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Mock Recall & Traceability Exercise Checklist

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Run a mock recall and traceability exercise to test the ability to trace product one step forward and back, and to reconcile quantities within target time.

21 CFR 11721 CFR 7GFSI

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Exercise Setup

  • Is the mock recall conducted at least annually (or per site policy)? *
  • Was a specific lot or code selected as the recall trigger for the exercise? *
  • Was the recall team notified and roles activated per the recall plan? *
  • Exercise start time

Trace-Back (One Step Back)

  • Can the raw materials and ingredients in the selected lot be traced to their immediate suppliers and received lots? *
  • Are receiving records, lot codes, and supplier documentation retrievable for the traced inputs? *
  • Were packaging and rework materials in the lot also traced?

Trace-Forward (One Step Up)

  • Can all finished product from the selected lot be traced to immediate customers and distribution destinations? *
  • Are shipping records, invoices, and lot codes retrievable for the affected product? *
  • Was any affected product still on-site identified and located?

Reconciliation and Review

  • Does the mass balance reconcile inputs, production, product on hand, and product shipped to an acceptable percentage? *
  • Was the exercise completed within the target time (e.g., 2 to 4 hours)? *
  • Percent of product accounted for (%)
  • Were gaps identified and corrective actions assigned to improve traceability? *

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