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.
How should a business apply Critical Defect?
Define critical characteristics and the response before production. The sampling or control plan may require zero acceptance and immediate escalation.
What records support Critical Defect?
Record the affected lot, evidence, containment, shipment status, investigation, corrective action and release authority.
Critical Defect: control and evidence
| 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. |
What should buyers verify about Critical Defect?
The label should follow a documented risk basis. Calling every serious complaint critical weakens the control and creates inconsistent decisions.
