It’s audit time. Do you know where your documents are?
We’ve all had the experience of keeping two or more versions of a document and—inevitably—sending or using the wrong one, uncertain of which is most current and accurate. If it’s just two versions of a letter to Aunt Minnie in Spokane, that’s one thing, but if operating procedures change and appear in a newer version of a document that doesn’t replace the old one, it may mean thousands of dollars in waste or lost sales.
Making sure that all employees—in all facilities, in every relevant department—have updated access to all documents related to an organization’s quality system, including the quality manual, procedures, work instructions, drawings and forms, is a Herculean task. Sisyphus would not have exchanged his rock for this job.
History of document control
Document control—assuring the accuracy of all documents—is an important element in any quality management system, for it provides the assurance that all key people have access to the same up-to-date documents, regardless of whether they are in Chicago, Xenia or Hong Kong. And yet without appropriate software programs, this would be virtually impossible. Keeping track of document revisions, including those related to corrective or preventive action steps, demands the use of the newest technologies.
Prior to 1980, document control was a bit of an oxymoron, for without electronic technology, it could only be a haphazard, poorly managed system of document inspection. Scanning documents or copying them for distribution represented a time-consuming, inefficient approach without any guarantee of accuracy. Before a description of a new procedure or process could reach the folks in San Antonio, the process might have changed. Electronic document management systems that managed proprietary file types emerged in the 1980s, and that was the beginning of accurate systems of document management and control. Today, as with so many technologies, we now take efficient distribution and control of documents for granted with software products that are on the market.
ISO 9001 and QS 9000 registration demands that its registered organizations are able to control all documents that drive critical quality actions. The mind-boggling task of reviewing, approving, issuing and securing documents has not only been simplified, but has become standard in organizations, especially those with requirements for conformance to standards or professional registrations. Audits are simplified because the paper trail is easily monitored and assuredly up to date.
In some document control programs, a customer can work directly with word processing, spreadsheet, CAD, flow charting, project planning and other programs, making it possible to create, edit and view documents in a familiar environment. This “open architecture,” when it is included, makes the document control software module completely flexible and preserves your investment in software and training.
Concerns about security affect every system in an organization, and document control is no exception. It is essential that access to documents is strictly controlled, so that users can access only documents for which they are authorized. In the paper-only days, systems could be wiped out by fire or by simple misplacement of documents, but in a document control software system, customers should make sure that their documents are internalized and stored inside a relational database, so they aren’t left in a computer’s file system where they might be damaged, deleted or copied. This kind of storage, of course, means that access is strictly controlled.
Making sure a document is up to date
Once a document is issued, revisions should be generated only through change request procedures. After these revisions have been approved, users can be notified of changes and the previous version of the document is archived. Throughout the process, users should be notified of relevant document activity via a built-in messaging system or an organization’s e-mail system.
Ideally, these systems enabled an organization to capture faxes and forms, to save copies of the documents as images, and to store the image files in a safe repository for security and quick retrieval (retrieval made possible because the system handled the extraction of the text from the document in the process of capture, and the text-indexer function provided text-retrieval capabilities).
Some EDM systems keep documents in their original file formats (such as Microsoft Word and Excel), but web-based document management systems store content as html files. This format helps with search capabilities, though some EDM systems have extensive search capabilities even without the use of html formatting.
The ability to control documents that drive critical quality actions in an organization can mean the difference between success and failure. That’s why document control is required for ISO 9001 and QS 9000 registration as well as compliance to FDA and many other quality standards.
Document control is more successful if it’s simple and intuitive. That’s where a software solution can help. Document control software acts as a single repository for all of an organization’s documents. It is used to securely store documents and keep an audit trail of when changes are made and by whom for traceability purposes.
Here’s a walk-through example of a process for electronic document control:
A document is generated that outlines procedure for handling a specific process.
Document is uploaded and saved with specific rights assigned as to who can add, change and approve the content, as well as others that may simply need to view the document. Different rights can be assigned depending on the department or group’s requirements within the organization.
When changes to the document are requested, emails are forwarded automatically to alert other users that the document is being submitted for revision. The users are then able to approve the document, reject it with comments as to why, or simply ask for additional information. Most systems can be set so that this process is completed within a specific period of time.
Once all the approvals are received, the document is assigned a revision number and is finalized in the system for view by others.
Intervals can be established so that each user must approve the document on a prescribed period to ensure the document’s relevance over time.
It seems obvious that the use of electronic document systems will save time and assure accuracy. Providing a clear audit trail while simultaneously reducing use of paper saves further time and resources; it also assures accurate records that are not susceptible to change by those without authorization to make changes. Further, check-in and check-out records indicate exactly who has had access to documents throughout their history.
As organizations are increasingly subject to professional and industrial standards, it has become more and more imperative to ensure that all records are both accurate and accessible when needed. Hand-written changes by unknown users will not provide these advantages, to be sure. Electronic record management with document control systems, on the other hand, will guarantee them.
Providing a clear audit trail saves time and resources while ensuring document accuracy.
It also assures accurate records that are not susceptible to change by those without authorization to make changes.
In addition, check-in and check-out records indicate who has had access to documents throughout their history.