Risk management should be part of the entire product life-cycle to ensure that finished devices and should include risk analysis, risk evaluation and risk control. Many tools and processes can be used for risk management, assessment, and control. Failure Modes and Effects Analysis (FMEA) is one of the suggested tools. The FMEA process identifies potential failure modes, the effects of the failure mode, the potential causes of the failure and controls (if any) that are in place to detect the failure. Risks are evaluated in terms of Severity, Occurrence and Detection providing a Risk Priority Number to asses the overall risk level and actions for risk abatement or elimination. This Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.
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This Webinar will provide an overview of risk management and detail the elements of Failure Modes and Effects Analysis (FMEA), the types of FMEAs and how to analyze data and outputs from an FMEA.
Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.
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