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Nonconformances and CAPA management

Nonconformance management ensures that any deviation from internal procedures, contractual agreements, laws and regulations are identified, addressed and prevented from recurring. It is a fundamental element of continuous improvement and involves several essential steps.


quality control of nonconformances

Identification

Nonconformances are usually detected through audits, customer complaints, or employee reports. It is important that all personnel are aware of the impact of their work on customer expectations, products and service quality and how to report nonconformances.


Evaluation

Evaluating the impact and root cause to determine an action plan would involve subject matter experts from different domains. Typical tools which are used for this are the 5 Why’s, Fishbone diagram, Failure Mode Effects Analysis.


Resolution

In resolving a nonconformance, a good action plan should include corrections, corrective actions and preventive actions. Corrections are typically immediate actions which are taken to eliminate the effects of a nonconformance that has occurred. Corrective actions are actions that eliminate the root cause of a nonconformance that has occurred to prevent its recurrence while preventive actions are proactive measures taken to eliminate the causes of potential nonconformances to prevent them from occurring.


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