Person identifies and registers a nonconformance on a piece of paper

Nonconformance: Definition, Types, Process, and Prevention

Nonconformance means that there was an event with a process, service, or product, and the result does not match the requirements.

The cost of nonconformance can be significant, making it crucial for all companies to actively reduce such events. Minimizing nonconformance helps ensure product quality, safety, and regulatory compliance.

Managing nonconformances is a requirement in Life Science industries. Companies involved in one or more stages of the life cycle of a product, such as drugs and medical devices, are subject to strict requirements that require products to be safe and effective. Nonconformances could indicate that companies are not in compliance with these relevant requirements.

This article covers what nonconformance is, the different types, and the process of effectively managing nonconformances. We will also discuss the role of QMS software in streamlining nonconformance management processes.

SimplerQMS offers comprehensive eQMS software equipped with nonconformance management capabilities tailored to the unique needs of Life Science companies. Book a free demo with our quality solution consultants to gain a deeper insight into the capabilities of our eQMS solution.

We will discuss the following topics in the article.

What Is Nonconformance?

Nonconformance is defined as the event in which a product, service, or process does not meet the established requirements.

Below are the definitions of nonconformance as outlined in some standards and regulations.

  • ISO 9001:2015: A nonconformance is the non-fulfillment of a requirement. This can encompass various issues, such as departures from established procedures, failure to meet customer expectations, or noncompliance with regulatory requirements.
  • ISO 13485:2016: Nonconformance refers to a product that does not conform to requirements. It signifies any instance where a medical device does not meet the specific requirements set for its design, manufacture, or performance. This can include manufacturing defects, inadequacies in labeling, packaging discrepancies, and more.
  • FDA 21 CFR Part 820: Nonconformance is the non-fulfillment of a specified requirement. It indicates occurrences where a medical device manufacturer fails to meet specific requirements established under the regulation. These requirements include design control, manufacturing processes, documentation, quality system procedures, and more.

In all of these definitions, nonconformance means failing to meet a requirement.

The requirements can be internal, such as those set by the company, or external, such as those imposed by regulations or customers.

What Are Variations for the Terms “Nonconformance”?

The most common variations of the term “nonconformance” are listed below.

  • Nonconformance
  • Non-conformance
  • Non conformance
  • Nonconformity
  • Non-conformity
  • NC (abbreviation for non-conformance)

These variations can be used interchangeably and have the same meaning.

They all refer to a failure to meet a requirement.

The specific variation may depend on the written content of the standard, guideline, and regulation applicable to a company.

What Is the Difference Between Nonconformance and Noncompliance?

Nonconformance refers to a failure to meet specified standards or expectations. It signifies that a product, service, or process does not align with the relevant company’s requirements.

On the other hand, noncompliance refers specifically to a violation of laws and regulations that have been set by external governing or regulatory bodies.

While nonconformance might result in a breach of law, noncompliance is inherently a legal issue that may lead to penalties, sanctions, or other legal ramifications.

What Are the Different Types of Nonconformances?

There are two main types of nonconformances: minor nonconformance and major nonconformance.

The company typically decides the criteria for defining the severity of a nonconformance based on its specific products, services, and processes.

What Is a Minor Nonconformance?

A minor nonconformance is an event that does not follow the requirements and is unlikely to significantly impact the product’s quality, safety, or compliance.

Minor nonconformances are often isolated incidents that can be easily corrected.

What are the Examples of Minor Nonconformances?

Minor nonconformance examples are listed below.

  • A single missing or unsigned document.
  • Any unauthorized alteration to a document.
  • Release of a purchase order without prior approval.
  • Using an instrument after its calibration date.
  • Customer complaint that is not resolved in a timely manner.
  • A failure to meet an internal deadline.
  • Slight variations in product dimensions within acceptable tolerances.
  • A minor defect in a product that does not affect its functionality or safety.
  • And more.

Please note that the list above is not exhaustive, and the order of presentation is random, with no implied priority.

What is a Major Nonconformance?

A major nonconformance is a failure to meet requirements that are likely to significantly impact the product’s quality, safety, or compliance.

Major nonconformances may be repeated occurrences or complex problems that require significant effort to correct.

What are the Examples of Major Nonconformances?

Major nonconformance examples are listed below.

  • Multiple missing or unsigned documents.
  • Multiple unauthorized alterations to documents.
  • Multiple violations of requirements.
  • Problems that adversely affect processes or operations.
  • Distributing a product that is unsafe to use.
  • Contamination of a product with foreign materials.
  • A serious safety hazard in the workplace.
  • Security vulnerabilities that could lead to data breaches or unauthorized access.
  • And more.

Please note that the list above is not exhaustive, and the order of presentation is random, with no implied priority.

