One of the main goals of quality is to avoid deficient parts entering into production and prevent deficient products from being shipped from your facility. Under very specific circumstances, exception from the written specification can be made after appropriate reviews by the quality and engineering departments. MasterControl Variance effectively manages this process and documents the scrutiny applied to these types of decisions.
MasterControl Variance, part of the integrated MasterControl document and GxP process management suite, provides out-of-the-box functionality for variance management. The MasterControl Variance software solution offers a formal mechanism for evaluating whether or not a material that fails its quality attribute specification should be accepted. The MasterControl system automatically routes requests to appropriate internal personnel to make a final decision. The rationale for decisions on variances are recorded and retained in MasterControl's secure, centralized repository, which creates a permanent record and supports future audits and/or investigations.
Here's how MasterControl addresses some of the major challenges companies face when dealing with variance issues:
Written specifications define the quality attributes components and final product has to meet to be acceptable. In the rare cases where product is acceptable despite a failure against the spec, it can be difficult to create a permanent record that shows the decision process.
MasterControl Variance defines a consistent process for approving a variance against specifications. A permanent repository makes records available at the click of a button and electronic signatures ensure accountability of actions taken.
Without formal variance processes and a secure system to store variance information, costly errors that may lead to unsafe products or recalls are likely to occur.
MasterControl not only provides an automated, formalized variance process but also guarantees that variance documentation is maintained in a secure and central repository.
Manual systems can’t connect forms-based processes such as variances. Such systems make continuous improvement almost impossible. Ensuring the sufficiency of documentation becomes error-prone and time consuming.
MasterControl integrates quality processes for a more effective and efficient quality management. The automated system ensures the accuracy of documentation and permanence of process records.
MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 03-6801-6147 (Japan).