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Introduction

What is nonconformance management?

Why is nonconformance management important?

The nonconformance management process

Nonconformance management best practices

Wrap Up

 

 

Best Practices for Nonconformance Management

August 5, 2024

Despite nonconformances being a matter of course in manufacturing, experiencing one can still be a burden. Beyond their effect on your production schedule, nonconformances require a lot of extra work, from report creation and analysis to potentially re-configuring an entire project.

 

Whether you're navigating the complexities of aerospace, food production or life science manufacturing, understanding and utilizing best practices for nonconformance management can propel your products toward greater safety, quality and compliance. We explore what nonconformance management is all about, why it matters and ways you can master it.

What is nonconformance management?

Nonconformance management involves developing and using policies and procedures that systematically identify, document, evaluate and appropriately resolve processes or output that do not conform to the manufacturer’s requirements. These departures from specifications can be anything from minor cosmetic defects in a product to significant breaches in compliance protocols, such as repeated, unapproved modifications. The goal of nonconformance management is to identify any issues before they can escalate, and if necessary, promptly investigate their cause, resolve the issue and implement solutions to prevent recurrence.

Why is nonconformance management important?

Being able to effectively manage nonconformances is essential to managing risk and ensuring the long-term success and sustainability of your business’ operations. What’s more, several common regulations, including from the U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO), address nonconformance. These require manufacturers to establish and maintain procedures to control and correct nonconformities and make any necessary changes to the quality management system. Primary reasons to develop a solid nonconformance management plan include:

 

Ensure Quality and Safety

Quality and safety are the ultimate goals to which manufacturers should aspire. Having a good nonconformance management program in place helps your business maintain high quality standards, ensuring that products meet customer expectations and regulatory requirements. It also helps your organization avoid distributing nonconforming products that could pose a safety risk to consumers, potentially resulting in injuries or even fatalities.

 

Compliance and Risk Management

In regulated industries, nonconformance management is integral to successful compliance with industry standards and regulations. Properly managing nonconformances helps avoid potential legal penalties, recalls and damage to a company’s reputation. Several common standards address nonconformance management, including FDA 21 CFR Part 820, ISO 9001:2015 and ISO 13485: 2016.

 

FDA 21 CFR Part 820 requires manufacturers to implement corrective and preventive actions (CAPAs) as part of the nonconformance resolution process. The procedures should address the identification, documentation, evaluation, segregation and disposition of nonconforming product.

 

ISO 9001 standards seek to prevent the unintended delivery or use of a nonconforming product (or service) by ensuring manufacturers control and correct nonconformities. It also requires an organization to evaluate the need for actions that will prevent the recurrence of a nonconformity.

 

ISO 13485 requires medical device manufacturers to address nonconforming products and ensure they are not distributed for use. The process needs to be documented and corrective actions undertaken.

 

Operational Efficiency

Nonconformance events can easily disrupt production processes, leading to delays in manufacturing schedules and shipment deadlines. Efficient nonconformance management streamlines nonconformance tasks, preserving time and resources and contributing to a leaner, more productive organization.

 

Customer Satisfaction and Market Share

Not properly managing nonconformances can lead to customer dissatisfaction, resulting in customer complaints, returns, warranty claims and loss of customer trust and loyalty. Customers may switch to a competitor’s products, resulting in a loss of market share and reduced competitiveness in your industry.

 

Continuous Improvement

By systematically analyzing and addressing nonconformances, organizations can identify trends and areas for improvement. This continuous feedback loop fosters a culture of ongoing improvement, driving innovation and operational excellence.

The nonconformance management process

Understanding the nonconformance management process is essential for effectively implementing a successful nonconformance management system. Nonconformance management involves several key steps:

 

1. Identification
2. Documentation
3. Evaluation
4. Segregation
5. Investigation
6. Disposition and Approval
7. Monitoring & Recording Results

 

Identification

The first step in the nonconformance process is nonconformance identification. Nonconformances are most often identified through routine testing and inspections against key performance indicators (KPIs), audits, customer feedback or automated detection systems. Once identified, a nonconformance report (NCR) is initiated.

 

Documentation

A nonconformance must be thoroughly documented, recording all relevant details, such as the nature of the nonconformance and its location, and attaching any associated documentation or records. Comprehensive documentation is vital for subsequent analysis and corrective actions, as well as regulatory compliance.

 

Evaluation

The next step is to evaluate the nonconformance to determine its severity and scope. This assessment helps prioritize actions based on the potential impact on product quality, safety and regulatory compliance.

