Risk based assessment | Cross-departmental analysis | Statistical reporting | Continuous improvement
Dordan's Quality Management system informs every process at Dordan Manufacturing, from thermoform design, tooling, production, and cleanroom manufacturing. The goal of the QMS is to ensure the on-time delivery of defect free products that meet our customers' expectations through cross-departmental collaboration, rigorous documentation, reporting, and analysis. Continuous process improvement is the foundation of our risk-based assessment to thermoform design and production.
Dordan is ISO 9001:2015 certified and ISO 13485:2016 certified for the design, manufacture, and distribution of custom thermoformed medical packaging. It's certified quality management system manages the entire packaging development process to allow for the production of high quality thermoformed packaging that meets the safety and regulatory requirements of the medical device industry.
Prior to each production run, engineering, production, and quality control management isolate potential challenges to production, determining critical tolerances and performance criteria.
Quality control inspection procedures are developed to ensure compliance with the project requirements for part form, fit, and function; and, a method for defining and measuring the process capabilities to verify our process is producing on-spec parts as a benchmark for production is confirmed.
At the conclusion of each production run, internal statistical software calculates the performance of the job, and the report is analyzed by engineering, production, and QC management to yield continuous process improvements.
Inspect | Verify | Document | Analyze | Validate
Dordan's Standard Operating Procedure includes work instructions for every process of the design, manufacture, and distribution of thermoformed packaging:
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.
ISO Class 8 cleanroom for the production of medical packaging trays, kits, clamshells, and blisters.
Dordan's Cleanroom Standard Operating Procedure is a step-above our non cleanroom production SOP.
All cleanroom production staff are trained in protocols and etiquette before entering the cleanroom, while operating within the cleanroom, and upon departure. Cleanroom staff are fitted with gowns, booties, hair nets, and gloves; each entry to the cleanroom requires a new set of gear.
Staff gown up in a separate room that is within the cleanroom hardwall construction, which has lower air pressure then the cleanroom, ensuring that upon entry, air is pushed out of the cleanroom into the gowning room.
Material rolls and tooling is de-skidded and wiped down with FDA certified cleaning agents, prior to being brought into the material staging room; this has lower air pressure then the and outside facility. After entry to the material staging room, the overhead door to is closed, creating an air tight chamber. Once the door to the outside facility is closed, the door to the cleanroom is allowed to open; the material is brought into the cleanroom utilizing custom designed material handing equipment certified for use in a cleanroom.
Strict terminal cleaning protocols with comprehensive sterilization procedures ensure the continued cleanliness of the cleanroom, gowning room, and material staging room.
Particulate counts are performed per a set schedule to monitor air quality; and, performance is tracked to verify and validate conformance to the environmental standards set forth in ISO.
Environmental monitoring risk assessments are performed quarterly to help identify risks and opportunities for continuous process improvements.
Process capability studies are performed for each job run, and automated optical inspection equipment technology and softwares allow for the rapid quantification of process performance.
