Nonconformance Management: Definition, Purpose, and Helpful Tools

When it comes to quality management software system, business tend to make continuous efforts to avoid nonconformities. But they still appear. Therefore, businesses need a comprehensive nonconformance management software system that can help them manage defects, deviations, and nonconformities without affecting the operational efficiency.  

In this post we will look at the most effective ways to manage nonconformities. Let’s start with a quick introduction: 

What are nonconformities? 

Nonconformities (defects, nonconformances, or nonconformances) are deviations from specifications, standards, or expectations. The seriousness of nonconformities can be classified in various ways, with three to four main categories, including critical, serious, major, and minor. 

Although some industries use the terms "nonconformity" and "defect" interchangeably, others distinguish between the two terms; a nonconformity means that the product fails to meet the intended state and specification, whereas a defect indicates that the product does not meet its fitness for use or normal usage requirements. Software engineering standards such as ISO/IEC 25010 (formerly ISO/IEC 9126) define nonconformities as failures to satisfy requirements and defects as failures to satisfy intended uses. 

What causes nonconformity? 

Nonconformities can be attributed to various causes so that they can be determined. The following are common causes of deficiencies: 

Ineffective communication  

A lack of or inadequate training of personnel 

Insufficient documentation  

A lack of quality materials  

The motivation of the workforce is low 

Inadequate equipment and tools  

A poor or dysfunctional work environment 

How should businesses address non-conformity? 

Non-conformity handling may vary from business to business, but three main components remain: 

1. Identify the Nonconformances 

Examine whether any processes or actions within the company are performing differently than expected. Again, watch out for all the sources of the nonconformances mentioned above. 

An experienced team knows how a process should work and can spot any non-conformity. Moreover, they might spot other opportunities before they occur if they are customer-focused, motivated, and confident. 

Record all non-conformities in a log or register, including details on how they occurred. 

2. Take the Necessary Actions 

In this section, all necessary corrective actions will be taken. Depending on the situation, immediate action may be required, or changes will need to be made over a more extended period. To address this non-conformity appropriately, in addition to making the necessary adjustments or solutions, you should also identify the root cause during the process of managing the non-conformity so that you can prevent the recurrence of the non-conformity or issues of a similar nature in the future. 

Keep a non-conformity log or register with details of actions taken and their reasons. After evaluating how effective your measures have been in resolving the non-conformity, you will need to update your log again with details of the effectiveness of your actions. 

3. Perform a review 

Management of any modern ISO management system must review the non-conformity register and log as a part of its oversight process. This is built into most modern ISO management systems. As part of this Management Review, it will be assessed whether the corrective actions taken have been effective and whether there has been enough effort put in to prevent the non-conformity from occurring in the future. 

A review can also reveal potential issues that may be hidden at first glance. This is done by taking the time to take a deeper look at the business and its interconnected processes in its entirety. 

Changing the management system or individual team processes is part of the continual improvement that is the primary purpose of any management system. 

Benefits of nonconformity management? 

The purpose of identifying nonconformities in an organization with a Management System is: 

Maintaining compliance – having your team actively look for nonconformities shows that your team knows your processes and procedures and will adhere to them. 

Ensuring the system's effectiveness – observing processes and identifying nonconformities allows you to identify areas in your management system where progress isn't being made, leading to improved effectiveness. 

Documenting nonconformity results - to use for corrective action programs and performance measurement, nonconformity results should be reported for review and analysis at management reviews. Recognizing improvement opportunities – when nonconformities keep repeating, that's a sign there is a problem. Observing such trends can highlight critical procedures and processes that need improvement. Fostering continual improvement – once you address your nonconformities, you are driving improvement, whether improving the process or evaluating how the change affects other areas. 

Nonconformity Management: Helpful Tools

To reap maximum efforts, businesses must have right tools and controls in place. You may need a cloud-based nonconformance management software solution like Qualityze EQMS Suite. This nonconformance management software streamlines all your quality processes as per the industry-proven best-practices to minimize product issues and maximize operational efficiency. Consequently, you will build a culture of quality and maintain compliance with applicable regulatory standards with this nonconformance management system.