EXPERIENCE STATISTICAL PROCESS CONTROLS&V Siu Associates helped a client resolve a recall, resume production, and re-establish their supply chain. BEFOREAn assessment of our client's production and quality process showed a lack of critical component testing as well as insufficient production monitoring. The insufficient monitoring resulted in a disconnect between field failures and the manufacturing and production process. IMPLEMENT SOLUTIONSWe developed and implemented critical component testing at our client and our client's vendor sites. Device functionality testing was implemented with a pass/fail criteria clearly determined. The testing data was collected and analyzed and used for Statistical Process Control (SPC) implementation. The SPC data was used to help improve the vendor's manufacturing process.
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