1. Our Quality department is staffed 24/7 with 14 individuals headed by Victor Gurany our Quality Assurance & Compliance Manager.
Why This is Important to You? Because inspections are performed during every shift of productionto ensure all customer quality requirements are being met and catch any issues or non-conformities immediately.
2. Our quality team utilizes automated and video inspection equipment to verify critical dimensions on first articles, production samples or entire runs.
Why This is Important? This eliminates visual judgement errors, creates measurement reports and allows quick, repeatable inspection of complex plastic components. Also verifies tolerance thresholds to enable timely correction to a process or interruption of production to minimize scrap and error.
3. An automated CMM inspection is located at our tooling and R&D facilityso machinists are able to periodically perform checks on the parts during the fabrication process.
Why is this Important? - This helps manage workflow and enhances quality by providing a hands free rapid part inspection, allowing for data that is repeatable and reliable.
4. Crescent has a validated ERP system, meaning that the inventory computer system has been certified by a third party and complies with FDA mandates.
Why is this important? The validated ERP system is used to track orders from incoming raw materials through production for complete lot traceability. Providing a resource to show where process improvements can be made or solving problems before they impact a large # of components.
5. Provide Process Validation, PFMEA, Control Plans and Capability Studies.
Why is this important? These are the necessary requirements for medical device manufacturing to meet all the regulatory, quality and commercial standardsthat the FDA requires and provides the necessary information to help achieve your 510K approval.
6. Our Quality Certifications and registrations include:
o ISO 9001:2008 Certified
§ This manufacturing certification standard is recognized globally.
§ We are currently in the process of updating this certification to ISO 9001:2015 and anticipate a full implementation in early 2017.
o ISO 13485:2003 Certified
§ ISO 13485:2003 quality certification is for companies manufacturing medical devices and are in line with the Food and Drug Administration’s QSR standards.
§ Crescent Industries is currently updating this certification to ISO 13485:2016 and plans for full system implementation by 2018.
o FDA Registered
§ Means we can manufacture not only components that are distributed to a finished device manufacturer; but to manufacture finished goods, devices or components that are packaged or labeled for commercial distribution for health related purposes to an end user.
§ This also means the Quality Management System has to be in compliance with the rules established underFDA quality System Regulation (QSR) as established under the 21 Code of Federal Regulation (CFR) Part 820 (Medical Devices).
o ITAR: International Traffic in Arms Regulations
§ This set of US government regulations, controls the export and import of defense related product and services on the United States Munitions list, which is a list the US government deems as defense related goods, services and technology.
§ All product identified as ITAR must be controlled, identified and secured, technical information must be identified and secured including electronic data, blue prints, BOM’s, work instructions, and email.
§ All facilities must be secured at all points of access as well as visitors must be escorted after access is granted.
o Federal Firearms License (FFL) - This is a license in the United States that enables Crescent Industries to manufacture components relating to firearms and ammunition. The license is a legal requirement within the United States, since the enactment of the Gun Control Act of 1968.