Episode Thumbnail
Episode 106  |  34:56 min

Is Your Medical Device Company CAPA Happy?

Episode 106  |  34:56 min  |  11.07.2019

Is Your Medical Device Company CAPA Happy?

00:00
00:00
This is a podcast episode titled, Is Your Medical Device Company CAPA Happy?. The summary for this episode is: The medical device industry could be more proactive than reactive when managing systemic issues. We’re talking about the Corrective and Preventive Action (CAPA) process. In this episode, Jon Speer invites Mike Drues of Vascular Sciences to be his guest as they discuss the importance of the Corrective and Preventive Action (CAPA) process. Is your company CAPA happy? Some of the highlights of the show include: ● CAPA is a means to formally investigate a systemic issue and properly take actions to prevent it from occurring again. ● Call it PACA, instead of CAPA: Place emphasis on prevention, not correction. Identify and predict issues and trends before they spin out of control. ● FDA “theoretically” defines CAPA by purposefully offering flexible and vague ideas, rather than specific details. Is that good or bad? It depends. ● Data doesn’t lie, companies struggle with CAPA. FDA’s lack of information leads to interpretation. ● When the FDA issues 483s and warning letters, the usual solution is mandatory training to require employees to know and understand design controls. ● CAPA is an indicator or biomarker of the health of a company’s quality management system (QMS). ● Metrics should measure the effectiveness of CAPA. Time constraints and root cause determination need to be addressed. Keep asking, “Why?” ● Companies need to go above and beyond to prevent problems. They should review their CAPA process, evaluate efficacy of QMS, and address root cause.
The medical device industry could be more proactive than reactive when managing systemic issues. We’re talking about the Corrective and Preventive Action (CAPA) process. In this episode, Jon Speer invites Mike Drues of Vascular Sciences to be his guest as they discuss the importance of the Corrective and Preventive Action (CAPA) process. Is your company CAPA happy? Some of the highlights of the show include: ● CAPA is a means to formally investigate a systemic issue and properly take actions to prevent it from occurring again. ● Call it PACA, instead of CAPA: Place emphasis on prevention, not correction. Identify and predict issues and trends before they spin out of control. ● FDA “theoretically” defines CAPA by purposefully offering flexible and vague ideas, rather than specific details. Is that good or bad? It depends. ● Data doesn’t lie, companies struggle with CAPA. FDA’s lack of information leads to interpretation. ● When the FDA issues 483s and warning letters, the usual solution is mandatory training to require employees to know and understand design controls. ● CAPA is an indicator or biomarker of the health of a company’s quality management system (QMS). ● Metrics should measure the effectiveness of CAPA. Time constraints and root cause determination need to be addressed. Keep asking, “Why?” ● Companies need to go above and beyond to prevent problems. They should review their CAPA process, evaluate efficacy of QMS, and address root cause.

More Episodes

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis