1
Does the risk acceptance process comply with ISO 14971 standards? Select compliance status.
To ensure that all risks are managed according to established guidelines. Compliant Non-Compliant Needs Attention Clear
2
What is the severity rating of the identified risks? Enter severity rating (1-5).
To assess the potential impact of identified risks on patient safety. 3
What mitigation measures are in place for identified risks? Provide details of mitigation measures.
To ensure that adequate measures are implemented to reduce risk. 4
When was the last review of the risk acceptance process conducted? Select the date of the last review.
To track the frequency of reviews and maintain compliance. 5
Has the risk acceptance been formally approved? Select approval status.
To confirm that all risks have received appropriate approval. Approved Pending Rejected Clear
6
Was the risk management team involved in the risk acceptance process? Select involvement status.
To ensure that all relevant stakeholders contribute to the risk assessment. 7
Provide any additional comments or observations regarding the risk acceptance process. Enter comments here.
To gather qualitative insights that may not be captured by structured questions. 8
How many risks were assessed during the risk acceptance process? Enter the total number of risks assessed.
To quantify the scope of the risk assessment conducted. 9
What is the scheduled date for the next review of the risk acceptance process? Select the next review date.
To ensure timely reviews and continuous improvement. 10
Has a check been conducted to ensure compliance with relevant regulations? Select compliance check status.
To verify that all legal and regulatory requirements are being met. 11
What are the key risks identified during the assessment? List the key identified risks.
To document the primary risks that need to be monitored and managed. 12
Is there documented evidence of risk acceptance? Indicate if documentation exists.
To ensure that all accepted risks are properly documented for accountability. 13
How often are risk assessments conducted? Enter the frequency in months.
To track the regularity of risk evaluation processes. 14
When was the last training conducted for staff on risk management? Select the date of the last training.
To ensure that staff are up-to-date on risk management practices. 15
Have all stakeholders agreed on the risk acceptance decision? Select stakeholder agreement status.
To confirm that the acceptance of risks is a collective decision. 16
What is the justification for accepting the identified risks? Provide justification for risk acceptance.
To ensure that there is a clear rationale for accepting each risk. 17
What is the estimated impact of the accepted risks on operations? Enter estimated impact score (1-10).
To quantify potential consequences of accepted risks. 18
Has the risk acceptance been communicated to all relevant parties? Select communication status.
To ensure that the acceptance of risks is known to all stakeholders. Effective Communication Ineffective Communication Clear
19
What is the scheduled frequency for reviewing accepted risks? Select the review frequency date.
To ensure that accepted risks are periodically evaluated. 20
What lessons have been learned from the risk management process? Provide lessons learned here.
To document insights that can improve future risk management efforts. 21
Have historical trends in risk acceptance been analyzed? Select analysis status.
To understand past decisions and improve future risk management. 22
What is the total number of risks logged in the system? Enter the total number of risks logged.
To track the overall scope of risks being managed. 23
When was the last training session held for staff on risk management? Select the last training date.
To ensure that staff are regularly trained on risk management practices. 24
Are there regular updates provided on the status of accepted risks? Indicate if updates are provided.
To maintain awareness and accountability regarding accepted risks. 25
What future strategies are planned for mitigating risks? Describe future risk mitigation strategies.
To outline proactive measures for managing potential risks. 