Document and Data Control

Document and data control, or document control,  refers to the over-all system of an organization or company  for accessing, reviewing, revising, approving, disposition, and obsoletion of documents, data, and software.   Document control plays such a major role in defining the quality standard and systems of a company that the ISO9000 standard devotes one whole section or element to it. 

Good document and datasheet control is critical to semiconductor manufacturing given the complex processes involved in its day-to-day operations.  Semiconductor companies are expected to have hundreds, if not thousands, of documents since they all follow the same adage: "Document what you practice and practice what you document."

Accessibility of Documents and Data

Accessibility of documents and data pertains to the company's system for retrieval of controlled documents and data.  Its foundation is the Document Reference Index , which is simply a master list of all company documents. Each document in this master list must bear a unique control or index number and revision level. The document reference index must be accessible to all company personnel and must show  the most current revision of each controlled document or data sheet of the company.

All of the company's controlled and documents must be organized in a structure that allows easy access to information.  Documents with related information must include trails and links to each other.  Furthermore, all controlled documents and data sheets must be formatted in a standard way, with the format designed  to make it readable, informative, and easy to use.

Controlled documents may be in the form of a hard copy, a computer file, or other media but they should always be accessible to personnel while ensuring proper control, i.e., only the latest revision must be accessible.  Obsolete documents must be removed from the system to prevent their accidental use. Obsolete documents that need to be retained for reference should be retained as quality records and identified as such.

Review, Revision, Approval, Disposition of Documents and Data Sheets

Every new or revised controlled document or data sheet must undergo a standard and systematized review and approval process by authorized personnel who are considered experts on and/or responsible for the subject matter of the document.  These reviewers and approvers must have access to supporting reference material if necessary.

Revised documents must include descriptions of all previous changes to the document in a continuous trail. A change notice must be issued to affected parties every time a document is revised, if necessary.

All obsolete documents must be immediately disposed of.

ISO 9000 does not require that periodic review of documents be done , but it is considered good practice to implement this as part of the company's document control.  This means that document owners will be required to review their documents at specific intervals whether or not they see any need to change them. 

In this day and age of modern computers, companies can very well afford to have a computerized document control system that meets all of the above requirements and more.

See Also:  Quality Systems;  Monitors and Controls;  The ISO9000 Standard;  Metrology and Calibration