Effective non-conformance management is crucial for maintaining quality standards in any organization. With the integration of a Quality Management System (QMS), non-conformance issues can be addressed more systematically, efficiently, and transparently. The QISS Quality Management System (QMS) provides a structured approach to managing non-conformances (NCRs) to ensure timely resolution and prevent recurrence.
Non-Conformance Management Procedure: Step-by-Step Guide
Here's a step-by-step guide on how to manage non-conformances using the QISS system:
1. Identify and Report the Non-Conformance
Detection: During inspections, testing, audits, or daily operations, actively look for any deviations from established standards, procedures, or customer requirements. Non-conformances can include product defects, process deviations, equipment failures, or any instance where requirements are not met.
Documentation: Once a non-conformance is identified, formally document it by raising an NCR in the QISS system. Access the NCR module and fill out the NCR form, providing essential details like the date, description of the non-conformance, affected area, and identification number. Upload any supporting files or evidence.
2. Initial Review and Assignment
- The NCR is sent to the NCR module manager for initial approval.
- The manager reviews the submitted NCR for completeness and accuracy. He then approves the NCR and assigns it to a responsible person for investigation and resolution.
- The manager may decide if a final verification is needed after the NCR is addressed by checking the appropriate box in the system.
3. Investigate the Root Cause
The responsible person conducts a thorough investigation to determine the underlying cause of the non-conformance. This may involve reviewing records, inspecting processes and products, conducting interviews, and analyzing data.
Root cause analysis tools such as the 5 Whys, Fishbone Diagrams, or Failure Mode and Effects Analysis (FMEA) can be utilized to identify the root cause effectively.
4. Determine and Implement Corrective Actions
Based on the root cause analysis, appropriate corrective actions are developed to address the non-conformance and prevent its recurrence. These actions could involve:
- Process changes
- Employee retraining
- Equipment maintenance or replacement
- Updates to standard operating procedures (SOPs)
Ensure that the corrective actions are practical, effective, and sustainable. Implement them within a defined timeline, notifying and providing resources to all involved parties.
5. MRB Review (Optional)
- The responsible person has the option to send the NCR for review by a Material Review Board (MRB). This step involves assigning the NCR to MRB members, who will provide their feedback and recommendations.
- The responsible person reviews the feedback from the MRB before proceeding with corrective actions.
6. Disposition Decision (Optional)
- The responsible person may delegate the decision on the disposition of the non-conforming item to another user by sending the NCR for a disposition decision.
- The assigned user will decide on the appropriate disposition type and assign users to carry out disposition actions.
7. Disposition Actions
Either the responsible person or the user delegated with the disposition decision will assign disposition actions to execute the chosen disposition. Assigned users will complete the required tasks, and the NCR will be returned to either the responsible person or the delegated user for approval.
8. Verification and Approval
If a disposition decision was made, the delegated user reviews the completed disposition actions and closes the disposition decision assignment. This is sent to the responsible person for approval.
The responsible person can then either make further assignments or approve the NCR. If final verification was requested by the module manager at the start, the approved NCR will be sent for final closure. If no verification was requested, the NCR will close automatically after the responsible person’s approval.
9. Documentation, Reporting, and Continuous Improvement
Maintain detailed documentation throughout the NCR process for traceability, audits, and process improvement.
Regularly review and analyze NCR data to identify recurring trends or systemic issues. Use this information to implement process improvements, update procedures, and enhance training programs, reducing the occurrence of future non-conformances.
Key Features of QISS for NCR Management:
- Centralized System: All NCR information, including details, actions, and decisions, is stored and managed within the QISS platform, ensuring easy access, traceability, and efficient communication.
- Task Management and Notifications: QISS automatically generates tasks and sends notifications to assigned individuals, ensuring accountability and timely completion of actions.
- Tracking and Monitoring: The system allows for real-time tracking of NCR status and progress. Users can view open NCRs, track assignments, and monitor overall performance through the dashboard.
- Search Functionality: QISS offers search features to easily locate and retrieve specific NCR records based on user-defined criteria, enabling efficient data analysis and reporting.
- CAPA Integration: QISS allows users to initiate Corrective and Preventive Actions (CAPAs) directly from an NCR, facilitating a seamless transition to a more comprehensive problem-solving process.
Conclusion
By effectively utilizing the features and workflow of the QISS QMS system, organizations can establish a robust and systematic approach to manage non-conformances. This ensures the timely resolution of issues and drives continuous improvement in processes and product quality, ultimately enhancing customer satisfaction and overall operational performance.