CAPA Training & Human Factors Flashcards
6 cards from real CAPA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CAPA Training & Human Factors flashcards as text
What is 'just culture' and how does it relate to CAPA investigations involving human error?
Answer: Just culture distinguishes between blameless human error and reckless behavior, enabling honest reporting that improves CAPA root cause accuracy
A just culture encourages employees to report errors without fear of unjust punishment, providing richer data for CAPA root cause investigations.
How does fatigue as a human factor influence the CAPA root cause analysis for a manufacturing deviation?
Answer: Fatigue impairs cognitive performance and vigilance, making it a contributing root cause that may require scheduling or workload changes as corrective action
Identifying fatigue as a contributing factor leads to systemic corrective actions such as shift rotation adjustments or mandatory rest periods.
What is the role of 'on-the-job training (OJT) verification' in a CAPA corrective action plan?
Answer: OJT verification confirms that employees can perform the corrected procedure correctly in the actual work environment, not just in a classroom
OJT verification ensures that training has transferred to real-world performance, closing the gap between knowledge and actual task execution.
When a CAPA identifies 'lack of training' as the root cause, what additional analysis is required to make the corrective action effective?
Answer: Determining whether the training was absent, inadequate, or whether the underlying procedure needs to be redesigned
Without understanding whether the gap is in content, delivery, or procedure design, training may be repeated without addressing the true systemic cause.
Under 21 CFR Part 211 (GMP for pharmaceuticals), what is required when personnel are assigned quality-affecting responsibilities?
Answer: They must have education, training, and experience, or any combination thereof, to perform their assigned functions
21 CFR 211.68 and 211.25 require that all personnel have the appropriate combination of education, training, and experience documented before performing quality-affecting tasks.
What is 'behavioral observation' as a CAPA effectiveness tool related to training?
Answer: Directly observing employees performing tasks in the work environment to verify that trained behaviors are consistently applied
Behavioral observation provides direct, real-world evidence that training changed on-the-job performance, which is stronger than test scores alone.
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