It can be defined as negligence or an unfavorable occurrence that happened anywhere in QMS or production. Nonconformity needs to be conducted and documented as an important part of the QMS system, to comply with current regulations such as GMP, FDA, and/or ISO requirements. They might be categorized by their criticality such as low, medium, high.
If it has effects on the final product and so on the patient, it should be conducted immediately with a high level of investigation by a multidisciplinary team including QA.
If you need further information about nonconformity management, you can read our article “ Using risk-based thinking to manage nonconformities and deviations”
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