Failing to Manage Your Non-Conformances Effectively

Non-conformances occur when a product or process does not meet regulatory requirements, quality standards, or approved in-house procedures. Failure to effectively manage non-conformances may jeopardise your CE UKCA marking status, lead to higher business costs, penalties from regulatory authorities, and even medical device recalls.

This can negatively impact your Quality Management System and raise concerns about patient safety, ultimately leading to a decline in the quality of care. This is why managing and reporting non-conformances in real-time is crucial.

The Process of Non-Conformance Management in Medical Devices

The management of non-conformances in medical devices involves several steps. These include identification, investigation, Root Cause Analysis (RCA), impact assessment, and planning Corrective and Preventive Action(s) (CAPA).

It is important that the process is well-documented and that all stakeholders are trained in the process to ensure its effectiveness.

This involves implementing measures to correct the issue and verifying the effectiveness of these measures through testing and monitoring of potential risks.

• Identification

This can be accomplished through various methods, such as internal audits, customer complaints, or routine inspections across all operations and shifts.

• Investigation

This involves gathering information about the non-conformance, analysing data and identifying the underlying problem.

• Evaluation

Once the root cause of the non-conformance is identified, the impact on patient safety and the medical device’s regulatory compliance must be evaluated.

• CAPA

This involves implementing measures to correct the issue and verifying the effectiveness of these measures through testing and monitoring of potential risks.