Advent brings all the necessary skills and resources to satisfy the healthcare industry’s most stringent manufacturing requirements. As a comprehensive solutions provider, Advent uses good manufacturing practices to deliver your parts and assemblies with procedures based on your validation and verification requirements, IQ-OQ-PQ protocols and all other appropriate FDA requirements.
The ADVENT Record of Success:
Case Study
This multi-part (cosmetic) and multi-assembly project required multiple part/process validations and demanded an extremely tight delivery deadline.
CHALLENGE: While the customer supplied debugged, off-shore tooling, it nonetheless necessitated the development of an optimized process for molding in our presses as well as accurate on-going in-process measurement techniques. Additionally, we needed to automate some of the quality data acquisition to ensure efficiency throughout the project. Lastly, we needed to find and develop contracted, value-added services on behalf of the customer.
SOLUTION: Even though the off-shore tooling was already de-bugged, it required completion of first article inspections. Due to the large amount of data required upfront all within a very short lead time before product launch, we had to implement automated inspection developed on our SmartScope® measurement system. Additionally, in-process gauging was designed and built collaboratively with our customer. Subtle tooling changes were then proposed, approved and implemented to support the challenged and capable molding process as well to aid the assembly operations. In completion of the project requirements, we were able to contract value added services at a cost-competitive price for the finishing of these parts and manage the inventory and planning functions with our advanced ERP system.
THE RESULT? A highly successful on-time product launch