Quality Assurance

Our Quality Policy Is Simple

“We shall meet or exceed our customers’ objectives for Quality and Service while emphasizing Integrity, Honesty and Trust.”

How do we do it?

Developing and retaining exceptional employees in a safe, clean and rewarding environment

Utilizing leading edge technology

Implementing continuous improvement while maintaining product quality, processes and the quality management system

It’s Our Passion

Our passionate commitment to quality can be seen by the care we take in our facility, the employees we hire, the customers we choose to do business with, and the amount of time we take to scrutinize over every detail of our Quality Management System and product realization processes.

The Polymer Conversions Quality Manual provides comprehensive proof to all customers, suppliers and employees of PCI that we are committed to maintaining exceptional levels of measurable quality in our products, processes and services. Our policies and procedures are designed to meet the requirements of the FDA Quality System Regulation – 21 CFR Part 820 Medical Devices, cGMP (Current Good Manufacturing Practices), ISO13485:2016, ANSI/ASQC/ISO9001:2015, customer quality assurance requirements, and the policies of our organization.

Regardless of the type or complexity of the project, PCI will work with the customer to determine the following:

  • Quality objectives and requirements for the product
  • The need to establish processes, documents and provide resources specific to the product
  • Required verification, validation, monitoring, measurement, inspection and test activities specific to the customer and product
  • Criteria for product acceptance
  • Records needed by the customer and applicable standards/regulations to provide evidence that the realization processes and resulting product meet requirements
  • Length of time PCI is required to keep all records, documentation & samples if it is not for the life of the product

Validations & Qualifications

  • Process Capability / Qualification Study
  • First Article Inspections (FAIR)
  • Sample Submissions
  • IQ/OQ/PQ (Validation Protocols for Installation, Operational & Performance qualifications)
  • PPAP level 1-5 (Production Part Approval Process; default is level 3)
  • FMEA (Failure Mode & Effects Analysis)
  • Process Flow Charts
  • Control Plans
  • DOE (Design of Experiments)
  • Gauge R&R (Repeatability & Reproducibility)

Currently registered to ISO 13485:2016 & ISO 9001:2015, Polymer Conversions strict Quality Management System is fully documented, controlled, regularly monitored by both internal and external audits, and guides our continuous improvement efforts to enhance the way we deliver professional and technical business solutions to our customers.

Polymer has always had a policy of purchasing brand new equipment when it comes time to upgrade, replace, or add new technology. It’s not “investing” if you are buying used equipment that could potentially be more trouble than it’s worth due to unseen quality or functionality issues. We felt that purchasing used equipment just because it’s cheaper, brings no value to our customers’ quality and precision needs because the life-saving devices we work with are too important, and warrant world-class, high-quality machinery. We try to maintain every piece of equipment throughout the facility in “as new” condition and have quite an extensive preventative maintenance program delivered by a professional, 24hr/day maintenance team.

After installation, the equipment must pass rigorous, documented validation & qualification processes before it is released for first use. We wholeheartedly believe that these investments allow us to perform at our very best, to ensure customers get quality products and services every time they need us.