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Defect management

Defect management enables manufacturers to track and trace deviations and corrective actions.

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 relates 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 identifies and documents 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 them. 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.

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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.

Streamlines management of quality events

Proactively identify, track and resolve deviations efficiently, contributing to improved overall product quality and operational effectiveness.

Provides visibility across facilities

Gain a centralized view of quality events, fostering consistent monitoring and facilitating proactive measures for quality improvement across multiple locations.

Contributes to Six Sigma and lean initiatives

Systematically identify and address quality events, promoting continuous improvement and ensuring adherence to quality standards, thereby enhancing operational efficiency and reducing defects.

Reduces costs

Minimize the impact of quality events, lowering the expenses associated with rework, scrap and potential product recalls, contributing to overall cost savings for manufacturers.

Reduces risk

Address and mitigate quality events, helping you navigate regulatory compliance and product risk more effectively, enhancing overall operational resilience.

Reduces rework and scrapping

Identify, analyze and resolve quality events, minimizing the need for corrective actions and preventing the production of defective products. This ultimately improves operational efficiency and reducing costs for manufacturers.

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

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