Using the criteria set forth in ISO 14971, complete the risk management evaluation for the following project. List at least 3 Harms in each category. Use the form attached to the test.
Risk Management Questions
- Using the criteria set forth in ISO 14971, complete the risk management evaluation for the following project. List at least 3 Harms in each category. Use the form attached to the test.
Johnson and Johnson is considering the development and marketing of a new wound care dressing (Zenorox). Zenerox is intended be used to stop bleeding and protect deep wounds up to 2 cm deep and 5 cm long. It incorporates a new clotting agent to help normal blood clotting action.
Construction is a combination of synthetic polymers bound to a natural cotton fiber which carries the clotting agent. It also contains an antibiotic and wound healing acceleration agents.
The product is supplied sterile for use by trained adults in an emergency situation. It can be used for up to 48 hours without changing
Complete the Risk Management assessment per the attached template.
Use the risk table below
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Risk table |
Max acceptable risk score =15
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Max acceptable risk score =15 |
Max acceptable risk score =15 |
Max acceptable risk score =15 |
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Frequency |
Frequency |
Frequency |
Frequency |
Frequency |
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Severity |
10 |
8 |
5 |
3 |
1 |
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10 |
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8 |
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5 |
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3 |
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1 |
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- Is the device’s risk acceptable? State rationale.
INTRODUCTION:
The process of locating, evaluating, and prioritizing any risks or uncertainties that might have an impact on a project or an organization is known as risk management. It entails assessing the possibility and potential consequences of these risks and then taking action to reduce, manage, or eliminate them. Risk management seeks to reduce the negative effects of prospective hazards while improving the chances of attaining goals.
Effective risk management includes several key steps, such as identifying potential risks, assessing the likelihood and potential impact of each risk, developing a plan to mitigate or control the risks, implementing the plan, and monitoring the effectiveness of the risk management strategy. Risk management is an essential process for organizations across industries, as it helps to identify potential hazards and to minimize their impact on operations, finances, reputation, and other critical business factors.
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