Quality Software & Analysis: The Power of Document Control

February 1, 2007
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ISO may have driven manufacturers into document control, but today’s systems have a lot more going for them than 10 years ago. After customers see the extent of what document control can accomplish today, “A lot of light bulbs go off,” says Roger Shugart, chief operating officer of Cebos Ltd. (Brighton, MI).

Experts say that document control is almost a given in today’s manufacturing plants. Whether it is as basic as Excel spreadsheets or a full-blown document control system, most companies have some type of document control system in place. What they may not realize is how much more document control has to offer.

 





ISO may have driven manufacturers into document control, but today’s systems have a lot more going for them than 10 years ago. After customers see the extent of what document control can accomplish today, “A lot of light bulbs go off,” says Roger Shugart, chief operating officer of Cebos Ltd. (Brighton, MI).

Experts say that document control is almost a given in today’s manufacturing plants. Whether it is as basic as Excel spreadsheets or a full-blown document control system, most companies have some type of document control system in place. What they may not realize is how much more document control has to offer.



IBS AMERICA

“Today document control is almost like talking about tubes instead of transistors in your radio; it’s kind of old-fashioned,” says Stephen Cummings, IBS America’s (Lexington, MA) vice president of marketing. “It’s really the foundation for any kind of compliance solution. It also provides a foundation for human resources and training.” With the right system, companies can manage policies, procedures and work instructions, and when employees check documents, they can be sure they have the correct version. “The marriage between training and qualification systems and document control systems is really critical,” Cummings says.

Document control should track when documents are modified and notify interested parties automatically. Companies can check that the document is still applicable or look for potential changes. “I think that some of that core capability is assumed now,” Cummings says. “People now are looking for support for multilingual documents or multilingual user communities.” They want access to the document through an interface specific to a community. The system will not necessarily translate documents, but perhaps will have two language versions within a single document, or an infrastructure in different languages. The system will be able to handle multiple document types.

People today are typically looking for a broader area of compliance control. With compliance systems such as ISO or FDA regulations, document control is assumed. “You have to have document control or you’re not going to be able to address any of these,” Cummings says. “Without a document control system, you don’t have a formal process or procedure that you can review.” When looking at performance management and procedures, it is difficult to improve them if they are not formalized and controlled.

Cost avoidance is another key reason for document control, because costs pile up if someone is working from out-of-date instructions or working from memory instead of a checklist.

Companies typically evolve by using Microsoft word and spreadsheets, and sending documents through e-mail. They are reluctant to spend money on document control. But, at a certain point, they realize they cannot find the information they need, or they were using out-of-date information. “Before, they didn’t want to invest in a document control system,” Cummings says. “They begin to realize that it’s a real advantage.”

At first, companies want to know how long it takes to get the system up and running, but that depends on the system. Tying document control into customer management systems, supplier management and nonconformances will yield more benefits, but take more time.

Considering the software’s future also is important for document control newcomers. Companies need a system with enough flexibility to accommodate changes, and it is useful to have software that anticipates and allows for customization.

Some companies aim to be out of the gate with complete integration, and the trend leans toward more and more integration as companies try to cover a broader set of requirements.

Meanwhile, some companies prefer to solve their document control needs with an immediate solution and then look to higher-level issues. Cummings mentions the comparison, “If you’re having a heart attack, you want someone to bring the paddles. You don’t want to talk about diet and exercise.”





PROQUIS

Bill Best, president of Proquis (Schaumburg, IL), has been involved with document control for 15 years, and says the basics have not changed, though “The electronic methods of control have improved, as computers have improved.” But only in the last two years, Best says, has there been wider recognition of the difference between document control and document management. Document management refers to the storage and indexing of documents, while document control also provides more security, version control and a controlled audit trail.

Companies recognize that some documents have a longer life, and just storing them is not enough. Previously companies paid lip service to these issues, but now with legislation rather than standards, organizations have been forced into document control. “People on the shop floor and in offices using these documents have always recognized the need, but were never given a budget to fix the problem,” Best says. Now management realizes they must abide by these rules or be in breach of the law, or be unable to supply to certain customers. “A lot of people are considering it as a problem they have to solve because of legislation,” Best says. “If it’s done properly and well, it should actually cut down on time dealing with these things.”

Many things are changing in document control, Best says. Linking systems together is a big issue. For example, a customer complaint may lead to a change in the specification or in the inspection procedure. However, in some systems, the complaint and change are not linked, and the operator has no way of tracing that connection. “Very few systems actually connect all of these things together,” Best says. Linking systems is a form of lean document control, by removing unnecessary steps to make it faster and more reliable.

