CAPA Process Fundamentals 2 — Questions and Answers
Question 1: In CAPA process fundamentals, what is the primary purpose of a process map or flowchart?
- To assign blame for defects
- To visually depict process steps, inputs, outputs, and decision points (Correct answer)
- To replace written procedures entirely
- To document employee performance metrics
Correct answer: To visually depict process steps, inputs, outputs, and decision points
Process maps visually depict steps, inputs, outputs, and decision points, making it easier to identify where nonconformances occur.
Question 2: Which process input category in an Ishikawa diagram refers to the tools and equipment used in a process?
- Method
- Machine (Correct answer)
- Material
- Measurement
Correct answer: Machine
In the 6M Ishikawa framework, 'Machine' refers to tools, equipment, and technology used in the process.
Question 3: A process is considered 'capable' when:
- Its Cpk index is greater than or equal to 1.33 (Correct answer)
- All operators are fully trained
- Defects occur less than once per month
- The process has been validated at least twice
Correct answer: Its Cpk index is greater than or equal to 1.33
Process capability is measured by the Cpk index; a value ≥1.33 indicates the process consistently meets specification limits.
Question 4: What distinguishes a special cause of variation from a common cause in process analysis?
- Special causes are always more costly to fix
- Special causes are sporadic, assignable events outside normal process variation (Correct answer)
- Common causes only appear in manufacturing processes
- Special causes are identified only through audits
Correct answer: Special causes are sporadic, assignable events outside normal process variation
Special causes are sporadic, identifiable events that fall outside the normal random variation inherent in a stable process.
Question 5: When performing a CAPA on a process, the 'Measure' phase in DMAIC is primarily concerned with:
- Implementing the corrective solution
- Collecting baseline process performance data (Correct answer)
- Identifying the problem statement
- Sustaining improvements over time
Correct answer: Collecting baseline process performance data
The Measure phase focuses on collecting current, baseline data to quantify the problem and process performance before improvement.
Question 6: Which tool is BEST suited for prioritizing which process defects to address first in a CAPA effort?
- Pareto chart (Correct answer)
- Run chart
- SIPOC diagram
- Control chart
Correct answer: Pareto chart
A Pareto chart applies the 80/20 rule to rank defect categories by frequency, directing CAPA resources to the most impactful issues.
Question 7: In process fundamentals for CAPA, what does 'process stability' mean?
- The process never produces defects
- The process output varies only due to common causes and is statistically predictable (Correct answer)
- The process has been running for more than one year
- All process parameters are identical each cycle
Correct answer: The process output varies only due to common causes and is statistically predictable
A stable process operates in statistical control, meaning its variation is due only to common causes and is predictable over time.
CAPA Process Fundamentals 2
In CAPA process fundamentals, what is the primary purpose of a process map or flowchart?