CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is commonplace for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process?

First, while it must be noted that there is no standard definition for risk that can be applied across organizations, the common goal is to eliminate risk and for those that cannot be eliminated, to reduce them to a level as low as reasonably practicable. Many companies spend plenty of time and money putting risk metrics in place that are at best subjective based on their level of tolerance. This leads to inconsistency in the response to negative events. By quantifying risk and developing a matrix-based response program, companies can more quickly realize a return on investment for their preliminary data gathering and work during the CAPA process.

Building a Risk-Based CAPA Matrix

Risk assessment (or impact assessment) is required for any CAPA process and involves the identification, analysis, and prioritization of risks and subsequent application of effort to minimize, monitor, and control the probability and/or impact of a negative outcome. First, review historical data to determine risk attributes, frequency, and impacts. From this information a company can clearly determine its baseline risk exposure as well as its appetite for risk (risk tolerance). Second, quantify the risks and impacts using an agreed-upon methodology.

Next, plot a 2 x 2 matrix (probability versus severity) to focus on the high-risk and high-impact category. This risk matrix becomes a tool that allows the organization to determine the corresponding actions to events based on those criteria, including no action if it falls within the acceptable risk category. Further, for events that required action based on its risk rank as defined by the matrix, an effectiveness review becomes more analytical since a new severity (in light of mitigation strategy employed) and frequency can be measured to produce a follow-up ranking.

In Life Sciences, where patient safety is foremost, quality related risks must be addressed swiftly and systematically.  Use of a matrix approach can therefore allow certain activities to be triggered automatically such that the quality of the product is adequately protected while resources can be returned to the business of innovation and helping patients.

To learn more about CAPA software to help minimize risk, download this complimentary webinar from Pilgrim Quality.


Konyika Nealy

Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions