Quality Tools and Regulatory Excellence

CRI has developed and implemented a state of the art Quality Management System, combining both simplicity and regulatory compliance. This system includes a Quality Manual consisting of only 3 pages, which is the road map for all of our employees to follow, to stay on track within the system. You will find this roadmap hanging in all areas, as a quick reference to procedural guidance. The document numbering system is designed to allow for quick retrieval and reference to quality procedures, manufacturing and inspection procedures, work instructions and forms. All new hires at all levels receive FDA QSR (GMP) and ISO13485:2003 training within their first week, ensuring critical requirements are understood. This training is repeated quarterly to re-emphasize critical objectives.

  • Fully integrated ERP system
  • Risk management
  • Fully compliant calibration and preventive maintenance system
    • Includes all fixtures and tooling
    • Equipment
    • Gages
    • Scales
    • Dispensing apparatus
  • Six Sigma and lean methodologies
  • Statistical sampling techniques - AQL, C=0, etc.
  • Process capability measurement - Cpk, Ppk, etc.
  • Process validations (IQ/OQ/PQ)
  • Sterilization Validations (ETO / Gamma)
  • Cost containment
  • Design control & documentation
  • Process yield / defect analysis
  • Process control (SPC)
  • Project Management
  • Formal corrective / preventive action
  • Material traceability systems
  • Precision measuring gages
    • Microscopes
    • Micrometers (digital / laser)
    • Pin gages, block gages
    • Calipers
    • Profile projector
    • Instron tensile and compression tester
    • Tubing burst test systems - high pressure
    • Pouch burst testers
    • Leak testing equipment
    • Other various precision gages
Quality Tools and Regulatory Excellence