What are document control procedures?
Document control procedures are the processes defined by a Document Control Procedures Manual. This includes:
Document creation
Who creates a document, and how
the document is created, are determined by the document control procedure. This
can include details on how the document is formatted, how it is named, and
other technical details about the document.
Document review and
approval
How a document is reviewed, who
approves a document, and how approvals or modifications are recorded, are all
spelled out in the document control procedure. Quality assurance principles
require documents be reviewed for accuracy.
Document revisions
After documents become final and
approved, they often still need changes in the future. Document control
procedures will determine the process for document revisions. The procedures
identify who can initiate or request revisions, and who can implement them.
Document revision levels, publish date, document owner, and next review date
are managed over the lifecycle of the document. Once revisions are drafted,
they follow an approval process similar or identical to the initial document
review and approval process. The document control procedure also defines how a
document will be identified according to its revision.
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Document publishing
Once documents are final and
approved, the document control procedures define the parameters of how and
where a document is published, and who is authorized to have access to it.
Publishing requirements may indicate whether the document is available
internally or externally, where a document is made available, what security
restrictions are on a document, and so on.
Document obsoleting
The
obsoleting of documents, or their removal from availability, is another
important process outlined in the document control procedure. Obsoleting may be
determined by date, or can occur when documents (or the content they reference)
are replaced.
Benefits of document
control procedures
Making sure that the correct,
up-to-date, and approved document is being used, is a key benefit of document
control procedures. Documents that are out of date or no longer accurate can be
a cause for major concern, and result in some of the most frequent audit
findings in compliance programs. Unapproved or outdated procedures,
uncontrolled documents, inaccessible or lost files… these are some of the more
preventable audit findings that can occur without document control procedures.
Who’s responsible for
document control procedures?
In most organizations, an
individual or group of individuals are identified as responsible for document
control procedures. This includes responsibility for the Document Control
Procedures Manual (itself following document control procedures).
Solutions using document
control procedures
There are several components of a
document management system that support document control procedures. Some of
the more commonly used:
- Revision control: capturing a record of every change that occurs.
- Audit logging: recording every action that occurs on a file.
- Security: determining who has access to a file, or what actions they can perform.
- Workflow: routing files electronically for review and digital approval