Metrics and Dashboards for Quality and Compliance

Why Should You Attend:

Bad data means bad decisions. 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.

Management needs to know how the business is performing, where the risks are, and where to invest precious dollars for improvement. Challenges that companies face include:

• Lack of data
• Data that is not timely
• Data that is incorrect or difficult to analyze
• Metrics that are lagging and not leading indicators
• Metrics that are not balanced leading to improper use of resources and unintended consequences

Areas Covered in the Webinar:

• How to create a balanced scorecard
• How to move from lagging to leading indicators
• How to use indices 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 Will Benefit:

• Managers of quality and compliance
• Quality and compliance professionals in medical device companies
• Individuals preparing information for management review

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA, 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. Ms. Manz also holds a Regulatory Affairs Certification (RAC) from RAPS and a Certified Quality Auditor (CQA) certification from the American Society for Quality. She has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Topic Background:

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.

A balanced scorecard can help companies identify the top areas for improvement. Well-developed metrics and scorecards can bring risks and improvement opportunities into focus. Thought should be given into both lagging and leading indicators for quality and compliance.

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