CAPA Implementation & Effectiveness Monitoring 2

Question 1

Which metric best indicates that a corrective action targeting defect escape rate has been effectively implemented?

Accepted Answer

Reduction in customer-reported defects post-implementation

Answer

A reduction in customer-reported defects after implementation directly measures whether the corrective action addressed the escape-rate problem.

Question 2

During implementation of a CAPA, a responsible team member leaves the organization. What is the most appropriate next step?

Accepted Answer

Reassign ownership and update the CAPA record immediately

Answer

Reassigning ownership and updating the record ensures continuity and maintains accountability without interrupting progress.

Question 3

A process change implemented as part of a CAPA shows improvement for 30 days, then performance degrades again. This MOST likely indicates:

Accepted Answer

The root cause was misidentified

Answer

Temporary improvement followed by regression typically signals the true root cause was not addressed, only a symptom was treated.

Question 4

Which document type is MOST critical to update when a CAPA changes a manufacturing process step?

Accepted Answer

Standard Operating Procedure (SOP)

Answer

SOPs must reflect any process changes resulting from CAPAs so that operators consistently follow the new, corrected process.

Question 5

An effectiveness check is scheduled six months after CAPA closure. What is the PRIMARY risk of this long interval?

Accepted Answer

A recurrence may go undetected for an extended period

Answer

Long verification intervals increase the window during which a problem could recur and cause harm or customer impact before being caught.

(CAPA) Corrective and Preventive Action Certified Practice Test