In life sciences, one of the most heard terms is non-conformity management or NC management. To utilize and maintain an ideal NC management process, first, you need to understand what it is for and what are the risks and costs if it doesn’t work properly.
Nonconformity management aims to identify, document, investigate, and resolve the events that occur in an organization’s processes, products, or services. The crucial step of resolving a nonconformity is to address the problem, prevent future nonconformities from recurrence, and of course continuously improve the organization’s processes.
Today, we’ll delve into the details of what nonconformity is, the different types of NCs, their impact on your business, and how to properly handle it. Additionally, we’ll discuss how to avoid nonconformances and the role of QMS software in streamlining nonconformance processes.
What is nonconformity?
It can be defined as negligence or an unfavorable occurrence that happened to the product, process, or anywhere in the QMS. For example, not using the management system properly or not following the SOPs can lead to nonconforming products.
Nonconformity is defined as an event of a product, service, or process that does not meet the predefined requirements.
Nonconformity (NC) refers to a malfunction or deviation occurring during an activity or a process. Nonconformities can be generated by an anomaly during the execution of an activity (human error, technical problem, etc.), by the occurrence of an external event that compromises the quality of the service (weather conditions, foreign object, contamination, etc.), or by the inadequacy of the operating procedure to the expected results.
Nonconformance management is listed as a requirement in several standards and regulations, including:
Domestic and foreign manufacturers, initial importers, and other businesses involved in producing and distributing medical devices intended for sale in the U.S. must register their establishments with the FDA to ensure that they have accurate information about all parties involved in the production and distribution of medical devices. Establishments must use the FDA’s Unified Registration and Listing System (FURLS) to complete their registration electronically. Once registered, establishments must list all medical devices they manufacture, prepare, propagate, compound, assemble, or process for commercial distribution in the US.
We can define nonconformance as failing to meet a requirement based on these definitions. It may be internal requirements where it’s set by the company or external requirements where it’s imposed by regulators. Regardless of the type (minor or major) of nonconformity, it affects the products or services and causes harm to the safety or health of patients. Therefore, a nonconformity (NC) always requires corrective actions. Each corrective action contains opportunities for the organization to identify improvement areas and take actions to enhance the quality of products or services. Therefore ISO 9001, Clause 10.2 emphasizes the importance of continuous improvement and sets a procedure for reacting to a nonconformity.
Recommended learning: If you want to have a more detailed definition, you can read about the term “Nonconformity” in our glossary.
What Is the Difference Between Nonconformance and Noncompliance?
Nonconformity is also referred to as nonconformances, non-conformities, or simply NCs throughout the industry. According to the International Standards Organization (ISO), "conformity" is the fulfillment of a requirement. The term "conformance" is obsolete. The term used is "conformity" (and "nonconformity"). There is a slight difference either in approach or in criteria between conformity and conformance. The term “conformity” means the fulfillment of an internal procedure while “conformance” is used for the fulfillment of external requirements specifically to a violation of laws and regulations that have been set by external governing or regulatory bodies. 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 nonconformities?
There are two main types of nonconformities: —minor and major nonconformities. The company typically decides the criteria for defining the severity of a nonconformance based on its specific products, services, and processes.
It is important to note that the severity and the level of nonconformity may vary depending on the context and industry. What is a minor nonconformity in one industry can be considered a major in another.
What Is a Minor Nonconformity?
Minor Nonconformity that does not significantly impact the quality and safety of the product or service and does not affect the reliability and integrity of the management system. Most minor nonconformities are often isolated cases that could be fixed easily.
What is a Major Nonconformity?
On the contrary, a Major Nonconformity is a failure to meet requirements that are likely to significantly impact the quality, safety, or compliance of the product or service. Major nonconformities may be repeated occurrences or complex problems that adversely affect production processes and products, and require great resources, effort, and time.
Examples of Minor and Major Nonconformities
Please note that these lists are not exhaustive, and the order of presentation is random, with no implied priority.
Common Nonconformances
In this part, we’ve listed the most common nonconformities for ISO 9001, ISO 13485, and FDA 21 CFR Part 820 and highlight the importance of maintaining rigorous quality management practices to ensure compliance with relevant standards and regulations.
You should address these areas effectively to avoid costly nonconformances and improve your overall quality management system.
