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Concerns & CAPA

Concerns & CAPA - Lighthouse MES Quality

CAPA software to improve the resolution of non-conformances


Looking to improve the management of Concerns & CAPA?  

Managing concerns (or non-conformances) raised in the manufacturing process is crucial to achieving high levels of quality and is the foundation to Continuous Improvement plans.
Lighthouse MES / MOM Software actively supports quality control management using the CAPA software module to:
  • Provide a solid platform to record, manage, resolve and track concerns
  • Prevent defective products from reaching the customer
  • Manage Corrective And Preventative Actions and avoid recurrences

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What are the benefits of the Concerns & CAPA module?

  1. Improve the response to adverse events: Lighthouse MES software enforces the process of concerns management and Corrective And Preventative Actions
  2. React faster: the resolution of non-conformances is accelerated with real-time traceability, automated notifications and escalations management
  3. Increase visibility: concerns information is available across the organisation
  4. Continuous Improvement: build up a detailed history of events and a richer knowledge of root causes

Record non-conformances

  • Record the concern as it arises in manufacturing
  • Attach traceability information e.g. product, defect, line, machine, nature of concern, detail, date, quantity affected and quantity received
  • Attach documents e.g. photographs to aid with capturing the problem

Manage Corrective and Preventative Actions

  • Assign ownership to manage the concern
  • Notify various people / groups
  • Workflow - manage the concern and change its status as it moves through the process
  • Create a template-based action plan to handle the concern e.g. containment action, corrective action, preventative action
  • Track the progress of the concern and the associated actions
  • Track the age of each complaint and escalate with email alerts  

Investigate & resolve non-conformances

  • Use the information in Lighthouse MES to assist the investigation: batch numbers, lot numbers, serial numbers, production runs, production dates, shifts, manufacturing lines
  • Investigate the root cause of the problem
  • Build up a library of root causes 

Support continuous improvement

  • Develop a history of concerns to support continuous improvement activities
  • Analyse the concerns e.g. by product, defect, line, department, shift, crew and many others
  • Monitor recurrences: have root causes been eliminated? Are they still causing problems? Was the preventative action successful?
Gain optimum value from Lighthouse MES' CAPA software by using it in conjunction with additional modules:
  • Job Tracking - to identify the production run or work order, production line or shift associated with the concern
  • Quality - to access the results of all quality checks performed or missed on the production run
  • Inventory Management - to manage traceability of lots of materials used in the process
  • Build Traceability - to manage traceability down to serialised parts
  • Labour - to determine who was running the manufacturing process at the time of the production
  • Customer Complaints and Supplier Complaints modules which have an external focus