Software & Analysis: Document Control is a Cornerstone of Effective QMS
When mentioning document control to most people the topic typically elicits two different reactions. The first is more like a yawn. Document control is not very interesting to the majority, and many people do not find it a very exciting topic. After all, how complicated can it possibly be?
While document control is not terribly complicated, it is highly relevant to the effective deployment of a variety of quality management processes which have a direct impact on an organization’s ability to serve their customers.
The second reaction, particularly if the organization has a certified ISO 9001 quality management system, is one of fear or dread. Auditors, internal and external, pay particular attention to document control, which typically results in frequent nonconformances. It is commonly reported that document control generates more nonconformances than any other quality management system (QMS) element. This is basically true but the reason is that most organizations make document control much more complicated than needed.
Document control is essentialDocument control, as with many other systems, is more successful if it is simple, intuitive, user-friendly, easy to monitor and effective at preventing the use of incorrect documentation.
Control of documents should be thought of as one of the cornerstones of an effective quality management system. Certainly it is not a glamorous activity. However, document control is an essential preventive activity that, when effectively managed, can ensure that once approved, current documents will be used throughout the organization. Inadvertent use of out-of-date documents, procedures, work instructions and the like can have significant negative consequences on quality, costs and customer satisfaction.
There are numerous situations that can be used as an example of what can happen when the proper documentation is not available. A design engineering change was made for a chamfer (a beveled edge connecting two surfaces on a machined outside diameter of a shaft to a corner-break). Design drawings were changed and manufacturing engineering (ME) notified. The ME made the change to the work instructions per procedure; however, the work instructions were not updated in the system. Consequently, the change was not implemented and failed to be detected until the new parts were assembled into units that reached field operations. The result was a significant field rework program with hundreds of thousands of dollars in failure costs and the loss of customer confidence, which translated into lost sales.
It's an investmentBecause of the importance to the business, more and more organizations are investing heavily in dedicated staff and detailed procedures. In the past, document control was an “add on” to someone’s responsibility. Today, it is an area of growth in the jobs market; with high demand and potential high pay that crosses over to multiple industries. However, there is really no formal training available. There are no college courses, let alone a degree program, which directly train anyone into this profession.
People working in this arena have had to learn the skills and techniques on their own. With many customers and suppliers requiring quality management systems in order to be certified, there have been a plethora of specialized software programs created to assist them in the control of their QMS and other business-related documents. This has been helpful, but it brings about other required skills in managing the overall system, which will not be discussed in this article.
Information contained in documents, procedures and work instructions drives nearly every action in any organization. The ability to control this information means the difference between success or failure. Control of documents, therefore, remains the single most important quality assurance discipline.
It is easier to control a smaller number of documents than a large number. While this seems elementary, there are many examples where organizations appear to think the quality of their document system is directly proportional to the quantity of documents and records.
A good document control system starts with document design and an understanding of the hierarchy and structure of documents. Document control administrators should be concise and work to keep the documents simple and multipurpose, when possible. An annual documentation review to uncover redundancies, obsolete documents and opportunities to consolidate will enable an organization to keep their documents lean, while effective, but with less cost.
Recently, a quality manager in an ISO 9001 certified organization worked to streamline the company’s document control system. With the goal of reducing administrative costs while maintaining an effective document control system, the quality manager was able to implement a 43% reduction in their overall costs to maintain and control documents.
Bring on the hierarchyIn order to bring about consistency and interrelationships governing an effective document control system, there needs to be a system or hierarchy. Arguably many organizations have been in existence for decades, managing their processes without much, if any, formal documentation. Some of these organizations continue to ship products that meet their customers’ specifications. However, in today’s environment, significant changes are impacting every organization. These dramatic changes are forcing organizations to change in order to remain competitive. These changes are causing organizations to become much more formal and structured.
One model for structuring documentation is the pyramidal structure, with each level in the structure interlocking with and supporting the next higher level.
This model is effective because it offers a logical arrangement that clarifies authority and interrelationships of each document. Lower-level documents must agree with requirements of related higher-level documents. Similarly, higher-level documents typically reference lower-level documents to drive connectivity. The message in many organizations is that lower-level documents cannot be in conflict with upper-level documents. The goal is not to be inflexible, but to ensure an organization is performing work in a consistent and efficient manner to deliver customer expectations.
While the basic tenets of document control are fairly simple, implementing and managing an effective and efficient document control system can be a challenge. Documents are not individual, stand-alone elements of the management process. They are interrelated, formatted in different media, and typically controlled by various and distinct functions. Keeping critical information current, in the right hands of the right people at the right time, requires more than just signing off (approving) on procedures. Document control is essential, but where should you begin?
Where to beginMaybe the simplest suggestion is to use the ISO 9001 quality management system requirements even if an organization is not interested in working toward a certifiable quality management system. ISO 9001 requires, and always has required, an organization to have a documented quality management system, and not a system of documents. It is very flexible, so it can be adapted to fulfill most organizational needs.
Simply work down the list of document control issues outlined in the requirements and briefly describe what the organization is doing for each one. Keep it simple and avoid creating too much bureaucracy. An effective document control system will provide documents to users quickly and not slow the process with lengthy and non-value-added procedures.
Philip B. Crosby once said that, “an organization that establishes a quality program will have the ability to do what it agreed to do.” Isn’t that what a document control program is all about? It is a direct reflection on the organization’s personal integrity and intensity about getting things done properly to satisfy the needs of their customers.
A effective document control system results in an organization having the data and information to properly train personnel, provide a basis for measuring performance, emphasize a consistent method of doing work, analyze trends, assess risk and benchmark good practices. It supplies the road map on how to do things correctly and establish a baseline for improvement. Q
Quality OnlineFor more information on document control, visit www.qualitymag.com to read the following articles:
“Document Collaboration and Control”
“Document Control Advances Quality”
“Manage Metrology Documentation”
BenefitsDocument control is more successful if it is simple, intuitive, user-friendly, easy to monitor and effective at preventing the use of incorrect documentation.
In order to bring about consistency and interrelationships governing an effective document control system, there needs to be a system or hierarchy.
An effective document control system will provide documents to users quickly and not slow the process with lengthy and non-value-added procedures.