Certified Pharmaceutical GMP Professional Practice

Which of the following is essential for managing complaint files?

1. Maintaining a secure storage area

2. Recording all written and oral complaints

3. Conducting regular employee training

4. Installing a digital complaint management system

The correct answer is: Recording all written and oral complaints

Recording all written and oral complaints is essential for managing complaint files because it creates a comprehensive record that can be referred to when investigating issues and determining trends in product quality or customer satisfaction. This systematic documentation ensures that each complaint is tracked accurately, allows for effective follow-up actions, and supports compliance with regulatory requirements. By having a detailed account of complaints, organizations can identify patterns over time that may indicate a recurring issue, enabling proactive resolutions and improvements. In addition, well-documented complaints facilitate effective communication among departments involved in the quality management process and can be critical during audits or inspections, demonstrating that the organization actively monitors and addresses customer concerns. Maintaining accurate records also plays a vital role in risk management and can significantly contribute to continuous improvement initiatives.