CAPA Supplier CAPA & External Nonconformances 2

Question 1

What is the primary purpose of verifying effectiveness of a supplier's SCAR response?

Accepted Answer

To confirm that the corrective actions have eliminated the root cause and prevented recurrence

Answer

Effectiveness verification confirms that the implemented corrective actions actually eliminated the root cause and that the nonconformance has not recurred, which is the ultimate goal of any CAPA.

Question 2

Which method is most objective for verifying that a supplier's corrective action prevented recurrence of a dimensional nonconformance?

Accepted Answer

Reviewing incoming inspection data from subsequent lots for conformance to the dimension

Answer

Incoming inspection data from subsequent lots provides objective, data-driven evidence that the nonconformance has not recurred, making it the most reliable effectiveness verification method.

Question 3

A supplier submits a SCAR response attributing a defect to 'operator error' without further depth. What is the most significant weakness of this root cause?

Accepted Answer

It identifies a symptom rather than the systemic root cause that allowed the error to occur

Answer

'Operator error' is a symptom-level finding; an adequate root cause analysis must identify why the system failed to prevent the error, such as inadequate training, unclear instructions, or missing mistake-proofing.

Question 4

A supplier has received three SCARs in six months for the same type of defect. What quality management action is most appropriate?

Accepted Answer

Conduct a supplier audit or re-qualification assessment to evaluate systemic quality issues

Answer

Recurring nonconformances of the same type indicate that previous corrective actions were ineffective and a deeper systemic audit or re-qualification is necessary to assess the supplier's quality system.

Question 5

In a supplier quality scorecard, which key performance indicator (KPI) most directly reflects CAPA effectiveness?

Accepted Answer

Defective parts per million (DPPM) trend over time

Answer

DPPM trend over time reflects whether defect rates are declining after corrective actions, making it the most direct indicator of CAPA effectiveness in supplier quality performance.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Supplier CAPA & External Nonconformances 2