When an inspector knocks there are certain documents they will ask to see. Some are required by the rule and others depend on the results of your Hazard Analysis and the requirements of the Feed Safety Plan you wrote and implemented. The first “record” you must produce is your written Feed Safety Plan signed by the Owner, Operator, Agent in Charge. We have discussed that extensively.
What other documents and records will be required and/or important to have?
21 CFR 507.4 (b) (2) requires that all employees “Receive training in the principles of animal food hygiene and animal food safety, including the importance of employee health and personnel hygiene, as appropriate to the animal food, the facility and the individual’s assigned duties.” 21 CFR 507.4 (d) requires that “records that document training required by paragraph (b)(2) of this section must be established and maintained and are subject to the recordkeeping requirements in subpart F of this part”. This means these records must be written. Every inspected mill I have spoken to has indicated that inspectors have asked to see training records. Training in animal feed safety and training on Standard Operating Procedures (SOPs) related to their job.
Documentation that your Preventive Controls Qualified Individual (PCQI) has completed Hazard Analysis and Preventive Controls training is also important. Although this training is not required, if your PCQI is not trained, you must be able to prove they are otherwise qualified as a PCQI.
Although records documenting the implementation of CGMP’s are not required by the rule. The next most frequently requested records inspectors ask for are those related to Pest Control. CGMP’s are the minimum standards that must be in place to produce safe animal food and pest control is one of the most difficult of those standards to achieve. It is important to document your success with this requirement.
If your Feed Safety Plan identifies the need for a Preventive Control you will have many required records. When your plan does not require a Preventive Control make sure you have strong justification for that determination in your plan. Records that document your Hazard Analysis and the hazards you considered are important. Tools such as the CFD Hazard Analysis Tool (CFD HAT) would support those decisions and will strengthen your plan.
Other records to support you plan may include:
- Mycotoxin testing SOP’s and records of test results.
- Sequencing SOP’s and records that prove the efficacy of those procedures.
- Medicated Feed SOP’s medication usage and inventory reconciliation records
- Mixer efficiency tests
- Scale certifications
This list is not all encompassing but it is important to understand that the more records you have that verify and support your compliance the better your inspection will go.