Controlled Documents

Controlled documents hold a title, version, effective date, attachment and status. The status values Draft, Review, Approved and Obsolete help the team distinguish work in preparation from the version intended for use. training acknowledgments connect a document to a Person and record when that person acknowledged it. Those two records give Quality Manager a simple way to ask which version is current and who has acknowledged a document.

A document title alone is not enough when instructions change. Keep the version and effective date together with the attachment. When a new version is prepared, the team can review the attachment before marking it Approved. Earlier versions can be marked Obsolete so a person opening the document list has a clear state to inspect.

• Prepare. Document Controller maintains the title, version, effective date and attached document.
• Review. Quality Manager checks the version while it is in Review and decides whether it is ready for approval.
• Acknowledge. People record an acknowledgment against the document they used.

The acknowledgment refers to a controlled documents record, not a free-text title. This matters when two versions share the same title. The person reference connects through People to Users, giving the team an identity to use when checking the acknowledgment trail. Use the document record as the stable starting point for that review.

Agree who authors document changes, who reviews them and who can move a version to Approved or Obsolete. Decide how version values are written and whether the effective date means approval day or first day of use. Establish which people need to acknowledge each type of document and when the acknowledgment should be recorded. Make that rule visible to Document Controller and Quality Manager during onboarding.

Use the acknowledgment date and document link when asking whether a person has confirmed the current instruction. Document Controller can review that link alongside the version and effective date before the next operating cycle.

A handling instruction is updated after the Q-104 corrective action. Document Controller creates the revised version, attaches it and places it in Review. Quality Manager reads the change and marks the version Approved when ready. The prior version is marked Obsolete. The affected Person acknowledges the approved record, and Document Controller can review the date and the exact document reference.

Rehearse a second case in which the acknowledgment points to the earlier version. The document link should reveal that difference without relying on a typed title. The team can then ask the person to acknowledge the correct version and retain the original record as history.

• Documents in review — Versions awaiting a decision, with effective date and attachment beside the title.
• Document acknowledgment trail — A report of linked people and acknowledgment dates by document.

See document review and implementation.