Nonconformance refers to a situation where a system, product, or process does not meet predefined standards or regulatory requirements. Even a minor nonconformance can lead to product recall, financial loss, and, most importantly, serious reputational damage.
According to the FDA Enforcement Report, a significant number of pharmaceutical recalls happened due to manufacturing nonconformance. If we consider the numbers, there were 237 drug recalls, and the majority of them were due to contamination, deviation, or mislabeling. Certainly, in these cases, nonconformance just can’t be labeled as a technical oversight; it can lead to serious health consequences—it can cost lives.
What are nonconformances? Is it critical to address them on time? And can we prevent them from happening? This comprehensive coverage will walk you through the concept of nonconformance and show how an effective quality management system (QMS) can help you minimize or eliminate the outcomes that follow.
What is Nonconformance?
In quality management, non-conformity is an issue or defect in the quality of a product, process, or system that arises out of a stakeholder’s failure to follow guidelines, standards, or a set procedure.
Both ISO 9001 and the FDA define a nonconformance as ‘‘non-fulfillment of the specified requirement,’’ highlighting a discrepancy, inconsistency, or deviation from the established or expected criteria.
Practically speaking, a nonconformance can be anything that indicates that something in the entire process has not met the set criteria. Certainly, it could be the use of contaminated raw materials in the food and beverages industry or the use of non-approved materials in manufacturing, which may directly compromise product safety.
However, in each case, a nonconformance not only impacts the quality of products or services, but it can also lead to unhappy customers, reputational damage, costly reworks, legal penalties, and even product recalls.
Understanding the Different Types of Nonconformances
The first and most important step in minimizing the impact of nonconformance is gaining a clear understanding of its type, nature, or severity, which ultimately makes the process far easier. Non-conformances can arise in any industry, including pharmaceuticals, oil and gas, construction, and manufacturing. Having a clear classification helps teams prioritize, assess risk, and implement an effective non-conformance management strategy. Let’s go through the different nonconformance types and examine how they can impact the processes and outcomes.
1. Major nonconformance
Nonconformances that pose a significant impact on the overall quality, safety, and compliance are categorized as major nonconformances. In terms of severity, they can lead to serious consequences, requiring immediate attention and a comprehensive corrective action plan for faster recovery. Often, the impact of a major nonconformance can be seen in the overall operational workflow from start to finish, causing a substantial financial loss and ending up in complete rework or recall.
- Example Failure of a critical safety component during a crash test—a batch of airbags fails to deploy correctly due to a defective sensor.
- Consequences
- It increases the risk of injuries or fatalities.
- It results in regulatory non-compliance and may lead to potential fines.
- The company may need to recall the entire batch, causing financial and reputational losses.
2. Minor nonconformance
Nonconformances that are relatively inconsequential in terms of product quality, safety, and compliance are categorized as minor nonconformances. It often includes minor deviations or minimal procedural errors that are isolated or localized in nature, impacting a specific stage of the operational or production process. In terms of severity, they do not pose an immediate risk but need an effective corrective and preventive action plan to systematically eliminate the associated risk.
- Example A quality check reveals that the dashboard trim in a few vehicles is misaligned. However, this does not significantly impact safety, functionality, or compliance.
- Consequences
- Considered as an aesthetic issue, it may affect customer satisfaction.
- It may need rework.
- It does not need a complete recall or lead to legal consequences.
Additional Types of Nonconformances Explained
In addition to the broader classification mentioned earlier, many organizations often group nonconformances in the below-listed categories depending on their impact. Each type can be further grouped into major and minor nonconformances based on their severity.
1. Product nonconformances
Product nonconformance occurs when the end product does not meet the predefined criteria or quality standards. There can be many factors contributing to the product nonconformance, such as incorrect dimensions, functionality failures, adulterated raw materials, and more. For instance, substandard quality of material used in brake pads can reduce the braking efficiency of the vehicle. It can lead to accidents, attract fines or penalties, or require recalls.
