Does your organization have an electronic document control system? Does it include electronic
change management? Can users collaborate on change documents that are electronically sent to them for review prior to electronic approval? Electronic document control systems allow organizations
to store documents in an access-controlled database that can route documents to reviewers for electronic editing and then to approvers for electronic signature approval. This article discusses
how organizations manage their document review and approval processes with advanced electronic document control systems.
Manual document routing Typical manual document control systems require document control and/or engineering change administrators to receive edited information in
hard-copy form. Many manual document control systems use document change and/or engineering change forms that accompany edited documents. If an organization requires its engineering personnel to
initiate their own engineering change forms, they're usually also required to contact engineering change administrators to get the next sequential document or engineering change number. At some
point, document control or engineering change administrators become involved in creating a "change package" that contains the changed documents, any required forms and the routing
information. Routes are the predefined steps and people through which the "change package" goes for review and approval. ISO 9001-registered organizations usually
reference the functions or positions required to review and approve new issues or changes to document types. Organizations that don't use electronic systems usually route documents serially,
meaning they are sent or hand-carried to reviewers/approvers one after another until complete. If more than one person is to receive information at a time (a parallel route), document control
personnel must make copies of the change package manually. Serial steps in a manual process allow each reviewer/approver to make changes or comments that subsequent
reviewers/approvers can read. Manual systems require significant time and resources to be spent preparing and routing change documents for review and approval. Bottlenecks include copying and
distributing change packages; manually tracking and reporting status; waiting for key personnel to sign off (especially if they are not in the originating facility); and redistributing,
communicating changes and ensuring that training is performed after approvals are received. Electronic document routing Implementing an electronic document control system allows organizations to take advantage of electronic document routing in parallel steps, including automatic time-based
reminders, escalations, tracking and reporting capabilities. Most advanced electronic document control systems allow document control personnel to route documents for approval
in serial or parallel steps while providing a variety of useful features: Automatic tracking and notifications are available to help document control personnel monitor the status of documents
that are in process; notifications can be automatically sent to those that need to review and approve; master list reports can be automatically generated showing current documents, revision
levels and revision history; and documents can be automatically updated to the latest revision and made available to system users while older versions are automatically archived.
Some advanced electronic routing systems allow users to escalate a review or approval step. If a review or approval step is not completed within a specified time period, the document
control system moves the document package to another user for signoff. This option can be used to ensure that a document is completed in a timely manner by sending the document package to higher
authorities or alternate reviewers/approvers. Advanced document control routing also has the potential to automatically link document changes to notification and training. The
system should notify selected users of updates to documents and require them to review new or changed documents. In this case, the electronic signature for the document review becomes a training
record. This reduces supervisors' and trainers' labor-intensive effort of having to track whose training has been completed. Users can be notified automatically when they need to access a
document for review, and supervisors and trainers can be notified when the "training" has been completed.
Document collaboration and approval Basic electronic document control systems carry out most of the document review process outside of the electronic system and only
use the document control software for routing and processing documents from "draft" to "released" phases. In these systems, the document control administrator enters the
document into the system after the external reviewers collaborate. The administrator creates an electronic version of the document after reviewing and compiling the edited hard copy
that has been hand-routed. After external review, the administrator enters the document into the system, where it is electronically routed for approval. During the approval route, the software
locks the document to ensure that the first approver sees the same document as the final approver. Approval routes are usually predefined according to the organization's document approval matrix
and cannot be modified during the approval process. Advanced electronic document control systems allow documents to be electronically sent on a collaboration route where
collaborators can review a document, make proposed changes or edits, or add their versions prior to being sent for approval. More advanced systems offer the flexibility to add collaborators and
even change the sequence of steps on a collaboration route while in process. A final collaborator can review the edited documents, compile a final version, and send the new or revised document
along an approval route where approvers can add their comments and electronically approve or reject. During this process, e-mail notifications can be automatically sent to
those on the route and to the originator as the document flows through the route steps. Management and system users can monitor the status of the document along the collaboration and approval
process. Route participants receive daily reminders of pending tasks. Automatic notification, escalation and tracking visibility significantly decrease collaboration and approval process cycle
time. Automating the engineering change process Many organizations implement an electronic document
