Defect Management
What is Defect Management?
Defect management is a critical function within a quality management system (QMS): it enables manufacturers to track and trace deviations and corrective actions. Defect management also generates data that can be used by QMS, manufacturing execution system (MES) and manufacturing intelligence software to identify root causes and implement preventive measures that reduce or eliminate similar defects in the future.
Defect management is related to the software functions of both nonconformance management and corrective and preventive action (CAPA). A nonconformance is an unplanned event in the manufacturing process that deviates from a set standard or requirement. Such a quality event does not always result in a defect. The software enables identification and documentation of these quality events and allows the manufacturer to apply standard risk criteria to assess and route events appropriately. It also enables enforcement of failure analysis, root cause identification, quarantine and final disposition.
CAPA software captures defects as well as nonconformances and complaints. It then analyzes associated manufacturing problems, identifies root causes, determines corrective measures to be taken, and documents these corrective measures. CAPA functionality extends beyond the manufacturing floor; CAPA software can interrogate the full spectrum of control points in a manufacturing operation, including design, production, documents, materials, facilities and equipment.
Defect Management Software Functionality
Defect management software tracks and traces both the occurrence and resolution of defects.
Defect management provides manufacturers with comprehensive data to provide early warnings to prevent quality escapes.
By employing defect management software, manufacturers can ensure compliance with standards and regulations. Defect management software documents quality events and confirms that appropriate corrective measures have been executed.
Specific functions of defect management software include:
- Recording and managing of quality events from single or multiple sites in one centralized system
- Root cause analysis performed through collaboration among different employees from one or multiple sites
- Enforcement of containment activities
- Systematic enforcement of approved quality actions
Defect Management Benefits
Defect management is part of a holistic approach to quality that enables manufacturers to be more proactive in preventing quality events and creating high-quality products.
Additional benefits
- Streamlines management of quality events
- Provides visibility across facilities
- Contributes to Six Sigma and lean initiatives
- Reduces cost of quality, including product recalls
- Reduces regulatory and product risk
- Reduces rework and scrapping