1
Are there established procedures for identifying risks associated with medical devices? Select the compliance status.
To ensure that all potential risks are recognized and documented. Compliant Non-Compliant Needs Attention Clear
2
What is the frequency of risk assessments conducted? Enter the frequency in months.
To evaluate how often risks are reviewed and updated. Min: 1
Target: Monthly
Max: 12
3
Is there regular training for staff on risk management procedures? Indicate whether training is conducted.
To ensure that staff are equipped with the necessary knowledge to manage risks effectively. 4
Describe the strategies in place to mitigate identified risks. Provide a detailed description of the strategies.
To assess the effectiveness of current risk mitigation strategies. 5
Is the organization compliant with ISO 14971 standards? Select the compliance status.
To verify adherence to international risk management standards for medical devices. Compliant Non-Compliant Clear
6
Is there documented evidence of risk analyses conducted for all medical devices? Select the documentation status.
To ensure that all risk analyses are recorded and can be reviewed for compliance. Not Reviewed Incomplete Complete but Inaccurate Complete and Accurate Clear
7
What is the maximum acceptable risk level defined for the medical devices? Enter the maximum acceptable risk percentage.
To understand the threshold for acceptable risk within the organization. 8
What process is in place for communicating risks to relevant stakeholders? Provide a brief description of the communication process.
To evaluate how risks are communicated and whether stakeholders are adequately informed. 9
When was the last risk assessment conducted? Select the date of the last risk assessment.
To track the frequency of risk assessments and ensure they are current. 10
What lessons have been learned from previous risk management activities? Provide a detailed account of lessons learned.
To ensure that past experiences are documented and used to improve future risk management. 11
Is the risk management plan reviewed and updated regularly? Indicate whether the plan is reviewed regularly.
To ensure the risk management plan remains relevant and effective. 12
Are stakeholders involved in the risk analysis process? Select the engagement status.
To assess the level of stakeholder engagement in risk management. 13
How many team members are involved in the risk assessment process? Enter the number of team members.
To evaluate whether sufficient resources are allocated for effective risk assessment. 14
What challenges have been encountered in the risk management process? Provide a detailed description of the challenges faced.
To identify obstacles that may hinder effective risk management. 15
When is the next scheduled review of the risk management plan? Select the date for the next scheduled review.
To ensure that the next review is planned and documented. 16
Is there compliance with established risk management procedures across all departments? Select the compliance status.
To ensure that all departments adhere to the organization's risk management protocols. Compliant Non-Compliant Clear
17
What is the average time taken to implement risk mitigation measures? Enter the average time in days.
To assess the responsiveness of the organization in addressing identified risks. Min: 1
Target: 30 days
Max: 365
18
What is the emergency response plan for critical risks identified? Provide a brief description of the emergency response plan.
To evaluate preparedness and response capability for critical risk scenarios. 19
What is the impact assessment outcome for the identified risks? Provide a detailed description of the impact assessment results.
To understand the potential effects of identified risks on operations. 20
When was the last training session on risk management conducted for staff? Select the date of the last training session.
To ensure staff are regularly trained and updated on risk management practices. 21
Is risk management integrated into the project planning process? Indicate whether risk management is integrated.
To ensure that risk considerations are part of all project planning activities. 22
How frequently are risk management meetings held? Select the frequency of meetings.
To evaluate the commitment to ongoing risk management discussions and updates. Weekly Bi-Weekly Monthly Quarterly Annually Clear
23
How many risks have been identified in the last assessment? Enter the number of identified risks.
To assess the volume of risks that need to be managed. 24
What is the protocol for communicating risk alerts to the team? Provide a detailed description of the communication protocol.
To ensure that there is a clear procedure for alerting relevant parties about risks. 25
When is the next scheduled training on risk management for staff? Select the date for the next training session.
To ensure that ongoing training is planned for continuous improvement. 