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Self-Diagnostic Tool: Corrective and Preventive Action (CAPA) Program

November 12, 2015 - Kestrel Food Safety

Compliance to the FDA Food Safety Modernization Act (FSMA) has presented challenges for industry, the public, and the FDA since it passed on January 4, 2011. With much being spent on further rulemaking and comments, many companies and industry segments are just now assessing and planning on how to meet FSMA’s requirements, including those for Corrective and Preventive Action (CAPA) programs.

Self-Diagnostic Assessment Tool

Kestrel’s self-diagnostic assessment tool is designed to help you better understand your organization’s current state of planning for FSMA compliance.

To complete the assessment, review your facility and answer the questions below. We encourage you to then contact to Kestrel to analyze your responses, and to discuss how to change “No” responses into “Yes” and establish best practices for your CAPA program.

  1. Does your organization maintain an established CAPA program?
  2. Are CAPAs rated for severity (qualified as a CAPA vs. an “improvement”) to focus on urgent-level CAPAs?
  3. Are your CAPAs tracked and monitored to ensure against recurrence until a final remedy is determined?
  4. Is the responsibility to monitor and track CAPAs assigned within the organization to ensure clarity for the program and each individual CAPA?
  5. Are all occurrences of CAPA subject to senior management review—both of determination and remediation?
  6. Is your CAPA program maintained under document management and reviewed within your Food Safety Management System (FSMS)?
  7. Has your CAPA program been developed for industry certification, customer requirements, and regulatory compliance?
  8. Is an annual review conducted to ensure your CAPA programs are up to date and current?
  9. Are CAPAs assigned to those most directly involved in implementing the necessary changes for a permanent solution?
  10. Is the process to close a CAPA formalized with analysis and recorded approval subjected to group signature, followed by a verifying internal audit confirmation?

Get Ready

Kestrel can provide recommendations to help you comply with CAPA requirements and FSMA. Led by a team of senior consultants averaging over 25 years of hands-on food safety experience, our industry experts offer guidance in evaluating and helping companies fulfill food safety certification requirements. Get your company compliance-ready.

Submitted by: Bill Bremer

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