CAPA Preventive Action Implementation 2 — Questions and Answers
Question 1: Which tool is MOST commonly used in the proactive identification of potential failure modes during preventive action planning?
- Pareto chart
- Failure Mode and Effects Analysis (FMEA) (Correct answer)
- Control chart
- Scatter diagram
Correct answer: Failure Mode and Effects Analysis (FMEA)
FMEA proactively identifies potential failure modes and their effects before a nonconformance occurs, making it a cornerstone of preventive action.
Question 2: When performing a risk assessment as part of preventive action, which factor determines the priority risk number (PRN) in an FMEA?
- Severity × Occurrence × Detection (Correct answer)
- Severity + Occurrence + Detection
- Severity × Detection only
- Occurrence × Detection only
Correct answer: Severity × Occurrence × Detection
The Risk Priority Number (RPN) in FMEA is calculated by multiplying Severity, Occurrence, and Detection scores.
Question 3: A preventive action plan should include which of the following elements as a minimum?
- Action item, owner, due date, and verification method (Correct answer)
- Action item and completion date only
- Root cause and corrective action reference only
- Risk ranking and departmental sign-off only
Correct answer: Action item, owner, due date, and verification method
A complete preventive action plan requires defined actions, assigned ownership, target dates, and a method to verify effectiveness.
Question 4: Which quality management system standard explicitly requires organizations to determine actions to address risks and opportunities as a form of preventive action?
- ISO 9001:2015 (Correct answer)
- ISO 9001:2008
- ISO 14001:2004
- ISO 45001:1999
Correct answer: ISO 9001:2015
ISO 9001:2015 replaced the traditional 'preventive action' clause with risk-based thinking, requiring actions to address risks and opportunities.
Question 5: During preventive action implementation, what is the purpose of a pilot or trial run before full deployment?
- To satisfy regulatory documentation requirements
- To validate that the proposed action effectively mitigates the identified risk (Correct answer)
- To generate additional nonconformance records
- To assign accountability to multiple departments simultaneously
Correct answer: To validate that the proposed action effectively mitigates the identified risk
A pilot run validates the preventive action's effectiveness on a small scale before committing to full organizational deployment.
Question 6: Which of the following BEST describes the relationship between a risk register and preventive action implementation?
- The risk register is created after preventive actions are closed
- The risk register documents identified risks and tracks associated preventive actions and their status (Correct answer)
- The risk register replaces the need for corrective action records
- The risk register is only required in regulated industries
Correct answer: The risk register documents identified risks and tracks associated preventive actions and their status
A risk register catalogues identified risks alongside the preventive actions assigned to mitigate them and tracks their implementation status.
Question 7: An organization identifies a trend in supplier delivery delays that has not yet caused a production stoppage. Which preventive action approach is MOST appropriate?
- Wait until a stoppage occurs, then issue a corrective action
- Analyze the trend, identify root cause potential, and implement mitigation before impact occurs (Correct answer)
- Document the trend and archive it for future reference
- Issue a customer complaint notice immediately
Correct answer: Analyze the trend, identify root cause potential, and implement mitigation before impact occurs
Proactive trend analysis followed by mitigation before impact is the essence of preventive action — acting on signals before they become failures.
CAPA Preventive Action Implementation 2
Which tool is MOST commonly used in the proactive identification of potential failure modes during preventive action planning?