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FSMA Compliance: Self-Diagnostic Assessment Tool

July 30, 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 the pending requirements to be published at the end of August 2015. An effective FSMA assessment and plan is essential for building a scalable program that can respond to the changing enforcement expectations.

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 FSMA compliance.

  1. Have you completed an assessment of the FSMA rules and statutes to ensure all aspects and impacts have been identified, including bi-annual registration of your site(s)?
  2. Has FSMA’s applicability been verified and formally reported to company management to confirm communication, risk impacts, and proper response actions?
  3. Does the FSMA review process include an assessment of the established FDA food requirements, including GMPs developed, implemented, and supported by evidential training of related employees?
  4. Do GMPs include the required building, equipment, process, and site requirements necessary for documented commissioning for food processing, handling, storage and distribution?
  5. Has compliance to GMP, building, and hazard assessment requirements been properly documented to ensure development of a Food Safety Plan with proper records if subjected to regulatory inspection?
  6. Are your policies and practices for a regulatory inspection current and in compliance with regulatory requirements and company policy?
  7. Are key records (program, training, traceability) readily available in response to the FDA authority to access all food production records without the need for a court order?
  8. Does your FSMA assessment include the impacts of foreign supplier verification for imported materials used at your site that involve a qualified 3rd-party auditor?
  9. Has the development of preventive controls been initiated to ensure all probable food safety hazards supported by scientific evidence are properly addressed?
  10. Does your FSMA assessment process include the pending Sanitary Transportation of Human and Animal Food rules and Food Safety and Security provisions?
  11. Do you have an effective process to monitor and update qualified suppliers to ensure the source and source locations of purchased food ingredients and materials?
  12. Does your corrective and preventive action process provide for ensuring proper severity and response to corrective actions?
  13. Are corrective actions and Food Safety Management System improvements verified as closed if subject to regulatory inspection or are related practices ceased until closed?
  14. Do you regularly monitor the status of your FDA FSMA Food Safety Management System to ensure integrity of the program at all times?

Get Compliance-Ready

Kestrel can provide recommendations to help you comply with 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. Contact Kestrel at or 847-533-5948.

Submitted by: Bill Bremer

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