RBC Product Development knows that interface points are critical. The design handoff into manufacturing can be the critical difference that makes or breaks schedules and budgets. 

Whether we use your in-house manufacturing, your chosen manufacturer or one of our existing partners, we have the experience to iron out any pre-production issues before they affect delivery dates or product quality. We design products that maximize manufacturability and testability, and our thorough manufacturing handoff process ensures a smooth design transfer of all delivery formats.

Manufacturing validation occurs at the manufacturing plant as an audit of the manufacturing process, assembly instructions, and test procedures. We make certain that the processes are in place to meet regulatory standards and to ensure consistent, issue-free manufacturing runs.

Manufacturing validation includes:

• Process Validation - Manufacturing process validation is a component of any solid manufacturing quality system. This validation is intended to ensure that processes are in place to ensure:
  
  
  • The product is built using qualified components.
  • The product is assembled according to approved procedures.
  • The product is tested with verified and validated test procedures and equipment.
  • If any issues are identified, they are documented, analyzed, fixed, and the original cause of the issue is addressed before production continues.
• First Official Manufacturing Run - We've worked to develop a manufacturing handoff process that ensures a seamless transition. In addition to incorporating manufacturability into each design, we take great care to plan for engineering support during manufacturing handoff so the manufacturing partner has everything they need to make assembly a snap—including things like:
  
  
  • Complete, working 3-D models/prototypes
  • Complete, verified and validated manufacturing test applications and tools
  • Assembly, test, quality, and process instructions
  • Build materials list
  • Primary and alternate sources for parts
  • Automated test devices
  • Manufacturing process validation procedures
• Automated Test Equipment (ATE) Validation - We consider these items from the beginning.  Items like automated test devices are created early to minimize handoff risk.
• Manufacturing Run Prototypes - The manufacturer's first formal run of the product is loosely termed a "prototype." This run is used to make certain the manufacturing process runs smoothly and correctly and allows the development and manufacturing teams to ensure both the quality of the product and that any issues are quickly caught and remedied. The "prototypes" produced during a successful manufacturing process validation run are the first units available for sale to your Customers!