Quality Control

PJR-1

Dordan is proud to be ISO 9001:2015 certified for the design, manufacture, and distribution of custom thermoformed packaging.

Dordan is equipped with an in-house ISO Class 8 Cleanroom for the production of sterile and non-sterile thermoformed medical packaging.

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's quality management philosophy incorporates participation at all levels of the organization. The management at Dordan believes in employee empowerment, individual responsibility, and authority within all functions of the company to retain our reputation of thermoform design and manufacturing excellence.

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.

Quality Objectives:

  • To prevent the generation of defective thermoformed parts and minimize the incidence of producing non-conforming thermoformed parts.

  • To detect out of control processes as early as possible to institute correction and reduce waste of materials and resources.

Quality Procedures:

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. Examples 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.

Process Validation

For clients that require it, we offer an ISO 9001:2015 certified procedure for process validation, which is comprised of three stages: (1) Installation Qualification; (2) Operational Qualification; (3) 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.

ISO 13485

Dordan is currently pursing ISO 13485 for the production of custom thermoformed medical packaging solutions.


ISO 9001:2015 CERTIFICATON