Digital forms, such as this one, called an InfoCard, hold document attributes such as document name, type, author and revision number, and each field is searchable. From the InfoCard, users can check-out and check-in the document and control document versioning. Anytime a field is changed or a document is viewed, copied or approved, an audit trail is maintained for each action to meet requirements for ISO quality standards. Source: Document Control Systems

All the necessary features for electronic signatures to comply with 21 CFR Part 11 should be available in every quality sub-system that plugs into the Web-based quality portal. Password and signature information needed for Part 11 compliance and to exceed ISO standards include: dual signatures for login and approval, encrypted passwords, automatic password expiration, complex password monitor, and intruder and account lock-out. Source: Document Control Systems

For more than a decade, technology has been available to manufacturers to automate quality management processes such as documentation control. With the rapid development of technology and the World Wide Web, document-control software has evolved from its genesis in the early 1990s. Today, technology trends and customer preferences dictate that document control software functions as much more than a mechanism to meet ISO document-control requirements; it must become an integrated piece to an overall quality system that generates benefits and a return-on-investment not previously realized.

Integrated quality systems are designed to ease system administration burdens on quality and IT departments. All users’ rights, passwords, security roles and privileges are maintained in one location for easy and accurate maintenance. In addition, users only have to remember one access point and one set of passwords to access the quality portal to complete their tasks. Source: Document Control Systems

ISO establishes role

As the manufacturing industry develops into a more complex business and consumers’ demand for high-quality products increases, controlled documentation plays an increasing role in quality control initiatives implemented during the manufacturing process.

Developed by the International Organization for Standardization (ISO), industry quality standards, specifically ISO 9000, have contributed significantly to defining, developing and emphasizing the need for controlled documentation. ISO standards have clarified the role of document control as a means of establishing and maintaining a healthy quality management system.

Original ISO requirements instituted document control to ensure that:

• Documentation was current and available to all users
• The correct people approved the information
• Document changes were handled in a controlled manner
• Access, distribution, revisions and control of obsolete documents was observed
• Documentation was archived for historical and legal reasons

As manufacturers endeavor to achieve ISO 9000 certification, document control has become an integral component of ensuring that the required documentation of policies, procedures and company quality manuals is handled in a responsible manner.

Evolution

The successful implementation of ISO standards has become increasingly important in today’s manufacturing environment. Historically, manufacturers have used a variety of paper-

intensive, manual document-control systems to create and manage company documents to meet ISO 9000 requirements.

In the early 1980s, technologies such as personal computers, word processors and printers enabled the creation and printing of essential documentation. Although electronic documentation reduced the time it took to create documents, document control essentially remained a manual process because it was still necessary to manually route documents for review and approval and then file the hard copies.

Technology continued to advance through the 1980s and early 1990s. Manufacturers started using technology to store and share documents in network repositories or distribute them via corporate e-mail systems, causing additional headaches. For example, after a file was created electronically and stored on a network or hard drive, it became difficult to control as unauthorized people could alter the document and then make and distribute copies.

Document control today

During the 1990s, document-control software evolved to handle the functions outlined in ISO standards. Capabilities have expanded and now address a greater variety of forms-based processes, including documents generated from audit findings, corrective and preventive actions, employee-training histories and calibration records.

In recent years, document-control software has taken on a greater role. Today, it often serves as an information and content-control repository with unlimited capabilities for managing all content type, not just individual word processing documents, spreadsheets or engineering drawings.

Stand-alone systems that control documentation for training, calibration management, corrective and preventive actions, audit management and combinations of each, handle a subset of quality system functions and are currently available on the market. However, the full integration of stand-alone documentation systems is not currently as advanced as it could be. Integrating disparate software into a complete quality management system enables interaction and communication between them and the ability to automatically initiate multiple sequential tasks.

Primary component

As document-control systems have matured, manufacturers and software developers alike have realized that document control is one piece in an overall quality system. To answer market demands, software manufacturers moved toward providing a complete range of quality system functions. In the near future, document-control software systems will be developed that function as a component of an overall quality system and will play an even greater role.

This type of software will serve as the foundation for managing any quality or other content-like data, including the documents and forms that are collected or generated throughout the quality processes. Implementing integrated quality systems allows manufacturers to reap benefits never realized previously through disparate or disconnected systems and will further improve efficiency, increase usability and accelerate return-on-investment (ROI).

Here are a few scenarios highlighting the functionality that an integrated document-control subsystem can provide within an overall quality system:

• Corrective action initiates notice of change. A corrective action automatically triggers a change request cycle affecting an existing work instruction.
• Notice of change or change management sparks collaboration process. A notice of change for a work instruction prompts an automated collaboration process to modify a work instruction, engineering design or content that needs to be changed.
• Collaboration generates routing and approval. After the completion of the collaboration process, the document or form is automatically launched on a route for approval. Using electronic signatures, the new version of the document automatically replaces the previous version upon approval in the location it resides—multiple electronic vaults, quality manuals or locations—and the older version is archived.
• Approval activates employee training. With the document change, appropriate users are automatically notified and employee training is triggered to assure understanding of the changes made in the document.

