Existing regulatory requirements mandate that “qualified individuals” oversee all food safety aspects of food processing operations that are subject to FSMA. The expectation is that a plant operator is designated and that these operators are present during processing at all food processing and handling sites. In addition, the qualified individual must maintain the company’s cGMP, Hazard Analysis, Preventive Controls and Food Safety Plans, and participate in all activities and FSMA regulatory inspections.
 
Kestrel’s self-diagnostic assessment tool is designed to help you better understand the role of the qualified individual. 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”
  • Ensure you are meeting compliance requirements

Question Title

* 1. Have you reviewed your food products and processes to determine the necessary qualifications within your organization to adequately comply with all food regulatory and certification requirements?

Question Title

* 2. Do you maintain a system to track organizational food safety qualifications for general employees and for food safety, sanitation, and quality lead positions/managers, as well as auditors?

Question Title

* 3. Are specific job descriptions, specifications, or expectations developed to outline food safety training requirements, education, certification, and experience for all positions impacting food safety?

Question Title

* 4. Are the designated food plant operator and food safety lead positions defined and filled by qualified individuals as defined by FDA under FSMA?

Question Title

* 5. Have alternatives been determined and assigned to back up lead qualified individuals during their absence?

Question Title

* 6. Has the role of the qualified individual been determined to oversee administration of daily activities—from receipt of raw materials, through processing and holding, to final product release?

Question Title

* 7. Have provisions been made to ensure that qualified individuals are part of the approval process for all food safety activities, including building, equipment, materials, products, vendors, customers, and specifications?

Question Title

* 8. Is a succession plan in place for the ongoing development of site staff to ensure adequate resources will be available all the time and over the course of time?

Question Title

* 9. Are provisions developed to continuously track the qualifications of the qualified individual and other key organizational resources under FSMA?

Question Title

* 10. Do you have a training and certification process to assess all qualified resources and implement periodic management review to ensure that qualified individual(s) and positions are adequately engaged in your operation’s food safety management?

0 of 10 answered
 

T