1
Is the risk assessment process compliant with ISO 14971? Select compliance status.
To ensure adherence to international safety standards for medical devices. Compliant Non-Compliant Needs Attention Clear
2
What is the severity rating of the identified risks? Rate the severity on a scale from 1 to 5.
To evaluate the potential impact of the risks on patient safety. 3
Describe the identified risks associated with the medical device. Provide a detailed description of the risks.
To document specific risks and their potential impacts. 4
What is the current status of risk mitigation actions? Select the current status of risk mitigation actions.
To track the progress of addressing identified risks. Complete In Progress Not Started Deferred Clear
5
When was the most recent risk assessment conducted? Select the date of the last risk assessment.
To ensure that risk assessments are performed regularly and are up to date. 6
How effective are the current risk controls in place? Select the effectiveness level of current risk controls.
To evaluate the effectiveness of measures taken to mitigate risks. 7
Who is responsible for managing the identified risks? Provide the name of the risk owner.
To identify the individual accountable for risk management. 8
What is the estimated impact of the identified risks on operations? Enter the estimated impact in monetary terms.
To quantify the potential impact of risks on healthcare operations. Min: 0
Target: 1000
Max: 1000000
9
What is the classification of the identified risks? Select the risk classification level.
To categorize risks based on their severity and impact on patient safety. High Risk Moderate Risk Low Risk No Risk Clear
10
What preventive measures are in place to mitigate the identified risks? Provide a detailed description of preventive measures.
To document the strategies employed to prevent risks from occurring. 11
Summarize the findings from the latest risk assessment. Write a summary of the risk assessment findings.
To compile a comprehensive overview of the risk assessment results. 12
How frequently are the identified risks monitored? Enter the frequency of monitoring in months.
To ensure that risks are being regularly reviewed and managed. 13
How effectively are the risks communicated to the relevant stakeholders? Select the effectiveness of risk communication.
To assess the clarity and effectiveness of risk communication strategies. Effective Needs Improvement Clear
14
Who are the members of the risk assessment team? List the names of the team members.
To identify the personnel involved in the risk assessment process. 15
How many risks were identified during the assessment? Enter the total number of identified risks.
To quantify the number of risks that require management. 16
When is the next review of the risk management plan scheduled? Select the date for the next review.
To ensure timely reviews of the risk management strategies. 17
Is the risk documentation complete and up to date? Select the status of risk documentation.
To verify that all risks are properly documented as per the standards. Not Reviewed Incomplete Complete but Inaccurate Complete and Accurate Clear
18
What historical risk issues have occurred in the past? Describe any notable historical risk issues.
To understand previous risk occurrences and their impacts. 19
What is the estimated cost for treatment of the identified risks? Enter the estimated cost in your currency.
To assess the financial implications of risk management actions. Min: 0
Target: 5000
Max: 100000
20
What is the action plan for mitigating identified risks? Provide a detailed action plan for risk mitigation.
To outline the steps to be taken for risk reduction. 