CAPA Root Cause Analysis & Investigation Techniques 2 — Questions and Answers
Question 1: Which RCA tool uses a structured tree diagram to display all possible causes of a problem, branching from general to specific?
- Fault Tree Analysis (Correct answer)
- Pareto Chart
- Control Chart
- Scatter Diagram
Correct answer: Fault Tree Analysis
Fault Tree Analysis (FTA) uses a top-down tree diagram to map all potential causes leading to an undesired event.
Question 2: In a 5 Whys analysis, what is the primary risk if the investigation stops too early?
- Identifying a symptom rather than the true root cause (Correct answer)
- Generating too many corrective actions
- Overcomplicating the CAPA documentation
- Exceeding the allotted investigation timeline
Correct answer: Identifying a symptom rather than the true root cause
Stopping prematurely in 5 Whys leads to treating a symptom or contributing factor instead of the actual root cause.
Question 3: What does the 'M' for 'Methods' represent in a cause-and-effect (Ishikawa) diagram applied to a manufacturing defect?
- The procedures, work instructions, or processes followed during production (Correct answer)
- The measurement instruments used to detect the defect
- The materials used in manufacturing
- The management decisions that led to the issue
Correct answer: The procedures, work instructions, or processes followed during production
In the 6M framework, 'Methods' refers to the standard operating procedures, work instructions, and processes involved.
Question 4: When conducting a timeline analysis during an investigation, what is the primary objective?
- To reconstruct the sequence of events leading up to the nonconformance (Correct answer)
- To assign blame to specific individuals involved in the incident
- To determine the financial cost of the defect
- To identify which product lots need to be recalled
Correct answer: To reconstruct the sequence of events leading up to the nonconformance
Timeline analysis reconstructs the chronological sequence of events to identify when and how the problem originated.
Question 5: Which of the following best describes the concept of 'escape point' in root cause analysis?
- The last point in the process where the defect could have been detected but was not (Correct answer)
- The location where a defective product left the facility
- The point at which a corrective action was first proposed
- The stage where a process deviation first occurred
Correct answer: The last point in the process where the defect could have been detected but was not
The escape point identifies the detection failure — the last opportunity where the defect should have been caught.
Question 6: A quality team uses a Pareto chart during RCA. Which principle does this tool apply?
- The 80/20 rule — roughly 80% of problems stem from 20% of causes (Correct answer)
- Every cause contributes equally to the overall problem
- The most recent cause is the most significant
- All identified causes must be addressed simultaneously
Correct answer: The 80/20 rule — roughly 80% of problems stem from 20% of causes
Pareto charts apply the 80/20 principle to prioritize the vital few causes responsible for the majority of defects.
Question 7: In CAPA investigations, what is 'containment action' and when is it typically implemented?
- An immediate action taken to isolate the problem and prevent further impact while the root cause is investigated (Correct answer)
- The final corrective action implemented after the root cause is confirmed
- A preventive measure applied to future product lines
- A documentation step required before closing the CAPA record
Correct answer: An immediate action taken to isolate the problem and prevent further impact while the root cause is investigated
Containment actions are short-term, immediate responses to limit the damage of a nonconformance while the full investigation proceeds.
CAPA Root Cause Analysis & Investigation Techniques 2
Which RCA tool uses a structured tree diagram to display all possible causes of a problem, branching from general to specific?