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Nonconformity

Glossary

Nonconformity is also referred to as nonconformances, non-conformities, or simply NCs throughout the industry. According to the International Standards Organization (ISO), "conformity" is the fulfillment of a requirement. The term "conformance" is obsolete. The term used is "conformity" (and "nonconformity"). There is a slight difference either in approach and in criteria between conformity and conformance. The term “conformance” is used for the fulfillment of external requirements and “conformity” means the fulfillment of an internal procedure.

 

What does nonconformity mean?

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 the level of nonconformity is higher, it needs a deeper investigation.

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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