The U.S. Food and Drug Administration (FDA) requires pharmaceutical and medical device companies to have CAPA processes in place to address problems. Should regulators come calling to investigate a problem, you can bet that any CAPA documentation related to the issue will be under the microscope.
Common documentation problems include:
• Lack of detail: Instead of just a generic description of the issue, you should include specifics on things like timing, batch information and exactly where in the process the problem occurred.
• Assuming familiarity: Often CAPA reports lack sufficient detail because the writer assumes the reader understands their internal quality process. Remember that you may be writing to someone completely outside the company, so you might need to provide more background on your processes and systems.
• Inadequate training: Many times, companies don’t train people on how to write CAPA reports, which leads to many of the problems discussed in this post.
Whether or not CAPAs adequately reduce risk in your company all comes down to your processes and the people behind them. Risk-based, automated CAPA processes can help, but it’s also critical that your people enter into the process with an open mind and a commitment to a fair and thorough analysis.
