Using Metrics to Monitor and Improve your Quality Management System
Duration: 90 Minutes
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.
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 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.
Objectives of the Presentation
Why Should you Attend
- Understand the use of Metrics and Dashboards in management review
- Concepts of Metrics, Dashboards, Scorecards
- How to collect, structure, and analyze your QMS data
- How to create a system for collecting information about your Quality Management Systems
- How metrics can help you to be more efficient and effective in managing your Quality System
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 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 consequences
In this course we will cover:
Who can Benefit
- 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
- Quality Systems Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Managers of Quality and Compliance
- Individuals preparing data for Management Review
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements