Standard Operating Procedure for Customer Complaints Handling for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the systematic handling, investigation, and resolution of customer complaints related to aerosol products to ensure customer satisfaction and regulatory compliance.
2) Scope
This SOP applies to all customer complaints received regarding aerosol products marketed by [Company Name], including complaints from consumers, healthcare professionals, distributors, and regulatory agencies.
3) Responsibilities
Complaints Handling Coordinator: Oversee the complaints handling process and ensure timely resolution of complaints.
Quality Assurance (QA) Team: Investigate complaints, assess root causes, and implement corrective actions.
Customer Service: Receive and document customer complaints, communicate with complainants, and provide feedback.
Regulatory Affairs: Ensure compliance with regulatory requirements for complaint handling and reporting.
4) Procedure
4.1 Complaint Receipt and Registration:
4.1.1 Establish procedures for receiving customer complaints through various channels (e.g., phone, email, website).
4.1.2 Document complaint details, including complainant information, product details, nature of complaint, and date of receipt.
4.1.3 Assign a unique complaint identification number and record complaints in the complaint handling database.
4.2 Complaint Evaluation and Investigation:
4.2.1 Review and assess the severity and potential impact of each complaint on product quality and safety.
4.2.2 Initiate investigation activities to determine the root cause of the complaint, including product testing, review of manufacturing records, and supplier evaluations.
4.2.3 Document investigation findings, including corrective actions taken or planned to prevent recurrence.
4.3 Complaint Resolution and Response:
4.3.1 Communicate with complainants to acknowledge receipt of the complaint and provide a timeline for investigation and resolution.
4.3.2 Provide a comprehensive response to the complainant, including investigation findings, corrective actions, and any compensation or replacement offered.
4.3.3 Obtain feedback from complainants to ensure satisfaction with the resolution and document follow-up actions if needed.
4.4 Escalation and Reporting:
4.4.1 Escalate unresolved or complex complaints to senior management or the complaints handling coordinator for further review and decision-making.
4.4.2 Report complaint trends, recurring issues, and corrective actions to management and regulatory affairs for review and potential regulatory reporting.
4.4.3 Maintain records of all complaint handling activities, including documentation of investigations, resolutions, and follow-up actions.
4.5 Continuous Improvement:
4.5.1 Conduct periodic reviews of the complaints handling process to identify opportunities for improvement.
4.5.2 Implement corrective and preventive actions based on trends, feedback, and regulatory requirements to enhance complaint handling effectiveness.
4.5.3 Provide training to personnel involved in complaint handling to ensure awareness of procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
Complaint Handling Database
Complaint Investigation Reports
Customer Correspondence Logs
Trend Analysis Reports
Regulatory Submission Forms (if applicable)
7) Reference, if any
FDA Guidance for Industry: Handling and Reporting of Adverse Events and Product Complaints
EMA Guideline on Good Pharmacovigilance Practices (GVP)
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
8) SOP Version
Version 1.0