1
When is the next scheduled training session on risk management? Select the date for the next training session.
To ensure that ongoing training is provided to staff on risk management practices.
2
How often are risk reviews conducted (in months)? Enter the frequency of risk reviews.
To ensure that risk reviews are performed at appropriate intervals.
Min:Â 1
Target:Â 6
Max:Â 12
3
Is there a clear incident reporting process in place for risk-related incidents? Indicate whether an incident reporting process exists.
To ensure that all incidents are reported and addressed promptly.
4
How effective is the current risk monitoring system? Select the effectiveness level.
To assess the adequacy of the risk monitoring activities in place.
1 - Very Poor 2 - Poor 3 - Average 4 - Good 5 - Excellent Clear
5
When was the last training session on risk management held? Select the date of the last training.
To ensure that staff are regularly updated on risk management practices.
6
How many risk mitigation actions have been implemented? Enter the total number of implemented actions.
To assess the organization's proactive approach to managing risks.
Min:Â 0
Target:Â 5
Max:Â 50
7
What challenges have you encountered in the risk management process? Describe any challenges faced.
To identify obstacles that may hinder effective risk management.
8
How effective is the risk communication process within the organization? Select the effectiveness level.
To evaluate whether risk-related information is effectively shared among stakeholders.
1 - Very Poor 2 - Poor 3 - Average 4 - Good 5 - Excellent Clear
9
When is the next scheduled risk assessment? Select the date for the next assessment.
To ensure that risk assessments are conducted regularly and on schedule.
10
How many risks were identified in the last risk assessment? Enter the total number of identified risks.
To keep track of the risk landscape and ensure thorough assessments.
Min:Â 0
Target:Â 10
Max:Â 100
11
Have all relevant personnel received training on risk management procedures? Indicate whether training has been completed.
To ensure that all staff are knowledgeable about risk management protocols.
12
How effective is the current risk identification process? Select the effectiveness level.
To assess the adequacy of the risk identification methods in place.
1 - Very Poor 2 - Poor 3 - Average 4 - Good 5 - Excellent Clear
13
When was the last review of the risk management process conducted? Select the date of the last review.
To ensure that the risk management process is regularly reviewed and updated.
14
What is the residual risk level after implementing controls (on a scale of 1 to 10)? Enter a value for residual risk level.
To evaluate the level of risk that remains after controls have been implemented.
Min:Â 1
Target:Â 3
Max:Â 10
15
Please upload the documentation related to the risk assessment. Attach relevant documents or notes.
To have a formal record of the risk assessment process for review and compliance.
Write something awesome...
16
What is the implementation status of the identified risk controls? Select the implementation status.
To ensure that all identified risk controls are being implemented as planned.
Complete In Progress Not Started Clear
17
What is the current status of the risk management plan? Select current status.
To track the progress of the risk management plan implementation.
Complete In Progress Not Started Clear
18
Please provide a summary of the most recent risk evaluation conducted. Enter a summary of the risk evaluation.
To maintain a record of risk evaluations for future reference and compliance.
19
What is the effectiveness rating of the implemented risk controls (on a scale of 1 to 5)? Rate the effectiveness of the risk controls.
To evaluate how well the risk controls are functioning in practice.
20
Is the risk assessment process compliant with ISO 14971 standards? Select compliance status.
To ensure that the risk assessment meets required regulations for medical device safety.
Compliant Non-Compliant Not Applicable Clear
