The news of an FDA investigator showing up unannounced at a medical device manufacturing facility generally sends a wave of panic throughout the organization! Even when it is a planned inspection, or an audit visit from a notified body, there is a high level of stress before, during and after the inspection. A lot of effort is spent in “getting ready” for the inspection or the audit, documentation is checked and re-checked, work areas are cleaned up and people are asked to be on their best behavior!
It is like cramming for a test, desperately hoping for a passing grade!
“Inspection readiness is a frame of mind, a daily practice, not a destination or a project deliverable”, says Vincent F. Cafiso in this Let’s Talk Risk! conversation. It is not about "managing” an inspection or audit; rather it is about creating a culture of Quality, open communication and collaboration where everyone feels confident in their work, and they are not afraid to be observed and challenged by an auditor.
In such an environment, every team member has a clear understanding of how their work relates to product quality and how it affects their end users and patients. They seek to improve on a daily basis, finding gaps and promptly addressing them. When people show passion and commitment to quality, working as if the product they are making will be used by a family member, you can feel a culture of Quality.
When it becomes a matter of daily practice, supported by a culture of Quality, you can be inspection ready any day!
About Vincent F. Cafiso
Vincent F. Cafiso started his career as an investigator at the US FDA, where he conducted hundreds of complex investigations at medical device and IVD manufacturers, both domestic and outside the United States. Subsequently, he spent over 25 years at leading medical device manufacturers helping them become inspection-ready through robust internal audit and compliance programs and a strategic focus on developing a culture of Quality. He is currently the Founder and Managing Consultant at Practical Compliance Results, LLC where he offers advisory services to clients in inspection readiness, compliance, quality assurance and quality systems consulting.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 34: Build a culture of Quality to achieve inspection-readiness at all times