Complaint Handling Process Overview:
- Receipt and Documentation:
When a complaint is received, it is immediately logged in our Customer Complaint Register. We record key details such as product name, batch or serial number, customer information, date of receipt, and a detailed description of the issue. Complaints can be submitted by customers, distributors, end users, or regulatory bodies.
- Initial Assessment:
The Quality Assurance (QA) team performs a preliminary review to determine if the complaint is product-related and whether it potentially involves adverse events, medical device reporting (MDR), or field safety corrective actions (FSCA). If regulatory reporting is required, we follow applicable national and international guidelines, including those from the Kuwait Ministry of Health (MOH) or KUDRA.
- Investigation:
A cross-functional team is assigned to investigate the root cause of the complaint. This may involve reviewing batch records, inspecting returned products, interviewing staff, and analyzing manufacturing and inspection data. We use tools such as root cause analysis (RCA), 5 Whys, and Ishikawa diagrams where applicable.
- Risk Evaluation:
As part of ISO 13485 Certification services in Kuwait compliance, any risks associated with the complaint are evaluated and compared to existing product risk assessments. If necessary, risk files are updated in accordance with ISO 14971 (Risk Management for Medical Devices).
- Corrective and Preventive Action (CAPA):
If the complaint reveals a systemic issue, a CAPA is raised. Actions may include retraining staff, modifying procedures, improving design, or initiating a product recall. All actions are tracked and verified for effectiveness.
- Communication and Closure:
Customers are updated during the investigation process and provided with a formal response upon resolution. Complaint cases are not closed until all corrective actions are completed and verified.
Compliance and Records:
All complaint records are maintained in compliance with (Control of Records) and are retained for a period defined in our Document Control Procedure. Records are available during audits and regulatory inspections.
Continuous Improvement:
Trends and recurring issues from complaints are analyzed during Management Review Meetings to identify opportunities for product or process improvements. Metrics such as complaint frequency, resolution time, ISO 13485 Certification process in Kuwait and customer satisfaction are monitored as part of our quality objectives.