Corrective and Preventive Actions

Addressing Systemic Problems


 

Corrective and Preventive Actions (CAPA)

The corrective action process documents the problem, initiates an investigation, documents the findings, root cause and the final resolution. Corrective action tracking can be driven by customer complaints, QA inspections, product returns and more.

Using corrective action tracking software can streamline this important quality system.  The benefits include a central database of all issues and problems, better communication; both internally and externally, reduction in failure analysis response time, improved customer relationships, real time reporting and an overall increase in quality and efficiency.

The corrective action can be assigned to an owner of the issue and then be re-assigned to others including a verification owner for resolution and verification.  Escalation of problems within the software systems will ensure that owners are notified of timing or scheduling issues.

Within Everest you can track internal quality concerns or non-conformances such as material defects as 'internal concerns.' An internal concern can be the result of audits, inspections, management reviews and process reviews.

The 'concern notebook' organizes a large amount of information into separate tabs which contain database fields including user-defined fields for further customization. Tab names and data names throughout the 'concern notebook' use terminology tailored to your organization. Some examples of the essential data commonly tracked for internal quality concerns are:


CAPA Highlights

  • Two-level concern type classification
  • Three-level defect codes
  • Products and product data including product groups
  • Serial and lot number traceability
  • Corrective Actions and Preventive Actions (CAPA)
  • Supplier Corrective Actions

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Internal Area Organization
The organization of internal concerns begins by selecting an internal area which is typically the primary area responsible for resolution. Areas can be based on departments, facilities or any other organizational structure including manufacturing stations on the shop floor.

Multiple Locations
Internal Area setup options include user-defined departments and locations. When the scope of the project includes more than one location or plant, a system option to control user access will limit users with access to only the Internal Areas associated with the same location they are at. When limiting Area access by location, the user access privilege, Access All Locations, is enabled only for those users who require it.

Real-time Data Analysis
Reports and Charts provide real-time data analysis of internal quality concerns based on a variety of selection criteria options easily controlled using a point-and-click menu. User Defined Queries allow you to select and sort by any field in the database.

A Corrective Action Software Form you can Customize
The Everest corrective action software form is customizable in setup so that it may be configured as a standard paperless template to be used for; Corrective Action Requests or CAR, Preventive Action Requests or PAR, Corrective and Preventive Action Requests or CAPA and Supplier Corrective Action Requests or SCAR.

Contact Lynk Software to discuss how Everest can be used to fulfill your corrective action tracking requirements.