Understanding Nonconformance in QMS: Causes, Impact, and Prevention

Ensure product quality and compliance by managing nonconformance effectively. Learn how to address issues and improve processes in your QMS.

1. Understanding Nonconformance in
QMS: Causes, Impact, and Prevention

2. Every organization striving for quality
excellence faces challenges in maintaining
compliance with established standards. One
such challenge is nonconformance, which
occurs when a product, process, or system
deviates from quality expectations. Managing
non-conformances effectively within a Quality
Management System (QMS) is crucial to
maintaining compliance, reducing waste, and
ensuring customer satisfaction.

3. Nonconformance refers to any instance where
operations fail to meet defined ISO, FDA, or industry-
specific quality standards. This can stem from human
errors, equipment malfunctions, material defects, or
procedural missteps. If left unresolved, non-
conformances can lead to product recalls, regulatory
penalties, and reputational damage.
What is Nonconformance in QMS? :

4. Non-conformances are generally classified into two
categories:
Major Nonconformance – A critical deviation that
affects product integrity, safety, or compliance.
These require immediate corrective actions to
prevent severe consequences.
Minor Nonconformance – A smaller deviation that
does not immediately compromise safety or
compliance but could escalate if ignored.
Types of Nonconformance

5. Managing Nonconformance in a QMS
A structured approach to nonconformance management
helps organizations minimize risks and improve quality.
Here’s how a QMS streamlines the process:
1. Detection and Documentation: Employees and quality
teams must be trained to identify and document non-
conformances accurately. Recording details such as the
nature of the issue, affected processes, and supporting
evidence is critical.

6. Determining the underlying cause of a nonconformance
is key to preventing recurrence. Methods like the 5 Whys,
Fishbone Diagram, or Failure Mode and Effects Analysis
(FMEA) help identify root causes.
2. Root Cause Analysis:

7. Corrective Actions – Immediate steps to fix the identified
issue.
Preventive Actions – Long-term improvements to ensure
similar issues do not occur in the future.
3. Corrective and Preventive Actions (CAPA) :

8. A QMS helps track the effectiveness of corrective actions
through regular audits and data-driven monitoring.
How to Prevent Nonconformance?
Automate Processes with a QMS – A digital SharePoint-based
QMS can streamline reporting, tracking, and compliance.
Conduct Regular Audits – Routine inspections help catch
deviations before they escalate.
Train Employees Continuously – Educating staff on
compliance requirements ensures adherence to best practices.
4. Implementation and Monitoring :

9. Proactive nonconformance management not only helps
maintain compliance but also fosters continuous
improvement. By leveraging a SharePoint-based QMS,
organizations can enhance efficiency, reduce manual
errors, and stay ahead of regulatory requirements.
Conclusion: