Documents and training

Controlled documents keep a title, version, effective date, attachment and status. Training acknowledgments link a person to a controlled document and record when they acknowledged it. Together these records let the quality team look up the revision behind an acknowledgment. The documents can represent SO ps, work instructions or device master records used by the team.

The record link is the critical handoff. If a work instruction changes, the team needs to see which people acknowledged the controlled document. A dated acknowledgment without a document reference would be hard to interpret, and a document list alone would not show who has acknowledged it.

• Revision. Title and version distinguish one controlled document record from another.
• Use. Effective date and status help the team identify the document intended for current work.
• Acknowledgment. Each entry ties a person and an acknowledgment date to the controlled document.

For a revised inspection instruction, the Document Controller adds the new controlled document with its version and effective date. The team reviews its status and attachment. As inspectors acknowledge it, their entries point to that document. The quality manager can inspect the revision and the people who have acknowledged it before starting the next inspection cycle.

Agree how the team names documents and versions. Decide who changes document status and how a new version is introduced. Set the point at which staff acknowledgment is expected and identify which people must acknowledge the revision. The person records are linked to users, so access setup should reflect the actual staff who perform inspections, reviews and audits.

A pilot should use one document that matters to the inspection case. The controlled record should carry an attachment the inspector can identify, with a meaningful effective date. Acknowledgment entries should refer to the intended version. This gives the document team a concrete way to check its handoff.

Open a controlled instruction in review, inspect its title, version and file, then move through the agreed document decision. Record an acknowledgment for a named person and return to the controlled document to confirm the relationship. Compare that document with the instruction used in a pilot inspection. The team should be able to say which revision was available and who acknowledged it.

Also inspect an older document marked obsolete. The status should help the team distinguish it from the current approved record. Decide how the operating team will find the correct version from its day-to-day inspection work.

• Documents in review — Revisions that need a document decision, with their version and effective date.
• Training acknowledgments — People, documents and acknowledgment dates in one list.

See document acknowledgment and inspection review.