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