Nonconformance is an event in which a product, service, or process does not meet the established requirements. A nonconformance report (NCR) is a document used to report, investigate, and address nonconformances.
Nonconformance reports help Life Science companies to address areas where improvement is needed, improve product quality, and comply with regulatory requirements.
Documenting and managing nonconformances is a requirement in Life Science industries, such as pharmaceuticals, medical devices, laboratories, and more. These industries are highly regulated and must ensure the safety and efficacy of their products, which includes addressing nonconformances.
This article discusses what a nonconformance report is, presents an example of a nonconformance report, and explains how to write, and close NCRs. We will also discuss the role of QMS software in managing the nonconformance management process.
SimplerQMS offers fully validated and integrated eQMS software designed for the unique needs of Life Science companies. Gain deeper insight into the capabilities of our eQMS solution by booking a free demo with one of our Quality Solution Consultants.
This article will cover the following topics:
- What Is a Nonconformance Report (NCR)?
- Nonconformance Report Example
- What Is the Nonconformance Report Process?
- Who Can Issue a Nonconformance Report?
- When To Issue a Nonconformance Report?
- Who Writes a Nonconformance Report?
- How To Close a Nonconformance Report?
- What Is the Role of QMS Software in Managing Nonconformance Reports?
What Is a Nonconformance Report (NCR)?
A nonconformance report (NCR) is a document that formally records and addresses the event of a product, service, or process failing to meet predetermined requirements.
Below are some of the ways companies refer to nonconformance reports.
- Nonconformance report
- Non conformance report
- Non-conformance report
- Nonconformity report
- Non-conformity report
- Non conformity report
- NCR (abbreviation for nonconformance report)
Nonconformance reports can be referred to using full form or abbreviations, but they all mean the same thing: a report that formally records a nonconformance.
The specific term used may depend on the specific industry or company.
The primary purpose of a nonconformance report (NCR) is to document nonconformances clearly, or events where performance has not met requirements, to facilitate a systematic evaluation of the nonconformance.
The NCR then helps to ensure that corrective actions can be taken to solve the problem, prevent recurrence, and maintain the integrity and quality of the product or service.
Additionally, the NCR provides a basis for continuous improvement by offering insights into potential weaknesses or gaps in existing systems or processes.
NCRs are used to demonstrate to regulatory authorities that a company is reporting and addressing nonconformances according to applicable requirements.
A few requirements that specify nonconformance management and NCRs are listed below.
- ISO 9001:2015 in Section 10.2.2
- ISO 13485:2016 in Section 8.3
- FDA 21 CFR Part 820 in Section 21 CFR 820.90
Nonconformance Report Example
Life Science companies have the flexibility to design various types of nonconformance reports tailored to their specific needs. However, some essential elements typically appear across these different NCR formats.
Common elements that appear across different formats of nonconformance reports are listed below.
- Reason for the Nonconformance Report
- Details of the Nonconformance
- Affected Product or Process
- Personnel Involved
- Root Cause Analysis
- Disposition (Including the Immediate Action Taken)
- Corrective Actions
- Preventive Actions
- Conclusion
The illustration below represents an example of a nonconformance report structure.
Reason for the Nonconformance Report
The NCR must describe in general terms the nonconformance that was identified. This may include the date and time the nonconformance occurred and the predefined specification, standard, guideline, or regulation that was not met.
Details of the Nonconformance
The report should provide a clear and detailed description of the nonconformance. This section could include any relevant data or observations, such as test results, photos, or witness statements.
The severity of the nonconformance should also be defined in this section, such as minor nonconformance or major nonconformance.
Affected Product or Process
The nonconformance report must clearly describe the product or process affected by the nonconformance.
Personnel Involved
The NCR must clearly state the assigned personnel involved in the nonconformance. These employees include the person who identified the nonconformance, the person who investigated it, and the person who is responsible for taking corrective action.
Root Cause Analysis
Root cause analysis is the process of identifying the source of an issue. The nonconformance report should contain an investigation of the root cause of the nonconformance.
The root cause analysis should be based on the findings of the investigation and should identify the underlying factors that contributed to the nonconformance. This can be done using a variety of techniques, such as the “5 Whys” method, the “Ishikawa diagram” (also known as the “fishbone diagram”), and the “Pareto chart.”
Disposition
The disposition is the outcome of the nonconformance handling process, which includes the immediate action taken, the corrective actions, and the preventive actions.
The nonconformance report must specify what will be done with the affected product, service, or process.
The disposition options may include the following actions:
- Scrap: The product or process is destroyed and cannot be used. This is typically the best option for major nonconformances that cannot be corrected.
- Return to Supplier: In case of supplier nonconformances, the product or process is returned to the supplier.
- Downgrade: When the current version of a product or process has nonconformances, it can be downgraded to a lower grade or category without the presence of nonconformances.
- Use as Is: The product or process is used even though it does not meet all requirements. This can be an option for minor nonconformances that do not affect safety or performance.
- Rework: Modifications are performed to the product or process to bring it into compliance with the requirements.
Corrective Actions
Corrective actions are taken to address a specific issue that has already occurred.
The nonconformance report should describe the actions that will be taken to correct the nonconformance.
The corrective actions should be based on the findings of the root cause analysis and, if necessary, should be escalated to the corrective and preventive action (CAPA) process.
Preventive Actions
Preventive actions are taken to prevent potential issues from occurring.
The NCR should describe the actions that will be taken to prevent similar nonconformances from happening in the future. These actions can be related to the CAPA process if necessary.
Conclusion
The nonconformance report must summarize the NC, including the initial risk assessment and the effectiveness assessment of the corrective action. The report should also mention any recommendations for improvement.