Some companies do not have these systems linked together, instead relying on silos of information, with documents stored in different places. The days of information coming in to the receptionist are gone, as information pours in from multiple locations. In certain countries, text messages, Skype chats and similar data will have to be maintained, Best says.

In many companies, when a specification change is requested, all companies involved-manufacturer, supplier and customer-each make their own change. However, technology is now available to bring the complete delivery of the product into one change system. Each company could sign off on the change at the same time. Best says this is the lean way to do it, and predicts this will be commonplace within the next five years.

When implementing document control, Best says resistance to change is usually the main problem, but success will follow after they embrace the change. “Usually, they spend more time doing the things they should be doing and improving the business as opposed to chasing bits of paper,” Best says.

Best recalls a company that bought the Proquis system with much trepidation. The managing director was pushing the system, but the employees were reluctant, and Best often received calls from the frustrated director. Eventually the director asked Best to go into the main office and tell the employees that he was going to uninstall the software. When Best went in, he found a complete turnaround-employees “defending their system like their lives depended on it.”

 



The MQ1 Document control module from Cebos can help companies manage their documents. Source: Cebos

CEBOS

Shugart has seen document control evolve. “We started doing quality software for companies in terms of production needs, and document control was just a natural extension of that,” says Shugart, who has been in the field for more than 10 years. ISO led to increased interest in document control, and the field took off.

Today’s systems have improved, allowing for more security and user rights, refining who can do what with the documents. Document control also may offer integration in Web sites, access from suppliers and internal training. Shugart particularly sees a strong connection between document control and training. When a document changes, treat it as a skill change. If it is a new process or procedure, companies must train personnel on this. Document control then allows for a formal sign-off process, to see who has learned of this new requirement, thus providing accountability.

 



Document control systems are often the component packaged along with other modules. Source: Cebos

Few companies have leveraged the software’s total potential, Shugart says. “People continue to try to be paperless. People are having a lot more success in streamlining that system.” Employees can access information in real-time from a computer monitor on the shop floor instead of using papers that may be obsolete.

Although document control used to be more ISO-driven, now the training component attracts customers. Training is not the greatest need, but a growing one. “A lot of customers are already ISO today,” Shugart says. “But they need to resolve problems in an easier way. They could do it with their current tools, but not nearly as effectively.”

People looking for other software modules tend to turn to document control. Today, people need other automated solutions, and then they will replace a lot of document control systems. “I don’t think people understand the power of what they could have,” Shugart says. “There’s a lot out there that people might want to look at and recognize the changes in the industry.”

 



The Qualtrax system is in use on site at Velocys Inc. Document control is almost a given at today’s manufacturing plants. Source: Qualtrax Inc.

QUALTRAX INC.

Brett Malone, director of QualTrax Inc. (Christiansburg, VA), says keeping documents well organized is a necessity, not a luxury, for many companies. “The fundamental daily necessity that companies have is just managing information,” Malone says. “Basically, there are more and more machines, hard drives and networks that are filling up with documents that are redundant or similar or very different.” QualTrax customers are primarily in regulated industries and it is crucial to keep documentation straight.

“Our mission is to help companies achieve and maintain compliance,” Malone says. With the right document control system, “You’re able to put your fingers on the information more readily,” Malone says. “You speed through audits which can be very painful if you’re not prepared.”

Many customers want a document control system to get their shop in order, particularly new companies. Eventually they will look toward ISO certification, but organizing their business is the first step. Customers tell Malone, “It’s the wild wild West out there with all these documents floating around.”

 



Qualtrax simplifies document and content management, workflow tracking and business and manufacturing process control. Source: Qualtrax Inc.

Ideally, customers should be able to grow with a system and manage changing standards. The system also must work well across different branches of the organization, and with different systems already in place. “You’ve got to get it to play nicely with the other tools you’ve already bought,” Malone says. The industry is moving toward automation and incorporating it into every business aspect. “Just knowing where the documents are is not good enough,” Malone says. “It’s no longer good enough to throw all your documents in a database. You’ve got to put them to work for you.” Events should trigger use of those documents, as companies and business processes become more automated. The system should put the right document at the right time, in front of the right person.

“Document control is the foundation,” Malone says. “It’s a means to a much bigger end.” Q

 



Tech Tips

When selecting a document control system, companies should look at ease of use, ease of managing the documents and automation.

• Today’s document control systems allow for more security and rights, and may also offer integration in Web sites, access from suppliers and internal training.

• Document control provides a formal sign-off process to training, allowing companies to keep track of who has learned the new requirements.

 

For more information on the companies mentioned in this article, visit their Web sites:

Cebos Ltd., www.cebos.com

IBS America, www.ibs-us.com

Proquis Inc., www.proquis.com

Qualtrax Inc., www.qualtrax.com

 

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