Determining the most effective way to categorize deviations is essential to quality assurance. Using risk-based categorization will improve quality assurance department efficiency by tagging deviations with different levels of quality. Ultimately, a quality assurance department can reduce the margin for human error by determining which variations are most likely to impact customer satisfaction.
It is a part of the MasterControl integrated suite
A deviation management system is an essential component of any manufacturing process, mainly if you are operating in an ISO or FDA-regulated environment. It is crucial to document deviations during sampling, testing, or even raw material acceptance and manufacturing. A Deviation Management System helps you manage and resolve these issues, a crucial aspect of quality improvement.
MasterControl’s Deviation Management System automates the entire process of tracking, evaluating, and resolving operational deviations. It also offers a fully integrated approach to continuous quality improvement and supports a wide range of compliance-related initiatives. For example, it provides the ability to automate data collection, routing, follow-up, and escalation processes. In addition, it allows you to track all active deviation tasks in an electronic in-box, giving you easy access to information when you need it.
It is a Part of the Lean Business Accountability Subsystem
The Deviation Management System is a tool that helps you measure variation in your measurement systems. The system measures the variation in different factors, such as the device used, the people who take the measurement, and the error that is seen from the parts of the system. The goal is to identify where to improve. By using these tools, you can improve your processes and increase your profit margins.
It Helps Lessen the Margin of Human Error
The effectiveness of a Deviation Management System depends on its ability to document errors accurately. The process of closing out a single inaccurate deviation does not indicate that a deviation process is efficient. Instead, a better metric would be a reduction trend of total deviations over time. Backlogs are proportional to closure times, which conforms to the calculus of queuing theory. While examining deviation processes, inspectors should identify the underlying causes for the absence of backlogs.
It has a defined lifespan and scope of implementation.
A Deviation Management System is a process for the systematic collection of critical quality data, early warning of potential failures, and redeployment of resources. The process must be suited to an organization’s specific needs and should incorporate risk-management principles. It should understand the conflicting interests of a company’s consumers, stakeholders, and regulatory agencies. Deviation Management Systems have a defined lifespan and scope of implementation.