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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 TrackWise 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 QMS and the TrackWise AI platform fosters collaborative engagement along with the concept of related processes through parent/child relationships.

WHITE PAPER

Enabling Quality by Design
Learn how the integration of Honeywell Experion and TrackWise Digital are increasing the value of QbD.

Blog

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.

Podcast

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.”

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?

SUPPORTS EFFECTIVE QUALITY MANAGEMENT
CULTIVATES CONTINUOUS IMPROVEMENT
SATISFIES REGULATORY COMPLIANCE
BUILDS TRUST WITH CUSTOMERS
CONTRIBUTES TO LONG-TERM SUCCESS

SUPPORTS EFFECTIVE QUALITY MANAGEMENT

Deviation management plays a key role in ensuring the overall effectiveness and efficiency of an organization’s quality management system. Beyond merely identifying discrepancies from established procedures, processes, or specifications, deviation management serves as a proactive mechanism for preventing and mitigating potential risks to product or service quality.

By systematically tracking and analyzing deviations, organizations gain valuable insights into the root causes of these variances, enabling them to implement corrective and preventive actions.

CULTIVATES CONTINUOUS IMPROVEMENT

Deviation management fosters a culture of continuous improvement within an organization. It provides a structured framework for learning from deviations, allowing companies to refine their processes, enhance their procedures, and optimize their specifications.

This iterative approach to quality management helps organizations not only rectify current issues but also fortify their systems against future challenges. It promotes adaptability and resilience, ensuring that the organization can evolve in response to changing circumstances while maintaining a steadfast commitment to delivering high-quality products or services.

SATISFIES REGULATORY COMPLIANCE

In regulatory environments, adherence to established standards is paramount, and deviation management becomes a crucial tool for compliance.

Properly managing and documenting deviations is essential for demonstrating regulatory compliance, as it provides a transparent record of how an organization addresses and rectifies issues to meet industry requirements. This documentation not only satisfies regulatory bodies but also serves as a valuable resource for internal audits and external inspections.

BUILDS TRUST WITH CUSTOMERS

The impact of deviations extends beyond the immediate realm of quality control. It can influence customer satisfaction, brand reputation, and overall business success.

Proactively managing deviations helps organizations build trust with their customers by demonstrating a commitment to delivering consistent, reliable products or services. This, in turn, can lead to increased customer loyalty, positive word-of-mouth referrals, and a competitive advantage in the market.

CONTRIBUTES TO LONG-TERM SUCCESS

Deviation management is a strategic imperative for organizations aspiring to maintain and enhance the quality of their offerings. It is not merely a reactive process but a proactive approach to quality assurance that contributes to long-term success, regulatory compliance, and customer satisfaction.

Embracing deviation management as an integral part of the quality management framework empowers organizations to navigate the complexities of modern business environments while upholding their commitment to excellence.

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

medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry.

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.

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.

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.

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.

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.

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.

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.

Download Whitepaper: Enabling Quality by Design