Root cause analysis MCQs With Answer

Introduction: Root Cause Analysis (RCA) MCQs With Answer is designed for M.Pharm students studying Quality Management Systems (MQA 102T). This set of focused multiple-choice questions explores fundamental and advanced RCA techniques used in pharmaceutical quality investigations — including Fishbone (Ishikawa), 5 Whys, FMEA, fault tree analysis, Pareto analysis, barrier analysis, process mapping, and CAPA verification. Questions emphasize both theoretical concepts and practical application in pharmaceutical manufacturing, regulatory investigations and deviation handling. Use these MCQs to strengthen problem-solving skills, prepare for exams, and build competence in identifying, validating and preventing recurrence of quality incidents in a regulated drug production environment.

Q1. What is the primary objective of Root Cause Analysis (RCA) in pharmaceutical quality management?

• To assign blame to the person who made the mistake
• To identify the fundamental reason(s) for a problem so effective corrective actions can be implemented
• To document every deviation without proposing actions
• To increase production speed regardless of quality impact

Correct Answer: To identify the fundamental reason(s) for a problem so effective corrective actions can be implemented

Q2. Which of the following is typically the first formal step in a structured RCA process?

• Implementing corrective actions
• Defining and describing the problem clearly with evidence
• Conducting a root cause audit
• Publishing a CAPA report

Correct Answer: Defining and describing the problem clearly with evidence

Q3. The Fishbone (Ishikawa) diagram commonly groups potential causes under which classic categories often called the “6 Ms”?

• Man, Machine, Method, Material, Measurement, Mother-nature (Environment)
• Management, Money, Manufacturing, Marketing, Measurement, Motivation
• Material, Measurement, Manufacturing date, Maintenance, Morale, Mobility
• Method, Mood, Machine, Market, Metrics, Materials

Correct Answer: Man, Machine, Method, Material, Measurement, Mother-nature (Environment)

Q4. The 5 Whys technique is most useful for which type of problem?

• Highly complex systemic failures involving multiple interacting subsystems
• Simple-to-moderate problems where a causal chain can be traced by iterative questioning
• Statistical process capability estimation
• Determining regulatory policy changes

Correct Answer: Simple-to-moderate problems where a causal chain can be traced by iterative questioning

Q5. Which statement best distinguishes corrective action from preventive action?

• Corrective action addresses actions to prevent future occurrences; preventive action fixes a current problem
• Corrective action eliminates a detected nonconformity’s root cause; preventive action reduces the likelihood of potential nonconformities
• Corrective action is optional in pharmaceutical quality systems; preventive action is mandatory
• Corrective action only involves documentation; preventive action only involves training

Correct Answer: Corrective action eliminates a detected nonconformity’s root cause; preventive action reduces the likelihood of potential nonconformities

Q6. In Failure Mode and Effects Analysis (FMEA), the Risk Priority Number (RPN) is calculated by multiplying which three factors?

• Severity × Occurrence × Detection
• Severity × Speed × Scope
• Occurrence × Cost × Complexity
• Detection × Discovery time × Documentation completeness

Correct Answer: Severity × Occurrence × Detection

Q7. Which of the following best reflects the Pareto principle as applied to quality problems?

• All causes contribute equally to a problem
• Roughly 80% of problems are caused by roughly 20% of causes, so focus on the vital few
• Detailed solutions require addressing every possible root cause first
• Statistical tests should be avoided when prioritizing corrective actions

Correct Answer: Roughly 80% of problems are caused by roughly 20% of causes, so focus on the vital few

Q8. Fault Tree Analysis (FTA) commonly uses logical gates to model how basic events combine to cause a top event. Which gates are fundamental in FTA?

• AND and OR gates
• XOR and NAND gates only
• Buffer and Inverter gates
• Only probabilistic gates with no logical operators

Correct Answer: AND and OR gates

Q9. Which of these is NOT a standard RCA technique used to identify root causes in pharmaceutical investigations?

