What is a discrepancy report, and when is it used?

• A. A report documenting deviations from the procedure; used to trigger investigations and CAPA
• B. A log of approved changes to the SOP
• C. A checklist used during SOP training
• D. A form for requesting new SOP templates

Answer: (A)

Discrepancy reports are used whenever a procedure isn’t followed or a specification isn’t met. They capture what happened, when and where it occurred, who was involved, any supporting data, and the immediate actions taken to contain the issue. The key purpose is to trigger a formal investigation to determine the root cause and to drive corrective and preventive actions (CAPA). This creates a traceable record for regulatory compliance and for analyzing trends to prevent recurrence.

It’s helpful to contrast this with related tools: a change control log tracks approved modifications to procedures, not deviations; a training checklist is used to confirm training completion, not to document deviations; and a template request form handles requests for new SOP templates, not incident reporting.