There are many manufacturing scenarios that the foregoing quality subsystems would help automate to “close the loop” on open quality processes.

• Customer complaints. A customer or supplier fills out a Web-based complaint form that is automatically routed to the correct individuals for review. If the complaint is determined to be valid, a corrective action process is triggered, routing the complaint form to individuals who can make the proper corrections. All comments and data collected along the route, including electronic signature approvals, are maintained throughout the process and stored in a centralized database for analysis.
• Process controls. A machine on the manufacturing plant floor goes out of range while delivering data. An explanation for its failure activates a corrective action, which invokes the correct quality sub-cycle.
• Inventory control. Incorrect or damaged parts are delivered to the receiving department. Someone in that department completes a Web-based form that triggers a corrective action process and the integrated quality management system cycle kicks into motion.
• Audits. A supplier audit is performed and negative findings are input via a Web form that starts a corrective action and initiates the subsequent quality subsystem.

These scenarios or portions of them are just a few of the many possibilities that can be addressed by an integrated quality system. Built-in triggers throughout an integrated quality system environment accelerate quality cycles and minimize errors. If processes are left incomplete, integrated systems will provide built-in ticklers or escalation steps to move the process to another individual or department for completion.

Benefits of integrated systems

What will the document control system of the future look like and what benefits can manufacturers expect from implementing such a system? The following are a few additional capabilities and benefits of the document control systems that will become part of integrated quality systems in the future.

• Consolidate and improve ease of system administration. Integrated systems will allow management to view all the information and quality processes currently in progress without having to access and monitor multiple systems. Seamless integration will provide a foundation of common system administration and functional services through one data portal, including strict security, regulatory and quality standard compliance, electronic approvals or signatures, complete audit-trail tracking, and reporting for trend and data analysis. In addition, integrating the time-consuming processes of creating and managing user names, passwords and security rights for multiple systems decreases errors and eliminates unnecessary work for busy quality or information technology managers. Centralizing quality system applications will ease system administrative burdens and improve productivity by saving time that could be spent completing more important duties.
• Improve compliance and security. Integrated systems will provide regulated manufacturers the audit trail and electronic signature capabilities necessary to consistently achieve compliance across the entire system, eliminating disparate system compliance worries. In addition, compliance with computer systems validation requirements will be accelerated. The common functionality used through an integrated quality portal, such as login, security and electronic signatures, will only need to be validated once during the installation qualification and operational qualification.
• Facilitate communication. Inte-grated systems will enable stronger communication between manufacturers, customers and supply chain partners. For example, as products and manufacturing processes change, automotive manufacturers can incorporate partners into Web-based review and approval processes to accelerate a Production Part Approval Process.
• Provide common access. Allowing one centralized point for user access is an important benefit of an integrated quality system. Web-based systems will break down the barriers for internal or external system access through one global point using a browser or personal data assistant. Users, including supply chain and other outside partners, have one central access point to complete assigned tasks, causing less confusion and thereby eliminating the need for managing multiple login names and passwords. Storing all data from each quality management process in one centralized location allows unlimited reporting capabilities for research and trends analysis. In addition, it provides better understanding of the documentation status during all internal and external manufacturing cycles.
• Accelerate ROI. Separate quality system applications offer an overall return on investment, and integrated systems significantly accelerate ROI. By consolidating system administration capabilities and providing one-point access, companies can dramatically reduce total cost of ownership and boost productivity.
• Extend quality enterprise-wide. Successful companies set quality as a priority to be built throughout the entire organization. As companies implement an integrated quality system, users and managers become savvy to its many applications and begin automating additional business processes in departments like accounting, human resources, and marketing and sales, further improving ROI.

Quality systems will eventually allow manufacturers to easily stay abreast of all quality processes and will eliminate incomplete cycles, as completion of a task in one sub-system will automatically launch a task in another subsystem.

On the horizon

The quality revolution and best practices associated with quality management systems have educated manufacturers about the benefits of maintaining an automated document-control system. Manufacturers have taken advantage of technology to electronically automate manual document control and change management processes to become more efficient, profitable and in the end, more competitive. Today’s manufacturers are looking for fully Web-based systems that are easily integrated into one quality management system to increase efficiency, achieve a greater return on investment and establish a competitive edge. As further uses for Web-based quality management software are developed and systems become fully integrated, companies will continue to benefit from ease of use, better connectivity and improved process efficiency that a truly integrated system brings.