Minor Nonconformance and Major Nonconformance Illustration on a Weighting Scale

What is the Nonconformance Management Process?

The nonconformance management process is a systematic approach for identifying, documenting, evaluating, and addressing divergences from established requirements to ensure corrective action and prevent recurrence.

Life Science companies manage nonconformances based on the nonconformance severity and according to the applicable requirement.

Nonconformance management is a requirement in many regulations, standards, and guidelines.

Companies must have procedures in place to control nonconforming products. This means identifying the root cause of nonconformances, implementing corrective actions, and reviewing the effectiveness of those actions.

A few requirements that specify nonconformance management are listed below.

  • ISO 9001:2015 in Section 10.2
  • ISO 13485:2016 in Section 8.3
  • FDA 21 CFR Part 820 in Section 21 CFR 820.90

The nonconformance management process involves a series of steps to address and resolve nonconformances.

The nonconformance management process steps are listed below.

  1. Identification
  2. Documentation
  3. Initial Assessment
  4. Containment
  5. Investigation
  6. Evaluation of Impact
  7. Corrective Action
  8. Verification
  9. Closure

1. Identification

Identify the nonconformance by monitoring key performance indicators (KPIs), customer feedback, inspections, audits, or other monitoring mechanisms to promptly detect any issues that may arise.

2. Documentation

Create a formal nonconformance report (NCR) that documents all the essential details about the identified issue, including its nature, location, date, personnel involved, affected products or processes, and any immediate actions taken.

The nonconformance report serves as an official record that provides a clear and comprehensive account of the nonconformance.

If you need support creating an NCR, download our nonconformance report template. This tool will help you document all information related to nonconformance.

Downloadable Non-Conformance Report Template Banner

3. Initial Assessment

Evaluate the severity of the nonconformance to determine the immediate steps needed.

Classify the nonconformance as either minor or major based on its impact on the quality of processes and products.

4. Containment

Take immediate action to contain the impact of the nonconformance, which may involve segregating affected products, halting production, or issuing recalls.

Proper segregation may involve labeling, tagging, or isolating nonconforming items in designated areas or within digital systems.

5. Investigation

Conduct a thorough analysis to determine the root cause of the nonconformance using tools such as 5 Whys, Fishbone Diagrams, FMEA, or Root Cause Analysis.

6. Evaluation of Impact

Assess the implications of the nonconformance on product quality, safety, and compliance.

This may include reviewing similar products or processes for potential issues.

7. Corrective and Preventive Action

Corrective actions are measures taken to address and solve existing nonconformances. Preventive actions involve proactively identifying and implementing measures to prevent potential similar events from occurring in the future.

Develop and implement corrective and preventive action (CAPA) plans to solve the nonconformance and prevent reoccurrence, if necessary. This step often involves revising procedures, retraining staff, or making changes to product design.

8. Verification

Monitor the effectiveness of CAPA to ensure processes are working as intended and that the nonconformance has been resolved satisfactorily.

9. Closure

Once the nonconformance is fully addressed and risks are mitigated, formally close the nonconformance report.

Document all actions taken during the process for future reference, transparency, accountability, and potential audits.

NC Management Process Steps

As a natural extension to the traditional nonconformance management process, Life Science companies are deploying eQMS software to automate and streamline the steps involved in managing nonconformances. These platforms offer a structured, evidence-based approach to nonconformance management, minimizing human error and significantly reducing the risk of regulatory noncompliance.

SimplerQMS provides eQMS software that streamlines the nonconformance management process. With automated workflows and capabilities, our platform guides users through every stage of identifying, documenting, evaluating, and rectifying nonconformances.

How To Prevent Nonconformances or Minimize Risk?

Preventing nonconformances or minimizing the risk of similar events happening again involves implementing preventive actions to reduce the occurrence of divergences from established requirements.

This section outlines the strategies to help prevent or minimize nonconformances, along with examples of how SimplerQMS further streamlines the process.

Strategies to consider for preventing or minimizing nonconformances are listed below.

  • Conduct Regular Internal Audits
  • Perform Quality Checks
  • Provide Employee Training
  • Establish Clear Procedures
  • Improve Record-keeping
  • Audit Suppliers
  • Perform Customer Surveys
  • Have a Comprehensive Root Cause Analysis
  • Implement Risk Assessment
  • Enable Automated Alerts
  • Implement a Process to Ensure Continuous Improvement
  • Implement Quality Management Systems (QMS) Software

Conduct Regular Internal Audits

Perform regular internal audits to have an opportunity to identify real and potential nonconformances.

SimplerQMS software solution takes the complexity out of audit management by offering features that enable you to design audit plans, set up schedules, record audit findings, and record all subsequent activities through a time-stamped audit trail.

