CAPA Process Fundamentals 3 — Questions and Answers
Question 1: A SIPOC diagram includes which five elements?
- Strategy, Input, Process, Output, Control
- Supplier, Input, Process, Output, Customer (Correct answer)
- System, Inspection, Plan, Outcome, Compliance
- Source, Issue, Process, Objective, Closure
Correct answer: Supplier, Input, Process, Output, Customer
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:
- An operator retires
- A significant change has been made to process parameters or equipment (Correct answer)
- A new audit is scheduled
- Customer complaints have decreased
Correct answer: A significant change has been made to process parameters or equipment
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?
- Scatter diagram (Correct answer)
- Histogram
- Check sheet
- Affinity diagram
Correct answer: Scatter diagram
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:
- The CAPA documentation is complete and signed
- The corrective action eliminated the root cause and the problem has not recurred (Correct answer)
- Management has approved the corrective action plan
- All employees have been retrained
Correct answer: The corrective action eliminated the root cause and the problem has not recurred
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?
- It documents who discovered the original defect
- It specifies monitoring methods, frequencies, and reaction plans to maintain the improved process (Correct answer)
- It authorizes engineers to make future process changes
- It replaces the need for corrective action going forward
Correct answer: It specifies monitoring methods, frequencies, and reaction plans to maintain the improved process
A control plan defines how key process parameters and outputs will be monitored and what actions to take if they go out of control.
Question 6: Which of the following BEST describes 'containment action' in a CAPA process?
- The long-term solution that eliminates the root cause
- An immediate step to protect the customer from defective product while the root cause is investigated (Correct answer)
- A management review of the CAPA record
- A statistical analysis of process variation
Correct answer: An immediate step to protect the customer from defective product while the root cause is investigated
Containment action is an immediate, short-term measure taken to prevent defective product from reaching customers while the root cause is being identified.
Question 7: When using a control chart for CAPA process monitoring, a point beyond the upper or lower control limit (UCL/LCL) signals:
- Normal process variation requiring no action
- A potential special cause that warrants investigation (Correct answer)
- That the specification limits must be widened
- Successful completion of the CAPA
Correct answer: A potential special cause that warrants investigation
A point beyond control limits signals a potential special cause of variation that should be investigated as part of ongoing process monitoring.
CAPA Process Fundamentals 3
A SIPOC diagram includes which five elements?