Standard Operating Procedure for Product Complaint Handling
1) Purpose
The purpose of this SOP is to establish procedures for the receipt, evaluation, investigation, and resolution of product complaints to ensure customer satisfaction, regulatory compliance, and continuous improvement.
2) Scope
This SOP applies to all departments and personnel within the organization responsible for receiving, documenting, and resolving product complaints.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Complaints Manager:
Responsible for overseeing the product complaint handling process and ensuring timely resolution.
3.2 Quality Assurance (QA) Specialist:
Responsible for reviewing and approving complaint investigations and corrective actions.
3.3 Customer Service Representatives:
Responsible for receiving and documenting product complaints from customers.
4) Procedure
4.1 Complaint Receipt and Registration:
4.1.1 Receive product complaints from customers through designated channels (e.g., phone, email, web portal).
4.1.2 Record complaint details including customer information, nature of complaint, and product identification.
4.1.3 Assign a unique complaint number and enter details into the Complaint Log.
4.2 Complaint Evaluation and Classification:
4.2.1 Evaluate the complaint to determine validity, seriousness, and impact on product quality or safety.
4.2.2 Classify complaints based on severity and regulatory implications (e.g., adverse events, recalls).
4.2.3 Notify QA and relevant departments of critical complaints requiring immediate action.
4.3 Complaint Investigation:
4.3.1 Form an investigation team including QA,
4.3.2 Conduct a thorough investigation to determine root cause(s) of the complaint.
4.3.3 Document investigation findings, including root cause analysis and impact assessment.
4.4 Corrective and Preventive Actions (CAPA):
4.4.1 Develop and implement corrective actions addressing root causes identified during investigation.
4.4.2 Propose preventive actions to prevent recurrence of similar complaints.
4.4.3 Obtain QA approval of CAPA plans and monitor implementation effectiveness.
4.5 Resolution and Follow-Up:
4.5.1 Communicate resolution of the complaint to the customer within defined timelines.
4.5.2 Document customer feedback or acceptance of resolution.
4.5.3 Follow up with customers as necessary to ensure satisfaction and closure of complaint.
4.6 Trend Analysis and Reporting:
4.6.1 Analyze product complaint trends to identify recurring issues or emerging patterns.
4.6.2 Prepare periodic reports on complaint trends, investigation outcomes, and corrective actions.
4.6.3 Present findings to management for review and decision-making on process improvements.
5) Abbreviations, if any
QA – Quality Assurance
CAPA – Corrective and Preventive Actions
6) Documents, if any
1. Complaint Log
2. Investigation Reports
3. CAPA Plans and Reports
4. Customer Communication Records
7) Reference, if any
1. FDA Guidance for Industry: Handling and Reporting of Product Quality Complaints
2. ISO 13485 Medical devices – Quality management systems
8) SOP Version
Version 1.0