2026 - April ASQ Orange Empire, Section 0701, Monthly Meeting

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In today’s competitive business environment, controlling waste and maintaining consistent quality are essential for organizational success. While most organizations have basic corrective action processes in place, many struggle to sustain improvements over time.

This clinic presentation focuses on building an effective corrective action system that goes beyond short-term fixes. Attendees will learn how to properly identify root causes, implement corrective actions, and sustain improvements throughout the product and process lifecycle. The session highlights practical approaches to system structure, effectiveness measurement, leadership accountability, and common myths surrounding root cause analysis (RCA). Key topics covered include:

• Core definitions and concepts
• Structure of an effective corrective action system
• Effectiveness factors and sustainability
• Common RCA myths
• Roles, responsibilities, and accountability

Babak Baghaei is the Founder and CEO of 7Q Solutions Corporation, leading a team dedicated to improving the performance and productivity of manufacturing and service organizations. He specializes in designing and implementing professional, user-friendly Quality Management Systems aligned with organizational culture and operational needs. With over 28 years of experience in Quality Management Systems and standards implementation across multiple industries, Babak has led numerous improvement initiatives and project teams. He holds several professional certifications, including ASQ Six Sigma Black Belt, ASQ Quality Engineer, ASQ Manager of Quality/Organizational Excellence, and Lead Auditor certifications for ISO 9001, ISO 14001, ISO 45001, ISO 13485, AS9100, IATF 16949, and ISO 17021.

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Life science professionals face enormous pressure to meet business objectives. To achieve key performance indicators, individuals may record notations during document review, use personal devices for company communications, or share instant messages that may be misinterpreted. There are well-known cases where Post-It or margin notes have been used as evidence in legal actions against an organization and/or individuals, costing millions of dollars and sometimes ending careers. In this high-energy, interactive session, you’ll learn how to protect yourself and your organization from unwelcome surprises. After completing the session, you’ll be able to:

• Recognize who can be held criminally liable under the FD&C Act
• Identify who should not be writing opinions on quality or regulatory issues
• Recognize how notations on documents can cause trouble for organizations during a lawsuit
• Recognize the dangers of writing casual emails on the organization's devices

Nancy Singer, JD, LLM, RAC, FRAPS founded Compliance-Alliance LLC to specialize in the professional development of government and business professionals in healthcare industries. She is an adjunct associate professor at the USC Alfred E. Mann School of Ph*rm*cy and Pharmaceutical Sciences. She teaches classes for the FDA Staff Colleges and the FDA Program District Offices. Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore's Reinventing Government Hammer Award and the FDA Commissioner's Special Citation. She began her career as an attorney with the Honors Program at the United States Department of Justice, doing litigation for FDA enforcement cases. Nancy received her BS from Cornell University and her JD and LLM from New York University Law School. She is a retired commander in the Navy Reserve.

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