CAPA Root Cause Analysis & Investigation Techniques 3

Question 1

Which investigative technique involves interviewing personnel and reviewing records to reconstruct exactly what happened during a failure event?

Accepted Answer

Event and Causal Factor (ECF) analysis

Answer

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?

Accepted Answer

A direct cause is the immediate event that triggered the failure, while the root cause is the underlying systemic reason it occurred

Answer

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?

Accepted Answer

Scatter diagram

Answer

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?

Accepted Answer

Adherence to established procedures

Answer

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?

Accepted Answer

To systematically narrow the problem scope by defining what the problem is and is not across multiple dimensions

Answer

The 'is/is not' technique (from Kepner-Tregoe) sharpens problem definition by contrasting observed facts with what was not observed.

(CAPA) Corrective and Preventive Action Certified Practice Test