All of the articles and tips flying around the food industry regarding FSMA almost sound like a ticking clock — reminding us that inspections are just around the corner.
Practical steps for compliance are a necessity and most can be prioritized according to a certain time frame. In this article, we will discuss what should be accomplished 30 days, hours, and minutes before the FDA walks through your door.
30 days prior to inspection marks the time that you should be getting all of your ducks in a row. Here is an outline of what that looks like:
- Finalize Documentation – All documentation should be reviewed for holes or mistakes. This includes Food Safety Systems, Corrective Actions, Allergen Controls, Environmental Monitoring, and a Microbiological Sample Retain Policy.
- Assign Designated Individuals and Primary Roles – To prepare for an FDA inspection, determining the people that will serve as liaisons with the inspectors is imperative. 3 main roles must also be assigned: a spokesperson who will accompany the inspectors throughout the process and answer any questions they have; a scribe that will record all of the activities that are carried out; and a runner that will be available to retrieve any requested documentation. There should also be backups for all 3 of these individuals in case they are absent on inspection day.
- Complete Training – At least one (but preferably two) designated individuals should be sent to the FDA’s Preventive Control Qualified Individual (PCQI) Training. Although this isn’t a required step, it is expected of facilities and will help the inspection process run smoothly.
- Upgrade Inspection Tools – While checking for risky areas and unclean surfaces, having effective tools will prevent overlooking things that the FDA will spot. High-powered flashlights are worth the investment, exposing problems in hard-to-see areas that inspectors will surely find. Calibration of instruments is crucial as well, confirming that all measurements are properly accounted for.
- Play FDA for a Day – Mock inspections are highly recommended from all that have employed them. These can be carried out by your own team or through an outside organization/company. Additionally, environmental sampling, done FDA-style will reveal what the FDA will find when they inspect. This will allow for immediate corrective actions.
- Develop Helpful Policies – A valuable trick of the trade is to develop useful policies that will deter inspectors. A “no photographs” policy incorporated for visitors may prevent the FDA from taking pictures. Another policy that could be wise to instate is a “do not sign policy” that states that written statements by investigators won’t be signed or acknowledged. This policy is fully legal.
- Find an FDA Lawyer – There are many benefits to being connected to an FDA lawyer that will serve as a resource. They should be familiar with both your company and the inspection process long before the FDA arrives.
- Review your FSVP – Foreign Supplier Verification Programs should be in place already. However, reviewing this plan is recommended. The tiers that have been assigned based on the type of food and compliance history of each supplier should be double-checked to ensure that the correct actions have been assigned to each one. A company that provides assistance with the tiering of suppliers is FDAzilla — offering relevant analytics to support preventive and corrective action allocation.
- Know your Legal Rights – Being aware of the inspection process legalities will put you in a position where you aren’t simply at the will of what the inspectors request. There are certain things that you can refuse and a level of privacy that your company is allowed — all that you should be familiar with.
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- Ensure Ease of Inspection – All paperwork should be easily accessible and in a place that is known to everyone aiding in the inspection (designated individuals). A quick run through of these things will eliminate much stress associated with locating the necessary information during the inspection.
- Designate a Meeting Place – A conference room or empty office could be a good option for the space in which the FDA will be hosted. The room should be spacious and comfortable for a large group to look through documentation. It should also be free of paperwork or records, to ensure that inspectors won’t have access to them while unaccompanied.
- Arrange Who Will Cover for Primary Roles – The spokesperson, scribe, and runner will need to be fully engaged for the duration of the inspection. That means that their usual day-to-day work should be covered by others. Finding substitutes can be done a couple of days in advance, or the day before to make sure that all the planned workers will be present.
- Order One Last Scrub-Down – All surfaces should be aggressively cleaned leading up to the inspection. What first meets the eyes of inspectors will be influential, you want that to be an immaculate work area.
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- Contact the FDA Lawyer to be “On Call” During Inspection – The lawyer who will be working with the company should be notified that the inspection will begin soon. Then he/she can be “on call” to answer any questions that arise.
- Briefly Meet with Designated Individuals – Expectations should be reiterated to the designated individuals, managers, and anyone else that will be instrumental in the process. Communicate who they can go to with questions or concerns.
- Make Sure All Materials for Recording are on Hand – It will be essential to track everything that the FDA does within the premise from the moment they walk in the door. Pens, paper, or whatever else will be used to do so will need to be collected and kept on hand.
This list ends when the FDA arrives, but that isn’t the end of your responsibility. Follow-up will be essential in the next days, weeks, and months after the FDA finishes their inspection. More information on how to deal with the aftermath of an inspection can be found here, a website that this article drew from heavily. Another useful tool for companies is this manual that walks through each step towards compliance with interactive, practical, in-depth measures. Other references that must be noted are The Produce Safety Rule: Be Prepared for a Food Regulatory Inspection and How to Prepare for an FDA Inspection. Overall, getting a head start by developing a plan through a variety of sources will be vital for effective compliance when the FDA comes knocking.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at email@example.com.
About the Author
Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.