control system but fail to automate their engineering change process. They maintain their documents in a controlled electronic system and may even route documents for approval, but they often
continue using a manually intensive hard-copy change process outside of the electronic system. They continue hand-routing edited documents and change forms such as engineering change requests
(ECRs), engineering change orders (ECOs) and engineering change notices (ECNs). Advanced document control systems have the capability to automate the initial review of proposed changes and the
use of change forms. The initial review process can be automated in a number of ways. For example, an engineer could initiate a change by getting an electronic copy of the
document that needs to be changed (e.g., a drawing or specification). After proposed changes are made to the document, it could be sent on a collaboration route to those in the organization who
need to review it and/or provide feedback. In an advanced document control system, reviewers on a collaboration route should be able to:  Receive e-mail notification regarding the collaboration
Review the proposed changes Add comments regarding the proposed changes Add edits, versions, additional files, and so on View comments and contributions of previous collaborators Add additional collaborators and modify the existing collaboration route if necessary
Close collaboration and automatically initiate e-mail notification to other collaborators and/or the originator Track the status of the document through the collaboration and approval processes
Change forms, such as ECRs, ECOs and ECNs, can be electronically routed individually or along with affected documents for review on collaboration routes and
for subsequent approval. If an organization requires a formal approval of a change request prior to initiating an ECO/ECN, the ECR is routed on a combination
collaboration/approval route or just on an approval route. After approval of the change request, a new collaboration or approval that includes the affected documents along
with the appropriate ECO/ECN form can be initiated. Reviewers and approvers on the collaboration and approval routes review document changes and the change form information at one time. Change management using Web access
Advanced document control systems now include controlled Web access to documents, giving users access to the system over the Internet with document
searching and viewing capabilities. In addition, remote users can participate in collaboration and approval processes. This allows traveling or off-site employees to
stay involved and keep the document control and change management process moving effectively.
Many organizations have taken advantage of controlled Web access to improve supply chain and customer involvement in their change management process. Do you wish
you had a record of supplier notifications and supplier reviews of relevant supplier document changes? Would you like to electronically send change requests to your
customers for approval? With controlled Web access to documents, suppliers and customers can be added to route steps for review and/or approval during a change
process. An example of the advantage of customer/supplier Web access to documents is found in the automotive industry, where suppliers are required to submit production
part approval process (PPAP) documents to their customers for change approval. Documents (such as drawings, reports, test results, control plans, flow charts and
capability studies) can be compiled in a cross-functional collaboration route and then electronically routed internally and externally for review and approval in accordance
with customer requirements. Reducing cycle time
Cycle-time reduction is just one of the many benefits companies experience when implementing an advanced electronic document control solution, according to Russ
Garrison, senior vice president of operations at Diagnostic Ultrasound Corp., a Seattle-based medical device manufacturer. "Prior to implementing an electronic
document control system, we had two full-time administrators focusing on the change control process," he reports. "Although our goal was to maintain a three-day approval
cycle, we rarely attained this goal. The document control process was a major source of employee contention and management attention.
"There were fewer than five people who could successfully implement a change using the old system. The document control process was a major bottleneck for the
introduction of new products. In January 2000, we implemented an electronic document control system and realized immediate improvement to our overall
processes. In addition, the company trained more people on the change process. Every functional department has a person capable of changing a document and launching it.
We are now able to maintain three times the volume of document changes with only five hours a week of document control support. Our approval cycle has been reduced to 24 hours."
Process cycle times can also be dramatically improved, according to Ray Goulet, quality assurance engineer at Marchi Systems Inc., a thermal systems manufacturer in
Redwood City, California. "Within three weeks of implementing an electronic document control solution, I was able to report to our management staff that the ECO
cycle had been cut from several days to just a couple hours," Goulet says.
Other benefits of electronic document control and change management There are many benefits that can be achieved by implementing an electronic document
control and change management system. Mary Retcher, corporate quality applications administrator at Defiance Metals in Defiance, Ohio, outlines the following benefits her company has realized: Reduced labor hours Reduced supply costs Return on investment in less than six months No QS-9000 assessment audit findings for four plants since the software was installed Benchmarking between sister plants without leaving their desks Eliminated travel for monitoring document control Development of corporate control plans, forms, etc. No more long core team meetings to approve document changes
Everyone knowing when to change the master documents in their department with the document approval e-mail notice
About the author Roger Crist, CQM, CQE, CQA, has been a quality engineer, quality manager, quality
auditor and quality trainer/consultant. He has also been an assistant professor at Weber State University and an ISO 9000/QS-9000 auditor. Crist has a master's degree
in technology management and a bachelor's degree in manufacturing. He is currently employed as the professional services manager at Document Control Systems Inc., in
Salt Lake City, Utah. E-mail him at rcrist@qualitydigest.com . |
