MANAGING RISK IN OUTSOURCED PRODUCT DEVELOPMENT AND MANUFACTURING

摘要

In today’s litigious society, products used by consumers can become the source of product liability lawsuits. Outsourcing product development and manufacturing can create additional risk because the electronics manufacturing services (EMS) provider’s practices may come under scrutiny in this type of lawsuit. What checks and balances should be built into this relationship? What elements should be built into the outsourced product development and manufacturing to help minimize this element of risk? Syncro Corporation has been an EMS provider for more than two decades and has been manufacturing proprietary automotive aftermarket products since the 1960s. This paper discusses its systems and processes for supporting robust product development and production of high quality products for clients in the automotive, medical and upscale consumer product sectors, who often have enhanced needs for traceability or regulatory reporting support. In particular, it will look at: · Critical design process review points · Product validation elements such as Failure Modes and Effects Analysis (FMEA), process control plans and mutually acceptable product acceptance criteria · Quality assurance processes and recordkeeping · Likely traceability support requirements