The 8 Simple Steps of Nonconformance Management

Nonconformance (NC) is an ISO 9000 audit term indicating the quality of a product or process does not meet established requirements. A nonconformance means that some aspects of a company’s standard operating procedures are not followed or need to be modified.

The cost of nonconformance issues can be significant, making it critical to address such events quickly. Minimizing nonconformity helps ensure quality, safety, and regulatory compliance.

Epsilon3 enables teams to confidently handle the unexpected through rapid assessment, triage, and resolution.

8-Step Nonconformance Management Process

With Epsilon3’s issue management solution, your team can execute these 8 steps to ensure an efficient and timely resolution of any nonconforming procedures or builds.

Step 1: Identification. Flag the nonconformance during a procedure to quickly alert your team and prevent further issues.

Step 2. Containment. Take immediate action to contain the impact of the nonconformance, which may involve pausing procedures, segregating parts, or halting production.

Step 3: Documentation. Create a formal nonconformance report (NCR) that documents all the essential details about the process, part, or product issue.

Step 4: Assessment. Evaluate the severity of the nonconformance, and label the issue as Minor, Major, or Critical. Procedures with Critical issues cannot be resumed until the issue is downgraded or resolved.

Step 5. Investigation. Conduct a thorough analysis to determine the root cause of the nonconformance. Assess the impact of the nonconformance on quality, safety, and compliance.

Step 6. CAPA. Develop and implement a corrective and preventive action (CAPA) plan to solve the nonconformance and prevent reoccurrence.

Step 7. Verification. Monitor the effectiveness of CAPA to ensure parts and processes are back to normal and the nonconformance has been resolved.

Step 8. Closure. Close the nonconformance report once the nonconformance is addressed and risks are mitigated. Record all actions taken during the process for future reference and traceability.

5 Benefits of a Nonconformance Management System

The primary purpose of this type of system is to identify the root cause of a problem and that corrective and preventive actions are put in place to address the issue. There are many reasons to adopt a modern issue-tracking solution:

• Maintain Regulatory Compliance. Processes for identifying and dealing with quality issues help your team understand and meet external requirements.

• Streamline Complex Workflows. Systems designed to address complex issues quickly make it much easier to work within high-risk environments.

• Continuous Improvement. Methodical issue-tracking and problem-solving will improve the overall quality of your processes, parts, and products.

• Save Time & Money. Resolving nonconformities will help prevent larger, more costly issues and production delays.

• Accountability & Traceability. Proper nonconformance reporting is essential if you want to be prepared for quality, safety, and compliance audits.

Are you interested in seeing how Epsilon3 can help your team achieve operational excellence? Book a demo with one of our product experts to learn more!