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NCR and CAPA definitions

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Guest user Created:   Sep 07, 2018 Last commented:   Sep 07, 2018

NCR and CAPA definitions

"I would like to get more clarity on Non-Conformance report in ISO 9001: 2015, my plan is to use NCR to manage product defect disposition plan and create CAPA for non-conformity quality incident to run the required investigation. What is the right definition to be used to comply with ISO 9001:2015?”
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Carlos Pereira da Cruz Sep 07, 2018

Answer:
ISO 9000:2015 defines nonconformity as the non-fulfilment of a requirement. Your NCR should record information about the occurrence of the nonconformity (day, hour, product, type of nonconformity, decision about the action to treat the nonconformity, responsible for the decision and when the decision is correction of the product, verification of effectiveness in the elimination of the nonconformity?

It is not mandatory to have the same kind of form to record all nonconformities. For example, I worked with a bottling company, there was a line operator that checked if labels in the bottles were correctly fitted and not stained. When there was a nonconformity, he removed the bottle from the line and made a mark in the product ion records. The occurrence was recorded without mentioning the action because the action was standard.

It is not mandatory that every nonconformity generates a corrective action. Corrective actions require an investment in searching the root cause(s) of the nonconformity and, sometimes, nonconformities are not serious enough to justify the investment.

After solving a nonconformity, your organization should ask: is this type of nonconformity serious enough or frequent enough to require a corrective action?

ISO 9000:2015 defines corrective action as the action to eliminate the cause of a nonconformity. Most of the time, causes are not obvious, it is needed to investigate and make trials to determine and verify the root cause(s).

The following material will provide you information about nonconformities and root causes:

- ISO 9001 – How to use root cause analysis to support corrective actions in your QMS - https://advisera.com/9001academy/blog/2016/03/01/how-to-use-root-cause-analysis-to-support-corrective-actions-in-your-qms/
- Seven Steps for Corrective and Preventive Actions to support Continual Improvement - https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/
- Procedure for the Management of Nonconformities and Corrective Actions - https://advisera.com/9001academy/documentation/procedure-control-non-conforming-products/
- free online training ISO 9001:2015 Lead Auditor Course - https://training.advisera.com/se/iso-14001-internal-auditor-course/o-9001-lead-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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