CAPA CAPA Training & Human Factors 3

Question 1

What is 'just culture' and how does it relate to CAPA investigations involving human error?

Accepted Answer

Just culture distinguishes between blameless human error and reckless behavior, enabling honest reporting that improves CAPA root cause accuracy

Answer

A just culture encourages employees to report errors without fear of unjust punishment, providing richer data for CAPA root cause investigations.

Question 2

How does fatigue as a human factor influence the CAPA root cause analysis for a manufacturing deviation?

Accepted Answer

Fatigue impairs cognitive performance and vigilance, making it a contributing root cause that may require scheduling or workload changes as corrective action

Answer

Identifying fatigue as a contributing factor leads to systemic corrective actions such as shift rotation adjustments or mandatory rest periods.

Question 3

What is the role of 'on-the-job training (OJT) verification' in a CAPA corrective action plan?

Accepted Answer

OJT verification confirms that employees can perform the corrected procedure correctly in the actual work environment, not just in a classroom

Answer

OJT verification ensures that training has transferred to real-world performance, closing the gap between knowledge and actual task execution.

Question 4

When a CAPA identifies 'lack of training' as the root cause, what additional analysis is required to make the corrective action effective?

Accepted Answer

Determining whether the training was absent, inadequate, or whether the underlying procedure needs to be redesigned

Answer

Without understanding whether the gap is in content, delivery, or procedure design, training may be repeated without addressing the true systemic cause.

Question 5

Under 21 CFR Part 211 (GMP for pharmaceuticals), what is required when personnel are assigned quality-affecting responsibilities?

Accepted Answer

They must have education, training, and experience, or any combination thereof, to perform their assigned functions

Answer

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.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA CAPA Training & Human Factors 3