Ethylene oxide sterilization is a well-established sterilization technology, utilized to sterilize approximately 50% of all medical devices in the United States annually. Despite comprehensive, complex, and extensive validations, some failures may occur during routine processing. It is important to conduct a complete investigation to understand and potentially correct the root causes to keep the failure risk under control. It is also important to develop a mitigation and resolution plan to prevent major financial and commercial impact, or product shortages. This presentation will help you learn how to conduct a thorough investigation and implement a plan for moving forward.