Improve Corrective Action Preventive Action (CAPA) System

Designed an effective CAPA process that took actions to eliminate the cause of nonconformities and potential nonconformities


Produce Safe and Effective Products

Designed an effective CAPA SOP that took action to eliminate the cause of nonconformities and potential nonconformities in order to prevent occurrence or recurrence. The process outlined how to:

Analyze (by employing statistical methodology) internal and external data sources to detect recurring quality problems.

Examples of data sources:

  • Customer complaints
  • Internal audits
  • Incoming components/materials
  • Inspection/test data
  • Record/document issues
  • Rework and nonconforming material
  • Supplier nonconformances
  • Management review

Investigate causes of nonconformities by using risk management techniques

CAPAs are based on risk, taking into account the frequency with which the nonconformity might occur and the severity of the risk if the nonconformity did occur.

CAPAs are based on risk

Identify actions needed to correct and prevent recurrence

  • Establish and approve action plan
  • Implement the action plan
  • Support continuous improvement within the CAPA
  • Monitore and analyze all CAPAs
  • Complete documentation and proper notifications

Verify/Validate the effectiveness of the actions performed after implementation

Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. For example, effectiveness addresses the following questions:

    Did my solution work?
    Did it create other potential nonconformances?

Implement and Record Changes

Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.

Accomplishments

  • Designed and delivered training to over 200 CAPA users to ensure 100% compliance with CAPA SOP
  • Designed and delivered Common Statistical Techniques training: Pareto charts, Run charts, Control charts, Mean and standard deviation, T tests for comparisons, Experimental design (DOE), Graphical methods (fishbone diagrams, histograms, scatter plots, spreadsheets, etc.), Management Reviews, Quality Review boards, Material Review boards
  • Designed and delivered root cause analysis tools training: Fishbone diagrams, 5 Whys, Fault tree analysis (FTA), Failure Mode Effects Analysis (FMEA), Hazard analysis
  • Led CAPA Board Meetings
  • Participated in the completion of CAPAs

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