THE NEED FOR A CAPA SOLUTION PLAN
Three types of events will typically result in the need for a CAPA solution plan: an anomalous result, an external finding, or a deviation from a written procedure. The anomalous result, which is known as an out-of-specification or out-of-trend result, falls outside of normal method behavior or manufacturing specifications. Anomalous results can stem from poor system suitability, equipment maintenance, or the improper preparation of samples or standards, or may be indicative of an unknown matrix effect. A thorough investigation will usually pinpoint an assignable cause or reason for the inconsistent result. There are instances where the assignable cause may not be discovered, however, and it is in these circumstances where a follow up CAPA program can prove useful.The external finding is generated as a result of an audit or complaint. The solution to these findings can fall into two categories. Short-term corrective actions are immediately apparent, such as a documentation error or safety violation. Long-term corrective actions may require extensive effort or cost, or may be multi-layered. Without the periodic review built into an established CAPA program, these long-term actions may fall between the cracks and never come to fruition.
Finally, a deviation is generally the result of human error, but is nonetheless crucial for identifying weaknesses. Corrective action may or may not be appropriate in the case of a deviation, but the preventive actions can help limit the recurrences seen over an extended period of time and may even result in stronger support mechanisms such as training.
The characteristics of these events do not necessarily lend themselves to an easy investigation or root cause determination. In some instances, such as an anomalous result, an investigation is straightforward and determines if the result is true or the by-product of a failure in some part of the testing system. Depending on the nature of the external finding, an investigation and root cause determination may not be needed in the traditional sense, but rather used to rule out causal factors.
Having an established CAPA program can help track the follow-up actions needed to close out an observation with a customer or regulatory agency and effectively demonstrate control over the quality of the systems. Also important is trending to identify repeat occurrences, which can be handled by a CAPA solution plan. The trending can point to systemic issues, such as procedural clarity, and exhibit a proactive approach toward risk management and continuous improvement.
BUILDING A CONTROLLED SYSTEM
There are four main elements of a CAPA program that will demonstrate control over the procedures and processes that make up the working environment: documentation, investigation, CAPA, and measurement. These elements often are in place informally, but without adequate follow-through they will be ineffective in demonstrating the systemic control desired.
An appropriate level of documentation must take place immediately following discovery or occurrence of the event. Quality and management will need to characterize the type of events anticipated and determine a suitable course of action. This also may be the point in the process where customers, sponsors, or study directors are notified of the event. Notification will depend largely on contractual obligations or protocol directions or the discretion of management.
This documentation will help recreate any variables that may affect the outcome of the investigation. Documentation also enables personnel down the line in the investigation or measurement phases to accurately gauge the risk associated with the event or effectiveness of the implemented actions. With risk assessment, management can determine the level of resources to be allotted for the investigation and CAPAs.