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...

Root Cause Analysis and the Tools You Need to Drive Continuous Improvement

Root Cause Analysis is part of an ecosystem of tools and techniques you can implement to help your organization harness the value from their EHSQ integrated management systems. Improving your organization’s processes requires identifying a methodology and approach that can spur innovation through evidence-based analysis.  

Root Cause Analysis (RCA) is one of several methodologies in your toolkit – including Failure Mode Effects Analysis (FMEA), Control Plans and Corrective Actions (CAR or CAPA) – that can be used to uncover the reasons for safety incidents or near misses, occupational health issues, environmental issues like repeated violations and quality events like recalls and nonconformances. Implementing a framework that incorporates multiple analysis tools to achieve a desired outcome can result in measurable results.  

Top Five Tools for Continuous Improvement

These tools can be extremely valuable for performance when used proactively — and in conjunction with one another. Here’s how they might be used together:   

  1. Identify potential failure modes through a Process Failure Mode Effects
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Neglect Corrective and Preventive Actions at Your Peril

The Second Law of Thermodynamics states that “all systems tend towards disorder.”

It’s interesting to me to think about actions (corrective or preventive) in the context of a management system in terms of energy and potential chaos. The reasoning for this is that without energy introduced into the system, there is a predictable outcome, which is a net loss to the system and inevitable tendency to disorder, possibly chaos. This helps me frame why paying lip-service to a management system is potentially worse than not having a management system in place at all. For some businesses, not having a management system at all (certified or not) can or will kill their ability to win contracts, operate in some markets, and ultimately identify opportunity, never mind have continuous improvement within their grasp.

Companies with management systems and those that manage actions well have an advantage over those that do not. These … Read more...