A woman investigating the quality of a product in hand to check for deviations

DEVIATIONS AND QUALITY EVENTS

Deviations handled in a centralized location, along with associated investigations, approvals, and resulting records 


Production deviations and investigation of quality events, along with the volume of data that must be reviewed and resolved make the process of batch record review and product disposition increasingly complex. TrackWise Digital® and QualityWise.ai harness the power of operational data from the shop floor by applying advanced technologies such as the Industrial Internet of Things (IIoT) connectivity to enable rapid decisions and faster product disposition.

About Deviation Management

Learn about deviation management and quality events, and learn how TrackWise Digital and the QualityWise.ai platform fosters collaborative engagement along with the concept of related processes through parent/child relationships.

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Learn how the integration of Honeywell Experion and TrackWise Digital are increasing the value of QbD. 

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Integration of Quality Management and Manufacturing Automation Systems 

Integrated quality and batch operations that give organizations real-time, end-to-end visibility, enable faster and better decision making and proactive response to quality events.   

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Patient-Centric Passion: Meet Dr. Oxana K. Pickeral

“It’s not just making sure that you’ve got the right pill of the right color and the right bottle, it’s safety and efficacy and reliability of supply.”

A man with hair nets checking on the quality of a product while holding a tablet to log any deviations

What Are Deviations?

 

Deviations refer to deviations from established procedures, processes or specifications, which can impact the quality of products or services. They are an essential aspect of quality management because they help organizations identify and address issues that could affect the quality of their products or services.

Why Is Deviation Management Important?

What are the Risks of Mismanaging Deviations?

The risks associated with poor deviation management can include:

release of products or services that are subpar or not up to company standards
increased costs due to the need to rework or replace defective materials or products
potential for noncompliance with industry regulations and standards
A worker in personal protective gear investigating the quality of a small white object

What Are Examples of Deviations Complexities?

As a quality manager in a regulated industry, managing deviations is a critical aspect of maintaining regulatory compliance and ensuring product quality and safety. A deviation is an unexpected or unintended event that deviates from standard operating procedures, and it can occur at any stage of the product lifecycle, from development to distribution.

 

 

Managing deviations effectively can be a complex and challenging process, particularly if deviations are frequent or complex. As a quality manager, you may face various business problems that make it difficult to manage deviations effectively. For example, you may struggle with identifying and investigating deviations, determining the root cause, and implementing corrective and preventive actions.

Implementing deviations management software can help you address these challenges. By centralizing and automating the deviations management process, software solutions can improve efficiency, reduce errors, and streamline workflows. Deviations management software can also provide real-time visibility into deviation status, progress, and results, making it easier for quality managers to track progress and ensure compliance.

 

For example, a quality manager in the pharmaceutical industry may be struggling to manage deviations related to the manufacturing process, including deviations related to batch production or equipment malfunction. Deviations management software could help them streamline the process, ensure that all deviations are adequately documented, investigated, and resolved, and track the implementation of corrective and preventive actions to reduce the likelihood of similar deviations occurring in the future.

 

Similarly, a quality manager in the medical device industry may use deviations management software to manage deviations related to product design or labeling, ensuring that all deviations are appropriately documented, investigated, and resolved, and that the implementation of corrective and preventive actions is adequately tracked and verified. By implementing deviations management software, quality managers can improve compliance, reduce the risk of errors, and demonstrate their organization’s commitment to quality and safety.

Benefits of Using Technology for Deviation Management

Quality management systems can help organizations manage deviations by providing tools and functionality to identify and report deviations, investigate root causes, implement corrective and preventive actions and monitor the effectiveness of those actions. A QMS can also provide visibility into the status of deviation activities, enabling organizations to make informed, data-driven decisions to reduce risk and improve quality.
A worker efficiently logging a deviation while in a lab with a digital deviation software on a tablet
Improved efficiency and productivity

Deviation management software can help automate many of the time-consuming tasks associated with managing deviations, such as identifying and documenting deviations, investigating their root causes, and implementing corrective actions. This can help reduce the time and effort required for these tasks, allowing quality managers to focus on more strategic tasks.

Two lab workers checking on site for deviation accuracy while holding a tablet
Enhanced Accuracy and Consistency

Deviation management software can help ensure that deviations are properly identified, assessed, and documented, improving the overall quality and reliability of the deviation management process. This can help reduce the risk of errors and discrepancies and ensure that all deviations are appropriately documented and tracked.

Two workers in personal protective gear sitting and pointing at clear deviation data on a computer
Better Data Management and Analysis

Deviation management software can help quality managers collect and analyze data more effectively, allowing them to identify trends and areas for improvement more easily. This can help quality managers develop more effective deviation management strategies and ensure that all deviations are appropriately prioritized and addressed.

A group of people, some in business suits and others in scrubs collaborating on deviation management
Improved Communication and Collaboration

Deviation management software can help facilitate communication and collaboration between different departments and stakeholders, making it easier to share information, track progress, and resolve issues. This can help ensure that all stakeholders are kept informed throughout the deviation management process and that all deviations are appropriately documented and tracked.

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Compliance with Regulatory Requirements

Deviation management software can help ensure that all deviations are appropriately documented and addressed in accordance with regulatory requirements. This can help reduce the risk of non-compliance and improve the overall quality and safety of the products or services being provided.

Two workers in personal protective gear in a production department sharing deviation management on a laptop while walking

Understand the Impact

Overall, using technology for managing deviations can help quality managers work more efficiently and effectively, improving the overall quality and safety of their products or services, while also reducing the risk of non-compliance and other issues. While there may be some upfront costs and disruption associated with implementing deviation management software, the benefits of doing so far outweigh the costs in the long run.

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