Contrary to what the CAPA acronym suggests, corrective action isn’t always accompanied by preventive action. “The

CAPA acronym causes confusion because many companies think a preventive action is something you do after corrective action to prevent a nonconformity from recurring. A preventive action is taken in response to data that indicates a potential nonconformity may occur sometime in the future,” Jacobs explains.

The CAPA acronym has become so misleading, according to Jacobs, that the Global Harmonization Task Force (GHTF) has decided not to use the term in their proposed document “Quality Management System—Medical Devices—Guidance on Corrective Action and Preventive Action and Related QMS Processes.” It states in the introduction, “The acronym ‘CAPA’ will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.”

The GHTF draft guidance will be explored at Jacobs’ session. She says it is of value because it outlines four phases—planning, measurement and analysis, improvement, and input to management—that OEMs should use to handle the CAPA process.

During the measurement and analysis stage, Jacobs says manufacturers should begin with design control when identifying data sources that are indicators of product performance. By outputting the design control process, OEMs can identify which processes “to monitor relative to the essential outputs of the device design and risks associated with the failure of the design through risk control decisions. Risk control decisions can be linked to a process and the output of that process monitored,” Jacobs says.

Horizontal analysis is another important part of the measurement and analysis phase. Jacobs defines horizontal analysis as investigating both a single data source and different data sources to determine the significance of a problem. “It’s important to recognize relationships and linkages between data sources so the extent of nonconformity can be determined.” 

When it comes to the final phase recommended by GHTF—management input—Jacobs stresses the importance of managers being involved in both the approval and oversight process. This ensures that the proper resources are allocated to supporting the CAPA process.

Additionally, Jacobs says, “If management doesn’t understand the CAPA process, they may unintentionally drive the wrong behavior in pushing for CAPAs to be closed, because they assume aging CAPAs are a bad thing.” Unlike complaints, there is no timeline for processing CAPAs. 

“Not all CAPAs are created equal,” Jacobs says. Therefore, manufacturers should make sure to devote the proper amount of time to investigating and implementing each CAPA. “Each CAPA needs to be specific to the problem being solved,” she says.

To learn more about the other presentations being offered at the MD&M East conference session, visit www.mdmeast.com.