Comprehensive Guide to Complaint Handling and Resolution in Quality Assurance

1) Purpose

The purpose of this SOP is to establish a systematic process for receiving, documenting, investigating, and resolving customer complaints in compliance with regulatory requirements. Proper complaint handling ensures product quality, customer satisfaction, and continuous improvement.

2) Scope

This SOP applies to all customer complaints related to medical devices, including product defects, adverse events, or performance issues. It is relevant to quality assurance, regulatory affairs, customer service, and product development teams.

3) Responsibilities

– Customer Service: Receives complaints, records initial details, and forwards them to quality assurance for investigation.
– Quality Assurance (QA): Oversees the complaint investigation, documents findings, and implements corrective and preventive actions.
– Regulatory Affairs: Submits adverse event reports to regulatory authorities when required and ensures compliance with local regulations.
– Product Development Team: Provides technical support for complaint analysis and resolution.
– Training Coordinators: Ensure relevant personnel are trained on complaint handling procedures and regulatory requirements.

4) Procedure

4.1 Receipt of Complaints
– Customer complaints can be received through various channels, including email, phone calls, online forms, or in-person reports.
– Customer service personnel record the complaint details in the Complaint Intake Form, including:
– Customer details (name, contact information, organization).
– Product details (model, serial number, batch/lot number).
– Description of the issue (defect, adverse event, or performance concern).
– Date and time of complaint receipt.

4.2 Complaint Classification
– QA reviews the complaint to classify its severity and impact:
– Critical Complaints: Issues posing significant safety risks, such as adverse events or device failures leading to injury or death.
– Major Complaints: Defects or performance issues that may impact product functionality but do not pose immediate safety risks.
– Minor Complaints: Non-conformance issues with minimal or no impact on product performance or safety.
– Document the classification in the Complaint Log.

4.3 Complaint Investigation
– Assign an investigator or investigation team based on the nature and severity of the complaint.
– Collect supporting documents, such as:
– Product usage records and maintenance logs.
– Manufacturing and testing records.
– Photographs or physical samples of the defective product.
– Conduct interviews with the complainant (if necessary) to gather additional details.
– Use root cause analysis techniques (e.g., 5 Whys, Fishbone Diagram) to identify the underlying cause of the complaint.

4.4 Implementation of Corrective and Preventive Actions (CAPA)
– Based on the investigation findings, develop corrective actions to resolve the immediate issue, such as:
– Replacing or repairing defective products.
– Issuing updated user instructions or training materials.
– Develop preventive actions to address the root cause and prevent recurrence, such as:
– Revising manufacturing processes.
– Enhancing quality control measures.
– Updating product design.
– Record all actions in the CAPA Log, including responsibilities and timelines.

4.5 Regulatory Reporting
– For complaints involving adverse events or significant safety concerns, prepare and submit required reports to regulatory authorities, such as:
– FDA (U.S.): Medical Device Reports (MDRs).
– EU: Vigilance Reports.
– Other local regulatory bodies as applicable.
– Document submission details, including report IDs, dates, and acknowledgments, in the Regulatory Reporting Log.

4.6 Communication with Customers
– QA communicates investigation outcomes and resolution actions to the complainant.
– For critical complaints, provide detailed explanations and timelines for corrective actions.
– Maintain a record of all customer communications.

4.7 Complaint Closure
– QA reviews all actions taken to ensure the complaint is resolved effectively.
– Approve closure of the complaint and update the Complaint Log.
– Archive all related records, including intake forms, investigation reports, CAPA records, and customer communications, in the document management system.

5) Abbreviations

– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions
– MDR: Medical Device Report
– FDA: Food and Drug Administration
– SOP: Standard Operating Procedure

6) Documents

– Complaint Intake Form
– Complaint Log
– Investigation Report
– CAPA Log
– Regulatory Reporting Log
– Customer Communication Records

7) Reference

– FDA CFR Title 21, Part 820.198: Complaint Files
– ISO 13485: Medical devices – Quality management systems
– EU MDR: European Medical Device Regulation

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Complaint Intake Form Template

Date	Customer Name	Product Details	Description of Complaint	Contact Information
DD/MM/YYYY	John Doe	Model: XYZ, Lot: 12345	Device malfunction during use	johndoe@example.com

Annexure 2: Complaint Log Template

Complaint ID	Date Received	Product Details	Complaint Type	Status	Resolution Date
CMP-001	DD/MM/YYYY	Model: XYZ, Lot: 12345	Critical	Resolved	DD/MM/YYYY