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

FDA 21 CFR Part 820.198 requires all complaints to be reviewed, evaluated, and investigated as necessary, and findings that indicate a quality system problem must feed into the CAPA process.

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

A confirmed audit finding of a skipped required step is an existing nonconformance, requiring a corrective action to investigate root cause, correct the deviation, and prevent recurrence.

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 field corrective action addresses quality issues with products already distributed to customers, which may include product recalls, field retrofits, or safety notifications.

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

CAPA prioritization should be risk-based, considering patient/customer safety impact, regulatory significance, and recurrence potential rather than automatically favoring findings by audit source.

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

An 'escape' occurs when a defective product bypasses all detection controls and reaches the customer, representing a failure of both the supplier's and the receiving organization's quality systems.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Supplier CAPA & External Nonconformances 3