Quality Control



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

Quality control

Above photo: Dordan Quality Manager and technician measure medical device tray material distribution

ISO 9001:2015 CERTIFICATON

Dordan's quality policy is to ensure complete customer satisfaction through the delivery of defect-free products and services. Dordan shall strive to continually improve the quality and value of the products and services it provides to it's customers. Dordan is committed to continually improving the effectiveness of our quality management system, establishing and reviewing quality objectives for continuing suitability, and communicating the quality objections to the organization.

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.

Cleanroom thermoforming

Above photo: Dordan's ISO Class 8 Cleanroom for thermoforming medical packaging

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.
COMPANY PROFILE