Corrective & Preventive Action (CAPA) Program: Food Safety Self-Diagnostic Assessment

Compliance to 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 how to meet FSMA’s requirements, including those for Corrective and Preventive Action (CAPA) programs.

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 our assessment questions. Kestrel will analyze your responses and get in touch to discuss:

How to change “No” responses into “Yes”
Recommendations to help you comply with CAPA requirements and FSMA
Best practices for your CAPA program

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* 1. Does your organization maintain an established qualified or audited CAPA program?

Yes

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* 2. Are CAPAs rated for severity (qualified as a CAPA vs. an “improvement”) to focus on urgent-level CAPAs?

Yes

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* 3. Are your CAPAs tracked and monitored to ensure against recurrence until a final remedy is determined?

Yes

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* 4. Is the responsibility to monitor and track CAPAs assigned within the organization to ensure clarity for the program, program management, and each individual CAPA?

Yes

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* 5. Are all occurrences of CAPAs subject to senior management review and approval—both of determination and remediation?

Yes

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* 6. Is your CAPA program maintained under document management/control and reviewed within your Food Safety Management System (FSMS)?

Yes

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* 7. Has your CAPA program been developed for FSMA compliance, global or industry certification, customer requirements, and/or other regulatory compliance?

Yes

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* 8. Is an annual review conducted to ensure your CAPA program is up to date and current?

Yes

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* 9. Are all CAPAs closed according to the required timing?

Yes

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* 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?

Yes