once a sample submission is approved by the customer, Polymer will maintain "customer approved" product samples, to ensure each batch is as repeatable as the last and represents the quality the customer signed off on.
Additional services supported by Polymer include:
Qualifications / Validation Protocols = Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ)
A validation team comprised of a representative from engineering, quality assurance, maintenance, injection molding, secondary and tooling, ensures a cross functional discipline that contributes to the overall success and effectiveness of the validation process.
Production Part Approval Process (PPAP)
Formal submission processes developed by the auto industry also adopted by other industries. The level of submission is determined through consultations with the client.
Failure Mode and Effects Analysis (FMEA)
Is a technique and document that identifies potential failure modes, and assigns rank to determine possible areas for improvement. This method often occurs during the product and operations development phases.
By using this technique, we can help you identify potential product failures, and help you design those failures out of the manufacturing process, saving you time and project expenditures that might have occurred later and at a much higher risk.
Process Flow Charts
When required by a customer, we will use process flow charts to list the flow of material through the manufacturing process, from receiving inspection to storing finished goods. These charts contain information on operations, product characteristics and control characteristics.
Control Plans
A control plan is a written description of the system(s) used to control processes and parts; it lists characteristics, measurement techniques & specifications/tolerances, and reaction plans.
Design of Experiments (DOE)
A six sigma tool used to find cause-and-effect relationships to better manage process inputs in order to optimize the outputs. This service can help improve the quality of your products and our service, by making the manufacturing processes more robust to variations that could occur.
Gauge R & R (Repeatability & Reproducibility)
Analysis that proves appropriate test fixture/measurement techniques are being used for producing the same results each and every time a product is measured and/or data measurements are collected, part to part and shift to shift, no matter who/what is performing the measurement(s).


