A critical defect is a nonconformity that could create an unsafe condition, breach a mandatory requirement or otherwise make the product unacceptable under the agreed classification rules.
The operating decision
Define critical characteristics and the response before production. The sampling or control plan may require zero acceptance and immediate escalation.
What to keep
Record the affected lot, evidence, containment, shipment status, investigation, corrective action and release authority.
| Area | What the record should show |
|---|---|
| Control | Define critical characteristics and the response before production. The sampling or control plan may require zero acceptance and immediate escalation. |
| Evidence | Record the affected lot, evidence, containment, shipment status, investigation, corrective action and release authority. |
| Tradeoff | The label should follow a documented risk basis. Calling every serious complaint critical weakens the control and creates inconsistent decisions. |
A practical limitation
The label should follow a documented risk basis. Calling every serious complaint critical weakens the control and creates inconsistent decisions.
Related definitions: supplier qualification, strategic sourcing, landed cost.
