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

Question Title

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

Question Title

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

Question Title

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

Question Title

* 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?

Question Title

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

Question Title

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

Question Title

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

Question Title

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

Question Title

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

Question Title

* 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?

0 of 10 answered
 

T