By: Christopher Snabes, TAG Director, Food Safety and IAVA-FDQI Lead Instructor
In July, FDA announced that it would be resuming on-site, prioritized food facility inspections. The inspections would be based on a COVID-19 Advisory Rating system, which uses real-time data to qualitatively assess the number of COVID-19 cases in a local area enabling the FDA to determine when and where it is safest to conduct the inspections. FDA also will continue to conduct for-cause inspections, as it has throughout the pandemic.
Along with the resumption of these inspections, which will be pre-announced, and any for-cause inspections, FDA investigators will be conducting a post-investigative Food Defense Quick Check. All large and small businesses are now required to comply with the food defense requirements of FSMA’s Intentional Adulteration (IA) Rule (see below for compliance notes); but rather than immediately implementing IA Rule inspections, FDA will be using the Quick Checks to “educate while we regulate.” This education period will be made up of 10-minute “conversations”. There is no reference to a specific duration of time the quick check inspections will continue in the future.
So what does a Quick Check “conversation” involve? And what can you do to be prepared?
The purpose of the Quick Check is to verify that the facility has satisfied the basic requirements of the IA Rule. So, the FDA investigator will ask the owner or operator of the facility a series of questions and may provide educational material. While FDA does not have a publication listing all the questions that its investigators could ask, TAG has developed documents to assist the industry in preparing for the Quick Checks.
These include a list of typical questions based on conversations with FDA Food Defense Instructors and experts in the field, and a:
,Potential FDA Quick Check Questions infographic, developed in partnership with SafetyChain.
Typical FDA Quick Check questions include:
Similar to this, the Potential FDA Quick Check Questions infographic lists 13 questions in six categories:
Of course, FDA could ask other questions based on the rule, but being prepared with answers for these, should enable you to answer just about any relevant question the investigator may ask.
A few notes on IA Rule compliance also are important here:
Take a look at the questions above and on the Infographic – if you have any concerns or questions, give us a call. We also can assist in your IA Rule compliance efforts, Food Defense Plan, and employee/supervisor or qualified individual training. Contact TAG today!