Quantify Risk to Boost CAPA Efficiency

Quantify Risk to Boost CAPA Efficiency

Kari Miller, Regulatory and Product Management Leader, IQVIA Quality Compliance

Corrective and Preventive Action (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 not uncommon 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 for aging reasons, 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?

What’s the Risk?

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 mitigate 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, 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 the subsequent application of effort to minimize, monitor, and control the probability and/or impact of a negative outcome.

You can conduct your assessment by building a simple CAPA risk matrix following these three steps:

  1. 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).
  2. Quantify the risks and impacts using an agreed-upon methodology.
  3. Plot a 2 x 2 matrix (probability versus severity) to focus on the high-risk and high-impact category.

This CAPA risk matrix becomes a tool that allows you to determine the corresponding actions to events based on those criteria, including no action if it falls within the acceptable risk category.

Further, for an event 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.

Data Integration for Effective Product Risk Management

Medical device manufacturers that effectively manage their product risk can improve the safety of their medical devices and improve their overall quality effectiveness.

Internal and external quality records such as CAPA, Nonconformance, Complaint and Design activities and data need to be pulled into periodic product risk reviews in order to manufacturers to meet compliance and consistently yield safe effective medical devices. As a part of the SmartSolve integrated ecosystem, information retrieval of process risk data like CAPAs is quick, precise and harmonized.

Risk-based CAPA Drives Innovation

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 based on risk such that the quality of the product is adequately protected, while resources can be returned to the business of innovation and helping patients.

By quantifying risk, companies can more quickly realize a return on investment for their preliminary data gathering and work during the CAPA process.

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CAPA Management


Kari Miller

Regulatory & Product Management Leader, IQVIA Quality Compliance