A Deviation Management System (DMS) is a process of identifying, documenting, and correcting deviations. It is the foundation for any quality management system and should be part of every organization’s quality control process. The DMS sets up corrective actions and next steps that prevent the recurrence of deviations and minimize the frequency of errors.
Implementing a quality management system that includes a deviation handling subsystem
Deviation handling is one of the essential components of the Lean business accountability system. Deviation management helps managers detect and control nonconformities and improve employee engagement. There are three main modes of deviation management: prevention, analysis, and elimination. Each mode has different functions and can be implemented at any level of an organization. Here are some tips for effective implementation. Read on to learn more.
In this step, managers gather data about nonconformances in a shared drive. Data elements include defect type, location, time, and immediate resolution (if initiated). Managers also use pivot table logic to summarize defect types and trends. Finally, they report their results monthly and quarterly to leadership, teams, and management. Using these reports, managers identify trends and prioritize improvement activities.
Benefits of implementing a deviation handling subsystem
One of the most important aspects of a quality system is the ability to handle deviations. There are numerous sources of deviations in a health care facility, and health authorities require documentation for these events. NextDocs’ Deviation software helps manage out-of-specs and deviations while automatically creating CAPAs to resolve them. In addition to handling these events, the system helps your organization comply with regulatory requirements.
The systematic control system makes spotting deviations easier. A deviation is a measured difference from an expected value or a documented standard. It can occur during the manufacturing or testing process. A deviation can happen for multiple reasons, including customer complaints, comments, and company standards not meeting the requirements in a certificate. The benefits of this subsystem can help a company improve its quality management.
Risks of implementing a deviation handling subsystem
Considering the risks involved in implementing a deviation handling subsystem in your deviation management system is essential. Not all deviations are created equal. Some are more critical of the quality of the product, while others have a relatively simple root cause. To mitigate these risks, you should identify and classify deviations into low-impact, moderate-impact, and high-impact.
The risk associated with a critical deviation is immediate and severe. It indicates the failure of a system and results in significant observations from regulatory agencies. The risk associated with a major deviation is more significant when the combination of several major deficiencies occurs. In addition, a minor deviation is less serious but may require correction. Therefore, a deviation handling subsystem is a crucial part of a deviation management system.
