CAPA Investigation Techniques 5

Question 1

When multiple root causes are identified in a CAPA investigation, the BEST practice is to:

Accepted Answer

Develop specific corrective actions for each confirmed root cause

Answer

Each confirmed root cause requires its own targeted corrective action; addressing only one while ignoring others allows the problem to recur through the unresolved causes.

Question 2

In hypothesis-based investigation, a hypothesis should be:

Accepted Answer

A testable, specific statement that can be confirmed or refuted through evidence

Answer

A valid hypothesis must be testable through data collection or experimentation so that investigators can objectively confirm or eliminate it as the root cause.

Question 3

Which of the following is a key output of the 'Define' phase in a structured problem-solving approach (e.g., 8D)?

Accepted Answer

Clear, quantified problem statement describing what, when, where, and extent

Answer

The Define phase produces a precise problem statement that scopes the investigation, establishes a baseline, and prevents investigators from solving the wrong problem.

Question 4

Process mapping during a CAPA investigation is valuable primarily because it:

Accepted Answer

Visually reveals handoffs, decision points, and gaps where failures can occur

Answer

Process maps expose the actual workflow, including handoffs and control points, making it easier to identify where a failure was introduced or went undetected.

Question 5

A 'reoccurrence check' conducted several months after CAPA closure is intended to:

Accepted Answer

Confirm that the root cause has not re-emerged after corrective actions were implemented

Answer

A reoccurrence check verifies long-term effectiveness by confirming the same or similar failure has not returned after corrective actions have been in place for a sustained period.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Investigation Techniques 5