Standard Operating Procedure for Non-Conformance Management

1) Purpose

The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of non-conformances to prevent recurrence and ensure continuous improvement within the organization.

2) Scope

This SOP applies to all departments and processes within the organization that may encounter non-conformances impacting product quality, safety, or regulatory compliance.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Non-Conformance Coordinator:

Responsible for overseeing the non-conformance management process and ensuring timely resolution.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving non-conformance investigations and corrective actions.

3.3 Department Managers/Supervisors:

Responsible for initiating non-conformance reports and implementing corrective actions.

4) Procedure

4.1 Non-Conformance Identification:

4.1.1 Identify and document instances of non-conformance from established processes or procedures.
4.1.2 Classify non-conformances based on severity and impact on product quality or safety.
4.1.3 Assign a unique non-conformance number and enter details into the Non-Conformance Log.

4.2 Non-Conformance Investigation:

4.2.1 Form an investigation team including relevant stakeholders (e.g., QA, Production).
4.2.2 Conduct a root cause analysis to determine factors contributing to the non-conformance.
4.2.3 Document investigation findings, including root cause(s) and impact assessment.

4.3 Impact Assessment:

4.3.1 Evaluate the impact of the non-conformance on product quality, safety, and regulatory compliance.
4.3.2 Determine immediate corrective actions to prevent further non-conformances.
4.3.3 Notify QA and relevant departments of the non-conformance assessment.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop and implement corrective actions addressing root causes of the non-conformance.
4.4.2 Propose preventive actions to prevent recurrence of similar non-conformances.
4.4.3 Obtain QA approval of CAPA plans and monitor implementation effectiveness.

4.5 Non-Conformance Closure and Documentation:

4.5.1 Verify completion and effectiveness of implemented corrective actions.
4.5.2 Close non-conformance report and document final disposition and approval.
4.5.3 Archive non-conformance records and maintain for regulatory inspections and audits.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Non-Conformance Log
2. Investigation Reports
3. CAPA Plans
4. Non-Conformance Closure Records

7) Reference, if any

1. FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0