Compliance to food safety regulations and industry certifications must consider readiness for audit or inspection at any time. GFSI emphasizes 24x7 readiness, and an FDA inspection can occur any time. A well-planned response should be developed. Whether formal or informal, plans should provide for both expected and unknown aspects of an audit/inspection based on the preference or knowledge of the auditor or regulator. With the potential for an unplanned audit/inspection, having a documented program and responsibilities is critical.
 
Kestrel’s self-diagnostic assessment tool is designed to help you better understand your organization’s current state of planning for unplanned or unannounced food safety audits/inspections. 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”
  • Create the sustained level of plans required to meet and support legal and certification requirements

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* 1. When developing your food safety plan and Food Safety Management System (FSMS), do you focus on the possibility of an unplanned audit/inspection?

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* 2. Do you have the most appropriate organizational structure (i.e., with qualified individuals, food plant operators, sanitation leads) to minimize possible impacts from an unplanned audit or inspection?

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* 3. Are you taking advantage of controllable benefits within your FSMA food safety plan and GFSI certification to be prepared for a favorable unplanned inspection/audit outcome, including verification of GFSI and regulated programs?

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* 4. Do you regularly review your compliance programs to determine how well-planned your response to an unplanned audit/inspection will be conducted by your site food safety team/staff?

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* 5. Do you correctly update all records, processes, roles, capabilities, and corrective actions to make sure you are meeting the minimum levels of compliance to laws and the GFSI standard?

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* 6. Do you audit your FSMS programs to meet unplanned audits/inspections as part of your internal audit process, FSMS reviews, and management reviews?

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* 7. Do your internal audits include all regulatory compliance requirements?

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* 8. If you import or export, have you ensured that your programs meet both legal (under FDA FSMA) and certification requirements for the products, supply chain, FSMA/FSVP, and suppliers that are included in these processes?

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* 9. When you build, modify, or change food sites, facilities, and equipment do you conduct hazard analysis and maintain “Management of Change” protocols for updating your site’s food safety plan, food safety risks and needs?

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* 10. Do you properly maintain all food product specifications and preventive controls as documented, approved, and up-to-date for all food risks and situations?

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