With every service performed, J-PAC provides a complete track record of process development and validation from Product Concept to full-scale production.
J-PAC's Project team interfaces with the client and strategic partners to provide seamless execution of development and validation processes. J-PAC's project team will:
Develop sampling plans and write needed protocols Fabricate test product and perform associated testing Compile and Analyze Data Perform EQ, IQ, PQ, OQ
All approvals are established jointly with the client and the Design Review Process within J-PAC Quality Systems reinforces the alignment required for the process execution expected by our clients.
When a new project is received by J-PAC, it is immediately assigned to a Process/Manufacturing Engineer and a Quality Engineer. These associates work closely with the customer and are accountable for the successful completion of the project. Additional resources are added to the team as required to ensure a successful outcome. Operations associates support product and process development transition from phase to phase and ultimately become the manufacturing team.
Development experience and continuity are maintained from program start to program finish, reducing execution risk. This strategy allows J-PAC to assist its customers with detailed Process FMEA (failure mode and effects analysis) highlighting the strengths and weaknesses of the manufacturing process as related to the performance of the device.
The process engineer will carry the project through to the manufacturing process, ensuring the process is documented, validated and capable. The QA Associate makes certain that the proper quality system checks are in place. The team stays intact through the initial manufacturing runs to ensure the processes perform as intended.
J-PAC's Design Review Process ensures a smooth transition from development phase to development phase, as well as in transition to manufacturing.
