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  • Using Metrics to Monitor and Improve your Quality Management System

Product Id IQW15C8532
Speaker Susanne Manz
Level Basic & Intermediate & Advanced
Duration 90 Mins
  • Description
  • Why should you attend
  • Areas covered
  • Who will benefit
  • Speaker

Many medical device companies are surprised when they have quality and compliance issues. To prevent quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and dashboards. Metrics and dashboards can help to proactively and consistently measure and improve the health of the Quality Management System. 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. Metrics and data are a key part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest precious dollars for improvement. This course can help you determine what to measure, how to present information and how to escalate issues for management review.

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 an efficient and effective use of resources. Without proactive and timely metrics, a company is blind to the health of its quality system and meeting the needs of its stakeholders. This can lead to disaster for the company or, even worse, its customers. 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 consequence
  • Determining Key Process Indicators
  • 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
  • Creating a Metrics Board for your company
  • Managers of Quality and Compliance
  • Directors of Quality and Compliance
  • Process Owners wishing to monitor and improve their processes
  • Individuals preparing data for Management Review
  • General Managers wanting greater insight into Quality Metrics and Data
  • Auditors 
  • Compliance Specialists
  • Quality Engineers

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.