AFIA Shares what its members have learned from CGMP Inspections…

American Feed Industry Association (AFIA)  is very active in FSMA education and outreach. They continually survey members to learn more about ongoing FSMA inspections. CFD’s membership in AFIA affords us the opportunity to share their findings. The following are excerpts of information they recently shared. I hope you find it helpful as you prepare for your facility inspection.

“More than 30 AFIA members representing 14 different states, mostly from the Midwest and Southeast, have responded to AFIA’s informal ongoing survey. The results of this survey are distributed relatively evenly among feed manufacturers, ingredient suppliers and integrators.

Most respondents said inspections involved only one inspector and were conducted in February, March and April. More than two-thirds of the respondents said inspections involved an FDA inspector whereas state personnel conducted the balance of inspections. Roughly 85 percent of inspections were completed in eight hours or less, which seems short in comparison to the three- to five-day long inspections currently taking place in the human food industry for the hazard analysis and risk-based preventive controls regulations.”

Note: Animal Food facilities (more than 500 employees) have only recently (September 17, 2017) been subject to compliance with the Hazard Analysis and Preventive Controls part of the rule. Those inspections are being delayed by the FDA for one year. Compliance with the rule is not delayed.

“Employee and training topics topped the list of apparent “focus areas” for the inspectors. Two-thirds of inspected firms in the survey were asked about their size classification, based on their number of employees. The survey also showed 81 percent of inspectors inquired about the training of qualified individuals (QI) and in half of the inspections, QI training records were viewed.

 In a display of agency efficiency, most of the respondents said the CGMP inspections were paired with another inspection, such as medicated feed or BSE regulation compliance.

As further evidence of FSMA’s emphasis, 88 percent of inspections in the AFIA survey included inquiries about the firm’s animal food safety plan or hazard analysis, even though these documents were not subject to inspection or compliance at the time. Inspectors also discussed topics such as: Preventive Controls Qualified Individuals, complaint files (not required), hazard analysis, pest control programs, and food defense plans (not required). In addition, inspectors seemed curious about employee-related subjects, such as organizational charts, numbers of direct reports, job descriptions, personal hygiene programs, and hours of operation. Inspectors also rounded out their inspections with questions and inquiries related to: products and processes, complaint files, traceability, lot codes, labeling, flushing, sampling schedules, and assaying.

Two-thirds of respondents said inspectors asked to see the entire facility, warehouses and/or mixing areas. Moreover, inspectors focused on seeing the load-out areas, receiving, product quarantine areas, grounds, medicated feeds and production zones. Interestingly, and supportive of personal hygiene adherence, inspectors asked to view employee restrooms.

Survey findings cast a favorable tone on inspector-firm interactions. Ninety-six percent of respondents indicated that inspectors were there to assist with compliance rather than to catch them in mistakes. However, in the same number of occurrences, the inspector did not leave a written copy of his or her findings. Encouragingly, 87 percent of survey responses signified that inspectors are knowledgeable about the FSMA final rule.”

Used with permission from AFIA