Susan Schniepp, Distinguished Fellow, and Andrew Harrison, Chief Regulatory Affairs Officer and General Counsel, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
Q. I work for a contract manufacturing organization and am responsible for hosting audits and preparing the responses to the observations. I have received multiple comments on my CAPA system from many groups, many with different perspectives. What are the real requirements for a successful CAPA system?
A. You can take comfort in the fact that you are not alone in this predicament. We consider investigations to be the cornerstone of any CAPA system and based on the data in the FDA database. FDA 483 citations are commonly issued for inadequate, incomplete, and undocumented investigations. For some reason or another, the industry tends to focus on the immediate correction to the non-conformance, resulting in a failure to investigate and execute the corrective and preventive actions of the CAPA system in an effective and timely manner.
Basically, we need to view CAPAs as improvements we make to our processes and procedures to eliminate non-conformances in our products. These improvements are based on the results of the investigations into the non-conformance for root cause. Once the root cause is determined, then a corrective action is identified and implemented into the process. The change is then monitored during a period of time to determine if the proper root cause was identified and if the corrective action was effective (i.e., effectiveness check). In some cases, the root-cause analysis may reveal a potential for an objectionable situation to occur resulting in compromised product. The solutions chosen to avert predicted non-conformance are preventive actions.
The key to any CAPA system is the initial investigation into the non-conformance to determine the root cause. However, not all investigations are the result of a non-conformance and not all investigations will result in a CAPA. It is important that the investigation be thorough and complete before the CAPA is initiated and implemented.
The investigation process should make use of root cause analysis tools designed to examine the impact of various process inputs and their effect on the non-conformance. These tools examine the impact of the equipment, process, people, materials, environment, and management on the identified non-conformance. In some cases, depending on the nature of the non-conformance, some areas can be eliminated as having no impact. The rationale for elimination, however, should be documented. As the elimination process progresses, the investigation will naturally and logically hone in on the root cause(s) of the non-conformance. Once this is completed, the actual CAPA can begin.
If we look at the CAPA system as an expressway, the immediate correction and the investigation are the on ramps, the corrective and preventive actions are the lanes, and the effectiveness checks are the off ramps. The immediate correction and investigation into that occurrence should determine if the non-conformance is a one-time occurrence or if it has happened before. If the non-conformance has happened before, the investigation needs to be conducted to determine the underlying root cause of the non-conformance. Once the root cause has been determined the corrective action and the preventive actions can be implemented and monitored. If the non-conformance does not recur in a specified time frame, the corrective action/preventive action is considered effective and the CAPA can be closed.
The bottom line is there are many perspectives on what constitutes a good CAPA system, but the reality is the quality and thoroughness of the investigations ultimately drive the effectiveness of the CAPA. When conducting the investigation, it is important not to jump to conclusions on what caused the non-conformance. The investigation should use root-cause analysis tools and should address why potential areas are either eliminated as the root cause or are a potential cause of the non-conformance. If you can conduct a complete investigation, you will ultimately have a robust CAPA program.
Vol. 39, No. 8