Meaningful Quality System Process Monitoring

Why Should You Attend:

When considering the requirements for process monitoring and measurement, the first thought is usually in regard to production processes. However, ISO 13485 and ISO 9001 require companies to monitor and measure all quality system processes. Too often, this is either ignored, considered to be addressed by internal audit, or focused primarily on cycle-time reduction; none of which actually address the intent of the requirements. This webinar will help attendees to better understand those intents, how to meet them to realize business value rather than just compliance, and to avoid common mistakes that can result in reduced business valueless clinical trials, nor bulk-solution processes. It applies to unitized products such as pills, drug-filled syringes, medical devices, and components.

• You probably monitor and measure your production processes, but what about the rest of your quality system processes?
• Are you relying solely on internal audits to satisfy the requirement for process monitoring?
• While internal audits can tell you whether your processes conform, how do you determine if the processes are effective?
• What does effective mean; e.g. – what constitutes effective document control?
• Have you considered whether your measurements drive the wrong behaviors in process participants?

Areas Covered in the Webinar:

• What are the requirements and what are their true intents?
• Let’s revisit what Deming said about management by objective
• Is there more to ensuring process conformity than just auditing?
• What does process effectiveness look like?
• How does process performance relate to product conformity?
• How to get Management to care?
• Common mistakes
• Scaling process monitoring to measure the entire quality system

Who Will Benefit:

• Quality Manager
• Quality Director
• Quality Systems Specialist
• Quality Engineer

Steve Gompertz
President, Quality Management Systems Potential LLC

Steve Gompertz is a leader in Quality Systems management with over 25 years' experience in the life-science industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. He is currently President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University's Master of Science in Medical Technology Quality program. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management.

Follow us :