Non-Conformance
What is non-conformance?
Non-conformance is a deviation from a specified standard, specification, or expectation identified during the quality control process. It indicates that a product, process, or service does not meet predetermined criteria or agreed-upon requirements. Examples of non-conformance can be found in manufacturing defects, service delivery failures, or process deviations in areas where standards are set and measured.
How is non-conformance identified?
Non-conformance is typically identified during inspections as part of a company’s quality assurance system. These evaluations compare the output—whether a product, service, or process—against the defined standards or specifications. Tools such as checklists, statistical software, and quality control charts are commonly used to detect and document any non-conformance instances.
Why is managing non-conformance important?
Non-conformance management is crucial because it impacts product quality, customer satisfaction, and regulatory compliance. Addressing non-conformances promptly helps prevent minor issues from escalating into major defects that can lead to product recalls, safety concerns, or legal issues.
What steps are taken to resolve non-conformance?
To resolve non-conformance, organizations typically follow a systematic approach as part of non-conformance management:
- Identification & documentation: Detecting the non-conformance and recording its details.
- Evaluation: Assessing the impact and severity of the non-conformance to determine the necessary actions.
- Containment: Taking immediate action to prevent the non-conforming product or process from further use or distribution.
- Root cause analysis: Investigating to identify why the non-conformance occurred.
- Corrective actions: Implementing changes to prevent the recurrence of the same issue.
- Review and closure: Evaluating the effectiveness of the corrective actions and closing out the non-conformance report once resolved.