Standard Operating Procedure for Customer Complaints Handling for Creams
1) Purpose
The purpose of this SOP is to establish procedures for the handling and resolution of customer complaints related to creams. This ensures that all complaints are documented, investigated thoroughly, and resolved promptly to maintain customer satisfaction and compliance with regulatory requirements.
2) Scope
This SOP applies to the Quality Assurance Department and all personnel involved in receiving, documenting, investigating, and resolving customer complaints related to creams. It covers complaints received from customers, healthcare professionals, distributors, and other stakeholders.
3) Responsibilities
The Quality Assurance Manager is responsible for overseeing and coordinating the customer complaints handling process. The Quality Assurance Team and Customer Service Team are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Complaint Receipt and Registration
4.1.1 Receive customer complaints through dedicated channels (e.g., customer service hotline, email, complaint forms).
4.1.2 Document all complaint details, including complainant information, product name, lot number, nature of complaint, and contact information.
4.1.3 Assign a unique complaint reference number for tracking purposes.
4.2 Initial Assessment
4.2.1 Conduct an initial assessment of the complaint to determine its nature and severity.
4.2.2 Classify complaints based on urgency and potential impact on patient safety or product quality.
4.2.3 Verify complainant identity
4.3 Investigation and Root Cause Analysis
4.3.1 Assign an investigation team to conduct a thorough investigation of the complaint.
4.3.2 Gather relevant information, such as batch records, testing results, and customer feedback.
4.3.3 Perform root cause analysis to identify the underlying cause(s) of the complaint.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop and implement appropriate corrective actions to address the identified root cause(s) of the complaint.
4.4.2 Implement preventive actions to prevent recurrence of similar complaints in the future.
4.4.3 Obtain approval from management for proposed CAPA actions.
4.5 Resolution and Communication
4.5.1 Communicate with the complainant regarding the investigation findings and proposed resolution.
4.5.2 Provide compensation or replacement products as appropriate, in consultation with customer service and regulatory affairs.
4.5.3 Document all communication with the complainant and maintain records of complaint resolution.
4.6 Closure and Follow-up
4.6.1 Close the complaint file after resolution and verification of complainant satisfaction.
4.6.2 Conduct follow-up with complainants, if necessary, to ensure satisfaction with the resolution.
4.6.3 Review and analyze trends in customer complaints to identify systemic issues and opportunities for improvement.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
Complaint Investigation Reports
CAPA Plans and Reports
Communication Logs with Complainants
Trend Analysis Reports
7) Reference, if any
ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
ICH Q10: Pharmaceutical Quality System
8) SOP Version
Version 1.0