Supplier Complaint Handling – Standard Operating Procedure

1) Purpose

To establish guidelines for the systematic handling and resolution of supplier complaints to ensure timely investigation, effective communication, and appropriate corrective actions within the pharmaceutical purchase department.

2) Scope

This SOP applies to all complaints received from internal stakeholders related to materials, components, or services supplied by external vendors or suppliers.

3) Responsibilities

Purchasing Department: Responsible for receiving and initiating investigations into supplier complaints.
Quality Assurance Team: Responsible for assessing complaint severity, conducting investigations, and implementing corrective actions.

4) Procedure

4.1) Complaint Receipt and Registration:
4.1.1) Receive supplier complaints through designated channels (e.g., complaint form, email, phone).
4.1.2) Register complaints in the complaint handling system with details of the complainant, nature of complaint, and urgency.

4.2) Complaint Assessment:
4.2.1) Evaluate the severity and potential impact of the complaint on product quality, safety, or compliance.
4.2.2) Classify complaints based on criticality and initiate appropriate investigation measures.

4.3) Investigation and Root Cause Analysis:
4.3.1) Form an investigation team to conduct a thorough root cause analysis of the complaint.
4.3.2) Gather evidence, interview stakeholders, and review relevant documentation to determine the cause of the complaint.

4.4) Corrective and Preventive Actions (CAPA):
4.4.1) Develop and implement corrective actions to address immediate concerns identified during the investigation.
4.4.2) Propose preventive actions to mitigate the risk of recurrence and improve supplier performance.

4.5) Resolution and Communication:
4.5.1) Communicate investigation findings, corrective actions, and timelines to the supplier.
4.5.2) Collaborate with the supplier to implement and verify effectiveness of corrective actions.

4.6) Documentation and Closure:
4.6.1) Document all stages of the complaint handling process, including investigation reports and correspondence with the supplier.
4.6.2) Close the complaint record in the system after verification of corrective actions and resolution of the complaint.

5) Abbreviations, if any

CAPA – Corrective and Preventive Actions

6) Documents, if any

• Supplier Complaint Form
• Investigation Reports
• Corrective Action Plans
• Communication Logs with Suppliers

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.198, ICH Q10
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0