Using Metrics to Monitor and Improve your Quality Management System
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Course Description:
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. 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. 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.
Why should you Attend?
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 cannot 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:
- Lack of data
- Data that is not timely
- Data that is incorrect or statistically insignificant
- Metrics that are not balanced leading to improper use of resources and unintended consequences
Areas Covered:
- 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
Who will benefit?
- 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
Registration Options
Speaker Details
Susanne Manz
Medical Device Consultant
Susanne Manz, MBA, MBB, RAC, CQA 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
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