How to avoid nonconformances and minimize risk
Avoiding nonconformances or minimizing the risk of recurrent events before they grow is key to maintaining quality and compliance. Let’s learn some practical tips to prevent or minimize risks and ensure your business stays on track and runs smoothly:
1. Regular Internal Audits
Systematically checking your processes against ISO 9001, ISO 13485, or FDA 21 CFR 820 with a well-established internal audit plan allows you to observe your processes with a fresh pair of eyes and detect potential issues early. Moreover, Scilife takes the complexity out of audit management by offering features that enable you to manage your internal audit without a hassle.
2. Continuous Employee Training
Training your employees continuously allows your team to be aware of the latest procedures and regulations. Additionally, adding an effectiveness check step makes training sessions more engaging.
The Scilife Training module offers you a more streamlined training management process with function-based training plans, automated training activities, and a dashboard where you can track the training-related metrics.
3. Risk Management Activities
Organizational risks should be assessed regularly, using quality tools like Failure Mode and Effects Analysis (FMEA). Proactively identify areas where nonconformances could occur and assess their impact to reduce the risk of those nonconformances happening by implementing controls before they become costly.
4. Establish Effective CAPA Processes
The CAPA process helps to correct and prevent any issues. Having a cloud-based QMS CAPA module helps you to manage the CAPA process systematically including addressing nonconformities quickly, investigating and identifying the root cause(s), as well as implementing (Corrective and or Preventative) actions to prevent recurrence, and regularly reviewing the effectiveness of these actions.
5. Implement Robust Document Control
A well-established document management system keeps operations running smoothly. Documents should clearly define processes to help eliminate misunderstandings and reduce the risk of errors, and the latest versions should be available to relevant employees within the organization to prevent outdated information. Good documentation supports compliance and makes it easier to track and improve your processes. Additionally, all employees should know that when a change is needed, it should be made through documents and change control systems.
6. Supplier Quality Management
Regular evaluation and audit of suppliers help you to ensure whether they meet predefined quality standards. The Scilife Supplier module offers you integration within other QMS processes so you can select, evaluate, quality, monitor, audit your suppliers, execute Supplier NC reports, and keep all supplier files digitally in one place.
7. Use Quality Management Software
Leverage quality management software to streamline processes and automate documentation. This can reduce manual errors and provide real-time data for better decision-making but also enhanced effectiveness and overall compliance.
Non-Conformance Report Template
Use a non-conformance report template to document all necessary details regarding a nonconforming process or product. The NCR template helps your organization to collect all the data that is required for ISO 9001, ISO 13485, and FDA such as the NC description, correction(s), corrective actions (and preventative actions if any), and approvals of NCR owner and Quality manager at a minimum of the personnel.
Guides & Tools: Download the nonconformity Report Template
Scilife Tips: The role of QMS software in nonconformance management
eQMS software offers automation and a streamlined nonconformance management process, and it makes the process more efficient and effective. The most common benefits of a well-designed eQMS with nonconformance management features are the following:
- Automated reminders, notifications,
- Predefined workflows
- Robust reporting tools
- Collect and analyze data efficiently
- Track corrective measures in real time
- Customizable non-conformance report templates
- Customizable workflows for approvals of each phase of NC
- Traceability of the NCR owner, task assignees, and approvers and timestamps of each action.
- Monitoring previous events with details such as their root causes, how they were handled, dispositioned, etc.
You cannot measure the cost of a nonconformity by summing up all resources used. It’s an ongoing process that requires continuous improvement; therefore, you should foster a quality culture where quality is everyone’s responsibility.
By integrating all these aspects, QMS software helps life sciences businesses maintain high and uniform quality, ensure compliance with requirements, and minimize the risks and costs associated with nonconformances.
Scilife Smart QMS offers a comprehensive cloud-based management system with nonconformance management features tailored to the unique needs of life science companies.
Conclusion
Scilife is designed specifically for the needs of life science companies, offering powerful features to help you strengthen nonconformance management capabilities, improve both quality and compliance efforts, and increase efficiency. By providing integration between QMS processes and pre-defined workflows, users are guided through the phases of the nonconformance management process.
Don't let nonconformities disrupt your operations. Scilife’s Smart QMS is here to help!
