Close the Loop on CAPAs with Verification of Effectiveness

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 through business processes.

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 can also 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 https://www.intelex.com/resources/whitepaper/reduce-high-cost-poor-quality-top-5-strategies-managing-ncrs-and-capas

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About Nicole Radziwill

Nicole Radziwill is a quality manager and data scientist with more than 20 years leadership experience in software, telecommunications, research infrastructure, and higher education. Prior to joining Intelex, she was an associate professor of data science and production systems at James Madison University, Assistant Director for End to End Operations at the National Radio Astronomy Observatory (NRAO), managed software product development for the Green Bank Observatory (GBO), and managed client engagements for Nortel Networks and Clarify (CRM). She is an ASQ-certified manager of operational excellence (CMQ/OE), an ASQ-certified Six Sigma Black Belt (CSSBB), and contributed to the development of ISO 26000—“Guidance on Social Responsibility.”

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