The example provided above illustrates some fundamental components necessary for documenting and addressing nonconformances within an effective quality management system.
With the eQMS software solution, such as SimplerQMS, you can create various types of NCR forms and templates tailored to specific purposes. The system helps ensure that NCRs are created and managed efficiently and effectively and contain all of the necessary information for investigation and corrective action.
Consider downloading our free Nonconformance Report template. The NCR template is designed to assist you in documenting information related to nonconformance clearly and concisely.
What Is the Nonconformance Report Process?
The nonconformance report process is a systematic approach to help formally document, investigate, and solve a nonconformance.
While companies can develop their own NCR process to meet the applicable requirements, several pivotal steps should be considered to ensure a comprehensive and effective approach.
Below are the essential steps to writing an effective nonconformance report.
1. Document the Nonconformance
The first step in the NCR process is to document the nonconformance, which can be done by completing an NCR form or template.
The NCR should include information such as the date and time of the nonconformance, the affected product or process, the personnel involved, and the severity of the nonconformance.
It is important to be as specific and detailed as possible when documenting the nonconformance, helping to ensure it is complete and informative.
2. Perform a Root Cause Analysis
Once the nonconformance has been documented, the next step is to perform a root cause analysis to identify the origin of the nonconformance.
The root cause analysis aims to identify the underlying factors that contributed to the problem.
3. Implement Corrective and Preventive Action
After identifying the reason for the nonconformance, corrective actions must be implemented. Corrective actions address the immediate issue and are designed to rectify the specific nonconformance.
Additionally, preventive actions aim to make systemic changes to prevent similar nonconformances from occurring in the future.
It is essential to review and update the risk assessment after implementing corrective and preventive actions to ensure their effectiveness in mitigating potential risks.
4. Monitor Actions Effectiveness
After implementing corrective and preventive actions, it is essential to monitor their effectiveness.
This involves evaluating whether the actions taken have successfully resolved the nonconformance and prevented its recurrence. If necessary, adjustments can be made to improve the actions’ effectiveness.
Who Can Issue a Nonconformance Report?
Nonconformance reports can be issued by all employees when they identify a nonconformance in their daily tasks, regardless of their role or department.
When employees identify a nonconformance, they should report it to their supervisor or a responsible person for issuing nonconformance reports. These responsible persons can be, for example, quality assurance personnel, project managers, or project consultants.
When To Issue a Nonconformance Report?
A nonconformance report should be issued whenever a product, service, or process does not comply with the requirements.
The following examples, in the context of the Life Sciences industry, can be an indication for issuing an NCR.
- A certain component fails during manufacturing.
- An instrument for a special test malfunction.
- The raw materials for a medication are accidentally swapped.
- Vaccine vials are discovered to be contaminated.
- A defective product is returned to the manufacturer.
- A batch of products fails inspection.
- A vendor supplies incorrect components.
- Products are delivered late to customers.
Whether or not to issue an NCR should be decided on a case-by-case basis. Life Science companies must consider the severity of the nonconformance and its potential impact on the product, process, or customer.
Who Writes a Nonconformance Report?
A nonconformance report is typically written by a designated individual or team responsible for writing and investigating NCRs. These people may be quality assurance specialists, project managers, or other responsible personnel.
How To Close a Nonconformance Report?
Closing a nonconformance report involves a systematic process to ensure that the nonconformance has been effectively addressed and resolved.
Once responsible persons have verified that the corrective actions have been implemented and are effective, they can approve the nonconformance report process to close the NCR.
What Is the Role of QMS Software in Managing Nonconformance Reports?
QMS software streamlines the entire process of managing nonconformances and nonconformance reports.
The nonconformance management software is an integral part of the eQMS and provides capabilities to handle all nonconformance-related tasks.
The system helps ensure that all nonconformances are properly documented and that all relevant documentation is controlled and organized.
In some companies, nonconformance reports are managed manually through paper-based or hybrid systems. However, this approach has significant drawbacks, including the risk of lost documents, a higher likelihood of errors, and a time-consuming process compared to using a nonconformance report software system.
A more efficient alternative is adopting eQMS software with nonconformance management capabilities, such as SimplerQMS.
SimplerQMS is a fully validated eQMS software solution. Our modules are interlinked for a seamless workflow.
SimplerQMS provides users with a predefined workflow that guides them through the necessary steps for handling nonconformances, ensuring comprehensive documentation.
The system automatically records all actions taken, along with a time-stamped audit trail. It sends automatic notifications and reminders to relevant personnel, ensuring that they are aware of assigned tasks promptly.
To assess the advantages of adopting an eQMS, we suggest downloading our eQMS Business Case template.
Our template assists in determining the impact of an eQMS on your company and facilitates clear communication of your findings to management. Through an evaluation of potential gains in efficiency, cost savings, and compliance improvements, you can build a compelling case for eQMS implementation.
Final Thoughts
A nonconformance report (NCR) is a document that is used to document, investigate, and address a nonconformance.
Documenting and properly managing nonconformances is a requirement in highly regulated life science industries, such as pharmaceuticals, medical devices, and laboratories, to ensure the safety and efficacy of their products.
Life science companies are increasingly turning to QMS software solutions to streamline their quality management processes and manage nonconformance more efficiently.
SimplerQMS provide eQMS software solution designed specifically for Life Science companies, offering quality and nonconformance management capabilities. With integrated processes and predefined workflows, the software guides users through each stage of the process, helping ensure compliance with requirements.
Experience firsthand how SimplerQMS can streamline your quality management processes by booking a demo with our Quality Solution Consultants.
