Audits and documents

Audits record a number, scope, planned date, completion date, status and auditor. Their findings carry a requirement, finding, severity, owner, due date and closure date. Controlled documents stores a titled version, effective date, file and revision status. Training acknowledgments connects a person to a controlled document and records when that person acknowledged it. Together these records let the team answer which audit finding is open and which version a person acknowledged.

For an internal audit of a packaging line, Auditor plans the scope and date, then records a finding against a named requirement. A finding owner is assigned with a due date. The team can read the finding while the audit moves through reporting and can check the closure date when work is complete. Separately, Document Controller can put a revised work instruction into review, then make the approved version available for acknowledgments.

• Audit case. The audit holds scope, schedule, auditor and overall state.
• Finding follow-up. Each finding identifies the requirement, issue, owner and closure date.
• Revision evidence. A document version and its acknowledgments show what was available to the team.

An audit finding is linked to its audit. An acknowledgment is linked both to the document and the person, so a reviewer can follow each relationship directly. A document marked Approved identifies a reviewed revision in the list; the effective date clarifies when it applies.

Define how audit scope is written, who owns findings and what a closure date means. Agree how auditors use Observation, Minor and Major severity. For documents, settle the version naming convention, who reviews a revision and when the effective date is set. Decide who must acknowledge an approved document and how the team checks acknowledgments before a procedure changes in daily work.

The quality team should rehearse the document handoff with the people who actually use the instruction. If files are distributed through another document service, agree how the approved revision and acknowledgment record remain aligned.

Plan a packaging audit and enter a finding with an owner and due date. Have another person locate the open finding from the audit record and describe what remains to close it. Then create a revised controlled document, attach the file, set its review state, and have Document Controller verify the version and effective date. Ask a named person to acknowledge the approved revision. Finally, trace that acknowledgment back to the exact document version. This exercise tests both the audit and document review paths.

• Open audits — Planned, active and reporting audits with an assigned auditor.
• Open findings — Finding owners and due dates alongside unresolved issues.
• Pending release — Controlled revisions awaiting the team’s release decision.

See audit and document review and implementation.