Perform Quality Checks

Regularly conduct quality checks at different phases of your production process.

This ensures that both products and services consistently meet quality standards and satisfy customer expectations.

Provide Employee Training

Provide training to support employees with the knowledge and skills they need to carry out their tasks correctly to help prevent nonconformances.

With SimplerQMS, managing employee training becomes more streamlined. The platform offers automated training activities and customizable learning rules, along with a KPI dashboard to keep track of overdue training sessions and other quality metrics.

Establish Clear Procedures

Have well-described procedures to help eliminate misunderstandings and reduce the risk of errors.

Improve Record-Keeping

Maintain comprehensive records of processes, inspections, audits, and corrective actions for tracking and managing nonconformances.

SimplerQMS further streamlines this by automating the documentation process and audit trails and centralizing all records in a secure, easily accessible digital repository. This makes it simpler to retrieve necessary information for audits and inspections or management reviews.

Audit Suppliers

Regularly audit suppliers to ensure that they are complying with applicable requirements.

SimplerQMS streamlines this process by offering supplier management capabilities. These include the ability to create and update an approved suppliers list, configure audit schedules, and keep track of crucial details like supplier certificate expiration dates and more.

Perform Customer Surveys

Periodically send out surveys or questionnaires to gauge customer satisfaction and gather insights into potential quality issues.

Have a Comprehensive Root Cause Analysis

Conduct a thorough investigation to identify the root cause of the nonconformance and prevent its reoccurrence with corrective action.

Implement Risk Assessment

Proactively identify areas where nonconformances could occur and assess their impact to reduce the risk of those nonconformances happening.

Enable Automated Alerts

Implement systems that send automated alerts for due activities or other important deadlines to help ensure that responsibilities are not forgotten and that tasks are completed on time.

With SimplerQMS, you can take advantage of automated reminders and notifications that are sent directly to the responsible individuals as task due dates approach.

Implement a Process to Ensure Continuous Improvement

Regularly review and update processes following the PDCA (Plan Do Check Act) cycle and based on KPIs and feedback to ensure that quality is always improving.

Implement QMS Software

Leverage modern QMS software to track and manage quality management-related processes.

This will enhance not only your operational efficiency but also your effectiveness and overall compliance.

What Is the Role of QMS Software in Nonconformance Management?

QMS software automates and streamlines the nonconformance management process, making it more efficient and effective.

The nonconformance management solution facilitates the identification, documentation, and tracking of nonconformances, enabling companies to react promptly. It allows for a centralized repository of all nonconformance reports, making it easier to conduct root cause analyses, implement corrective actions, and verify their effectiveness.

Automated reminders, notifications, and pre-defined workflows can accelerate the nonconformance resolution process, while robust reporting tools enable better monitoring.

By integrating all these aspects, QMS software helps Life Science maintain high and uniform quality, ensure compliance with requirements, and minimize the risks and costs associated with nonconformances.

SimplerQMS is a fully validated eQMS software solution for Life Sciences designed to simplify and improve the quality management, including the management of nonconformances.

Our QMS platform supports compliance with several Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, EU GMP, and more.

SimplerQMS software helps Life Science companies comply with regulatory requirements by providing comprehensive QMS process support.

Some QMS processes supported by the SimplerQMS solution include document control, employee training management, CAPA management, customer complaints management, audit management, supplier management, and more.

To evaluate the benefits of implementing an eQMS, we recommend downloading our eQMS Business Case template.

It can help you assess the value of an eQMS for your company and effectively communicate your findings to management. By analyzing potential efficiency increases, cost reductions, and compliance improvements, you can make a strong case for implementing an eQMS.

Downloadable eQMS Business Case Template Banner

Final Thoughts

Nonconformances are any issues or divergences that occur when a process or product does not meet its established requirements.

The financial and regulatory implications of nonconformance can be severe, making it vital for companies in the Life Science sector to take proactive steps to minimize these incidents.

Companies must have procedures in place for identifying, investigating, and correcting nonconformances effectively.

Nowadays, electronic QMS are substituting paper-based and hybrid systems for managing nonconformances as they offer several benefits. QMS software streamlines the handling of nonconformances, ultimately improving both quality and compliance efforts.

The SimplerQMS QMS software is designed specifically for the needs of Life Science companies, offering quality and nonconformance management capabilities. By providing interconnected processes and pre-defined workflows, users are guided through the stages of each process, helping ensure compliance with Life Science requirements.

See SimplerQMS in action – schedule a personalized demo with our Quality Solution Consultant to explore how our QMS software can simplify your quality management processes.

Non-Conformance Report Template

Illustration of Non Conformance Report Template