Risk Management
Slide 5: If the health risk management process is inadequate, the result could be frequent product quality issues (in the field) leading to significant financial losses such as loss of sales, loss of market share, warranty costs (repair and replacement), product field action costs (recalls and market withdrawals), and personal injury lawsuit costs. All of these financial losses caused by poor product quality can be grouped together as “cost of quality”.
Slide 5: Examples of business risk management topics that do not pertain to health risk management include: project feasibility risks (premarket), project cost risks (excluding product quality issues), sales strategy risks, marketing strategy risks, intellectual property risks, and regulatory clearance risks (excluding product quality issues).
Slides 6-7: The Risk Management standard ISO 14971:2019 is available for purchase on the ISO website.
Slide 8: The term Normal Use is from the Usability Engineering standard IEC 62366-1:2015, which leverages the ISO 14971 Risk Management process.
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