Rob Packard Verification of purchased product has always been part of ISO 13485 in clause 7.4.3 and in the QSR under 21 CFR 820.80. However, it is also common for PCB manufacturers to have AOI libraries to look for specific features printed on components in order to detect potential counterfeit parts. The grade and type of metal stock received by companies is also routinely checked for impurities and identity to ensure that there are no off-grade metals received and lots are not mixed.

Ed Odette "Do you exhaust all of your resources to prevent Counterfeit Parts from entering your supply chain?"

There are several misconceptions concerning traceability and authentication to screen out counterfeit parts that are purchased from Independent Sources. No combination of traceability or component testing keeps out all Counterfeit Silicon nor ensures Reliable Silicon.

The NRE costs to develop test programs and fixtures for component testing is expensive and needs to be destructive for reliability testing. Parametric testing is not reliability testing.

After Buyers and Engineers have exhausted all of their authorized aftermarket and franchised sources, they should submit their obsolete parts to Global Circuit Innovations to determine if a potential quick reaction and low cost franchised solution is available prior to purchasing parts from the Open Market.

Please see contact Ed Odette at ed.odette@gci-global.com to learn more.