Automotive Document Control Software - What is TS 16949 Compliance?
TS 16949 applies to the design/development, production, and, when relevant, installation and servicing of automotive products. It is based on ISO 9001 and was published in 2002 as ISO/TS 16949/2002. In 2009, the ISO published a new edition of ISO/TS 16949, ISO/TS 16949:2009, which incorporates the requirements of ISO 9001:2008 and also includes detailed, sector-specific requirements for employee competence, awareness and training, design and development, production and service provision, control of monitoring and measuring devices, and measurement, analysis and improvement. With the global nature of the automotive industry, and the ever-increasing compliance challenges facing automotive suppliers, an automotive document control software system provided by MasterControl is critical to the development of a successful quality management system.
In addition to adhering to stringent TS 16949 standards, many automotive manufacturers adhere to ISO 14000, which incorporates environmental aspects into a company's operations and product standards. Similarly, ISO 14000 requires document control procedures to help manufacturers continually improve their environmental management system. In today’s lean, complex automotive manufacturing environment, automotive document control software systems provide the improved productivity, quality, and delivery your company needs to be profitable and competitive.
How can MasterControl Documents Benefit You?
The MasterControl Document Control Software System addresses many of the major challenges that automotive companies face in establishing and maintaining a document control system.
|TS 16949 Document Control Control Challenges||MasterControl Documents Software Solution|
|Paper-based Document Control Systems are Grossly Inefficient|
Although paper-based and hybrid automotive document control systems seem less expensive to maintain, in the long-run, these systems are costly and inefficient—particularly for multi-facility companies with employees in different locations. Extensive man-hours are required to route documents, obtain approvals and signatures, and conduct manual document search and retrieval for ISO audits and inspections.
|Automated Document Control Systems are Highly Efficient|
MasterControl software automates the routing and delivery of SOPs, policies, and other documentation. Our system can handle all types of documents— regardless of the software used to create them—and provides a secure, centralized document control repository that allows for easy search and retrieval. For multi-facility companies, MasterControl’s automotive document control software is ideal; its Web-based design allows authorized users to access data from virtually anywhere.
|Paper-based Document Control Systems Lack Revision Control|
In a paper-based or hybrid system, because employees must check out materials manually, keeping track of documents and document activity is a challenge. Making a change in a document requires manual submission of a change request or a discussion of the change in face-to-face meetings. This results in lost time, lost revisions, and lost documents.
|Automated Document Control Systems Offer Superior Revision Control|
To ensure that only the most current version of a document is available, MasterControl provides automatic revision control, which allows changes to be initiated and approved electronically. The system tracks these changes and makes them available through reports ensuring advanced automotive document control.
|In a Paper-based Document Control System, Miscommunication is Unavoidable |
When a company relies on disparate tools and processes to manage its quality control system, communication breakdown is inevitable and can lead to costly delays and inadequate results.
|In our Automotive Document Control System, Integration Allows for Clear Communication|
MasterControl's automotive document control software system is an integrated solution; it connects all quality sub-systems, including change management, customer complaint, CAPA, training, and audit. This allows for timely and thorough change procedures. For example, a customer complaint that warrants a CAPA will be immediately escalated, and any CAPA that results in an SOP change will, upon its approval, automatically invoke training of all affected employees.
|In a Paper-based Document Control System, Managers Miss the “Big Picture”|
It's virtually impossible for managers to generate accurate, timely reports and trends using dissimilar tools (electronic spreadsheets, flowcharting software, documents in binders). Without a uniform reporting tool, managers are unable to “see the big picture” and gain control of their quality management system.
|In an Automated Document Control System, Managers See the “Big Picture”|
MasterControl’s advanced analytics and reporting capabilities, including customizable reports and online charting, allow for refined automotive document control. Reports are streamlined and analogous, offering managers a comprehensive real-time view of the quality processes, which empowers them to be more proactive with improvements.
Automotive Document Control Software Systems Facts
- MasterControl Documents has been successfully implemented in ISO environments without any instances of non-compliance since its introduction in 1993
- Dramatically reduces the time it takes to bring a new product to market by speeding up the process for document change, approval, notification, and distribution
- Is an off-the-shelf configurable product designed for rapid installation, implementation, and validation
- Ensures documentation integrity so employees always have the most updated document at their fingertips
Document Control Software Systems Core Capabilities
- Combines powerful electronic routing and approval
- Full audit trail and reporting
- Electronic signature management and control
- Ensures 21 CFR Part 11 compliance with security and integrity of documents
- Computer systems validation plan and implementation including
- Validation-ready for IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification)
- Scalable, open systems architecture
- Supports industry-standard databases