CAPA Supplier CAPA & External Nonconformances 3

Question 1

Under FDA 21 CFR Part 820, how must customer complaints be handled in relation to the CAPA system?

Accepted Answer

All complaints must be reviewed and evaluated to determine whether a CAPA investigation is warranted

Answer

Complaints must be logged only if the customer requests a refund

Answer

Complaints are only forwarded to CAPA if they involve a product recall

Answer

Customer complaints are managed separately from CAPA and do not require cross-referencing

Question 2

A third-party audit identifies a finding that a required process step is routinely skipped. What is the correct CAPA classification for this finding?

Accepted Answer

Corrective action, because a nonconformance has already been confirmed

Answer

Preventive action only, since no product has been released yet

Answer

A risk assessment item requiring no formal CAPA

Answer

A management review agenda item with no CAPA needed

Question 3

What is a 'field corrective action' (FCA) as it relates to external nonconformances?

Accepted Answer

An action taken to address product nonconformances that have already been distributed to customers or the field

Answer

A corrective action issued to employees working in manufacturing floor areas

Answer

An action performed by external consultants to correct internal process failures

Answer

A corrective action limited to agricultural or outdoor field environments

Question 4

When prioritizing CAPAs originating from external audit findings versus internal audit findings, which factor should most influence prioritization?

Accepted Answer

The risk level and regulatory significance of the finding, regardless of audit source

Answer

The seniority of the auditor who identified the finding

Answer

External findings always take priority over internal findings automatically

Answer

Internal findings always take priority because they affect production directly

Question 5

What is an 'escape' in the context of supplier and external quality management?

Accepted Answer

A nonconforming product that passed through all quality controls and reached the customer

Answer

A supplier's failure to meet a SCAR response deadline

Answer

An employee resignation following a quality audit

Answer

A deviation that was intentionally excluded from the CAPA system

Question 6

How should an organization respond when a regulatory inspection (e.g., FDA, ISO auditor) issues an observation or finding?

Accepted Answer

Open a CAPA, perform root cause analysis, and submit a written response with corrective actions by the required date

Answer

Dispute the finding in writing and request it be removed from the inspection report

Answer

Log the finding for future reference but take no immediate action until the next audit

Answer

Implement the corrective action internally without notifying the regulatory body

Question 7

Which of the following best describes a preventive action that originates from analysis of supplier performance trend data?

Accepted Answer

Proactively working with a supplier to strengthen their process controls after noticing an upward trend in minor defects before a major nonconformance occurs

Answer

Issuing a SCAR after a confirmed lot rejection

Answer

Switching to a different supplier after a single failed lot

Answer

Conducting a root cause analysis on a defect that already caused a customer complaint