2. Process nonconformances
Process nonconformance usually occurs when a process or operational workflow is not followed correctly or deviates from the set standards. It can be due to human errors, equipment malfunctions, noncompliance with the standard operating procedures, and more. Let’s say the workers assembling engines for a specific batch of cars followed the incorrect procedure, resulting in a knocking sound during inspection. It can lead to production delays, rework, or even reduced performance.
3. Systemic nonconformances
Nonconformances arising out of fundamental issues in organizational policies, practices, or overall management. It can be recurring in nature and may have a widespread impact, affecting multiple departments and processes. For example, if the manufacturing company is receiving faulty or low-quality brake pads from the supplier, leading to multiple instances of product failure, it represents a lack of proper audit, inspection, and accountability.
Nonconformance Management Process: Key Stages
The nonconformance management process is a systematic approach to identifying, reporting, recording, and resolving quality issues, minimizing risks, and establishing quality standards.
The way nonconformances are managed differs across industries and is shaped by various global regulatory requirements. However, the standard approach to managing nonconformance typically includes identification, documentation, root cause analysis, corrective and preventive actions (CAPA), and closure.
Let’s explore the standard process and learn how an effective nonconformance management solution can enhance workflow efficiency.
1. Identification of nonconformance
Identifying or detecting the nonconformity is the first step. There are numerous processes, like quality control checks, customer complaints, audits, or routine inspections, that help teams to constantly check the process for nonconformities.
Evidently, early identification of nonconformance prevents defective products from entering the consumer market, reducing safety and compliance risks. Managing them digitally allows teams to easily log issues in a centralized system and generate automated alerts for immediate attention.
2. Documenting and reporting
Once a nonconformance is detected, it is essential to document it along with the necessary supporting details such as description, date, time, and location, and also the severity of the issue. Clearly documenting nonconformances helps quality teams easily assess the data, prioritize issues, improve audit readiness, and enhance traceability within the organization.
A digital nonconformance management solution can be leveraged to create standard, predefined templates for reporting and documenting issues. It empowers users to add supportive evidence, such as photos or documents, for better record-keeping.
3. Root cause analysis (RCA)
Investigation and root cause analysis play a crucial role in the nonconformance management process. While investigation suggests the primary cause of the quality event, RCA emphasizes more on analyzing the underlying cause to prevent it from recurring.
Carefully reviewing nonconformance reports, examining affected products or processes, and analyzing data obtained from historical records, machine logs, and customer complaints can contribute to effective RCA.
A nonconformance management solution with centralized reporting and data-driven insights helps cross-functional teams to easily spot trends, assess logs, and track changes in SOPs and policies while allowing them to investigate issues together.
4. Corrective and preventive actions (CAPA)
A well-structured nonconformance handling focuses on both immediate fixes to minimize the damage and eliminating potential causes to prevent future defects.
Once the RCA is done, a robust CAPA plan is developed, highlighting the changes in SOPs, employee training, responsibilities, validation and testing, a long-term improvement plan, and more.
An effective CAPA process is mandated by quality and safety regulations such as ISO 9001, IATF 16949, FDA, and GMP. A digital QMS, by offering a collaborative workplace for teams, helps them create, implement, and monitor CAPA effectively. Users can maintain a CAPA action log, leverage version control, and utilize a dedicated training and audit module to enhance the effectiveness of nonconformance handling.
5. Closure and documentation
A comprehensive audit is conducted to verify the changes made in the process, product, or system. Once approved, the nonconformance must be formally closed, and all the related documentation and data must be archived and retained for future reference. Certainly, this adds value to the organization’s knowledge bank and can be referred to for a quick resolution of similar issues in the future.
A SharePoint-based nonconformance management solution with its ability to create, organize, share, and control documents offers a robust ecosystem for quality teams to easily search, approve, and track changes for a seamless audit experience. Users can implement a well-structured document retention policy, and with added advanced search functionality, it becomes quite easy to quickly access past records, enhancing decision-making and overall efficiency.
