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.
  • A corrective action request (CAR) has to be launched to kick off a root cause investigation. The result of a corrective action is that the nonconformity will not happen again.

A nonconformity is just a fact with no associated action — while a correction is an action taken to respond to a nonconformity. A corrective action, however, is actually a series of actions — a full process of identifying and taking actions that will permanently adjust people, machines, and procedures. For organizational learning to occur as a result, it is important to define a specific, measurable, actionable, relevant, and time constrained verification plan to ensure that the corrective action had the intended result.

Three Key Questions

There are three questions that can help you identify which direction to go. First, assume that a problem emerged during a process.

  1. Can the problem be fixed in the process without incurring waste, scrap, significant rework, or dissatisfaction to the customer — and it is not likely that the problem will occur again? If so, this usually does not need to be recorded at all.
  2. Did the problem result in waste, scrap, significant rework, or dissatisfaction to the customer? If so, a nonconformity should be noted. If it can be fixed or repaired, a correction should be made.
  3. Is the nonconformity an indication of a more systemic problem, or is it likely to reoccur? If so, then a corrective action should be launched to identify and remedy the root cause. 

Even though the term themselves are specific, it is up to each organization to interpret how the definitions will map to their operations. Hoyle says “one should apply a pick and mix approach and apply a dash of commons sense.” Not every issue discovered, or nonconformity identified, will require a corrective action — it is up to each organization to define the scope of what each term means.

Additional Reading

Hoyle, D. (2017). ISO 9000 Quality Systems Handbook – Updated for the ISO 9001: 2015 standard: Increasing the Quality of an Organization’s Outputs. Routledge.

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

This entry was posted in EHSQ, Quality, Uncategorized and tagged , , , by Nicole Radziwill. Bookmark the permalink.

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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