Inadequate Complaint Handling Procedures

Overview

Company:
Sun Pharmaceutical Industries Limited
Issued on:
15-Dec-23
Feinumber:
3004561553
Inspection Dates:
04 Dec 2023 to 15 Dec 2023
Location:
Survey No. 1012, Dadra, Dadra & Nagar Haveli and Daman, 396191 India
Investigators:
  • Pratik S Upadhyay

Detailed Analysis

Key Observations

  • The firm's approach to handling product quality complaints lacks depth in investigation and trend analysis, potentially resulting in recurrent issues being unaddressed. There is a critical need for process enhancement to ensure effective complaint resolution and to improve overall product quality.

Possible Root Cause :

  • Lack of comprehensive procedures for handling product quality complaints.
  • Insufficient training or oversight for staff analyzing and investigating complaints.
  • Inadequate trend analysis and historical data review practices.
  • Failure to escalate significant or repeated complaints for thorough investigation.
  • Absence of clear guidance for contracted third-party call centers on product-specific questions.

Corrective Action:

  • Revise the existing SOPs related to complaint handling to ensure comprehensive coverage of complaint investigation process, including escalation procedures for significant or repeated complaints.
  • Institute a robust training program for staff responsible for complaint handling to ensure proper assessment and investigation of complaints.
  • Implement a more extensive trend analysis process that considers the product's entire shelf life to identify recurring issues promptly.
  • Develop and implement a system for thorough investigation of recurring complaints, ensuring root causes are identified and addressed.
  • Provide detailed guidelines and training to contracted third-party call centers outlining specific product-related questions to gather meaningful information from complainants.

Preventive Action

  • Establish a continuous improvement program for complaint handling processes, including regular review and update of SOPs.
  • Introduce a more robust training and assessment program for staff and third-party service providers to ensure competency in handling complaints.
  • Implement an advanced analytical tool for trend analysis to identify potential product quality issues based on historical complaint data.
  • Develop and maintain a quality dashboard for real-time tracking of complaints, investigations, and outcomes to facilitate timely decisions.
  • Engage in regular review meetings with third-party service providers to ensure compliance with the firm's standards for complaint handling.
View 483 Notice
350+ pharma facilities globally use Leucine
to stay compliant.
350+ pharma facilities globally
use Leucine
to stay compliant.
350+ Pharma
Facilities Globally
use Leucine
to stay compliant.
Speak with one of the expert consultants at Leucine to know how.
Schedule Demo