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Nonconformance Management

A manufacturing nonconformance is an unexpected event that occurs in the manufacturing process that deviates from a set standard or requirement. Nonconformance management solutions enable identification and documentation of these quality events, apply standard risk criteria to triage, route events appropriately, and enforce structured failure analysis, root cause identification, quarantine and final disposition. 

Nonconformance Management

It is important to integrate nonconformance management into manufacturing execution systems to allow easy search across facilities or multiple facilities, find the affected work in process (WIP), route it through review and investigation and then take appropriate actions.

The benefits of Nonconformance Management include:

  • Focus on prevention 
  • Streamlined compliance 
  • Reduced cost of quality 
  • Reduce regulatory and product risk

Challenges During A Manufacturing Process

There can be many challenges during a manufacturing process, particularly regarding nonconforming products, materials and components. These nonconformances could lead to rework and scraping, product recalls, and decreased productivity. Ask yourself these pertinent questions regarding nonconformances in your manufacturing environment: 

  • How long does it take you to find, analyze, resolve manufacturing issues? 
  • Are you sure you’ve really solved the issue? 
  • Is it reoccurring? 
  • How do you implement and enforce preventive measures? 
  • Do you really have the data required to indentify nonconformances?

Nonconformance Management Systems Answer These Questions

Nonconformance Management systems answer these questions via automatic recognition and reaction to nonconformance events such as deviations in processes, materials, and test results. They enforce structured failure analysis, root cause identification, quarantine and final disposition (release, rework, scrap, etc.) these systems also provide Manufacturers with the comprehensive data to provide early warnings and real-time visibility into operations to prevent quality escapes. 

It is important to integrate nonconformance management into manufacturing execution systems to allow easy search across facilities or multiple facilities, find the affected work in process (WIP), route it through review and investigation and then take appropriate actions. When systems are tightly integrated, actions are taken directly against material affected by a nonconforming event. 

To improve product quality, manufacturing nonconformance materials and processes must be readily visible, enforceable, easy to analyze, and fully traceable to their origins. It is important to identify and contain product and production events rapidly to drive down the costs of quality. Nonconformance management solutions enable the identification and documentation of quality events from any production source across the enterprise, and apply standard risk criteria to triage and route events appropriately. 

Configurable Nonconformance Management solutions include:

Identification 

Documentation 

Evaluation 

Analyze for root cause 

Containment 

Disposition 

  • Identification enables organizations to streamline recording and managing of all types of production and product events from single or multiples sites in one centralized system. 
  • Web-forms enable documentation of different types of nonconformance events from one or multiple sites. 
  • Comprehensive triage for conformances that originate in one or multiple sites. 
  • Collaboration among different employees from one or multiple sites to perform root cause analysis. Contextual data easily accessed and retrieved for analysis 
  • Enforcement of containment activities ensures nonconforming material is controlled and prevented from improper usage. 
  • Approved disposition activities such as scrap, repair and use as-is can be systematically enforced in the production system, ensuring effective and efficient results.

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