CAPA Investigation Techniques 3 — Questions and Answers
Question 1: What does the 'Is / Is Not' analysis tool help investigators accomplish?
- Prioritize corrective actions by cost
- Sharpen problem definition by contrasting where and when the problem occurs versus where it does not (Correct answer)
- Assign owners to each root cause
- Validate the effectiveness of a corrective action
Correct answer: Sharpen problem definition by contrasting where and when the problem occurs versus where it does not
Is/Is Not analysis narrows the investigation scope by systematically comparing conditions where the problem is present against those where it is absent.
Question 2: In the context of CAPA investigations, 'systemic root cause' refers to:
- A hardware or equipment failure
- A flaw in a process, system, or management practice that allows failures to occur repeatedly (Correct answer)
- A one-time human error with no recurring pattern
- A supplier-related defect traced to raw materials
Correct answer: A flaw in a process, system, or management practice that allows failures to occur repeatedly
Systemic root causes reflect weaknesses in underlying systems or processes and must be corrected to prevent recurrence across multiple product lines or processes.
Question 3: When using a Cause-and-Effect (Fishbone) diagram for a manufacturing defect, which category would 'inadequate training records' fall under?
- Machine
- Method
- Man (People) (Correct answer)
- Material
Correct answer: Man (People)
Training records relate to the people (Man) category in the 6M fishbone framework, as they reflect personnel competence and qualification.
Question 4: Which statistical tool is BEST suited for determining whether a process change actually caused an improvement during CAPA verification?
- Pareto chart
- Histogram
- Control chart (Correct answer)
- Scatter diagram
Correct answer: Control chart
Control charts track process performance over time and can statistically confirm whether a shift in process behavior occurred after a corrective action was implemented.
Question 5: A thorough CAPA investigation should trace the problem back to its origin primarily to:
- Satisfy audit requirements without additional effort
- Determine when and where the problem was introduced so containment and correction are accurate (Correct answer)
- Identify which employee made the error
- Calculate the financial cost of the defect
Correct answer: Determine when and where the problem was introduced so containment and correction are accurate
Tracing to the origin pinpoints the exact process step or input where the nonconformance began, enabling targeted and effective corrective actions.
Question 6: During a CAPA investigation, 'stratification' of data is useful because it:
- Confirms that all defects share the same root cause
- Separates data into subgroups to reveal patterns hidden in aggregate data (Correct answer)
- Eliminates outliers from the dataset before analysis
- Ranks defects by financial impact
Correct answer: Separates data into subgroups to reveal patterns hidden in aggregate data
Stratification breaks data into meaningful subgroups (by shift, operator, machine, etc.) to identify whether the problem is concentrated in a specific subset.
Question 7: Which of the following BEST describes 'comparative analysis' in failure investigations?
- Comparing the current CAPA to previous CAPAs to estimate closure time
- Analyzing differences between defective and nondefective items to identify distinguishing characteristics (Correct answer)
- Evaluating two corrective action options and selecting the lower-cost solution
- Benchmarking the process against industry standards
Correct answer: Analyzing differences between defective and nondefective items to identify distinguishing characteristics
Comparative analysis contrasts failing and passing items to isolate unique factors present only in the defective population, pointing toward root causes.
CAPA Investigation Techniques 3
What does the 'Is / Is Not' analysis tool help investigators accomplish?