How to manage nonconformances in medical devices

It's important for medical device manufacturers to have a clear understanding of nonconformances—often referred to as NCs—and how to properly manage them. Why? Nonconformances can have a significant impact on patient safety and the quality of care they receive. In addition, nonconformances can lead to increased costs, regulatory penalties, and recalls.

A nonconformance occurs when a product doesn’t meet its specified requirements, which can occur at both the product and process level. Documenting and responding to a nonconformance is a crucial part of a quality management system for medical device manufacturers. Doing so successfully can be challenging, but it's essential to maintaining a high-quality product and protecting patients.

Nonconformance regulations

The word 'conformity' is mentioned throughout the internationally agreed medical device quality management system standard ISO 13485:2016 and the United States Food and Drug Administration (FDA) Code of Federal Regulations, 21 CFR Part 820. In fact, both the standard and the CFR have entire sections dedicated to nonconforming product, highlighting how important the control of nonconforming product for medical devices is within an organization.

Key points from the regulations

Important points in the regulations about managing nonconforming product include:

  • Identifying and controlling the product, so that it’s not used unintentionally or sent for delivery. This is typically a quarantine area where the product is segregated and labeled with a distinct quarantine label to ensure product mix-up does not occur.
  • A procedure needs to be created to ensure proper controls have been established. The procedure must also include information on the responsibilities/authorities for the identification, documentation, segregation, evaluation and disposition of nonconforming product.
  • When the nonconformance is being evaluated, a decision needs to be made as to whether or not an investigation is needed. Furthermore, the party responsible for the nonconformance must be notified.
  • Nonconformances need to be documented and maintained.
  • Products that have been reworked must meet acceptance criteria and regulatory requirements. Records of rework need to be maintained, specifically in the Device History Record (DHR) when complying with FDA regulations.

Identifying nonconformances in medical devices

A nonconformance can be identified at all stages of the product lifecycle. It can be caused by many different factors, including errors in the manufacturing process, design defects, poor quality materials, or user error. 

Product and process nonconformances

Product nonconformances occur when the physical product does not meet the requirements specified, but it’s important to remember that nonconformances aren't limited to just the product. In addition, there are also process nonconformances, and a nonconforming process can result in nonconforming product. For example, not following a Standard Operating Procedure (SOP) for a manufacturing process can lead to a product defect and therefore, a nonconformance report (NCR).

A process nonconformance is often more difficult to identify and correct than a product nonconformance. This is because a process nonconformance can result in the production of many non-conforming products, even if the individual products themselves meet all specifications. Processes, such as equipment calibration and document control activities, should be audited regularly to ensure continuous improvement throughout the organization.

What should you do when you encounter a nonconformance?

Expect nonconformances to be audited; an auditor will want to see how your company handles nonconformances. When you encounter a nonconformance, it's important to be proactive, be prepared and follow your procedures. Here are some important steps to take when you've identified a nonconformance:

  1. Initiate a nonconformance report (NCR). A nonconformance report should be initiated as soon as possible after the nonconformance is identified. We'll review the contents of a nonconformance report later on.

  2. Segregate nonconforming product immediately. Ensure access is not easily granted to quarantined product and have someone visually confirm that all affected product has been removed from production and labeled appropriately. Don't wait for a nonconformance report to be initiated to segregate the nonconforming product, even if you’re not sure the issue is a nonconformance. It's better to be proactive in preventing potential nonconforming product from getting out in the market than to wait until it’s too late.

  3. Investigate. Once the nonconformance report has been initiated, it's important to investigate the root cause of the problem. This will help you determine what actions need to be taken to prevent similar nonconformances from occurring in the future. If the issue has already occurred, and an investigation was conducted, then you don’t need to perform another investigation, but you should evaluate if a corrective and preventive action (CAPA) needs to be opened.

  4. Know the difference between a correction and a corrective action and proceed accordingly. A correction is when an action is taken to eliminate a nonconformity. Corrective action is when an action is taken to eliminate the cause of the nonconformity and prevent its recurrence.

  5. Set up a Material Review Board that meets regularly to discuss and evaluate the nonconformances raised. Use nonconformances to continually improve your product and processes. Learn from errors and always strive for safe, effective products for customers.

Creating a nonconformance report

When a nonconformance is identified, it must be documented in a nonconformance report. The nonconformance report should include a description of the issue, identification of the affected product, location of the issue and potential cause of the issue. 

Nonconformance reports are a necessary part of a quality management system and are used to track and trend nonconformances. They should be reviewed regularly to identify issues and prevent them from happening again in the future.

Tips for writing an effective nonconformance report:

  • Keep the reports clear and concise. 
  • Only involve the necessary stakeholders; Material Review Boards are helpful for this.
  • Make sure any changes to the product are done in real time, e.g., if the disposition is to continue using the product, remove the quarantine labels from the product and remove it from the quarantine area once the decision has been documented. 
  • Justifications for your disposition are critical, especially if you continue to use the product as is.
  • Use Quality Tools, such as fishbone diagrams and the 5 whys to help determine the root cause of the nonconformance.

Nonconformance and Corrective and Preventive Action (CAPA)

It's important to know when a nonconformance needs to be escalated into a CAPA. This decision should be based on the severity of the issue, its regulatory impacts, and how often it occurs. 

When a nonconformance is escalated into a CAPA, there should be an investigation to determine the root cause of the problem and corrective actions put in place to stop it from happening again. The goal of a CAPA is to prevent the issue from recurring. If the root cause cannot be determined, then multiple corrective actions may need to be put in place to mitigate the risk of the issue occurring again. Preventive actions can also be implemented if unfavorable trends have been identified in the product and/or processes, thus preventing a nonconformance from occurring in the future.

Documenting the decision making process is important. This documentation can be used to show that the company is proactive in addressing quality issues and that they value continuous improvement within the organization. It can also be used to defend the company against potential liability in the event of a patient injury or death. 

CAPA and nonconformance management software

CAPAs can be challenging to close out because they often require changes to processes or products. It's important to have a robust system in place to track CAPAs and ensure they are closed out in a timely manner. There are many software solutions available to help companies manage nonconformances and CAPAs. QMS software can be used to track nonconformances, investigate root causes, document CAPAs, and verify that actions were effective.

Use nonconformances to strengthen quality

A culture of quality adopts the mindset that a nonconformance is an opportunity to learn and improve. By viewing a nonconformance in this light, companies can create a feedback loop that strengthens the quality of their products and processes. In turn, this creates a more positive customer experience and builds trust in the brand. Implementing a robust nonconformance process will help you avoid costly mistakes, improve overall product quality and keep your customers safe.

Looking for an eQMS that offers customizable nonconformance and CAPA workflows? Check out Qualio.