Audits

The audit header holds its type, scope, schedule, assigned auditor, status and result. Checklist rows carry clause, question, result, observed evidence and check date. They remain linked to both the audit and the standard. This lets the auditor show how a conclusion follows from individual observations rather than a summary alone.

A finding has its own number, clause, type, severity, description, evidence, owner for response and due date. It moves through open, response due, response received, verified and closed states. The response owner records the reply; the verifier checks whether it addresses the finding. Observation and opportunity for improvement values remain distinct from minor and major nonconformance values. A major finding can be the source of a CAPA.

Audit status progresses from scheduled to in progress, reporting and closed. The auditor can run an assigned audit through reporting. Quality Manager handles sign-off and controls closure. Reports can compare findings by audit and standard, while the open finding list keeps individual responses visible.

• Plan and scope. Record the standard, audit type, date and auditor before the check.
• Clause evidence. Use checklist rows for observations and per-clause results.
• Response work. Give each finding an owner and due date, then verify its answer.

Choose the standard version, checklist questions and how audit scope is expressed. Assign the auditor and identify who owns finding responses. Decide when a finding is escalated to CAPA and who verifies the response. A scheduled audit should have enough context for the auditor to start without guessing which area or standard applies.

Schedule an internal process audit against an active standard. Add checklist questions for a clause and record one conformant observation and one major finding with evidence. Give the finding an owner and due date. Move the audit into reporting and ask Quality Manager to review the result. Follow the finding from response received through verification, then inspect any linked CAPA before closure. Confirm that the audit result and finding status tell a consistent story.

• Scheduled Audits — Planned work by date, scope and assigned auditor.
• Open Audit Findings — Findings whose responses and verification remain active.

Use audit to finding response and CAPA effectiveness.