 

Segregation

Nonconforming products may need to be physically segregated to prevent unintended use or delivery. This could involve quarantine areas or designated storage locations.

 

Investigation

A thorough investigation may be conducted to uncover the root cause of the nonconformance. This may warrant creating a cross-functional team to analyze data, processes and systems and identify any underlying problems.

 

Disposition and Approval

Based on investigation findings, corrective and preventive actions (CAPAs) may be developed and implemented. Corrective actions focus on rectifying the immediate issue and restoring compliance. Immediate corrective actions are implemented to address the nonconformance. This might involve reworking a defective product, halting production to fix a process issue, or employing any other measures necessary to rectify the problem.

 

Preventive actions go a step further by addressing the root causes of nonconformances. They aim to prevent similar issues from occurring in the future. For instance, if the root cause of the defects is traced back to a specific machine calibration error, establishing preventive actions might involve more regular maintenance and employee training on proper calibration techniques.

 

Recording Results

The final step of the nonconformance process is to verify the effectiveness of the implemented CAPAs. This involves monitoring outcomes and making any necessary adjustments to ensure that the nonconformance does not reoccur.

Nonconformance management best practices

Once manufacturers have established nonconformance management processes relevant to their product, industry and regulatory objectives, they need to ensure the process can be undertaken as quickly and effectively as possible. One of the best ways to accomplish this is through automation.

 

Automate Processes

Automated workflows streamline the nonconformance management process and ensure that each step is completed promptly and efficiently. One of the most impactful nonconformance management automations is digitizing document management, which gives manufacturers a centralized platform where quality details are automatically captured and are readily accessible for analysis and reporting.

 

Quality Management System (QMS) software automates other nonconformance processes and integrates with document control. These include:

• Root cause analysis
• CAPAs
• Inspections
• Audit management
• Customer feedback
• Employee training
• Supplier management

 

A dedicated, web-based eQMS also facilitates collaboration across departments and teams, allowing for seamless information sharing and ensuring all employees are working with the same data. Electronic alerts and approval signatures keep the noncompliance process on track and provide built-in traceability.

 

Systematic Inspections

Systematic inspections performed at various stages of production can help prevent nonconformances and identify issues early in the production process. With an eQMS, inspection results from across a product’s lifecycle are connected, documented and centrally located, so real-time data can be examined and shared at any time. This allows for simpler control, better collaboration and more informed decisions.

 

Supplier Management

Problems with third-party-supplied components are one of the main sources of nonconformances, impacting everything from production timelines and product quality to customer satisfaction and brand reputation. Having a supplier management system that can track and evaluate supplier performance, allows you to more easily partner with suppliers who can best meet your needs.

 

Surveys and evaluations are common ways to gather supplier performance data. Automated supplier management applications store these details and help to maximize relationships with suppliers by providing a centralized source for communications, enabling easier collaboration and faster resolution in the event that there is an issue. Conduct regular audits, provide feedback, and work with suppliers on continuous improvement initiatives to ensure that the materials and components you receive are of the quality you expect.

 

Employee Training and Engagement

Well-trained and engaged employees are crucial for preventing nonconformances. Regular training programs, clear communication of quality standards and fostering a culture of quality awareness empower employees to identify and address potential issues proactively. Proper staff training and communications is easy to manage with automation, where you can create training, track employee progress and issue reminders for completion.

 

Real-Time Monitoring and Reporting

With QMS software, you can monitor nonconformances in real time and generate comprehensive reports using the most current data. This can provide valuable insights into production trends and patterns, helping to make data-driven decisions and prioritize improvement efforts.

 

Preventive Measures

Taking steps to prevent nonconformances is always better than dealing with their consequences. Strategies that can help prevent nonconformances in your organization:

 

Management/Employee Reviews

Regular management review of company quality objectives and systems are an opportunity to make process changes and set new objectives for better success moving forward. Employee reviews can provide valuable input into process improvements by offering input from the perspective of someone with in-depth knowledge of the entire system.

Ensure your business has a system to collect and analyze customer feedback so that issues are not overlooked and can be addressed early on.

 

Quality Management System Software

Implementing robust QMS software standardizes processes and provides a central location where documentation and data can be accessed. A QMS is a source of SOPs and instructions, as well as training to support employee understanding of quality objectives and how to attain those goals. QMS software can also help assess risk and identify potential nonconformances before they become problems.