Earlier this year I wrote a series of blogs on Current Good Manufacturing Practice. Compliance with these practices is the foundation for manufacturing safe animal feed. If you have not already been inspected by FDA for compliance with CGMP’s, inspections have resumed and you should expect one at any time. It is also likely that future inspections will include your compliance with Hazard Analysis and Preventive Controls. Are you ready for the question, “Can I see your Feed Safety Plan?”?
This document must be written, current and contain the following required elements:
- Hazard Analysis
- Reanalysis
- Implementation Records
If Your Hazard Analysis identifies a Hazard Requiring a Preventive Control, it also must include:
- Preventive Controls
- PC Management Components
- Monitoring
- Corrective Actions and Corrections
- Verification
- Validation
- Verification of Implementation and Effectiveness
- Recall Plan*
*Although the rule only requires a Recall Plan when you have a Hazard requiring a Preventive Control, I strongly encourage you to have a plan in place as a good business practice.
While the following background information is not required, it would be in your best interest to include the following elements to tell you safety story:
- Food Safety Team members (identify your PCQI)
- Facility Overview
- Flow Diagram
Again, if you participated in the FSMA CGMP Program, all these optional components and a Recall Plan were included in your materials.
Over the next several months, I will post answers to the following questions:
- How do I conduct a Hazard Analysis?
- When and why, would I need to reanalyze my plan?
- What should be included in my implementation records?
- What if I need a Preventive Control?
- What should a Recall Plan include?
If you have a question you would like added to this list… email me at [email protected]
If you do not have a written plan or if you do not have a Preventive Controls Qualified Individual (PCQI) on staff in your facility to write this plan, consider training someone to be a PCQI. While there are no classes scheduled at CFD at the moment, there is a wait list for a class you can add your name to: https://fsma.cfd.coop/training/