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A Blueprint for Quality Culture with Vincent Cafiso

A former FDA Investigator and industry expert shares his playbook for creating a robust, modern quality culture

In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman sat down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector.

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Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise.

Here’s a high-level look at some of the items in Vincent’s quality culture “blueprint”:

  • Develop and publicly display a Quality Charter signed by top management, affirming their commitment to prioritize patient improvement in all decisions.

  • Hold regular town hall meetings led by executives to discuss quality-related achievements, challenges, and future goals.

  • Hold regular workshops to reinforce the principles and practices of the quality culture among employees.

  • Introduce a recognition program to celebrate individuals and teams who make significant contributions to quality improvements.

  • Establish both digital and physical platforms for employees to propose improvements, with a system for evaluation and implementation of viable ideas.

  • Revise change control procedures to facilitate quicker, yet responsible, decision-making for quality improvements.

  • Form teams from various departments to identify and execute continuous improvement initiatives.

  • Design an orientation program that includes sessions on quality culture, featuring insights from experienced employees.

  • Conduct bi-annual anonymous surveys to gauge the effectiveness of the quality culture and identify areas for enhancement.

  • Implement a clear process for reporting, analyzing, and addressing product failures or quality issues.

  • Set up a system for teams to present their quality-related actions and outcomes, fostering accountability.

  • Schedule regular interactions between leaders and various departments to discuss quality culture and gather feedback.

We’d add a few more things to this list based on programs we’ve seen and helped implement with our own clients:

  • Implement a dashboard that tracks key quality metrics like defect rates, time to resolution, and customer satisfaction scores. Use this data to identify trends and inform strategic decisions.

  • Establish a yearly training calendar that includes internal workshops on the latest quality standards and allocate a budget for employees to attend relevant external conferences or online courses.

  • Set up a monthly Q&A session with the CEO or quality leaders, where employees can submit questions or concerns about quality issues, and these are addressed in an open forum.

  • Conduct bi-annual risk assessment workshops to identify potential quality risks in upcoming projects or processes and develop preemptive action plans.

Vincent is a distinguished expert in quality assurance and regulatory compliance with over 30 years of extensive experience in the life sciences industry. As the Founder and Managing Consultant of Practical Compliance Results, LLC, he specializes in inspection readiness, compliance, and quality systems, focusing particularly on medical devices and in vitro diagnostics (IVD).

His expertise includes the development, management, and auditing of quality systems to ensure adherence to both domestic and international regulatory standards. Vincent is known for his skill in building and leading effective quality and regulatory compliance teams, ensuring their operational excellence and sustained inspection preparedness.

With a background as an internal and supplier auditor, Vincent brings practical insights into FDA inspection techniques and a comprehensive understanding of quality system standards such as ISO 13485 and ISO 9001. His experience is extensive in the European and Global regulatory landscape, including the EU Medical Device Regulations. He also offers valuable expertise in collaborating with contract design and manufacturing organizations (CDMOs), ensuring products are designed and manufactured in compliance with global quality system requirements. His proficiency covers a wide range of areas, including FDA Regulations, Quality Assurance, Regulatory Compliance, Change Control, and FDA Readiness and Remediation.

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