Run a mock recall. Before a real one runs you.

Start the clock when you pick the lot, and tick each item as your team finds it. Stop the clock when you’re done, then save a summary of how long each step took and what you couldn’t find. Those are the gaps to fix.

1. Pick a lot and start the clock

   • Pick a lot you received in the last two weeks, without warning the team
   • Write down the time you started
   • Note the product, the lot code and where the request came from

2. Trace it back one step

   • Find who you received the lot from, and their facility
   • Find the date, quantity and the receiving paperwork
   • Find the lot code on the supplier’s label

3. Follow it through your building

   • Find every repack, mix or relabel the lot went into, and the new lot codes
   • Count what’s still on hand, by location, for the lot and its repacks
   • Put that stock on hold and label it

4. Trace it forward one step

   • List every customer who received the lot or its repacks
   • For each, find the date, the quantity and the invoice or bill of lading
   • Find a contact name and phone number for each customer

5. Build the spreadsheet and stop the clock

   • Put the receiving, repack and shipping records in one sortable spreadsheet
   • Write down the time you finished
   • Check the records match what you found on hand

6. Review

   • Note every record that was missing, unreadable or hard to find
   • Decide who fixes each gap, and by when
   • Schedule the next mock recall

Under FSMA 204, the FDA can ask for these records within 24 hours, as a sortable spreadsheet in a recall. If your mock recall took longer than a morning, that’s the gap to close. Read the FSMA 204 guide

Get the records template