CAPA Root Cause Analysis & Investigation Techniques 3 — Questions and Answers
Question 1: Which investigative technique involves interviewing personnel and reviewing records to reconstruct exactly what happened during a failure event?
- Event and Causal Factor (ECF) analysis (Correct answer)
- Failure Mode and Effects Analysis (FMEA)
- Statistical Process Control (SPC)
- Design of Experiments (DOE)
Correct answer: Event and Causal Factor (ECF) analysis
ECF analysis systematically identifies events and conditions that contributed to an incident by reviewing evidence, records, and interviews.
Question 2: What is the key difference between a 'direct cause' and a 'root cause' in an RCA investigation?
- A direct cause is the immediate event that triggered the failure, while the root cause is the underlying systemic reason it occurred (Correct answer)
- A direct cause requires corrective action while a root cause requires only documentation
- A direct cause is identified by management while a root cause is identified by operators
- A direct cause is always human error while a root cause is always a process gap
Correct answer: A direct cause is the immediate event that triggered the failure, while the root cause is the underlying systemic reason it occurred
The direct cause is what immediately caused the failure; the root cause is the deeper systemic deficiency that allowed the direct cause to occur.
Question 3: Which quality tool would be most appropriate to confirm a suspected cause-and-effect relationship between two variables statistically?
- Scatter diagram (Correct answer)
- Check sheet
- Histogram
- Affinity diagram
Correct answer: Scatter diagram
A scatter diagram plots two variables against each other to visually and statistically reveal potential correlations.
Question 4: During an RCA, investigators discover that a written procedure existed but was not followed. Which category does this root cause fall under?
- Adherence to established procedures (Correct answer)
- Inadequate measurement systems
- Environmental factors
- Material specification failures
Correct answer: Adherence to established procedures
When a valid procedure exists but is not followed, the root cause is classified as a procedural adherence or compliance failure.
Question 5: An investigator applies the 'is/is not' analysis technique during RCA. What is the purpose of this approach?
- To systematically narrow the problem scope by defining what the problem is and is not across multiple dimensions (Correct answer)
- To categorize CAPAs as corrective versus preventive in the tracking system
- To determine whether an escape point exists in the detection process
- To assign probability ratings to potential causes identified in a fishbone diagram
Correct answer: To systematically narrow the problem scope by defining what the problem is and is not across multiple dimensions
The 'is/is not' technique (from Kepner-Tregoe) sharpens problem definition by contrasting observed facts with what was not observed.
Question 6: What is a 'contributing cause' in the context of root cause analysis?
- A factor that increased the likelihood or severity of the failure but alone would not have caused it (Correct answer)
- The single most important cause that must be eliminated to prevent recurrence
- A cause identified only after the root cause has been verified
- A cause related exclusively to human error in the process
Correct answer: A factor that increased the likelihood or severity of the failure but alone would not have caused it
Contributing causes are factors that worsened or enabled the failure but are not solely responsible for it occurring.
Question 7: In regulated industries, why is objective evidence critical during the RCA phase of a CAPA?
- Regulators require documented, verifiable facts to demonstrate that conclusions are data-driven rather than assumption-based (Correct answer)
- Objective evidence is needed only during the effectiveness check, not the investigation
- It allows companies to assign individual accountability for the nonconformance
- It satisfies the requirement to perform corrective actions within 30 days
Correct answer: Regulators require documented, verifiable facts to demonstrate that conclusions are data-driven rather than assumption-based
Regulatory agencies such as FDA expect documented objective evidence to support every conclusion drawn in a CAPA investigation.
CAPA Root Cause Analysis & Investigation Techniques 3
Which investigative technique involves interviewing personnel and reviewing records to reconstruct exactly what happened during a failure event?