Do You Have A Document System?

An efficient process to establish a document system would be as a documented process or flow chart demonstrating how documented records are to be started, reviewed, and retained.

Security precautions and continuing observance of standard procedures relative to document control is essential. Document management must develop a contingency plan for safety and preservation of retained documents, electronic files and software. The contingency plan would include the prevention of unauthorized cyber attacks, limiting access to update servers, and a failsafe systematic method of backing up of essential business related information at scheduled intervals.

Document management is controlling changes to documents in a systematic fashion and ensuring that only valid versions of documents are available at points of use.

The document management system must have:

• a current, readily available master list
• a process for controlling changes
• a process for distributing new revisions and retrieving obsolete revisions
• a process for controlling cross references and external documents

Document management is a quality system function. That quality requirement is defined by international standards, such as ISO, and is also inherent in traditional non-ISO systems. The document management system is in place as empirical evidence of the maintenance of both internal and external company or customer documents.

The document management system is to ensure that all documents are current, readily identifiable, and accessible to those on a need to know basis. Controlled documents are usually accessible through a company intranet and in a .pdf format to prevent unauthorized changes.

Document management administration is responsible for the distribution, maintenance and the security of documents from unauthorized changes. The document administrator is also responsible for replacing any obsolete documents when a new revision has been received or a change has been issued. The definition of a “document” can also include customer-supplied specifications, electronic files and software.

Since documents, such as designs, work instructions, and contracts can be in characterized as “living” documents, a significant part of the management of the system is in its ability to react quickly to document revisions or obsolescence. This is usually done either through a revision to an existing document, after approval of those who would be affected by this change, or through the complete removal of the document as from “active” into an “obsolete” file. And if the document must be retained in some manner, is there an internal, customer, or regulatory requirement for document retention for a defined period of time?