CAPA Supplier CAPA & External Nonconformances 1 — Questions and Answers
Question 1: What is a Supplier Corrective Action Request (SCAR)?
- A formal document issued to a supplier requiring investigation and correction of a nonconformance (Correct answer)
- An internal audit report summarizing supplier performance metrics
- A purchase order amendment adjusting quality requirements
- A preventive maintenance schedule sent to a supplier
Correct 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.
Question 2: Which condition most appropriately triggers issuance of a SCAR to a supplier?
- A supplier's on-time delivery rate drops below the contractual threshold
- Incoming inspection rejects a lot of supplier material due to dimensional nonconformance (Correct answer)
- A supplier requests a change to their manufacturing process
- A supplier's lead time increases by two weeks
Correct 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.
Question 3: What critical element must a supplier's SCAR response always include to be considered complete?
- A revised pricing schedule reflecting additional inspection costs
- Root cause analysis, corrective actions taken, and evidence of implementation (Correct answer)
- A list of alternative suppliers the organization may use instead
- Updated shipping documentation and carrier information
Correct 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.
Question 4: According to best practice, who within the receiving organization is primarily responsible for reviewing and accepting a supplier's SCAR response?
- The procurement manager who manages the supplier contract
- The supplier quality engineer or supplier quality team (Correct answer)
- The shipping and receiving department supervisor
- The finance department handling supplier invoices
Correct 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.
Question 5: What document typically establishes the required response timeframe for a supplier to submit a SCAR response?
- The organization's internal corrective action procedure
- The supplier quality agreement or supplier quality manual (Correct answer)
- The ISO 9001 standard clause on supplier controls
- The purchase order terms and conditions
Correct 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.
Question 6: If a supplier fails to submit a SCAR response by the agreed deadline, what is the most appropriate immediate escalation action?
- Automatically approve the SCAR as satisfactorily resolved
- Place the supplier on probation and notify procurement and management of non-response (Correct answer)
- Issue a new SCAR to restart the timeline
- Transfer responsibility for the corrective action to an internal team
Correct 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.
Question 7: Which of the following best describes the concept of 'containment' in the context of a supplier nonconformance?
- Permanently redesigning a part to eliminate the defect source
- Immediate short-term actions to prevent defective material from reaching the customer or production (Correct answer)
- Training the supplier's workforce on quality standards
- Updating the supplier's control plan to reflect new specifications
Correct 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.
CAPA Supplier CAPA & External Nonconformances 1
What is a Supplier Corrective Action Request (SCAR)?