CAPA CAPA Process & Documentation 2 — Questions and Answers
Question 1: Which document typically serves as the formal input to initiate a CAPA in a regulated environment?
- Customer satisfaction survey
- Nonconformance report or deviation (Correct answer)
- Annual product review
- Risk management file
Correct answer: Nonconformance report or deviation
A nonconformance report or deviation is the most common formal trigger that initiates a CAPA by documenting an identified problem.
Question 2: In CAPA documentation, what does the term 'effectiveness check' refer to?
- A financial audit of CAPA costs
- Verification that implemented actions eliminated the root cause (Correct answer)
- A review of supplier qualifications
- A statistical sampling plan
Correct answer: Verification that implemented actions eliminated the root cause
An effectiveness check confirms that the corrective or preventive actions taken have successfully eliminated the root cause and prevented recurrence.
Question 3: When documenting a CAPA, the 'scope' field should describe:
- The budget allocated for corrective actions
- The extent and boundaries of the problem being addressed (Correct answer)
- The names of personnel responsible for verification
- The timeline for closure
Correct answer: The extent and boundaries of the problem being addressed
The scope defines the extent and boundaries of the identified problem, clarifying what is and is not included in the CAPA investigation.
Question 4: Which of the following best describes a 'containment action' in CAPA documentation?
- A long-term solution to prevent recurrence
- An immediate step to limit the impact of a nonconformance (Correct answer)
- A training program for employees
- A supplier audit plan
Correct answer: An immediate step to limit the impact of a nonconformance
A containment action is an immediate, short-term measure taken to limit the spread or impact of a nonconformance while the root cause investigation proceeds.
Question 5: Under 21 CFR Part 820, what must a manufacturer document regarding CAPA procedures?
- Only the final corrective action taken
- Procedures for analyzing quality data to identify CAPAs (Correct answer)
- Customer complaint responses only
- Monthly management review minutes
Correct answer: Procedures for analyzing quality data to identify CAPAs
21 CFR Part 820.100 requires documented procedures for analyzing quality data to identify existing and potential causes of nonconforming product or quality problems.
Question 6: What is the primary purpose of linking a CAPA to a specific risk level in documentation?
- To satisfy financial reporting requirements
- To prioritize investigation resources and timelines appropriately (Correct answer)
- To assign blame to responsible departments
- To reduce the number of open CAPAs
Correct answer: To prioritize investigation resources and timelines appropriately
Assigning a risk level to a CAPA helps organizations prioritize investigation depth and response timelines based on potential impact to product quality or patient safety.
Question 7: Which section of a CAPA record documents the specific actions planned, responsible parties, and due dates?
- Problem statement
- Root cause analysis
- Action plan (Correct answer)
- Effectiveness criteria
Correct answer: Action plan
The action plan section captures what actions will be taken, who is responsible for each, and the target completion dates for both corrective and preventive actions.
CAPA CAPA Process & Documentation 2
Which document typically serves as the formal input to initiate a CAPA in a regulated environment?