What should be done with the observations and findings of auditors?

• A. They should be summarized only if major.
• B. They should be documented.
• C. They should be kept confidential and not documented.
• D. They should be disclosed publicly.

Answer: (B)

Documenting auditor observations creates a clear, traceable record of what was found, where, when, and how it relates to the study processes. This formal record is essential for assessing impact, guiding corrective and preventive actions, and ensuring accountability throughout the quality management system. By documenting observations, you capture the evidence, reference the applicable protocol or SOP, note the severity or priority, assign responsibilities, and track completion dates, which supports follow-up, re-inspection if needed, and regulatory review.

Keeping findings in summary form only would risk missing important details that drive effective remediation. Not documenting undermines traceability and quality improvement, and sharing findings publicly is inappropriate due to confidentiality and sensitivity of the information.