6. Answer the question being asked
Once you understand the context and are asked a question, answer it; then shut up. The investigator has limited time to make his assessment. Answer the question directly and keep it to the point. Do not venture off into territory that is not relevant. Do not give excuses or jump to conclusions based on what they are asking. Don’t assume you know where the investigator is going with a line of questioning. If you are unclear, ask for clarification before answering. Once you have given your answer, stop talking, and wait for the next question.
7. Know What is in Scope and What is Out of Scope
With FSMA now in place, this tip is critically important. The FDA now has the legal authority to view all the documentation associated with your food safety plans, prerequisite programs, and preventive controls; this includes all the recording forms as well. You have to manage these very closely so everything is in order and documents are reviewed for compliance in the timeframes allowed.
Remember, FDA can now take your food safety documentation with them. Are they written so that they are clear and limits are communicated? The forms need to be able to speak without your presence as to what they are, whom they come from, and what they address. These documents may be used in a court case. Don’t confuse the issue by putting food safety and food quality information on the same forms.
Bottom line: You need to understand the law, your obligations, and FDA authority like an expert. The FDA is learning how to implement FSMA in the field, so you need to know when things go astray.
8. Don’t sign or initial anything
FDA will not sign anything, and neither should you. The only possible exception to this would be a receipt for a sample that was taken. Other than that, your signature or initial may be taken as an admission on your part. You are not authorized to sign or initial based on company policy. If corporate does not have this policy in place, put one in place now.
Your signature and initials as the PCQI will be on documentation attesting to the parameters measured. Make sure that these forms are clear and can stand on their own.
An FDA visit does not need to be overly stressful. If you are trained, have excellent systems and documentation, and a support team around you, things should go as planned. If you do get a Form 483 or warning letter, make sure that the mechanisms are in place to respond within the required timeframe. Every audit is different and needs to be handled according to the situation. This comes with experience, and the tips I have given here are based on real world experience in dealing with the FDA.
Any questions? Drop me a line at firstname.lastname@example.org or comment on it below. I can provide general information, but cannot respond with specific answers for an actual investigation in the forum.