SOP Guide for Pharma

Good Warehousing Practices: SOP for Complaint Handling

Standard Operating Procedure for Complaint Handling

Purpose

The purpose of this SOP is to establish procedures for handling and resolving customer complaints related to warehouse operations in the pharmaceutical facility to ensure timely resolution, customer satisfaction, and continuous improvement.

Scope

This SOP applies to all personnel involved in receiving, documenting, investigating, and resolving customer complaints related to warehouse operations.

Responsibilities

  • Customer Service Representatives: Responsible for receiving and documenting customer complaints, escalating complex issues, and communicating with customers throughout the complaint resolution process.
  • Warehouse Managers: Responsible for overseeing complaint handling procedures, coordinating investigations, implementing corrective actions, and monitoring complaint trends.
  • Quality Assurance Department: Responsible for conducting investigations into customer complaints, identifying root causes, and implementing corrective and preventive actions to address underlying issues.
  • Operations Staff: Responsible for providing relevant information and assistance during complaint investigations and supporting corrective actions to prevent recurrence.

Procedure

  1. Complaint Receipt and Registration:
    • Establish a designated channel or point of contact for customers to submit complaints related to warehouse operations, such as damaged or delayed shipments, incorrect orders, or poor service.
    • Ensure that all customer complaints are promptly recorded in a centralized complaint management system or database, including details such as the nature of the complaint, customer information, and complaint resolution status.
    • Assign unique complaint reference numbers or identifiers to track
and manage each complaint throughout the resolution process.
  • Complaint Investigation:
    • Assign trained personnel to investigate each customer complaint thoroughly, including gathering relevant information, conducting root cause analyses, and identifying contributing factors.
    • Document the investigation process, findings, and conclusions in a complaint investigation report, detailing actions taken, evidence collected, and corrective actions proposed.
    • Involve cross-functional teams, including quality assurance, operations, and customer service, as needed to address complex or systemic issues identified during the investigation.
  • Corrective Action and Resolution:
    • Develop and implement corrective and preventive actions (CAPAs) to address root causes identified during the complaint investigation and prevent recurrence of similar issues in the future.
    • Communicate with the customer to provide updates on the status of the complaint investigation and resolution process, including proposed actions and timelines for resolution.
    • Follow up with the customer after implementing corrective actions to ensure satisfaction with the resolution and address any remaining concerns or issues.
  • Complaint Monitoring and Analysis:
    • Track and monitor the status and progress of all customer complaints through regular reviews of complaint logs, reports, and metrics.
    • Analyze complaint data and trends to identify recurring issues, systemic problems, or opportunities for process improvement within warehouse operations.
    • Implement continuous improvement initiatives based on lessons learned from complaint handling activities to enhance customer satisfaction and prevent future complaints.
  • Abbreviations

    • SOP: Standard Operating Procedure
    • CAPAs: Corrective and Preventive Actions

    Documents

    • Complaint Handling Procedure Manual
    • Complaint Investigation Report Template
    • Corrective Action Plan (CAPA)
    • Customer Communication Templates
    • Complaint Trend Analysis Report

    SOP Version

    Version 1.0

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