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Close the Loop on CAPAs with Verification of Effectiveness

Nicole Radziwill

In addition to meeting compliance requirements for many ISO defined management systems, corrective and preventive actions (CAPAs) serve another critical role: to be the backbone for your organization’s continuous improvement efforts.

CAPAs help you keep track of problems that are observed, problem-solving processes used to investigate them and resolutions. Additionally, the CAPA process provides a way to trace exactly how a quality management system evolves and matures.

From Durivage (2017)

In ISO 9001:2015, the emphasis has shifted exclusively to corrective actions (CARs), since a risk-based approach - which includes continuous risk assessment, and regular dispatch of actions to mitigate or otherwise manage risks - should theoretically accomplish the same goals as preventive actions did in the past.

Despite the value that can be driven by a robust CAPA process, it also can quickly become overwhelming and unmanageable. Not every quality event has to be immortalized in a CAPA -- some don’t require a full investigation and systematic change, which can be time-consuming and have ripple effects throughout the organization. But for the changes that do come about from a corrective action, the verification step is critical - and sometimes left incomplete, or even completely overlooked.

“Although most quality managers would agree that corrective and preventive actions (CAPAs) result from NCRs at their company, inefficient and ineffective CAPA implementation can cripple an organization’s quality performance and ultimately its ability to remain competitive.” - Intelex Insight Report (2014)

How can organizations fix this? CAPA expert and quality auditor Mark Durivage advocates using the SMART method to develop Verification of Effectiveness (VOE) checks. This involves first formulating a verification plan, and then examining whether that plan is Specific, Measurable, Achievable, Relevant and Time Bound. The example he gives is this:

Adapter 1674 Revision C critical characteristic No. 3 produced on Acme Press 112 will be monitored for conformance to specifications over three consecutive days of production (three lots) using a tightened level of inspection per the sampling procedure.

This CAPA VOE is very specific: it describes exactly which critical characteristic to monitor, and which machine to check. It is measurable, and references a (presumably written) sampling procedure. Conformance to specifications is both achievable and relevant to quality objectives. Finally, the VOE is time bound: conformance will be monitored for three lots over three consecutive days.

By following these guidelines Durivage notes that you will strengthen the effectiveness of your CAPA process, “ultimately provid[ing] CAPA closure… [improving] the effectiveness of your CAPA program and demonstrat[ing] compliance with regulations, standards and expectations.”

Additional Reading

Durivage, M. (2017). Work Smarter, Not Harder. Quality Progress, 50(3), 40.

Intelex (2014). Reduce the High Cost of Poor Quality: Top 5 Strategies for Managing NCRs and CAPAs. Intelex Insight Report. Available from

About the Author: Nicole Radziwill is the Vice President, Global Practice Leader, Quality & Supply Chain at Intelex Technologies. Before Intelex, she was an Associate Professor of Data Science and Production Systems, Assistant Director (VP) End-to-End Operations at the National Radio Astronomy Observatory (NRAO), and manager and consultant for several other organizations since the late 1990's bringing quality management to technologically-oriented operations. She is a Fellow of the American Society for Quality (ASQ) with a Ph.D. in Quality Systems from Indiana State University. Nicole serves as Editor of Software Quality Professional (SQP) journal and is a former Chair of the ASQ Software Division. She is an ASQ Certified Manager of Quality and Organizational Excellence (CMQ/OE) and Certified Six Sigma Black Belt (CSSBB). 



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May 02, 2019 @ 09:40 AM EDT Manufacturing Quality

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