#325 The Role of dFMEAs in Risk Management for Medical Devices
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The Importance of Divergent Thinking in Risk Management
Ishikawa: I was talking to Mike Drew's recently on another podcast episode about the common issues that companies face or let me see if I can get the title right. The common issues found in an FT inspection that result in a form 483 are Kappa design controls and complaints, he says. But within that a large majority is tied to risk analysis and inadequate risk analysis methodology," Ishikawa adds. "When you use root cause analysis thinking and you apply it to your risk management, you're going to go a lot deeper"
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