Complaint Investigations

Perform Complaint Investigation

Complaint Investigations document the work performed to understand the cause of a complaint. Investigators review available information, such as the Product History Review, sample evaluations, and related quality records, and document the findings. The investigation records product failures, tools used during the review, contributing factors, reporting codes, root cause, and any follow‑up actions. Investigators complete the required checklists and summarize the conclusions before the complaint moves to the next stage.

Additional Resources

ComplianceQuest

• Adding Complaint Steps for Investigations

• Updating Primary Complaint Investigation

• Creating New Complaint Investigations

• Adding Investigation Reporting Codes

• Performing Complaint Investigations

• Adding Product Defects / Failures

• Adding Associated Items

• Adding Product History Reviews

• Reopening Complaint Investigations

• Redoing Complaint Investigations

• Escalating Complaints to CAPA

• Creating New CAPAs

• Linking Existing CAPAs