Standard Operating Procedure for Handling Customer Complaints
1) Purpose
The purpose of this SOP is to establish procedures for the receipt, documentation, investigation, and resolution of customer complaints to ensure timely and effective handling, customer satisfaction, and continuous improvement.
2) Scope
This SOP applies to all departments involved in the receipt and management of customer complaints within the facility.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Customer Service Representative:
Responsible for receiving and documenting customer complaints.
3.2 Quality Assurance (QA) Specialist:
Responsible for investigating and resolving customer complaints.
3.3 Sales and Marketing:
Responsible for communicating with customers regarding complaint resolutions.
4) Procedure
4.1 Complaint Receipt and Documentation:
4.1.1 Receive customer complaints via designated channels (e.g., phone, email, website).
4.1.2 Document complaint details including customer information, product details, and nature of complaint.
4.1.3 Assign a unique complaint identification number and enter complaint into the Complaint Log.
4.2 Complaint Evaluation and Investigation:
4.2.1 Evaluate the severity and potential impact of the complaint on product quality and safety.
4.2.2 Initiate investigation to determine root cause(s) of the complaint.
4.2.3 Gather relevant information and conduct necessary tests or analyses.
4.3 Corrective and Preventive Actions (CAPA):
4.3.1 Implement immediate corrective actions to address urgent complaints.
4.3.2 Develop and implement corrective and preventive actions (CAPA)
4.3.3 Monitor and verify effectiveness of CAPA through follow-up and review.
4.4 Resolution and Communication:
4.4.1 Communicate complaint resolution to the customer in a timely manner.
4.4.2 Provide appropriate compensation or replacement as per company policies.
4.4.3 Document resolution details and obtain customer acknowledgment if required.
4.5 Trend Analysis and Reporting:
4.5.1 Conduct trend analysis of customer complaints to identify recurring issues.
4.5.2 Report complaint trends and analysis findings to management.
4.5.3 Implement improvements to prevent recurrence of similar complaints.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Complaint Log
2. Investigation Reports
3. CAPA Records
4. Trend Analysis Reports
7) Reference, if any
1. ISO 10002: Customer Satisfaction – Guidelines for Complaints Handling in Organizations
2. FDA Guidance for Industry: Handling and Reporting of Adverse Events and Product Complaints in Medical Devices
8) SOP Version
Version 1.0