Audits and documents

Audits identify scope, planned date, completion date, auditor and status. A finding belongs to an audit and has its own requirement, finding text, severity, owner and due date. This gives Quality Manager a way to review the audit as a whole while assigning specific follow-up to the people who will address each finding. Planned, in progress, Reporting and Closed describe the audit’s progression; a finding also has its own closure date.

Controlled documents hold a title, version, effective date, attachment and status of Draft, Review, Approved or Obsolete. Training acknowledgments link a person to the controlled document they acknowledged and record the acknowledgment date. Keep the precise version in the document record so an acknowledgment can be interpreted against the material that person saw.

• Audit scope. The auditor and planned date make upcoming work visible; findings stay under their source audit.
• Document control. A version moves through review and approval before it is treated as the operative document for the team.
• Acknowledgment. A named person records their acknowledgment against the controlled document, preserving the date as evidence of receipt.

The Audit work list follows open audits through Reporting. Open document review shows versions awaiting a decision. Training acknowledgments gives Quality Manager a record of who acknowledged which document.

Agree the audit numbering convention and how scope is written. A finding requirement should identify the condition being checked; the finding text should describe the actual observation. Decide how Minor, Major and Observation are used for findings, who owns due work and who records closure. The audit’s Closed state and each finding’s closed at date answer different questions.

For documents, agree how versions are named and when an approved version becomes effective. Decide who can approve a document and who needs to acknowledge it. The attachment should be the version people are asked to read. If an old version becomes Obsolete, the acknowledgment history should still point to that older controlled document record rather than to a rewritten current file.

Quality Manager plans an audit for an electronics assembly process and assigns an auditor. During the audit, the auditor records a Major finding about an observed quality condition, links it to the audit, assigns an owner and sets a due date. The audit moves to Reporting while the finding remains traceable. The team can later record the finding’s closure date without changing the original requirement or observation.

In the same operating cycle, a controlled work instruction is prepared as a new version and moved to Review. Quality Manager approves the correct attachment and effective date. A person acknowledges that controlled document, and the acknowledgment date appears with the person and document. Rehearse an acknowledgment against the prior version and confirm the record still identifies that prior version. Do not infer training completion from a document status alone; inspect the acknowledgment record.

• Audit work — Planned and active audits with scope, auditor and dates in one list.
• Open document review — Document versions awaiting a quality decision.
• Training acknowledgments — Recorded person, document and acknowledgment date.

See audit and document control and implementation for the first operating cycle.