CAPA Process Fundamentals 3

Question 1

A SIPOC diagram includes which five elements?

Accepted Answer

Supplier, Input, Process, Output, Customer

Answer

SIPOC stands for Supplier, Input, Process, Output, Customer — a high-level tool used to scope a process before deeper CAPA analysis.

Question 2

Process revalidation after a CAPA implementation is MOST critical when:

Accepted Answer

A significant change has been made to process parameters or equipment

Answer

Significant changes to process parameters or equipment require revalidation to confirm the modified process still meets requirements.

Question 3

Which statistical tool helps determine whether two process variables are related as part of root cause analysis?

Accepted Answer

Scatter diagram

Answer

A scatter diagram plots two variables against each other to reveal potential correlations that may indicate a root cause relationship.

Question 4

In the context of CAPA process fundamentals, 'verification of effectiveness' (VoE) confirms that:

Accepted Answer

The corrective action eliminated the root cause and the problem has not recurred

Answer

VoE confirms that the implemented CAPA actually eliminated the root cause and that the nonconformance has not recurred.

Question 5

What is the role of a control plan in sustaining CAPA process improvements?

Accepted Answer

It specifies monitoring methods, frequencies, and reaction plans to maintain the improved process

Answer

A control plan defines how key process parameters and outputs will be monitored and what actions to take if they go out of control.

(CAPA) Corrective and Preventive Action Certified Practice Test