CAPA Supplier CAPA & External Nonconformances

Question 1

What is a Supplier Corrective Action Request (SCAR)?

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

The supplier quality engineer or supplier quality team

Answer

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.

Question 5

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

Accepted Answer

The supplier quality agreement or supplier quality manual

Answer

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

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Supplier CAPA & External Nonconformances