Nonconformance Report Example: Key Elements and Structure
A nonconformance report, or a nonconformity report (NCR), is a formal, comprehensive document that identifies and records inconsistencies or discrepancies between the predefined quality standards or specifications and what is actually observed in the final product, service, or process.
The nonconformance report acts as a standard document that is referred to track and assess the nonconformity and serves as a foundation for developing a corrective and preventive action plan, ensuring that they are systematically addressed and resolved.
The structure or template of the nonconformance report may vary based on industry-specific requirements, regulatory compliance, and operational needs. While manufacturing industries might focus on defects in materials, final products, and production processes, healthcare sectors place more importance on drug quality, adulterated raw materials, and packaging. Let’s take a standard nonconformance report as an example to examine the structure and key elements more closely.
Standard Nonconformance Report Structure
- NCR Identification Details It includes a report number (unique identifier), date and time (when nonconformity was identified), and department or location (affected area). It helps quality management teams to track the nonconformance details.
- Description of Nonconformance This section of the nonconformance report offers a clear record of the discrepancy (issue summary) along with the test report or photographs (supportive evidence) to validate the quality event.
- Category of Nonconformance Categorizing nonconformance helps identify the root cause and prioritize the corrective and preventive measures. This section highlights the category of nonconformance along with the comments or observations from the assigned stakeholder.
- Root Cause Analysis (RCA) This section includes a summary of the investigation conducted by the quality team. It may include an overview and summary of the RCA, the origin and category of the root cause, and concluding suggestions for further actions.
- Impact Assessment Users can leverage this section to identify associated risks, create a mitigation plan, assign responsible personnel, and provide a completion date to bring down the financial, safety, and compliance risk associated with the nonconformance.
- Corrective and Preventive Actions (CAPA) It includes a list of immediate, corrective, and preventive actions required to mitigate the existing nonconformity. To ensure accountability, users can assign responsibilities and set a deadline for executing the CAPA plan.
- Verification and Closure The final and the most critical field of the nonconformance report may have two key sections: first, to monitor follow-up inspections, and second, the approval from authorized personnel to validate the resolution of the nonconformance.
Nonconformance report sample
Proven Best Practices for Preventing Nonconformances
- Implement a robust QMS to establish a structured quality framework that aligns with industry-specific requirements and global compliance standards. QMS helps streamline and automate the quality processes, minimizing errors and enhancing consistency.
- Set clear quality objectives and performance metrics for defect rates, reworks, and complaints and review them regularly to identify nonconformance trends and minimize defects.
- Conduct regular employee training and awareness programs on quality standards, safety protocols, compliance requirements, and SOPs, and keep them aware of the latest techniques and best practices.
- Thoroughly evaluate suppliers before onboarding and audit them regularly to ensure you receive high-quality raw material and components. This will eventually restrict the substandard quality products from entering the production line, reducing nonconformance.
- Conduct regular internal audits and inspections to detect potential nonconformances before they escalate into major ones. Certainly, random sample testing for inconsistencies or performing layered process audits can help.
- Ignoring even a minor nonconformance can lead to accumulated failures, increased rework costs, and potential safety risks. So, it becomes crucial that you perform a thorough root cause analysis for every nonconformance and record it for future reference.
- The process of nonconformance management is not restricted to any specific department or team. Maintain clear and consistent communication, improve the approval workflows, add automated email notifications for pending tasks, and centralize records for enhanced accessibility and collaboration.
BizPortals QMS: Revolutionizing the Way You Handle Nonconformances
A digital quality management system is necessary to maintain consistent product or service quality. BizPortals QMS, a SharePoint-based quality management system, is a key to delivering excellence every single time. With its robust document control features, including versioning, role-based access, automated workflows, and e-signatures, it offers custom modules to easily track, manage, and resolve nonconformances, incidents, deviations, and more—all in one place.
BizPortals QMS, with added functionalities like cross-module integration, fully configurable modules, and more, can prove to be a game changer for modern, rapidly evolving organizations like yours.
Would you like to know more about BizPortals QMS? Schedule a free demo at your convenience, engage with experts, and watch its robust features live in action.
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