Case Study – CAPA and Warning Letters

Background and Problem

A medical products company received a warning letter indicating their CAPA process was deficient. They found that their CAPA process lacked adequate investigation, preventive actions, details and clarity in their close out reports.

Analysis

Working with key managers, an assessment of key staff members was conducted, and it was found that there was a severe lack of understanding on how to work through CAPAs, conduct root cause analysis, and write, clear and concise reports.

Solution

A two day training/coaching program was run for 60 cross functional employees at the site. Participants learned root cause analysis via simulated games of real life work scenarios, practiced creating CAPAs, and writing reports. Then they examined and re-wrote previous reports, correcting the errors and gaps. The training with quick and direct application of what was learned proved effective in eliminating the audit findings.