Complaint Investigation Toolkit
FDA pulls complaint files at random during inspections. Every file needs a documented MDR reportability determination. These templates make your complaint system inspection-ready.
What You Get
Complaint Investigation Procedure (21 CFR 820.198 + ISO 13485)
Complete complaint investigation SOP covering FDA 21 CFR 820.198 and ISO 13485 Section 8.2.2. Defines complaint receipt, triage, investigation scope, evaluation methodology, MDR reportability determination, and record retention. Includes decision criteria distinguishing complaints requiring investigation from those that do not, per FDA guidance.
Complaint Investigation Form and Tracking Log
Complaint initiation form capturing all required fields: complaint source, product identification, event description, patient outcome, investigation findings, root cause, corrective action, MDR determination, and closure authorization. Companion tracking log for open/closed status, investigator assignment, due dates, and overdue escalation.
MDR Reportability Decision Worksheet (21 CFR Part 803)
Step-by-step MDR reportability worksheet applying the 21 CFR Part 803 decision criteria to individual complaints. Covers the three reportability questions (death, serious injury, malfunction), the 30-day and 5-day reporting timelines, the malfunction reporting threshold, and the documentation FDA expects to see supporting a no-report determination.
Complaint Root Cause Analysis Template
Structured RCA template for complaint investigations applying 5-Why and fishbone analysis to device failures, use errors, and labeling issues. Differentiates between device design root cause, manufacturing root cause, use error, and no-fault-found determinations. Includes documentation requirements for each root cause category.
Complaint Trend Analysis and KPI Dashboard
Monthly complaint metrics template for management review: complaint volume by product, complaint rate per units sold, MDR reportability rate, investigation cycle time, root cause distribution, and complaint-to-CAPA conversion rate. Pre-built for ISO 13485 and FDA QMSR management review input requirements.
Complaint-to-CAPA Escalation Criteria Template
Decision framework for determining when a complaint investigation requires CAPA escalation. Covers frequency thresholds, severity criteria, root cause systemic indicators, MDR report triggers, and field safety corrective action considerations. Includes escalation authorization matrix and the documentation required to justify no-CAPA decisions.
Why It Works
MDR reportability documentation built in
The reportability worksheet creates a documented decision chain for every complaint — including no-report determinations. That documentation is exactly what FDA looks for in complaint files.
Escalation criteria remove guesswork
The CAPA escalation criteria template defines objective thresholds for when a complaint requires CAPA — eliminating the subjective calls that create inconsistent records and audit findings.
Trend analysis feeds management review
The KPI dashboard is pre-structured for management review inputs required by ISO 13485 and FDA QMSR — one template closes the gap between complaint data and management reporting.
From the Field
"Complaint handling is the one area where FDA investigators can walk in on any day and your system has to be ready. They pull complaint files at random. If your investigation records do not show how you reached the MDR reportability determination, you are getting a 483."
"The MDR reportability worksheet alone is worth the price. Having a documented decision chain for every no-report determination is what keeps your complaint files defensible during inspection."
FAQ
What is the difference between a complaint and a non-complaint?
Under 21 CFR 820.198, a complaint is any written, electronic, or oral communication alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance of a device. Not all complaints require formal investigation — the procedure template includes triage criteria for determining investigation scope.
How long do I have to submit an MDR report?
30 calendar days for deaths and serious injuries, 5 work days for events that require remedial action to prevent unreasonable risk of substantial harm. The MDR reportability worksheet guides you through both timelines.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use as controlled QMS documents.
Ready to get started?
6 templates. Instant access. Built for inspection-ready complaint systems.
This website and all content are for informational purposes only. Not legal or regulatory advice. Legal