Nonconformance vs. CAPA: Three Key Questions

Communicating the differences between nonconformances (NCRs) and corrective/preventive actions (CAPAs) to staff can be challenging. It’s extremely important, too, that everyone fully grasps the distinctions — because consistency in using your organization’s quality management system will directly contribute to the accuracy of your metrics. Furthermore, this will impact the quality of the insights that can be generated by studying them.

In ISO 9001:2015, there is a defined progression between nonconformity, correction, and corrective action:

  • A nonconformity occurs when a requirement is not fulfilled. The result of a nonconformity, according to Hoyle (2017), is a failure to meet product requirements, carry out a task as required, or meet customer or stakeholder requirements.
  • A correction is the step taken to remedy that single nonconformity. Removing the nonconformity does not prevent the issue from happening again. The result of a correct is to prevent the nonconformity from advancing further in the process.
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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 … Read more...