Audit the system by following one real lot

Select a recently released lot and trace it backwards through testing, production and incoming material. Then select an incoming lot and trace it forwards to every affected finished lot. This exposes gaps that a clause-by-clause document review may miss.

Use a simple evidence rating

Suggested finding classification
RatingMeaningAction
ConformingRequirement demonstrated with current evidenceRecord evidence sampled
ObservationControl exists but could become weakAgree preventive action
Minor nonconformityIsolated failure without immediate system breakdownCorrect and verify by due date
Major nonconformitySystemic gap or product-status riskHold approval until effective correction

Working checklist

Evidence to verify

0 of 20 checked