neconformitate

Neconformitate, in Romanian quality management terminology, refers to a deviation from specified requirements in a product, service, or process. It denotes that something does not meet defined criteria, whether set by customers, regulators, or internal standards. The term is used across industries such as manufacturing, construction, healthcare, and software development.

Nonconformities are commonly classified as major or minor. A major nonconformity indicates a significant defect that could affect safety, legal compliance, or the ability to meet essential requirements. A minor nonconformity is a less critical deviation that does not immediately affect compliance or function but still requires correction. Nonconformities can be detected through inspections, testing, audits, customer complaints, or process monitoring.

The handling of neconformitate follows a structured process. First, immediate containment or quarantine of affected items prevents further use or production. Next, an investigation and root cause analysis are conducted to identify why the deviation occurred, often using methods such as 5 Whys or fishbone diagrams. Corrective actions (CAPA) are planned and implemented to address the root cause, and preventive actions may be taken to avoid recurrence. The effectiveness of these actions is verified before closure.

Documentation is central to the process. A nonconformity report (NCR) or deviation report records the issue, decision, actions taken, and verification results. Effective management of neconformitate helps maintain quality, regulatory compliance, and customer satisfaction, while reducing risks associated with defective products or services. In standards such as ISO 9001, addressing nonconformities is a mandatory element of continual improvement.