• Ishikawa (Fishbone) diagram
• 5 Whys
• FMEA
• Marketing SWOT analysis

Correct Answer: Marketing SWOT analysis

Q10. After implementing a corrective action, what is the key step to ensure the issue has been resolved permanently?

• Archive the investigation and close the file without follow-up
• Conduct an effectiveness check with objective evidence over an appropriate timeframe
• Announce the action to all staff and assume behavior will change
• Reduce documentation to prevent duplication

Correct Answer: Conduct an effectiveness check with objective evidence over an appropriate timeframe

Q11. According to Reason’s Swiss Cheese Model, what is the difference between active failures and latent conditions?

• Active failures are system design issues; latent conditions are operator slips
• Active failures are immediate unsafe acts; latent conditions are hidden system weaknesses that can align to allow failure
• Active failures are always intentional; latent conditions are always accidental
• There is no difference; the terms are interchangeable

Correct Answer: Active failures are immediate unsafe acts; latent conditions are hidden system weaknesses that can align to allow failure

Q12. Which data-gathering tool is most useful to visualize the actual steps and handoffs where a process deviation occurred?

• Process mapping (flowcharting)
• Pareto chart
• Affinity diagram
• Control chart

Correct Answer: Process mapping (flowcharting)

Q13. In RCA, why is it important to distinguish correlation from causation?

• Because correlated events always cause the problem
• Correlation may be coincidental; assuming causation can lead to ineffective or misdirected corrective actions
• Causation is irrelevant when documenting nonconformities
• Statistical significance automatically implies causation

Correct Answer: Correlation may be coincidental; assuming causation can lead to ineffective or misdirected corrective actions

Q14. Barrier analysis focuses on which aspect of an incident investigation?

• Assessing which administrative policies are missing
• Identifying defenses or barriers that failed or were absent which would have prevented the incident
• Listing all employees present during the incident
• Only assessing the final human error without system review

Correct Answer: Identifying defenses or barriers that failed or were absent which would have prevented the incident

Q15. A well-written root cause statement should ideally include which elements?

• Vague descriptions of the event and a list of potential fixes
• Specific cause, underlying reason(s), supporting evidence, and how it links to the observed effect
• Only management conclusions without evidence
• Predictions about future unrelated failures

Correct Answer: Specific cause, underlying reason(s), supporting evidence, and how it links to the observed effect

Q16. Which RCA tool is best when multiple causes interact and you need to group ideas generated by a multidisciplinary team?

• 5 Whys used by a single investigator
• Affinity diagram to cluster related ideas and causes
• Simple checklist without team input
• Random sampling without brainstorming

Correct Answer: Affinity diagram to cluster related ideas and causes

Q17. Which statistical tool is most appropriate to detect whether a process is stable or showing special-cause variation prior to RCA?

• Control chart (e.g., X-bar, R chart)
• Histogram with no time context
• Affinity diagram
• SWOT analysis

Correct Answer: Control chart (e.g., X-bar, R chart)

Q18. In which situation is the 5 Whys technique least likely to yield a complete root cause analysis?

• When a quality deviation arises from multiple interacting system-level failures
• When the problem has a single, linear human error cause
• When the investigator documents each why and evidence
• When the issue is simple and well-defined

Correct Answer: When a quality deviation arises from multiple interacting system-level failures

Q19. Which elements are essential components of an effective CAPA process following an RCA?

• Root cause identification, corrective action plan, preventive actions, implementation, documentation and effectiveness verification
• Immediate firing of staff, removal of equipment, and no documentation
• Only filling a form without assigning responsibility
• Publishing the incident on social media

Correct Answer: Root cause identification, corrective action plan, preventive actions, implementation, documentation and effectiveness verification

Q20. Which approach is most likely to produce sustainable improvements after an RCA in a pharmaceutical environment?

• Implementing quick fixes that address symptoms only
• Addressing underlying system and process weaknesses, validating effectiveness, and embedding changes into procedures and training
• Relying solely on verbal instructions without procedure updates
• Documenting the incident but taking no follow-up actions

Correct Answer: Addressing underlying system and process weaknesses, validating effectiveness, and embedding changes into procedures and training

Download