Supplier CAPA & External Nonconformances Flashcards

What is a Supplier Corrective Action Request (SCAR)?

Answer: A formal document issued to a supplier requiring investigation and correction of a nonconformance

A SCAR is a formal written request issued to a supplier demanding root cause analysis and corrective action for an identified nonconformance or quality failure.

Which condition most appropriately triggers issuance of a SCAR to a supplier?

Answer: Incoming inspection rejects a lot of supplier material due to dimensional nonconformance

A product quality nonconformance discovered during receiving inspection is a direct trigger for a SCAR because it indicates a process failure at the supplier that requires root cause investigation and correction.

What critical element must a supplier's SCAR response always include to be considered complete?

Answer: Root cause analysis, corrective actions taken, and evidence of implementation

A complete SCAR response must address the root cause, describe the corrective actions implemented, and provide objective evidence that the actions were carried out.

According to best practice, who within the receiving organization is primarily responsible for reviewing and accepting a supplier's SCAR response?

Answer: The supplier quality engineer or supplier quality team

The supplier quality engineer or supplier quality team has the technical expertise to evaluate whether the root cause analysis is credible and the corrective actions are adequate.

What document typically establishes the required response timeframe for a supplier to submit a SCAR response?

Answer: The supplier quality agreement or supplier quality manual

The supplier quality agreement or supplier quality manual explicitly defines expectations for SCAR response timelines, acceptance criteria, and escalation procedures governing the supplier relationship.

If a supplier fails to submit a SCAR response by the agreed deadline, what is the most appropriate immediate escalation action?

Answer: Place the supplier on probation and notify procurement and management of non-response

Non-response to a SCAR is itself a performance failure; escalating to procurement and management triggers formal supplier status review and maintains accountability.

Which of the following best describes the concept of 'containment' in the context of a supplier nonconformance?

Answer: Immediate short-term actions to prevent defective material from reaching the customer or production

Containment is a short-term protective action—such as quarantine, sorting, or inspection—taken to immediately prevent nonconforming material from advancing while the root cause is investigated.