As a contract manufacture, Jabil ca

As a contract manufacture, Jabil carries a portion of the burden with our OEM customers for the management of risk. Primarily, Jabil’s risk management deals with the risks associated with manufacturing to the product specification. This differs from the concept of risk management described in ISO 14971,which focus primarily on patient safety. Clinical safety and user effects are aspects that Jabil cannot manage and are wholly the responsibility of our OEM customers. Jabil relies on our OEM customers to translate those clinical and user risks into technical specifications that can be processed through our standard FMEA processes. As a result, our OEM customers are critical to our application of risk management, especially for identification of issue severity.