Complaint Handling SOP

This procedure defines the process for receiving, documenting, evaluating, investigating, and closing customer complaints related to medical devices. It ensures timely evaluation of all complaints for reportability to regulatory authorities and that trends are analyzed to drive corrective and preventive actions.

This procedure applies to all complaints received from any source including customers, distributors, healthcare professionals, patients, and regulatory authorities. A complaint is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a medical device after it has been released for distribution.

Customer Service / Complaint Intake Personnel: Receive and log all complaints within 1 business day of receipt using the Complaint Intake Form (FRM-CH-001). Quality Engineer (Complaint Investigator): Conduct investigations, determine root cause, and assess need for CAPA. Regulatory Affairs: Perform reportability assessment within 5 calendar days of complaint receipt. File adverse event reports (MDR, MedWatch, Vigilance) within regulatory timeframes. Quality Manager: Review complaint trends, ensure timely closure, and present complaint data at Management Review. Medical Safety Officer (if applicable): Assess patient safety impact and contribute to medical risk assessments.

4.1 Complaint Receipt & Logging - All complaints must be logged in the Complaint Database within 1 business day of receipt - Information to capture: date received, complainant details, product identification (name, model, lot/serial number), description of the event, injury or risk of injury, initial complainant expectation - Assign a unique Complaint Number using format: CMP-[YYYY]-[Sequential] 4.2 Complaint Classification - Severity: Critical (death or serious injury), Major (non-serious injury or potential for harm), Minor (no injury, quality/performance issue) - Type: Safety/adverse event, product performance, labeling/packaging, delivery/logistics, service 4.3 Reportability Assessment - Regulatory Affairs performs reportability assessment within 5 calendar days - Determine if the event meets reporting criteria under: - FDA MDR (21 CFR 803): Report within 30 days (or 5 days for emergent situations) - EU Vigilance (MDR Article 87): Serious incidents reported within 15 days (or 10/2 days per severity) - Health Canada (CMDR): Report within 10/30 days depending on severity - Document the assessment rationale regardless of whether a report is filed 4.4 Investigation - Investigate all complaints unless a documented justification for non-investigation is provided and approved by the Quality Manager - Investigation includes: review of complaint details, examination of returned product (if available), review of manufacturing records (DHR), root cause analysis - Request product return for critical and major complaints - Target investigation completion: 30 days for critical, 60 days for major, 90 days for minor 4.5 CAPA Assessment - Determine if the complaint warrants a CAPA per SOP-CA-001 - Mandatory CAPA triggers: reportable adverse events, repeat complaints (same root cause), complaints indicating design deficiency 4.6 Complaint Response & Closure - Communicate findings and resolution to the complainant where appropriate - Document all investigation findings, conclusions, and actions taken - Quality Manager reviews and approves closure 4.7 Trending & Analysis - Complaint data shall be trended quarterly (at minimum) by product, complaint type, severity, and root cause - Trend analysis shall be presented at Management Review - Statistical signals or clusters shall trigger investigation or CAPA as appropriate

- Complaint Intake Form (FRM-CH-001) - Complaint Investigation Form (FRM-CH-002) - Complaint Log / Database - Reportability assessment records - Regulatory authority reports (MDR, MedWatch, Vigilance) - Complaint trend analysis reports

- ISO 13485:2016 Clause 8.2.2 Complaint Handling - FDA 21 CFR 820.198 Complaint Files - FDA 21 CFR Part 803 Medical Device Reporting - EU MDR 2017/745 Article 87 Vigilance - SOP-CA-001 CAPA Procedure