Quality Control



Dordan is ISO 9001:2015 certified for the design, manufacture, and distribution of custom thermoformed product and packaging solutions.

ISO 9001:2015 CERTIFICATON

Dordan's has 12 thin-gauge in line plastics thermoforming machines, including Kiefel thermoformers dedicated to cleanroom manufacturing. We have different QC procedures per our customers' quality and production environment requirements. 

Plastic thermoforming

Dordan standard production environment

Cleanroom for manufacturing medical packaging

Dordan ISO Class 8 Cleanroom for thermoforming medical packaging

Our quality management policy is to ensure complete customer satisfaction through on time delivery of defect-free thermoformed products and packaging. 

We are committed to continually improving the quality and value of the products and services we provide. This is addressed through quarterly reviews of our KPIs to determine the overall effectiveness of our quality management system and isolate areas for improvement. This quality management system dictates every procedure utilized for the design, tooling, and manufacturing of consistently high quality parts in quick turnaround at competitive pricing. 

Standard Operating Procedure

Dordan's Standard Operating Procedure includes work instructions for every process that is implemented and executed for the design, manufacture, and distribution of thermoformed packaging. Processes include:

  • Incoming plastic material inspection; material traceability; pre-production material verification; material handling; post-production material management; material inventory.

  • Equipment checklist i.e. stainless steel tables, static-bar, hairnets, etc. and equipment inspection

  • Job inspection record

  • Pre-production inspections i.e. first articles of approval

  • QC DWG with critical dimensions to be measured during routine QC inspections

  • Production check and in-process inspections are conducted according to established QC standards & values. Standard analytic tools are used to determine production part control. Inspections and measurements are recorded and filed. Measurement devices are calibrated on an annual basis.

  • Finished parts are removed from thermoformers via robotics; parts are inspected, sorted, and counted before being packed for shipment in custom configurations based on our customers' incoming shipping requirements.

Non Cleanroom Medical Standard Operating Procedure

Dordan's non cleanroom medical standard operating procedure applies to healthcare and medical products and procedures that require a heightened level of QC documentation, monitoring, analysis, and management. While not required to be produced in a cleanroom, Dordan employs strict QC operations to ensure that our thermoformed parts meet with the specific quality and performance requirements of our clients.

Cleanroom Operating Procedure

Dordan's cleanroom operating procedure ensures that the particulate level is minimized and managed per the ISO Class 8 certification. Every part of the cleanroom thermoforming production process-- from personnel work instructions, attire, ancillary equipment, material handling, packaging, etc.-- has specific procedures and documentation requirements required for verification of medical packaging performance and cleanliness.

MEDICAL FACT SHEET

First Article Validation Procedure

Dordan's first article validation procedure is an extended version of its standard operating procedure for first article inspection. This Procedure is available for clients looking for an in-depth investigation and analysis of a small-volume validation run to provide production quality thermoformed packaging for secondary validation procedures.

Process Validation Procedure (IQ/OQ/PQ)

Dordan's Process Validation Procedure is comprised of three stages:

  • Installation Qualification

  • Operational Qualification

  • Performance Qualification

Through these stages, the CPK is defined, measured, documented, and charted to verify that our process is producing parts that meet our customers expectations and requirements. This CPK is used as the benchmark against which all future production runs are managed.
Cleanroom QC

QC inspects parts for compliance with target CPK

Cleanroom quality control

Medical Production Manager programs machine