Investigation Techniques Flashcards

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

Answer: Develop specific corrective actions for each confirmed root cause

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.

In hypothesis-based investigation, a hypothesis should be:

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

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

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

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

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

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

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

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

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

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

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.

Which investigation tool would be MOST useful to prioritize which of ten identified potential root causes to investigate first?

Answer: Risk matrix (likelihood × impact)

A risk matrix scores each potential cause by likelihood and impact, enabling the team to focus investigation resources on the most probable and consequential candidates first.

When an investigation reveals that a procedure existed but was not followed, the root cause investigation should next determine:

Answer: Why the procedure was not followed—whether due to training gaps, workload, unclear instructions, or systemic pressures

Blaming a procedure violation without understanding why it occurred leads to inadequate corrective actions; the systemic reason behind the deviation must be addressed to prevent recurrence.