What Is a Controlled Document?

by Rick Kaiser

A controlled document is any digital or hard-copy entity which is required by a company, a standards organization, or a regulatory agency to be managed within a tightly controlled process that maintains the integrity of the document’s content through revisions. Examples of controlled documents include engineering drawings, industrial diagrams, operating procedures, contracts, and plans.

The process of document control manages the revisions of documents insuring that only the latest version is available to its users. At a minimum, the document control process must perform the following functions: edit, review, approval, revision, and distribution. Other desirable features include search, security, training, transmittal, and certification.

Edit

Controlled documents being edited come from three sources; existing controlled documents checked out for editing, new documents created for editing, and outside documents imported for editing. If an existing controlled document is checked out for editing, only a copy of the master document is edited to preserve the integrity of the master document. Editing should only be performed by users who have the authorization to check out, create and import documents.

Technical Review

A controlled document must be reviewed any time it has been edited, created, or imported. Who reviews the document and how extensively it is reviewed depends on the importance of the document. The review process can involve discipline reviews across multiple stakeholders, or it can involve a technical review by a few key people. Reviews can be either linear (sequential delivery) or distributed (simultaneous delivery). Any changes found in the review cycle are returned to the editor.

Manager Approval

Approval is the final review of a controlled document. While some controlled documents can bypass the technical review, they all must pass a manager’s approval. This “second set of eyes” insures that all of the technical issues as well as the legal, financial, and MOC (management of change) issues have been addressed and resolved. The manager may disapprove the controlled document and send it back to the editor for rework.

Revision

After the controlled document is approved, the document control process must increment the document’s revision number or letter . This identifies it as the current revision as of a particular date.

Distribution

The controlled document is finally distributed either digitally or manually to all users. Distribution must be with a method that places the current document in common use and removes all earlier revisions. It should also be in a form that cannot be changed by unauthorized users outside of the document change procedure. These previous revisions, although obsolete, should be saved.

E*Doc, the electronic document management solution from AIS for industrial document control, meets all of these requirements (and more) with a user-friendly intuitive interface that allows unlimited users in an organization to instantly view and print unlimited documents from unlimited devices, at any time from anywhere.