We learned this week that Risk Analysis for a process is conducted when the process is first designed, changes are made to process, and when a Corrective and Preventative Action (CAPA) is filed on the process. Corrective actions are put in place in response to customer complaints, non-conformities with the product, or issues in processes found during an internal audit.
To comply with the FDA code FDA 21 CFR 820.100 medical device companies need to establish a CAPA process within their QMS. In 2017 there were 1,030 483s issued for medical devices. I think its better to have a proactive system in place vs being reactive to CAPAs as a result of issues that have already occurred. For medical devices, do you think it’s better from a business standpoint to be proactive or reactive?