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 requirements published September 2015, 2016 and 2017 (for large, small, and very small producers, respectively). An effective FSMA assessment and plan is essential for building a scalable program that can respond to the changing enforcement expectations.
 
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 question. Kestrel will analyze your responses and get in touch to discuss how to:
  • Change “No” responses into “Yes”
  • Establish best practices for FSMA compliance

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* 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)?

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* 2. Has FSMA’s applicability been verified and formally reported to company management to confirm communication, risk impacts, and proper response actions?

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* 3. Does the FSMA review process include an assessment of the established FDA food requirements, including Section 117 cGMPs, developed, implemented, and supported by evidential training of related employees? 

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* 4. Is FSMA compliance under the direction of an FSPC for Preventive Control Human or Animal Food?

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* 5. 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?

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* 6. Do your cGMPs include the required building, equipment, process, and site requirements necessary for documented commissioning for food processing, handling, storage and distribution?

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* 7. Are programs audited and updated under a Qualified Auditor?

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* 8. Has compliance to cGMP, building, sanitation, and hazard assessment requirements been properly documented to ensure development of a food safety plan with proper records if subjected to regulatory inspection?

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* 9. Is sanitation conducted under a Qualified Sanitation Manager?

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* 10. Are your policies and practices for a regulatory inspection current and in compliance with FSMA regulatory requirements and company policy?

0 of 10 answered
 

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