Non-Conformance

TECHNICAL DEFINITION

Non-conformance refers to any deviation of a product, process, or system from specified requirements, standards, or customer expectations, necessitating investigation, disposition, and corrective action to restore compliance and prevent recurrence.

BACKGROUND

Nonwoven fabric or non-woven fabric is a fabric-like material made from staple fibre (short) and long fibres, bonded together by chemical, mechanical, heat or solvent treatment. The term is used in the textile manufacturing industry to denote fabrics, such as felt, which are neither woven nor knitted. Some non-woven materials lack sufficient strength unless densified or reinforced by a backing. In recent years, non-wovens have become an alternative to polyurethane foam.

SYNONYMS & ALIASES

• Defect
• Deviation
• Failure
• Out-of-spec
• Non-compliance
• Discrepancy

USAGE NOTE

Identifying and addressing non-conformances is a core activity in quality management systems.

DEVELOPERS

Organizations developing technology related to Non-Conformance.

• SAP

  SAP offers extensive enterprise resource planning (ERP) and manufacturing execution systems (MES) that include robust Quality Management (QM) modules. These modules enable manufacturers to define quality plans, perform inspections, manage defects, and track non-conformances and corrective actions (CAPA) throughout the production lifecycle, integrating quality data with other business processes.

• Siemens Digital Industries Software

  Siemens provides a comprehensive suite of software solutions, including Teamcenter Quality and Manufacturing Operations Management (MOM), which enable integrated quality planning, control, and management. Their tools help identify, track, and resolve non-conformances, facilitating closed-loop quality processes from design to production and service.

• MasterControl

  MasterControl specializes in quality management system (QMS) software for regulated industries. Their platform includes dedicated modules for Nonconformance Management, allowing organizations to efficiently document, investigate, resolve, and prevent non-conformances, ensuring compliance and continuous improvement.

• ETQ (part of Hexagon)

  ETQ provides cloud-native quality management system (QMS) software, ETQ Reliance, which offers powerful capabilities for Nonconformance Management (NCM) and Corrective and Preventive Actions (CAPA). Their solutions help automate the non-conformance process, from identification and root cause analysis to resolution and verification, improving product quality and operational efficiency.

• PTC

  PTC offers industrial IoT (IIoT) platforms (ThingWorx) and product lifecycle management (PLM) solutions (Windchill) that can integrate quality data from various sources across the manufacturing floor. This enables real-time monitoring, predictive analytics for potential non-conformances, and streamlined processes for identifying, reporting, and resolving quality issues.

• Dassault Systèmes

  Dassault Systèmes, through its DELMIA brand, offers manufacturing operations management (MOM) solutions that include quality management capabilities. Their platforms help manufacturers establish quality controls, detect deviations, manage non-conformances, and implement corrective actions, leveraging a virtual twin approach to optimize production processes.

• Veeva Systems

  While primarily focused on life sciences, Veeva Systems provides cloud-based quality management solutions (Veeva QualityOne) that are highly relevant for manufacturing. These solutions include robust capabilities for managing non-conformances, deviations, and CAPA, ensuring compliance with strict industry regulations and promoting continuous quality improvement.

• Arena Solutions (part of PTC)

  Arena Solutions offers cloud-native product lifecycle management (PLM) and quality management system (QMS) software. Their QMS module is designed to manage quality processes, including non-conformance reporting, deviation handling, and CAPA, providing a centralized system for tracking and resolving product and process quality issues.