Nearly all feed mills are required to be in compliance with all FSMA regulations now that the September 17, 2018 HARPC compliance date has passed.
FDA and it’s state partners plan to increase the number of inspections at regulated facilities this fiscal year. More inspectors have completed training to conduct CGMP inspections. Routine inspections for HARPC requirements will be conducted at the large firms this year. Instead of taking the wait and see approach, a proactive approach will help make for a much better inspection. Here are some steps you can take to be ready for an inspection.
Take a look at the justifications you listed to show that you did not need to implement a preventive control for a hazard. What have you committed to doing? Is it something you were already doing or is it something you need to begin doing? Remember that you need to explain what you do and show that you are in fact doing it. If you claim that your supplier approval program mitigates or reduces certain hazards to a safe level you need to explain your supplier approval process and may need to show the inspector evidence of the program.
Prepare your employees for the questions they are likely to be asked by an investigator. Can your receiving employee explain the receiving procedures and what he looks for when conducting an inspection? Is there something in writing for the employee to follow? Is there documentation to show what is being done? Can the employee explain why the inspection and other procedures are important?
Housekeeping and pest issues have been the greatest areas of concern during FDA CGMP inspections of feed mills. Are you satisfied with your housekeeping program? Would you have any concerns if an inspector showed up at your door today?
Did you conduct Qualified Individual training covering food safety and personal hygiene? Have you hired new employees since you did this training? Have they received training? Is this training documented?
If you wrote any procedures relating to current good manufacturing practices, have affected employees reviewed these procedures? The employee who performs the task may have some thoughts regarding the procedure. It is very important that anything this is in writing is actually being done. Employees need to understand what is expected of them.
Can you show an inspector what you do for equipment preventive maintenance? Maintenance procedures are a core piece of an effective food safety effort. You should at least have a schedule and documentation that show when tasks were completed.
Do you have any sort of plan relating to requests for records or to take photos during an inspection? Do you know what you are required to provide and what you are not required to provide?
You can be confident that an inspection will go much better when you take a proactive approach to your animal food safety program. You can also remain confident that you are producing a safe product when attention is paid to the basics.