Using Metrics to Monitor and Improve Your Quality System

Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders:

Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and effective products. Metrics that measure and trend product quality and customer satisfaction are critical. Fast or real-time systems are needed to ensure proper responsiveness.

Regulators: Proper metrics can help you identify, analyze, and mitigate compliance risks.

Business Stakeholders: Better decision making is enhanced by good data and information. Good metrics and scorecards help create a transparent environment where key indicators are proactively measured and addressed. Proper metrics should escalate and inform the appropriate levels of management, improving decisions on where to put resources.

Medical device companies face ever increasing scrutiny from the FDA and other regulators. Customers demand quality and safety. The business requires efficient and effective use of resources. Without proactive and timely metrics, a company is blind to the health of its quality system. This can lead to disaster for the company or, even worse, its customers.

Areas Covered in the Session :

• How to create a balanced scorecard
• How to move from lagging to leading indicators
• How to use indices or profiles to create a more complete picture of performance
• Lack of transparency in quality/compliance data
• Use of metrics and dashboards for management review
• Maturity levels in use of metrics
• Scalability and hierarchy in metrics

Who Should Attend:

• Quality Assurance Managers
• Quality Control Managers
• Regulatory Affairs Teams
• Compliance Managers
• Individuals preparing data for Management Review
• Directors, VPs, and others attending Management Review

Course Director: SUSANNE MANZ

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.