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Hello It is interesting to note that 3 of the 4 performance related factors relate more to the commercial/business side of the relationship. Only 1 - Quality of Parts upon delivery is directly relates to product quality. I would also recommend that you look at what quality attributes you have included ...

Hi Chris - thanks for your thoughtful and detailed response. I think you have accurately identified many of the common challenges in the industry. When it comes to the real world practice of risk management, we still have a long way to go! I hope conversations like these offer new insights to help ...

👋Dear colleagues, hello! 📊Recently I posted a poll question on LinkedIn that generated a lot of good discussion. 🌟To estimate risk, we need to estimate severity and probability of harm. 🤔We want to be as accurate as possible in our estimates. 🔥Often, we don't have a lot of data and we have ...

Thank you Ed for your insightful comment. This exercise of clearly articulating a hazardous situation proves to be challenging in practice. I have been thinking about it for many years, and I will be the first to admit that the concept of a hazardous situation as outlined in ISO 14971 is extremely ...

Hello @Dan O'Leary - thank you for your thoughtful and detailed response. I love these examples. They illustrate the value of working through a detailed sequence of event starting from an initiating event. Thanks for contributing to this discussion. ------------------------------ Naveen Agarwal, Ph.D. ...