CAPA Training & Human Factors Flashcards

Which of the following is a common human factors root cause identified during CAPA investigations in US pharmaceutical manufacturing?

Answer: Inadequate procedure clarity leading to misinterpretation by operators

Ambiguous or overly complex procedures are a frequent human factors root cause because they allow different operators to interpret the same step differently.

What is a 'skills, knowledge, and behavior (SKB)' gap analysis in CAPA training?

Answer: An assessment identifying what employees currently know versus what they need to know to prevent recurrence

SKB gap analysis maps existing competencies against required competencies to design targeted training that closes the specific gaps linked to the nonconformance.

How should training records related to a CAPA be maintained to satisfy FDA inspection requirements?

Answer: They must be documented, dated, signed, and retained as part of the CAPA record for traceability

FDA requires training records to be traceable, properly attributed, and retained as objective evidence that corrective actions were implemented.

What human factor is most commonly associated with 'normalization of deviance' contributing to CAPA-worthy events?

Answer: Gradual acceptance of non-standard practices as normal over time due to repeated exposure without consequence

Normalization of deviance occurs when teams repeatedly violate standards without immediate negative outcomes, causing deviations to become accepted as the new norm.

Which corrective action best addresses a CAPA where the root cause is identified as high cognitive load on operators during a complex process step?

Answer: Redesigning the process step or job aid to reduce cognitive demands and simplify decision-making

Reducing cognitive load through process simplification or improved job aids addresses the human factors root cause directly and sustainably.

In CAPA, what is the difference between 'error-likely situations' and 'error-tolerant systems'?

Answer: Error-likely situations are conditions that increase mistake probability, while error-tolerant systems detect and recover from errors before they cause harm

Distinguishing between conditions that breed errors and systems that absorb them helps CAPAs target both prevention and detection strategies.