CAPA Implementation & Effectiveness Monitoring 2 — Questions and Answers
Question 1: Which metric best indicates that a corrective action targeting defect escape rate has been effectively implemented?
- Number of CAPAs closed on time
- Reduction in customer-reported defects post-implementation (Correct answer)
- Increase in internal audit findings
- Number of root cause analyses completed
Correct answer: Reduction in customer-reported defects post-implementation
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?
- Close the CAPA and open a new one
- Extend the due date indefinitely
- Reassign ownership and update the CAPA record immediately (Correct answer)
- Suspend implementation until a replacement is hired
Correct answer: Reassign ownership and update the CAPA record immediately
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:
- The root cause was misidentified (Correct answer)
- The effectiveness check period was too long
- The CAPA was implemented too quickly
- The verification plan was too strict
Correct answer: The root cause was misidentified
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?
- Customer complaint log
- Corrective action request form
- Standard Operating Procedure (SOP) (Correct answer)
- Internal audit schedule
Correct answer: Standard Operating Procedure (SOP)
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?
- Auditors may question the CAPA format
- A recurrence may go undetected for an extended period (Correct answer)
- The CAPA owner may forget the corrective actions
- Regulatory bodies require shorter intervals
Correct answer: A recurrence may go undetected for an extended period
Long verification intervals increase the window during which a problem could recur and cause harm or customer impact before being caught.
Question 6: Which statement BEST describes 'implementation verification' in the CAPA process?
- Confirming the root cause analysis is complete
- Confirming that planned actions were actually carried out (Correct answer)
- Confirming that the problem has not recurred
- Confirming that the CAPA was approved by management
Correct answer: Confirming that planned actions were actually carried out
Implementation verification specifically checks that the actions described in the CAPA plan were executed as intended, distinct from checking effectiveness.
Question 7: A quality manager notices that corrective actions are consistently marked 'implemented' before training records are complete. Which CAPA control is MOST deficient?
- Root cause analysis methodology
- Implementation completion criteria (Correct answer)
- Effectiveness monitoring schedule
- Problem statement definition
Correct answer: Implementation completion criteria
Incomplete implementation completion criteria allow actions to be closed prematurely when supporting tasks like training are still outstanding.
CAPA Implementation & Effectiveness Monitoring 2
Which metric best indicates that a corrective action targeting defect escape rate has been effectively implemented?