Standard Operating Procedure for Customer Complaints Handling for Transdermal Patches
1) Purpose
To establish procedures for receiving, documenting, evaluating, and resolving customer complaints related to transdermal patches, ensuring timely resolution and continuous improvement in product quality and customer satisfaction.
2) Scope
This SOP applies to all personnel involved in customer service, quality assurance (QA), regulatory affairs, and production departments responsible for handling customer complaints related to transdermal patches.
3) Responsibilities
3.1 Customer Service Representative: Receives and documents customer complaints.
3.2 QA Manager: Oversees the investigation and resolution of complaints.
3.3 Regulatory Affairs: Ensures compliance with regulatory reporting requirements.
3.4 Production: Provides input on manufacturing issues related to complaints.
3.5 Senior Management: Reviews trends in complaints and approves corrective actions.
4) Procedure
4.1 Complaint Receipt:
4.1.1 Receive customer complaints through designated channels (e.g., phone, email, web portal).
4.1.2 Document complaint details including product name, batch number, description of complaint, and contact information.
4.2 Evaluation and Investigation:
4.2.1 Assign a unique complaint number and classify the complaint based on severity and potential impact on patient safety.
4.2.2 Initiate an investigation to determine the root cause of the complaint, involving relevant departments as necessary.
4.3 Corrective and Preventive Actions (CAPA):
4.3.1 Develop and implement corrective actions to address immediate issues identified by the investigation.
4.3.2 Implement preventive actions to prevent recurrence of similar complaints in the future.
4.4 Communication:
4.4.1 Communicate with the customer to acknowledge receipt of the complaint and provide updates on the investigation and resolution process.
4.4.2 Provide a formal response to the customer detailing the findings of the investigation and any corrective actions taken.
4.5 Documentation and Reporting:
4.5.1 Maintain accurate and complete records of all customer complaints, investigations, and resolutions.
4.5.2 Report serious complaints to regulatory authorities as per regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
Complaint Forms
Investigation Reports
Corrective and Preventive Action Plans
7) Reference, if any
ISO 13485: Medical devices – Quality management systems
FDA Guidance for Industry: Handling of Customer Complaints
8) SOP Version
Version 1.0
