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Questions and Answers
Which form is specifically designed to document the determination of trigger confirmation?
Which form is specifically designed to document the determination of trigger confirmation?
- Product Impact Assessment (PIA) Form SOP-QA107-F002
- Process Issue Escalation (PIE) Form SOP-QA107-F001
- Health Hazard Evaluation (HHE) Form SOP-QA107-F007 (correct)
- Escalation Assessment Form SOP-QA107-F004
Which role is responsible for completing the Health Hazard Evaluation (HHE) form for all Product Impact Assessments (PIAs)?
Which role is responsible for completing the Health Hazard Evaluation (HHE) form for all Product Impact Assessments (PIAs)?
- Medical Safety Officer (MSO) or Designee (correct)
- Compliance Officer
- Regulatory Affairs Specialist
- Quality Assurance Manager
What is one of the primary functions of the Risk Management Board (RMB)?
What is one of the primary functions of the Risk Management Board (RMB)?
- Conduct independent audits of product safety issues
- Review, assess, and evaluate Medical Safety data throughout the Product Lifecycle (correct)
- Provide financial forecasts for risk management activities
- Regulate compliance with international safety standards
What does the Risk Management Board (RMB) do during the Product Impact Assessment process?
What does the Risk Management Board (RMB) do during the Product Impact Assessment process?
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What is the target timeline for escalation in calendar days?
What is the target timeline for escalation in calendar days?
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Study Notes
Trigger Confirmation and Process Documentation
- The Process Issue Escalation (PIE) Form SOP-QA107-F001 is used to capture the determination of trigger confirmation and subsequent process documentation.
Health Hazard Evaluation (HHE) Form
- The Medical Safety Officer (MSO) or Designee completes the Health Hazard Evaluation (HHE) form for all PIAs.
Risk Management Board
- The Risk Management Board (RMB) is a product-based, cross-functional, collaborative team responsible for reviewing, assessing, and evaluating Medical Safety data from any source throughout the Product Lifecycle.
- The RMB escalates safety signals/issues to the Medical Devices Medical Safety Council as appropriate during the Product Impact Assessment process.
- The RMB is established by management to review results from the monitoring of risk information.
Escalation Timeline
- The escalation timeline target is 45 calendar days.
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