Non-Conformance & Corrective Action SOP

Purpose

To outline the process for identifying, documenting, and addressing non-conformances to ensure continuous quality improvement.

Scope

Applicable to all laboratory personnel involved in quality management.

Responsibilities

• Quality Manager: Oversee the non-conformance process
• Laboratory Staff: Report non-conformances
• Quality Assurance Team: Review and verify corrective actions

Materials & equipment

• Non-conformance report form
• Corrective action plan template
• Quality management system documentation

Procedure

1. Identify non-conformance and document it using the non-conformance report form.
2. Notify the Quality Manager of the non-conformance.
3. Conduct a preliminary assessment to determine the impact of the non-conformance.
4. Assign a team to investigate the root cause of the non-conformance.
5. Develop a corrective action plan based on the root cause analysis.
6. Implement the corrective action plan and monitor its effectiveness.
7. Document the entire process in the quality management system.

Records

• Non-conformance reports
• Corrective action plans
• Meeting minutes from investigation discussions

Safety

• Ensure all personnel are trained on reporting non-conformances
• Maintain confidentiality of sensitive information during investigations