Man investigating a potential nonconformance next to machinery wearing personal protective equipment


Manage and trend nonconforming product, investigations and approval of resulting actions and product dispositions

Nonconformance refers to any deviation or noncompliance from established quality standards, regulations or requirements that do not meet specifications or acceptance criteria. It is an essential aspect of quality management because it helps organizations identify and address issues that could impact the quality of their products or services. Nonconformances can occur in various areas of the life science industry, including pharmaceuticals, medical devices, biotechnology, and clinical research.

About Nonconformance Software

Gain insights into TrackWise Digital nonconformance process as we specifically walk through the data capture and example reporting that we have found to be very effective


How to Ensure Supplier Quality in Medical Devices 

SQM systems can help manufacturers ensure high-quality processes across an increasingly complex supply chain. These systems help address supplier selection and evaluation, nonconformances, risk and product deviations. 


Beyond Compliance: The Benefits of Integrated Risk Management 

An integrated risk management system can resolve process and product deviations and nonconformances quickly. 


Uncovering the Root Cause and Overcoming Challenges Along the Way 

The main benefit of a robust RCA process is it allows an employer to discover the underlying or systemic, rather than the generalized or immediate, causes of an incident. Correcting only an immediate cause may eliminate a symptom of a problem, but not the problem itself. 

A man with a tablet digitally logging a nonconformance in a medical device production plant

Why Is Managing Nonconformances Important?


Nonconformances can manifest in diverse ways. In pharmaceutical manufacturing, for instance, it might involve a deviation from the specified production process, resulting in a product that does not meet the required quality standards. In medical device manufacturing, nonconformance could arise from a flaw in the design or production process, compromising the device’s functionality or safety. In biotechnology, deviations from established protocols during the development or production of biologics may lead to nonconformances. Even in clinical research, noncompliance with established research protocols or regulatory requirements can be considered nonconformance.


Identifying nonconformances is a proactive measure to ensure the overall quality and safety of products and services. It involves a systematic approach to detecting deviations, understanding their root causes, and implementing corrective actions to prevent recurrence. The goal is not only to meet regulatory requirements but also to uphold the organization’s commitment to delivering products and services that consistently meet or exceed customer expectations.


The significance of managing nonconformances extends beyond regulatory compliance; it influences an organization’s reputation, customer satisfaction, and operational efficiency. Timely and effective resolution of nonconformances demonstrates a commitment to quality and customer safety, fostering trust among stakeholders. Furthermore, the ability to systematically address and prevent nonconformances contributes to operational excellence, minimizing disruptions, and optimizing processes.

Risks of Poor Nonconformance

Inadequate nonconformance management poses significant risks, including the release of substandard products or services, increased costs due to the need to rework or replace defective materials or products, and potential noncompliance with industry regulations and standards. The consequences involve potential damage to the organization’s reputation as customers may experience dissatisfaction or loss of trust. Poor nonconformance management escalates operational costs, requiring expenditures on rework processes and replacement resources, diverting financial resources from strategic initiatives.

Potential legal risk

The inherent risk of noncompliance with industry regulations compounds challenges associated with subpar nonconformance management. Failing to meet regulatory requirements jeopardizes legal standing and can lead to severe penalties and sanctions, potentially impeding the organization’s ability to operate in specific markets. The ripple effect of noncompliance extends beyond financial repercussions, encompassing potential legal battles, product recalls, and damage to relationships with regulatory authorities.

inefficiency with increased time and cost

Moreover, poor nonconformance management hinders overall operational efficiency. The time and resources expended on addressing nonconformities detract from core business activities, affecting productivity and hindering the ability to meet delivery timelines. This strain on relationships with customers and suppliers occurs as delays and disruptions become more frequent.

Long-term impact on Reputation

Risks associated with deficient nonconformance management are multifaceted, ranging from immediate financial implications to long-term damage to reputation and regulatory standing. A proactive and robust approach to nonconformance management is imperative to mitigate these risks, ensuring that products or services meet or exceed established standards, minimizing operational costs, and safeguarding the organization’s adherence to industry regulations and standards.

Man in personal protective equipment logging a nonconformance on his digital quality management system on site using a tablet

Nonconformance Complexities

As a quality manager in a regulated industry, managing nonconformance is a critical aspect of maintaining regulatory compliance and ensuring product quality and safety. A nonconformance is any deviation from a specification, standard, or procedure that could affect the quality or safety of a product or process.


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

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


For example, a quality manager in the automotive industry may be struggling to manage nonconformances related to the production of critical parts, including deviations in product dimensions or material quality. Nonconformance management software could help them streamline the process, ensure that all nonconformances are adequately documented, investigated, and resolved, and track the implementation of corrective and preventive actions to reduce the likelihood of similar nonconformances occurring in the future.


Similarly, a quality manager in the electronics industry may use nonconformance management software to manage nonconformances related to component specifications or assembly processes, ensuring that all nonconformances are appropriately documented, investigated, and resolved, and that the implementation of corrective and preventive actions is adequately tracked and verified. By implementing nonconformance management software, quality managers can improve compliance, reduce the risk of errors, and demonstrate their organization’s commitment to quality and safety.

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What to Look for in a Solution

Quality management systems can help organizations manage nonconformance by providing tools and functionality to identify and report nonconformance, investigate root causes, implement corrective and preventive actions and monitor the effectiveness of those actions. A QMSs can also provide visibility into the status of nonconformance activities, enabling organizations to make informed, data-driven decisions to reduce risk and improve quality.
A man in a lab coat logging a nonconformance on site in a medical device production plant on a tablet
Increased Visibility and Control

Nonconformance management software can help provide greater visibility and control over the entire nonconformance management process, from identification to resolution. This can help ensure that all nonconformances are appropriately prioritized and addressed, reducing the risk of quality issues or safety hazards.

A man in personal protective equipment closely observing medical device production machinery
Enhanced Efficiency and Productivity

Nonconformance management software can help automate many of the time-consuming tasks associated with nonconformance management, such as investigation, documentation, and corrective action. This can help reduce the time and effort required for these tasks, allowing quality managers to focus on more strategic tasks.

Three workers in lab coats and protective eye wear discussing nonconformances with focused expressions clear communication
Improved Collaboration and Communication

Nonconformance 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 nonconformance management process and that all nonconformances are appropriately reviewed and resolved.

A woman in lab gear efficiently tracking a nonconformance on a computer while on site in a lab
Better Data Management and Analysis

Nonconformance 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 nonconformance management strategies and ensure that all nonconformances are appropriately prioritized and addressed.

Two compliance workers in suits looking at a digital record of nonconformance tracking on a computer
Compliance with Regulatory Requirements

Nonconformance management software can help ensure that all nonconformances are appropriately identified, documented, investigated, and resolved 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.

A man facing the camera and smiling on site for a medical device production facility

Designing for the Future

Overall, using technology for nonconformance management 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 nonconformance management software, the benefits of doing so far outweigh the costs in the long run.

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