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 and resources for improvement. This course can help you determine what to measure, how to present information, and how to escalate issues for management review.
Many medical device companies are surprised when they have a recall, a 483, or even a warning letter. 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 the health of the Quality Management System. Metrics are communicated in management review to make informed decisions about the suitability of the QMS. A balanced scorecard can help companies identify the risks and prioritize areas for improvement. Well-developed metrics and scorecards can bring improvement opportunities and actions into focus.
Bad data means bad decisions! Without proactive and timely metrics, a company is blind to the health of its quality system. Without metrics, a company can’t ensure they are meeting the needs of their stakeholders.
This can lead to disaster for the company or, even worse, its customers. 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. And companies need a good set or metrics to meet these stakeholder needs.
Challenges that companies face include:
From medical device companies
President and Principal Consultant, Manz Consulting Inc/p>
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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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