Our Quality Management System is the foundation of all processes at Dordan. From risk-based packaging engineering to full process validations, Dordan ensures the on time delivery of defect free products.
Above: Quality Control technicians inspect a medical device tray manufactured in Dordan's cleanroom
Dordan’s QMS supports a risk-based, data-driven approach to the design and manufacture of thermoformed packaging. Every project undergoes cross-departmental analysis between engineering, production, and quality control teams to identify critical dimensions and tolerances to ensure regulatory and functional compliance.
Thermoforming Quality Control Features
Thermoforming quality control encompasses a comprehensive set of procedures and standards designed to ensure that each product meets specified requirements.
Above: Some of Dordan's thermoforming machines that manufacture custom packaging
Our Quality Control measures include:
Pre-Production: Incoming material inspections for quality and traceability; First Article Inspections and Validations to verify form, fit, and function; equipment readiness checks and calibration verification; Quality Control Drawings (QC DWGs) created with critical-to-quality dimensions.
In-Process: Routine in-process inspections using calibrated measurement tools; automated optical inspection systems for real-time defect detection; documentation of all inspections and dimensional measurements; CPK analysis and reporting for process capability tracking.
Post-Production: Finished parts sorted, inspected, counted, and packed according to client shipping specifications; statistical performance reports generated and reviewed by engineering and QC for continuous improvement.
Above: Automated optical inspection equipment for rapid CPK studies
Our Quality Control system emphasizes:
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Continuous process improvement
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Document control and traceability
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Statistical analysis and reporting
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Internal audits and validation protocols
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Defect detection
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Documentation of all inspections and dimensional measurements
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CPK analysis and reporting for process capability tracking (when requested)
Cleanroom Manufacturing Quality Procedures
The quality control features of cleanroom manufacturing require elevated quality procedures for the production of medical-grade packaging. Cleanrooms are controlled environments where the level of particulate and bio burdens are monitored and minimized. This production environment is ideal for sterile medical packaging applications.
Above: ISO Class 8 cleanroom manufacturing of medical packaging
Cleanroom thermoforming features:
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Enhanced gowning protocols and material staging room with controlled air pressure zones
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FDA-certified cleaning agents for all tooling, equipment, and material entry
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Routine cleaning of all tooling and equipment before and after each shift
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Ability to produce complex geometries with tighter-than-standard tolerances
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Extensive quality control inspection, documentation, and analysis to verify each production part meets the required specifications
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Critical cleanroom packaging and tooling development procedures
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First Article Validations and process capability studies (IQ/OQ/PQ)
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Terminal sterilization and room sanitization protocols
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Particulate count monitoring and environmental data tracking
What Sets Us Apart
63-Years of Custom Thermoforming Experience
Full Validation Support
Fully-Integrated Supplier
Risk-Based Engineering
4th-Generation Family-Owned Since 1962, Made in USA
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