Supplier Corrective Action – Standard Operating Procedure

1) Purpose

To establish a standardized process for addressing and correcting non-conformances and deficiencies identified with suppliers, ensuring continuous improvement and adherence to quality standards within the pharmaceutical purchase department.

2) Scope

This SOP applies to all supplier-related non-conformances, including quality issues, delivery delays, and failure to meet specifications.

3) Responsibilities

Quality Assurance (QA) Manager: Responsible for overseeing the supplier corrective action process.
Procurement Manager: Responsible for initiating and coordinating corrective actions with suppliers.
Quality Control (QC) Team: Responsible for identifying and documenting supplier non-conformances and assisting with investigations.

4) Procedure

4.1) Non-Conformance Identification:
4.1.1) Document and report non-conformances identified through quality inspections, audits, or customer complaints.
4.1.2) Classify non-conformances based on severity and impact on product quality and regulatory compliance.
4.1.3) Initiate immediate corrective actions for critical non-conformances affecting product safety or regulatory compliance.

4.2) Supplier Notification:
4.2.1) Notify the supplier of identified non-conformances promptly and provide detailed information, including evidence and impact assessment.
4.2.2) Request the supplier to investigate the root cause of the non-conformance and propose corrective actions.

4.3) Root Cause Analysis:
4.3.1) Conduct a thorough investigation to determine the root cause(s) of the non-conformance using appropriate problem-solving techniques (e.g., 5 Whys, Fishbone diagram).
4.3.2) Identify contributing factors and potential systemic issues within the supplier’s processes.

4.4) Corrective Action Plan (CAP) Development:
4.4.1) Collaborate with the supplier to develop a comprehensive CAP addressing identified root causes.
4.4.2) Define corrective actions, responsibilities, timelines, and success criteria for each action item.
4.4.3) Obtain approval from relevant stakeholders, including QA and Procurement, for the CAP.

4.5) Implementation of Corrective Actions:
4.5.1) Monitor and oversee the implementation of agreed-upon corrective actions by the supplier.
4.5.2) Verify the effectiveness of implemented corrective actions through follow-up inspections, tests, or audits.
4.5.3) Document the completion and verification of corrective actions.

4.6) Effectiveness Review:
4.6.1) Evaluate the effectiveness of implemented corrective actions based on predefined success criteria.
4.6.2) Determine if additional actions are necessary to prevent recurrence of non-conformances.
4.6.3) Close the corrective action process once the non-conformance is effectively addressed.

5) Abbreviations, if any

• CAP: Corrective Action Plan
• QA: Quality Assurance
• QC: Quality Control

6) Documents, if any

• Non-Conformance Reports
• Corrective Action Requests (CAR)
• Root Cause Analysis Reports
• Corrective Action Plan (CAP)
• Verification Records

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211, ISO 13485:2016
Industry Standards: Best practices in supplier quality management

8) SOP Version

Version 1.0