Are You Struggling with Nonconformance Management at Your Enterprise? Here’s Everything You Need to Excel at it.
Blog | October 21st, 2022

Are You Struggling with Nonconformance Management at Your Enterprise? Here’s Everything You Need to Excel at it.

The modern manufacturing company is transforming at a rapid pace. Digital tools, automation, and transformation efforts have improved the speed and efficiency of manufacturing processes – empowering organizations to do better in terms of quality and compliance metrics.

Even so, businesses are facing the challenge of products coming out of the production line with easily identifiable issues and defects. These nonconforming products do not meet the specifications and, therefore, have to be scrapped or reworked, adding to costs and operational inefficiencies.

The defects can be due to raw materials not meeting the specifications or the processes not being aligned with the standard operations procedure or regulatory requirements. If not caught before being released in the market, they can harm the brand’s reputation leading to a loss in revenues. It can also lead to regulatory bodies levying fines and penalties, adding to the costs.

To reduce the CoQ, quality issues must be caught as early as possible in the product lifecycle. With a comprehensive (and automated) nonconformance management solution, it becomes easier to spot and fix quality issues before it leaves the proverbial four walls of the company!

Common Types of Nonconformances

Nonconformances can be of two kinds, categorized based on ease of detection, recurrence rate, and the ease of rectification measures. The two categories are:

Minor – These are isolated cases, easy to detect and rectify. For instance, wrong segregation of nonconforming products and machines not calibrated right. However, if not rectified in time, they can become major.

Major – These are errors that have a significant impact on costs and compliance and can include issues such as frequently making unauthorized changes, shipping out products without testing, or not taking corrective action for the root cause of a problem.

Effective Management of Nonconformance

When a nonconformance is identified, it should be addressed immediately, regardless of whether it is major or minor. For effectively managing the nonconformance and ensuring it is rectified and does not recur, it entails the following:

1. Identifying the Root Cause: Companies often react to a nonconformance by addressing the most obvious cause. While it may or may not rectify the issue, the potential for its recurrence is high. It is important to understand the root cause for the nonconformance and to address the core issue. Since there can be more than one root cause, it is important to identify all of them.

2. Trigger CAPA: Once the root cause has been identified, action must be taken to rectify it. It is also important to analyze historical data to assess if it is a recurring problem. Whether it is or not, it is essential also to identify and put preventive measures to ensure the defect does not recur.

3. Document: Documentation is a regulatory requirement and should contain all relevant information about the nonconformance. This should detail the issue, the materials used, and how it was segregated and disposed of. It should also include the signatures of the relevant employees or managers and a copy of the standard operating procedures and work instructions. The findings of the investigations into the nonconformance should be included in the document.

4. Segregation: The segregation of the defective product is important to prevent its being released into the market by mistake.

5. Disposing of the Nonconforming Product: A nonconforming product may be scrapped if it is unusable, reused with a minor nonconformance, or repurposed.

Prevention of Nonconformance

Prevention is better than cure. Continuous improvement of the quality management system helps to minimize errors and increase compliance with standards such as the ISO 9001:2015 standard and regulations such as the FDA. CAPA is highly recommended to address the issue and reduce repetition. It is also important to document the corrective action that was taken.

According to the Code of Federal Regulations (CFR) 820.90(b), nonconforming products are required to be scrapped, returned to the supplier, or reverted to previous versions if this was a new version.

Some of the Preventative Measures to Reduce the Possibility of Nonconformance include:

Adhering to SOP: Adhering to the SOP is essential due to these procedures incorporating controlled variables for ensuring the production of quality products. Employees must be provided with the SOP documents, and any change to the procedures should be reported to avoid nonconformance.

Training: Along with being made aware of the SOPs, the employees must also be provided training, as required by ISO 9001. This can help to prevent mistakes, improve compliance, and minimize nonconformance.

Product Testing: Regular testing of products is a best practice recommended by ISO 9001 for quality assurance and control. This will ensure that nonconforming products are not released in the market.

ISO 9001 Audit Checklist: Provide employees with an audit checklist or report form to doubly ensure compliance.

ComplianceQuest to Automate and Streamline Nonconformance Management Processes

Nonconformance management involves many processes and can be difficult to monitor and implement in a manual system. An automated solution helps to improve the efficiency and effectiveness of the process.

The ComplianceQuest Nonconformance Software is a cloud-based solution, part of the enterprise-wide quality management platform that helps with end-to-end management of nonconformance. It helps Reduce the Cost of Quality (CoQ) from internal failure and prevents product recalls with an automated, data-driven process for identifying and managing nonconformance of both products and processes.

The solution facilitates capturing, triaging, investigating, and disposing of all nonconformances in a timely and effective manner. It also ensures FDA and ISO-compliant environments, reduces CoQ, and captures and acts on a nonconformance before it is released. With analytics, quality leaders can capture trends and effect continuous improvement.

It also integrates with the other modules of CQ EQMS, such as document, risk, and CAPA. The 5 Why Root Cause Analysis is a tool from CQ that helps leaders and employees collaborate and identify root causes to take effective action.

To know more about CQ’s Nonconformance Management Solution and how you can reduce it in your organization while increasing the quality of your products, contact us:

To know more about CQ Nonconformance Management Solution, visit:

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