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

To confirm that the supplier submitted paperwork on time

Answer

To validate that the supplier's pricing remains competitive after the nonconformance

Answer

To ensure the supplier updated their website with the new quality procedures

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

Reviewing the supplier's written assurance letter

Answer

Asking the supplier's sales representative to confirm the fix verbally

Answer

Checking that the supplier updated their quality manual

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

It does not specify the operator's name and employee ID

Answer

It fails to mention the specific machine used during production

Answer

It was not written by a certified quality engineer

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

Issue a fourth SCAR with a shorter response deadline

Answer

Reduce the incoming inspection sample size to lower detection costs

Answer

Waive future SCARs since the defect type is already documented

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

Supplier's annual revenue growth percentage

Answer

Number of SCARs issued to the supplier in a quarter

Answer

Supplier's on-time delivery rate

Question 6

What does 're-qualification' of a supplier typically involve in the context of repeated quality failures?

Accepted Answer

Re-evaluating the supplier's quality system, capabilities, and processes to determine continued approved status

Answer

Renegotiating the supplier's contract pricing

Answer

Requiring the supplier to resubmit their W-9 tax form

Answer

Re-sending the original purchase order to reset delivery timelines

Question 7

How does closed-loop supplier CAPA data benefit an organization's overall quality management system (QMS)?

Accepted Answer

It feeds into management review, supplier performance trends, and risk-based procurement decisions

Answer

It reduces the need for internal audits by outsourcing quality to suppliers

Answer

It eliminates the requirement for incoming inspection of supplier materials

Answer

It automatically generates purchase orders for replacement parts